ReShape Lifesciences® Presents Pre-clinical Data on Its Proprietary Diabetes Neuromodulation Device at the 12th Annual Minnesota Neuromodulation Symposium

Rhea-AI Summary

ReShape Lifesciences (RSLS) presented pre-clinical data on its Diabetes Neuromodulation device at the Minnesota Neuromodulation Symposium. The device uses Hypoglycemia Vagus Nerve Stimulation (HVNS) to target the sub-diaphragmatic posterior vagus nerve, effectively increasing blood glucose during hypoglycemic episodes without cardiac side effects. In the Type 1 diabetic swine model study, HVNS successfully elevated glucose levels from 45 to 58 mg/dL and 51 to 68 mg/dL in two subjects after 30 minutes, while increasing glucagon levels. The technology demonstrated a clear therapeutic window, with side effects only occurring at current amplitudes above therapeutic levels. This innovation could potentially reduce dependence on injections and wearable glucose monitors for Type 1 and Type 2 diabetes patients.

Positive

• Pre-clinical data showed successful increase in blood glucose levels without cardiac side effects
• Technology demonstrated clear therapeutic window with minimal side effects
• Device could potentially reduce dependence on traditional diabetes management methods
• Sub-diaphragmatic stimulation avoids speech-related complications common in conventional vagal stimulation

Negative

• Still in pre-clinical phase with testing limited to swine models
• Company needs to seek non-dilutive funding for further development
• Vomiting observed at higher current amplitudes (6mA)

Insights

Medical Device Analyst

ReShape's pre-clinical diabetes device shows promise in animal testing but remains years from potential commercialization with significant development hurdles ahead.

ReShape Lifesciences has presented early-stage pre-clinical data on its Diabetes Neuromodulation technology using a targeted approach called Hypoglycemia Vagus Nerve Stimulation (HVNS). The animal study data shows their device can increase blood glucose levels during hypoglycemic episodes without affecting heart rate - overcoming a key limitation of conventional vagal stimulation techniques.

The data demonstrates specific, measurable outcomes in the swine model:

• Blood glucose increased from 45 to 58 mg/dL in one animal and from 51 to 68 mg/dL in another
• Glucagon levels rose from 4.1 to 12.3 pmol/L and from 3.5 to 7.6 pmol/L
• No significant changes in heart rate were observed
• Therapeutic effects occurred at lower stimulation levels (~3 mA) than adverse effects (vomiting at ~6 mA)

This represents a potential expansion of ReShape's technology portfolio beyond its core weight management products. However, these results represent one of the earliest stages in medical device development. The path from pre-clinical testing to commercial product involves numerous scientific, regulatory, and commercial hurdles that many candidates never successfully navigate.

The company's mention of seeking "non-dilutive funding" and strategic partners suggests additional capital will be needed to advance through clinical development phases. Unlike pharmaceuticals, medical device commercialization typically requires establishing not just efficacy but also demonstrating reliability, surgical placement protocols, and long-term safety in human subjects - processes that typically require years of development.

Endocrinology Specialist

Novel vagal stimulation approach shows potential for hypoglycemia management in diabetes, with unique advantages over conventional techniques but still in early research stage.

This pre-clinical research targets one of the most significant challenges in diabetes management: preventing dangerous hypoglycemic episodes. The data demonstrates that targeted stimulation of the sub-diaphragmatic posterior vagus nerve can trigger natural glucose regulation mechanisms by increasing blood glucagon levels that subsequently raise blood glucose.

Two technical innovations distinguish this approach:

• The sub-diaphragmatic placement avoids speech effects that limit therapeutic stimulation levels in conventional vagal approaches
• The selective posterior trunk targeting appears to minimize cardiac impacts - a critical improvement over traditional vagal stimulation

The measured increases (13-17 mg/dL in glucose) observed in the swine model would be clinically meaningful if reproduced in humans, potentially preventing progression from mild to severe hypoglycemia. Currently, severe hypoglycemia management relies heavily on glucagon injections, which require third-party administration when a patient is often already unconscious.

The establishment of a therapeutic window (efficacy at ~3 mA, side effects at ~6 mA) suggests a potential safety margin. However, animal models of diabetes don't perfectly translate to human physiology, and questions remain about long-term efficacy, device durability, and surgical implantation requirements.

While innovative, this technology remains in early research stages with numerous scientific and technical challenges to address before clinical trials could begin. If eventually developed into a viable therapy, such a device would likely complement rather than replace existing glucose monitoring technologies that remain essential for diabetes management.

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
ir@ReShapeLifesci.com

Investor Relations Contact:
Rx Communications Group
Michael Miller
917-633-6086
mmiller@rxir.com

FAQ

What is ReShape Lifesciences' (RSLS) new diabetes device and how does it work?

ReShape's Diabetes Neuromodulation device uses Hypoglycemia Vagus Nerve Stimulation (HVNS) to target the sub-diaphragmatic posterior vagus nerve, increasing blood glucose during hypoglycemic episodes without cardiac side effects.

What were the results of RSLS's pre-clinical trials for their diabetes device?

In swine models, the device increased blood glucose from 45 to 58 mg/dL and 51 to 68 mg/dL after 30 minutes, while raising glucagon levels, without affecting heart rate.

What advantages does RSLS's diabetes device have over conventional treatments?

The device avoids cardiac side effects, doesn't affect speech, and could reduce dependence on injections and wearable glucose monitors, potentially improving quality of life for diabetes patients.

What are the potential side effects of ReShape's diabetes neuromodulation device?

Vomiting was only observed at current amplitudes of ~6mA, which is above the therapeutic level of ~3mA needed for glucose changes, indicating a clear therapeutic window.

What is the current development stage of RSLS's diabetes device?

The device is in pre-clinical testing phase, with the company seeking non-dilutive funding and working with researchers and strategic partners to bring it to market.