Epitomee Medical, an Israeli biomedical company that develops novel ingestible devices for metabolic disorders, has announced the success of its pivotal study of its weight loss capsule. The company’s stock price soared by over 70% on the Tel Aviv Stock Exchange on Monday, reaching a market cap of over $100 million.
A Swallowable Device that Mimics Solid Food
The company’s weight loss 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 classified as a medical device and works by a mechanical rather than a biological mechanism. It is considered a gentler treatment suitable not only for patients with high excessive weight, but also for those with low to moderate excessive weight.
A Pivotal Study with Significant Outcomes
The pivotal study involved 279 subjects in nine medical centers in the US, with one group of participants provided with a placebo and the other with Epitomee’s capsules. The subjects took the product over six months, followed by another month of monitoring.
The aim of the study was to show a weight loss in the experimental group that was greater than the control group, as well as a weight loss of over 5% for at least 35% of the participants. The company stated that it clearly met these two endpoints and showed a significantly greater weight loss compared to the control group.
The company has not yet published the full results of the experiment, such as the average weight loss observed in the experimental group compared to the control group, and the level of statistical significance achieved in the experiment. The company said that the final data will be released at a later time, once received from the external company responsible for conducting and overseeing the experiment.
A Plan to Seek FDA Approval and Global Commercialization
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 product already has marketing approval in Europe and a marketing agreement with Nestlé Health Science, a global leader in nutritional science. Nestlé Health Science will be responsible for marketing and distribution of Epitomee’s weight loss capsule in selected markets around the world.
Epitomee Medical was founded in 2005 by Doron Marco and Shimon Eckhouse, the founder of Lumenis and Syneron. Eckhouse serves as both chairman and is an active investor. The company’s CEO is Dan Hashimshony. In December 2021, the company held its IPO on the TASE, raising $51 million at a pre-money valuation of $200 million.