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Leadership transition comes as Company focuses on clinical evaluation of its novel Ovarian Rebalancing™ technology, a one-time transvaginal ablation procedure designed to restore ovulation in women with PCOS, a leading cause of infertility
领导层过渡之际,公司正专注于其新型卵巢再平衡™技术的临床评估,这是一种旨在恢复多囊卵巢综合症(PCOS)女性排卵的一次性经阴道消融手术,而PCOS是导致不孕的主要原因。
PARIS
巴黎
,
,
March 10, 2025
2025年3月10日
/PRNewswire/ --
/PRNewswire/ --
May Health
健康之月
, a
,一个
Paris
巴黎
- and
- 和
California
加利福尼亚州
-based, clinical-stage medical device company dedicated to the development of a new treatment for Polycystic Ovary Syndrome (PCOS), today announced that
基于临床阶段的医疗器械公司,致力于开发多囊卵巢综合征(PCOS)的新疗法,今天宣布
Colby Holtshouse
科尔比·霍尔特豪斯
has joined the Company as President and CEO. Colby brings a wealth of senior leadership and women's health expertise to the organization, having held executive positions with Organon (NYSE:
已加入公司担任总裁兼首席执行官。科比带来了丰富的高级领导经验和女性健康专业知识,曾担任欧加农(纽约证券交易所代码:
OGN
OGN
), Alydia Health, and Pelvalon.
),Alydia Health,和Pelvalon。
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Colby Holtshouse appointed CEO of May Health
科尔比·霍尔特豪斯被任命为梅健康公司的首席执行官
'I am delighted to have Colby join and lead the company as we look to complete the REBALANCE study, a landmark investigational device exemption (IDE) clinical trial which is being conducted to support marketing authorization for our Ovarian Rebalancing procedure so that we can bring it to millions of women who experience PCOS-related infertility,' commented Dr.
“我非常高兴Colby能够加入并领导公司,因为我们即将完成REBALANCE研究——这是一项具有里程碑意义的研究性器械豁免(IDE)临床试验,该试验旨在为我们的卵巢再平衡程序获得市场授权提供支持,以便我们能够将这一技术带给数百万因多囊卵巢综合症(PCOS)相关不孕问题而困扰的女性,”博士评论道。
.
。
Robert Auerbach
罗伯特·奥尔巴赫
, May Health Chairman. 'Colby has deep experience bringing groundbreaking technologies to market, making her the ideal fit to spearhead May Health as we continue to validate the technology and drive towards commercialization.'
,May Health董事长。‘Colby在将突破性技术推向市场方面拥有深厚的经验,这使她成为引领May Health的理想人选,因为我们继续验证该技术并朝着商业化迈进。’
'May Health is pioneering a first-of-its-kind treatment for PCOS, a condition that affects 10% of women and presents serious health challenges, including infertility,' stated
“May Health正在开创一种前所未有的多囊卵巢综合症(PCOS)治疗方法,这种疾病影响了10%的女性,并带来了包括不孕在内的严重健康挑战,”声明表示。
Antoine Papiernik
安托万·帕皮尔尼克
, Chairman and Managing Partner at Sofinnova Partners and the former Chairman of May Health. 'We are excited to welcome Colby to guide the company in bringing this therapy to women around the world.'
索菲诺瓦合伙公司的董事长兼管理合伙人,以及前May Health的董事长表示:“我们很高兴欢迎科尔比来指导公司,将这种疗法带给世界各地的女性。”
May Health's proprietary technology, Ovarian Rebalancing, is an investigational treatment designed to restore ovulation in patients with PCOS who are resistant to oral ovulation induction medication. The ultrasound-guided, transvaginal procedure utilizes radio frequency (RF) energy to ablate excess androgen-producing ovarian tissue in order to establish regular ovulatory menstrual cycles.
May Health的专有技术——卵巢再平衡(Ovarian Rebalancing)是一种研究性治疗方法,旨在恢复对口服促排卵药物无反应的多囊卵巢综合症(PCOS)患者的排卵功能。该治疗通过超声引导下的经阴道手术,利用射频(RF)能量消融产生过多雄激素的卵巢组织,以建立规律的排卵月经周期。
The goal of this one-time, in-office procedure is to allow for same-day recovery and return to normal activities with minimal patient discomfort and downtime. May Health previously completed clinical feasibility studies in .
这项一次性、在办公室内完成的程序的目标是让患者在当天恢复并返回正常活动,同时尽量减少患者的不适和停工期。May Health 公司此前已完成临床可行性研究。
Europe
欧洲
and the U.S. and is actively enrolling for its IDE clinical study in
并且美国正在积极招募其IDE临床研究的参与者
the United States
美国
.
。
'I am thrilled to join May Health at this important time. Following the strong clinical feasibility results, we are encouraged that the REBALANCE study will provide the evidence necessary for U.S. FDA marketing authorization and for broad adoption by physicians and patients seeking options for PCOS-related infertility,' Colby shared. 'I look forward to working with the May Health team to deliver the Ovarian Rebalancing procedure to women suffering from PCOS-related infertility.'.
“我非常高兴在这个重要时刻加入五月健康。在取得强劲的临床可行性结果后,我们相信REBALANCE研究将为美国FDA市场授权提供必要的证据,并让寻求多囊卵巢综合症相关不孕治疗方案的医生和患者广泛采用,”科尔比分享道。“我期待与五月健康团队合作,为受多囊卵巢综合症相关不孕困扰的女性提供卵巢再平衡手术。”
About Polycystic ovary syndrome (PCOS)
关于多囊卵巢综合征 (PCOS)
Polycystic ovary syndrome (PCOS) is a common endocrine condition where the ovaries produce abnormal levels of androgens, which are male sex hormones that are usually present in women in lesser amounts. In many cases, those with PCOS are unable to ovulate and become pregnant. PCOS is one of the most common causes of female infertility, affecting roughly 10% of reproductive-aged women.
多囊卵巢综合症(PCOS)是一种常见的内分泌疾病,患者的卵巢会产生异常水平的雄激素,这种男性性激素在女性体内通常含量较少。许多情况下,患有PCOS的女性无法排卵和怀孕。PCOS是导致女性不孕的最常见原因之一,大约影响10%的育龄女性。
Other common, persistent symptoms of PCOS include irregular menstruation, acne, thinning scalp, excess hair growth on the face and body, high blood pressure, and sleep apnea. PCOS is a lifelong challenge that can significantly increase a patient's risk for Type 2 diabetes, heart disease, and stroke.
PCOS的其他常见、持续症状包括月经不调、痤疮、头皮稀疏、面部和身体多余毛发、高血压和睡眠呼吸暂停。PCOS是一个终生的挑战,会显著增加患者患2型糖尿病、心脏病和中风的风险。
The condition is also associated with an increased risk of pregnancy complications..
该病况还与妊娠并发症风险增加有关。
About May Health
关于五月健康
May Health is a
健康就是五月
Paris
巴黎
- and
- 和
California
加利福尼亚州
-based clinical-stage medical device company developing novel treatments for women with Polycystic Ovary Syndrome (PCOS). The company is currently investigating its Ovarian Rebalancing
基于临床阶段的医疗器械公司,致力于为患有多囊卵巢综合症(PCOS)的女性开发新型治疗方法。该公司目前正在研究其卵巢再平衡技术。
™
™
technology as a treatment for PCOS-related infertility in the REBALANCE clinical study. The FDA-approved IDE study is being conducted to support marketing authorization. The May Health Ovarian Rebalancing procedure is a novel approach to PCOS-related infertility issues and is intended to induce ovulation in patients resistant to oral medical therapy.
技术作为治疗多囊卵巢综合症相关不孕症的方法,正在REBALANCE临床研究中进行。这项获得FDA批准的IDE研究旨在支持市场授权。May Health的卵巢再平衡程序是一种针对多囊卵巢综合症相关不孕问题的新方法,旨在诱导对口服药物治疗无效的患者排卵。
May Health is led by a team of serial medtech and women's health entrepreneurs and executives with extensive experience in product development, therapy validation, and commercial launch. In 2024, the Company completed a .
May Health由一群拥有丰富产品开发、治疗验证和商业发布经验的连续医疗科技和女性健康企业家及高管领导。2024年,公司完成了 。
$25M
2500万美元
Series B raise co-led by Trill Impact and BPI France to complement the earlier €10M in a Series A led by Sofinnova Partners. May Health, formerly known as Ziva Medical and Ablacare was founded in 2012 by serial medical device innovators
B轮融资由Trill Impact和BPI France共同领投,补充了此前由Sofinnova Partners领投的1000万欧元A轮融资。May Health成立于2012年,前身为Ziva Medical和Ablacare,由连续医疗设备创新者创立。
Neil Barman
尼尔·巴曼
,
,
Andy Wu
吴安迪
and
和
Garrett Schwab
加勒特·施瓦布
, and then acquired in 2017 by Sofinnova's medtech acceleration team, Sofinnova MD Start. May Health is headquartered in
,并于2017年被索菲诺瓦的医疗技术加速团队索菲诺瓦MD Start收购。May Health总部位于
Paris, France
法国巴黎
, with its US team based in
,其美国团队位于
Menlo Park, CA.
门洛帕克,加利福尼亚州。
For more information, visit
欲了解更多信息,请访问
www.mayhealth.com
www.mayhealth.com
.
。
About Sofinnova Partners
关于索菲诺瓦合伙人
Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in
Sofinnova Partners是一家领先的生命科学领域的欧洲风险投资公司,专注于医疗保健和可持续性。总部位于
Paris
巴黎
,
,
London
伦敦
and
和
Milan
米兰
, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.
该公司汇聚了一支来自世界各地、具备强大科学、医学和商业专业知识的团队。Sofinnova Partners是一家全程参与的生命科学投资公司,覆盖从种子阶段到后期的整个价值链。该公司积极与有雄心的企业家合作,作为主导或基石投资者,开发具有变革性的创新技术,这些创新有望对我们共同的未来产生积极影响。
Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in .
Sofinnova Partners 成立于1972年,是一家根基深厚的风投公司。
Europe
欧洲
, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €4 billion under management. For more information, visit:
,拥有50年的经验,支持了500多家公司,并在全球范围内创造了市场领导者。如今,Sofinnova Partners管理的资产超过40亿欧元。欲了解更多信息,请访问:
sofinnovapartners.com
sofinnovapartners.com
.
。
About Trill Impact
关于Trill Impact
Trill Impact is an established Impact House with around
Trill Impact 是一家成熟的影响力机构,拥有大约
EUR 1.3 billion
13亿欧元
in assets under management. Its impact investment strategies span Buyout, Ventures and Microfinance, supported by experienced professionals based in
管理的资产。其影响力投资策略涵盖收购、风险投资和小额信贷,并由驻地的专业人士支持,这些专业人士经验丰富,位于
Europe
欧洲
and
和
North America
北美
. Trill Impact aims to be a force for positive change through impact private investments, delivering Real Returns and Lasting Impact for the benefit of investors, businesses and society at large – encouraging others to follow. For more information, please visit:
Trill Impact 旨在通过影响力私募投资成为积极变革的推动力,为投资者、企业和社会带来真正的回报和持久的影响力——鼓励其他人效仿。欲了解更多信息,请访问:
www.trillimpact.com
www.trillimpact.com
.
。
About BPIFrance
关于法国公共投资银行(BPIFrance)
Bpifrance Investissement is the management company that handles Bpifrance's equity investments. Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra financial services (training, consultancy) to help entrepreneurs meet their challenges from innovation to export.
Bpifrance Investissement 是负责管理 Bpifrance 股权投资的管理公司。Bpifrance 是法国国家投资银行:它通过贷款、担保、股权投资和出口保险,为企业在各个发展阶段提供融资。Bpifrance 还提供额外的金融服务(培训、咨询),帮助企业家应对从创新到出口的各种挑战。
For more information, please visit: .
如需更多信息,请访问:。
https://www.bpifrance.com/
https://www.bpifrance.com/
.
。
Media Contact
媒体联系人
Charlene Herndon
查琳·赫恩登
SPRIG Consulting
SPRIG咨询公司
charlene@sprigconsulting.com
查琳@斯普里格咨询.com
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