Consolidation Dominates the Fertility Market as Independent Practices Dwindle
All-Woman Independent Practice Heartland Fertility Grows to Five Physicians [] New technology in egg banking on the horizon
DR. STEPHANIE GUSTIN SAYS SHE’S NOT SELLING, ENCOURAGES OTHER DOCS TO BUY PRACTICES
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As more fertility clinics and chains are bought up by investment firms across the U.S., reproductive endocrinologists who choose to own their own practices are becoming more of a rarity.
Stephanie L.F. Gustin, M.D., is one of the few who chose to take the leap into independent ownership. She is now managing partner at The Heartland Center for Reproductive Medicine in Omaha and Lincoln, NE, and has grown her all-women physician team from one reproductive endocrinologist to a total of five in five years.
Gustin told Inside Reproductive Health that after she finished her fellowship program at Stanford University, she knew she wanted to work either in an academic setting or at a private practice. As a University of Nebraska School of Medicine-affiliate, Heartland was a mix of both, and she started working there shortly after her fellowship ended.
Heartland offers a partnership track to its doctors, which is how Gustin was eventually able to become a partner and partial owner in 2019 and purchase the practice entirely from the previous owner, Dr. Victoria Maclin, in 2021. She said that once a doctor has a patient load that is similar in quantity to the other partners, that doctor will also have an opportunity to purchase part of the practice.
Gustin said the biggest changes she made upon purchasing the practice were in an area she still prioritizes today–recruitment. Shortly after she became the owner of Heartland, she hired Barry R. Behr, Ph.D., who was formerly the IVF laboratory director at Stanford.
“He was one of my mentors [at Stanford] and someone that I have a profound respect for,” Gustin said. “And I felt really confident that our practice, in terms of our success rates, was going to evolve quickly with his help.”
“When it comes to egg banking, there are technologies and protocols that are on the horizon that you need to know about.”
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Gustin said that though she believed recruitment may be difficult given the clinic’s more rural location, she has now hired a total of four reproductive endocrinologists in five years. She said she built relationships with the new staff before offering the job through advocacy, collaboration and mutual connections, and after introducing her business model, they each decided to make the leap.
The staff, Gustin said, has made all the difference.
“We all work really hard, but it's easy to do that when we really love who we work with,” she said. ”I don't think many people have the kind of job that I have.”
Though all five of Heartland’s reproductive endocrinologists are early or mid-way into their careers, and the IVF market is only getting more lucrative, Gustin said they have no interest in selling the practice, as they value the autonomy of private ownership and the ability to prioritize patient care over profits.
“We really enjoy the autonomy of creating the culture and running the practice in a way that feels authentic to us,” she said.
Gustin said she thinks the business side of owning a private practice might deter some doctors, especially those without a background in business. Still, she emphasized the importance of being confident in one’s own skill set to learn along the way and hire experts to fill any knowledge gaps.
“I haven't heard a single person [who has bought a private practice] say that they regret it,” Gustin said. “It’s something that I wish more people coming out of training would seek out.”
The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.
THE NEW TECHNOLOGY IN EGG BANKING: IMPROVED PROTOCOLS, AUTOMATION, AND AI, OH MY!
BY: KATHRYN WOZNIAK, MS SENIOR EMBRYOLOGIST & LEAD CRYOBIOLOGIST AT ASIAN EGG BANK
No matter the area of life or business, the newest and most notable advancements are often cause for excitement. When it comes to egg banking, there are technologies and protocols that are on the horizon that you need to know about. Here are three in particular that are worth your attention.
The overarching expectation is that technology moves fast and is constantly improving. While that’s certainly the case in some areas, the opposite can also be true. Over the past decade, there's been minimal progress made towards improving oocyte freezing techniques. At Asian Egg Bank, we are researching and reviewing the current processes of oocyte vitrification and warming, and this work is showing very promising results in the field with blastocyst embryos. While current methods have an over-90% survival rate, this new ultra-fast vitrification and rapid elution protocol gets outcomes much closer to fresh eggs, with survival rates close to 100%. It's still very new in terms of oocyte cryopreservation and the protocol will need to go into clinical trials to be implemented across the country, but we are very excited for the increased reliability of frozen oocytes so that they can be accessible to patients worldwide.
Like many industries, the field of ART is moving into an era of AI. This technology is going to be particularly relevant in the egg banking space because it will allow us to remove technologist bias and subjectivity from the egg selection process. It may also be able to provide additional information that is not visible with the human eye. AI uses images and markers, which will allow us to grade and group oocytes before the vitrification process, according to the likelihood that they'll produce the viable blastocysts. This is extremely valuable information for egg banks and for intended parents, so that they can make better decisions on their family planning.
While a little further out on the horizon, we could eventually see automated oocyte freezing. Oocyte vitrification can be a very tedious and lengthy process and automated vitrification could potentially alleviate the manual labor, and also help to standardize the outcomes by removing some of the operational error. And less manual labor could mean lower cost as well. We will have to wait and see on this one.
In addition to conducting our own research, Asian Egg Bank team members attend regular educational conferences and workshops to stay on top of new information. The fertility industry is so dynamic, and it’s growing every day. We need to have the most up-to-date techniques and technology in order to provide our patients with the best care.
Discover how Asian Egg Bank is leading the industry in new technology. Visit asianeggbank.com/for-professionals to learn more.
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Improvements in quality control, donor recruitment, in donor egg IVF
VIDEOING PROCEDURES, ADDING ‘SHARE AND FREEZE’ PROGRAM PARTS OF MEASURES
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Evolving standards of egg-freezing care
Leading network of donor egg banks, MyEggBank, has introduced specific quality control measures to optimize egg freezing for fertility preservation. “Most of the quality control is based on the timing of the process,” Dr. Daniel Shapiro, Clinical Director of MyEggBank, says. “A lab director times everybody’s moves during the freeze process since it is done by hand and speed is essential,” adds Dr. Shapiro. MyEggBank also videos every procedure so they can monitor the entire process.
MyEggBank requires the inventory-producing centers to adhere to American Society for Reproductive Medicine (ASRM) criteria, Food and Drug Administration (FDA) guidance, genetic testing and counseling, and strict criteria for the states that require licensure. In addition, MyEggBank maintains strict policies and procedures when accepting donors for donor inventory.
Donors also have to do extensive screening before they are accepted. “The percentage of people who begin the process of enquiry and get to egg retrieval is very low,” Danielle Sheehan, President of the New England Fertility Society (NEFS), says. This increases potential productivity leaks and extensive time spent on administration. “Some egg banks have a model whereby they do all the recruiting, which is attractive to IVF center programs,” shares Sheehan.
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Maximizing donor recruitment
MyEggBank is raising the standard of freezing eggs to positively impact donor recruitment.
“Network recruitment numbers are high, or referred to as top of the funnel, meaning, many applications are received,” shares Deb Mecerod, Director of Clinical Operations at MyEggBank. “However, during the process of screening and testing donors, the number drastically reduces due to initial disqualification in the screening process, lack of donor commitment, or disqualification later in the process,” Mecerod added.
MyEggBank also strictly adheres to internal and external guidelines, which affects the number of donors accepted. “However, the quality of the donor candidates who pass all the milestones are quality donors who are presented to our intended parents,” Mecerod states.
Share and freeze solutions
As part of its unique egg donor value proposition, MyEggBank has a “share and freeze” program. The egg bank’s network has options at the local donor sites for its share program. For example, most donors recruited produce 24-26 mature egg (MII) oocytes. “Most donors with good outcomes will return for additional donation cycles,” says Mecerod.
Typically, on the third donation cycle, the donor is offered eight eggs for egg preservation and storage at no cost to the donor. The donor is paid full compensation for the donation, and the remainder of the eggs are added to the general inventory for intended parent selection.
The share and freeze program gives donors the benefit of fertility preservation for future use. “Many of our donors are single working towards advanced degrees. Freezing their eggs allows them a unique opportunity to control the timing of their own family building,” says Mecerod. This dually provides a service to the intended parents and donors, Mecerod adds: “The fertility clinics providing the service look at this as a goodwill gesture, or as some would say ‘paying it forward’”.
Technology enabling ‘premium’ standardized care
MyEggBank provides a strategic service in training the egg producing centers, maintaining strict quality control, and updating standard operating procedures (SOPs) and policies and procedures.
“The criteria for accepting donors is rigorous, but results in quality eggs being retrieved,” says Mecerod. Additionally, the intended parent clinics are trained by MyEggBank's embryologists to warm eggs and embryos to achieve the best possible outcomes.
“Recently, scientists proposed a simplified oocyte warming protocol with promising results that could potentially improve clinical pregnancy rates as well as its potential to significantly improve IVF success rates,” says Mecerod.
The research and collected data for the updated process are on the horizon. “Yet, it is currently too early to say if the simplified oocyte warming technique could be used in a clinical or laboratory setting,” Mecerod adds.
What is here, however, is the egg bank’s ability to collect “a profound amount of analytical data related to egg freezing and outcomes”, Mecerod says. This data is then utilized to troubleshoot when needed in their partner fertility clinics and production centers. “Ultimately, the data is used to provide ‘best in class’ outcomes,” Mecerod adds.
This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by 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.
Progyny stock falls 15% day after earnings call, down 35.9% since February
Company says decision from Alabama Supreme Court dampened utilization of ART services.
BY RON SHINKMAN
Progyny’s leadership said the Alabama Supreme Court’s ruling that embryos created by IVF are human beings was largely responsible for its missing first quarter revenue estimates that led to a $1 billion drop in its market capitalization.
Stock in Progyny – a New York City-based firm that provides fertility benefits to employers – dropped about 15% the day after it announced earnings on May 9, from $32.50 a share to $27.53. It has since dipped to $26.67 a share as of the end of trading on May 28. The company’s shares are down nearly 36% from its 2024 high of $41.62 per share on Feb. 12.
Progyny reported net income of $16.9 million on revenue of $278.1 million for the first quarter ending March 31. That compares to net income of $17.7 million on revenue of $258.4 million for the first quarter of 2023.
Although Progyny’s net income was in line with estimates from Wall Street analysts, its revenue for the quarter was more than $11 million short of the consensus number of $289.3 million.
Progyny leadership tied the revenue dip to a decrease in utilization of services for the first quarter. About 0.46% of people offered fertility benefits through Progyny used its services. During the first quarter of 2023 the utilization rate was 0.48%. That means utilization dropped about 4.2% year-over-year.
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The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.
“We began to see the ramp in member activity leveling off slightly in March, coinciding with the national conversations about women’s access to reproductive healthcare sparked by the Alabama Supreme Court ruling,” Progyny Chief Executive Officer Pete Anevski told stock analysts during the company’s earnings call.
Anevski added that “the modest dip in activity that we saw across the country was more pronounced in the states [which have] the most restrictive laws for women’s reproductive healthcare, suggesting that a relatively small number of members were proceeding with a greater degree of caution before commencing their fertility journey.” He noted that initial user levels during the second quarter of this year were also lower than the second quarter of 2023.
Nevertheless, Progyny says activity is up. Chief Financial Officer Mark Livingston said during the earnings call with analysts that the number of overall assisted reproductive technology cycles performed during the first quarter totaled 14,800, up 12% from the first quarter of 2023. And the number of insured individuals who have access to Progyny through their health insurance rose to 6.4 million during the quarter, compared to 5.3 million during the same period a year ago.
However, Livingston also cautioned that with its utilization rate essentially remaining unchanged going into April, Progyny projects second quarter 2024 revenue of between $300 million and $310 million. The forecast from Wall Street is on the higher end, at $307.2 million, suggesting another revenue miss for the second quarter was possible.
Livingston said full-year 2024 revenue is now forecast at between $1.23 billion and $1.27 billion. Wall Street forecasts $1.24 billion. The company’s 2023 revenue was just under $1.1 billion.
“Our range assumes that utilization in the second half of the year will be nearer to what we saw in 2022 at the low end and closer to what we saw in 2023 at the high end,” Livingston said.
Progyny has responded by buying back its own shares, including a plan to repurchase $100 million worth of stock announced on May 22.
Accurate IVF Conversion Rates Published
FINALLY. The Data Every Fertility Executive Has Been Asking For. Stop paying consultants tens of thousands of dollars for less accurate information. eIVF has the real numbers, pulled from 130,000+ IVF cycles and 550+ providers. To promote their Fertility Vision Dashboard, they’re giving you this information for free, right now, in one report.
Only this report has accurate figures for:
Avg ART Conversion Rate
Avg IUI Conversion Rate
Avg days from registration to consult
Avg days from consult to ART
Avg days from consult to IUI
Avg new patients
Stop using random estimates. Download this free report to accurately benchmark your providers’ performance using real nationwide averages.
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Down 70%. The IVF Clinic Network that Just Made Their IPO on the US Stock Market
How the Operator of a Handful of Asian IVF Clinics Wound up on Nasdaq
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BY RON SHINKMAN
A small chain of IVF clinics in Asia has gone public, with its stock listed on the Nasdaq exchange.
NewGen IVF Group operates single clinics in Hong Kong, Thailand, Cambodia and Kyrgyzstan. Its stock began trading on April 4, according to a statement issued by the company.
NewGen IVF was founded a decade ago, according to a video posted in 2019 by Alfred Siu, founder of its parent company, First Fertility Group. Siu said in the video that the clinic in Cambodia was conducting about 700 IVF cycles per year.
How did a company as small as NewGen IVF go public? It relied on a fairly new path for making an initial public offering: A blank check company or special purpose acquisition company, also known as a SPAC.
A SPAC is essentially a shell company that raises money from outside investors and issues stock. It then acquires a privately-held company that becomes the face of the organization as it is listed on a stock market such as Nasdaq. The best known SPAC transaction took Donald Trump’s Truth Social platform public, which combined the Digital World Acquisition Corp. SPAC with Trump Media & Technology Group.
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However, Goodman also noted that the company was not sizable and its stock offering wasn’t much different from so-called “penny stocks” or “pink sheet” stocks – shares issued by companies so minuscule they often can’t meet the requirements for trading on traditional stock exchanges.
To date, the market expressed extreme skepticism to the NewGen IVF stock. It was initially priced at $10 per share but dropped to around $3 per share on its first regular trading day on Nasdaq. The stock was trading at $1.22 per share midday on April 16. It had fallen below $1 a share, but was bolstered in late April by the announcement of a pending reverse merger with a company called European Wellness Investment Holdings Limited. That briefly pushed the NewGen IVF price above $2 a share, but it has since dropped.
“This may be an easier way to get to the IPO market for some companies, but you still have to be deserving (to remain there),” Goodman said of NewGen IVF Group’s approach. “You still have to have the fundamentals of a good management team and a good strategy to make the business work.”
In this case, the Bangkok-based NewGen IVF Ltd. was acquired by A SPAC I Acquisition Corp., which is based in the British Virgin Islands, according to a filing with the Securities and Exchange Commission. The merged companies then renamed itself NewGen IVF Group. Its stock trades on Nasdaq’s Capital Market, a tier of the exchange for newer and smaller companies whose rules are more relaxed than the Nasdaq Global Select Market and the Nasdaq Global Market, which are venues for larger and more established companies.
“We believe our public listing will help us to accelerate our growth and execute on our long-term vision,” Siu said in a statement announcing the merger, although no further details were provided. A spokesperson for NewGen IVF Group in New York City did not respond to a request seeking comment.
SPACs are a relatively rare vehicle for taking a company public, and this appears to be the first instance of a reproductive medicine company to take that route, according to Robert Goodman, vice president of healthcare for MidCap Advisors, a New York firm that assists in transactions among mid-sized companies.
“I think (Siu) saw value in the SPAC concept,” Goodman said, adding that the NewGen IVF founder was educated in the U.S. and is likely familiar with such an esoteric transaction.
The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.
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How These Fertility Centers Are Effectively Using APPs
NPs and PAs improve quality of care for patients, quality of life for physicians
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Advanced Practice Providers (APPs) can be effectively integrated into fertility clinic teams to enhance patient care. “APPs are often used as physician extenders in the fertility space,” Dr. Courtney Failor, Medical Director of Aspire Fertility, told Inside Reproductive Health.
Formerly called physician extenders, APPs manage new patient consults and introduce patients to the breadth and depth of fertility. They also help perform diagnostic workups with ultrasounds and radiology and monitor patients for lower-acuity fertility treatments like ovulation induction and insemination.
A recent patient survey by Inception Fertility found that over 80% of people considering fertility services across the US stated they were willing to see an APP if it would mean they were seen sooner.
“Fertility practices can integrate APPs in meaningful ways that support both patients and physicians, increase fertility center efficiency and productivity, and ultimately enhance patient care,” Dr. Jamie Grifo, Chief Executive Physician at Inception Fertility and the Program Director at NYU Langone Fertility Center told Inside Reproductive Health.
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How These Fertility Centers Are Effectively Using APPs
NPs and PAs improve quality of care for patients, quality of life for physicians
This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.
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Advanced Practice Providers (APPs) can be effectively integrated into fertility clinic teams to enhance patient care. “APPs are often used as physician extenders in the fertility space,” Dr. Courtney Failor, Medical Director of Aspire Fertility, told Inside Reproductive Health.
Formerly called physician extenders, APPs manage new patient consults and introduce patients to the breadth and depth of fertility. They also help perform diagnostic workups with ultrasounds and radiology and monitor patients for lower-acuity fertility treatments like ovulation induction and insemination.
A recent patient survey by Inception Fertility found that over 80% of people considering fertility services across the US stated they were willing to see an APP if it would mean they were seen sooner.
“Fertility practices can integrate APPs in meaningful ways that support both patients and physicians, increase fertility center efficiency and productivity, and ultimately enhance patient care,” Dr. Jamie Grifo, Chief Executive Physician at Inception Fertility and the Program Director at NYU Langone Fertility Center told Inside Reproductive Health.
Transform your career with Prelude Fertility
Award-Winning Expertise: Join a team recognized with “Top Doctors” awards and accolades as America’s Top Obstetricians and Gynecologists.
Innovative Environment: Work in facilities equipped with the most advanced reproductive technology, enhancing your ability to provide transformative care.
Expansive Network: Be part of the fastest-growing fertility network in North America, spanning over 90 locations, offering flexibility and security for your career growth.
Profound Impact: Contribute to a meaningful mission, having helped bring over 165,000 babies into the world, turning hopeful dreams into joyful realities.
Your expertise and passion can redefine fertility care. Start shaping the future now.
Improving the entire fertility journey
APPs have served as educators and ambassadors to patients during the fertility journey; fertility centers are now leveraging them to drive innovation. “Because many APPs have worked across various specialties, they bring a different perspective to ‘Fertility 101’ conversations, which can be especially helpful to someone who has never spoken to a reproductive specialist before,” says Dr. Grifo.
Underutilized APPs can result in lengthy new patient consultation timelines or geographical limitations due to challenges opening freestanding fertility clinics. “Access to care is a barrier that patients across the country face,” says Dr. Failor. Clinics can use APPs as an extender to these locations and improve access for more patients. “APPs can be ideal bridges into the often-overwhelming world of assisted reproduction,” says Dr. Grifo. The team also sees them as skilled providers who augment physician capacity.
APPs play a crucial role at satellite offices as leaders who can effectively expand a practice’s geographic footprint without the investment required to establish a new full-service clinic. Fertility clinics also use APPs to lead niche teams. “Many clinics have found specialty programs—such as third-party reproduction, including Donor Egg and Gestational Carrier services—to be game-changers for their practices and patients,” Dr. Grifo shares.
Wellbeing success and staff retention
A 2022 APP wellness survey conducted at Stanford Health Care broadly indicated that APPs with higher levels of professional fulfilment and self-compassion were less likely to experience burnout and, ultimately, leave the organization.
“Stanford’s initiatives closely align with the best practices identified at our own clinics,” says Dr. Grifo. Inception Fertility’s patient experience steering committee has found a highly effective way to maintain efficient, compassionate, and safe patient care is to care for its employees. It focuses on opportunities for professional development, role clarity, and the ability to practice at the “top of licensure”.
Clinics implementing and optimizing APP models have reported significant improvements in key performance indicators. “Having an APP can reduce the number of patients that need to be screened for an initial evaluation and ensure that all diagnostic testing is done and up-to-date prior to meeting with a physician,” says Dr. Failor.
At Aspire Austin, adding a nurse practitioner to their two-doctor practice has enabled them to see more patients and grow their revenue within the first year. Patients don’t have to wait three months to get in the door, but they have a treatment plan within six weeks of calling to set up an appointment.
APP-led consults, ultrasounds, IUI cycles, and third-party reproduction programs create space in REI schedules they can use with value. They may spend this extra time facilitating more IVF cycles, consulting with higher-risk patients, and following up with patients who have experienced an adverse outcome or multiple unsuccessful cycles.
Expanding an invaluable part of patient care
“APPs are already an extremely important part of patient care throughout The Prelude Network,” says Dr. Grifo. Inception Fertility has tested four models for leveraging APPs across its expansive network of 90+ clinics in North America. Its next step will be to roll out all four across all our regions, where applicable, allowing additional growth opportunities for each APP in the network.
“Prelude continues to maximize patient care from both a patient-experience mindset and success-driven outcomes,” says Dr. Failor. “The networking of APPs across the country and specifically across our network of clinics will enhance our ability to share and implement best practices.”
This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by 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.
Lawsuits Against Ovation Prompted by Physician and Company ‘Whistleblower’
Physicians may later be named in suit, lawyer says
The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.
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BY RON SHINKMAN
A referring fertility physician and an employee are what led Ovation Fertility in part to face four separate lawsuits alleging it negligently killed embryos by exposing them to hydrogen peroxide.
According to one lawsuit, Terence Lee, M.D., an Ovation referring physician who is medical director of Fertility Care of Orange County, notified his patients that his recent patients suddenly had a zero IVF success rate. Lee and other physicians who work with Ovation pressed the company to conduct an investigation, according to the lawsuit. Although Lee is mentioned in the lawsuit, he is neither a plaintiff nor defendant in the case.
The lawsuits were filed in Orange County, Calif. Superior Court in late April. Seventeen different plaintiffs – most of whom are only referred to by their initials – accused Ovation’s laboratory in Newport Beach, Calif. of “killing” their embryos last January by exposing them to hydrogen peroxide during the thawing process and then failing to tell them about it.
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Also named in the lawsuits were FPG Services, LLC, FPG Labs LLC and Newport Beach IVF, LLC. Corporate records indicate they are all Ovation subsidiaries. The lawsuits state they all do business under the Ovation name.
Lee is one of 39 doctors listed as “partner physicians” on Ovation’s website.
An Ovation spokesperson did not respond to requests for comment on Ovation’s corporate structure.
According to Robert Marcereau, a Dana Point, Calif.-based attorney representing eight of the plaintiffs, Ovation’s physicians are either given an ownership interest in Ovation, or are paid financial incentives to make referrals to its laboratories.
No physicians are currently named as defendants in the lawsuits, but that may change, according to Marcereau.
“Were these doctors being forthright with their patients once they learned of what happened?” he asked. “Because a lot of these doctors were very slow to provide information to their patients and were not in my opinion forthcoming. That's something that's going to have to be explored.”
Marcereau said his firm was contacted by an Ovation employee at the Newport Beach lab. That employee made allegations of poor work being performed by embryologists, which was attributed in part to lax training provided by Ovation. Similar allegations were made in another of the four lawsuits.
Although Marcereau declined to name the whistleblower, the suit his firm filed mentioned an Ovation embryologist by name. It referred to her as an “unqualified and inexperienced employee” whose errors – along with others allegedly committed by Ovation staff – regularly killed embryos.
Ovation’s official statement on the incident appears to confirm at least a portion of Marcereau’s allegations. “This was an isolated incident related to an unintended laboratory technician error that impacted a very small number of patients,” Ovation said. “As soon as we recognized that pregnancy numbers were lower than our usually high success rates, we immediately initiated an investigation.”
However, Ovation did deny one of the primary accusations in the lawsuits: That embryos were implanted in patients even after the company was aware they were non-viable.
“We have been in close contact with these few impacted patients since the issue was discovered,” Ovation’s statement concluded. “We are grateful for the opportunity to help patients build a family and will continue to implement and enforce rigorous protocols to safeguard that process.”
The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.
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Under-utilization of fertility benefits negatively impacts patients and practices
One fertility savings program proves a useful tool for patients and practices.
This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.
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Reproductive Medicine Associates of New York (RMANY) has had to counsel their fair share of patients who have exhausted their fertility benefits.
“Patients may not be fully educated on the medical criteria of their fertility benefits, which plays a vital role,” said Romain Singramdoo, Finance Manager at RMANY.
In “cases where implantation needs to occur within a certain time frame, the patient was not fully educated, and did the implantation past the allowed time,” Singramdoo said. In this instance, the finance coordinator informed the patient that their Global Health Insurance (GHI) policy mandated her to have her frozen embryo transfer (FET) cycle within 60 days of the retrieval. “When the implantation happened past the allowed time, the implantation cycle counted as ‘another try’,” Singramdoo added.
Patients may see a total dollar amount ‘covered’ and want to use the entirety of that coverage as soon as possible to afford fertility treatment without understanding their potential treatment path. “They may need more than one cycle to achieve their goal, based on their individual circumstance”, Amanda Travis, Director of Brand Marketing, US Fertility at EMD Serono, said. “Or that the medication part of the treatment costs may be extracted and paid out of pocket”.
Fertility LifeLines™ enrolled nearly 139,000 patients from 2013-2023, saving them approximately $69 million in total*.
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1. Domar, et al. Barriers and factors associated with significant delays to initial consultation and treatment for infertile patients and partners of infertile patients, RBMO, VOLUME 43, ISSUE 6, 2021
Often, patients meet with the appropriate staff member at the fertility clinic to ask the important questions: How much will this cost me, and how much will my insurance pay? Typically, at this point, patients have “a minimal understanding of how their ‘coverage’ can be best and most efficiently leveraged”, Travis shared.
By the very nature of fertility treatment, patients experience a range of emotions, not to mention challenges, one of which is the affordability of expensive fertility treatment programs. “Couple these complexities with what a patient seeking infertility treatment may be feeling at the point in time when they’re exploring costs; they are overwhelmed and feeling ‘challenged’ from the start,” Travis said.
The underutilization or misutilization of fertility benefits is devastating for patients, who have to pay the extra costs out of pocket.
But forward-thinking fertility centers like RMANY have also found ways to help patients maximize their fertility benefits efficiently. Whether they “had a specific dollar amount of $25,000 to utilize for IVF”, or other stipulations and amounts, Singramdoo said.
Benefit challenges impact fertility centers and patients
“Insurance and coverage are foundationally complex, regardless of how and where a patient is accessing it,” Amanda Travis, Director of Brand Marketing, US Fertility at EMD Serono, said.
Confusion over how to optimize benefits can also impact patients’ fertility treatments and entitlements. “Patients may be paying more than they should be to achieve the outcome they are looking for,” Travis shared. “They may miss the chance to apply for a manufacturer or pharmacy savings program for their medications if they choose to entirely pay through their insurance coverage or plan,” Travis added.
Limited knowledge of fertility benefits can also impact the patient’s fertility center. “Frustration could lead to bad reviews for the finance team for not giving clarity, or patients may begin to lose trust in the practice,” said Singramdoo. Financial counselors and patient navigators face several hurdles when allocating benefit coverage. “Insurance reps tend to be very vague and inconsistent when explaining benefits, leaving the practice to relay information that may be incorrect,” Singramdoo detailed.
How fertility centers can help their patients get the most from their benefits
Fertility clinics can help their patients properly navigate, optimize, and advise their patients. “Insurance coverage is a good starting point for the financial conversations, but prepare a process and questions to best educate and set the patient up for success,” said Libby Horne, Senior Vice President of US Fertility & Endocrinology at EMD Serono.
Bespoke fertility benefit packages are available to clinics. In today's fertility sector, it's recommended that clinics implement a process that builds in personalization and doesn’t treat all patients with ‘coverage’ the same.
Expanding supply chains to involve pharmacies in patients’ fertility treatment plans can optimize operations for facilities. “If the clinic doesn’t have the process or personnel to do this effectively with every patient, outsourcing to their pharmacy may be an effective idea,” Horne said.
Three-way calls with patients, insurance providers, and fertility practices help clarify benefits. “Asking the patient to get their written certificate of coverage or provide us with a concierge number for their benefits can also assist in clarifying benefits,” Singramdoo noted.
EMD Serono’s savings program saves eligible fertility patients an average of $1,700
EMD Serono encourages all eligible patients to apply to see their potential savings and confer with their EMD Serono network pharmacy if they do not immediately qualify to see if there is potential for other savings.
The biopharmaceutical company hosts a Fertility LifeLines Resource Hub featuring program descriptions, patient materials, program logos, and patient-facing instructional videos for clinics to educate patients on Fertility LifeLines.
Fertility LifeLines is a program for eligible patients who will be paying out-of-pocket for EMD Serono fertility medications. EMD Serono offers a Compassionate Care program to support certain eligible patients’ access to affordable fertility treatment.
On average, eligible patients save over $1,700 on EMD Serono Fertility medication, but some may save more. The savings patients can expect to make are based on several factors, including financial need, number of dependents, and military status.
This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by 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.
Doors Shut: Nashville IVF Clinic Closes Without Notice to Patients
Staff walked out, and now patients want answers.
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BY: ROSEMARY SCOTT
Patients of the Nashville Center for Reproductive Health were left with more questions than answers when the clinic suddenly closed during the first week of April with little explanation.
An anonymous clinic staff member told Nashville’s Channel News 5 that on April 4, clinic staff staged a walkout after receiving letter over email from administration that stated their paychecks would be late. The letter cited “unforeseen financial circumstances” and told staff their checks would be paid “as quickly as possible” once the money is available.
Since then, patients have struggled to get in contact with clinic owner and director Dr. Jaime Vasquez, despite some patients having paid in advance for treatments. Other patients also have sensitive information like medical records, and in some cases, embryos, stored at the facility.
Patients Left in Limbo
It is unclear whether the facility will reopen. Some patients, like April Moore of Murfreesboro, TN, arrived at their appointments over the last week to find the doors locked with no staff inside to answer their calls.
Moore told Inside Reproductive Health she stood outside the clinic on Thurs., April 11 with several other patients who were there either for appointments or to follow up on unreturned calls.
The next day, Moore said her husband received a call from Vasquez informing him his wife’s procedure scheduled for later that day would be canceled. After being informed that the procedure had actually been scheduled for the day before, Vasquez hung up the phone, Moore said.
Moore said she will likely return to her previous provider, Kindbody, despite having to make the trip from Murfreesboro to Atlanta.
“At 40, time is not in my favor, and this [has] wasted more time,” Moore said. “Now, I have to start back over from the beginning, because I don’t even have the test results I need to move forward again.”
The Nashville Center for Reproductive health has made no mention of the office closure on its social media and has responded to negative reviews on its business pages with canned responses that don’t address any particular situation. The center has continued to post on its Facebook page as normal, and many patients have commented on the company’s most recent post for World Health Awareness Month on April 8 asking for answers.
This led to patients using the comment section to help one another by suggesting other doctors with openings and linking to Support for families of CRH, a Facebook group formed for those affected by the clinic’s closure to connect with one another.
Rumors of Bankruptcy
Kristyn Rogers-Escudero of Clarkesville, TN started fertility treatments at the Center for Reproductive Health in February. She told Inside Reproductive Health that it took over a month of back-and-forth to schedule her next appointment, and clinic staff blamed the lack of availability on updates to the facility.
On Monday, April 8, Rogers-Escudero received a text from the center canceling her appointment for the next day. After calling and emailing the facility with no response, she stopped by the center on Tuesday while she was in the area for work. Rogers-Escudero stated that she is familiar with property improvement in her line of work as a commercial property manager, and she did not see any signs of construction or improvements being made to the facility.
The door was unlocked, but no staff answered Rogers-Escudero when she called and rang the desk bell for help.
As Rogers-Escudero continued through the building, Vasquez came out of his office to speak with her. The day before, Channel News 5 reported news of the closure, including a patient who stated they heard the center’s receptionist say the clinic was bankrupt. Vasquez dismissed these claims to Rogers-Ecudero, calling them “rumors” and emphasizing that once staff returned, all would be well.
“He said, ‘We are not broke. Everything is fine here…We just need to get people back in the office so they can answer the phone,” Rogers-Ecudero said.
When she asked Vasquez if she could have a copy of her medical records before she left to take to her new provider, he directed her to the secretary. When Rogers-Ecudero pointed out there were no other employees in the building, Vasquez told her he couldn’t provide the records and asked her to leave.
No bankruptcy filings for The Center for Reproductive Health were found as of this writing.
How did this happen?
There are myriad reasons a fertility clinic could close its doors, Robert Goodman, VP Healthcare, MidCap Advisors, told Inside Reproductive Health. He stated reasons for closing could be financial, like poor financial management, an excess of debt or a slowdown post-COVID.
“Why would a practice close this abruptly?... I think it certainly can be poor management in terms of their finances. They could be over leveraged with too much debt…or maybe they overpriced themselves,” Goodman said.
Goodman stated the abrupt nature of the closure is uncommon in the field, even due to financial reasons, and it could also be a result of embezzlement or theft by someone at the center.
“Is this typical? The answer is no, no it isn’t…unless there's some big bombshell [that you haven’t uncovered yet].”
Goodman stated that the closure could also be due to declining market share caused by competition in the area.
According to the most recent CDC data, the clinic has at least one major competitor in the city. In 2021, the Nashville Center for Reproductive Health logged 187 total cycles, according to CDC data. Nashville Fertility Center, the only other Nashville clinic the CDC listed in 2021, logged 1375 total cycles, resulting in 374 total infants born.
Regardless of the cause, the negative effects of the clinic’s closure have spread beyond the center’s walls and into the lives of patients.
“I'm thankful that I wasn’t super far along in my fertility journey with [the Center for Reproductive Health], but I do feel very sad for the other couples that are having to deal with this…I just hope they get justice,” Rogers-Escudero said.
The Center for Reproductive Health did not respond to Inside Reproductive Health’s request for comment.
The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.
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Kindbody Shakes Up C-Suite with Six New Hires
Who they are, where they came from, and what’s next for the New-York based company
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BY: ROSEMARY SCOTT
New York-based end-to-end fertility network Kindbody has undergone shifts in its leadership and financial landscape over the last year. On March 19, the company announced the appointment of six new executives onto its leadership team in an effort to support what the company called its “next stage of growth.”
In the same press release, the company also announced expansion plans that include opening clinics in four cities: Charlotte, NC, Miami, FL, Newport Beach, CA and San Diego, CA.
Of the new appointments, three were hired for previously existing roles, while the other three will be the first to hold their respective titles. Here’s the details on each new player, including who they’re replacing and how they fit in Kindbody’s strategy.
New People in Existing Roles
Scott Bruckner, Chief Financial Officer (CFO)
Bruckner was able to get a head start on his role compared to the other new hires, as he left his role as CFO of Fluid Truck, a technology-based sharing platform, to start at Kindbody in June 2023. The role of CFO has been vacant since Debbie Markowitz, former Kindbody CFO, left the role in November 2020 after a little under two years at the company. Markowitz is now CFO at Spring Health.
Haleigh Tebben, Chief Revenue Officer (CRO)
Tebben most recently served as Chief Commercial Officer at Brightline after leaving her role as CRO at Collective Health. Tebben is replacing Taryn Branca, former Kindbody CRO, who left the company in February and is now Chief Commercial Officer at Airvet, an employee benefit service for pets.
Jason Barritt, Chief Scientific Officer (CSO)
The appointment of a new CSO may seem like déjà vu, as it comes only a few months after Kindbody announced Alison Bartolucci, Ph.D., HCLD, had been hired for the position. However, Kindbody Spokesperson Margaret Ryan told Inside Reproductive Health that Bartolucci accepted a promotion from her employer, First Fertility, instead of taking on the role at Kindbody.
For his part, Barritt brings relevant experience to the role, as he served over 10 years as CDO and Lab Director at Southern California Reproductive Center in Beverly Hills, CA.
Dr. Angie Beltsos’s title had been CEO, Clinical, and is now Chief Executive Physician (CEP). Kindbody explained to Inside Reproductive Health how Dr. Beltsos’ role interfaces with other medical leadership roles in the company. She leads clinical strategy across Kindbody national fertility clinic network. Dr. Beltsos is responsible for establishing and implementing superior clinical standards and patient care at Kindbody clinics to yield exceptional outcomes and high, patient satisfaction levels. As CEP, Dr. Beltsos provides strategic leadership to the Chief Medical Officers to ensure the execution of consistent clinical care and safety. Kindbody’s four Chief Medical Officers cover the following:
Dr. Lynn Westphal, Chief Medical Officer, Lead CMO, Medicine + Research
Dr. Amber Cooper, CMO, Genomics + Lab Operations
Dr. Roohi Jeelani, Chief Growth Officer
Dr. Kristin Bendikson, CMO, Clinical Development”
Newly-Created Roles
Gina Bruzzichesi, Chief Operating Officer (COO)
Bruzzichesi has a background in human resources and previously served as COO at Aspen Dental Management. Prior to that role, she held positions at CLEAR, WeWork and Avis. In her early career, Bruzzichesi worked as an employment attorney.
Tim Springer, Chief Compliance Officer (CCO)
Prior to his role at Kindbody, Springer oversaw healthcare ethics and compliance programs at One Medical. Before that role, he ran financial services global anti-fraud programs at MetLife and John Hancock.
Matt Slepian, Chief Accounting Officer (CAO)
Though Slepian’s role as Chief Accounting Officer (CAO) sounds similar to the CFO role filled by Bruckner, Ryan told Inside Reproductive Health that Slepian’s role is “focused specifically on managing the company’s accounting functions, including audits, compliance and accounts receivable and payable.”
In contrast, Bruckner “oversees the company’s financial strategy and operations and plays a critical role in scaling the finance, accounting, and revenue cycle management teams to support the [c]ompany’s rapid growth,” Ryan stated. Slepian brings over 25 years of finance experience to Kindbody, and most recently served as CAO at Casa Systems.
What Happens Next
These new appointments are the latest in a series of changes Kindbody has made to its leadership team.
In September, Kindbody president Gregory Poulos stepped down from his role and now works as a strategic advisor for the company. No replacement for this position has been announced. Two months later, Bloomberg reported that Kindbody is paying a search firm $750,000 to replace CEO Annbeth Eschbach, citing sources familiar with the matter.
Kindbody Spokesperson Margaret Ryan confirmed Eschbach will be leaving the company in a statement to Inside Reproductive Health.
“Annbeth and the Board have been working together to develop a succession plan which ensures that Kindbody remains responsive to its employees, patients and all stakeholders.”
Kate Krejci, current Vice President of Operations at The Fertility Partners, left her role as GVP, Growth Operations at Kindbody in October after working at the company for about two years. Prior to her role at Kindbody, she was Vice President of Operations at Vios, which Kindbody acquired in 2022.
Krejci told Inside Reproductive Health that when she left, Kindbody was still trying to clearly define the responsibilities of each team following the acquisition. Krejci said she’s hopeful the new additions to the leadership team will help make expectations and strategy for each team more clear.
“I think there needed to be more guidance and expertise making those decisions and driving that change,” Krejci said. “I'm hopeful that it's the right direction for the organization to really bring expertise at a high level to drive each of those departments independently.”
Though Krejci left before many of the new hires started their roles, she did spend time working with Scott Bruckner, CFO, and called him a “really good fit” for the role.
Kindbody told Inside Reproductive Health it hopes these new players will help the company reach its goals of continued growth.
“The expansion of our leadership team ensures we have the right leadership and dedicated resources in place to continue our focus on excellent patient experience and delivering successful outcomes for every patient and employer we serve,” Kindbody stated.
The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.
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UK Government Halts IVF at Clinic After Loss of Embryos
The Homerton Fertility Centre reported three incidents in seven months last year that led to the loss of embryos.
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BY RON SHINKMAN
A reproductive medicine practice in London had its license suspended by the United Kingdom’s top fertility regulator after three incidents in recent months where embryos were mishandled, authorities said.
The Homerton Fertility Centre had its license suspended by the United Kingdom’s Human Fertilisation & Embryology Authority on March 8. The suspension will remain in effect until at least May 8 while the clinic fixes issues cited by the regulator, according to a letter issued by the clinic’s parent organization, Homerton Healthcare.
“The HFEA License Committee made this decision because of the potential risk to patients, gametes and embryos if the clinic’s license is not suspended with immediate effect,” said HFEA Chief Executive Officer Peter Thompson in a statement.
The terms of the suspension did allow the clinic to continue to treat patients who were in the middle of IVF cycles, Homerton CEO Louise Ashley said in a letter to patients.
Homerton Healthcare is a regional healthcare provider affiliated with Britain’s National Health Service. It provides medical services in the Hackney and City of London neighborhoods in northeast London. Its fertility clinic has been licensed to operate since 1995.
According to Simon Lumsdon, who operates a consulting firm in the U.K. called Lighthouse Fertility, such suspensions of clinics are rare.
“It really doesn’t happen very often,” he said, adding that the U.K.’s regulation of fertility clinics is among the most robust in the world. “You have to have quite high standards just to be operating."
Shaun Rogers, a clinical scientist who has worked and consulted for numerous IVF laboratories in the United Kingdom, observed that fewer than five U.K. fertility clinics have had their licenses suspended or revoked in the 30 years he’s been in the business.
According to minutes of the March 7 HFEA License Committee meeting, the suspension was in the wake of three incidents at the clinic that took place last year that were reported to the regulator under NHS rules. The first incident occurred in May 2023 and involved not following the correct procedure for storing frozen embryos. The second incident, which took place in October, some frozen and stored embryos “displayed a lower rate of embryo thawing survival rate,” according to the minutes. The third incident, which took place in December, involved embryos missing from a cryogenic straw after the thawing process.
Additional details about the incidents were not available. The HFEA declined to comment beyond what is already in the public record, while a spokesperson for Homerton Healthcare did not respond to a request seeking comment. Ashley said in her letter to clinic patients that in each case other embryos were located and that the IVF cycles were completed
These incidents were not the first indication that Homerton Fertility’s operations were troubled. According to minutes from an HFEA License Committee meeting from May of last year, Homerton Fertility “has had a poor history of compliance in recent years and has been subject to considerable regulatory scrutiny.”
An April 2021 inspection for the renewal of the clinic’s license turned up issues. That inspection “identified two critical areas of non-compliance relating to swab counts performed during surgical procedures and the reporting of adverse incidents and near misses.” A followup inspection in March 2022 indicated that some improvements had been made but that the HFEA was “made aware of several whistleblowing communications from various sources. The concerns raised included leadership, working conditions, the welfare of patients and staff, training, policies and procedures, decision-making, non-reporting of incidents, and information to be provided to patients.” The agency also noted that the center was short-staffed in comparison to the volume of procedures it performed.
Nevertheless, the HFEA License Committee agreed to renew Homerton’s license for three years with an interim inspection to take place one year after the approval was granted.
Lumsdon observed that these events along with the more recent mishaps is what led to the suspension.
“You have to almost repeatedly push and push and push to get to this point where your license is (suspended),” he said.
In response to the suspension, the clinic said in two separate letters to patients that all of its staffers now work in pairs; all of the licenses and competencies of the staff have been vetted and verified, and that the fertility clinic’s security had been improved.
Lumsdon believes the issues at Homerton partly reflect austere funding of the NHS over the past decade-and-a-half. Fifteen years ago, funding for Britain’s single-payer system routinely rose 5.5% per year. It’s been trending about half of that in recent years
Lumsdon did add that some NHS-operated fertility centers are able to overcome the wage disparity through their affiliations with prestigious teaching hospitals.
“Homerton didn’t really have that draw,” he said.
The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or 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.
Invitae Sells $10M in Assets to Natera, But Can’t Shrink $1B Debt Before Ch. 11 Bankruptcy
The company will auction off the rest of its assets under court’s supervision.
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On Feb. 13, genetic testing company Invitae Corporation announced it had filed for Chapter 11 bankruptcy protection in New Jersey.
At the time of the filing, the company had assets worth $500 million to $1 billion and debts of $1 billion to $10 billion. Invitae stated in the filing it plans to auction its assets under the court’s supervision.
On Jan. 22, Invitae announced it had sold its reproductive health assets, which include carrier screening and non-invasive prenatal screening, to genetic testing company Natera for $10 million upfront and up to $42.5 million in milestone payments and litigation credits. Weeks later, on Feb. 5, the Wall Street Journal reported Invitae would likely file for bankruptcy soon, citing anonymous sources familiar with the matter.
The same day the WSJ article was published, Invitae’s stock dropped over 75% to about $0.10 per share.
From the time of its launch, Invitae’s stock remained steady for years, hitting a high of about $55 per share in December 2020. Ever since, the stock has been on the decline, trading for less than $1.00 a share since August 2023. This prompted a warning from the New York Stock Exchange in September that the company may soon be removed from the exchange.
Invitae offered its line of genetic carrier screening tests in the following areas: oncology, women's health, pediatric & rare diseases, cardiology and neurology. According to Invitae’s Q3 2023 earnings report, the company served 4.4 million patients over the quarter, with oncology generating the most revenue ($62 million), followed by women’s health ($27 million).
Was Invitae’s Business Model Too Good to be True?
Launched in 2018, Invitae stated the tests provide “affordable, accessible information on genetic changes that pose a risk for parents of having a child with an inherited genetic disorder.”
David Sher, founder and CEO of global fertility agency Elite IVF, told Inside Reproductive Health that Invitae’s average test price was about $200, versus about $1000 per test from some competitors.
As a former customer of Invitae, Sher was disappointed to hear of Invitae’s bankruptcy filing. Sher said the company’s low price allowed genetic testing to be more accessible for his patients. Now that the company is no more, Sher believes the rise in cost could keep many of his patients from being able to afford the service.
“Invitae changed the way the world looks at testing,” Sher said. “Testing became more standardized as a result of its accessibility, and I wonder what’s going to happen now.”
The business model and price point drove millions in annual sales for Invitae–in its 2022 full year financial report, the company reported $516 million in revenue, a 12% increase from the year prior. Still, the revenue couldn’t keep up with the money Invitae was spending. Despite a restructuring effort put in place by a new CEO that included laying off over 1,000 employees in July 2022, it lost over $654.4 million between Q3 of 2022 and the year before due to its total expenses of $1.3 billion.
Additionally, with more than $1 billion of debt, interest payments may have been too high to maintain, and a loan would likely share a similarly high interest rate, given the company’s income to debt ratio at the time of the filing.
“As a customer of theirs, I was astonished by their excellent offering and their service–it was amazing,” Sher said. “I thought it was almost too good to be true, and unfortunately, it seems like it was.”
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IVF centers moving from “pay per treatment” to “pay for baby” model
Fertility clinic pricing strategies enter a new era with assistance from AI company
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AIVF™
With the prominence of sophisticated artificial intelligence (AI) systems like AIVF’s EMA progressing the fertility industry from standardization to personalization, fertility clinics can shift to a “pay for baby model” over the traditional “pay per treatment” pricing structure.
Today’s fertility industry has struggled to keep up with treatment demands. In the US, clinics are only serving 20% of the need for IVF, leaving 80% of patients giving up on starting the process of having a child, Daniella Gilboa, CEO and co-founder of AIVF, conveyed.
However, as AI-powered scoring systems, such as AIVF’s EMA, lower uncertainties, expedite embryo evaluation, and provide clear, accurate information, clinics now have the potential to meet this demand. Clinics utilizing AIVF’s software have seen a 30% increase in success rates, Gilboa said in a July 2023 New York post article.
Non-invasive AI systems analyze multiple parameters that, when put together, give much more predictive information about embryo development.
The in-depth operating systems help doctors understand implantation failures and multiple failed cycles.
“The timing of the cell divisions, the evenness of the cell divisions and the amount fragmentation of certain features will give us ideas as to the embryo’s true quality and genetic potential,” Dr Conor Harrity, Consultant Gynecologist and Subspecialist in Reproductive Medicine at Rotunda and Beaumont hospitals in Dublin, Ireland, told Inside Reproductive Health.
Predictive power
Dr. Harrity sought a non-invasive tool that would provide more information on blastocysts than standard morphology. “AIVF stands out because it gives us much more information about the potential of the embryo without the need to biopsy the embryo with the extra risk of embryo damage or the extra cost involved with preimplantation genetic testing technology (PGT),” said Dr. Harrity.
“If the embryo is not good enough, you can modify and personalize the regime,” said Dr Harrity. Therefore, AIVF helps clinicians identify scenarios where good embryos haven’t worked, and they need to modify the transfer regime. With AI scoring, the tool also lets clinicians see that embryos they thought were good morphologically weren’t as good as they had thought.
“AIVF gives more confidence to both the doctor and the patient about how to shorten their journey to either success or to knowing why it’s not working, and then changing tack and doing something that will help them succeed,” said Dr. David Walsh, Director of FirstIVF.
The use of AI and tools like AIVF indicate a move to a 'pay per baby' pricing model over a 'pay per treatment' model, Walsh confirmed. “The closer you can get to a higher probability of outcome and shared risk between the fertility clinic and patient, the more likely we are to see the move to a ‘pay per baby model”, Walsh said.
Due to its expense, clinics cannot afford to return this cost to patients, Walsh said, if treatment does not result in pregnancy. “Anything that gets closer to the prediction of outcome allows clinics to make calculated outcomes, therefore increasing their predictive power”.
Time-lapse capabilities
Progressing beyond PGT, AIVF enables retrospective use by recording time-lapse videos. Over the past year, Dr. Harrity confirmed that the industry has started to see instances where it has been very useful to look retrospectively at embryos and learn more about previous failed transfers.
AIVF’s EMA uses time-lapse monitoring to understand an embryo’s development. Several cameras record the embryo to give a multi-dimensional view of the embryo’s growth. The system shows how the embryo divides from a single cell into multiple cells until it forms a blastocyst.
Rather than just using snapshots at certain points of development, embryologists continuously monitor the embryo’s growth over five to six days until it reaches the blastocyst stage, providing much more information.
Non-clinical benefits
EMA’s automated embryo evaluation and quality scoring modules (AIVF Day-3, AIVF Day-5 and AIVF Genetics) automate the embryo evaluation process, entirely replacing manual steps, such as visual inspections, morphokinetic and morphological annotations, and manual data recording and transfer into the electronic medical record (EMR).
The integrated system directly transfers all embryo evaluations and scores from the time-lapse incubator to the EMR through the EMA platform, eliminating redundant data recording and transfer between multiple operating systems within the IVF laboratory. “It is documented in the patient’s information record, another data point,” said Walsh.
A 2023 research study found the average manual evaluation and recording time without and with EMA was 3.1 minutes versus 30.9 seconds per embryo, respectively. Overall, using AIVF reduces the average embryo evaluation time per cycle by 83%, a case study on efficiency revealed.
By utilizing EMA's automated messaging dashboard, IVF analytics tool, and laboratory documentation for performance monitoring and calculation, clinics can also lower administrative time for each cycle from 9.0 hours to just 5.58 hours, a 38% reduction. (1)
AIVF audits field transfers; offering information about embryos that did not implant.
Developers are adding features to AVIF’s time-lapsed five-minute videos to increase predictive power. Standing out in a way that isn’t true for all other non-invasive programmes, Walsh said, “AIVF is constantly learning, so it is getting better over time”.
“The big thing about non-invasive testing is that it can become universal,” said Walsh. It is accessible to everybody going through a fertility lab because it is relatively low cost, particularly compared to genetic testing. As long as the information is stored securely, non-invasive testing enables clinicians to look back in time and use it in the future. Clinicians can receive that information and run the data. “It’s eternal,” said Walsh.
While a move to subscription pricing models is uncertain at the moment, Walsh said, “clinics may justify this move based on confidence and outcomes”. He said confidence in AI technology like AIVF and its outcomes will help clinics move to different financial models, with ‘pay for baby’ treatment a permissible and viable alternative to the 'pay for baby' treatment option.
(1) Validated by AIVF partners. Internal data on file
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Washington Post Describes Unbridled Price Hikes For Cryostorage
Industry Experts Predict Steadier Market
BY: MEG ST-ESPRIT
There is recent speculation in the media that cryostorage prices are rising. A May 2023 article in The Washington Post noted a 40 percent increase in storage prices in a single year, though they did not cite a source for the statistic.
Inside Reproductive Health was unable to independently verify that statistic. Patients interviewed for the article reported feeling “stuck” or forced to make decisions about storing their genetic material while concerned that the price of cryostorage in the United States will rise.
Within the reproductive health industry, there are less clear-cut answers on pricing trends.
Are cryostorage prices in the United States actually rising?
Hard data about how much prices have risen remains scarce, though patients report receiving notifications of increases to their monthly or yearly storage bills.
Eric Widra, chief medical officer at Shady Grove Fertility, was interviewed by the Post. He declined to comment on national pricing trends at this time. Other cryostorage facilities do not expect to raise their prices anytime soon.
Pete Anevski, CEO of Progyny, expects costs to remain stable for patients. “We can confidently say that costs for our members will not be going up – this includes overall costs and the costs directly associated with tissue freezing and storage” he said in an email.
He added that their pricing structure does not vary depending on the genetic material being stored.
Inside Reproductive Health did reach out to Luis Fernandez, partner at Red Barn Equity Partners, the investor-operator of ReproTech, for commentary on cryostorage pricing trends. Mr. Fernandez did state he would provide commentary but did not respond by publication deadline.
At TMRW Life Sciences, Chief Impact Officer Linsday Beck said that while most of their business is providing B2B storage to fertility clinics, they do have a small sector of their business that offers direct-to-consumer storage options. In both their DTC and B2B sectors, Beck said TMRW Life Sciences has not increased prices in the last year.
She said for the clinics they work directly with they have also not instituted any significant change in pricing structure at this time. “We have not increased our pricing due to inflation, but it's sort of a different beast.” she said in an interview. “We're not an apples-to-apples [comparison] with fertility clinics.”
What are the barriers to reducing cryostorage costs?
Dr. Widra cited several reasons via email that clinics may be paying more to store eggs and embryos — a cost that could be passed down to consumers.
The price of hardware such as tanks and monitoring devices as well as square footage to store them in is subject to inflation, like any consumer good. Supplies such as liquid nitrogen as well as electronic monitoring equipment to reduce the risk of tank failure are also expensive, he says. “Liability insurance costs have risen in the wake of the recent tank failures,” he adds.
A 2021 settlement in California awarded patients $15 million in damages after a major storage failure destroyed thousands of samples of genetic material.
Beck said Many clinics, she said, use a manual system. “It's handwritten labels; it's manually filling in the tag. There is manual inventory. Information is written down either in a binder or an Excel spreadsheet.” This process, she said, is very human-labor intensive.”
As the demand for cryostorage increases, Beck said the best way to keep storage affordable to patients is to automate it. Not only does it reduce labor costs for clinics, it reduces that risk of failure Widra cited. “Robots reduce potential points of failure by 94%. So it's a far better system for a similar price,” she said.”
Beck noted that cryostorage is not marked up as much as other medical procedures, but due to lack of insurance coverage the cost is largely covered by patients — including unexpected increases.
Despite industry efforts to keep costs low, any increases are passed along to consumers. “So for the patient it does feel expensive,” said Beck. “I think there's a really important perspective to consider.”
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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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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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.
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20 Years After Toft Report, Most Fertility Centers Have Yet to Automate
90% OF Fertility Centers Still Doing Manual Witnessing, Exec Says
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.
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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
All external links active as of 4/27/23.
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.
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.
All external links active as of 3/30/23.
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.
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
All external links active as of 3/9/23.
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.