FEMSelect Announces Completion of Enrollment In Post-Market Clinical Study

Monday, September 23, 2019 General News
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FEMSelect, Ltd., manufacturer and marketer of EnPlace™, a patented meshfree and dissectionless approach to minimally invasive pelvic floor ligament fixation, today announces completion of enrollment in the EnPlace Post-Market Clinical Study

TEL AVIV, Israel, Sept. 23, 2019 /PRNewswire-PRWeb/ -- FEMSelect, Ltd., manufacturer and marketer of EnPlace™, a patented

meshfree and dissectionless approach to minimally invasive pelvic floor ligament fixation, today announces completion of enrollment in the EnPlace Post-Market Clinical Study. The global, two-phased study enrolled 60 patients across 15 sites in the US, Germany and Israel.

EnPlace was cleared by FDA (Food and Drug Administration) in 2016 and received CE Mark in mid-2018. Initial (six-month) clinical study data will be presented at the combined IUGA/AUGS meeting (Sept 23-28, 2019) in Nashville, TN.

FEMSelect is raising a Round B to prepare for a limited launch in the US in Q4 2019.

About FEMSelect

FEMSelect develops technology, manufactures and markets patented products within the Women's Health market. EnPlace, is a patent-protected product designed for pelvic floor ligament fixation during prolapse repair procedures. EnPlace was cleared by the FDA in 2016 for attaching sutures to ligaments of the pelvic floor. FEMSelect is preparing for a methodical launch by identifying Female Pelvic Medicine and Reconstructive Surgery (FPMRS) specialists who will follow a rigorous training regimen to learn the steps for fixation with EnPlace.

For more on FEMSelect Ltd. visit http://www.femselect.com

*Prior to a rebranding campaign, FEMSelect was formerly known as POP Medical Solutions and the EnPlace device was formerly known as NeuGuide™.

 

SOURCE FEMSelect



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