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Last updated on May 29, 2012 at 7:22 EDT

PolyTouch Medical Ltd. Announces the Submission of a Premarket Application for PatchAssist – an Innovative Mesh Deployment and Placement Device for Laparoscopic Hernia Repair

May 3, 2010
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MISGAV, Israel, May 3, 2010 /PRNewswire/ — PolyTouch Medical Ltd., a
leading developer of laparoscopic hernia mesh placement technologies, today
announced that it has filed a Premarket 510(k) Application with the US Food
and Drug Administration for PatchAssist, an Innovative Laparoscopic Mesh
Deployment and Placement Device that enables accurate mesh placement in
laparoscopic ventral hernia repair potentially reducing procedure time by
30%-50%.

PatchAssist is a standalone surgical mesh placement device that is
compatible with all common hernia meshes and supports a wide span of mesh
sizes including the largest mesh sizes in the market. PatchAssist enables
surgeons to choose their preferred mesh during LVHR procedures.

“We are extremely excited to have reached this value-creating milestone
with the filing of a Premarket 510(k) Application for PatchAssist,” said Ofek
Levin
, Founder and CEO of PolyTouch Medical. “LVHR is a relatively
complicated laparoscopic procedure mainly due to the hurdle of mesh
deployment and placement stage. With over 400,000 annual ventral hernia
repair procedures in the US, and with laparoscopic surgeries growing over 21%
annually, we believe that PatchAssist will become the standard of care in
LVHR, will reduce operation time and costs, and will enable an easier and
shorter learning curve for surgeons who wish to convert from the open
technique to the laparoscopic repair. We are receiving strong indications
from surgeons, at all levels of experience, that the product answers a clear
clinical need and that they look forward to using this device once it is
cleared.” Mr. Levin added, “We are currently reviewing several commercial
strategies for bringing PatchAssist to market following clearance of the
510(k) pre-market application. Clinical and commercial interest in patch
Assist is extremely high. Recent clinical surveys conducted during the
American Hernia Society Congress on Orlando last month, suggests that nearly
half of surgeons performing LVHR will switch to an alternate surgical mesh if
offered with Patch Assist.”

David Earle, MD, FACS, Assistant Professor of Surgery, Tufts University
School of Medicine
, PolyTouch’s Medical Advisor 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.
Additionally, 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.

About PolyTouch Medical Ltd.

PolyTouch Medical was founded in March 2009 and is located in the Misgav
Venture Accelerator, Israel. Realizing the need for an improved method for
mesh deployment and placement, PolyTouch has developed PatchAssist (patents
pending), a novel and proprietary mesh deployment and placement device
initially targeting laparoscopic ventral hernia repair (LVHR). PatchAssist is
a standalone surgical mesh placement device that is compatible with all
common hernia meshes enabling the surgeons to choose their preferred mesh
during LVHR procedures and it supports a wide span of mesh sizes including
the largest mesh size category. PatchAssist enables accurate abdominal cavity
mesh placement, potentially reducing procedure time by 30%-50%. PolyTouch
plans to introduce the PatchAssist device into the U.S. market in the
beginning of 2011.

    Contact:
    Ofek Levin, Founder & CEO
    PolyTouch Medical Ltd,
    Email: ofek@polytouch-med.com
    Phone: +972-72-260-7066

SOURCE PolyTouch Medical Ltd.


Source: newswire