May Health Secures $11.7M for PCOS Infertility Breakthrough
March 13, 2026, 9:56 am
May Health, a medical device innovator, closed an $11.7 million funding round. New investor Nexpring Health led the investment. Existing partners Sofinnova Partners, Bpifrance, and Trill Impact also participated. This capital fuels the REBALANCE U.S. pivotal clinical trial. It also advances FDA authorization for the Anavi™ System. European market launch preparations are underway. The Anavi™ System is an office-based therapy. It restores ovulation for women with PCOS-related infertility. PCOS affects millions. This device offers a vital alternative. It targets underlying condition drivers. This could transform fertility treatment options. The system achieved EU CE Mark in October 2025. U.S. enrollment continues across fifteen centers.
Polycystic Ovary Syndrome (PCOS) presents a formidable global health challenge. Millions of women contend with its complex symptoms. It stands as the most common endocrine disorder among women of reproductive age. A staggering 10 to 13 percent of women worldwide are affected. This chronic condition often leads to significant reproductive health issues. Female infertility is a primary concern. PCOS disrupts the normal ovulatory cycle. Consistent ovulation becomes elusive. Many women struggle with conceiving naturally. Current treatment options exist, but gaps remain. First-line fertility medications do not work for all patients. Some women cannot tolerate these therapies. Others choose different paths. The need for innovative **PCOS infertility treatment** is pressing. May Health addresses this critical need.
May Health is pioneering a novel solution. The company develops advanced medical devices. Its focus is on expanding **PCOS treatment options**. The Anavi™ System represents a significant step forward. This proprietary technology targets a root cause of **PCOS-related infertility**. It aims to restore ovulation directly. The system utilizes a one-time, office-based therapeutic procedure. This approach offers convenience and potentially reduced invasiveness. It avoids daily medication regimens. It offers a unique alternative for specific patient populations. Women who previously had limited choices may now find hope. This includes those unresponsive to traditional fertility drugs. It also serves those unable or unwilling to use them.
The Anavi™ System's development marks a new era. It promises a clinical alternative in fertility care. The device's design focuses on fundamental physiological drivers. By addressing these underlying mechanisms, it seeks sustainable results. This is crucial for **ovulation restoration**. Success in restoring ovulation directly impacts fertility potential. It enhances the chances of conception for women facing **female infertility**. The system already secured CE Mark certification. This crucial regulatory milestone came in October 2025. It validates the device's compliance with strict European Union Medical Device Regulation (EU MDR) standards. This allows for initial commercialization efforts in Europe.
Recently, May Health announced substantial new funding. The company raised $11.7 million in a significant investment round. This capital infusion will accelerate key strategic initiatives. Nexpring Health emerged as a new lead investor. Their participation signals strong confidence in May Health’s vision. Existing prominent shareholders also reaffirmed their commitment. Sofinnova Partners, Bpifrance, and Trill Impact continued their support. This diverse syndicate of investors strengthens May Health’s financial foundation. It provides the resources needed for critical developmental phases. The funding round totaled approximately €10 million.
The capital inflow serves multiple vital purposes. A primary objective is the completion of the REBALANCE study. This is a pivotal U.S. Investigational Device Exemption (IDE) clinical trial. The REBALANCE study is a prospective, multicenter, randomized controlled trial. It evaluates the Anavi™ System’s safety and effectiveness. Its primary endpoint is **ovulation restoration** in women with **PCOS-related infertility**. The trial is actively enrolling participants. More than 15 leading **fertility centers** across the United States are involved. This widespread participation underscores the medical community’s interest. It highlights the perceived potential of this innovative device.
Advancing FDA marketing authorization activities is another key use of funds. Gaining U.S. Food and Drug Administration approval is paramount. It opens the door to the vast American market. This regulatory pathway is rigorous. May Health is dedicating resources to navigate this process efficiently. Simultaneous efforts support the European launch of the Anavi™ System. The CE Mark certification provides a foundation for this expansion. Commercialization planning is well underway for the European market. These concurrent strategies reflect a global ambition. May Health aims to bring its solution to women worldwide.
The company leadership drives this ambitious agenda. Colby Holtshouse serves as President and CEO. He leads a team experienced in medical technology. Their collective expertise spans product development, regulatory strategy, and clinical validation. Commercialization planning is also a core strength. May Health's roots trace back to France. It evolved through the Paris-based accelerator MD Start. The company was previously known as Ziva Medical and Ablacare. Today, its headquarters are in **Menlo Park, CA**. This blend of European innovation and American entrepreneurial spirit defines its trajectory.
The potential impact of the Anavi™ System is profound. It addresses a long-standing unmet medical need. Women seeking to build families often face significant emotional and physical tolls. Current treatment paradigms offer limited options for some. The Anavi™ System seeks to reshape this landscape. By providing a novel, office-based therapy, it could expand access. It offers a more targeted approach to **PCOS-related infertility**. This innovation could become a cornerstone of future fertility care. It offers hope for countless individuals.
Optimizing search engine visibility is crucial for such a company. Terms like **PCOS infertility treatment** are highly relevant. So are **female infertility** and **ovulation restoration**. Users search for these solutions. May Health's progress directly addresses these queries. The company's name, May Health, is a key search term. The Anavi™ System is also critical. Mentioning its headquarters in **Menlo Park, CA**, enhances local search relevance. Key investors like **Nexpring Health** also contribute to search authority. This comprehensive approach ensures discoverability.
The future for May Health appears promising. The secured funding provides a clear runway. Clinical trial completion is in sight. Regulatory approvals are being actively pursued. Market expansion strategies are unfolding. The company's commitment to women's health is evident. Its focus on **PCOS** and **infertility treatment** fills a critical void. The Anavi™ System could redefine care. It could empower women with new choices. May Health is poised to make a significant difference. The journey continues toward providing effective **fertility solutions**.
This innovative medical device holds immense promise. It represents a significant advancement. May Health's dedicated efforts are paving the way. They are working towards a future with broader, more effective **PCOS-related infertility** therapies. The medical community watches closely. Patients facing these challenges eagerly anticipate its availability. The Anavi™ System aims to be a beacon of progress. It will offer renewed hope for many.
Polycystic Ovary Syndrome (PCOS) presents a formidable global health challenge. Millions of women contend with its complex symptoms. It stands as the most common endocrine disorder among women of reproductive age. A staggering 10 to 13 percent of women worldwide are affected. This chronic condition often leads to significant reproductive health issues. Female infertility is a primary concern. PCOS disrupts the normal ovulatory cycle. Consistent ovulation becomes elusive. Many women struggle with conceiving naturally. Current treatment options exist, but gaps remain. First-line fertility medications do not work for all patients. Some women cannot tolerate these therapies. Others choose different paths. The need for innovative **PCOS infertility treatment** is pressing. May Health addresses this critical need.
May Health is pioneering a novel solution. The company develops advanced medical devices. Its focus is on expanding **PCOS treatment options**. The Anavi™ System represents a significant step forward. This proprietary technology targets a root cause of **PCOS-related infertility**. It aims to restore ovulation directly. The system utilizes a one-time, office-based therapeutic procedure. This approach offers convenience and potentially reduced invasiveness. It avoids daily medication regimens. It offers a unique alternative for specific patient populations. Women who previously had limited choices may now find hope. This includes those unresponsive to traditional fertility drugs. It also serves those unable or unwilling to use them.
The Anavi™ System's development marks a new era. It promises a clinical alternative in fertility care. The device's design focuses on fundamental physiological drivers. By addressing these underlying mechanisms, it seeks sustainable results. This is crucial for **ovulation restoration**. Success in restoring ovulation directly impacts fertility potential. It enhances the chances of conception for women facing **female infertility**. The system already secured CE Mark certification. This crucial regulatory milestone came in October 2025. It validates the device's compliance with strict European Union Medical Device Regulation (EU MDR) standards. This allows for initial commercialization efforts in Europe.
Recently, May Health announced substantial new funding. The company raised $11.7 million in a significant investment round. This capital infusion will accelerate key strategic initiatives. Nexpring Health emerged as a new lead investor. Their participation signals strong confidence in May Health’s vision. Existing prominent shareholders also reaffirmed their commitment. Sofinnova Partners, Bpifrance, and Trill Impact continued their support. This diverse syndicate of investors strengthens May Health’s financial foundation. It provides the resources needed for critical developmental phases. The funding round totaled approximately €10 million.
The capital inflow serves multiple vital purposes. A primary objective is the completion of the REBALANCE study. This is a pivotal U.S. Investigational Device Exemption (IDE) clinical trial. The REBALANCE study is a prospective, multicenter, randomized controlled trial. It evaluates the Anavi™ System’s safety and effectiveness. Its primary endpoint is **ovulation restoration** in women with **PCOS-related infertility**. The trial is actively enrolling participants. More than 15 leading **fertility centers** across the United States are involved. This widespread participation underscores the medical community’s interest. It highlights the perceived potential of this innovative device.
Advancing FDA marketing authorization activities is another key use of funds. Gaining U.S. Food and Drug Administration approval is paramount. It opens the door to the vast American market. This regulatory pathway is rigorous. May Health is dedicating resources to navigate this process efficiently. Simultaneous efforts support the European launch of the Anavi™ System. The CE Mark certification provides a foundation for this expansion. Commercialization planning is well underway for the European market. These concurrent strategies reflect a global ambition. May Health aims to bring its solution to women worldwide.
The company leadership drives this ambitious agenda. Colby Holtshouse serves as President and CEO. He leads a team experienced in medical technology. Their collective expertise spans product development, regulatory strategy, and clinical validation. Commercialization planning is also a core strength. May Health's roots trace back to France. It evolved through the Paris-based accelerator MD Start. The company was previously known as Ziva Medical and Ablacare. Today, its headquarters are in **Menlo Park, CA**. This blend of European innovation and American entrepreneurial spirit defines its trajectory.
The potential impact of the Anavi™ System is profound. It addresses a long-standing unmet medical need. Women seeking to build families often face significant emotional and physical tolls. Current treatment paradigms offer limited options for some. The Anavi™ System seeks to reshape this landscape. By providing a novel, office-based therapy, it could expand access. It offers a more targeted approach to **PCOS-related infertility**. This innovation could become a cornerstone of future fertility care. It offers hope for countless individuals.
Optimizing search engine visibility is crucial for such a company. Terms like **PCOS infertility treatment** are highly relevant. So are **female infertility** and **ovulation restoration**. Users search for these solutions. May Health's progress directly addresses these queries. The company's name, May Health, is a key search term. The Anavi™ System is also critical. Mentioning its headquarters in **Menlo Park, CA**, enhances local search relevance. Key investors like **Nexpring Health** also contribute to search authority. This comprehensive approach ensures discoverability.
The future for May Health appears promising. The secured funding provides a clear runway. Clinical trial completion is in sight. Regulatory approvals are being actively pursued. Market expansion strategies are unfolding. The company's commitment to women's health is evident. Its focus on **PCOS** and **infertility treatment** fills a critical void. The Anavi™ System could redefine care. It could empower women with new choices. May Health is poised to make a significant difference. The journey continues toward providing effective **fertility solutions**.
This innovative medical device holds immense promise. It represents a significant advancement. May Health's dedicated efforts are paving the way. They are working towards a future with broader, more effective **PCOS-related infertility** therapies. The medical community watches closely. Patients facing these challenges eagerly anticipate its availability. The Anavi™ System aims to be a beacon of progress. It will offer renewed hope for many.