MISGAV, Israel, June 21, 2010 PolyTouch Medical Ltd., aleading developer of laparoscopic soft tissue prosthetic placementtechnologies, today announced that it has received broad FDA 510(k) clearanceto commercialize PatchAssist(TM). PatchAssist is an innovative laparoscopicsurgical instrument that enables accurate and rapid delivery and placement ofsoft tissue prosthetics for a variety of procedures, including laparoscopicventral hernia repair (LVHR).
PatchAssist(TM) is a stand-alone surgical device that is compatible withall currently commercialized soft tissue prosthetics. PatchAssist enablessurgeons to rapidly deliver and position soft tissue prosthetics over thedefect potentially reducing operation time by 30% - 50%.
Arik Levy Founder and Chief Technical Officer of PolyTouch commented,"PatchAssist is compatible with all currently commercialized soft tissueprosthetics, a technically challenging design requirement. We are pleasedthat the FDA has granted broad commercial clearance to PatchAssist."
"We are thrilled to have reached this value-creating milestone with theFDA clearance of PatchAssist," said Ofek Levin, CEO and Founder of PolyTouchMedical. "According to the Millennium Research Group, surgeons will performover 160,000 laparoscopic ventral hernia repair (LVHR) procedures this yearin the U.S. We believe PatchAssist has the potential to shorten the proceduretime for all these cases." Mr. Ofek continued, "Clinical and commercialinterest in PatchAssist is extremely high. Recent clinical surveys conductedduring the American Hernia Society Congress in Orlando, suggests that nearlyhalf of surgeons performing LVHR will switch from current to alternate softtissue Prosthetics if offered with PatchAssist. We are currently consideringa number of strategic options to commercialize PatchAssist."
Karl A. LeBlanc, MD, MBA, FACS, a member of the PolyTouch MedicalAdvisory Board and Clinical Professor of Surgery, Louisiana State UniversitySchool of Medicine, commented: "PolyTouch has been working very diligently toproduce a product that fills a need that surgeons have long desired. ThePatchAssist Device represents a first step in the technology of PolyTouch.This device will greatly enhance the repair of ventral and incisionalhernias. It will make the introduction, manipulation and fixation of anyprosthetic material that will be used in the repair of these hernias mucheasier. The FDA 510(k) represents an acknowledgement that this laparoscopicinstrument will benefit the surgical technique but most importantly, thepatient. It will ultimately save costs because the time saved with the use ofthe PatchAssist will be significant."
David Earle, MD, FACS, a member of the PolyTouch Medical Advisory Boardand Assistant Professor of Surgery, Tufts University School of Medicine,commented: "When I first saw the device, I was intrigued. It had thepotential to really improve the way both specialists and general surgeonsperform laparoscopic hernia repair. When I first used the device, I wasconvinced."
As previously reported, PolyTouch announced on April 26th, theappointment of Karl A. LeBlanc, MD, MBA, FACS, as Medical Advisor.
PolyTouch announced April 12th, the appointment of Morris E. FranklinJr., MD, FACS, as Medical Advisor.
On January 25th, PolyTouch announced the appointment of William Edelmanas Chairman of the Board.
About PolyTouch Medical Ltd.
PolyTouch Medical was founded in March 2009 and is located in the MisgavVenture Accelerator, Israel. PolyTouch is a portfolio company of TheTrendlines Group's (http://www.trendlines.com) Misgav Venture Accelerator(http://www.misgav-venture.com). PatchAssistTM is an innovative laparoscopicsurgical instrument that enables accurate and rapid delivery and placement ofsoft tissue prosthetics for a variety of procedures, including laparoscopicventral hernia repair (LVHR) potentially reducing procedure time by 30%-50%.PolyTouch plans to introduce the PatchAssistTM device into the U.S. market inthe beginning of 2011.Ofek Levin, Founder & CEO PolyTouch Medical Ltd, Email: firstname.lastname@example.org Phone: +972-72-260-7066
SOURCE PolyTouch Medical Ltd.