Released on: October 4, 2008, 4:01 am

Press Release Author: Vishal Saxena

Industry: Healthcare

Press Release Summary: Thursday, October 2, 2008. Austin, TX—Apollo Endosurgery
Inc. announced today that the FDA has cleared a 510(k) application to market its
OVERSTITCH™ endoscopic suture system. This allowance opens the way for US
commercial release of the product which is anticipated for late 2008.

Press Release Body: A robust new surgical tool for endoscopic surgical procedures

Thursday, October 2, 2008. Austin, TX—Apollo Endosurgery Inc. announced today that
the FDA has cleared a 510(k) application to market its OVERSTITCH™ endoscopic suture
system. This allowance opens the way for US commercial release of the product which
is anticipated for late 2008.

The OVERSTITCH system is a single-use device that fits onto standard flexible
endoscopes and enables physicians to place full thickness running or interrupted
sutures into targeted tissues.

“Adapting suturing to a standard flexible endoscope platform is a major
accomplishment” explained Dr. Santiago Horgan, Director of Minimally Invasive
Surgery and the Center for the Future of Surgery at the University of California San
Diego. “The OVERSTITCH system will enhance the ability to perform full thickness
tissue apposition and anastomosis reliably by letting us mimic how we would suture
laparoscopically.”

“The capability to suture endoscopically makes the device a valuable tool for a
variety of endolumenal GI procedures,” said Dr. Jeffrey Marks, Associate Professor
in the Department of Surgery at University Hospitals Case Medical Center. “The use
of a tool like the OVERSTITCH system will enable the advanced endoscopist to perform
more aggressive procedures such as EMR and full thickness resection.”

The OVERSTITCH endoscopic suture system is a fully disposable suturing system that
allows a physician to use a standard flexible endoscope to place sutures. The
device quickly mounts to common therapeutic endoscopes and is designed to safely
navigate through delicate areas of the anatomy. Once at the surgical site, custom
needle-suture sets—available with standard absorbable and non-absorbable materials
up to 2-0 in thickness—can be loaded and reloaded without removing the device or the
endoscope. The physician can then place either an interrupted or running stitch
which can be secured with an included cinching device or by using the device itself
to tie a surgical knot.

“The 510(k) clearance of the OVERSTITCH endoscopic suture system is a significant
step towards making the benefits of endolumenal surgery a realistic therapeutic
option in hospitals and clinics across the country,” said Dennis McWilliams, CEO of
Apollo Endosurgery, Inc. “This is a major milestone for the company and is a
testament to Apollo Endosurgery’s continued commitment to be an innovative leader in
the field of advanced minimally invasive surgery.”

About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. develops and markets medical devices for minimally invasive
surgical procedures conducted through natural orifices. These minimally invasive
procedures are at the convergence of flexible endoscopy and general surgery, and
include procedures inside the gastrointestinal tract (endolumenal surgery) as well
as procedures that cross the lumen to the peritoneal cavity (known as translumenal
surgery, or NOTES). Using a new class of Apollo’s proprietary flexible access
devices and surgical tools, surgeons and gastroenterologists will be able to perform
scarless interventions for the treatment of early stage cancers, obesity, and
general surgical procedures in the peritoneal cavity. In addition to avoiding the
scars caused by abdominal incisions, these procedures are expected to result in less
pain, require less sedation, and lead to faster recovery times. Apollo Endosurgery
was cofounded with the Apollo Group, a unique collaboration of physicians from the
Mayo Clinic, Johns Hopkins University, Medical University of South Carolina, the
University of Texas Medical Branch, and the Chinese University of Hong Kong. The
company is funded by PTV Sciences and H.I.G Ventures.


Web Site: http://www.apolloendo.com/flexible_endoscopic_suturing_system.html

Contact Details: APOLLO ENDOSURGERY, INC.
7000 BEE CAVES ROAD
SUITE 250
AUSTIN, TX. 78746
CALL US 512.328.9990