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

---

Compare Your Third Party IVF Cycle Pricing

Family Inceptions reveals cost averages for IVF cycles with Gestational Carriers.

See How Your Center Compares on

• Surrogate and Partner Workup

• Embryo Transfer with Gestational Carrier

See Price Averages for IVF Centers in all four quadrants of US

• Northwest

• Southwest

• Northeast

• Southeast

See how your Third Party IVF Program stacks up by clicking the button below

---

This News Digest Brought to You by
Family Inceptions

---

---

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.

---

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

---

---

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.

---

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

---

---

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

---

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

---

---

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

---

---

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

---

---

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

---

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 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

---

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 8/31/23.

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

---

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.

Medications Finally Included with Price of IVF

Program Expands to Remove Variable from Patients and Clinics

This News Digest Is Paid Sponsored Content From
BUNDL

BY: ERIN FLYNN JAY

Historically, IVF medications have almost never been included with the price of an IVF cycle. That was, until very recently.

The popular fertility financing program BUNDL has launched BUNDL with Medications℠, a new partnership with InspireRx to finally include patient medications with the price of IVF.

Separate Medication Costs Negatively Impact Patients, Providers

When patients can’t plan for medication costs, they may not be able to start their cycle when they’d like…or they may not be able to start their cycle at all. They may need more of a certain drug or a different protocol and they can’t afford it. 

“It puts an extra stressor on patients--maybe they finally have an IVF plan and finally have their treatment scheduled. But then they have to figure out what's going to happen with the meds?,” said Cheryl Campbell, Director of Operations for BUNDL. “It continues to grind at them and halt their process. They’re left alone to research where they’re going to get the best and most inexpensive meds.”

When patients face financial strain because of medication costs, it puts their treatment in jeopardy and may end up canceling their IVF cycle, which negatively impacts the fertility center’s scheduling.

BUNDL with Medications℠ allows fertility clinics and patients to consolidate treatment and medication costs into one plan with the backing of a financial guarantee. 

Campbell said it's hard for fertility physicians to see patients struggle with medication costs.

“As an ex-fertility patient myself, time is of the essence, right? When a patient can’t move forward with their provider’s treatment plan because they are hindered by medication costs, that's very daunting for physicians. They want those patients to move forward.”

How to Reduce Stress of Medication Costs for Patients

BUNDL with Medications℠ is a multi-cycle program. “Patients’ financial barriers are being removed because we are discounting their treatment. We’re going from top to bottom for the patient; all they have to do is focus on their IVF cycle.” Campbell added.

“It works as a layer onto our existing discount program. When a patient buys a two-cycle program from us, for an extra X amount of dollars, they can choose to add the costs of their medications and we'll handle that back and forth with their clinic.”  

BUNDL with Medications℠ covers everything a patient might need. “If a patient needs more but we didn't realize it, they're going to get it,” said Campbell. “If they're a poor responder and they need more, we're going to give it to them. Our patients will get what they need when they need it. The only exception drug is omnitrope, an off-label drug; other than that, patients will be able to access what they need.”

Which Fertility Clinics Can Benefit

BUNDL with Medications℠ is open to any clinic who has partnered with BUNDL.

Karol E. Bonilla, Strategic Account Manager for InspireRx, said there are many patients who don't have any coverage for either treatment or medications. “It's not difficult to actually combine great providers and great pharmacies to provide brand name medications,” she said.

Patients go with the provider of their choice. “Through InspireRx, they have less medication pricing for their fertility drugs since they don't have any coverage,” she said. “You're going to get multiple cycles so there are savings on the treatment and then also savings on the medication. It's a win-win for our patients.”

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.

---

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, 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 8/10/23.

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.

Oma Robotics, also Known as Thread Robotics and Thread Fertility, the Parent Company of Oma Fertility is Reported to be Going Out of Business

BY: ROSEMARY SCOTT

“I was informed that Thread Robotics will be closed by the end of the month.” Oma Fertility Lab Director, Dr. Barry Behr, confirmed in a phone call with Inside Reproductive Health. 

“They are moving quickly to try to sell the clinics and labs”. Dr. Behr said he did not know which companies might buy the clinics nor did he say if the company was filing for bankruptcy. 

In an email to Inside Reproductive Health on July 21, Oma Fertility CEO, Gurjeet Singh said “I can confirm that we are not filing for bankruptcy. I’ve heard the rumor as well and it is unfortunate.”

Mr. Singh did not respond to other requests for comment about the future of the company.

Oma Fertility employees who announced their layoffs on LinkedIn said the layoffs began on Tuesday, August 1, but no official number of eliminated posts has been released by the company. One Oma Fertility employee, who wished to remain unidentified, said that office and corporate staff had been laid off.

Both the employee and Dr. Behr said that no official announcement about layoffs has been made to the employees.

Oma Fertility launched in 2022 with the raising of $37.5 million in debt and venture funding. On May 31, Oma Fertility opened a new clinic in Atlanta. Oma opened the doors of its Atlanta location in the same month as it opened new locations in St. Louis and New York City.

Singh, told Inside Reproductive Health that Oma had been practicing in the three cities since 2022. Singh said he rented a space in each city for about six to nine months while the permanent locations were being built. 

Dr. Behr said he did not believe layoffs were planned for lab and clinical personnel. “The parent company will pay my check until the end of the month. As far as I know the lab and clinic staff are going to keep working. They need them to be valuable to a potential buyer”.

---

Larkin out, Reymann in as Top Boss of First Fertility 

BY: STAFF

Inside Reproductive Health obtained an email sent by a First Fertility executive that said that CEO Derek Larkin stepped down as CEO to pursue another opportunity. 

The executive said that Larkin’s last day was Monday July 31 and that Cara Reymann will take over as CEO on September 6. Ms. Reymann was previously president of Fertilitas for one year and held Market President and other roles at Capital Digestive Care for 12 years, according to her LinkedIn profile. 

The email did not specify the role for which Larkin left. Inside Reproductive Health has not yet reached out to Larkin, Reymann, or First Fertility for comment.

---

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

---

---

All external links active as of 8/2/23.

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

US Fertility Acquires RMA of New York, Largest Fertility Center in New York City

Now Totals Almost 200 REIs, >100 locations, >30 IVF labs

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

BY: STAFF

US Fertility will expand its presence in the second largest city in North America, with the acquisition of Reproductive Medicine Associates of New York (RMA-NY)  it said in a press release this morning.

The acquisition brings US Fertility to “nearly 200 Reproductive Endocrinologists and five fellowship programs for Reproductive Endocrinology and Infertility. With the addition of RMA NY, US Fertility will now provide advanced fertility care through [105] clinic locations and 32 IVF laboratories” the press release stated.

According to the CDC’s latest finalized reports from 2020, RMA-NY performed more IVF cycles than any other clinic in the nation’s largest city, with roughly 7.200 cycles between its Manhattan and Long Island labs. RMA-NY opened an IVF lab in Mt. Kisco, NY in 2021.RMA-NY has seven partner physicians, eleven associate REIs, and four IVF labs, according to its website.

US Fertility currently has an IVF lab in Manhattan with an office in Brooklyn, Shady Grove Fertility New York. SGF New York opened in 2019 and performed 527 IVF cycles in its first full year in 2020, according to CDC data. Five REIs now practice there according to their website. No announcement has been made about whether the SGF New York and RMA-NY brands will remain distinct.

This is US Fertility’s second acquisition of the year, after its purchase of Ovation Fertility from Morgan Stanley in April.

The financial terms of the deal were not disclosed.

US Fertility CEO Richard Jennings and RMA of New York did not respond in time for comment.

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

Correction:
It was originally stated that North America's largest city is New York. It's actually second largest after Mexico City.

---

FDA on “Monster Hunt” for IVF Labs in Violation

One west coast fertility center reports being inspected by the FDA eight times in the last year. 

Because the FDA halted inspections due to the pandemic in 2020 and 2021, they are now going after fertility centers at greater frequency than ever before.

The FDA Consultants protect fertility centers by doing a “Mock FDA inspection” but they have a waitlist, and priority will go to clinics in their second year post-inspection and/or already have a warning letter.

---

This News Digest Brought to You by
FDA Consultants

---

---

All external links active as of 8/1/23.

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

Recharge Capital Launches $200M Investment Vehicle to Streamline Fertility Services, Women’s Health

Aims to Consolidate IVF Service Verticals by Continent, Starting with Southeast Asia

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

BY: RON SHINKMAN

In an attempt at consolidating a fragmented global market for reproductive medical services, Recharge Capital has launched a $200 million vehicle to invest in women’s health, including IVF.

New York and Singapore-based Recharge Capital announced last month that the new holding company – called the Women’s Healthcare Investment Vehicle – will “be strategically deployed to invest, roll up, and create an end-to-end ecosystem within the women's fertility value chain across Southeast Asia, Latin America, Europe, and the Middle East.”

Recharge, which has assets of about $6 billion, has placed funds in “thematic-focused” investments. Along with women’s healthcare, these include clean biotech, semiconductors and fintech, among others.

The vehicle has at least eight big investors attached. Among them are Thiel Capital, run by billionaire Peter Thiel; the Al Rashid Family, headed by Saudi billionaire Nasser Ibrahim Al-Rashid; and Shamrock Holdings, the investing company for the estate of Roy Disney and members of the Disney family.

Lorin Gu, the 30-year-old founding partner of Recharge Capital, said in an email that “we aim to transform the sector by creating full-scale integration of disruptive technologies, diagnostic solutions, and seamless patient experiences through digital platforms and local clinic chains.”

One of the biggest issues causing fragmentation of reproductive medical services, according to Gu: Different laws and regulations by country.

“For example, many couples start their experience in China for consultation, believing that China has the best medical quality, but only to realize that the country has many restrictions such as egg freezing requirements, genetic testings and sex selection, which are allowed in other markets like Thailand and Malaysia,” Gu said. 

Generation Prime Planned to Launch 15 Clinics

Partly as a result, Gu predicts that about 70% of its customers in Asia will be Chinese medical tourists seeking services in other countries. “We want to demonstrate how a streamlined service can bring much more efficiency and less opacity to the process as patients navigate across different jurisdictions,” he said. 

One of the first ventures invested in by the Women’s Healthcare Investment Vehicle is Generation Prime, which received seed backing. It has plans to open 15 clinics in Thailand, Malaysia and Singapore.

“For Chinese patients seeking services not currently available in their home country, Generation Prime provides hand-holding experience for patients, starting from virtual education and consultation to understand the customization needs of the IVF journey, and then travel and treatment arrangements for specific services in our clinics in Singapore, Malaysia, Thailand,” Gu said. He added that some clients may also elect to obtain some services in the U.S., such as surrogacy. 

Global Expansion of IVF

David Sable, M.D., a life sciences portfolio manager in New York City who also founded two separate reproductive technology firms, suggests entrepreneurs are beginning to see reproductive medicine in global as opposed to regional terms, and it’s clear there is a mismatch between demand and available services. Worldwide, he said there are about 3 million IVF cycles a year performed on between 1.5 million and 2 million people when repeat cycles are included. But based on his company’s research and making some assumptions about the market, Sable believes there is probably enough demand worldwide to perform 20 to 30 million cycles annually.

“If you really map out demand for it, it’s easily a half-trillion-dollar industry,” he said. “Right now, it’s disguised as a $20 billion-a-year niche industry. So, I’m not surprised that people who have a lot of money to invest are putting capital into it.”

Gu said that in addition to Asia, Latin America, Europe and the Middle East are also expected to see enormous demand for services in the coming years. As in Asia, it is expected that clients will engage in foreign travel in order to receive the services they specifically desire but may not be able to obtain in their home countries. “A primary focus will be placed on international fertility medical tourism,” he noted. 

“Novel” Structure for Accountability to Investors

The Women’s Healthcare Investment Vehicle also has what Recharge has described as a novel structure for investors, based on a “milestone-driven deployment schedule.” According to Gu, the milestones are connected to revenue numbers and earnings before interest, taxes, depreciation and amortization.

“Investors and managers have clear visibility into how capital is being deployed (as opposed to a blind pool with little visibility), as well as reduced risks for capital usage,” Gu 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

---

FDA on “Monster Hunt” for IVF Labs in Violation

One west coast fertility center reports being inspected by the FDA eight times in the last year. 

Because the FDA halted inspections due to the pandemic in 2020 and 2021, they are now going after fertility centers at greater frequency than ever before.

The FDA Consultants protect fertility centers by doing a “Mock FDA inspection” but they have a waitlist, and priority will go to clinics in their second year post-inspection and/or already have a warning letter.

---

This News Digest Brought to You by
FDA Consultants

---

---

All external links active as of 7/27/23.

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

2020 Yale Fertility Fentanyl Incident: New York Times Releases Miniseries

Serial’s “The Retrievals” Podcast Tells Stories of 12 Women Who Underwent Sober Egg Retrievals

BY: ROSEMARY SCOTT

In November 2020, Susan Burton, a staff member of the weekly podcast “This American Life,” came across an article published by a local news outlet that detailed an incident at the Yale Fertility Clinic in which a nurse was caught stealing fentanyl intended for outpatient surgical procedures for her own personal use. This caused the women at the clinic to undergo egg retrieval procedures partially or completely sober. 

This was the start of what is now known as The Retrievals–a five-part podcast series produced by Burton for Serial Productions, which, as of 2020, is a unit of The New York Times. The first episode was released on June 29, with a new episode scheduled for every Thursday following for four weeks. 

At the Yale Fertility Center in November 2020, Donna Monticone was caught replacing fentanyl with saline and putting the vials back to be administered to patients, causing women to undergo egg retrieval procedures with little to no painkillers for a total of five months. Shortly after being confronted with the accusations, Monticone admitted that she had been doing this for about five months. 

Seven of those women, after being informed of Monticone’s actions through a letter in the mail, sued Yale University in November 2021, accusing the facility of failing to safeguard its supply of fentanyl. As of now, there are 68 plaintiffs involved in the lawsuit, and as many as 200 women could have undergone this reality over the five months in 2020 that Monticone admitted to tampering with the medication, The New York Times reported. 

In the series, Burton tells the stories of 12 of those women, in which they detail the physical pain they went through during the egg retrievals and the emotional pain they were caused when, according to them, no one at the center seemed to care. 

An audit by the U.S. Drug Enforcement Administration showed that in total, there were discrepancies in 665 units of controlled substances, including fentanyl, ketamine and midazolam. Monticone eventually pleaded guilty in federal court and admitted to tampering with the products in March 2021. She was sentenced to four weekends in prison, three months of home confinement and three years of supervised release.

In episode one of the podcast, Laura Czar tells the story of her egg retrieval at the clinic. Two months prior to the procedure, she said she had been diagnosed with breast cancer and underwent a double mastectomy. She scheduled the egg retrieval in the hopes that she could use them later if her cancer treatment affected her fertility. 

When the procedure began, she recalled saying to the doctors and nurses, “I feel everything.” A nurse responded, she said, and told her she had been given the maximum dose of painkillers. Her story mirrors what others told in the podcast–some were fully alert during the procedure, and others woke up in what they described as “excruciating pain” after. When they told their physicians of their pain, they all got the same response: they were given the maximum dose of painkillers, and could be given no more. 

Karen Peart, a spokesperson for Yale, told the Yale Daily News that Yale “deeply regrets the distress suffered by some of the patients.” 

“After Yale discovered the nurse’s misconduct, it removed her from the Center, alerted law enforcement agencies and notified patients who might have been affected,” Peart said. “The Center also reviewed its procedures and made changes to further oversight of pain control and controlled substances.”

When the news outlet asked what those changes entailed, Peart declined to comment. Researchers shall store schedules I-V controlled substances in a securely locked, substantially constructed cabinet.

In October 2022, Yale University agreed to pay $308,250 to settle the lawsuit and resolve the allegations that it violated civil provisions of the Controlled Substances Act. According to the U.S. Department of Justice, the act requires clinics and researchers to store schedule I-V controlled substances in a “securely locked, substantially constructed cabinet.”

The American Society for Reproductive Medicine frequently issues guidance for fertility clinics such as Yale’s on best practices for patient safety and positive outcomes. When asked to comment about any guidelines about how best to safeguard drugs and painkillers in a clinic that the organization might issue as a result of the public nature of the incident, Dr. Michael Thomas, president of ASRM, told Inside Reproductive Health he is not familiar with the incident and declined to comment further. 

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

---

All external links active as of 7/20/23.

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.

Washington Post Describes Unbridled Price Hikes For Cryostorage

Industry Experts Predict Steadier Market

BY: MEG ST-ESPRIT

There is recent speculation in the media that cryostorage prices are rising. A May 2023 article in The Washington Post noted a 40 percent increase in storage prices in a single year, though they did not cite a source for the statistic.

Inside Reproductive Health was unable to independently verify that statistic. Patients interviewed for the article reported feeling “stuck” or forced to make decisions about storing their genetic material while concerned that the price of cryostorage in the United States will rise.

Within the reproductive health industry, there are less clear-cut answers on pricing trends. 

Are cryostorage prices in the United States actually rising?

Hard data about how much prices have risen remains scarce, though patients report receiving notifications of increases to their monthly or yearly storage bills. 

Eric Widra, chief medical officer at Shady Grove Fertility, was interviewed by the Post. He declined to comment on national pricing trends at this time. Other cryostorage facilities do not expect to raise their prices anytime soon. 

Pete Anevski, CEO of Progyny, expects costs to remain stable for patients. “We can confidently say that costs for our members will not be going up – this includes overall costs and the costs directly associated with tissue freezing and storage” he said in an email.

He added that their pricing structure does not vary depending on the genetic material being stored.

Inside Reproductive Health did reach out to Luis Fernandez, partner at Red Barn Equity Partners, the investor-operator of ReproTech, for commentary on cryostorage pricing trends. Mr. Fernandez did state he would provide commentary but did not respond by publication deadline.

At TMRW Life Sciences, Chief Impact Officer Linsday Beck said that while most of their business is providing B2B storage to fertility clinics, they do have a small sector of their business that offers direct-to-consumer storage options. In both their DTC and B2B sectors, Beck said TMRW Life Sciences has not increased prices in the last year.

She said for the clinics they work directly with they have also not instituted any significant change in pricing structure at this time. “We have not increased our pricing due to inflation, but it's sort of a different beast.” she said in an interview. “We're not an apples-to-apples [comparison] with fertility clinics.” 

What are the barriers to reducing cryostorage costs? 

Dr. Widra cited several reasons via email that clinics may be paying more to store eggs and embryos — a cost that could be passed down to consumers.

The price of hardware such as tanks and monitoring devices as well as square footage to store them in is subject to inflation, like any consumer good. Supplies such as liquid nitrogen as well as electronic monitoring equipment to reduce the risk of tank failure are also expensive, he says. “Liability insurance costs have risen in the wake of the recent tank failures,” he adds.

A 2021 settlement in California awarded patients $15 million in damages after a major storage failure destroyed thousands of samples of genetic material. 

Beck said Many clinics, she said, use a manual system. “It's handwritten labels; it's manually filling in the tag. There is manual inventory. Information is written down either in a binder or an Excel spreadsheet.” This process, she said, is very human-labor intensive.”

As the demand for cryostorage increases, Beck said the best way to keep storage affordable to patients is to automate it. Not only does it reduce labor costs for clinics, it reduces that risk of failure Widra cited. “Robots reduce potential points of failure by 94%. So it's a far better system for a similar price,” she said.” 

Beck noted that cryostorage is not marked up as much as other medical procedures, but due to lack of insurance coverage the cost is largely covered by patients — including unexpected increases.

Despite industry efforts to keep costs low, any increases are passed along to consumers. “So for the patient it does feel expensive,” said Beck. “I think there's a really important perspective to consider.”

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

---

All external links active as of 7/13/23.

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.

Monash IVF moves to complete the acquisition of PIVET Medical Centre for AUD 9.4 million

Implements digital front door, stock steady

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

BY: LISA MUNGER

Monash IVF has been one of the largest IVF providers in Australia for more than 40 years. 

Monash offers various services, including IVF, donor programs and fertility preservation. Recently, its stock has been featured in international media

Stock Steady, Speculation Raises Profile

Recent stock reports suggest that Monash is a strong investment opportunity with the potential for significant growth in the coming years. The company went public in June 2014 with CEO Michael Knapp. 

The company's shares could be worth as much as AU $1.81 compared to their current trading price of AU $1.16, according to analysts with Simply Wall Street.

The report used a discounted cash flow model to estimate the company's intrinsic value by forecasting future cash flows and discounting them to their present value. The model assumes that Monash will experience two stages of growth, with a higher growth rate in the initial period and a stable growth rate in the second stage.

The report estimates that Monash IVF Group's free cash flow will increase from AU $5.45 million in 2023 to AU $42.2 million in 2032, with a growth rate of between 2.32 and 5.27%. The present value of these cash flows, discounted at a rate of 6.7%, is estimated to be AU $233 million.

The report also noted that the analyst price target for Monash IVF Group is AU $1.32, which is 27% less than the estimated fair value of AU $1.81.

Monash’s stock hit its highest point ever in July 2016 at $2.54 USD. By contrast, on May 2, 2023, the stock hit its highest point in the last year, starting the opening bell at $1.60 USD, according to Rask Media. 

New Technology Implemented

In 2020, Monash became the first clinic in Australia to offer a new genetic screening technique called karyomapping, which can identify genetic disorders in embryos before they are implanted. By using this technique, Monash aims to reduce the risk of genetic disorders in children born through IVF.

The company has implemented a digital front door, which is a digital interface that optimizes the collection and sharing of critical information with patients throughout their treatment, thus increasing accessibility. 

The portal offers patients various services and information, including the ability to schedule appointments, access medical records, receive personalized treatment plans and access educational resources about fertility treatments. 

The digital front door is a centralized platform that enhances patient engagement, facilitates communication and ensures that individuals are well-informed throughout their fertility journey. 

Monash partnered with Personify Care to set up digital patient pathways, allowing patients to access their treatment plans, communicate with their care team, and receive reminders and education materials through a mobile app. 

PIVET

Monash acquired PIVET Medical Centre (PIVET), a leading fertility provider headquartered in Pert, in May 2022. The initial upfront cost of the acquisition was set at $9.4 million USD.

PIVET played a role in Western Australia's first successful IVF birth in 1982. Over the years, PIVET has expanded its operations and extended its services to Cairns in 2009. PIVET has assisted in the birth of more than 8,000 babies through its comprehensive range of treatments, according to Business News Australia.

The acquisition, which is due to be completed during the third quarter of FY23, is expected to be funded through Monash IVF's operating cash flows and/or available debt facilities of $105 million.

Currently generating annual revenues of approximately $8 million, PIVET may be entitled to additional earnouts depending on its performance over a one-to-two-year period following the deal's completion, according to the report. The deal was supposed to have been completed by projected to conclude by the end of September 2022, as of the latest update in February 2023.

Neither Monash IVF nor Michael Knapp responded to Inside Fertility Health’s requests for comment for this story. 

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

---

These 5 Deficiencies Lead to FDA Nightmare

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

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

---

---

All external links active as of 7/6/23.

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.

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

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

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

BY: RON SHINKMAN

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

---

These 5 Deficiencies Lead to FDA Nightmare

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

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

---

---

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

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

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

What the FDA has been looking for in their audits

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

BY: ERIN FLYNN JAY

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

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

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

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

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

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

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

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

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

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

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

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

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

---

These 5 Deficiencies Lead to FDA Nightmare

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

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

---

---

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

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

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

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

BY: RON SHINKMAN

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

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

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

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

Francisco Lobbosco, FutureLife 

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

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

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

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

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

Beth Zoneraich, Pinnacle

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

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

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

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

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

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

Richard Jennings

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

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

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

Jennings did not respond to a request for an interview. 

Different Jobs, Different Situations

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

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

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

Amplification

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

Original sentence:

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

Amplification: The quote that the sentence referred to was 

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

---

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

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