FEMSelect raises $9M to expand its pelvic floor fixation device

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The company will continue to expand in the US so that more women can use their Enplace devices

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Pelvic organ prolapse (POP) occurs when the normal support of the vagina is lost, resulting in “loosening” or prolapse of the female pelvic organs. It’s very common: 50% of women will have some degree of prolapse and more than 12% of American women will have surgery for it in their lifetime.

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The current standard of care for POP includes either hysterectomy or complex surgery, which are invasive procedures with long recovery periods and the potential for serious complications, or a pessary, a non-invasive option that involves inserting an insertion into the vagina to provide support. A device is applied to the tissue of the vagina.

Neither of these is a good choice, though, for a variety of reasons, FEMSelect co-CEO Debbie Garner told VatorNews.

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“Hysterectomy is a major operation with the potential for intraoperative complications and may involve psychological trauma. A pessary provides a molded plastic/urethane form for the contour of the vaginal anatomy and helps to maintain prolapsed organs. Because pessaries do not heal or cure prolapse. Pessaries need to be used indefinitely. Pessaries are usually associated with discomfort, bacteria, odor and a higher need for regular cleaning,” she said.

FEMSelect’s product, called EnPlace, takes a different approach: It’s a minimally invasive device that’s reticulated, meaning it solves the issue of POP for the patient without requiring invasive surgery.

“The enplacement approach provides comparable clinical outcomes and yet significantly reduces the cost and complications of prolapse repair compared to the standard of care with an amputationless and meshless procedure,” Garner said.

Tel Aviv-based FEMSelect recently raised a $9 million Series B led by New Age Ventures with participation from Robin Hood Ventures, Mid Atlantic Bio Angels, MEDA Angels, Kiretsu Forum Mid-Atlantic, Red BioMed and co-led by TriVentures. Announced round of funding. , Kiretsu Capital and Transpacific Venture Partners. This new funding raises the total amount raised so far to approximately $14 million.

As part of its investment in FEMSelect, New Age Ventures will be joining the company’s board of directors.

EnPlace is composed of two main elements: an anchor unit and a guided delivery system. The system uses FEMSelect’s patented finger guide as a working channel for the anchor unit’s insertion and deployment. The anchor may be introduced through the vaginal wall and secured with a ligament to provide pelvic floor stabilization without amputation.

After a procedure with an enplacement, which can be performed under mild sedation, a woman usually returns to her normal activities with two or three days, and most women in clinical studies only have over Go home with over-the-counter pain relievers whether or not pain medication at all, Garner said. This is compared to the recovery time for standard of care surgery, which is often four to six weeks and involves general anesthesia and pain medication.

A study conducted last year found that the surgical success rate of enplacement was 92.3%.

EnPlace is currently available in more than 25 states across the US and approximately 60 hospitals/ASCs, and with this round of funding, FEMSelect plans to expand internationally; It will initially focus on expanding further to the US and will explore markets outside the US such as Europe, Australia and China in the coming year.

“FEMSelect seeks to grow the business in the coming years to integrate EnPlace technology into a larger women’s health strategic organization or to roll-up other women’s health/pelvic floor technologies to form a larger women’s health company. expand your own business,” Garner said.

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