Vagal Neuromodulation Offers a Novel Approach to Treating Diabetes and Hypoglycemia

Device Demonstrates the Ability to Modulate Glucose Levels Without Cardiac Side Effects, Overcoming a Key Limitation Of Conventional Vagal Stimulation Techniques

IRVINE, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- 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 Device
The 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.

CONTACTS
ReShape Lifesciences Investor Contact:
Paul F. Hickey
President and Chief Executive Officer
949-276-7223
[email protected]

Investor Relations Contact:
Rx Communications Group
Michael Miller
917-633-6086
[email protected]