bioworld - Medical Device Daily

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stomach. Should the balloon deflate, it
will remain harmlessly in the stomach
until removed via a standard endoscopy
procedure,” said Evzen Machytka, the
doctor who performed the first
implants with the device.
“Currently, intragastric balloons must
be removed after six months, due to
the rising incidence of balloon deflation
after six months, which in turn increases
the risk of intestinal obstruction.
Spatz FGIA will be presenting evidence
to the European regulatory authorities
to show how the Spatz Balloon
System’s special uncrushable ‘tail’ eliminates
this risk. Until the regulatory
authorities approve leaving the balloon
in place for longer periods, patients and
physicians will be advised to ensure
removal of the Spatz System after six
months,” said CEO Jeffrey Brooks in a
release.
In October 2009, Spatz reported that
the first patients had been implanted
with the device, at the University
Hospital in Ostrava, Czech Republic.
ReShape Medical – ReShape
Balloon
ReShape Medical Inc., of San
Clemente, Calif., is developing the
ReShape intragastric balloon, which is
designed to occupy space in the stomach
to create a feeling of satiety. It is
implanted endoscopically (attached to
the end of a catheter), then filled with
saline. Unlike other intragastric balloons,
which tend to be comprised of
one round balloon, ReShape’s product
is composed of two balloons that are
attached together by a flexible tube.
Each balloon has independent channels,
so the other is not impacted in
the event of deflation or leaks. It is left
in a patient for six months, and used
in conjunction with diet and exercise.
ReShape has obtained CE Mark and ISO
certification for the product, and clinical
investigations are under way outside of
the U.S. Studies are being planned for
the U.S. as well.
THE BIOWORLD AND MEDICAL DEVICE DAILY OBESITY REPORT
Fulfillium
Fulfillium Inc., of San Francisco, has
filed a patent for a gastric balloon.
Other Space-Filling Products
Tulip Medical
Tulip Medical Ltd., of Tel Aviv, Israel, is
developing a disposable and biodegradable
medical device that is swallowed as
a capsule and creates pressure or tension
on the gastric wall, which sends
satiety signals to the brain, thereby
reducing food consumption. The product
is based on reports in medical literature
that the creation of tension in the
stomach walls is picked up by stress sensors,
which cause a feeling of satiety.
The device’s mechanism of action is
purely mechanical and does not involve
any chemical activity, Tulip said.
In September 2008, 7 Health Ventures,
a professional venture capital fund
dedicated to investing in health care
technologies and products, said it had
joined a deferred closing of Tulip
Medical’s Series A financing.
BaroSense – TERIS
BaroSense Inc., of Redwood City,
Calif., is a medical device company
focused on treatments for obesity. It is
working on the development of a minimally
invasive treatment for obesity.
The BaroSense Trans-oral Endoscopic
Restrictive Implant System (TERIS) is
being investigated for safety in
Canada. It uses an endoscopic procedure
to implant a restrictive reservoir in
the stomach, in order to create a sense
of satiety. The study began in June
2008, and is expected to be complete
in May 2010.
In August 2009, BaroSense reported
that it raised $27 million, of a targeted
$30 million, in its fourth round of
financing. Previous investors joining
the latest round were Delphi Ventures,
Frazier Healthcare Ventures, Invesco
Private Capital, RWI Ventures, Synergy
Life Science Partners and Wharton
Ventures. They were joined by new
investor Pappas Ventures. The amount
brings the total the company has raised
to $53 million. BaroSense was founded
in 2001.
Gelesis
Gelesis Inc., of Boston, is a private
developer of treatments for obesity and
other unmet medical needs. The
Boston-based company has remained
under the radar since its founding in
2006, and Eric Elenko, interim vice
president of business development,
declined to comment on its technology
or pipeline in 2008.
Yet Gelesis’ patents may provide a clue
to its obesity approach. The company
has intellectual property relating to synthetic
polymers that swell in the stomach
to create a feeling of “fullness.”
Another clue might be gleaned from
that fact that Gelesis was co-founded
by ExoTech Bio Solutions, an Israeli
chemistry company that has developed
a biodegradable, superabsorbent polymer
called ExoSAP.
Whatever Gelesis is up to, the company
has managed to attract an impressive
roster of scientific advisors. SAB members
include Elazer Edelman, of Harvard
University; former FDA executive David
Feigal; gastric balloon pioneer Allan
Geliebter; James Hill, of the University
of Colorado; Lee Kaplan, of
Massachusetts General Hospital Weight
Center; and Stephen Woods, of the
University of Cincinnati’s Obesity
Research Center.
Gelesis was co-founded in 2006 by
PureTech Ventures and ExoTech Bio
Solutions, with the participation of a
group of obesity experts and scientists.
Gelesis CEO, Yishai Zohar, was formerly
a partner at PureTech Ventures where
he co-founded Gelesis.
In February 2008, Gelesis announced that
is raised $16 million in a Series A financing.
OrbiMed Advisors led the round, and
also participating were Queensland
BioCapital Funds, PureTech Ventures,