ReShape Lifesciences Stock Soars On Regulatory Certification For Medical Devices In EU, UK: Retail Eyes Fair Valuation

ReShape Lifesciences (RSLS) on Tuesday announced that its Quality Management System (QMS) and entire commercial portfolio of medical devices sold in Europe and in the United Kingdom have been certified under the European Union Medical Device Regulation (EU MDR) and UK Conformity Assessment (UKCA), respectively.

Following the announcement, shares of the company skyrocketed 62% by Tuesday noon.

While the EU MDR’s aim is to improve patient safety, transparency, and product quality across all 30 countries within the European Economic Area, the UKCA ensures that products meet the U.K.'s regulatory requirements for safety, health, and environmental protection.

ReShape CEO Paul F. Hickey said that the company achieved MDR and UKCA certification “well in advance” of the Dec. 31, 2027, regulatory deadline and added that the certifications secure the company’s presence in the European market.

ReShape Lifesciences is a weight loss and metabolic health solutions company, and offers a range of products and services that manage and treat obesity and metabolic disease.

The company’s products include the FDA-approved Lap-Band System, which is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy, and the Obalon balloon technology, which is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss.

In July 2024, ReShape Lifesciences Inc. entered into a definitive merger agreement with India’s Vyome Therapeutics, Inc., under which ReShape and Vyome will combine in an all-stock transaction. At the closing of the merger, ReShape will be renamed Vyome Holdings, Inc. and expects to trade under the Nasdaq ticker symbol "HIND."

On Stocktwits, retail sentiment around ReShape LifeSciences soared from ‘neutral’ to ‘extremely bullish’ over the past 24 hours while message volume improved from ‘extremely low’ to ‘extremely high’ levels.

A Stocktwits user opined that the company is now ready to be more fairly valued, and the stock would touch $15 this week.  

RSLS stock is down by about 94% this year and by about 98% over the past 12 months.

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