ReShape Lifesciences® Presents Pre-clinical Data on Its Proprietary Diabetes Neuromodulation Device at the 12th Annual Minnesota Neuromodulation Symposium
2025年5月2日 - 9:31PM
ReShape Lifesciences® (Nasdaq: RSLS), the premier
physician-led weight loss and metabolic health solutions company,
today announced it will present pre-clinical data on its
proprietary Diabetes Neuromodulation device in a poster
presentation at the 12th Annual Minnesota Neuromodulation
Symposium, being held in Minneapolis.
Poster Presentation Details:
- Poster Title: Stimulation of the Posterior
Sub-Diaphragmatic Vagal Trunk Reverses Insulin-Induced Severe
Hypoglycemia in a Swine Model of Type 1 Diabetes Mellitus
- Poster Number: 3308
- Author: Jonathan J. Waataja, Ph.D., Director
of Research at ReShape Lifesciences®
- Session: Session B
- Date: May 2, 2025
- Time: 10:45 am -1:00 pm CT
“Hypoglycemia remains a significant barrier to
effective diabetes management, contributing to severe health risks
and reduced quality of life,” stated Dr. Waataja. “Our Diabetes
Neuromodulation technology utilizes Hypoglycemia Vagus Nerve
Stimulation (HVNS), targeting stimulation of the sub-diaphragmatic
posterior vagus nerve (PVN) to rapidly increase blood glucose (BG)
during hypoglycemic episodes. The ability to avoid cardiac side
effects while effectively mitigating BG is critical for clinical
viability. Unlike conventional vagal stimulation techniques, our
targeted HVNS approach alters glucose levels without impacting
heart rate, blood pressure or respiration, overcoming a key
limitation of conventional vagal stimulation techniques. Also,
sub-diaphragmatic stimulation does not affect speech, which is an
obstacle to increasing desired therapeutic levels with conventional
vagal stimulation. The pre-clinical data presented today paves the
way for the continued development of our proprietary technology
aimed at reducing dependence on injections and wearable glucose
monitors, with the potential to dramatically improve quality of
life for people with Type 1 or Type 2 diabetes.”
Designed to evaluate HVNS efficacy and
off-target systemic effects in a Type 1 diabetic swine model,
laparoscopic placement of an electrode on the PVN successfully
increased blood glucose levels and glucagon secretion without
impacting cardiac output. Following insulin-induced hypoglycemia
(blood glucose <55 mg/dL), HVNS elevated glucose from a baseline
of 45 to 58 mg/dL in one swine and from 51 to 68 mg/dL in another
after 30 minutes of stimulation. Correspondingly, blood glucagon
levels rose from 4.1 to 12.3 pmol/L and from 3.5 to 7.6 pmol/L.
Importantly, mean heart rate remained stable, with no significant
changes observed during stimulation. Vomiting was only observed at
current amplitudes (~6 mA) above those needed to elicit therapeutic
glucose changes (~3 mA), underscoring a clear therapeutic window.
Positive control tests using intramuscular glucagon produced
similar blood glucose increases, further validating HVNS as an
effective alternative.
“The presentation of this data at such an
important industry conference is a testament to the strength of the
pre-clinical evidence showing the potential effectiveness of our
proprietary Diabetes Neuromodulation device,” stated Paul F.
Hickey, President and Chief Executive Officer of ReShape
Lifesciences. “As demonstrated in this model, our technology offers
a fast-acting, device-based intervention for insulin-induced
hypoglycemia. Given the promise of this approach, we will continue
to seek non-dilutive funding, while simultaneously working with top
researchers and industry leading strategic corporate partners to
potentially bring this novel therapeutic to market.”
About The ReShape Diabetes
Neuromodulation DeviceThe ReShape Diabetes Neuromodulation
system (formerly, Diabetes Bloc-Stim Neuromodulation™ (DBSN™) is a
novel minimally invasive therapeutic implant concept that delivers
bio-electronic neuromodulation of vagus nerve branches that are
innervating organs which regulate plasma glucose. The 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 system utilizes a
proprietary, reversable and adjustable electrical blockade that may
represent the future of personalized medicine. Reshape Lifesciences
believes its system is superior to both standalone stimulation of
the vagus nerve, and vagus nerve ligation which has undesirable
side effects and causes irreversible damage to the nerve.
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 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 the promise of the Diabetes Neuromodulation
technology and the potential path to commercialization of the
technology. 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
ReShape Lifesciences (NASDAQ:RSLS)
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