ReShape Lifesciences® Receives Health Canada Approval for its Next-Generation Lap-Band® 2.0 FLEX
Rhea-AI Summary
ReShape Lifesciences (Nasdaq: RSLS) has received Health Canada approval for its next-generation Lap-Band® 2.0 FLEX and Tubing Kit. The enhanced device features new Flex technology that acts as a relief valve, allowing larger food pieces to pass through more easily by temporarily relaxing before returning to its resting diameter. Like its predecessor, the device can be adjusted post-operatively to optimize eating habits and comfort. The company has completed a market release in the U.S. with positive surgeon feedback and plans to launch the product in Canada soon.
Positive
- Health Canada approval obtained for Lap-Band® 2.0 FLEX
- Successful completion of U.S. market release with positive surgeon feedback
- Product expansion into Canadian market
Negative
- None.
Insights
The Health Canada approval for Lap-Band® 2.0 FLEX represents a significant regulatory milestone, but comes with measured market implications. The enhanced device features FLEX technology - a novel relief valve mechanism that addresses a key patient complaint about traditional gastric bands by allowing easier passage of larger food pieces. While this improvement could potentially reduce post-operative complications and enhance patient satisfaction, several market factors warrant consideration.
The U.S. market release has reportedly generated positive surgeon feedback, suggesting potential for market acceptance. However, the gastric band segment has faced declining popularity compared to other bariatric procedures like sleeve gastrectomy. With ReShape's micro-cap status (
FLEX Technology Designed to Improve the Patient Experience
IRVINE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that Health Canada has updated the Medical Device License granting approval for the company’s next generation, enhanced Lap-Band® 2.0 FLEX and Tubing Kit.
“Approval by Health Canada for the Lap-Band® 2.0 FLEX is yet another significant milestone for ReShape and an important growth catalyst for the company’s Lap-Band® franchise,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “As a reminder, the enhanced Lap-Band® 2.0 FLEX was designed with physician feedback with the goal of improving the patient experience. Like the current Lap-Band, Lap-Band® 2.0 FLEX can be adjusted postoperatively to increase or decrease the band opening, thus optimizing eating habits and comfort. Additionally, Lap-Band® 2.0 FLEX has a new feature called Flex technology, which acts as a relief valve, enabling larger pieces of food to pass through the narrowed passage more easily. Specifically, the band momentarily relaxes before returning to its resting diameter, while minimizing discomfort caused by swallowing large food pieces. Recently, we have successfully completed the limited market release of the Lap-Band® 2.0 FLEX in the U.S., and initial surgeon feedback has been overwhelmingly positive, we are analyzing data and metrics that will be used to support our U.S. commercial launch. Additionally, we now look forward to launching the product in Canada in the near future.”
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. 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 the company’s expected commercial launch of the Lap-Band® 2.0 in the U.S. and Canada. 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 new Health Canada approval for ReShape Lifesciences (RSLS)?
What are the key features of ReShape Lifesciences' (RSLS) Lap-Band® 2.0 FLEX?
When will ReShape Lifesciences (RSLS) launch Lap-Band® 2.0 FLEX in Canada?
