PolyTouch Medical's PatchAssist device receives FDA clearance

PolyTouch Medical Ltd., a leading developer of laparoscopic soft tissue prosthetic placement technologies, today announced that it has received broad FDA 510(k) clearance to commercialize PatchAssist(TM). PatchAssist is an innovative laparoscopic surgical instrument that enables accurate and rapid delivery and placement of soft tissue prosthetics for a variety of procedures, including laparoscopic ventral hernia repair (LVHR).

PatchAssist(TM) is a stand-alone surgical device that is compatible with all currently commercialized soft tissue prosthetics. PatchAssist enables surgeons to rapidly deliver and position soft tissue prosthetics over the defect 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 tissue prosthetics, a technically challenging design requirement. We are pleased that the FDA has granted broad commercial clearance to PatchAssist."

"We are thrilled to have reached this value-creating milestone with the FDA clearance of PatchAssist," said Ofek Levin, CEO and Founder of PolyTouch Medical. "According to the Millennium Research Group, surgeons will perform over 160,000 laparoscopic ventral hernia repair (LVHR) procedures this year in the U.S. We believe PatchAssist has the potential to shorten the procedure time for all these cases." Mr. Ofek continued, "Clinical and commercial interest in PatchAssist is extremely high. Recent clinical surveys conducted during the American Hernia Society Congress in Orlando, suggests that nearly half of surgeons performing LVHR will switch from current to alternate soft tissue Prosthetics if offered with PatchAssist. We are currently considering a number of strategic options to commercialize PatchAssist."

Karl A. LeBlanc, MD, MBA, FACS, a member of the PolyTouch Medical Advisory Board and Clinical Professor of Surgery, Louisiana State University School of Medicine, commented: "PolyTouch has been working very diligently to produce a product that fills a need that surgeons have long desired. The PatchAssist Device represents a first step in the technology of PolyTouch. This device will greatly enhance the repair of ventral and incisional hernias. It will make the introduction, manipulation and fixation of any prosthetic material that will be used in the repair of these hernias much easier. The FDA 510(k) represents an acknowledgement that this laparoscopic instrument will benefit the surgical technique but most importantly, the patient. It will ultimately save costs because the time saved with the use of the PatchAssist will be significant."

David Earle, MD, FACS, a member of the PolyTouch Medical Advisory Board and Assistant Professor of Surgery, Tufts University School of Medicine, commented: "When I first saw the device, I was intrigued. It had the potential to really improve the way both specialists and general surgeons perform laparoscopic hernia repair. When I first used the device, I was convinced."

As previously reported, PolyTouch announced on April 26th, the appointment of Karl A. LeBlanc, MD, MBA, FACS, as Medical Advisor.

PolyTouch announced April 12th, the appointment of Morris E. Franklin Jr., MD, FACS, as Medical Advisor.

On January 25th, PolyTouch announced the appointment of William Edelman as Chairman of the Board.