ReShape Lifesciences® Receives NIH SBIR Grant to Further Develop Proprietary Diabetes Bloc-Stim Neuromodulation™ Device
September 14 2023 - 8:31AM
ReShape Lifesciences® (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health solutions company, today announced that the Company was
awarded a $331,541 Small Business Innovation Research (SBIR) grant
for the development of ReShape’s Diabetes Bloc-Stim
Neuromodulation™ (DBSN™) device, which utilizes its proprietary
vagus nerve block (vBloc) technology platform, combined with vagus
nerve stimulation, for the treatment of Type 2 diabetes, a
prominent disorder associated with obesity. Specifically, the grant
will fund the exploration of high-resolution endoscopic ultrasound
(EUS) probes to aid accurate placement of the electrodes
laparoscopically on the celiac and hepatic branches in large
animals.
“ReShape’s DBSN™ device selectively modulates
vagal block and stimulation to the liver and pancreas to manage
blood glucose. Increased glycemic control, has been successfully
demonstrated in a Zucker rat model of Type 2 diabetes as well as in
an alloxan treated swine model of type 2 diabetes, both of which
were completed with the help of an initial NIH grant,” stated
Jonathan Waataja, Ph.D. Director of Research at ReShape
Lifesciences®. “We are currently exploring the device’s ability to
treat hypoglycemia. We believe high-resolution EUS probes can be
used to quickly and accurately locate the fine branches of the
vagus nerve and aid in minimally invasive placements of DBSN™
electrodes and study off target effects during stimulation.”
“Awarding this third NIH SBIR grant brings the
total received awards to $900,000, and is a testament to both our
non-dilutive funding strategy and the NIH’s strong interest in the
development of the novel DBSN™ device and its potential to address
the significant, global diabetes market,” stated Paul F. Hickey,
President and Chief Executive Officer of ReShape Lifesciences®.
“With the funding, to date, our team has successfully completed the
pre-clinical development of the device, which utilizes
bioelectronics to adjust insulin production and manage blood
glucose to potentially treat Type 2 diabetes and hypoglycemia. It
has also shown that this innovative technology may reduce
diabetics’ dependence on medications in a very individualized
manner with the goal of reducing costs of treatment and
complications that arise from poorly controlled blood glucose and
non-compliance with diabetes medications. The promise of the DBSN™
device is evidenced, not only by the volume of NIH funding, but
also by the presentation of compelling preclinical evidence at
multiple medical conferences. Backed by a strong intellectual
property portfolio of 74 issued or pending patents related to
vBloc, glucose control, AI and Bluetooth applications, we remain
committed to furthering its development through similar NIH grants
or potential strategic alliances.”
About Diabetes Bloc-Stim
Neuromodulation™ DeviceThe Diabetes Bloc-Stim
Neuromodulation™ (DBSN™) system is a novel therapeutic concept that
is implanted minimally invasively and delivers bio-electronic
neuromodulation of vagus nerve branches that are innervating organs
which regulate plasma glucose. The DBSN™ system stimulates vagus
celiac fibers of the pancreas to release insulin during
stimulation, while blocking the hepatic vagal branch, innervating
the liver, to decrease glucose release and decrease insulin
resistance following ligation. The DBSN™ system utilizes a
proprietary, reversable and adjustable electrical blockade that we
believe is key to the future of personalized medicine. We believe
the DBSN™ system is superior to both standalone stimulation of the
vagus nerve that has shown mixed results, and vagus nerve ligation
that has undesirable effects.
About ReShape
Lifesciences®ReShape Lifesciences® is America’s premier
weight loss and metabolic health-solutions company, offering an
integrated portfolio of proven products and services that manage
and treat obesity and metabolic disease. The FDA-approved Lap-Band®
System provides minimally invasive, long-term treatment of obesity
and is an alternative to more invasive surgical stapling procedures
such as the gastric bypass or sleeve gastrectomy. ReShapeCare™ is a
virtual weight-management program that supports lifestyle changes
for all weight loss patients led by board-certified health coaches
to help them keep the weight off over time. The recently launched
ReShape Marketplace™ is an online collection of quality wellness
products curated for all consumers to help them achieve their
health goals. The investigational Diabetes Bloc-Stim
Neuromodulation™ (DBSN™) system utilizes a proprietary vagus nerve
block and stimulation technology platform for the treatment of type
2 diabetes and metabolic disorders. The Obalon® balloon technology
is a non-surgical, swallowable, gas-filled intra-gastric balloon
that is designed to provide long-lasting weight loss. For more
information, please visit www.reshapelifesciences.com.
Forward-Looking Safe Harbor
Statement This press release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Actual results could differ materially from
those discussed due to known and unknown risks, uncertainties, and
other factors. These forward-looking statements generally can be
identified by the use of words such as "expect," "plan,"
"anticipate," "could," "may," "intend," "will," "continue,"
"future," other words of similar meaning and the use of future
dates. Forward-looking statements in this press release include
statements about our the DBSN™ system’s potential treatment of
T2DM. These and additional risks and uncertainties are described
more fully in the company's filings with the Securities and
Exchange Commission, including those factors identified as "risk
factors" in our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q. We are providing this
information as of the date of this press release and do not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise, except as required by law.
CONTACTSReShape Lifesciences Investor
Contact:Thomas StankovichChief Financial
Officer949-276-6042ir@ReShapeLifesci.com
Investor Relations Contact:Rx
Communications GroupMichael
Miller(917)-633-6086mmiller@rxir.com
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