FEMSelect News
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FEMSelect transforms women's quality of life with innovative pelvic floor solutions | CTech
FEMSelect, an Israel-based company, aims to enhance womens quality of life through their solution for pelvic organ prolapse. They offer a minimally invasive approach called EnPlace, which is the only solution of its kind on the market. Other existing solutions are highly invasive and involve long recovery periods. FEMSelect recently raised $9 million in their Series B funding round led by TriVentures and co-led by New Age Ventures. The global market for medical devices addressing pelvic organ prolapse is estimated to be worth $10 billion. FEMSelects mission aligns with the growing demand for womens health solutions, particularly for those affected by childbirth, menopause, and aging.
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FEMSelect Raises US$9M in Series B Financing
FEMSelect, a Tel Aviv-based developer of an innovative approach to pelvic floor ligament fixation, has raised US$9M in Series B funding. The investment will support the growth and market penetration of their product, EnPlace®, primarily in the US. EnPlace® is a minimally invasive, meshless approach to pelvic floor ligament fixation that is cleared by the FDA. FEMSelect has partnered with womens healthcare company LiNA Medical USA and has obtained a procedure code from CMS, enabling healthcare facilities to receive reimbursement for the procedure. The technology is currently available in more than 25 states across the US.
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FEMSelect, Ltd. Announces CMS Reimbursement for Innovative Minimally Invasive Approach to Pelvic Organ Prolapse Repair Procedure
FEMSelect, a medical device company, has announced that the Centers for Medicare and Medicaid Services (CMS) has created a new HCPCS code to describe the procedure associated with its EnPlace system. The EnPlace procedure is positioned for appropriate payment as a Level 5 GYN procedure and designated as device-intensive, enabling broader access to EnPlace for women in ambulatory surgery centers. This is a major milestone for FEMSelect and the clinical community, as it provides reimbursement for a procedure that addresses pelvic organ prolapse, a condition that affects millions of women in the U.S. The EnPlace technology is available nationwide through FEMSelects exclusive partner in the U.S., LiNA Medical USA.
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FemSelect closes enrollment for mesh-free pelvic floor device study
FemSelect has closed enrollment for the EnPlace post-market study of its mesh-free pelvic floor repair device. The study aims to assess the long-term safety, durability, clinical effectiveness, and cost-effectiveness of the EnPlace system for vaginal colpopexy in uterine prolapse treatment. The company plans to do a limited launch in the U.S. in Q4 2019 following a Round B fundraising. The study is estimated to be completed by August 31, 2024.
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Mid Atlantic Bio Angels Initiates Second Investment Pool and Makes Inaugural Investment in POP Medical Solutions, Ltd.
Mid Atlantic Bio Angels (MABA) has announced the initiation of a second closed-end investment pool funded by current members. The inaugural investment from this pool has been made into Israel-based POP Medical Solutions, which focuses on the treatment of pelvic organ prolapse (POP). MABAs first investment pool was fully invested within 18 months and invested in several companies. The second pool is twice as large as the first. POP Medical has developed a minimally-invasive surgical system called NeuGuide for the treatment of POP. The company has received FDA clearance for the product and plans to complete a post-marketing study, gain European CE Mark Certification, transfer the product to mass production, and build a commercial organization in the US.
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A new mesh-free way to repair pelvic organ prolapse
Israeli company POP Medical Solutions is introducing NeuGuide, a minimally invasive repair system for pelvic organ prolapse (POP). The system, which does not require dissection or mesh, has been FDA-cleared. POP Medical Solutions aims to provide a safe and durable solution for POP, a condition that affects up to half of all women. The companys patented NeuGuide device, made of Nitinol, is proven to be stronger than other anchors in the market. The procedure takes less than 20 minutes and patients can leave the hospital within a few hours. NeuGuide has been tested successfully on 15 women and future trials are planned to build up clinical data. POP Medical Solutions has attracted investors from Taiwan and is closing a Series A funding round.
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POP Medical given FDA nod on pelvic device
POP Medical has obtained FDA approval for its medical device for treating pelvic floor prolapse. The device anchors the pelvic floor tissue to tendons, reducing treatment time and risk. The company was founded by Prof. Menahem Neuman and has raised a few million dollars. The CEO is Debbie Garner, who has experience in marketing and healthcare consulting. The product was tested on 15 women in a clinical trial with successful results. The company received a follow-up investment from the Triventures fund.
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