IRVINE, Calif. - ReShape Lifesciences Inc. (NASDAQ:RSLS), a company focused on weight loss and metabolic health solutions, announced today that Health Canada has granted approval for its Lap-Band® 2.0 FLEX and accompanying Tubing Kit. This regulatory milestone is expected to bolster the company's Lap-Band® portfolio and signifies the launch of the product in the Canadian market.
The Lap-Band® 2.0 FLEX, an enhancement of the existing Lap-Band® system, incorporates new Flex (NASDAQ:FLEX) technology, which includes a relief valve feature designed to improve patient comfort by allowing larger food pieces to pass more easily. This feature temporarily expands the band when swallowing larger pieces before returning to its original size.
ReShape Lifesciences President and CEO, Paul F. Hickey, highlighted that the updated device was developed in response to physician feedback aimed at enhancing patient experience. The company has already conducted a limited market release in the U.S., receiving positive initial feedback from surgeons. Data and metrics from this release are being analyzed in anticipation of a broader commercial launch in the U.S.
The Lap-Band® System is FDA-approved and offers a minimally invasive, long-term obesity treatment, providing an alternative to more invasive surgical options such as gastric bypass or sleeve gastrectomy. ReShape Lifesciences also has other products in its portfolio, including the investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system for type 2 diabetes treatment and the Obalon® balloon technology, a non-surgical weight loss solution.
The company's statement includes forward-looking information, which is subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those discussed. This includes expectations about the commercial launch of Lap-Band® 2.0 in the U.S. and Canada. These forward-looking statements are based on information available as of today and the company does not commit to updating them in the future except as required by law.
This news is based on a press release statement from ReShape Lifesciences.
In other recent news, ReShape Lifesciences has announced a series of significant developments. The company has declared a 1-for-58 reverse stock split, set to take effect soon. This follows a shareholder approval at the annual meeting and will convert every 58 shares of issued and outstanding common stock into one share.
In financial news, ReShape Lifesciences reported a decrease in revenue but an increase in gross profit margin for its second quarter of 2024. The company also announced a 45% reduction in operating expenses, and remains debt-free with $2.9 million in net working capital.
Furthermore, the company has outlined its merger with Vyome Therapeutics, leading to the formation of Vyome Holdings, which will focus on immuno-inflammatory diseases. This strategic merger aims to tap into the growing healthcare market in India and the US. Lastly, the company has paused clinical trials to conserve cash and is preparing for the commercial launch of LAP-Band 2.0 Flex. These are among the recent developments within the company.
InvestingPro Insights
As ReShape Lifesciences (NASDAQ:RSLS) celebrates its regulatory milestone with Health Canada's approval of the Lap-Band® 2.0 FLEX, investors should consider some key financial metrics that provide context to the company's current position.
According to InvestingPro data, ReShape Lifesciences has a market capitalization of just $2.87 million, reflecting its status as a micro-cap company in the medical devices sector. The company's revenue for the last twelve months as of Q2 2023 stood at $8.05 million, with a concerning revenue growth decline of 23% over the same period.
InvestingPro Tips highlight that ReShape Lifesciences is "quickly burning through cash" and "not profitable over the last twelve months." These factors are critical for investors to consider, especially given the company's focus on expanding its product portfolio and entering new markets like Canada.
On a more positive note, one InvestingPro Tip indicates that ReShape Lifesciences "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it pursues the commercialization of the Lap-Band® 2.0 FLEX.
The company's price-to-book ratio of 0.94 suggests that the stock is trading slightly below its book value, which may interest value-oriented investors. However, this should be weighed against the InvestingPro Tip noting that the "price has fallen significantly over the last three months," indicating recent market skepticism.
For those seeking a more comprehensive analysis, InvestingPro offers additional tips and metrics that could provide deeper insights into ReShape Lifesciences' financial health and market position.
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