ReShape Lifesciences® to Present Data on its Proprietary Diabetes Bloc-Stim Neuromodulation™ Device at the Keystone Symposia on Type 2 Diabetes
27 4월 2023 - 9:30PM
ReShape Lifesciences™ (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health solutions company, today announced it will present data on
its proprietary Diabetes Bloc-Stim Neuromodulation™ (DBSN™) device
in a poster at the Keystone Symposia on Type 2 Diabetes:
Understanding its Early Drivers and the Road to Therapeutics, being
held in Palm Springs, CA, May 1 – 4, 2023.
“Neuromodulation has demonstrated utility for
the treatment of multiple diseases, representing a potential,
unique treatment option for type 2 diabetes mellitus (T2DM), and we
have demonstrated increased glycemic control in Zucker rodent and
swine models of T2DM by utilizing sub-diaphragmatic vagus nerve
neuromodulation with our DBSN™ device,” stated Jonathan Waataja,
Director of Research at ReShape Lifesciences. “That said, there
remains a need for treatments for T2DM in early- or pre-stage
diabetes, a time that offers greater potential for strategies to
delay or reverse diabetic progression. While lifestyle changes are
often recommended to patients at this stage, there is a high degree
of non-compliance. To this end, we tested two groups of swine that
had attributes consistent of pre- and early-stage diabetes and
determined that DBSN™ increased glycemic control in both groups.
Hypothesizing that a barrier to utilizing this therapy, for
diabetic patients, would be the willingness to have a device
implanted. We surveyed 182 type 2 diabetics and found that 82%
pursuing lifestyle modification would consider a device such as the
DBSN.”
Poster Details:
- Poster Title: Targeted Dual Sub-Diaphragmatic
Vagus Nerve Neuromodulation Increased Performance on Oral Glucose
Tolerance Tests and Reversed Fasting Plasma Glucose from
Pre-Diabetic to Non-Diabetic Levels in Alloxan Treated Swine with
Mild Glucose Intolerance
- Poster Number: 2004
- Authors: Jonathan J Waataja, ReShape
Lifesciences Inc.; Maneesh Shrivastav, Medtronic, Inc.; Charles J
Billington, Veterans' Administration Medical Center, Minneapolis,
MN
- Session: Poster Session 2
- Date: Wednesday, May 3, 2023
- Time: 7:30 pm PT
Increased glycemic control was demonstrated in a
Zucker rodent model of T2DM by utilizing sub-diaphragmatic vagus
nerve dual neuromodulation, utilizing reversible high frequency
alternating current (at 5000 Hz) induced conduction block of the
hepatic branch of the vagus nerve (innervating the liver), with
simultaneous stimulation of the celiac branch of the vagus nerve
(innervating the pancreas). The dual neuromodulation was found to
be superior to standalone block or stimulation. These results were
replicated in a chronic study in glucose intolerant alloxan treated
swine. In both experiments, the animals demonstrated high fasting
plasma glucose (FPG) and significant glucose intolerance,
characteristics of an overt diabetic state. Subsequently, dual
neuromodulation was tested on swine that had attributes consistent
of pre- and early-stage diabetes, including non-alloxan and alloxan
treated with mild glucose intolerance. Dual neuromodulation
increased glycemic control in both groups which was demonstrated by
increased performance on oral glucose tolerance tests (OGTTs) and
also induced long lasting decreases in FPG. Following applications
of block and stimulation (two days of separation), FPG decreased
from an average of 102±8 mg/dL (considered prediabetic) to 74±2
mg/dL (considered non-diabetic).
“The compelling data on our proprietary DBSN™
device, presented at the Keystone Symposia on Type 2 Diabetes,
further validates the market potential of this technology,” stated
Paul F. Hickey, President and Chief Executive Officer of ReShape
Lifesciences. “Backed by a strong intellectual property portfolio,
the DBSN™ device’s dual vagus nerve neuromodulation selectively
modulates vagal block and stimulation to the liver and pancreas,
respectively, to manage insulin and blood glucose levels, which may
be able to reduce patients’ dependence on medications in a very
individualized manner. We will continue to collaborate with leading
researchers and industry-leading strategic corporate partners, all
while seeking additional NIH grant support for this program. If
approved for commercial use, the DBSN™ device will further enhance
our differentiated medical device offerings.”
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 electrically blocking the hepatic vagal branch,
innervating the liver, to decrease glucose release and decrease
insulin resistance following nerve blockade. The DBSN™ system
utilizes a proprietary, reversable and adjustable electrical
blockade felt to be key to the future of personalized medicine. 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
ReShape Lifesciences (NASDAQ:RSLS)
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