ReShape Lifesciences has presented promising preclinical data on its proprietary Diabetes Neuromodulation device at the 12th Annual Minnesota Neuromodulation Symposium in Minneapolis. The data demonstrates the device's ability to effectively modulate glucose levels without cardiac side effects, overcoming a key limitation of conventional vagal stimulation techniques.
The poster presentation, titled "Stimulation of the Posterior Sub-Diaphragmatic Vagal Trunk Reverses Insulin-Induced Severe Hypoglycemia in a Swine Model of Type 1 Diabetes Mellitus," was presented by Dr. Jonathan J. Waataja, Director of Research at ReShape Lifesciences.
Novel Approach to Hypoglycemia Management
Hypoglycemia remains a significant barrier to effective diabetes management, contributing to severe health risks and reduced quality of life for patients. ReShape's technology utilizes Hypoglycemia Vagus Nerve Stimulation (HVNS), specifically targeting the sub-diaphragmatic posterior vagus nerve (PVN) to rapidly increase blood glucose during hypoglycemic episodes.
"Unlike conventional vagal stimulation techniques, our targeted HVNS approach alters glucose levels without impacting heart rate, blood pressure or respiration," explained Dr. Waataja. "Also, sub-diaphragmatic stimulation does not affect speech, which is an obstacle to increasing desired therapeutic levels with conventional vagal stimulation."
Compelling Preclinical Results
The study evaluated HVNS efficacy and off-target systemic effects in a Type 1 diabetic swine model. 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 during stimulation, with no significant changes observed. Vomiting was only observed at current amplitudes (~6 mA) above those needed to elicit therapeutic glucose changes (~3 mA), demonstrating a clear therapeutic window. Positive control tests using intramuscular glucagon produced similar blood glucose increases, further validating HVNS as an effective alternative.
Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences, stated, "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."
Patent Protection Strengthens Commercial Potential
In a related development, ReShape Lifesciences recently announced receiving a Notice of Allowance from the U.S. Patent and Trademark Office 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.
This patent adds to ReShape's robust intellectual property portfolio, which comprises 62 issued or pending patents covering vagal neuromodulation, glucose control, AI, and Bluetooth applications. The company believes this portfolio ensures a clear path to commercialization while providing strong protection against competitive threats.
Technology Mechanism and Advantages
The ReShape Diabetes Neuromodulation system (formerly Diabetes Bloc-Stim Neuromodulation™ or DBSN™) delivers bio-electronic neuromodulation of vagus nerve branches that innervate organs regulating plasma glucose. The system stimulates vagus celiac fibers of the pancreas to release insulin during stimulation, while blocking the hepatic vagal branch to decrease glucose release and insulin resistance.
A key advantage of the system is its use of proprietary, reversible, and adjustable electrical blockade. ReShape Lifesciences believes this approach 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.
Future Development Plans
Given the promising results, ReShape Lifesciences plans to continue seeking non-dilutive funding while simultaneously working with top researchers and industry-leading strategic corporate partners to potentially bring this novel therapeutic to market.
The company has already completed pre-clinical development of the device, employing bioelectronics to optimize insulin production and manage blood glucose levels in a personalized manner. The technology shows potential for treating both Type 1 and Type 2 diabetes, as well as hypoglycemia.
Dr. Waataja noted, "Type 2 diabetes is a worldwide issue and continues to be difficult to treat effectively, despite the availability of medication, surgery, and dietary interventions. Our technology aims to reduce dependence on medications for diabetics through a personalized approach."
Corporate Transition
It's worth noting that 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 the Diabetes Neuromodulation system. At the closing of the transactions contemplated by the asset purchase agreement, the system will be owned by Biorad.
ReShape Lifesciences is currently America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of products and services that manage and treat obesity and metabolic disease, including the FDA-approved Lap-Band® and Lap-Band® 2.0 Flex Systems and the Obalon® balloon technology.
