Weight loss pill success sparks stock surge at Epitomee Medical
Weight loss pill success sparks stock surge at Epitomee Medical
The company, which has not yet published the full results of its study, plans to seek FDA approval via the 510(k) pathway
Israeli company Epitomee Medical has reported success in a pivotal study of its weight loss capsule, causing its stock to soar on the Tel Aviv Stock Exchange.
This capsule, classified as a medical device, is essentially a swallowable pill that expands in the stomach, creating a sensation of satiety. Following the announcement of this success, the company's stock surged by over 70% at one stage on Monday, reaching an all-time high and achieving a market cap of over $100 million.
It's worth noting that this stock jump occurred despite the fact that the company has not yet published the full results of the experiment; it has only reported the success. The company's report lacks crucial details, such as the average weight loss observed in the experimental group compared to the control group, and it does not specify the level of statistical significance achieved in the experiment.
The criteria for success in the experiment had been predetermined, requiring that 35% of the subjects in the trial lose more than 5% of their baseline body weight. The experiment involved 279 subjects, and Epitomee has stated that the final data will be released at a later time, once received from the external company responsible for conducting and overseeing the experiment.
Epitomee next intends to seek FDA approval for the sale of this medical device via the 510(k) pathway, which permits the sale of devices with a strong resemblance to existing devices in the market (Substantially Equivalent). This approach aims to expedite the FDA approval process by leveraging the similarities to other approved devices. The company anticipates receiving approval during 2024.
The 510(k) pathway is favored by companies looking to introduce their products to the market because it generally involves a shorter approval timeline and reduced FDA oversight compared to the full approval process. However, this route has faced criticism for its relatively lenient standards, allowing medical devices to enter the American market with greater ease.
Epitomee's weight management product is a shapeshifting polymeric scaffold composed of swellable biopolymers that imitates solid food to achieve a sensation of satiety. Once it reaches the stomach, it expands into a flexible triangle, interacting with the stomach wall and activating key pathways that regulate satiety and food intake. It is then cleared out through normal bowel movements and is not absorbed by the body. The capsule is already CE cleared.
In response to Calcalist's inquiries regarding the missing details in Epitomee's report, the Israel Securities Authority responded: "The Authority does not comment on its interactions with supervised entities, and if necessary, any such interactions will be reflected in the companies' reports."
Epitomee partnered with Nestlé Health Science in the study, with the latter having the exclusive rights to commercialize the capsule globally.
Epitomee completed its IPO on the Tel Aviv Stock Exchange in December 2021. The company raised $51 million from institutional investors, including leading insurance companies. The offering was made at a pre money valuation of $200 million.
