ReShape Lifesciences® Receives Notice of Allowance for U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology
Rhea-AI Summary
ReShape Lifesciences (RSLS) has received a Notice of Allowance from the USPTO for patent application 17/046,677, focused on their Diabetes Neuromodulation technology. The patent, valid until April 2039, covers 'Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control System and Methods.'
The technology combines vagus nerve block (vBloc™) with vagus nerve stimulation to treat Type 2 diabetes. It aims to reduce medication dependence through personalized glucose control. The system is backed by a robust IP portfolio of 62 issued or pending patents covering vagal neuromodulation, glucose control, AI, and Bluetooth applications.
Pre-clinical development has shown promising results in both Zucker rat and alloxan-treated swine models of Type 2 Diabetes Mellitus (T2DM). The technology works by selectively modulating vagal block and stimulation to the liver and pancreas, potentially offering treatment for both Type 2 diabetes and hypoglycemia.
Positive
- Secured patent protection until 2039 for diabetes neuromodulation technology
- Strong IP portfolio with 62 issued/pending patents
- Successful completion of pre-clinical development
- Demonstrated positive results in animal studies
Negative
- Technology still in pre-clinical phase, far from commercialization
- No human trial data available yet
- Faces competition from established diabetes treatment methods
Insights
ReShape Lifesciences' patent allowance for its diabetes neuromodulation technology represents a strategic intellectual property victory in the metabolic health space. The technology, which combines vagus nerve blocking and stimulation to regulate blood glucose levels, now has protection until April 2039 - providing nearly 14 years of market exclusivity potential.
This development strengthens ReShape's competitive positioning in the diabetes treatment landscape through several key mechanisms:
- The technology targets the autonomic nervous system pathways between the brain and important metabolic organs (liver and pancreas), potentially offering a device-based alternative to pharmaceutical interventions
- Pre-clinical studies in both Zucker rat and alloxan-treated swine models demonstrated improved glycemic control, establishing proof-of-concept
- The approach aligns with growing interest in bioelectronic medicine as an alternative to traditional drug therapies
The allowance adds to ReShape's robust IP portfolio of 62 issued or pending patents spanning vagal neuromodulation, glucose control, AI and Bluetooth applications. This creates a significant barrier to potential competitors and positions the company more favorably for potential partnerships or licensing opportunities.
From an investment perspective, this represents a long-term value driver rather than a near-term catalyst. The technology remains pre-clinical, meaning human trials have not yet begun. A typical development timeline would include:
- IND (Investigational New Device) application
- Phase I safety studies
- Phase II efficacy studies
- Pivotal trials for regulatory approval
This process typically spans 5-7 years before potential commercialization. While the patent strengthens ReShape's long-term prospects in the massive diabetes market, investors should view this as building foundation value rather than expecting immediate revenue impact.
ReShape Lifesciences' patent allowance for their diabetes neuromodulation technology represents a strategic expansion beyond their core obesity treatment focus into the substantially larger Type 2 diabetes market. With over 37 million Americans living with diabetes and global prevalence exceeding 530 million, this technology targets one of healthcare's most significant chronic disease markets.
The technology leverages ReShape's expertise in vagal nerve modulation but applies it innovatively to glucose regulation through a dual-mechanism approach:
- Selective blocking of vagal signals to the liver to reduce glucose production
- Simultaneous stimulation of vagal pathways to the pancreas to enhance insulin production
- Personalized, bioelectronic approach that could reduce medication dependence
Pre-clinical results in both rodent and porcine models demonstrate the technology's ability to improve glycemic control, completing a important de-risking step. However, investors should understand the development timeline ahead:
- Human feasibility trials likely 1-2 years away
- Pivotal trials would follow, requiring 2-3 additional years
- Regulatory review and commercialization preparation add another 1-2 years
For ReShape, with its
The patent allowance creates tangible value through:
- Extended exclusivity period to 2039
- Strengthening potential partnership negotiations
- Diversifying beyond current product offerings
- Building upon established expertise in neuromodulation
While this development strengthens ReShape's long-term strategic position in a massive market, investors should recognize that material revenue impact remains years away, with significant development and regulatory hurdles still ahead.
Vagal Neuromodulation Provides Route to Treat Type 2 Diabetes and Hypoglycemia
IRVINE, Calif., March 10, 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 17/046,677, entitled, “Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control System and Methods.” When issued, the patent will provide protection until April 12, 2039. 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.
“Allowance for this newest patent, on the heels of the recently announced Israeli patent, serves as strong evidence of the promise of this groundbreaking technology, which has shown the potential to reduce dependence on medications for diabetics through a personalized approach. By optimizing glucose control, the technology aims to lower treatment costs and minimize complications related to poorly managed blood sugar and medication non-compliance,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences®. “Like other patent families within ReShape, the Diabetes Neuromodulation technology is supported by a robust intellectual property portfolio, comprising 62 issued or pending patents. These cover vagal neuromodulation, glucose control, AI, and Bluetooth applications, ensuring a clear path to commercialization while providing strong protection against competitive threats.”
“Type 2 diabetes is a worldwide issue and continues to be difficult to treat effectively, despite the availability of medication, surgery, and dietary interventions,” stated Jonathan Waataja, Ph.D. Director of Research at ReShape Lifesciences. “ReShape’s Diabetes Neuromodulation technology regulates blood glucose by selectively modulating vagal block and stimulation to the liver and pancreas. Studies have shown improved glycemic control in both a Zucker rat model of Type 2 Diabetes Mellitus (T2DM) and an alloxan-treated swine model of T2DM. To date, our team has successfully completed the pre-clinical development of the device, employing bioelectronics to optimize insulin production and manage blood glucose levels in a personalized manner, with the potential to treat Type 2 diabetes and hypoglycemia.”
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 the expiration date of ReShape Lifesciences' (RSLS) new diabetes patent?
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What animal models has RSLS tested their diabetes technology on?
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