ReShape Lifesciences® Receives NIH SBIR Grant to Further Develop Proprietary Diabetes Bloc-Stim Neuromodulation™ Device

Rhea-AI Summary

ReShape Lifesciences® receives $331,541 SBIR grant for development of DBSN™ device to treat Type 2 diabetes

Positive

• ReShape Lifesciences® awarded $331,541 SBIR grant for DBSN™ device development
• Successful pre-clinical development of DBSN™ device
• Strong interest from NIH in DBSN™ device

Negative

• None.

$331,541 Grant will Explore the use of High-Resolution Endoscopic Ultrasound to Aid in the Placement of the DBSN™ Device

IRVINE, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- ReShape Lifesciences^® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that the Company was awarded a $331,541 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, a prominent disorder associated with obesity. Specifically, the grant will fund the exploration of high-resolution endoscopic ultrasound (EUS) probes to aid accurate placement of the electrodes laparoscopically on the celiac and hepatic branches in large animals.

“ReShape’s DBSN^™ device selectively modulates vagal block and stimulation to the liver and pancreas to manage blood glucose. Increased glycemic control, has been successfully demonstrated in a Zucker rat model of Type 2 diabetes as well as in an alloxan treated swine model of type 2 diabetes, both of which were completed with the help of an initial NIH grant,” stated Jonathan Waataja, Ph.D. Director of Research at ReShape Lifesciences^®. “We are currently exploring the device’s ability to treat hypoglycemia. We believe high-resolution EUS probes can be used to quickly and accurately locate the fine branches of the vagus nerve and aid in minimally invasive placements of DBSN^™ electrodes and study off target effects during stimulation.”

“Awarding this third NIH SBIR grant brings the total received awards to $900,000, and is a testament to both our non-dilutive funding strategy and the NIH’s strong interest in the development of the novel DBSN^™ device and its potential to address the significant, global diabetes market,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences^®. “With the funding, to date, our team has successfully completed the pre-clinical development of the device, which utilizes bioelectronics to adjust insulin production and manage blood glucose to potentially treat Type 2 diabetes and hypoglycemia. It has also shown that this innovative technology may reduce diabetics’ dependence on medications in a very individualized manner with the goal of reducing costs of treatment and complications that arise from poorly controlled blood glucose and non-compliance with diabetes medications. The promise of the DBSN^™ device is evidenced, not only by the volume of NIH funding, but also by the presentation of compelling preclinical evidence at multiple medical conferences. Backed by a strong intellectual property portfolio of 74 issued or pending patents related to vBloc, glucose control, AI and Bluetooth applications, we remain committed to furthering its development through similar NIH grants or potential strategic alliances.”

About Diabetes Bloc-Stim Neuromodulation^™ Device
The Diabetes Bloc-Stim Neuromodulation^™ (DBSN^™) system is a novel therapeutic concept that is implanted minimally invasively and delivers bio-electronic neuromodulation of vagus nerve branches that are innervating organs which regulate plasma glucose. The DBSN^™ 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 DBSN^™ system utilizes a proprietary, reversable and adjustable electrical blockade that we believe is key to the future of personalized medicine. We believe the DBSN^™ system is superior to both standalone stimulation of the vagus nerve that has shown mixed results, and vagus nerve ligation that has undesirable effects.

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^® System 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 investigational Diabetes Bloc-Stim Neuromodulation^™ (DBSN^™) system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. 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.

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 our the DBSN™ system’s potential treatment of T2DM. 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:
Thomas Stankovich
Chief Financial Officer
949-276-6042
ir@ReShapeLifesci.com

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