Lumendi Receives FDA Clearance to Market DiLumen™ for Endolumenal Therapy

NEW YORK–(BUSINESS WIRE)– Connecticut-based medical device innovator Lumendi, LLC http://www.lumendi.com
has announced it has received United States Food and Drug Administration
(FDA) 510(k) clearance for the DiLumen™, an endoscopic accessory
that is indicated to ensure complete positioning of an endoscope in the
large intestine and assist with optical visualization, diagnosis and
endoscopic treatment.

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DiLumen™ (Photo: Business Wire)

DiLumen is a pioneering technology that stabilizes a colonoscope to
better facilitate incision-free endolumenal therapeutic procedures,
which are complex procedures utilizing a flexible colonoscope and
therapeutic devices inserted into the colon to locate and treat diseased
tissue while preserving the colon. The device was developed by Lumendi
in collaboration with the Minimally Invasive New Technologies program
(MINT) at Weill Cornell Medicine and New York-Presbyterian http://www.mint.weill.cornell.edu
It is the first device from the Endolumenal Interventional Platform
based on Lumendi and MINT’s initiative to migrate many gastrointestinal
surgeries to endolumenal procedures.

According to Dr. Peter Johann, CEO of Lumendi, Ltd., “DiLumen is the
first step in a family of devices to enhance endoscopic treatment,
including many promising endolumenal therapeutic procedures, that may
ultimately improve patient care. Lumendi sees a great potential in
endolumenal interventions and is committed to build on this opportunity.”

DiLumen facilitates endoscopic treatment of colonic lesions such as
polyps, a common condition that affects millions worldwide. Such
treatments may take the place of open surgical or laparoscopic
procedures, potentially reducing healthcare costs.

DiLumen consists of a single-use, soft flexible sheath that fits over
standard and small-diameter colonoscopes. The device employs two
balloons, one behind the bending section of the colonoscope and the
second in front of the tip of the colonoscope. When both balloons are
deployed, and inflated, a stable Therapeutic Zone (TZ) is created. This
TZ facilitates more localized insufflation and manipulation of the colon
and provides improved access to lesions to enable endoscopists and
surgeons to perform precise endolumenal interventions. Once the
procedure is complete, the balloons are deflated and removed along with
the colonoscope.

“DiLumen’s use during flexible colonoscopy is an important technical
advance in a field that has previously been defined by laparoscopic and
open surgical procedures. DiLumen can stabilize a section of colon and
facilitate the endoscopic removal of complex adenomas or polyps, with
the potential to positively impact patient outcomes. Although reporting
of results in patients awaits clinical studies, we are extremely
optimistic that this technology will be transformative in treating
digestive diseases,” said Jeffrey Milsom, M.D., Chief of Colorectal
Surgery at New York-Presbyterian/Weill Cornell Medical Center and
Co-Director of the MINT Program, and the Jerome J. Decosse, MD,
Distinguished Professor of Surgery at Weill Cornell Medicine. Dr. Milsom
is a co-inventor of DiLumen and a paid member of a clinical advisory
board for Lumendi, Ltd.

About Lumendi, LLC http://www.lumendi.com
Headquartered in Westport, Connecticut, Lumendi, LLC is a wholly owned
subsidiary of Lumendi, Ltd., a privately held innovative, medical device
company headquartered in London, England. Lumendi is focused on
developing, marketing and distributing surgical tools and devices that
provide safe, cost-effective solutions for minimally invasive
gastrointestinal interventions. Lumendi Ltd. holds a worldwide exclusive
license from Cornell University on the DiLumen technology.

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