ReShape Lifesciences® Receives Health Canada Approval for its Next-Generation Lap-Band® 2.0 FLEX
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.
ReShape Lifesciences (Nasdaq: RSLS) ha ricevuto l'approvazione da Health Canada per il suo dispositivo di nuova generazione Lap-Band® 2.0 FLEX e il Kit di Tubazione. Il dispositivo migliorato presenta una nuova tecnologia Flex che funge da valvola di rilascio, consentendo a pezzi di cibo più grandi di passare più facilmente grazie a un temporaneo rilassamento, prima di tornare al suo diametro originale. Come il suo predecessore, il dispositivo può essere regolato dopo l'intervento chirurgico per ottimizzare le abitudini alimentari e il comfort. L'azienda ha completato un rilascio sul mercato negli Stati Uniti con feedback positivi da parte dei chirurghi e prevede di lanciare il prodotto in Canada a breve.
ReShape Lifesciences (Nasdaq: RSLS) ha recibido la aprobación de Health Canada para su dispositivo de nueva generación Lap-Band® 2.0 FLEX y el Kit de Tubos. El dispositivo mejorado cuenta con una nueva tecnología Flex que actúa como una válvula de alivio, permitiendo que piezas de comida más grandes pasen con mayor facilidad al relajarse temporalmente antes de regresar a su diámetro de reposo. Al igual que su predecesor, el dispositivo se puede ajustar después de la operación para optimizar los hábitos alimenticios y la comodidad. La compañía ha completado un lanzamiento en el mercado estadounidense con comentarios positivos de los cirujanos y planea lanzar el producto en Canadá pronto.
ReShape Lifesciences (Nasdaq: RSLS)는 차세대 Lap-Band® 2.0 FLEX 및 튜빙 키트에 대한 캐나다 보건부의 승인을 받았습니다. 개선된 장치는 새로운 플렉스 기술을 특징으로 하며, 완충 밸브 역할을 하여 더 큰 음식 조각이 일시적으로 이완한 후 원래 지름으로 돌아가면서 더 쉽게 통과할 수 있게 도와줍니다. 이전 모델과 마찬가지로 이 장치는 수술 후 조정 가능하여 식습관과 편안함을 최적화할 수 있습니다. 이 회사는 미국에서 긍정적인 외과 의사 피드백과 함께 시장 출시를 완료했으며, 곧 캐나다에서 제품을 출시할 계획입니다.
ReShape Lifesciences (Nasdaq: RSLS) a reçu l'approbation de Santé Canada pour son dispositif de nouvelle génération Lap-Band® 2.0 FLEX et le Kit de Tubes. Le dispositif amélioré présente une nouvelle technologie Flex qui agit comme une soupape de soulagement, permettant ainsi à des morceaux de nourriture plus gros de passer plus facilement en se relaxant temporairement avant de revenir à son diamètre de repos. Comme son prédécesseur, le dispositif peut être ajusté après l'opération pour optimiser les habitudes alimentaires et le confort. L'entreprise a achevé un lancement sur le marché aux États-Unis avec des retours positifs de la part des chirurgiens et prévoit de lancer le produit au Canada prochainement.
ReShape Lifesciences (Nasdaq: RSLS) hat die Genehmigung von Health Canada für sein nächstes Lap-Band® 2.0 FLEX und das Tubing-Kit erhalten. Das verbesserte Gerät bietet eine neue Flex-Technologie, die als Druckventil fungiert und es größeren Nahrungsstücken ermöglicht, leichter hindurchzugleiten, indem es sich zeitweise entspannt und dann wieder auf seinen Ruhe-Durchmesser zurückkehrt. Wie sein Vorgänger kann das Gerät postoperativ eingestellt werden, um Essgewohnheiten und Komfort zu optimieren. Das Unternehmen hat einen Markteinführungsprozess in den USA mit positivem Feedback von Chirurgen abgeschlossen und plant, das Produkt bald in Kanada auf den Markt zu bringen.
- 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
- 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?
