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Pelvic organ prolapse (POP) occurs when the normal support of the vagina is lost, resulting in the “sagging” or dropping of the female pelvic organs. This is very common: 50% of women will have some degree of prolapse and over 12% of American women will have surgery for it in their lifetime.
The current standard of care for POP either involves hysterectomy or complex surgery, which are invasive procedures with a long recovery period and potential for serious complications, or a pessary, a non-invasive option in which a device is fitted into the vagina to provide support to vaginal tissues.
Neither of these are good options, though, for a variety of reasons, Debbie Garner, co-CEO of FEMSelect, told VatorNews.
"Hysterectomy is a major operation with a potential for intraoperative complications and can involve psychological trauma. A pessary provides a molded plastic/urethane form to contour to the vaginal anatomy and help retain the prolapsed organs. Since the pessary does not fix or cure the prolapse, the pessary needs to be used indefinitely. Pessaries are commonly associated with discomfort, bacteria, smell and high need for routine cleaning," she said.
FEMSelect's product, called EnPlace, takes a different approach: it's minimally invasive device that's meshless, meaning it solves the issue of POP without requiring the patient to have invasive surgery.
"The EnPlace approach offers comparable clinical outcomes and yet significantly reduces the cost and complications of prolapse repair compared to standard of care with a dissectionless and meshless procedure," said Garner.
The Tel Aviv-based FEMSelect recently announced a $9 million Series B round funding led by New Age Ventures and co-led by TriVentures, with participation from Robin Hood Ventures, Mid Atlantic Bio Angels, MEDA Angels, Keiretsu Forum Mid-Atlantic, RAD BioMed, Keiretsu Capital and Transpacific Venture Partners. This new funding brings its total raised to approximately $14 million to date.
As part of its investment into FEMSelect, New Age Ventures will join 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 insertion and deployment of the anchor unit. The anchor can be introduced through the vaginal wall and secured to the ligament to provide pelvic floor stabilization without dissection.
After a procedure with EnPlace, which can be performed under light sedation, a woman is usually back to her typical activities with two or three days, and the majority of women in clinical studies went home with only over-the-counter pain relievers or no pain medication at all, Garner said. That is compared to the recovery time for standard of care surgeries, which is often four to six weeks and involves general anesthesia and pain medication.
A study conducted last year found that EnPlace had a a surgical success rate of 92.3%.
EnPlace is currently available in more than 25 states across the US and is in nearly 60 hospitals/ASCs, and with this Round of funding, FEMSelect plans to expand internationally; it will initially focus on penetrating the US further and will explore markets outside the US such as Europe, Australia and China in the coming year.
"FEMSelect is looking to grow the business over the coming years to then integrate the EnPlace technology to a larger women’s health strategic organization or to expand its own business to roll-up other women’s health/pelvic floor technologies to create a larger women’s health company," said Garner.
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