SAN CLEMENTE, Calif., Sept. 22, 2022 (GLOBE NEWSWIRE) — ReShape Lifesciences™ RSLS, the premier physician-led weight loss and metabolic health solutions company, today announced that the Company was awarded a $300,000 Small Business Innovation Research (SBIR) grant for the development of ReShape’s Diabetes Bloc-Stim Neuromodulation™ (DBSN™) device, which utilizes its proprietary vagus nerve block (vBloc) technology platform, combined with vagus nerve stimulation, for the treatment of Type 2 diabetes and metabolic disorders. Specifically, the grant will fund development of the device for the treatment of hypoglycemia. The technology is currently protected by 48 issued and pending patents related to vBloc, glucose control, AI and Bluetooth applications.
The ReShape DBSN™ utilizes hypoglycemia vagal nerve stimulation (HVNS) using an implantable pulse generator (IPG) in a closed loop with a continuous glucose monitor (CGM). The HVNS System consists of an IPG, stimulation electrodes/leads attachable to the posterior vagal nerve (PVN), a CGM and a programmer to alter settings for therapeutic customization. This dual vagus nerve neuromodulation selectively modulates vagal block and stimulation to the liver and pancreas to manage blood glucose in the treatment of diabetes and individualized glucose control. The technology has demonstrated safety and efficacy through experiments in diabetic swine utilizing a previous Phase I funding from a NIH SBIR grant.
“The award of our second NIH SBIR grant is a testament to the strength of the commercial opportunity of our novel DBSN™ device to address the significant, global diabetes market,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences™. “With the assistance of a previous grant from the NIH, our team successfully completed the pre-clinical development of the device, which is able to adjust insulin production and potentially treat Type 2 diabetes. With this latest grant, we will now focus on the development of the DBSN™ to treat the metabolic disorder, hypoglycemia. Severe hypoglycemia negatively affects many diabetics, which can require intervention, cause loss of consciousness, stroke, coma or death.1,2 We are eager to further the development of the DBSN™ to bring an important therapeutic device to diabetes patients in need and help reduce their dependence on medications. We are committed to continuing the evaluation of DBSN™, backed by a strong intellectual property portfolio, through potential strategic alliance opportunities and a non-dilutive funding strategy.”
About NIH SBIR Grants
The Small Business Innovation Research (SBIR) program allow U.S.-owned and operated small businesses to engage in federal research and development that has a strong potential for commercialization. NIH’s SBIR program invests into health and life science companies that are creating innovative technologies that align with NIH’s mission to improve health and save lives. A key objective is to translate promising technologies to the private sector and enable life-saving innovations to reach consumer markets.
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® Program provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. Reshapecare™ is a virtual weight-management program that supports lifestyle changes for all weight-loss patients led by board certified health coaches to help them keep the weight off over time. The recently launched ReShape Marketplace™ is an online collection of quality wellness products curated for all consumers to help them achieve their health goals. The ReShape Vest™ System is an investigational (outside the U.S.) minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating the gastric volume reduction effect of conventional weight-loss surgery. It helps enable rapid weight loss in obese and morbidly obese patients without permanently changing patient anatomy. For more information, please visit www.reshapelifesciences.com,
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1 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “Low Blood Glucose (Hypoglycemia)”. NIDDK.nih.gov. Archived from the original on 28 July 2017. Retrieved 12 January 2022.
2 Cryer PE, Axelrod L, Grossman AB, Heller SR, Montori VM, Seaquist ER, Service FJ. Evaluation and Management of Adult Hypoglycemic Disorders: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism. 2009;94(3):709-728.