Vagal Neuromodulation Offers a Novel Approach to Treating Type 2 Diabetes and Hypoglycemia

Patent Enables Equivalent Efficacy with 10 times Lower Energy Consumption Than Current Device

Fully Compatible with Standard Implantable Pulse Generators, Enabling Cost-Effective Development

IRVINE, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences ® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that the Company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 18/069,689, entitled, “High-Frequency Low Duty Cycle Patterns for Neural Regulation.” When issued, the patent will provide protection until August 4, 2037. The Diabetes Neuromodulation system leverages its proprietary vagus nerve block (vBloc™) technology platform, along with vagus nerve stimulation, to treat Type 2 diabetes, a prominent disorder linked with obesity.

“Type 2 diabetes remains a global health challenge and continues to be difficult to treat effectively, despite the range of available medications, surgical options, and dietary interventions,” stated Jonathan Waataja, Ph.D. Director of Research at ReShape Lifesciences ® . “Our Diabetes Neuromodulation technology addresses this by regulating blood glucose through targeted vagal nerve modulation, specifically, blocking and stimulating signals to the liver and pancreas. This patent will cover discontinuous high-frequency signals with interwoven micro- and millisecond pauses, forming an energy-efficient algorithm that ‘taps’ the nerve with bursts of stimulation to achieve a blocking effect. By using approximately 10 times less energy than traditional continuous signals, the system enables the use of smaller batteries or devices and allows for longer intervals between charges. Preclinical testing on rat vagus nerves has demonstrated equivalent efficacy to continuous signals, while remaining fully compatible with standard implantable pulse generators, which will allow for cost-effective development. To date, our team has successfully completed preclinical development, harnessing bioelectronic technology to personalize treatment, boost insulin production, and manage blood glucose levels. This innovation shows strong promise for the treatment of both type 2 diabetes and hypoglycemia.”

“The recent allowance of this patent—coming shortly after the Notice of Allowance received in March—further reinforces the promise of our groundbreaking Neuromodulation technology. Designed to personalize diabetes management, this innovation has demonstrated the potential to reduce reliance on medications by optimizing glucose control. In doing so, it aims to lower overall treatment costs and decrease complications associated with poor blood sugar management and medication non-compliance,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “Similar to other patent families within ReShape, the Diabetes Neuromodulation technology is backed by a strong intellectual property portfolio, consisting of 63 issued or pending patents. These patents span key areas such as vagal neuromodulation, glucose regulation, artificial intelligence, and Bluetooth-enabled applications—collectively securing a clear path to commercialization and offering robust protection against competitive threats.”

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]