ASRM, SART, SRBT Withdraw Proposal to Eliminate Doctoral Requirement For Embryology Lab Directors

Dropped after pressure from current IVF lab directors 

The content and themes expressed within the article are that of the news. The advertisers do 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 advertisers or of Inside Reproductive Health.

This News Digest Brought to You by
Future Fertility and Mind360

BY: RON SHINKMAN

The American Society for Reproductive Medicine (ASRM) and two of its affiliates proposed last year to eliminate the longstanding doctoral degree requirement for embryology laboratory directors, but withdrew it earlier this month after it came under criticism from current lab directors.

The proposal from the ASRM, the Society for Assisted Reproductive Technology (SART) and the Society of Reproductive Biologists Technologists (SRBT) was first submitted to the American Board of Bioanalysis (ABB) last April, according to followup correspondence the groups sent to ABB last September. The proposal was to reinstate an examination and certification pathway for non-doctoral technical supervisors to become embryology laboratory directors. The ABB oversees the certification of laboratory professionals in the United States.

A doctoral degree has been required for embryology lab directors since 1999. That’s when the federal Clinical Laboratory Improvement Amendments (CLIA) regulating labs in the U.S. were expanded to include embryology laboratories. The CLIA regulations also classified embryology labs as conducting “high complexity” testing. All labs with such a designation require physician or doctoral-holding directors. Non-doctoral embryology lab directors at the time were exempted from the new rule, and a small number still hold such jobs, according to Eva Schenkman, an embryology lab director and consultant based in Rocky Mount, N.C.

The September letter to the ABB mentioned “extreme staffing shortages” cited by the SRBT president at the time, Brad Milette. He referenced numerous job openings on the ASRM jobsite, LinkedIn and other sites. However, the letter does not clarify if the shortage includes embryology lab directors.

Milette, a laboratory supervisor and embryologist for the Women & Infants Fertility Center in Providence, R.I., did not respond to phone calls seeking comment.

Also signatory to the letter was past SART president Sangita Jindal. The letter noted that half of current embryology laboratory directors direct more than one lab, although she did not delve further into the average number of laboratories they supervise. Under CLIA, a single individual may direct as many as five high complexity laboratories simultaneously.

Jindal did not respond to emails seeking comment.

The third signatory to the letter was ASRM Chief Executive Officer Jared Robins, M.D. Neither he nor an ASRM spokesperson responded to emails seeking comment. ABB did not respond to a query sent through its website.

Current embryology lab directors believe there was an ulterior motive for the proposal: a concerted cost-cutting campaign among the owners of reproductive medicine practices.

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“There are people who are working for big venture capital and private equity firms (in the fertility business),” and I don’t think they want to pay for PhDs,” said Marlane Angle, director of the laboratory at the Caperton Fertility Institute in Albuquerque, N.M.

Schenkman concurred. She suggested that along with the presence of private equity, inflation and deteriorating margins may be pressuring practice owners to cut costs.

Another laboratory director who asked not to be identified said that the salary differential between someone in a supervisorial position with a doctorate degree and without could be as much as $60,000 per year. A recent salary survey conducted by ASRM and SRBT concluded that the large majority of experienced lab directors with doctorates working at private assisted reproductive technology labs received base salaries between $175,000 and $275,000 per year. But among those lacking a doctoral degree, the majority reported salaries of between $100,000 and $225,000.

“It’s just insane,” Schenkman said of the possibility that someone with a bachelor’s degree and a few years experience could direct an embryology lab.

When Schenkman discovered the proposal had been submitted, she launched a petition to have the proposal withdrawn. The multi-page petition also questioned the jobs data cited in the September letter to the ABB. It stated that the number of embryology lab director positions being posted were perhaps one or two per month. It also noted data from the Centers for Disease Control and Prevention of a 35% increase in cycles using assisted reproductive technology since 2018. Meanwhile, lab growth has been static; the petition also cited CDC data indicating that there are three fewer embryology labs operating in the U.S. now compared to 2018.

“This data aligns with the notion that the rise in cases, unaccompanied by a proportional increase in clinics, underscores a shortage of embryologists rather than laboratory directors,” the petition stated.

The campaign orchestrated by Schenkman appears to have had its impact: more than 400 individuals have signed the petition to date. And on Feb. 2., ASRM, SBRT and SART sent a joint email to ASRM members stating that it had withdrawn the proposal.

“We regret that this process has not been as transparent and inclusive as it should have been and has clearly caused polarized discussions among our SRBT members. Based on the number of comments from our members, we realize that this request was clearly premature and may not be representative of the broad SRBT membership,” read the email, which was signed by ASRM President Paula Amato, M.D., SART President Steven Spandorfer, M.D. and SRBT President Marina Gvakharia, M.D.

In addition to withdrawing the proposal, the email said it would conduct a survey of SART-affiliated laboratories regarding “the current status and future needs of lab directors.” It also planned to conduct a survey of SRBT members on the embryology lab director requirements, and “conduct a series of town hall meetings to present these findings and to listen to our members’ perspectives on addressing workforce challenges.”

The content and themes expressed within the article are that of the news. The advertisers do 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 advertisers or of Inside Reproductive Health.

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Eight Fertility Clinic Employees Arrested, Clinic Shut Down By Greek Government

What We Know About What Was Alleged in Crete in August

The Greek clinicians were accused of working with illegal brokers to bring in surrogate mothers and egg donors from Eastern European and Balkan nations.

The content and themes expressed within the article are that of the news. The advertisers do 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 advertisers or of Inside Reproductive Health.

This News Digest Brought to You by
Future Fertility and LEVY Health

BY: RON SHINKMAN

The central European fertility sector was rocked in August when Greek police raided a long-established fertility clinic on the island of Crete as part of an investigation into the trafficking of surrogate mothers.

Eight employees of the Mediterranean Fertility Institute (MFI) were arrested in the raid, along with a local midwife who also participated in the alleged scheme. Those taken into custody include the clinic’s founder, Ioannis Giakoumakis, an OBGYN who opened the clinic in 1992. Giakoumakis did not respond to a request seeking comment sent to him through LinkedIn. His attorney, Michalis Mavros, has told Greek media that once more facts about the case emerge, Giakoumakis will be vindicated.

According to the Hellenic Police, the national law enforcement agency that is Greece’s equivalent of the FBI, the clinic had pursued the “industrialization of births,” primarily by working with traffickers who brought foreign-born women living in northern Greece – many refugees from Balkan and Eastern European countries – to act as surrogates and egg donors.

The Hellenic Police said it had been investigating MFI since December 2022. It concluded that at least 98 women were allegedly trafficked by the clinic as surrogates, while another 71 women were “exploited” as egg donors. Many of the surrogates were being housed in 14 residences allegedly procured and operated by MFI. At least 30 pregnant surrogates were found in the residences, which were described as squalid.

In addition to the trafficking charges, Greek authorities also allege that MFI and the eight staffers, “falsified birth records, falsified medical documents, prepared fictitious leases and fictitious cohabitation agreements.” It also alleges that embryos were illegally sold and that as many as 400 patients who underwent IVF procedures may have been defrauded.

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The Hellenic Police claim that MFI paid its own employees bounties ranging from about $3,100 to $5,200 for each surrogate or egg donor they brought in, while the surrogates were paid anywhere from $315 to $630 a month while pregnant. Would-be parents, meanwhile, were charged anywhere from $73,000 to $126,000 for each surrogate birth.

A Hellenic Police spokesperson said that the investigation had recently been handed over to prosecutors in Chania, the city in Crete where MFI is located. A spokesperson for the prosecutor’s office did not respond to a request seeking comment. It is unknown when trials will take place.

The arrests have created an upheaval among would-be parents using the clinic, including as many as 150 from Australia. That nation bans payment for surrogacy, although it is legal if done for free. Greece is one of the few nations that permits surrogacy contracts with foreigners, a law that has been on the books since 2014. Georgia, which also permits overseas commercial surrogacy, is moving to ban the practice by next year.

According to Australian media reports, Greek police have kept newborns linked to the surrogacy scandal in a hospital in Crete, barring contact with their would-be parents until DNA testing can confirm genetic links to MFI clients. And with the clinic shuttered immediately after the raid, many other would-be parents have their eggs and embryos caught in legal limbo.

Along with the chaos created by the scandal, it has also shaken the region’s fertility sector to the core. Nikolaos Vrachnis, a distinguished OBGYN in Athens, was fired by the Greek government as president of the Hellenic National Authority for Medically Assisted Reproduction shortly after the arrests were announced.

The content and themes expressed within the article are that of the news. The advertisers do 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 advertisers or of Inside Reproductive Health.

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This News Digest Brought to You by
Future Fertility and LEVY 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.

Northstar Fertility Expands Its Portfolio with Strategic Acquisitions

Include Surrogate Support and ‘Ethical’ Egg Donation

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.

This News Digest Brought to You by
MyEggBank

BY: LISA MUNGER

In a move that expands its reach in the fertility sector, Boston-based Northstar Fertility has announced its latest acquisitions, Surrogacy.com and Everie in calendar 2023, in November and October, respectively. 

In addition to Everie and Surrogacy.com, Northstar's companies include Circle Surrogacy, Growing Generations and Reproductive Possibilities surrogacy agencies. Northstar companies also offer services related to fertility, like insurance coordination, financing and escrow management, according to the parent company, the CortecGroup. Key partners formed Northstar in 2019.

The price tags paired with the acquisitions have not been made publicly available as of this writing. Representatives of Northstar, Surrogacy.com and Everie declined to speak to Inside Reproductive Health for this article.  

These additions to Northstar's already portfolio signal a new era in the fertility space, catering to a growing and increasingly diverse fertility business portfolio, outside of fertility clinic consolidation.

Surrogacy.com, a new platform dedicated to the needs of surrogates, represents a shift in the approach to surrogacy. Niki Renslow, Surrogate Success Manager for Surrogacy.com, said in a prepared statement. 

Renslow said the web community promises to provide candid answers from people with experience in surrogacy, including support networks, education and help in determining if surrogacy itself is an appropriate avenue for consideration. 

A month before the Surrogacy.com acquisition, Northstar acquired Everie, a frozen egg donation company, launching “Mutual Match,” a system designed to foster transparency with donors and recipients. 

Aisha Lewis, president of Everie and a bioethicist, said in a prepared statement that she hopes the new relationship will foster growth and evolve with the field.

"The traditional egg bank system has previously lacked overt consent from donors on who the recipient parents are for their genetic lineage," said Steuart Botchford, CEO of Northstar Fertility in the same statement.

Everie said in the statement that their Medical Director is Dr. Mark P. Trolice, principal of Fertility Care: The IVF Center in Central Florida.

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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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 

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.

This News Digest Is Paid Sponsored Content From
AIVF™

BY NATASHA SPENCER-JOLLIFFE

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

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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AIVF is at the vanguard of transforming reproductive medicine through cutting-edge AI technology. The EMA™ platform stands at the forefront of a technological revolution in reproductive medicine, offering fertility clinics an unparalleled advantage. This platform is not merely a tool; it's a groundbreaking innovation, reshaping the future of fertility treatments. By integrating advanced AI technology, EMA™ elevates the standard of care, bringing unmatched precision and significantly improved success rates to every treatment.

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This News Digest Is Paid Sponsored Content From
AIVF™

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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.

Kindbody and Bloomberg. What started the three article series and what journalist expects next

Media outlet’s coverage, company’s responses

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.

This News Digest Brought to You by
AIVF™

BY: ROSEMARY SCOTT

On Oct. 13, 2023, Jackie Davalos of Bloomberg published her first article on Kindbody, the New-York based end-to-end fertility network, outlining the mishaps some patients reported experiencing at the company’s clinics. The second and third articles covered changes in Kindbody’s financial outlook and a procedure quota for providers, respectively.

These articles led to statements from Kindbody in response, as well as other announcements to defend their reputation in the fertility field.  

What Prompted Bloomberg Coverage

Davalos is a technology reporter at Bloomberg and has been with the company since January of 2020. She typically covers the intersection of tech and business, such as AI products in development and powerful tech companies experiencing financial issues. Davalos told Inside Reproductive Health that originally, Kindbody piqued her interest due to its unique business model–Kindbody states it is the only family-building benefits provider for employers that owns and operates fertility clinics.

“I didn't think that this was going to be as big of an investigation as it turned out to be,” Davalos said. 

In the first article, Davalos outlined alleged understaffing and inconsistent safety protocols that plague many Kindbody clinics, citing “three dozen current and former employees and patients interviewed by Bloomberg.”

Though Kindbody disputed claims of being understaffed, it acknowledged the mislabeling of embryos in at least one case, Davalos reported. In a statement sent to Bloomberg from an unidentified company spokesperson, Kindbody responded by stating that “no Kindbody laboratory has had an incident, accident or other issue that is unusual to what occurs in IVF laboratories generally.”

Cash Burn and C-Suite Shuffle

In November, Davalos published her second article on Kindbody, stating the startup had made significant changes to its 2023 revenue forecast, lowering its goal from $240 million to $186 million and seeking to raise an additional $50 million by the end of the year.

In March 2023, Kindbody founder Gina Bartasi stated in a press release that the company was valued at $1.8 billion. Now, Kindbody anticipates it will not be profitable until mid-2024, according to documents that Davalos says were given to her by unnamed sources. Bloomberg reported that according to these documents, Kindbody is losing an average of about $7 million each month of 2023 through September and spending about $60 million total in that time period.

Just after the November article in which this information was stated, Kindbody published a press release on Dec. 5 in which CEO Annbeth Eschbach said 2023 was an “exceptional year for Kindbody, highlighted by record levels of revenue.” On Dec. 14, the company published another press release detailing its “2023 Year in Review,” with a list of accomplishments over the year, including partnerships forged and positive financial statistics.

Kindbody is also experiencing leadership changes, according to Davalos’s investigation. Davalos stated Kindbody is paying a search firm $750,000 to replace Annbeth Eschbach, though no timeline has yet been determined for this search, and the new hire has yet to be announced. Additionally, she stated, Kindbody’s president, Gregory Poulos, stepped down from his role in September. 

One month later, Kindbody announced that they hired a new chief scientific officer in October. It is also planning to recruit new chief operating and people officers, the sources told Davalos.

Unreasonable Targets vs. Industry Standard, Expanding Access to Care

In an article published Dec. 22, Davalos reported that the company's internal practices have sparked ethical debates among its doctors. The article states that Kindbody executives, during a retreat in September, informed reproductive endocrinologists that they needed to increase their IVF volumes by 12 egg retrievals per month The article reports that the quota aims to increase net income and meet the company's goals for going public. 

According to Davalos, several physicians called the targets “unreasonable” and warned these new measures could result in physicians pushing IVF to women who may not need it. She did not specify exactly how many physicians spoke out. 

In response, Kindbody defended its practices in a statement sent to Bloomberg. Kindbody stated that tying monthly egg retrieval targets to compensation and revenue forecasts is an “industry standard.” Bloomberg did not report on what other fertility networks do or do not follow the same practices.

Shortly after that article was published, Kindbody announced the opening of a new office in the San Francisco Bay Area.

More Bloomberg Articles on Kindbody

For her part, Davalos told Inside Reproductive Health that as long as sources keep coming forward with information, she plans to continue reporting on Kindbody. 

“If there's fresh reporting, and if there's people coming forward, I'm certainly going to report on that as it comes through,” she said.

Neither Gina Bartasi, Kindbody’s founder, or Annbeth Eschbach, CEO, responded to Inside Reproductive Health’s request for comment through LinkedIn or through the company's general press email.

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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With EMA™, clinics can harness the power of AI to navigate the intricacies of reproductive medicine with confidence and finesse

AIVF is at the vanguard of transforming reproductive medicine through cutting-edge AI technology. The EMA™ platform stands at the forefront of a technological revolution in reproductive medicine, offering fertility clinics an unparalleled advantage. This platform is not merely a tool; it's a groundbreaking innovation, reshaping the future of fertility treatments. By integrating advanced AI technology, EMA™ elevates the standard of care, bringing unmatched precision and significantly improved success rates to every treatment.

Free Cost Efficiency Calculator

To learn more on how to optimize your IVF clinic, click the link below.

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This News Digest Brought to You by
AIVF™

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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.

Law Firm Suing CooperSurgical Says More Lawsuits Forthcoming

Firm’s partner suggests that suits may combine into class-action.

This News Digest Brought to You by
MyEggBank

BY RON SHINKMAN 

The Los Angeles law firm of Peiffer Wolf, which is representing two couples suing Cooper Surgical, says that more lawsuits will be filed against the company, their attorney told Inside Reproductive Health.

Two Current Lawsuits Against Cooper Surgical for Destruction of Embryos

CooperSurgical is being sued by two Los Angeles couples who claim their attempts at conception through IVF were derailed by a faulty culturing solution that destroyed their developing embryos. 

The lawsuits were filed earlier this month in Los Angeles County Superior Court, records show. They essentially make identical allegations: CooperSurgical sold culturing media to fertility practices that did not undergo sufficient testing. Those lots of solution “turned out to be toxic to human embryos, eggs, and sperm.”

CooperSurgical issued a recall notice of three lots of culturing media to its customers and distributors on Dec. 5, 2023. Entitled “Urgent Media Recall: Field Safety Notice,” the recall noted “a high volume of customer complaints for the three associated lots.” It also warned that the lots pose a risk of “impaired embryo development prior to the blastocyst stage.”

The lawsuits allege CooperSurgical’s recall efforts “intentionally did not immediately disseminate notice of the recalled lots publicly or throughout the IVF community.”

The plaintiffs in the two cases were referred to by random initials to protect their privacy. The clinics that provided the IVF services were not disclosed and were not named as defendants in the lawsuits.

A.B. and C.D., the plaintiffs in one case, allege that faulty culturing media destroyed all but one of “numerous embryos” within a few days of a fertilized egg being cultured in November of last year. E.F. and G.H., the plaintiffs in the other case, claim that all of their embryos were destroyed last November. 

“Plaintiffs are devastated. They may no longer be able to have additional children with their genetic material as a result of defendants’ conduct,” the lawsuits state.

The litigation seeks damages for product liability regarding design and manufacturing defects and failure to warn, negligence and negligent failure to recall the defective culturing lots.

A spokesperson for CooperSurgical, a subsidiary of Pleasanton, Calif.-based medical device manufacturer The Cooper Companies, told Inside Reproductive Health it does not comment on pending litigation.

More Lawsuits Against Cooper Surgical Could Develop Into Class-Action

Peiffer Wolf partner Adam Wolf said that more lawsuits against CooperSurgical are forthcoming. He currently represents some 20 clients who claim the faulty culturing media damaged their embryos.

“It would not surprise me if we end up representing more than 100 people against Cooper. We will file those additional lawsuits in both state court and federal court.” Wolf said in an email. He noted that some clients are in other states outside of California, necessitating the use of federal courts. He added that he would not be surprised if any lawsuits filed in federal court are combined into a class-action, which could expose CooperSurgical to tens of millions of dollars in damages should the company take the case to trial and lose.

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

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Fertility Clinics Across Globe Grow Egg Freezing Programs with AI-led Tool

Programs scale access to fertility preservation using Future Fertility’s oocyte assessment tool, Violet

This News Digest Is Paid Sponsored Content From
Future Fertility

BY Natasha Spencer-Jolliffe

The number of women electing to freeze their eggs in the US increased to 12,438 in 2020, up from 7,193 just four years prior in 2016, The Society for Assisted Reproductive Technology reported. 

However, a limiting factor to fertility clinics’ egg-freezing programs has remained: patient confidence. Practitioners could not tell patients the quality of their eggs, making egg freezing programs an expensive and stressful gamble.  

Some fertility clinics have been able to dramatically improve their egg freezing programs leveraging an AI-based oocyte assessment tool, Violet. This technology measures egg quality to gain an objective view of the probability of successful fertilization and blastocyst development to help clinics guide egg freezing cycles, empowering patients with personalized insights and improving confidence in clinic decision-making.

Growing clinics’ egg freezing programs through a stronger patient experience

The AI tool informs patients about their fertility health, helping to guide patients’ next steps and aiding practitioners in attracting patients to their egg freezing programs.

Professor Alison Campbell, Chief Scientific Officer at Care Fertility Group, first heard of Violet several years ago following a presentation by Future Fertility’s co-founder Dr. Dan Nayot, a reproductive endocrinologist. “I had to investigate!”, she shared. 

“I was very skeptical about the power of AI to predict quality or viability potential from a photograph of oocytes in the IVF laboratory,” Professor Campbell added. With no standardized visual scoring system in place, evaluating oocyte quality had previously not been possible by embryologists.

Professor Campbell’s clinic network, Care, went on to become the first in the UK to adopt Violet and is now using the tool in all egg freezing cycles. “Having data like this from Violet helps clinic staff have more meaningful conversations with patients to support their decision-making and fertility planning,” she continued.

“The first question all patients opting for the oocyte freezing programs have, is how many oocytes they need to freeze to have a viable embryo,” said Dr. Ernesto Escudero, Gynecology Fertility Specialist at Inmater, a fertility clinic in Peru that has been using Violet for over a year now.

“Violet is a very helpful tool to show patients the real number of oocytes they need to store for, not just their age, but also for the viability of each oocyte,” he added.

These insights are guiding counselling conversations and helping patients connect the clinician’s treatment recommendations with their own personalized data – for example, when egg quality is lower than expected for their age and additional retrievals are recommended to give them the best chance of reaching their family planning goals. 

Violet is also filling a gap in ensuring patients have appropriate expectations for the usage of the frozen eggs in the future – information that, until now, has been shared only in terms of general estimates, based on population health statistics that consider only the patient’s age and number of mature eggs retrieved. 

Delivering this level of information and building a relationship of trust means these patients are more likely to return for future treatments, enabling clinics to grow their programs. This also helps create a positive reputation in the patient community, helping to attract new clients through differentiated service levels. 

Dr. Sergio Papier, Medical Director and CEO of CEGYR in Argentina, attests to this approach – his clinic has adopted Violet as part of every freezing cycle as the clinic expands its precision medicine program. “It is a tool that we have quickly incorporated for all patients,” he says. 

AI tools scale access to fertility preservation through standardization and repeatability

“AI has the potential to improve reliability, accuracy, efficiency, and reproducibility in the IVF lab and wider clinic,” Professor Campbell relayed. Using advanced deep learning technology to evaluate oocyte images, Violet answers the need for more certainty regarding oocyte quality. 

“My concern has always been to have an objective biomarker that can evaluate oocyte quality, the most important variable in the results of ART,” said Dr. Papier. It was this interest that led Dr. Papier to discover Violet. The AI tool not only informs treatment planning but also provides clinics with new research projects, exploring the impact of clinical and lab variables on oocyte quality.

“It’s very important in a lab to have tools that will help achieve better pregnancy rates and reduce time to pregnancy – AI is the future for that,” comments Dr. Escudero.

Future Fertility’s technology has also proven to integrate seamlessly with existing lab set-ups and workflows. “It doesn’t need to alter what the clinical embryologists do with the eggs, in terms of cryopreservation, and it can help the team counsel patients, set their expectations, and aid their decision-making,” said Professor Campbell.

“Future Fertility makes AI accessible to IVF laboratories,” she highlighted, detailing how the company stands out as the go-to AI egg-freezing tool. 

“They have a strong expert team and work closely with clinics to educate staff and implement their technology,” added Professor Campbell. Care Fertility has seen its egg freezing program grow since implementing the tech.

“Without a doubt, Violet is a very useful tool for evaluating oocyte quality and gives doctors, biologists and patients a more objective perspective of potential future results,” shared Dr. Papier.

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

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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.

Red to Green: The UK's System for Rating IVF Add-Ons compared to US

Thirteen add-ons have been evaluated by a British public agency. In U.S., fertility patients and doctors are mostly on their own.

This News Digest Brought to You by
AIVF™

BY RON SHINKMAN

The United Kingdom is not only the birthplace of IVF, but of a distinctive ratings system of “add-on” services unique among developed countries.

In 2019, U.K.’s Human Fertilisation and Embryology Authority – an affiliate of its National Health Service – introduced a rating system on add-on services. First known as “Traffic Light,” the ratings initially followed a color-coded system of green, yellow and red. However, the ratings expanded earlier this year into five colors, according to an HFEA spokesperson.

A green rating means the add-on can improve the outcome; yellow means improvement is unclear. A black rating means the add-on has no impact on the treatment outcome. A red rating means the add-on could actually degrade the chance of a positive outcome, or even pose safety concerns for the patient. A gray rating means there is not enough clinical evidence to evaluate the add-on.

The ratings are based on research and analyses conducted by an HFEA subcommittee called the Scientific and Clinical Advances Committee. Currently, 13 add-ons have received grades. They include assisted hatching, endometrial scratching, PGT-A and time-lapse imaging and incubation. The ratings are for the procedures only, and do not apply to individual companies. However, “in line with the HFEA Code of Practice, clinics must give patients a clear idea of what any treatment add-on will involve, how likely it is to increase their chance of a successful pregnancy…how much it will cost, and link to the HFEA ratings system,” said HFEA CEO Peter Thompson said in a statement on the agency’s website.

No add-on has received a green rating. All-cycle elective freezing, endometrial scratching and a process known as “EmbryoGlue” have all received yellow ratings. IVIG, the use of glucocorticoids and endometrial receptivity testing have all received red ratings. IMSI, assisted hatching, immunological testing and treatments for fertility and intrauterine cultures all received gray ratings.

“I don’t think there is anything like this in any part of healthcare in the U.S.,” said Sean Tipton, chief advocacy and policy officer for the American Society for Reproductive Medicine. Tipton added that the fact the United Kingdom has a nationalized single-payer healthcare system means the government takes a much larger role compared to other countries in assessing and rating treatments.

Kate Devine, M.D., an OBGYN who works as medical director and chief research officer for Shady Grove Fertility, noted that patients and clinicians in the U.S. are largely on their own regarding the use of add-ons.

“Unfortunately, in the U.S. patients and their physicians must decide on a case by case basis whether there is enough evidence to warrant the additional cost, time, and/or discomfort entailed by IVF add-ons,” she said.

That’s further compounded by the fact that many fertility patients have done deep research on reproductive medicine and are highly driven to succeed. “They are often willing to try anything and everything, and sometimes beg for unvalidated add-ons,” Devine said.

As for Shady Grove, Devine said that it prefers to offer only add-ons that have a clear benefit, ideally proven through clinical trials. Devine said the practice conducted a randomized controlled trial on endometrial receptivity testing that was published in JAMA late last year.  Igenomix, the biotech company that created the add-on, collaborated, by providing free embryo genetic testing and endometrial receptivity testing to patients who participated in the study. The conclusion: Such testing doesn’t improve the chances of a pregnancy. “It should not be offered on a routine basis,” Devine said.

As for Shady Grove, Devine said that it prefers to offer only add-ons that have shown efficacious results in clinical studies. Devine said the practice sponsored and was the investigator for a study published in JAMA late last year on endometrial receptivity testing. The study was conducted with the cooperation of Igenomix, the biotech firm that created the add-on. The conclusion: Such testing doesn’t improve the chances of a pregnancy. “It’s not something that should probably be offered,” Devine said.

What guidance is offered to patients in the U.S. is more informational than advisory. For example, ASRM has materials on its website regarding add-ons and research about their outcomes, but none of the material is rated in any fashion.

“Our (medical) practice committees and other committees are in the business of trying to inform our members with the latest research so they can better inform their patients,” Tipton said.

However, translating such communications for the general public is complicated. Too high a level of detail overcomplicates the ability to make a decision about a specific add-on. But Tipton also believes that the Traffic Light system oversimplifies the issue.

“There is no way to control (for a specific patient),” he said. “Maybe it’s a green light for me, and maybe it’s a yellow light for somebody else, based on what the underlying conditions are.” Tipton noted that may be the “price to pay” to have a ratings system that is simple for everyone to understand.

Whether the U.S. ever gets an official rating system for add-ons remains in the air. But Devine noted that patients are going to keep coming in for treatment no matter what. 

“Until these things are proven, the better part of valor is to keep calm and transfer another embryo,” she said.

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

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Private Equity Backed Solutions to REI Shortage. ASRM, SREI Oppose Reducing Fellowship Length

Inside Reproductive Health follows up on fall Wall Street Journal article

This News Digest Brought to You by
The Prelude Network

BY: MALLIKA MITRA

Fertility clinics still face a shortage of specialists to meet the demand for their services. 

Proposed solutions include funding for REI fellowships from private equity-backed clinics — and shortening the length of Fellowship. Inside Reproductive Health followed up on the Wall Street Journal’s report of the debate, published in early October. 

Funding REI Fellowships 

There are just 49 reproductive endocrinology and infertility fellowship programs in the 2022-2023 academic year, according to the Accreditation Council for Graduate Medical Education (ACGME). In the past five years, there has not been an unfilled reproductive endocrinology position once matching algorithm was processed — every available REI position in the matching program was filled, data from the National Resident Matching Program shows. Data on obstetrics and gynecology fellowship matches for the 2024 appointment year show there is just one reproductive endocrinology fellowship unfilled. 

More recently, private-equity-backed private practices are showing an increased willingness to self-fund fellowship programs, said Rachel Weinerman, MD, of the University Hospitals Fertility Center. The challenge is that the goal of private equity may not align with that of academic practice, Weinerman said: The goal of private equity backed groups may be to increase profitability while the goal of an academic practice is to train a well-rounded fellow who is able to further scientific knowledge in the field.  

Dr. John Storment, an REI practicing in Louisiana, said there isn’t an issue with allowing private equity to help with the growing demand for REI fellowships as long as the fellowships and training remain pure and without any strings attached. 

“We have to maintain our integrity… and not let the industry dictate how we treat patients,” Storment said. Private-equity backed fellowships should not have different admission criteria, job benefits, salaries or opportunities than other fellowships, and they can’t be allowed to require a fellow to later join the private practice that’s providing the training, he added.  

Storment said he is not afraid that private equity funding is currently compromising integrity. But ensuring it stays that way should be a top priority, he added.   

Beth Zoneraich, CEO of Webster Equity Partners-backed Pinnacle Fertility, said multiple options need to be considered to meet demand. She is working on creating a program with key industry partners to train OBGYNs to assist REI physicians in practicing fertility treatment. She said that with appropriate training and REI supervision, OBGYNs could support REI physicians by performing initial fertility assessments, basic fertility workups and various REI procedures. They can also oversee routine follow-ups and monitor patient responses throughout the treatment process, guided by REI physicians, she adds. 

“When you look at needing to meet a supply-demand imbalance, certainly increasing the number of REIs — either through reducing the time of the fellowship or increasing the number of fellowships — are both options that should be considered. But also looking to OBGYNs to help is critically important,” Zoneraich said. 

Potential of Shortening the REI Fellowship

The REI fellowship was initially two years but was expanded to three years to account for an extra year of research. There is now talk in the industry of shortening the fellowship back to two years in an effort to increase the number of fellows. 

“The importance of training motivated, talented researchers in the field of REI should be maintained as a paramount goal,” said Kate Devine, M.D. and medical director and chief research officer at US Fertility, which is owned by Amulet Capital Partners. “That said, we can't turn people who are not researchers into researchers, and that is the rationale behind potentially shortening the fellowship to two years, rather than paying to support 18 months of research training for every REI in training.” 

Jay Rose, managing partner and co-founder at Amulet Capital Partners could not be reached for comment. 

Devine added that shortening the fellowship to two years could be a good solution if and only if two things were guaranteed: extra funds that would result from shortening the fellowship were used to train additional fellows, and that funds would be earmarked to provide the best possible training to those trainees who were motivated and talented in research. 

An ad hoc committee of the Society for Reproductive Endocrinology and Infertility (SREI) co-authored a white paper, which was endorsed by the American Society for Reproductive Medicine (ASRM), in September that recommended not shortening the fellowship to two years. 

“Our lens is that of what’s best for patients, what’s best for patient care and what’s best for our trainees so that they can go out and optimize patient care,” Erica Marsh, president of SREI and board member of ASRM, told Inside Reproductive Health. “That generally requires that they spend time learning about not only the physiology and pathophysiology of the diseases that we treat, but also understanding how to interpret research and apply research findings to clinical care independent of whether or not they ever conduct research.” 

OBGYN and Advanced Practice Provider (APP)’ roles 

TJ Farnsworth, CEO of Lee Equity Partners-backed Inception Fertility, said more practices have to better utilize APPs to the highest level of their licenses to try and improve the capacity of REIs. That would include more complex ultrasounds, IUIs, pre-consult workups and minor procedures. He added that there’s a move toward using generalist OBGYNs to provide fertility care, but his company has decided not to do that at this point. 

“Using generalists as part of fertility practices to me makes sense as long as you’re talking about them doing general care,” Farnsworth added. That may include hysteroscopies, HSGs, and surgical cases so that the REI can focus on fertility patients.

Zoneraich agreed that there are places where APPs can and should do tasks that they are able to do instead of having the physicians do them, such as monitoring ultrasounds, baseline testing, consultations for less complicated cases and intrauterine inseminations (IUI). That will give physicians the ability to do more new patient consults or follow-up consults, for example, she added.

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

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

Simplified psychological evaluation for donors, gestational carriers, and intended parents revolutionizes third party IVF

Texas Fertility Center saves $100 per donor evaluation, Northstar Fertility portfolio company ensures compliance

This News Digest Is Paid Sponsored Content From
Mind360

BY: Rachel Leland

The lengthy, arduous process of conventional psychological evaluations often stalls fertility journeys for weeks or months, but a new telehealth platform is already speeding up the process while improving screening quality.  

You can send people to Labcorp to get a lab almost right away. You can get several screening tests done in a very short period of time, Mind360 executive director Julius Varzoni said. “[The psychological screening] was the only one that was taking weeks to get done…and we brought it down to a couple of days.”

Mind360 allows potential donors, gestational carriers, and intended parents to book a virtual psychological evaluation in 30 seconds with just a few clicks. Within two business days after the appointment, clients receive a comprehensive report of the assessment with all the ASRM criteria included.

As of November, roughly 167 million Americans live in an area with mental health provider shortages, with over 8,000 more providers needed to ensure adequate care. The average wait time to see a mental health professional is six weeks, according to the National Council for Mental Wellbeing.

Northstar Fertility portfolio company ensures compliance

Everie, the newest addition to Northstar Fertility’s portfolio, works with donors from across the country, which made finding qualified mental health professionals in every state a donor lived in cumbersome. 

“Before Mind360, we really had to make a lot of different relationships to ensure we were in compliance and then we had to nurture those relationships because we wanted to have reports that were similar even though we had been working with several businesses to get the job done,” Everie President Aisha Lewis said.

Furthermore, even available mental health professionals may be unfamiliar with the standards for third-party psychological evaluation set forth by the American Society for Reproductive Medicine. 

While Mind360 employs Ph.D. psychologists to conduct screenings, clinics often hire social workers, Varzoni said, adding that even then, thorough screenings are not guaranteed and some practitioners charge more for specialized services.

Silverberg: TFC saves $100 per mental health eval

Before partnering with Mind360, Texas Fertility Center would refer potential donors to local mental health professionals in Austin, but test results were not as specialized as desired, Dr. Kaylen Silverberg said. 

“It’s kind of like forcing a square peg into a round hole,” Silverberg said. “People don’t just do this, they do all kinds of therapy for different patients. We’ve allowed patients to use their own therapists and their own therapists who may not know anything about reproductive services or the questions we’re getting at. Here we see a lot more consistency.”

Silverberg estimated that Texas Fertility Center had saved up to $100 per evaluation since partnering with Mind360. 

In some areas of the country, the savings add up to 50% through utlizing Mind360’s services, Varazoni said.

Organic Growth

Since launching in August 2022, Mind360 has grown its business to 25 clients, including Cryos,  Fairfax EggBank, Nodal, and the recently launched Everie. By December, Mind360 will have conducted 2,500 psychological screenings in its first year, Varzoni said. 

Clients like Lewis said Mind360's most considerable value wasn't simply cost or time savings, but the personal attention its psychologists provide.

Often, when working with non-specialists in mental health, clinics or egg banks need to inform potential donors if they failed the screening, but Lewis prefers how Mind360 psychologists inform the donors directly. 

“I think, if the donor is not a good fit for the organization right now, that's a conversation that should be had at that level of the psychologist and donor, so they do that and I appreciate that. I really appreciate that,” Lewis said.

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

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Wait time for third party IVF mental health screening reduced from six weeks to a few days

Mind360 shares their average psychological evaluation wait times and cost savings for intended donors, recipients, and gestational carriers.

Don’t let cost or limited availability delay your patient’s cycle. Download Mind360’s informational report to find out how quickly this process can be completed and compare it to your own services.

Mind360 provides:

• Seamless online booking

• Immediate availability

• Telehealth appointments

• ASRM trained psychologists

• Compliance with ASRM and FDA recommendations 

Learn how your clinic’s process can be sped up and improved by clicking the button below.

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This News Digest Is Paid Sponsored Content From
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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.

IVI RMA’s Plans for Boston IVF’s Stern, TRIO’s Condon, brands, staff, after $535M Eugin Sale

The two chains are part of the assets the KKR-owned IVI RMA and GED Capital has just bought from the Eugin Group.

This News Digest Brought to You by
Family Inceptions

BY: RON SHINKMAN

IVI RMA has pursued one of the largest acquisitions of a reproductive medicine group in the United States, agreeing to acquire the North American assets of the Eugin Group – including Boston IVF and TRIO – as part of a larger deal to buy the entire company.

The transaction sheds a little light on how private equity firm KKR – which owns IVI RMA  – will consolidate and manage its recent dive into reproductive medicine. KKR finalized its acquisition of the Spanish-based IVI RMA earlier this year for $3.2 billion.

In conjunction with Spanish private equity firm GED Capital, IVI RMA is acquiring the Eugin Group assets for around $535 million from Fresenius Helios, the German-based hospital operator and dialysis giant. 

While IVI RMA will own and operate the Eugin clinics in the U.S. and Canada, GED Capital will own and operate the three-dozen clinics in Spain, Italy, Sweden, Denmark, Latvia and Portugal. It will also operate the Latin American properties in Brazil, Argentina and Colombia, GED spokesperson Alicia Hernández told Inside Reproductive Health.

A spokesperson for IVI RMA told Inside Reproductive Health that the acquisition of both Eugin’s North American and global operations are part of the same transaction. He declined to break out terms for the U.S. portion of Eugin’s assets. Hernandez also declined to break out terms for the GED portion of the purchase, but noted that the European and Latin American operations generate about $110 million in annual revenue.

Fresenius acquired Eugin less than three years ago for around $460 million from NMC Health. 

A KKR spokesperson has not responded to a request seeking comment.

IVI RMA’s acquisition includes two fertility clinic chains: Boston IVF and the Toronto-based TRIO. IVI RMA’s footprint in North America will expand from its current 29 clinics and 10 laboratories to 62 clinics and offices and 23 laboratories. Altogether, the combined enterprise will have more than 4,000 employees in North America.

There are no plans to rebrand Boston IVF and TRIO. The IVI RMA spokesperson said both will continue to operate under the same names.

“IVI RMA in other parts of the world have multiple brands in countries like Spain and Italy, so it’s not unusual for them to do that,” Boston IVF CEO David Stern told Inside Reproductive Health. He added that he will continue with the company in the same position.

The IVI RMA spokesperson also confirmed that TRIO CEO Nicole Condon will remain with the company. Condon could not be reached for comment. Both Stern and the company spokesperson said there are no layoffs planned after the acquisition closes.

Meanwhile, IVI RMA’s U.S. division recently named Lynn Mason as its president. The spokesperson said she will oversee all of the operations for IVI RMA, TRIO and Boston IVF.

“We’re actually continuing to expand and grow our network,” Stern said. He noted that Boston IVF recently opened a new clinic in Rochester, N.Y. Another expansion is planned for Springfield, Mass. before the end of the year. That new clinic will be based at the Baystate Medical Center in Springfield and be called Boston IVF at Baystate, Stern said. He suggested that expansion would continue in conjunction with IVI RMA.

“We’re really excited, because IVI RMA already has a strong brand in the United States and globally,” Stern said. He added that IVI RMA is also very strong in terms of research and training, and that Boston IVF’s ongoing fellowship programs with Harvard Medical School and Beth Israel Deaconess Medical Center in Boston will complement IVI RMA’s existing fellowship programs.

Stern said he expects the acquisition of the Eugin Group’s North American assets to close during the first quarter of 2024, in line with when IVI RMA said the entire Eugin acquisition will close.

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

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All external links active as of 11/16/23.

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

The hidden threat to third party IVF. Are ethically sourced eggs being used in your clinic?

In an underregulated industry, its critical that clinics step up to ensure their practices are ethical

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

BY: Rachel Leland

While human trafficking for sexual exploitation is widely acknowledged, exploitation in the fertility industry lurks under the radar.

In August, Greek authorities arrested eight suspects connected with a Crete fertility clinic for allegedly exploiting vulnerable foreign women who were used as egg donors and surrogate mothers. 

Allegedly the directors of the clinic recruited brokers to locate and extract consent from vulnerable foreign women to transport them inside Greece where they were subjected to substandard treatment, and in some cases had their eggs harvested before becoming surrogate mothers according to a Greek police news release. 

Between 2015 and 2018, Indiana University Ph.D student Polina Vlasenko studied Ukraine’s ova market as part of her dissertation, interviewing over 100 egg donors, surrogates, medical professionals and fertility brokers. One egg donor admitted to donating 24 times across India, Georgia, Cyprus and Ukraine! 

More concerning, some U.S. fertility clinics and egg banks may be selling eggs retrieved from exploited donors in developing countries, without patient knowledge, Diana Thomas, Founder and CEO of The World Egg & Sperm Bank said.

Thomas said what first set off the alarm that stateside practitioners were entering foreign data into their CDC records that showed egg retrievals were not from U.S. donors. 

“It just struck me that this is rampant and it’s not being disclosed to potential parents, to doctors, to embryologists,” Thomas said. “You have these arrests going on around the world where they're walking into clinics and arresting the secretary, the embryologist, the doctor and then the organized criminals who are brokering the donors to get them there.”

Thomas performed an informal survey of 185 embryologists and asked them if they knew the origin of the eggs they were warming in the lab. Only half of respondents said they knew.

When it comes to accountability, the waters are murky. The FDA’s regulation of human tissues has a loophole that is widely abused in the industry according to Thomas. While the regulation requires foreign establishments that import human tissue register and list with the FDA, registration is not the same as pre-market review. 

Still, regulators are stepping up and industry professionals should take notice, Thomas said.

Clinics risk a huge financial loss in potentially using trafficked eggs. The U.S. ratified the UN’s human trafficking protocol which demands repatriation of profits made from human trafficking. 

In addition, to legal accountability the reputational consequences for a clinic that uses human trafficked eggs will be catastrophic. 

Though Thomas feels that the industry is not currently regulated sufficiently, she believes that individual egg banks and fertility clinics can take steps to ensure they aren’t using eggs from trafficked victims. At The World Egg & Sperm Bank all donors must provide two forms of ID, undergo internal and independent psychological and medical interviews and be a U.S. resident. 

“We’ve got to do something to save this industry,” Thomas said. “If we're labeled as human traffickers, we are going to start having all of this regulation come down and nobody really wants that when we can self regulate right now.”

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

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Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

---

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 10/16/23.

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

Meikle’s and Larkin’s New Roles at The Fertility Partners

Larkin one of two fertility CEOs to take top job at other network

This News Digest brought to you by
The World Egg & Sperm Bank

BY: Lisa Munger

The Fertility Partners (TFP) announced Derek Larkin as its new CEO on August 16, the same month that Cara Reyman took over as CEO of First Fertility, Larkin’s old post. Reyman was the CEO of a different fertility clinic network, Fertilitas, from July 2022 to July 2023.

Andrew Meikle, founder of TFP, served as the company’s first CEO from September 2019 to August 2023. Meikle will continue to serve as founder and executive chairman as the transition occurs to supporting partner relationships, corporate development and strategic decision-making. 

The Fertility Partners, founded in 2019, is a network of fertility practices with 36 clinic locations across North America, including 14 IVF centers. With more than 75 physicians and 1,000 employees, TFP operates in six provinces in Canada.

Larkin's experience extends beyond his time as CEO of First Fertility from May 2020 to July 2023. He held various leadership positions over a span of 12 years at Boston IVF, including CEO. In his roles at Boston IVF, Larkin demonstrated developed expertise in managing operations and guiding strategic direction, according to TFP. 

This background places him in an ideal position to lead TFP and further enhance its offerings to partner clinics, according to TFP. 

"My life's work has been in fertility, striving to improve the patient experience along their journey of family building," Larkin said in a statement. “I am excited to continue to lead this amazing organization with that purpose.” 

“This is a transformational time in our business, and we are very excited to have Derek guide the TFP team as we continue our growth across North America,” Meikle said in a statement.  “We have a tremendous alignment of vision and values, and his extensive operational expertise, sector knowledge and leadership will enhance our offering to partner clinics.”

Dr. Brijinder Minhas was a partner and COO at NewLIFE in Florida for 22 years before it was acquired by First Fertility in 2022. MidCap Advisors were investment bankers. After the sale, Minhas joined MidCap as vice president of healthcare.

“It is important that management companies truly understand the nuances of the practice they are dealing with,” Minhas said. 

“Having managers and C-suite folks with prior fertility experience, in my opinion, is essential and leads to a much more productive and profitable relationship … The reasons for the shake-up at First Fertility are not known. A good warning for other CEOs: ‘Hire the right team and keep both the practices and private equity bosses happy.’ Ultimately, clinicians want to provide the best patient care, and management partners want to maximize profitability. A good balancing act is required.”

Meikle and Larkin declined to comment on the transition for the purposes of this article.

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

Amplification:
10/4/23, KKR Moves to Acquire Eugin Group for $525M, Fresenius declined to comment about the Eugin deal.

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Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

---

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 10/12/23.

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.

KKR Moves to Acquire Eugin Group for $525M

The deal would make the investment banking firm one of the biggest global players in the fertility space.

This News Digest brought to you by
The World Egg & Sperm Bank

BY: RON SHINKMAN

Months of speculation as to which company would have the resources to purchase the massive fertility network the Eugin Group has narrowed down to a single candidate: Investment banking giant KKR. The deal could help it become one of the biggest global players in the fertility sector.

The Spanish media outlet CincoDías reported this week that KKR has entered into exclusive negotiations with Eugin’s parent company, Fresenius Helios, to make the purchase for an estimated $525 million. The investment banking firm Lazard is also involved in the transaction, according to CincoDías. Lazard helped Fresenius in consummating a $551 million biopharmaceutical acquisition last year.

KKR has been making significant inroads into the fertility space in the past couple of years. It acquired IVIRMA for about $3.2 billion earlier this year. It performed nearly 80,000 IVF cycles in 2021, primarily in Europe, but it also has clinics in the U.S. and Latin America. KKR also acquired the smaller GeneraLife Group last year, which performed some 25,000 cycles in 2021. It operates 30 clinics in Spain, Italy, the Czech Republic, Sweden and Portugal.

A KKR spokesperson declined to comment. Spokespersons for Fresenius and Lazard did not immediately respond to requests seeking comment.

Eugin operates 69 clinics in 11 countries on three continents, performing 45,000 cycles a year. And it is a big player in North America, owning and operating the Boston IVF network and TRIO, one of the biggest fertility practices in Canada. It also has a significant footprint in Latin America, with clinics in Colombia and Brazil. In Europe it has a large presence in Spain, along with clinics in Italy, Latvia and Sweden. 

Although Fresenius has only owned Eugin since late 2020, it is not a core business for the company, which is a leading dialysis provider in the U.S. and operates more than 80 hospitals in Europe. It has been under pressure to divest Eugin after Elliott Investment Management acquired a large stake in the company about a year ago and its management expressed dissatisfaction with Fresenius’ financial performance. The company’s stock has risen by about 33% since Elliott purchased the stake, although shares dropped about 7% since the news of a potential sale to KKR was made public.

Robert Goodman, vice president in charge of healthcare for New York City-based MidCap Advisors, said a sale to KKR makes sense. 

“It is a very large, very savvy firm that has made some big inroads into healthcare, and they are clearly a company with the capacity to do this,” Goodman said. He added that if KKR were to close the deal, it would likely use all its recent acquisitions to become the predominant player in the fertility space. 

“They will have a big footprint to get it started, and if they have their eyes on that prize, they have the capability,” Goodman said. “There’s no question about that.”

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

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Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

---

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 10/5/23.

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.

Why Amazon Chose Maven for Fertility Benefits in These 50 Countries, Sticks with Progyny in US, Canada

The partnership will provide free fertility and family building coverage to Amazon employees in 50 countries outside the U.S. and Canada.

This News Digest brought to you by
The World Egg & Sperm Bank

BY: ROSEMARY SCOTT

Amazon employees in 50 countries outside the U.S. and Canada will soon have access to free fertility and family-building services as part of a newly-formed partnership with Maven Clinic, the world’s largest virtual clinic for family and women’s health.

Amazon employees will have access to virtual appointments and referrals to local clinics and providers, including board-certified reproductive endocrinologists, obstetricians, gynecologists, nutritionists, mental health providers, adoption coaches and others. This coverage includes IVF, though neither Maven Clinic or Amazon could provide Inside Reproductive Health with specific information regarding how many IVF cycles are covered for each patient. 

Coverage will extend to full-time, part-time and hourly Amazon employees in the following countries:

• Europe: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, Greece, Iceland, Poland, Portugal, Norway, Republic of Serbia, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom

• Asia / Pacific: Australia, India, Indonesia, Japan, South Korea, Malaysia, New Zealand, Philippines, Singapore, Thailand, Vietnam

• Latin America: Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, Peru

• Middle East and Africa: Bahrain, Egypt, Israel, Jordan, Kenya, Kuwait, Mauritius, Morocco, Nigeria, Saudi Arabia, South Africa, Turkey, United Arab Emirates

Maven Clinic was the first female-focused health start-up valued at over $1 billion and currently manages the care of over 17 million patients through partnerships with hundreds of other companies, including Fortune 500s such as Snap Inc. and Buzzfeed. 

Still, as the world’s second-largest employer with over 1.5 million employees, this partnership with Amazon is a large undertaking for Maven. Amazon told Inside Reproductive Health that it chose Maven due to the company’s global presence and its flexible, digital-first approach that tailors coverage to each individual’s needs. 

Neel Shah, Chief Medical Officer at Maven Clinic, told Inside Reproductive Health that one of the primary challenges of offering fertility services on a global scale is accessibility. Maven is able to work around this challenge by offering a digital first approach, in which each patient is matched with a “Care Advocate” employed by Maven who can meet virtually with patients to offer advice and referrals to the best providers and IVF clinics in the patient’s area.

In some places, Shah said, this is easier than others. For example, he said that in the U.K., there is ample third-party data available in which Maven can determine the quality of each clinic and recommend the best option to their patients. In other countries, he said, that data isn’t available, so Maven has to perform its own vetting process. 

Ultimately, each patient’s care is up to them, and their needs will vary based on their physical locations and reproductive journeys. There are about 4,000 clinics in Maven’s global referral network, but if a patient wants to visit a clinic not recommended by their Care Advocate, “We don’t tell people that they can’t go somewhere,” Shah said. 

Since 2019, Amazon employees in the U.S. and Canada have had reproductive health coverage through Progyny, which has served more than 30,000 Amazon employees since the partnership began. 

Though Progyny was founded in 2008, its larger success began after a rebrand in 2016 and an IPO in 2019. Before Amazon’s partnership with Progyny in 2019, the company’s reproductive health benefits were bundled with its larger benefits package as confirmed by Brad Senstra, CEO of ReproTech and former executive director of Seattle Reproductive Medicine. 

Senstra told Inside Reproductive Health that before 2016, it was much less common for employers in the U.S. to offer fertility benefits, and those that did provide coverage put a cap on how much employees could spend on their treatment, ultimately resulting in lower success rates for patients and higher costs for employers. 

Senstra said that Amazon’s decision to partner with Progyny for its reproductive health coverage in 2019 was likely due to Progyny’s unique benefit structure that did not put a cap on coverage.

Only time will tell if Maven Clinic’s partnership with Amazon will have a similar butterfly effect outside the U.S. In the meantime, Shah said, Maven’s goal is simple: “to provide the best possible care to as many Amazonians as possible.”

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

---

Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

---

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 9/28/23.

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.

Twig Fertility secures second round of funding through Rhino Ventures in an $8 million CAD investment

Plans to open one more clinic in Ontario, expand to other provinces

This News Digest brought to you by
The World Egg & Sperm Bank

BY: Meg St-Esprit

In Toronto, Twig Fertility has secured a second round of funding from the venture capitalist firm Rhino Ventures, totalling $8 million CAD. 

Zach Shapiro, the co-founder and CEO of the startup says he and his co-founder Dr. Rhonda Zwingerman, who is also the medical director of Twig, needed capital, guidance, and alignment in vision to take their clinic to the next level. "We are beyond excited to be growing the Twig footprint and bringing our elevated, modern, tech-forward patient experience to more Canadians,” says Zwingerman. 

The first round of funding, which they’ve chosen not to disclose an amount for, was secured through family and friends. To grow, however, the team needed to look beyond their circle. Shapiro says venture capital funding is not a common choice. “Venture capital firms and private equity have different parameters.” Since the clinic had recently opened, Shapiro said they did not have the cash flow that private equity firms generally want to see, but this was not the sole reason they explored venture capital funding. “It was really about finding the right people, and to us they just blew us away.”

In the Toronto infertility market, there is a need for both more clinics and more focused care, says Samantha Diamond, co-founder and CEO of  Bird&Be, also located in Toronto. Bird&Be provides supplements and fertility supplies aimed at giving patients more successful outcomes. “We do know that if you zoom out, about 30% of Canadians live in provinces that don't have IVF funding, and there are out of pocket expenses like IUI/IVF medication, alternative medicine, and supplements that are sometimes not covered in provinces that do have coverage.” 

That’s why improved technology and patient care are critical, says Shapiro. Twig Fertility plans to open two more clinics — one in Ontario and one outside of the province, but they say they don’t yet know where. Tech, Shapiro says, means patients are more likely to have a successful cycle.

 “We are always paying attention to how we can use data to achieve best outcomes in the industry and using analysis to help our patients in the best way we can,” he says. For example, more advanced electronic medical records and storage systems require less administration time — the investment in software pays off in a better bottom line and more face-to-face time for patients. Shapiro is also interested in some of the automated sample storage systems in use in the U.S., but they are not yet approved in Canada. Twig plans to stay abreast of upcoming reproductive tech that will improve patient experiences and outcomes. 

At another Toronto clinic network, The Fertility Partners, medical director Dr. Dan Nayot says a focus on expanding clinic space and the use of technology makes sense in the Ontario market. While the majority of clinics in the province are located in Toronto, there are still wait times at most Canadian clinics — and they tend to be much longer in less populated areas. Nayot says wait times vary, and Shapiro adds that in his experience most waits are around three to four months long. “All of us in the field are hoping to increase access to care and improve the patient experience,” says Nayot. “We want to improve the treatment protocols and success rates. The whole field is trying to increase accessibility, and we are all hoping to use tech to enable that.”

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

---

Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

---

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 9/21/23.

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.

Jinxin Fertility, 3rd Largest IVF Provider in China, Revenue and Stock Reports

Down in revenue, volume from 2021 to 2022, reported that Insiders bullish on stocks, growth

This News Digest brought to you by
BUNDL

BY: RON SHINKMAN

With a population of 1.4 billion, China is one of the world’s biggest markets for IVF services. Jinxin Fertility Group Ltd., based in Chengdu in Eastern China, is among its biggest players.

The stock analysis site, Simply Wall St, reported in June that company insiders have secured a larger position of Jinxin, buying approximately HK$54m worth of shares – or about $6.9 million in U.S. dollars – in the 12 months prior to the article, but Inside Reproductive Health wasn’t able to independently verify Simply Wall Street’s figures with information from the Hong Kong Stock Exchange.

Background on Jinxin Fertility

Although Jinxin’s history of operating hospitals and clinics dates back to the early 1950s, Jinxin Fertility’s focus on reproductive medicine began in 2003. A group of physicians formed Jinjiang IVF Center in Chengdu that year; the practice joined Jinxin in 2010, according to a company stock prospectus issued in 2019.

Today, Jinxin Fertility Group operates eight clinics at hospitals it owns in China, along with another clinic it operates jointly, the Chengdu Jinjiang District Maternal and Child Health Hospital Reproductive Medicine Center.

Jinxin also has a footprint in the U.S. after it acquired HRC Management in December 2018. HRC operates a chain of nine clinics in Southern California stretching from Los Angeles to San Diego. It also has a relationship with USC Fertility Clinic in Los Angeles that includes a fellowship program to train more physicians in reproductive medicine, according to Jinxin’s most recent annual report.

The company made an initial public offering on the Hong Kong Stock Exchange in 2019. Its stock price debuted at around $1.24 U.S. It was recently trading at around 57 cents U.S. per share.

Executive Leadership

Jinxin Fertility CEO Sunny Dong was named CEO in April 2020 after serving as CFO and board member for an affiliate, Jinxin Medical Investment Co. Dong, who is in his mid-30s, previously served as a director with the China asset management arm of Dongxing Securities in Hong Kong, as well as accounting/business consulting giant PwC, according to his LinkedIn profile. He did not respond to written questions for comment, nor did another executive with the firm.

Volume, Revenue and Competition

Last year, Jinxin-owned clinics performed 26,125 IVF cycles, down from 27,354 in 2021, according to the company’s annual report. That is equivalent to some of the largest fertility chains in the U.S. However, the company was impacted  by COVID-19 in 2020, Jinxin performed just 22,879 cycles that year, down nearly 18% from the 27,854 cycles it performed in 2019.

Jinxin Fertility Group’s bottom line has since suffered. It reported adjusted net income of $38.4 million on revenue of $331.1 million last year. That compares to adjusted net income of $63.8 million on revenue of $257.5 million in 2021.

Overall, Jinxin said in the introduction to its 2022 annual report that it is the third-largest provider of IVF services in China (as of 2018), and that its number of annual cycles represent about 3.1% of the country’s total market share. Its biggest competitors, according to its 2019 stock prospectus, are the Reproduction Hospital Affiliated to Shandong University, Peking University Third Hospital, Shanghai Ninth People’s Hospital and the Reproductive and Genetic Hospital of Citic-Xiangya.

Expected Growth from Public Policy Changes

There is room for growth in China in the coming years. Despite it currently leading the world in population, the nation has seen its fertility rates plummet in recent years to 1.2 births per woman, down more than half from 1989. That has prompted the Beijing city  government last month to announce it would pay for 16 different types of assisted reproductive technology, including IVF, to increase the birth rate.

Jinxin said in its annual report that it “expects the penetration rate and market size for assisted reproductive services in China to significantly increase as the government implements supportive policies and supportive measures to encourage fertility.” The nation as of earlier this year had just 539 institutions performing IVF and only 27 sperm banks to serve a population more than four times larger than the United States, according to a Chinese government survey issued late last year.

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

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How to Finally Streamline Medication Costs for Your Patients
 

Medication costs are a huge stressor for patients working through IVF and IUI treatments.

They can be costly, and the variability of when they’re needed means an even more difficult process. But it doesn’t have to be this way, and that’s why BUNDL has streamlined the process with their new BUNDL with Medications℠ program.

BUNDL with Medications℠ is a multi-cycle offering that includes all the patient’s medications, for one up-front cost.

Contact BUNDL today to learn about their exclusive virtual pharmacy program partnership, and how this can optimize treatments for your practice and patients.

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This News Digest Is Paid Sponsored Content From
BUNDL

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All external links active as of 9/14/23.

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.

What’s In the Fertility Pharma Pipeline

Three Companies and What They’re Working On

This News Digest brought to you by
BUNDL

BY: Lisa Munger

The biotech sector has experienced a surge in venture capital (VC) funding in recent years, providing a boost to fertility-related research and development, according to a report by analysts at McKinsey & Company.

In 2016, VC companies invested in 2,200 biotech start-ups worldwide, growing to 3,100 by 2021. These investments have contributed to developing next-gen biopharmas and biotechs actively working on fertility innovations.

PIPELINE HIGHLIGHTS

Granata Bio

Founder Evan Sussman said he started Granata Bio five years ago because he saw an unmet need in the field. Before that, he spent 10 years at EMD Serono. He said there was more bandwidth for drug development in the U.S. and hoped Granata would help fill the gap. 

Now, the company is focused on a pipeline intended to minimize market monopolies and bring new therapeutics to market. 

“We hope to bring clomiphene citrate back to the market by the end of the year,” Sussman said. “That product is symbolic of what's going on in women's health generally. There's a paucity of available drugs. Clomiphene is a 50-year-old class of drugs, but there's only one commercialized product, and the price has gone up significantly in the last year or two years because there's no competition.”

Also in Granata’s pipeline development: subcutaneous progesterone, menotropins for injection and a commercially-available ganirelix acetate injection.

Oral Allosteric Agonists Show Promise in Preclinical Studies

High-complexity methods like controlled ovarian stimulation - in vitro fertilization (IVF) or low-complexity methods like ovulation induction - intrauterine insemination (IUI) for treatment. In preclinical studies, researchers discovered that two oral follicle-stimulating hormone receptor allosteric agonist compounds, TOP5668 and TOP5300, have pharmacology, drug metabolism, pharmacokinetics and safety profiles suitable for clinical use.

While more testing is necessary before clinical use, these results provide avenues for infertility treatment. If clinical trials prove successful, these oral follicle-stimulating hormone receptor allosteric agonists could offer a more convenient and efficient single-agent treatment for infertility patients than existing therapeutic approaches.

Celmatix

Celmatix announced a development in their pipeline - an oral follicle-stimulating hormone (FSH) candidate. This treatment can potentially shift fertility care and allow individuals more options other than traditional injections associated with IVF. 

Celmatix's oral FSH candidate aims to unlock a more convenient and accessible fertility treatment option for patients. 

“Our goal is to eliminate the need for injections during ovarian stimulation ahead of egg freezing and IVF procedures,” said Dr. Piraye Yurttas Beim, founder and CEO of Celmatix. “We also want to reduce the need for women to undergo IVF procedures in the first place by both providing a more effective strategy for restoring ovulatory function in women with ovarian conditions like polycystic ovary syndrome (PCOS) and addressing the significant burden that male infertility places on couples by also advancing our program to help men increase their sperm count and viability.”

While Celmatix's oral FSH candidate shows some promise, Sussman said, he said any oral application is likely 10 years from the market. Further research, clinical trials and regulatory approvals are necessary to validate its safety and efficacy. 

While an oral therapeutic may appeal to some and enhance tolerability, Sussman said it’s Celmatix’s “moonshot,” but other companies are focused elsewhere. Specifically, he pointed to targeting poor ovarian response and diminished ovarian reserve patients- as one of the industry’s moonshots. 

Oviva Therapeutics 

A biotech startup called Oviva Therapeutics has emerged to develop drugs to prolong fertility and delay menopause. This approach could affect women's reproductive health and overall well-being. Sussman pointed to Oviva’s work as “one to watch.”

Led by Dr. Patricia K. Donahoe, director of Pediatric Surgical Research Laboratories at Massachusetts General Hospital, Oviva Therapeutics is focused on harnessing the potential of a little-studied hormone to achieve these revolutionary goals. Dr. Donahoe said that the hormone, or drugs that mimic its effects, could slow down or even halt the natural loss of eggs that women experience every month. This ability to preserve eggs could extend a woman's fertility and potentially delay the onset of menopause.

Oviva Therapeutics plans to test its AMH-based therapies in the clinic, starting with using AMH to aid women struggling to conceive through IVF. This initial step will serve as a platform for broader indications and applications.

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

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How to Finally Streamline Medication Costs for Your Patients
 

Medication costs are a huge stressor for patients working through IVF and IUI treatments.

They can be costly, and the variability of when they’re needed means an even more difficult process. But it doesn’t have to be this way, and that’s why BUNDL has streamlined the process with their new BUNDL with Medications℠ program.

BUNDL with Medications℠ is a multi-cycle offering that includes all the patient’s medications, for one up-front cost.

Contact BUNDL today to learn about their exclusive virtual pharmacy program partnership, and how this can optimize treatments for your practice and patients.

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This News Digest Is Paid Sponsored Content From
BUNDL

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All external links active as of 8/31/23.

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.

IVIRMA Global Recruits Former Head of Airline Iberia as New CEO

Javier Sánchez-Prieto began his new position in mid-July

This News Digest brought to you by
BUNDL

BY: RON SHINKMAN

IVIRMA Global, one of the largest multinational chains of fertility clinics, has named former Iberia Chairman and Chief Executive Officer Javier Sánchez-Prieto as the company’s new CEO.

Sánchez-Prieto started the position on July 17, according to company spokesperson Michael Samuelson. He has taken over a company with 74 clinics in nine countries, including 20 in the United States and 30 in Spain, where IVIRMA is headquartered. He had been the CEO of Iberia – Spain’s flagship airline – since September 2020.

Sánchez-Prieto replaces Antonio Pellicer, M.D., who launched IVIRMA’s predecessor with the opening of its first fertility clinic in Spain in 1990. Samuelson said that Pellicer has been named IVIRMA’s executive chairman.

“It was clear during the recruitment process his skills and experience would complement Dr. Pellicer’s medical leadership,” Samuelson said of Sánchez-Prieto, who did not have any experience in the healthcare business prior to taking the position at IVIRMA.

Sánchez-Prieto began as chief financial officer for Iberia’s regional subsidiary before becoming the parent company’s CFO a decade ago. Before Iberia, Sánchez-Prieto spent nearly a decade as an executive with Spanish construction giant Uralita Group, according to his LinkedIn profile

Sánchez-Prieto was unavailable for an interview, but Samuelson said that he became interested in the job after the giant investment fund KKR acquired IVIRMA for just over $3 billion earlier this year, likely with the intent to expand aggressively in the coming years.

“For IVIRMA to achieve the next phase of transformative growth, it was essential to recruit a business leader with Mr. Sanchez-Prieto’s track record and experience,” Samuelson said.

Iberia announced back in May that Sánchez-Prieto would be leaving after 12 years with the company, but did not say where he was going, other than to a career outside of aviation.

According to Sánchez-Prieto’s LinkedIn feed, he spent the first week on the job undergoing the onboarding process at IVIRMA Global’s headquarters in Valencia, Spain, and then spent several days at RMA New Jersey’s clinic in Basking Ridge, N.J.

“More to come in the next weeks,” Sánchez-Prieto posted.

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

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How to Finally Streamline Medication Costs for Your Patients
 

Medication costs are a huge stressor for patients working through IVF and IUI treatments.

They can be costly, and the variability of when they’re needed means an even more difficult process. But it doesn’t have to be this way, and that’s why BUNDL has streamlined the process with their new BUNDL with Medications℠ program.

BUNDL with Medications℠ is a multi-cycle offering that includes all the patient’s medications, for one up-front cost.

Contact BUNDL today to learn about their exclusive virtual pharmacy program partnership, and how this can optimize treatments for your practice and patients.

---

This News Digest Is Paid Sponsored Content From
BUNDL

---

---

All external links active as of 8/24/23.

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.

BPEA EQT Acquires Majority Stake in Indira IVF for $656.6 Million, ‘Sets a New Benchmark’

In One of the Largest M&As in the IVF Space, Indira Now Valued at an Estimated $1.1 Billion.

This News Digest brought to you by
BUNDL

BY: Lisa Munger

Hong Kong-based investment firm BPEA EQT, formerly known as Baring Private Equity Asia, is set to acquire a 60% stake in Indira IVF, an Indian fertility services provider, for $656.6 million, according to a report on July 28 by multiple outlets.  

The Deal

The deal places a valuation of $1.1 billion on Indira IVF, according to a reporter by Mint Media. Indira operates a network of 116 clinics across India.

Indira IVF CEO Kshitiz Murdia, M.D. told Inside Reproductive Health the company employs 250 full-time Gynecologists. Indira has 2,700 employees and 150 Embryologists, Gitika Sharan, a company representative told Inside Reproductive Health.  The company does 33,000 IVF cycles on average each year. 

Given Indira’s wide scope of influence in India and beyond, analysts note the import and historical landmark of the deal. 

“It’s a big milestone event for the Indian health industry, especially for the business because it’s the second most valuable IVF transaction across the globe,” Vinesh Gadhia, an IVF industry expert on the Indian market told Inside Reproductive Health. 

In another billion dollar M&A in the space, The New York-based buyout firm KKR & Co. Inc., completed the acquisition of Spanish-based  IVIRMA Global SL in January for approximately $3.8 billion according to Market Screener. 

Further, in February 2022, fertility startup Kindbody completed its acquisition of Vios Fertility Institute, along with its network of clinics. This move has allowed Kindbody to achieve a valuation of $1.15 billion, another high-figure M&A of late.  

Sweden's EQT, the parent company of BPEA EQT, released a statement confirming the acquisition, specifying that the stake would be purchased from private equity firm TA Associates and Indira IVF's founders. While the statement indicated that the founders would retain a minority stake in the company and continue to lead it, it did not disclose the exact size of the stake or the deal's total value.

Indira was the last IVF related company in TA Associates’  possession according to its publicized portfolio. TA Associates sold its stake in CCRM Fertility in 2021, according to a report by Business Wire. 

Beyond TA’s divestiture, BPEA representatives said they plan to expand in Asia in their statement on the subject. 

“BPEA EQT will invest in Indira IVF’s R&D capabilities and technology while further broadening its footprint across India and exploring expansion into neighboring markets, making fertility services and reproductive health more accessible to couples,” the statement read. 

BPEA EQT representatives declined a request for comment. 

Growth Beyond India

Murdia said the deal will help the company to expand its influence in the rapidly growing market. 

“Indira IVF has a solid foundation built in the last four to five years on compliance, governance, systems and processes that has truly institutionalized the whole medical and non-medical operations we do,” he said.

“With many years of experience training people and being successful in many geographies in India the company feels very comfortable to take on international expansions and acquisitions to grow beyond the Indian subcontinent especially in Asia Pacific and BPEA has had the experience of owning businesses in Asia Pacific which would really fuel the growth of Indira IVF in Asia Pacific,” he said. 

Testing Business Viability with Increased Regulation

For analysts like Gadhia, the deal portends positive outcomes for both parties. 

The investment firm's strategic move into India's healthcare industry will likely position Indira IVF for further growth and expansion under the new ownership, Gadhia said. It shows the hand of the Assisted Reproduction Assistance (ART) Act in motion, he added.

The ART Act, passed in 2021 by the Rajya Sabha, was aimed at overseeing and governing ART clinics and ART banks in India. Its primary focus was to ensure proper supervision, regulation, licensing and promotion of ethical practices in the rapidly evolving field of assisted reproduction. 

For Gadhia, the deal with BPEA is a litmus test to determine how the ART Act operates in the “real world.”

“It’s significant because the deal may stand as a new benchmark," he said. It proves as testimony that the Indian IVF business is set to take off and is on a major growth trajectory. It also reveals that the ART regulation act hasn’t significantly increased global investors’ confidence in the Indian IVF space.”

The deal remains subject to regulatory approvals and finalization processes, according to multiple outlets. 

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

---

How to Finally Streamline Medication Costs for Your Patients
 

Medication costs are a huge stressor for patients working through IVF and IUI treatments.

They can be costly, and the variability of when they’re needed means an even more difficult process. But it doesn’t have to be this way, and that’s why BUNDL has streamlined the process with their new BUNDL with Medications℠ program.

BUNDL with Medications℠ is a multi-cycle offering that includes all the patient’s medications, for one up-front cost.

Contact BUNDL today to learn about their exclusive virtual pharmacy program partnership, and how this can optimize treatments for your practice and patients.

---

This News Digest Is Paid Sponsored Content From
BUNDL

---

---

All external links active as of 8/17/23.

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.