TORONTO--(BUSINESS WIRE)--Cosm Medical proudly announces FDA clearance for Gynethotics™ Pessaries, marking it as the first personalized pessary available to patients. This milestone follows a recent Health Canada clearance and marks a significant advancement in pelvic care, emphasizing Cosm’s commitment to enhancing patient outcomes and revolutionizing treatment options for women worldwide..

多伦多--（商业新闻短讯）--Cosm Medical骄傲地宣布FDA批准Gynethodics™子宫托，标志着它是第一个可供患者使用的个性化子宫托。这一里程碑事件发生在加拿大卫生部最近的一项批准之后，标志着骨盆护理取得了重大进展，强调了Cosm致力于提高患者预后并彻底改变全球女性的治疗选择。

Gynethotics™ are the first pessary to be FDA cleared in about 5 years with almost 10 million pessary configurations that clinicians can conveniently order online. That is compared to about 100 configurations that are offered by other commercially available pessaries. The benefits of personalized Gynethotics™ Pessaries were demonstrated in a pilot study completed at Sinai Health Systems and published in Urogynecology, the Journal of the American Urogynecology Society, in 2023..

Gynethodics™是大约5年来FDA批准的第一个子宫托，具有近1000万个子宫托配置，临床医生可以方便地在线订购。相比之下，其他市售子宫托提供的约100种配置。个性化Gynethodics™子宫托的益处在西奈卫生系统完成的一项试点研究中得到证实，该研究于2023年发表在《美国泌尿妇科学会杂志》泌尿妇科学上。

“Our vision is to become the world leader in precision gynecological devices for unique bodies and needs.” said Derek Sham, Founder & CEO of Cosm Medical. “With our first FDA clearance, we are one step closer to realizing this vision and making a meaningful impact on the lives of over a million patients by 2030.

Cosm Medical创始人兼首席执行官德里克·沙姆（DerekSham）表示：“我们的愿景是成为世界领先的精密妇科设备，以满足独特的身体和需求。”“随着我们首次获得FDA批准，我们离实现这一愿景又近了一步，到2030年将对100多万患者的生活产生重大影响。

This will set a new standard of care in gynecology like the established billion-dollar markets of custom orthotics, dental and hearing.”.

这将确立妇科护理的新标准，就像已建立的数十亿美元的定制矫形器、牙科和听力市场一样。”

Half of all women will experience a pelvic floor disorder such as prolapse and incontinence in their lifetime. “Aging and women’s health are both severely underserved markets with high clinical unmet needs, demonstrated by the fact that Femtech and Agetech are both projected to be growing at over 15% CAGR.” said Ivneet Bhullar, Investment Partner at Fusion Fund and Cosm Board Member.

一半的女性在一生中会经历骨盆底疾病，如脱垂和尿失禁。Fusion Fund投资合伙人兼Cosm董事会成员Ivneet Bhullar表示：“老龄化和女性健康都是严重服务不足的市场，临床需求未得到满足，Femtech和Agetech预计将以超过15%的复合年增长率增长。”

“It’s been great supporting Cosm over the past 2 years as they’ve achieved major milestones towards driving precision care into gynecology.”.

“在过去的两年中，Cosm获得了巨大的支持，因为他们在推动精准护理进入妇科方面取得了重大里程碑。”

Beyond pessaries, Cosm has signed a strategic partnership with the University of Alabama at Birmingham to work with Holly E. Richter, Ph.D., M.D. and Max Cadena, M.D. on a novel design and indication for Gynethotics. “We look forward to improving surgical outcomes and are currently completing Phase 1 of a clinical study with the goal of implementing a new paradigm for impacting post-operative healing,” Richter said.

除了子宫托之外，Cosm还与阿拉巴马大学伯明翰分校签署了战略合作伙伴关系，与霍莉·E·里克特（HollyE.Richter）博士、医学博士和马克斯·卡德纳（Max Cadena）博士合作，为妇科学提供一种新颖的设计和适应症。里克特说：“我们期待着改善手术效果，目前正在完成一项临床研究的第一阶段，目的是实施一种影响术后愈合的新范例。”

“This is especially important as there are limited evidence-based options for augmenting vaginal native tissue repairs.”.

“这一点尤其重要，因为增加阴道天然组织修复的循证选择有限。”

About Cosm Medical

关于Cosm Medical

Based in Toronto, Canada, Cosm Medical is personalizing gynecological devices for precision care because every woman is different. Cosm’s digital gynecology platform leverages novel diagnostics, AI, cloud software, and 3D printing to create patient-specific gynecological devices for unique bodies and needs..

总部位于加拿大多伦多的Cosm Medical正在为精准护理个性化妇科设备，因为每个女性都不一样。Cosm的数字妇科平台利用新颖的诊断、人工智能、云软件和3D打印技术，为独特的身体和需求创建针对患者的妇科设备。

About Fusion Fund

关于Fusion Fund

Based in Palo Alto, California, Fusion Fund is a venture capital firm that focuses on backing early-stage entrepreneurs in building forward-thinking companies with technical and data advantages. Since 2015, Fusion Fund has invested in over 80 portfolio companies across the US and Canada in the healthcare, enterprise AI, and industrial automation sectors..

Fusion Fund总部位于加利福尼亚州帕洛阿尔托，是一家风险投资公司，专注于支持早期创业者建立具有技术和数据优势的前瞻性公司。自2015年以来，Fusion Fund在美国和加拿大的医疗保健、企业人工智能和工业自动化领域投资了80多家投资组合公司。