ReShape Lifesciences® Receives NIH Supplementary Grant with the University of Southern California’s Center for Autonomic Nerve Recording and Stimulation Systems (CARSS) to Further Develop Next-Generation Electrodes for ReShape’s Proprietary Diabetes B
2024年11月11日 - 10:31PM
ReShape Lifesciences® (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health solutions company, today announced that the Company was
awarded an approximately $241,000 supplementary grant from the
National Institutes of Health (NIH), with the University of
Southern California’s Center for Autonomic Nerve Recording and
Stimulation Systems (CARSS), for the development of the
next-generation electrodes for ReShape’s Diabetes Bloc-Stim
Neuromodulation™ (DBSN™) device. The DBSN™ 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. The supplementary grant
will be utilized to conduct minimally invasive laparoscopic
surgical electrode implantation techniques as well as long duration
safety and blood glucose modulation experiments in a porcine model
of diabetes.
“ReShape's DBSN™ device effectively regulates
vagal block and stimulation to the liver and pancreas,
respectively, resulting in improved blood glucose management. This
has been demonstrated through successful glycemic control in a
Zucker rat model of Type 2 diabetes and an alloxan treated swine
model of Type 2 diabetes, with the support of prior NIH grants,”
stated Jonathan Waataja, Ph.D. Director of Research at ReShape
Lifesciences®. “This non-dilutive supplemental grant, awarded over
the course of one year will fund studies to test the safety and
efficacy of a the next-generation electrodes which can potentially
double the nerve contact area to increase the effectiveness of
delivering DBSN signals while reducing power consumption. We look
forward to collaborating with CARSS to further the development of
the novel DBSN™ device as a potential treatment for diabetes and
hypoglycemia.”
“This fourth grant from the NIH brings our total
received awards to $1.15 million, demonstrating the viability of
our non-dilutive funding strategy and the NIH’s keen interest in
our novel DBSN™ technology and its potential in the global diabetes
market,” stated Paul F. Hickey, President and Chief Executive
Officer of ReShape Lifesciences®. “With these funds, our team has
successfully completed the pre-clinical development of the device,
utilizing bioelectronics to regulate insulin production and manage
blood glucose levels for the potential treatment of Type 2 diabetes
and hypoglycemia. This innovative technology has demonstrated the
ability to reduce the reliance on medications for diabetics in a
personalized manner, aiming to lower treatment costs and
complications associated with poorly controlled blood glucose and
medication non-compliance. The effectiveness and potential of a
DBSN™ device is reflected, not only by the substantial NIH funding,
but also by the presentation of compelling preclinical evidence at
various 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®
and Lap-Band® 2.0 Flex Systems provide minimally invasive,
long-term treatment of obesity and are an alternative to more
invasive surgical stapling procedures such as the gastric bypass or
sleeve gastrectomy. 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.
As previously announced ReShape has entered into
an asset purchase agreement with Biorad Medisys, Pvt. Ltd.,
pursuant to which ReShape has agreed to sell substantially all of
its assets to Biorad (or an affiliate thereof), including ReShape’s
Lap-Band® System, Obalon® Gastric Balloon System and the
DBSN™ system (but excluding cash). Therefore, at the closing of the
transactions contemplated by the asset purchase agreement, the
DBSN™ system will be owned by Biorad.
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 continued development of the DBSN™ system and
use of the NIH grant funds. 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:Paul F. HickeyPresident and Chief Executive
Officer949-276-7223ir@ReShapeLifesci.com
Investor Relations Contact:Rx
Communications GroupMichael Miller917-633-6086mmiller@rxir.com
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