Fresenius Reportedly Looking to Unload Eugin Group. Includes Boston IVF, TRIO

Sale would include the parent company according to Spanish news media and industry sources

This News Digest Is BROUGHT TO YOU BY
THE FDA CONSULTANTS, LLC

BY: RON SHINKMAN

European healthcare conglomerate Fresenius Helios is looking to sell its major fertility holding, the Eugin Group, according to a European media outlet and industry sources.

Fresenius, which is based in Germany, acquired Eugin in late 2020 for about $520 million.

“Eugin and Fresenius Helios are an excellent fit. Eugin is highly profitable and holds excellent positions in attractive country markets,” then Fresenius CEO Stephan Sturm said at the time.

Founded in 1994, the Barcelona-based Eugin is a massive global provider of fertility services. It operates 69 clinics in 11 countries on three continents and performs 45,000 cycles a year. Its footprint includes Spain, Italy, Latvia, Sweden, Colombia and Brazil. It is also a major player in the U.S. and Canada, where Eugin owns Boston IVF, Ohio Reproductive Medicine and TRIO. That latter is one of the largest fertility providers in Canada.

A potential sale of Eugin was first reported by the Spanish publication PlantaDoce. The news outlet reported that Fresenius is under pressure to divest by Elliott Investment Management, which obtained a significant stake in the conglomerate last fall and is apparently unhappy with its financial performance in recent months. Fresenius’ stock price is down about 6% from a year ago, although it has risen about 25% since Elliott bought shares in the company.

Strurm departed as CEO just before Elliott bought its stake in Fresenius. His replacement, Michael Sen, spoke of the company needing a “reset” just weeks after taking over.

“We have embarked on a top-to-bottom review of every business activity, looking at the entire corporate portfolio,” Sen said at the time. 

Fresenius is also reportedly shopping its hospitals in Colombia and Peru, according to the Colombian news outlet El Pais. The holdings are part of Fresenius’ Quirónsalud Group affiliate, which also owns hospitals in Spain.

Fresenius declined to comment about a sale of Eugin. “Please understand that as a matter of principle we do not comment on market speculation or rumors,” said company spokesperson Steffen Rinas in an email. That was the exact response Rinas gave to El Pais about the potential Quirónsalud sale.

However, along with the coverage in the Spanish media, two sources have confirmed with Inside Reproductive Health that they’ve been told that Eugin is on the market. 

“I’ve heard they’re for sale, but I don't know who is the likely buyer,” said Richard Groberg, who regularly advises businesses in the fertility sector on mergers and acquisitions.

Walt Conrad, vice president of marketing for Pinnacle Fertility, an IVF platform that has been active in dealmaking as of late, observed in an email earlier this month that he did hear of Eugin being on the market, but that he was not aware of Pinnacle pursuing a deal “at this time.”

Who might actually bid on Eugin is a major question among industry observers. Its size and geographical breadth may be hard for a potential acquirer to swallow whole.

“Eugin is a large network of IVF centers in diverse markets around the world, and finding an existing player in the space that can offer advantages to all of their markets may be very hard to do,” said Robert Goodman, vice president in charge of healthcare for New York City-based MidCap Advisors. “There are several fertility platforms that may have the ability to absorb them, but it will be a significant undertaking.”

Goodman, who was not aware Eugin was for sale, speculated about a list of potential buyers. They include Carefertility, which operates 23 clinics in England and Ireland; Inception Fertility, which includes The Prelude Network, which operates more than 80 clinics in the U.S.; and US Fertility, which acquired Ovation Fertility last month.

Goodman noted that all those companies have either solid financial backing or have recently expanded into new markets.

“The backers and senior management teams of these platforms…could be interested if the opportunity is made attractive enough,” he said.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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These 5 Deficiencies Lead to FDA Nightmare

HCLD IVF lab director comes together with reproductive health attorney  to make checklist of what she wishes she had known about what the FDA is looking for in the IVF lab. 

Download their free FDA checklist for the five most common IVF lab deficiencies before the FDA audits you.

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All external links active as of 6/29/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

FDA Issues Warning to Over 30 Fertility Centers In Last Five Years

What the FDA has been looking for in their audits

This News Digest Is Paid Sponsored Content From
THE FDA CONSULTANTS, LLC

BY: ERIN FLYNN JAY

Last year, the FDA issued a warning letter to a New York City fertility center after an FDA investigator documented significant deviations for human cells, tissues, and cellular and tissue-based products. In 2020, the FDA issued a warning letter to a California IVF fertility center after an FDA investigator found the same issue.

In 2019, the FDA ordered a San Juan, Puerto Rico clinic and its Medical Director to cease manufacturing immediately due to significant violations of FDA regulations. An FDA inspection revealed violations regarding donor eligibility determinations. According to the FDA, the clinic put patients at risk for exposure to communicable diseases, including HIV and Hepatitis.

How does the FDA audit fertility centers? According to Rijon Charne, Fertility Attorney with Sunray Fertility and Chief Legal Officer with The FDA Consultants, the FDA performs random inspections whenever they want. The inspector arrives without notice to inspect the clinic. “They go straight into your lab, they start pulling files, and they start looking at the specimens to see if any of them violate FDA regulations under the specific code.”

Sunday Crider, PhD, HCLD/ELD (ABB), Chief Scientific Officer with The FDA Consultants, said when the FDA finds an offense during a laboratory inspection, they generate a “Form 483”, which is an official documentation of deficiencies .. “The FDA will review areas of concern with the responsible person at the clinic in a debriefing session post-inspection.  The official Form 483 is then sent to the clinic within a few weeks. The laboratory will generally have 30 days to respond to the FDA on how they are going to address those deficiencies.”

Once a clinic registers with the FDA, they are subjected to routine, unannounced inspections at the Agency’s discretion. However, Crider said if serious issues are found on any laboratory inspection,, the FDA may come and inspect more frequently..  Inspection records are retained by the FDA for every registered facility.  Inspections are generally on a two year rotation and almost always unannounced.  FDA inspections are nerve-racking for clinics because of the repercussions if the FDA finds something. Charne spoke of issues of donor eligibility, one of the most common deficiencies the FDA discovers. There are specific labeling requirements for donors that might have HIV or a sexually transmitted infection (STI). Regarding donor oocytes, “those eggs have to be specifically labeled and they need to be put in a separate freezer so that there is no chance of possible cross-contamination with other eggs or other specimens that are being held in the lab.”

If the FDA finds there are egregious issues with donor screening, testing, labeling or storage  during an inspection, they issue a public warning and post it to the FDA website. The clinic then needs to address the issue with a written plan, to be approved by the FDA. Charne said the FDA will return and either pass the lab’s inspection or shut them down.

“The worst part of it all is that the warning to the clinic becomes public,” added Charne. “The notice is put out in an FDA Warning Letter and the clinic goes on the FDA warning list. Any patient (current or potential) of the IVF clinic can see the warning letter on the FDA website. As the fertility space is such a small community and reputation is everything, when people talk, it looks very bad for the clinic.”

FDA violations and warnings can be especially harmful during mergers or acquisitions, especially for private equity firms or Management Services Organizations (MSO) that may want to sell a fertility clinic in the future. An FDA violation could affect the price valuation of the entity and create pause for an insurance company to underwrite a policy for the clinic.

“An FDA violation or warning will raise questions and concerns,” said Charne. “That is why private equity companies and law firms assisting in fertility acquisitions bring on people like the FDA Consultants to do a neutral third party inspection before getting caught in are a unknown FDA violation. The worst issue that could occur is the FDA shutting you down.”

Crider said that while the FDA is only concerned about donor issues, a warning or violation from the FDA tarnishes the reputation of the entire clinic. “You don't want it made public that you do not have good patient care and are okay putting a patient at risk,” she said.

The FDA requires clinics to maintain donor records for at least 10 years.   This is to ensure traceability of donor records, such as communicable disease testing.  For instance, Crider stated, if the recipient of donor eggs or sperm contracted HIV at some point in their life after receiving the donor tissue, it would be important to have records on file to show that the source likely did not come from their anonymous donor, as they are thoroughly screened and tested as a part of becoming an eligible donor.     Proper documentation that the donor was thoroughly screened and tested would become critical should any patient care or legal issues arise. 

Bottom line: every IVF laboratory that processes, screens, stores, tests or distributes any type of donor tissue--be it egg, sperm, or embryo--must register with the FDA and follow the Federal Code 21 CFR Part 1271, guidelines they have set forth. If not, prepare for that FDA violation.

This News Digest Story is paid featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.

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These 5 Deficiencies Lead to FDA Nightmare

HCLD IVF lab director comes together with reproductive health attorney  to make checklist of what she wishes she had known about what the FDA is looking for in the IVF lab. 

Download their free FDA checklist for the five most common IVF lab deficiencies before the FDA audits you.

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All external links active as of 6/22/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Three New Fertility Network CEOs And What They Have Done In Their First Calendar Year

Francisco Lobbosco of Future Life, Beth Zoneraich of Pinnacle and Richard Jennings of US Fertility

BY: RON SHINKMAN

Since being named group CEO of FutureLife in April, Francisco Lobbosco has been visiting every clinic in the company’s network. There are 44 in all, including 16 in the Czech Republic, where FutureLife is based. Lobbosco says he is traveling two to three days a week to visit all the locations. They include company-owned sites in Slovakia, the United Kingdom, Ireland, Spain, Romania, the Netherlands and Italy, along with affiliated clinics in Finland and Estonia.

Lobbosco says in an email that the visits are part of a steep learning curve in his new job that has “allowed me to immerse myself in the unique dynamics of each clinic, gain firsthand insights into the challenges and opportunities they face, and develop a strong rapport with the dedicated teams.”

Lobbosco is one of three new CEOs named to major fertility companies in recent months. They also include Beth Zoneraich, named CEO of Florida-based Pinnacle Fertility in late March, and Richard Jennings, CEO of Maryland-based U.S. Fertility, in January.

All three companies are completely or mostly financed by venture capital firms. CVC Capital and Hartenberg Holding back FutureLife; Pinnacle is held by Webster Equity Partners and Amulet Capital backs US Fertility.

Francisco Lobbosco, FutureLife 

Of the three CEOs, Lobbosco had the most circuitous journey to the top job. An Argentinean by birth whose family relocated to Italy when he was an adolescent, Lobbosco was serving as chief operating officer for AniCura, a chain of veterinary hospitals and clinics, when he was contacted by a recruiter. Prior to AniCura, Lobbosco had been in senior positions with GrandVision and Vission Express, two European eyewear chains.

“The initial contact came as a surprise since I was content in my prior position,” Lobbosco says, but the top job resonated with him. He went through several rounds of interviews with the FutureLife board before being offered the position. He replaced Matěj Stejskal, who remains on the board of directors and is overseeing FutureLife’s mergers and acquisitions. Lobbosco relocated his family from the Netherlands to the Czech Republic for the new job.

He adds the experience in both the veterinary and vision worlds helped him with the transition.

“They provide a deep understanding of complex healthcare industries and regulatory compliance, which translate well into reproductive medicine,” he says.

Aside from visiting the various clinical sites, Lobbosco notes that the company is expanding. “We have been actively hiring more professionals to support our clinics and strengthen our team,” although he did not provide specific details on the new hires.

Beth Zoneraich, Pinnacle

Zoneraich joined Pinnacle as its chief operating officer in October 2021, after it acquired Advanced Fertility Care, the company she co-founded and served as CEO since 2005. She replaced Andrew Mintz, an executive whose primary expertise was in general medical group and hospital operations and was in the top job exactly a year. Mintz is now the CEO of a dental network.

Richard Groberg, who heads a consulting firm that works closely with companies in the fertility sector, says the changing of the guard at Pinnacle was sudden. He suggests that it likely took Zoneraich by surprise.

Zoneraich initially agreed to answer written questions, but had a change of heart after they were submitted. A spokesperson said Zoneraich was “finalizing a large partnership” and was unavailable.

Groberg says Zoneraich has been particularly aggressive regarding mergers and acquisitions since she became CEO.

“She’s made extraordinary progress in a very short period of time,” says Groberg, who represents several companies that have been in talks with Pinnacle. “I’ve had nothing but good experiences.” He adds that issues with absorbing some of Pinnacle’s acquisitions prior to Zoneraich’s elevation have also been resolved. 

Zoneraich recently worked out a deal with TMRW for Pinnacle’s frozen egg and embryo storage, according to a TMRW press release.

Richard Jennings

Jennings was eased into his new job. U.S. Fertility named him to its board of directors last September, and also announced that he would become CEO on Jan. 1. He replaced Mark Segal, who had guided U.S. Fertility’s largest practice group, Shady Grove Fertility, since the 1990s. Segal was promoted to chairman of the U.S. Fertility board. Jennings was previously CEO of Generate Life Sciences and a board member of Gallant Therapeutics. He also held the top job at California Cryobank Life Sciences and MediScan Diagnostics.

Groberg says the appointment of Jennings was due to its top leadership wanting to transition into less strenuous roles. 

Jennings and US Fertility have also been busy during his first five months at the reins. In March, the company agreed to acquire Ovation Fertility, a deal that was finalized late last month, creating a powerhouse with nearly 100 clinics and 28 laboratories. It also recently opened up its network of clinics to members of the Stork Club. And the company has also launched partnerships with two professional women soccer teams: Gotham FC and the Washington Spirit of the National Women’s Soccer League.

Jennings did not respond to a request for an interview. 

Different Jobs, Different Situations

Groberg notes that although three major players in the fertility field have changed out their leadership in just a span of four months this year, it is not an indication of greater turmoil in the sector as a whole.

“These are three jobs – and three very different situations,” he says.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health.

Amplification

Amplification from Three New Fertility Network CEOs And What They Have Done In Their First Calendar Year on 6/15/2023,

Original sentence:

Richard Groberg, who heads a consulting firm that works closely with companies in the fertility sector, says the changing of the guard at Pinnacle was sudden. He suggests that it likely took Zoneraich by surprise.

Amplification: The quote that the sentence referred to was 

"When they first bought her practice, my understanding is that she was going to have a role, but there was no intention of her being CEO, nor did she intend to be CEO, but I don't know the inner details about what happened".

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All external links active as of 6/15/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

SREI Weighs Options to Deal with Fellowship Scarcity in REI

Taking fellowship training from three years to two, corporate-academic partnerships considered primary options

BY: LISA MUNGER

There are 49 accredited fellowship programs, as of the Accreditation Council for Graduate Medical Education's most recent data from the 2021-2022 academic year. ACGME assumed accreditation responsibilities for the first year in 2016 from the American Board of Obstetrics and Gynecology; 41 REI fellowships existed. 

As first reported by Inside Reproductive Health, the University of Miami/Jackson Health System Program and the University of Washington Program received ACGME approval in fall 2022, making them the latest programs to receive approval. 

Academic Years and New Programs Accredited By ACGME

2021-2022 University of Rochester

2020-2021 None

2019-2020 SUNY Downstate Health Sciences

2018-2019 None

Before the 2018-2019 academic year, all previously ABOG-accredited programs had to apply for accreditation with ACGME. Thus, in 2016-2018 all existing were re-approved.

What’s more, the National Resident Matching Program matched 49 out of 49 open fellowship positions in 2022. There were 78 individual applicants for REI fellowship program positions for the 2021-2022 academic year in the most recent available data.

The Pipeline for New Programs

ACGME cannot estimate new programs coming in the pipeline. 

“It depends on receiving and approving new program applications,” said Susan Holub, director of communications at ACGME. 

Currently, 49 fellowship programs exist, with 175 fellows, according to ACGME. 

How to Increase REI Fellowships: Challenges

One hurdle in establishing new REI Fellowships is finding qualified faculty. REI is a specialized field; a limited number of qualified physicians can teach in fellowship programs. Another barrier is finding a suitable location for the program. REI programs require access to a large number of patients, as well as state-of-the-art facilities—all costly prospects.

Ruben Alvero, M.D., past president of SREI, professor of Obstetrics and Gynecology at Stanford Medical School and division director of Reproductive Endocrinology and Infertility at the Lucille Packard Children’s Hospital told Inside Reproductive Health there are several impediments to establishing programs and in adding fellows. 

“It's onerous to establish new programs or fellows,” he said. The biggest stumbling blocks that exist are securing financing and in terms of the paperwork and the actual application itself.” 

Alvero said the cost of adding fellows is highly variable, as is the prospect of beginning a new fellowship program. Costs vary based on the geographic area, cost of living, demographics, facilities in place, availability of private partnerships and faculty recruitment needs; thus, no amalgamate data exist as these factors are unique to each case. 

Securing Accreditation: The Process

The process of starting an REI fellowship program is complex and requires a significant investment of time and resources. The first step is to obtain accreditation from the ACGME. A five-step journey is outlined on their website. 

This process involves submitting a detailed application with information about the program's curriculum, faculty and facilities. Once accreditation is granted, the program can begin recruiting fellows.

Step 1—Locate and Read Program Requirements and FAQs

Step 2—Locate and Save Review Committee Staff Contact Information

Step 3—Gather Information Needed to Prepare the Application

• Complete the specialty-specific application, which can be found on the Program Requirements and FAQs and Applications page of the REI specialty section of the ACGME website. 

• Provide a block diagram for each year of education in the program

• All Program Letters of Agreement for participating sites with required rotations

• Policies and procedures for resident/fellow clinical and educational work hours, including policies on moonlighting

• Policy for supervision of residents and fellows

• Establish competency-based goals and objectives for one educational experience at each educational level.

• Evaluation forms for residents/fellows, faculty, program assessors

• Semi-annual, summative and final evaluation forms

• Policy for resident/fellow and faculty member well-being 

Step 4—Initiate Application to ACGME’s Accreditation Data System

Step 5—Submit the Application

• A Letter of Notification (LoN) will be sent through ADS after the Review Committee reviews the application. 

• The LoN will detail the accreditation decision and any citations or areas for Improvement issued during the review.

• It can take four to 12 months following the submission of an application to undergo a review and receive an accreditation decision from the Review Committee. 

Viable Options for Expanding Fellows

Alvero said one option under discussion is possibly shortening the fellowship term from three years to two. However, given the rigor the programs require, this may not be an appealing choice. 

Alvero’s colleague and current president of the American Society for Reproductive Medicine, Michael A. Thomas, MD, told Inside Reproductive Health that though ASRM will look to SREI for guidance, as an REI specialist himself, moving from three years to two may be untenable. 

“In a short amount of time, it’s not just learning how to get the eggs and put the embryos back, but also learned understanding the physiology, understanding and contributing to the research,” said Thomas, professor and department chair of Obstetrics and Gynecology at the University of Cincinnati College of Medicine. “From what we know from a clinical standpoint, it takes longer than six months to contribute the research necessary to advance the field.” 

Alvero said that a second option is to secure public/private investments to support academic programs financially. 

One example is private funding from Shady Grove Fertility with publicly-held Walter Reed National Military Medical Center, intended to benefit military families. 

“The program at Shady Grove has fellows from Walter Reed from the National with support through NIH [fellowship program] so that there's a collaboration there,” he said. 

Alvero said he expects more of these collaborations to develop. 

In the interim, Thomas said he hopes more fellows will mean REI specialty services will be available to a broader audience and, promisingly, with insurance coverage to increase access to more marginalized populations. 

“The problem is you can’t just expand a program; they must be good programs. You want to make sure that you have fellows that are being trained rigorously and make sure that those fellows have the opportunity to go wherever they want [rather than limited by geography near major population centers.].”

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health.

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All external links active as of 6/8/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

FTC to Fine Easy Healthcare $100K For Data Breaches Connected to Premom App

Justice Dept., Connecticut, Oregon and D.C. Attorneys General Also Take Action

By: RON SHINKMAN

The U.S. Federal Trade Commission (FTC) on May 17 proposed fining the maker of the Premom smartphone app $100,000. It is also working with the U.S. Department of Justice to obtain curbs on how it manages the highly sensitive information provided by users. Attorneys specializing in healthcare and privacy law say other reproductive health companies may soon find themselves the target of similar actions.

Premom, which was created by the Chicago-area firm Easy Healthcare, helps users get pregnant by charting their ovulation cycles. Pregnant users can also use the app to chart their pregnancies. It has been downloaded more than 1 million times by Android users, and has been reviewed more than 19,000 times by iPhone and iPad users.

The FTC also said that data gathered by the Premom app was illegally shared with third parties, among them two Chinese companies. According to a complaint the Justice Department filed against Easy Healthcare in federal court in Illinois on May 17, the companies are Umeng, a mobile app analytics firm owned by the e-commerce firm Alibaba, and Jiguang, a mobile development and data analytics company that goes by the name Aurora Mobile Ltd.

Premom also disclosed sensitive medical data to both Google and a company called AppsFlyer, which engages in data analytics. The Justice Department complaint describes the data that was shared as “identifiable health information,” a term for medical data that can be used to identify a specific individual. Such data includes names, addresses and dates of birth, among others.

Easy Healthcare, the Illinois-based firm that operates Premom, also failed to notify consumers of such disclosures, an alleged violation of the federal Health Breach Notification Rule.

“Premom broke its promises and compromised consumers’ privacy,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, in a statement. “We will vigorously enforce the Health Breach Notification Rule to defend consumer's health data from exploitation.” 

In conjunction with the Justice Department, the FTC has also proposed that Easy Healthcare be barred from sharing users’ personal health data for advertising or marketing purposes, obtain their consent before sharing that data for any other purpose, and must also tell consumers how their personal data is being used. Although a federal judge is required to approve this order, a recent court filing states that Easy Healthcare is not contesting any of the proposed actions.

Michelle Merola, a partner with the New York-based law firm of Hodgson Russ and a former U.S. Assistant Attorney in Washington, D.C., called the FTC/Justice Department action a “shot over the bow to developers and vendors of health apps,” and that similar steps against other app makers will be forthcoming.

Cynthia Khoo, a senior associate at the Center on Privacy and Technology at the Georgetown University school of law, agreed that enforcement is being ratcheted up.

“The FTC has become overwhelmingly cognizant of the harms of not just privacy…but the social, psychological and economic harms of technology companies engaging in these types of privacy practices,” she said.

Andrea Frey, San Francisco-based senior counsel and co-chair of the digital health practice of the law firm Hooper Lundy Bookman, added that regulators have a target-rich environment for enforcement.

“My guess is that there are certainly a lot of companies (that are) intentionally or unintentionally, gathering information through tracking technologies that are potentially in violation of FTC or HIPAA rules,” she said.

Khoo said that last year’s decision by the U.S. Supreme Court to strike down Roe v. Wade has made the feds and some state attorneys general particularly sensitive to the legal risks posed by not protecting personal information regarding the ovulation and pregnancy cycles of individual women. That has been further compounded by the growth of healthcare apps in recent years and gaps in the Health Insurance Portability and Accountability Act (HIPAA) that do not completely cover businesses that work with consumers but not with healthcare providers.

Khoo noted that the federal health breach notification rule – which requires companies managing breaches of healthcare information impacting 500 or more individuals report the incident to the general public – has been on the books for 14 years. However, it has only been used twice to punish violators – both times in 2023.

“This suggests to me that they are willing to use it again going forward,” Khoo said. She added that was further reinforced by the FTC recently introducing new guidelines for how businesses collect and manage biometric data.

In addition to the federal fine, Premom’s parent company, Illinois-based Easy Healthcare, has also agreed to pay an additional $100,000 in fines to attorneys general in Connecticut, Oregon and the District of Columbia for state-level violations.

“District residents who used the Premom app were entitled to have their locations and devices kept confidential, but Easy Healthcare shared that private information with third parties without notice or consent, putting users at risk,” said D.C. Attorney General Brian Schwalb in a statement.

In a statement issued in mid-May, Easy Healthcare said “our agreement with the FTC is not an admission of any wrongdoing. Rather, it is a settlement to avoid the time and expense of litigation and enables us to put this matter behind us and focus on you, our users. Rest assured that we do not, and will not, ever sell any information about users’ health to third parties, nor do we share it for advertising purposes.” Easy Healthcare’s statement ended with a pitch for a new line of supplements for those trying to conceive and an upcoming line of prenatal vitamins; a segue Merola and Khoo said was extremely odd for a company responding to a federal regulatory action.

“Odds are that the FTC takes issue with Easy Healthcare’s response and that it is removed from the website before the settlement is finalized,” Merola said.

An Easy Healthcare spokesperson would only refer back to the posted statement when asked to comment about the specifics of the settlement and the product pitches.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health.

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All external links active as of 6/1/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Chart Inc reserves >$300 million to settle suits from 2018 PFC Tank Failure, sues insurance provider, contractor

The Latest: More Than 550 Legal Actions from 2018 Pacific Fertility Tank Failure

By: RON SHINKMAN

March 4, 2018 was a day that shook U.S. reproductive medicine in a way few others have.

That Sunday, a seal in a cryogenic tank at the Pacific Fertility Center in San Francisco failed. That caused the liquid nitrogen inside to vaporize and the tank’s temperature to rise above the optimal temperature for storing eggs and embryos. Its contents – some 4,000 eggs and embryos belonging to approximately 600 clients – were soon ruined.

The first lawsuit over the failure was filed just nine days after the crack was discovered – and only two days after Pacific Fertility had informed its clients of the issue, court records show. That first suit was filed by a client known only as a female San Francisco resident who is referred to by the initials “S.M.” Virtually all of the subsequent suits were filed by plaintiffs who did not reveal their identities. Pacific and its parent Prelude Fertility were accused of negligence in that first suit for failing to monitor the liquid nitrogen tanks more closely.

That initial legal volley was a mere preview of a flood of litigation in both state and federal court, as well as in private arbitrations – more than 550 cases in total, according to court records. 

The legal battles have also embroiled collateral parties. Chart Industries, the Georgia-based manufacturer of the tank that cracked, was added to the initial lawsuits after they were filed. According to court records, the failed tank was manufactured by a Chart subsidiary company in 2012. Chart’s warranty guaranteed the tank would perform without issue for at least a decade. Altogether, that company is trying to resolve some 217 state and federal lawsuits in total, according to a report the company filed in January with the Securities and Exchange Commission. 

Chart also disclosed to the SEC that it is “in ongoing discussions in an effort to establish a settlement framework for the various lawsuits” and that it would be in place as early as the first quarter of 2023. Chart also said it has set aside $305.6 million to fund settlements, or about $1.4 million per case. However, records indicate that only one case in federal court has been settled. Chart did not respond to a query seeking comment.

Chart also filed suit against Navigators Specialty Insurance Co. in February 2019, claiming it refused to provide a high enough payout to cover some costs for its legal counsel. Chart dropped that suit last March and agreed not to refile it, also suggesting a settlement was reached. 

Law Firms Involved

Chart has been represented by Zenere Cowden and Stoddard of Santa Clara, Calif.; the Chicago law firm Swanson Martin & Bell; and until May 2020, Morgan Lewis & Bockius in Los Angeles. Pacific Fertility has been represented by San Francisco-based law firm Morrison & Foerster and another Northern California firm, Galloway, Lucchese, Everson & Picchi, court records show. 

More than four-dozen plaintiffs in the state lawsuits are represented by Lieff Cabraser Heimann & Bernstein in San Francisco. Another San Francisco firm, Walkup, Melodia, Kelly & Schoenberger, represents 33 state case plaintiffs. Five other firms represent between two and four plaintiffs apiece.

Among the federal cases, where multiple law firms are often representing a single client, the Gibbs Law Group of Oakland, Calif. is representing 39 plaintiffs, while Girard Sharp of San Francisco is representing 36. Lieff Cabraser is representing eight clients, while New Orleans-based Peiffer Wolf Carr Kane & Conway is representing seven. Two other firms are representing a handful of other plaintiffs. Pennsylvania-based Sauder Schelkopf is representing three plaintiffs, while the Clarkson Law Firm in Malibu is representing a single plaintiff jointly with Gibbs, Girard Sharp and Lieff Cabraser.

Cases Consolidated

The litigation surrounding the tank failure has been so large and complex “due to the sheer size and how many people were affected” by the incident, said Rob Marcereau, an attorney and founder of the Fertility Law Group, a firm in Irvine, Calif. that often represents fertility clients in malpractice suits. And while a large number of the 600 clients were California residents, many were not. That led to litigation in both state and federal court.

Eventually, the number of lawsuits became so voluminous – more than 60 filed in state court alone – that those were mostly consolidated into a single case. The state cases were settled in late 2021 for an undisclosed sum, court records show. Most of the nearly 150 federal suits have yet to be resolved.

Pacific Fertility Benefited From Contract Terms, >340 Cases Arbitrated

Pacific Fertility eventually scored legal victories. Most of its contracts with its clients contained an arbitration clause. In March 2019, it obtained a court ruling forcing most of the state lawsuits into arbitration. The process is intended to work much more swiftly – and less expensively – than a lawsuit. A retired judge usually hears the case, and their rulings are binding and almost always private. Court records indicate that Pacific Fertility has arbitrated more than 340 cases to date.

However, Chart – which did not have direct contracts with the affected clients – could not move its cases to arbitration. Along with the state lawsuits, there have been at least 140 cases filed in federal court against Chart, records show. 

To give breadth and scope to the federal litigation, a case involving just five Pacific Fertility clients contained more than 1,000 docket entries – individual motions and other documents pertinent to the case. Nevertheless, the lawsuit moved fairly quickly for a federal civil case, which can take five years or more to get to trial. In June 2021, a jury awarded the five clients $14.975 million. The jury also decided that Chart and its manufacturing defect was 90% responsible for the damages. Pacific Fertility was found 10% liable.

“This is an important and emotional ending for our clients who have been through so much pain and hardship since the 2018 tank failure,” said Amy Zeman, a partner with the Gibbs Law Group, after the verdict was delivered.

It didn’t end there, however. Chart and Pacific appealed the verdict. Nearly two years into the appellate process and just days before oral arguments were scheduled in front of the U.S. Ninth Circuit Court of Appeals, the plaintiffs agreed to settle the case last March for an undisclosed sum, the Washington Post reported. The Gibbs attorney who handles media inquiries on the case did not respond to a request seeking comment.

Chart Inc Files Suits of Its Own Against Associates

The episode also embroiled Chart in litigation with its insurers. It was sued in June 2022 by its primary liability insurer, Starr Indemnity & Liability. The carrier asked the court to declare that Chart’s claim for excess liability insurance payouts of up to $231.9 million should not be honored. Chart quickly countersued Starr, accusing it of engaging in a “classic insurance company preemptive strike” to try and get out of paying a claim.  Starr and Chart dismissed their lawsuits in March and April, respectively, suggesting a settlement was reached. 

And even as Chart is moving to settle all the lawsuits against it, it is also suing other parties it believes contributed to the tank failure.

Chart filed a lawsuit in federal court in Ohio against electronics manufacturer Extron, accusing it of supplying a faulty control panel that did not provide accurate pressure and temperature levels for the tank, which it claims contributed to its failure. It is seeking reimbursement from Extron for all liability payments it must make connected to the tank failure.

Whether Chart will prevail in that case remains to be seen. In the 2021 federal trial, the jury found that Chart was aware of potential defects in the tank’s electronics but took no steps to repair or recall them. 

An Extron executive did not respond to a request seeking comment.

Litigators Call For More Regulation

Despite all the ramifications from this single tank failure, the incident did not lead to tighter regulations for egg and embryo storage at either the state or federal levels, according to Marcereau.

“There should be basic, uniform requirements in place for cryogenic storage of embryos or eggs, but sadly there aren’t,” he said. “Until state or federal laws mandate it, many fertility clinics will continue to cut corners – even in the wake of this litigation.”

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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All external links active as of 5/25/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

How Spring Fertility Became a Bi-Coastal IVF Player in Seven Years

It started with 13 employees in 2016. Now it has 300.

BY: RON SHINKMAN

In just seven years, Spring Fertility grew from a partnership of two physicians to a bicoastal business with seven clinics and hundreds of employees.

The San Francisco-based Spring Fertility’s two co-founders –

Nam Tran, M.D. and Peter Klatsky, M.D. were its only doctors when the practice opened in 2016. Despite their geographical separation – Klatsky began working from Spring’s offices in midtown New York City in 2019 while Tran’s office remained in the Bay Area – they have been extremely successful in continuing to grow their practice. Spring Fertility started with 13 employees just seven years ago. It just hit the 300-employee mark, according to Vice President of Marketing Meghan Dwyer.

Tran and Klatsky met during their residencies at the University of California at San Francisco in the mid-aughts and became fast friends, often sharing hotel rooms at academic conferences.

“We both wanted to make a difference in the field. We thought that the best way to do that initially was being in academic medicine,” Klatsky recalls of that time. Tran was unavailable for an interview.

But sometime after Tran and Klatsky joined the faculties at UCSF and the Albert Einstein College of Medicine in New York City, respectively, they realized they were on the outside looking in.

“Once we were out of our fellowships and in academic roles, we noticed that the big changes in our field were coming from the private sector, and that’s where the best fertility centers were as well,” Klatsky says. “And when it came to patient experience and what we would want if we were patients, there were so many things we wanted to do differently. And at those larger academic medical centers, we didn’t have the flexibility to do that.

“We went through every step and thought about what was necessary and what would bother us if we were patients," Klatsky adds. "And we asked how can we achieve the same or better outcomes and minimize (patient) discomfort and annoyance.”

That included offering evening and weekend consultations with patients, extended hours for monitoring and other ways to streamline the care experience, according to Klatsky.

The pair have combined this focus on patient needs with innovation – Spring Fertility developed the first process to ensure that eggs and embryos weren’t exposed to air during the harvesting and fertilization cycles – with growth. Last year, Spring Fertility performed 4,500 egg retrievals, either for immediate use in IVF or to freeze for a future procedure. That’s up from 3,400 in 2021 and just 2,000 cycles in 2020. Spring Fertility opened up new labs and clinics in the East Bay and Silicon Valley in early 2021 that helps explain the increase, according to Dwyer.

Currently, Spring Fertility operates seven clinics, six in the Bay Area (including two in San Francisco) and one in New York City. It also operates labs at its sites in New York, its clinic in the Pacific Heights neighborhood of San Francisco, Oakland, and Sunnyvale, Calif. Tran travels to each clinic on a monthly basis in his role as Spring Fertility’s chief medical officer, according to Klatsky.

Spring Fertility currently has 13 physicians on staff, of which 10 are board certified in reproductive endocrinology and infertility. The other three doctors are in the process of obtaining their certifications, Dwyer says. Spring also has four nurse practitioners and 22 embryologists on staff.

A basic IVF package at Spring Fertility runs $15,900 at its New York clinic, and about $100 less at its California locations. A more advanced package of services that includes ICSI and embryo transfer costs $18,700 in New York and $19,600 in California. The American Society of Reproductive Medicine estimates that the average IVF cycle in the U.S. costs about $12,400, but it can run significantly higher in urban areas.

Newsweek recently ranked Spring Fertility 23rd of the 100 best reproductive medicine clinics in the U.S. It’s ranked higher on the list than a number of fertility clinics operated by academic medical centers, including the University of Pennsylvania and UCLA.

However, Spring Fertility’s future is likely to include working with medical academia. Klatsky says plans are in the works to open a clinic in a new “major metropolitan area” in 2024 that would include a “strong academic affiliation,” although he declined to disclose any other details.

Such a collaboration “will allow us to further promote both education and research, which are things we’ve really been touching on” at Spring Fertility, Klatsky says.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health.

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External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

20 Years After Toft Report, Most Fertility Centers Have Yet to Automate

90% OF Fertility Centers Still Doing Manual Witnessing, Exec Says

BY: NATASHA SPENCER-JOLLIFFE

A boom in demand for fertility treatment means more embryologists are turning to management to invest and implement processes and systems to modernize fertility care through implementing automated technologies.

“As the UK regulator of fertility treatments, we expect clinics to have robust systems in place to ensure eggs, sperm, and embryos are safely stored for patients,” Rachel Cutting, Embryologist and Director of Compliance & Information at the Human Fertilisation & Embryology Authority (HFEA) told Inside Reproductive Health.  

Long-standing, antiquated, manual tools have traditionally been the process of choice, despite the risks associated with being prone to human error and inconsistencies that subsequently compromise the standard of care. 

However, some fertility managers and embryologists are changing their approaches to embrace automation and ensure they continue to deliver a standard of care to patients that provide cell transparency and safety. For example, managers want to automate the tracking and storage of frozen eggs and embryos.

Swapping antiquated for automated

Regarding IVF laboratories, the main problem with automation and artificial intelligence (AI) is “a lack of standardization”, Danilo Cimadomo, Science and Research Manager of GeneraLife IVF, told Inside Reproductive Health. 

While there is a “very good concordance and reliability”, among people working within the same IVF center, the same is not true across different centers. “When it comes to the procedures as well as to the assessments that we make, there is not very much concordance between embryologists,” says Cimadomo.

Global managers are exploring automation in response to the estimated over 300 million anticipated to be born from IVF by 2100. Automation enables them to continue to provide cell transparency and safety – while ensuring compliance. 

“Advances in technology have meant greater success for patients using cryopreserved eggs and embryos and therefore, more patients are storing them for treatment or to preserve their fertility,” Cutting shares.  

“Even now, around more than 90% of fertility centers around the world are still not using any form of electronic witnessing,” says Matt Pettit, Chief Scientific Officer at IMT International, responsible for developing and implementing Matcher, an electronic witnessing and quality management system. Many fertility centers still handwrite Petri dishes, test tubes, and items.

“It is still a problem within the industry, still a change that needs to take place,” says Pettit. Serious adverse events are still happening, he continues. There are still reported incidents, year after year, where incorrect sample handling means babies are born to the wrong parents or embryos have been discarded.

As a result, today, we are seeing “a paradigm shift towards the use of electronic systems”, Pettit notes, continuing, “we are seeing a big wave now where there has been a very rapid 
adoption of electronic systems”. “Covid has expedited that realization,” Pettit adds.

Despite the release of the Toft Report almost two decades ago, implementing new automation-led processes and systems to support the fertility sector has been slow to adopt. Yet, increasingly, managers are conducting audits to recognize risks in manual systems and seeking tech to reduce the risks of these existing systems. 

Managers are exploring tech with specific features to improve digital tracking, robotic automation, and 24/7 remote monitoring to take the burden off of manual staff procedures and overcome identified risks. They see the benefits of automating embryo tracking and storage to reduce errors and ensure their infrastructure is robust to meet patient demand. 

Advancing tech encourages acceptance and adoption

Electronic tech innovations are entering the reproductive health space and finding acceptance in the wider healthcare sphere, helping to foster trust and uptake among managers of fertility centers and donor banks. 

With a focus on automation, transparency, and standardization, the tech connects to the company’s software, which assigns a unique identifier for each specimen and captures real-time information. It aims to reduce most manual inputs that risk failure in the existing cryogenic process.  

“Systems such as electronic witnessing systems and other automated technologies are becoming more commonly used, and clinics will use these to ensure security and safety is optimized,” Cutting details. 

Electronic witnessing systems are currently “the easiest and most effective way” for fertility centers to embrace automation and AI, Cimadomo says, describing it as “one of the most impactful automation tools” he has seen implemented in his clinic.

Fertility centers and donor bank managers are implementing automated patient tracking information to reduce errors, like Matcher IVF electronic witnessing technology. Described as a double-checking system, IMT’s Matcher tech is a barcode-based electronic witnessing, labeling, scheduling, traceability, and data insights system.

Teaming up with academia to provide education on the potential of automation in IVF is a priority for fertility researchers, clinicians, and embryologists. The electronic witnessing system’s upgrade is in response to an increasing number of treatments that require labeling, identifying, selecting, and matching a specific embryo for a predetermined fate, such as biopsy, transfer, cryopreservation, or disposal.

In an MIT Technology Review, researchers found almost three-quarters of health professionals (72%) show significant interest in implementing AI in their work. Embracing the technology appears more likely as professionals perceive it to be an extension rather than an extinction of professional capacity in health care. Research has found that the number of AI publications in medicine and health has also grown, with 61.6% of the papers dated between 2008 and 2017.

Encouraging change through embracing convenience 

Sharing information between databases is a powerful tool. It enables centers to cross-reference data across different systems and use that to effectively help drive further efficiencies, mitigate error, and for root cause analysis. 

Describing this realization as “probably the tipping point”, Pettit continues, it means people will “very rapidly adopt these types of technologies because it is more about the collection of data and that knowledge is power than it is about the prospective error prevention”, says Pettit. 

“The real advantage of automation will be for smaller centers that do not get the same experience as centers that are managing large volumes in terms of procedures,” says Cimadomo. However, cost-effectiveness remains a barrier to implementation. “That perhaps is the reason why we still do not have any automatic tool in the IVF laboratory, you need an investment in terms of money that should be justified from the volumes you have,” Cimadomo adds.

The use of technology and its specific applications varies from lab to lab. Research labs, for example, may require automatic timing and sanitation, whereas a lab engaging in clinical activities may not need this data. Therefore, the technology and the strategies need to be framed for the country, the regulations applied, the population of patients, and the specific center’s needs. 

“There is not really any effective automatic tool in the lab, it is still very manual the activity that we do, but that doesn't mean that there's no research,” says Cimadomo.

Automation

However, researchers have found that the answer does not have to lie in automation. Scientists developed an embryo tracking system (ETS) with six control steps to see if it increased the safety, efficacy, and scalability of massively parallel sequencing-based preimplantation genetic testing (PGT). The researchers found that the ETS approach precluded error-prone manual checks and did not impact preimplantation embryos’ genomic landscape.

Yet, increasingly, the benefits of automation in assisted reproduction technology (ART) are being recognized. Researchers of the review, Paving the Way for the Future of Infertility Treatment, said in August 2022 that implementing novel technologies to automate ART “will soon become a reality”. 

On 13th May 2023, the Italian Society of Embryologists Reproduction (SIERR) is dedicating its 2023 event to understanding the role of AI in IVF, demonstrating the growing interest in the possibilities of automation in fertility. Understanding how AI applications in embryology and reproductive medicine work and defining the state of the art is the goal of the 2023 event.

“We thought it was about time to talk about AI because there are lots of companies commercializing tools and are approaching us in the laboratories, and there are people who do not know what AI is”, says Cimadomo, a member of the Italian Society of Embryologists at Production and Research.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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All external links active as of 5/11/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Fertility Clinic M&A Halved In First Four Months of 2023, Compared to 2022. May be Accelerating Again

Buying Prices of REI Practices Down In Multiples of EBITDA, According to Sector Advisors

BY: RON SHINKMAN

M&A activity in the fertility sector was sluggish during the first quarter of 2023 compared to the same period last year, although momentum toward bigger deals is building in the second quarter.

According to Irving Levin & Associates, a Connecticut-based firm that closely tracks M&A in the healthcare space, there have been eight transactions involving fertility practices or platforms so far in 2023. That compares to 16 through the first four months of 2022 and 40 for all of last year, according to Irving Levin Managing Editor Ben Swett. 

The slowdown in healthcare M&A – specifically the acquisition of physician practices, which include fertility clinics – began in the second half of 2022, according to a report by Bain & Co.

Among the factors behind the slowdown: Borrowing costs have quintupled since the start of 2021. The Federal Funds Rate – the benchmark for setting interest on loans – rose from below 1% at the start of 2021 to 4.83% as of the end of April. .

Richard Groberg, the managing member of RSG Advisors in Las Vegas, noted that buyers were wary toward the end of last year into the beginning of 2023.

Buyers for fertility practices and related businesses “were nervous,” Groberg said. “They were nervous about interest rates. They were nervous about inflation, and they were nervous about whether (those factors) would affect demand for fertility treatment.”

However, some of those concerns appear to have dissipated according to Groberg, who noted that his current pipeline is “very busy.”

The year 2022 was record-breaking for deals involving physician practices, which includes fertility clinics. According to Irving Levin, there were 608 such transactions last year, up from 457 in 2021, a 33% increase. In related healthcare services – which includes fertility storage businesses – there were 574 deals last year, compared to 477 in 2021. 

Among the deals that were publicly announced: 

• Ivy Fertility acquired Fertility Associates of Memphis (announced February 14)

• INVO Bioscience acquired the Wisconsin Fertility Institute (announced March 20)

• Maven Clinic also acquired the digital health company Naytal, but that was with the intent of building business in the United Kingdom, not the U.S. (announced March 21)

Meanwhile, there are stronger tailwinds toward dealmaking at the start of the second quarter. Among the deals announced or closed in recent weeks include: 

• The planned acquisition of Morgan Stanley-owned Ovation Fertility by US Fertility (announced on April 3); 

• CCRM Fertility’s acquisition of the New Hope Center for Reproductive Medicine (announced April 18); 

• Ivy Fertility’s acquisition of Virginia Fertility and IVF (announced April 17).

Executives at several major fertility companies: First Fertility, Pinnacle Fertility, Inception Fertility and The Fertility Partners, either declined comment on current acquisitions and trends, or did not respond to a request seeking comment.

While M&A activity appears to be perking up, both Groberg and Hayden Rosenthal, an associate with Intrepid Investment Bankers in Los Angeles, say that the multiples of earnings before interest, taxes, depreciation and amortization (EBITDA) to determine purchase prices have gone down.

“In the first or second quarter of last year, (fertility practice multiples) were at 12 or 13. Now it’s 10, or maybe 11,” Groberg said.

According to Rosenthal, multiples continue to be fairly strong, but they are off from their late 2021 highs. He said they are currently running in the high single digits for one or two physician practices, and the low to mid-teens for larger operations.

Swett noted that there are few multiples publicly available on transactions. Irving Levin was only able to obtain clear numbers on INVO’s purchase of Wisconsin Fertility Institute. The three-physician practice reported 2022 revenue of $5.5 million, and EBITDA of $1.9 million, according to Irving Levin. The $10 million sale price was based on an EBITDA multiple of 5.2. The payments will be made in equal payments over four years, with the first payment in cash. The sellers have the option of taking future payments in INVO stock, according to Irving Levin data.

“Times are a little tougher, and people are a little more hesitant, particularly investors or private equity-backed platforms,” Rosenthal said. “Some of them are still doing acquisitions for sure, but some people have been a bit more conservative and are taking a ‘wait and see’ approach.”

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health.

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External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

CNY Fertility triples IVF cycles since 2017 with no investor funding

Independently owned fertility center reports more than 7,300 IVF cycles in 2022

BY: RON SHINKMAN

Robert Kiltz, M.D., is a Los Angeles native who mostly studied and trained within California. Buffeted by the civil unrest and major earthquake that struck the city in the first half of the 1990s, he decided to move his family to the Finger Lakes region of New York. combined, the population of the region’s biggest cities, Rochester and Syracuse, have less than one-tenth the population of L.A. However, the region was still welcoming enough newborns to support Kiltz’s obstetrics practice.

Back in the mid-1990s, Kiltz received about $2,000 for a delivery. “When I started (offering) IVF, that sounded like a reasonable price,” he said. “I don’t have to deliver a baby at two in the morning and it’s a lot less work.”

Since CNY Fertility’s founding in 1997, Kiltz’s original single-site practice has steadily grown. It now operates nine clinics in upstate New York, Georgia, Pennsylvania, Colorado and Florida. That includes clinics that opened in Colorado Springs last year and Sarasota, Fla. this year. Companywide, CNY Fertility employs nearly 500 workers. That includes 15 physicians and osteopaths and 33 practitioners in total. Eight of the doctors are board certified in reproductive endocrinology and fertility (REI), with a ninth currently obtaining their certification, according to Kiltz.

CNY Fertility’s IVF cycle numbers have grown rapidly in recent years. It performed more than 7,300 cycles last year, triple the 2,429 performed in 2017. Just a decade ago in 2013, it performed fewer than 1,800.

Kiltz is the sole owner of CNY Fertility, and he has financed its expansion primarily through loans, he said. The company has accepted no venture capital or private equity investments.

Despite possessing the singular ambition to steadily grow CNY Fertility over the years into a national player, Kiltz said he didn’t do it to become rich.

“I went into medicine to help people and to make a reasonable living doing it. But I never did it for the money,” he said.

Low Price Points, Direct-to-patient Marketing

One of the keys to CNY’s growth has been its low price point, which it has maintained over the decades and is prominently advertised on the homepage of its website. That $2,000 IVF cycle in 1997 is now $4,275, or $4,720 including remote monitoring. Add a frozen transfer, remote monitoring, and a one-year embryo storage and the cost is just over $10,000. By comparison, the National Conference of State Legislatures estimates that the average IVF cycle costs between $12,000 and $17,000, not including medication. CNY Fertility also promotes travel programs where patients can undergo bloodwork and cycle monitoring by a local doctor before traveling to one of its clinics for a procedure. 

Kiltz said that prices are kept low through aggressive negotiations with all its suppliers, including medications. About 60% of CNY Fertility’s patients pay cash, with the rest paying through insurance, in line with recent data about payer mix in the reproductive medicine space.

Aside from aggressive pricing, CNY Fertility is also quite active on social media. Kiltz’s nephew, William Kiltz, directs its marketing and business development full-time.

CNY Fertility’s TikTok page, for example, has 55,000 followers. A few individual fertility doctors have similar or higher numbers, but the handful of fertility clinics using TikTok do not come close to that, based on searches on the TikTok application. CNY Fertility’s feed includes dozens of videos on subjects ranging from the egg retrieval process, TSH levels and employee and patient testimonials. Most are produced and edited and often include multiple camera angles and graphical overlays.

Kiltz, sporting a short black t-shirt, jeans and a thick silver chain, narrated one video on immunologic issues and IVF that has drawn thousands of views.

CNY has also trademarked various slogans for marketing purposes, including “Making Priceless Affordable.” Another slogan, “Miracles by CNY” was used to brand clinic merchandise, including a baby bag that made the “Today Show’s” list of top baby bags in 2021. 

Meanwhile, Kiltz is focused on continuing to grow CNY Fertility. He plans to add about 50 employees over the next year, including three to five new physicians and practitioners for the New York, Colorado and Florida sites. Plans are also on the drawing board to expand into Orlando, Fla., Texas and Kiltz’s old stomping grounds of Southern California. And Kiltz suggested his expansion strategy may soon no longer be a solo venture.

“If we’re going to open up three to five new centers in the next couple of years, then we’re certainly up to other joint partners to help CNY Fertility grow,” he said.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Compared: Progyny, Kindbody, Carrot, and Maven as fertility benefit coverage increases 33% in two years

BY: RON SHINKMAN

According to a recently released survey by the International Foundation of Employee Benefit Plans, 40% of U.S. employers offered some form of fertility coverage last year. That’s up dramatically from 2020, when only 30% offered fertility benefits – a 33% jump in just two years. More employers now offer fertility benefits than financial assistance or paid leave for an adoption.

“We’ve been seeing family-friendly benefits like fertility coverage continue to grow as part of the larger trend of expanding work-life integration policies to be more inclusive of all employees,” said IFEBP Vice President of Content Julie Stich.  “Fertility benefits hold a high value by talent no matter their gender identity or relationship status. Providing these benefits helps nurture overall happiness and well-being.”

However, coverage can differ dramatically between employers. For example, among companies that offer fertility benefits, less than 35% cover egg harvesting or freezing services, and less than 45% cover fertility services that are not related to in vitro fertilization (IVF). There are numerous other variations along those lines.

Larger employers – those with more than a few hundred workers – often self-fund their employee medical costs and use a third-party administrator to handle claims (typically a subsidiary of a large health insurer). They may also outsource their benefits to major fertility platforms such as Progyny, Carrot or others in what are known as benefit “carveouts.” In those cases, the fertility firms usually act as a one-stop shop, offering benefits in line with the limits of coverage set by the employer, managing claims and collecting payments. Here is a breakdown of the four largest platforms:

Kindbody
Founded: 2018
Headquarters: New York City
Valuation: $1.8 billion
Locations: 27 Clinics in 21 cities in 15 states and the District of Columbia, Including New York City, Los Angeles, Atlanta and Houston
Senior Management: Gina Bartasi, Founder and Chairwoman; Angeline Beltsos, M.D., CEO, clinical operations; Annbeth Eschbach, CEO, corporate operations; Greg Poulos, President; Taryn Branca, Chief Revenue Officer
Major Employer Clients: Walmart, Lyft, Activision

Walmart, the nation’s largest company with more than 2.3 million employees, entered into a fertility benefits carveout with Kindbody last September.

“Our partnership with Walmart signals that fertility benefits have joined medical, dental, and vision as standard workplace benefits for leading employers,” said Bartasi when the deal was announced.

The pact with Walmart is an indication of how all-in-one fertility companies have grown in just a few years. Kindbody was founded only five years ago. That it was able to raise more than $281 million, according to Crunchbase, helped turbocharge its growth.

Although Kindbody does not post specifics regarding its benefits packages for employers, a recent webinar conducted by its senior management indicated that companies should curate a benefit that takes into account projected utilization by employees, medical and drug costs per cycle, and sources of direct and indirect savings.

Progyny
Founded: 2008
Headquarters: New York City
Enterprise Value: $2.7 billion
Coverage: It networks with 650 clinics and 950 physicians and clinicians
Leadership: David Schlanger, Executive Chairman; Peter Anevski, CEO; Michael Sturmer, President; Mark Livingston, Chief Financial Officer; Jennifer Bealer, General Counsel
Major Employer Clients: Detroit Pistons (NBA Team and its employees); Children’s Hospital Association

Progyny is the elder statesman of the group with its founding in 2008. Its 2022 revenue of nearly $787 million was 57% higher than 2021’s. It works with 370 corporate clients nationwide representing some 5.4 million employees, although the company has been mostly tight-lipped about its clientele. Unlike the other companies, it does not post the names and logos of its major corporate clients on its website. And the employer pacts it has announced – with an NBA team and a healthcare trade association – likely only cover a few hundred employees apiece.

Progyny and Maven were the only companies to respond to a request seeking comment for this article prior to publication. According to Progyny spokesperson Alexis Ford, the company assigns each patient an advocate “to better understand their Progyny benefit, their deductible, co-insurance, etc., since this is dependent on each employer’s health plan. The patient care advocate also provides unlimited education and is the patient’s go-to resource during the entire journey.”

Ford provided a single detail regarding Progyny’s carveouts: 90% of employers working with the company also offer their workers ProgynyRX, which includes medication coverage, next-day deliveries and access to support from pharmacists and other medication clinicians.

According to Holly Hutchison, co-owner of Reproductive Health Center in Tucson, Ariz, a carveout firm such as Progyny offers a “smart cycle.” That is specifically an egg retrieval and transfer along with anesthesia, laboratory and monitoring services. “Employers choose how many cycles they want to include in coverage, from one to five cycles,” she said.

According to Progyny’s website, an IVF procedure where one embryo is implanted and rest are tested and/or frozen represents three-quarters of a cycle. An intrauterine insemination represents one-quarter of a cycle. Egg freezing is half a cycle. A reciprocal IVF procedure involving a same-sex couple is 1.25 cycles, while a surrogacy IVF is 1.5 cycles.

Carrot Fertility
Founded: 2016
Headquarters: Menlo, Park, Calif.
Valuation: $500 million (estimated)
Locations: NA
Leadership: Tammy Sun, Founder and CEO; Ashima Ahmad, M.D., Co-Founder and Chief Medical Officer; Tim Kelly, Chief Commercial Officer; Brooke Quinn, Chief Customer Officer
Major Employer Clients: Zoom; Clif Bar; Lucid Motors (luxury electric automaker)

Carrot Fertility has raised more than $114 million since its founding, according to Crunchbase. Its $500 million valuation is an estimate made by Inside Reproductive Health based on available revenue data and multipliers for the healthcare industry.

Carrot Fertility did not respond to a request seeking comment about their company’s differentiation in the fertility space.

Maven Clinic
Headquarters: New York City
Founded: 2014
Valuation: $1.35 billion
Locations: NA
Leadership: Katherine Ryder, Founder and CEO; Kalliope White, Chief of Staff
Major Employer Clients: Snap, Bumble, Sanofi, Booz Allen Hamilton

A Maven spokesperson said the company offers “typical” carveouts, but did not provide specifics. 

Maven has raised more than $292 million since its founding, according to Crunchbase.

Carveouts Provide More Guidance Than Traditional Insurance Companies

Despite the dramatic increase in fertility benefits from employers, there are still no standardized guidelines mandated by nationwide governmental bodies such as the U.S. Department of Health and Human Services. As a result, fertility benefits and carveout structures vary from company to company.

“The coverage will vary depending on the employer and which fertility benefit management group they choose,” said Hutchison. State mandates on fertility benefits also play a role, she added. Hutchison estimated that about 45% of its patients currently have some form of insurance coverage. “They all have co-payments and deductibles and out of pocket amounts that apply prior to the coverage kicking in,” she added.

David Stern, the chief executive officer of Boston IVF – which operates 18 fertility clinics in six states – observed that most employees receive minimal guidance regarding their fertility benefits.

“You might have fertility coverage and IVF coverage, but the employee is told by their insurer ‘you’ve got to figure out yourself,’” he said. That puts enrollees at risk of using up their benefits on unneeded testing and procedures before they even start IVF, Stern added.

By contrast, carveouts can provide direction to health plan enrollees. According to Stern, one of the most important parts of a carveout is that fertility platform companies can provide care managers “who will talk to you about what the process is and what it looks like.” Boston IVF is a network provider for several major fertility benefits companies , including Progyny, Maven, Carrot and Stork Club Fertility, according to Stern.
 

Controlling Unexpected Costs

Stern noted that many platforms also emphasize “centers of excellence” models where they only refer patients to clinics with the highest standards and outcomes. This not only helps with success rates, but can also protect the employer, which may rely on rigorous standards to avoid multiple births. A triplet birth, even if all are healthy, can cost a self-insured company more than seven times the cost of a single birth, Stern said. As a result, he observed that many carveout arrangements specify only one embryo transfer at a time may be attempted for an IVF or similar procedure. Currently, about 95% of Boston IVF’s procedures are comprised of only a single transfer, according to Stern.

Whether employers offer carveouts or not, most coverage Stern sees from companies is minimal.

“You can go to a doctor and you can be seen by a specialist, but they don’t pay for medication or treatment,” he said.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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Number of REI Fellowship programs since ACGME’s takeover from ABOG

BY: LISA MUNGER

If REI fellowships and physicians with this expertise are limited, there are several consequences, some of which can be seen in evaluating patient care today. Without enough fellowship programs, qualified REI specialists may be unable to care for patients with infertility and other reproductive health issues. Without enough fellowship programs, there may be reduced research on infertility and other reproductive health issues, limiting progress in the field, according to the NIH.

Escalating Need

Rachel Weinerman, M.D. and REI specialist, credited as a nationally-recognized educator in the field, said REI fellowships and specialists are needed now more than ever. REI services demand has experienced a precipitous uptick in recent years, even as the number of fellowships haven’t increased properly to meet the demand. 

Increased coverage for IVF among employer-sponsored insurance and more states requiring coverage accounts for part of the equation. 

The International Foundation of Employee Benefit Plans has tracked fertility benefits over the past since 2016. According to their most recent survey in 2022, 40% of overall U.S. employers  currently offer fertility benefits (an increase from 30% in 2020).

• 28% cover fertility medications (8% covered in 2016, 14% in 2018, 24% in 2020)

• 30% cover in vitro fertilization (IVF) treatments (13% in 2016, 17% in 2018, 24% in 2020)

• 16% cover genetic testing to determine infertility issues (11% in 2018, 12% in 2020)

• 17% cover non-IVF fertility treatments (6% in 2016, 11% in 2018, 11% in 2020)

“People are accessing IVF services for fertility and fertility preservation, " Weinerman said. “There is a much wider population of people accessing services, including members of the LGBTQ community, who are increasingly seeking IVF services.”

REI Fellowships

There are 49 accredited fellowship programs, as of the Accreditation Council for Graduate Medical Education most recent data from the full 2021-2022 academic year. The National Resident Matching Program’s (NRMP)’s April 2023 The Match report says that there were 41 REI Fellowship programs in 2022. ReportingWhen ACGME assumed accreditation responsibilities for the first year in 2016 from the American Board of Obstetrics and Gynecology; 41 REI fellowships existed.

The University of Miami/Jackson Health System Program and the University of Washington Program received ACGME approval in September 2022, making them the latest programs to receive approval. 

The University of Miami/Jackson Health System Program and the University of Washington Program received ACGME accreditation in September 2022, making them the latest programs to get the nod. 

ACGME cannot estimate new programs coming in the pipeline. 

“It depends on receiving and approving new program applications,” said Susan Holub, director of communications at ACGME. 

The National Resident Matching Program matched 49 out of 49 open fellowship positions in 2022.There were 78 individual applicants for REI fellowship program positions for the 2021-2022 academic year in the most recent available data.

Creating an REI Fellowship: Obstacles

Potential programs must meet the ACGME requirements for the REI specialty and the Common Program Requirements to be accredited. 

The organization is solely responsible for accrediting new programs, said Susan Holub, vice president of communications for ACGME. 

Obstacles are inherent in beginning an REI program, as doing so requires significant resources, expertise and infrastructure. 

Securing funding to developing and sustaining a fellowship program can be difficult, Weinerman said. 

Besides the dollars required to pay staff, upstart also needs to include the resources for educational resources and materials, equipment and technology, according to the American Society for Reproductive Medicine. 

Programs must undergo accreditation by ACGME, which is sometimes a time-consuming and complex process. Further, new programs require many resources, including access to clinical facilities (reproductive surgery spaces, labs for testing and access to assisted reproductive technologies like IVF and IUI. 

Since ACGME took over accreditation from the American Board of Obstetrics and Gynecology in 2016, guidelines for establishing a new fellowship are more stringent and often more complex, which often translates into cost in actual dollars and time. 

“There are very specific guidelines and an intense application process. There's the review, so establishing a new program can take up to a year,” she said.

A Field, Underserved

While training obstetricians and gynecologists in a private setting can provide valuable experience in diagnosing and managing REI issues, it’s not necessarily a sufficient substitute for an REI fellowship, said Ruth Lathi, M.D., program director of the REI Fellowship at Stanford Health Care. 

“This requires access to complex patients and advanced specialists, which are rarely encountered in private clinics,” she said. “While many providers do not care for all aspects of reproductive life, this knowledge is used in managing complex patients with infertility.” 

Nonetheless, she said REI fellowships are needed to further the industry. 

“Without sufficient REI fellowships, there may not be a sufficient pipeline of providers and research to serve the future men, women and people who require reproductive care.”

Weinerman concurred. 

“We have a lot more use of advanced practice providers like NPs, PAs and general OBGYNs to fill those roles because of demands, she said. “There are a lot of practices that have very long waitlist practices because it’s hard to hire REIs … That may change overall the field provides patient care.”

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U.S. Fertility to Acquire Ovation Fertility

BY: RON SHINKMAN

U.S. Fertility, which bills itself as the nation’s largest physician practice management platform in the fertility space, is acquiring Ovation Fertility, the companies announced on Tuesday.

The Los Angeles-based U.S. Fertility works closely with 14 major medical practices in 11 states, along with an additional practice in Chile. It provides healthcare IT and business information services, facilities and operations management and fertility treatment financing programs, among others.

The Nashville, Tenn.-based Ovation operates a network of 21 laboratories in 11 states that perform fertility-related services, including IVF, genetic testing and egg and embryo storage. A significant number of its laboratories are concentrated in the Southeast and Midwest.

Both companies are relatively youthful and have close ties to venture capital firms. U.S. Fertility was founded less than three years ago when Amulet Capital and Shady Grove Fertility joined forces to create a platform-specific company.

Ovation was founded in 2015. It is owned by Morgan Stanley Capital Partners with an additional investment from WindRose Health Investors.

Although a joint statement issued by the two companies described the transaction as a merger, Morgan Stanley Capital Partners described the deal as a sale of Ovation to U.S. Fertility. It noted that Harris Williams acted as financial advisor to Ovation, while DLA Piper advised Morgan Stanley Capital Partners on legal issues.

Terms of the deal were not disclosed. Executives with both companies did not immediately respond to requests seeking comment.

“By creating one of the leading fertility networks in the U.S., we can utilize shared best practices to enhance the patient experience, provide outstanding care, and deliver improved research and innovation to the fertility industry. Collectively, the company will provide a platform for growth and expansion into new geographies and additional life sciences verticals,” said U.S. Fertility CEO Richard Jennings in a statement.

The companies said they expect the deal to close sometime during this quarter, subject to regulatory approval.

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Fight for Families: RESOLVE’s 2023 Initiatives in a post Roe world

This News Digest Is Donated Sponsored Content From RESOLVE

BY: MELANIE KALMAR

When the Supreme Court overturned Roe v. Wade last year, one organization renewed its focus on access to care for patients battling infertility.

Since 1974, RESOLVE: The National Infertility Association  has provided education, advocacy and emotional support to people nationwide who are trying to build families. The 501c3 is funded by individuals, corporations, fertility clinics, and individual professionals/experts in the field. 

A majority of the work RESOLVE does involves ensuring patients have access to emotional support and all family building options, no matter their zip code. This work includes, —support groups, federal and state advocacy, a program to encourage employers to include IVF coverage in benefits packages, public awareness campaigns and patient education, explained Barbara Collura, CEO of RESOLVE.

In FY 2022, RESOLVE helped 1.4 million people gain new or improved family building benefits through its access to care initiatives. According to Collura, the non-profit’s three big initiatives for 2023 include: protecting access to IVF services, opening access to it in California, Minnesota, Oregon and Washington State (four states that don’t have IVF insurance mandates) and increasing emotional support by returning to in-person support groups. RESOLVE offers peer-led support groups in 30 states and Washington, D.C. (42 in-person; 78 virtual; and 31 professionally led).

Protecting access

In response to the Supreme Court overturning Roe v. Wade, a move that could restrict access to IVF and people’s rights over their embryos, RESOLVE launched a new campaign: Fight for Families. Its goal is to amplify the non-profit’s existing state advocacy work and protect access to care.  

“What’s different now is the stakes are so much higher,” Collura said. “We felt we needed a louder voice and brought in PR support.” RESOLVE recently hired New York-based Fenton Communications to work with IVF patients on how to succinctly tell their stories to the media, to change minds and influence public policy.

Increasing access

Sharing stories of people who face barriers to building their family is so important in RESOLVE’s work, especially the Fight For Families campaign and when it comes to increasing access to IVF insurance through state laws,, Collura said. RESOLVE sees even more of an opportunity to increase access to care in California, Minnesota, Oregon and Washington State because after Roe v. Wade was overturned, legislators from those four states announced reproductive rights of women are protected in their regions, yet  those states don’t have an insurance mandate for IVF to back it up, Collura explained. She went on to say that this state advocacy work largely happens because of a strong coalition of other non-profits and corporate partners that work together. 

She said a robust insurance mandate would include coverage of at least two cycles of IVF, medication, unlimited frozen embryo transfers and fertility preservations (insurance coverage to preserve sperm, egg or embryo of patients experiencing Iatrogenic Infertility; infertility caused by medical interventions like chemotherapy, surgery or other medications someone facing Cancer treatments may undergo).

It’s critically important for people in those states to know what’s going on and speak with legislators,” Collura explained. “RESOLVE can show up and advocate but if constituents, the people that vote these lawmakers into office, don’t show up it doesn’t move our issues forward. “If legislators are hearing from their constituents about how important it is, it changes their mind and gets them to support our issues.”

She said RESOLVE has put coalitions to work made up of doctors, patient advocates, attorneys, grassroots influencers and bill sponsors and hired a team of paid lobbyists to help advance legislation they introduced in those state capitols.

Mental health matters

The third initiative is restarting and reinvigorating in-person support groups across the country that were virtual during the pandemic. “We believe your mental health and ability to take care of yourself enhances and directly correlates to your ability to stay in medical treatment,” Collura said. “Connecting with others, finding a sense of community and taking care of yourself is vitally important to everyone as they go through this journey.”

Introducing federal legislation

With the overturning of Roe v. Wade, access to IVF was not federally protected. RESOLVE is hopeful that the Right to Build Families act that was introduced at the end of last year will be reintroduced this year. It aims to reintroduce to Congress the Right to Build Families Act that was introduced at the end of last year. “It would create a new law at the federal level that says people have a right to access IVF, medical professionals have a right to offer that service and people have a right over their embryos,” Collura said. “We’d love to see it in federal law, then states wouldn’t need to pass their own laws restricting access.”

On April 25, RESOLVE and the American Society for Reproductive Medicine (ASRM) will host a federal advocacy day, an opportunity for people to join RESOLVE and ASRM to advocate on a federal level. Participation is free.

“We provide training and an opportunity to tell you what to say, what the issues are, why these issues are important,” Collure explained. “We help people develop their own story and make it very bite size and succinct so that it will hit on the really important points members of congress need to hear.”

Meetings between participants, senators and state representatives are virtual and last 15 to 20 minutes. Most conversations actually take place with legislators’ staff who relay the messages.

“So many members of congress don’t know about all these issues,” Collura said. “This is our chance to tell them what’s important to us.”

This News Digest Story is donated featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.

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Silicon Valley Bank’s Ties to The Fertility Sector

BY: RON SHINKMAN

Silicon Valley Bank (SVB) played a role in providing financing to companies in the fertility business. However, the impact of its recent failure on the sector appears to be minimal for now.

The Santa Clara, Calif.-based SVB failed on March 10, after its heavy investments in U.S. bonds were sunk by rising interest rates and inflation, eventually triggering a liquidity crisis and then a run on deposits. Its holdings are currently being managed by the Federal Deposit Insurance Corp. 

FDIC has promised to make all depositors whole. And all lines of credit have been transferred to a stopgap facility called the Silicon Valley Bridge Bank, the FDIC said.  

The bank, which was founded in 1983, had extensive involvement with the biotech industry, which is at the core of providing in vitro fertilization and other fertility services. SVB was involved in more than 250 investments with biotech and healthcare firms, according to data from Crunchbase.

“Silicon Valley Bank was generally focused on the tech space. For the most part, the folks in (the fertility space) are not quite like that,” said Robert Goodman, vice president of healthcare at MidCap Advisors, a New York City-based investment banking firm focusing on companies with annual revenue up to $250 million. However, Goodman noted that SVB was involved with some of the companies offering an all-in-one platform of fertility services.

SVB’s biggest investment in a fertility firm, that Inside Reproductive Health found, occurred in August 2021, when it was part of a consortium providing $75 million in Series C funding to Carrot Fertility, the Menlo Park, Calif. firm that provides services to health plans, self-funded employers and other entities, including major firms such as Slack and Peloton. Executives from Carrot did not respond to requests seeking comment about their financial future.

The bank also played a role in financing Progyny, a New York-based firm that like Carrot also offers fertility benefits to employer groups and other entities. It had a line of credit with SVB that was at least $15 million, according to a February 2022 report by the Australian financial information service News Bites. A Progyny spokesperson declined to comment.

SVB also played a role in securing financing for Oma Fertility. Last June, SVB provided the firm $8.5 million in credit. The announcement of the financing coincided with the startup’s unveiling of Oma Sperm InSight, a service guide with artificial intelligence that assists embryologists in identifying “the most promising sperm cell to pair with an egg in IVF,” the company said at the time. Oma was founded in 2020.

Along with the debt facility, Oma has raised an additional $29 million in series A funding. Oma executives declined to comment about its relationship with SVB and how it might impact the sector.

For now, the demise of SVB appears to have left a minimal footprint on the fertility sector. Goodman noted that the platform companies such as Carrot and Progyny are “pretty strong” financially and were not overly reliant on lines of credit or other bank services to keep their operations going. 

Goodman also believes that SVB’s failure had virtually no impact on smaller practices offering financing services to patients. He added that patient finance is typically the realm of bigger financial institutions, such as Barclays Bank and Wells Fargo Bank, as well as credit card firms such as Visa.

“I’d be very surprised” if such financial services took a hit, Goodman said.

Executives from Oma Fertility declined to comment on the security of the company’s financial future.

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KindBody raises $100M debt investment from Perceptive Advisors

BY: ERIKA RILEY

KindBody recently announced a $100 million debt investment from the life sciences division of investing firm, Perceptive Advisors, which puts its total debt-equity at $290 million. With a valuation of $1.8 billion following its last equity round (Series C), the company is poised to go public – something that founder Gina Bartasi says they plan to do in 2023 according to Fierce Health Care.

“Our focus is on profitable growth and achieving both EBITDA positive and cash flow positive this year. We believe both are essential for a successful IPO,” said Bartasi in an email to Inside Reproductive Health.

KindBody is a multi-channel fertility clinic network that also provides fertility benefits for employers. Bartasi shared that about half of KindBody’s revenue comes from employers and about 30% comes from its managed care service line. The remaining 20% of revenue comes from direct access of services.

This new raise also pushes KindBody’s total funding well over competitors in the fertility benefits space, such as Carrot, with a total $114.2M in funding, according to Crunchbase. Progyny raised a total $115.5M before their initial public offering, according to Crunchbase, and their market capitalization is now $3.06 billion according to Google Finance. 

Its 2022 acquisition of Vios Fertility Institute, which operated clinics in Illinois, Michigan, Missouri, Oregon, Washington, and Wisconsin, doubled KindBody’s number of brick-and-mortar clinics to a grand total of 31. With this new $100M investment, the company plans to open 10 more clinics in underserved areas, KindBody shared in a press release. 

“We’re prioritizing opening clinics in ‘fertility deserts,’ or underserved markets that are often outside major metropolitan areas or lack significant competition, that have a high need and long wait times to see fertility doctors,” Bartasi said.

In 2023, KindBody plans to open clinics in Seattle, Brooklyn, Philadelphia, and Miami, said Bartasi, who previously founded fertility benefits company Progyny. 

Vios was one of three companies KindBody acquired in 2022. In June, it acquired genetics testing company Phosphorus Labs and combined it with its KindLabs division. Then, in August, KindBody acquired the Chicago-based surrogacy agency Alternative Reproductive Resources, combining it with its KindEOS division.

These acquisitions position KindBody to be an end-to-end solution for fertility services. The company already offers fertility benefits to employers in addition to clinical care both in-person and virtually. Now, the company can offer genetic testing and surrogacy as well. 

An investor-executive in the fertility space, who did not wish to be named, said in an interview that companies are currently having trouble profiting off of genetics testing due to its oversaturation in the market.

“There's overcapacity in the number of sequencers out there. And that means that drives down the price of what you can charge for those tests. So it's most likely a loss-making genetics company that they are carrying there,” the investor-executive said.

While surrogacy can be a bit more profitable, it is also subject to legal and ethical changes that can happen overnight, the source said. 

According to Bartasi, KindBody is also using the $100M loan to “sharpen our operations and make strategic acquisitions to increase access to care.” The company is looking to acquire both “virtual and fertility” companies that can help to expand KindBody’s access, Bartsai said.

Last year, KindBody also added 42 new employer clients, including Walmart, bringing its grand total to 112. 

On the clinical side, KindBody employs 34 reproductive endocrinologists and 52 embryologists. The company’s spa-like practices aim to appeal to millennial and Gen Z patient-consumers who don’t want their healthcare to appear sterile; the waiting rooms are called “lobbies”.
“There are not many interesting assets [in reproductive medicine] with strong branding,” the investor-executive said. “And KindBody has done branding fantastically in the market.”

Perceptive Advisors has invested in KindBody previously during its Series C funding round. The New York-based firm specializes in life science and biotech companies. KindBody is currently the only fertility company located on its website’s list of investments.

Corrections and Amplifications:

Correction: 3/9/23 News Digest Article titled Natera revenue over $800 million, net loss almost $600 million for 2022 by Natasha Spencer. Natera's 2022 net loss was actually $547.8 million, which means that rounding up to "almost $600 million" is inaccurate.

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Natera revenue over $800 million, net loss almost $600 million for 2022

BY: NATASHA SPENCER

On 28th February 2023, the US clinical genetic testing company released its full-year financial results for 2022, which include information on milestones achieved in 2022 and early 2023 and its financial statements. 

Net loss increase

Natera’s net loss increased to over half a billion dollars, reaching $547.8 million for the full year in 2022, compared to a net loss of $471.7 million in 2021 and 229.7 million in 2020. On the newly-released earnings call, a spokesperson for Natera told Inside Reproductive Health: “The company reiterated its goal of hitting a cash flow breakeven quarter in 2024.”

Despite these losses, Natera reported cash reserves, cash equivalents, short-term investments and restricted cash totaling approximately $898.4 million at the end of 2022, compared to $914.5 million at the end of 2021. 

As of 31st December 2022, the company had a total outstanding debt balance of $362 million. The amount comprises $80.4 million including accrued interest from its credit line with investment bank, UBS, along with a gross outstanding balance of $287.5 million under its seven-year convertible senior notes, which it received in April 2020. 

Total revenue projections

In 2023, Natera’s total revenue guidance is between $980 million- $1 billion. If Natera reaches this projected revenue, it is expected to reduce cash burn—the rate a company loses money—by approximately $150 million in 2023. 

“Our guidance for 2023 reflects our expectations for robust top-line growth as we reduce operating expenses and continue to position the company for ongoing success,” said Natera’s CEO, Steve Chapman. The company’s increased operating expenses were primarily due to growing its headcount, it reports, to support new product offerings.

Natera’s total operating expenses increased by 16.7% in 2022 year-on-year, amid its changing product portfolio, increased labor, and overhead costs. In 2023, Natera will focus on lowering these total operating expenses to achieve its projected targets.

The company anticipates its 2023 gross margin to be approximately 41% to 44% of revenues. Natera’s selling, general and administrative costs are estimated to reach approximately $510-$540 million in 2023; research and development (R&D) costs are projected at $325-$345 million, and net cash consumption is expected to be between $300-$325 million.

Revenue is up, gross profit margin is down

Speaking to Inside Reproductive Health, Natera provided information on the company’s revenue breakdown. Natera generated total revenues over the last three years of $820.2 million in 2022, $625.5 million in 2021, and $391.0 million in 2020.

The company’s gross profit equaled $364.0 million in 2022, $307.1 million in 2021, and $187.4 million in 2020, representing a gross margin of 44.4%, 49.1%, and 48%, respectively. While Natera’s gross revenue and gross profit are up, the company’s gross margin has dropped by 4.7% year-on-year.  

In 2022, medical device provider for women’s healthcare, Cooper Surgical, also saw a drop in its gross margin, decreasing from 67% in the fiscal year 2021 to 65% in 2022. The company stated that this was driven mainly by currency. 

It was also a similar story at science and technology company Merck, which saw its gross margin decline from 72.0% in 2021 to 70.6% in 2022. Merck said this decrease is primarily due to higher amortization of intangible assets, along with increased sales of the oral antiviral medicine Lagevrio and revenue from third-party manufacturing arrangements, both of which have lower gross margins.

Natera cited its changing product mix, increased labor, and overhead costs as the primary reasons behind its lower margins in 2022. Volume growth and customer support drove these, as well as one-time revenue of £28.6 million recognized from its Qiagen arrangement in 2021. Natera saw a year-over-year volume improvement of 31.6% in 2022, the company’s spokesperson shares.

No fertility services breakdown

When asked, Natera was unable to detail how much of the revenue and net income comes from fertility-related services. “We don’t break out revenues or other financials by product,” Natera’s spokesperson confirmed. 

Currently, the company’s fertility-related product portfolio includes Spectrum, a preimplantation genetic test, Anora, a miscarriage test, and Horizon, a carrier screening test. 

New board member 

Natera announced that Ruth E. Williams-Brinkley is joining its board of directors, growing its total board members to ten, effective in the position from 2nd March 2023.

As the current president of Kaiser Permanente Health Plan of the Mid-Atlantic States (KPMAS), a position Williams-Brinkley will continue to hold, the healthcare executive oversees the company’s care delivery and health plan operations.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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After End of Ferring License Deal, INVO Bioscience Moves to Acquire Fertility Practices

BY: RON SHINKMAN

In a bid to gain traction with its intravaginal device for IVF patients, INVO Bioscience has modified its business strategy to focus on acquiring freestanding fertility practices.

For the first nine months of 2022, INVO reported a loss of $8.1 million on revenue of $544,000. By contrast, the company lost $6.8 million on revenue of $1.1 million during the first nine months of 2021.

INVO has had to refocus its business strategy after a distribution deal with Ferring Pharmaceuticals ended in late 2021. Ferring had issues convincing physicians at busy practices to bring its products on board, INVO Chief Executive Officer, Steve Shum, said in an interview with Inside Reproductive Health.

“For a medical practice operator that is generally running at 100% of capacity or close to it, the idea of bringing in a completely new treatment methodology leads to the question ‘why? Why do it if nothing is broken?’” Shum said.

Nevertheless, soon after the Ferring pact began in 2019, it immediately became one of INVO’s leading sources of revenue. In the last year of the agreement, $3.6 million of INVO’s $4.1 million in revenue came from Ferring’s licensing fees. 

By comparison, INVO reported revenue of just $544,054 for the first nine months of 2022. Nearly $395,000 of that revenue came from INVO’s branded clinics in Georgia, Alabama and Monterrey, Mexico, which are operated in joint venture with existing fertility practices. Less than $150,000 was derived from direct product sales. 

“We see quite a few smaller practices that have one to two or maybe three physician operators, and we think that's the right sort of size practice for us to entertain potential acquisitions,” Shum said. 

The Sarasota, Fla.-based INVO is close to completing its first acquisition, which involves what Shum described as a “great practice” in an area of the U.S. he declined to disclose. 

“It’s been around for quite a while, it does good business and it’s nicely profitable,” Shum said. “It has a good reputation in the area, which is important. So, we’re excited about it.” He later added that he hoped to announce specifics of the acquisition when the company releases 2022 year-end earnings, likely sometime next month.

Shum discussed the new strategy during the company’s third-quarter earnings call in November, and suggested there may be as many 100 clinics nationwide with annual revenue of $1.5 million to $6 million that could be purchase targets.

John Heerdink, managing partner of Vista Partners, a San Francisco-based investment management firm, noted during the earnings call that “If you tucked in one, two or three of these (practices), you would reach breakeven (or) profitability very quickly.”

A Ferring spokesperson did not respond to a request seeking comment on the agreement’s end. Shum said that the company looked for similar distribution deals with other firms, but that there has not been any success as of yet.

Shum noted that the cash-pay policies of many fertility practices and the INVO product may be at odds. According to INVO, the average cycle with its product runs $5,000 to $8,000, versus $12,000 to $15,000 for a traditional round of IVF, although both have similar chances for success. Although the lower cost may be attractive to clients, selling it to clinicians who rely almost exclusively on cash-paying patients bred a fear they may “cannibalize” their own revenue streams, Shum said.

By acquiring its own practices, INVO is able to provide its products to patients directly. Shum noted INVO would also provide administrative and other forms of support to the practices it intends to acquire. It plans to keep the practicing physicians and other staff in place.

INVO has plans to open as many as 20 joint venture clinics in the U.S., with plans to open new sites in Tampa and Kansas City soon. It is also offering its products in Malaysia and Spain, with plans pending to enter the Chinese and Indonesian markets.

Shum did not immediately respond to a follow up request to describe how the acquisition strategy will be funded. Shum noted that the company has identified and executed a letter of intent for specific funding to close the acquisition, but has not released any other details.

INVO has raised $1.025 million since late 2022 for general business purposes, according to recent filings with the Securities and Exchange Commission. That came from the issuance of $500,000 in debentures, $275,000 in unsecured convertible notes and even $250,000 chipped in by Shum and Andrea Goran, the company’s chief financial officer, along with the latter’s colleagues. 

Regardless, the practice acquisitions will be a linchpin of INVO’s business moving forward. “We’re definitely going to work to try to find additional acquisitions this year and beyond, so it will become an ongoing part of our strategy,” Shum said. “But I would say right now we have a very intense focus on completing this first (transaction).”

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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All external links active as of 3/2/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Profit Down for 11 of 12 Publicly Traded Fertility Companies

This News Digest Brought to You by
BUNDL

BY: RACHEL LELAND

At least 12 publicly traded companies have multi-million dollar divisions, or their entire corporate focus, in the reproductive health space. 

The companies have different fiscal years. Some ended their 2022 fiscal year last summer. Most will not until the end of March 2023. In their most recent quarterly or annual reports, only one company, Jinxin Fertility Group which owns HRC Fertility, reported a gain in net profit. Inside Reproductive Health indicates the reporting periods below.

Jinxin Fertility Group
According to Jinxin Fertility Group’s half-year earnings report, the company experienced a 27.8% increase in gross profit, jumping from ¥363.2 million in June 2021 to ¥464.3 million the same month in 2022. In the same period, the company’s total revenue climbed from ¥859.3 million to ¥1.1 billion, a jump of 32.5%. The Group’s net profit bumped from ¥162.6 million to ¥187.6 million, a 15.4% climb. Jinxin Fertility Group is listed on The Stock Exchange of Hong Kong Limited. 

Femasys
Femasys’ third-quarter report shows that the company’s gross sales jumped 24.7% from $105,403 to $131,451 from Q320, largely due to the increase in U.S. FemVue sales. The report flagged the company’s YoY revenue up 28.89% from $269,580 to $347,460. Their income statement reports an $8.5 million net loss for the first three fiscal quarters of 2022. Femasys is listed on the NASDAQ.

Cryoport 
According to Cryoport’s third-quarter report, revenue from the company’s reproductive medicine  increased to $7.6 million, a gain of 15% or $1.0 million compared to the same period in 2021. The report noted that the increase was driven by strong demand for the company’s CryoStork solutions as well as new international fertility clinic partnerships. YoY net loss attributable to common stockholders was $33.9 million, or $0.69 per share, for the nine-month period ending in September 2022. Cryoport is listed on the NASDAQ.

Hamilton Thorne 
According to Hamilton Thorne’s third-quarter report, YoY gross profit increased a total of 11.8% from $18.2 to $20.4 million. Year over year sales increased 14% to $41.8 million. Hamilton Thorne’s net income dropped 41.8% from $1.6 million to $930,000. Hamilton Thorne is publicly traded on the Toronto Venture Exchange.

Monash IVF
Monash IVF’s group revenue grew 4.7% from AU$183.6 million to AU$192.3 million. 26,22236,200 Their net profit for fiscal year 2022, which ended June 30 of the same year, decreased from 2021’s AU$36.2 million to $26.2 million, a drop of 27.6%. Monash IVF is publicly traded on the Australian Securities Exchange. 

Natera
According to Natera’s third-quarter report, gross profit for the third quarter in 2022 and 2021 were $94.1 million and $76.7 million, respectively, representing a gross margin of 44.7% and 48.5%, respectively. The company’s total revenue climbed from $452.4 million in 2021 to $602.9 million, a 33.2% increase. Natera reported a net loss for the third quarter of 2022 of $121.5 million, or ($1.25) per diluted share, compared to a net loss of $151.3 million, or ($1.63) per diluted share, for the same period in 2021.

EMD Serono
Merck KGaA is publicly traded on the Frankfurt Stock Exchange and the Xetra Stock Exchange.In the United States and Canada, Merck operates as EMD Serono in the healthcare business. According to Merck’s third quarter report, fertility sales grew 6.2% from €1.003 billion to €1.066 billion. The company’s healthcare specific income loss was substantial, dropping to € –133 million from € 129 million in 2021.

Organon
According to Organon’s third quarter report, the company’s gross profit in 2022 of $991 million was close to last year’s gross profit of $986 million. Total net revenues were $1,537 million for the third quarter of 2022, a decrease of 4% as-reported and an increase of 3% excluding the impact of foreign currency, compared with the third quarter of 2021. Net income from continuing operations for the third quarter of 2022 was $227 million, or $0.89 per diluted share, compared with $323 million, or $1.27 per diluted share, in the third quarter of 2021. According to the report, Follistim AQ (follitropin beta injection), increased 2% ex-FX in the third quarter of 2022, and ganirelix acetate injection increased 52% ex-FX. Organon is publicly traded on the New York Stock Exchange. 

INVO Bioscience 
According to INVO Bioscience’s third-quarter earnings report, revenue decreased by more than 87% following the termination of the company’s license with Ferring Pharmaceuticals on January 31, 2022. Gross profit for the YoY third quarter also dropped by 36% from $198,456 to $126,205. In the third quarter, INVO had a net loss of $2.5 million. INVO Bioscience is listed on the NASDAQ.

Cooper Surgical
In its fourth quarterly report, CooperSurgical, a subsidiary of CooperCompanies, saw revenue up 35% to $277.1 million. YoY gross profit for the entire CooperCompanies climbed from $1.95 billion to $2.14 billion, 9.4%. All in all, CooperCompanies’ net income fell by 86.9% from $2.94 billion to $385 million. Cooper Companies is traded on the New York Stock Exchange. 

Myovant Sciences
In its third-quarter earnings report, Myovant Sciences showed its cumulative total revenue for 2022 reached $321.5 million surpassing the previous year’s total of $173.4 million by 85%. Net loss for the Q3 2022 was $57.6 million compared to $63.4 million for the same period a year ago. Myovant Sciences is traded on the New York Stock Exchange. 

Progyny
In its third-quarter report, Progyny, reported a 53% year-over-year growth increase to $572.5 million from $373 million. The company’s gross profit was $122.8 million, an increase of 41% from the $87 million reported in 2021. Finally, net income was $26.9 million, a decrease of 46.8% from last year’s $50.6 million. Progyny is listed on the NASDAQ.

Pete Anevski, Chief Executive Officer at Progyny attributes the biggest driver of demand for fertility benefits to need and increased interest among millennials, the largest demographic in today’s workforce.

“Traditional insurance plans attempt to control the cost of care by restricting utilization with dollar maximums, step therapies, prior authorizations, and treatment exclusions. Their approach results in low live-birth rates and high-cost, high-risk pregnancies and multiple births, which negatively impact employers and their members,” Anevski said. 

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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IVF Center loses >$300,000 from 20 lost patients

This formula calculates the economic value of a fertility center’s patient retention by using your SART data and IVF prices. Email Courtney from BUNDL to get your fertility center’s  patient retention valuation calculated for free.

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All external links active as of 2/23/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Program Prevents IVF Patient Drop Out. 100% Retention Through Shared Risk

This News Digest Brought to You by
BUNDL

BY: MELANIE KALMAR

After an initial IVF cycle fails, money and emotions can become a complicated mix for patients without insurance or those who exhausted their benefits.

Disappointed, they might switch to another clinic, especially in markets saturated with competition. But starting over is a mistake. Each cycle gives doctors clinical information that informs how they approach the next one, in order to have a chance at success. By eliminating that step, patients risk wasting time and resources.

Still, it happens. They may even take a break from IVF or use the money for something else and potentially miss out on becoming parents. According to the National Library of Medicine financial burden is the top reason 62.5% of couples drop out of IVF treatment. 

BUNDL, an innovative shared risk program, removes financial concerns from the process. Patients pay for two or three IVF cycles upfront at a discount—a full suite of services—and never see another bill again. Most importantly, doctors can automatically move to the next cycle and do what they need to do to help couples start families.

“Statistically, one IVF cycle isn’t enough for patients faced with an infertility diagnosis,” explained Cheryl Campbell, director of operations at BUNDL. “We’re not a lender or financial institution. But we’re helping on the financial piece.”

The program provides the patient with a good experience while giving the practice a chance to retain that patient who might otherwise drop-off. “BUNDL is driving 100% retention,” Campbell said. “Patients want to take off that pressure upfront.”

If a patient has services remaining after a loss, they will pick up right where they left off, Campbell explained. If they don’t and the program ends unsuccessfully, they can reup and try again.

“The risk for BUNDL is you may use more services than we collected for; the risk for the patient is they may leave services on the table,” Campbell explained. “But those funds go back into the program, to help it grow.”

BUNDL is an extension of a participating clinic’s financial counseling center. Doctors refer patients based on their medical histories and/or finances. “We try to mirror what our practices offer, so patients understand they’re getting the same services just at a discounted rate,” Campbell said. Once they pay the enrollment fee, BUNDL takes care of the billing and goes back and forth with the clinic on their behalf.

BUNDL can accept payments from patients until they meet the enrollment fee required to start treatment, direct them to grants or, when applicable, offer tips on how to improve their credit score.

The team at BUNDL understands the client experience because half of them are fertility patients.

“The best conversations we have with patients are ‘I’m pregnant or here’s a picture of my newborn that I had through BUNDL,’” Campbell said. “If you take home a baby that is our measure of success. It’s important that our patients understand we want them to take home a baby.”

Already creating a buzz online, BUNDL directs patients to clinics nationwide that offer the program.

This News Digest Story is paid featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.

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IVF Center loses >$300,000 from 20 lost patients

This formula calculates the economic value of a fertility center’s patient retention by using your SART data and IVF prices. Email Courtney from BUNDL to get your fertility center’s  patient retention valuation calculated for free.

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All external links active as of 2/16/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.