Israeli ingestible medical devices company Epitomee Medical (TASE: EPIT) today reported a successful clinical trial on its product to support weight loss. Following the report, the company's share price jumped over 60% on the Tel Aviv Stock Exchange to a market cap of NIS 387 million.
Epitomee has developed a pill that swells in the stomach, creates a sense of satiation and then disintegrates. In a trial conducted by the company, the patients took the product over six months, followed by another month of monitoring. The aim of the trial was a weight loss in the trial 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 states that it clearly met these two endpoints. These positive results come after positive interim results from the trial that were published in July 2022.
Following these results, the company can submit its product for marketing approval by the US Food and Drug Administration (FDA) in 2024. The product already has marketing approval in Europe and a marketing agreement with Nestle but has yet to have been fully launched in Europe.
The company's announcement does not include the figure of the average weight loss in the experimental group, a figure that could allow a comparison of the product with the slimming drugs of companies like Novo Nordisk and Eli Lilly that have become popular recently, and were found in trials to reduce 10%-20% of body weight within a year. In the past, the company stated that in an initial trial in Israel, results were more modest and cut about 7.5% of body weight. However, Epitomee's pill works by a mechanical rather than a biological mechanism, and is considered a gentler treatment suitable not only for patients with high excessive weight, but also for those with low to moderate excessive weight, so the competition will not necessarily be directly against these drugs.
The company expects FDA approval for prescription use by patients with BMI of 25-40 and no chronic illnesses.
Epitomee Medical, formerly called Tulip 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 NIS 162 million at a company valuation of NIS 632 million, before money. The company has $38 million in cash.
In the first half of 2023, Epitomee recorded no revenue and a net loss of $5 million. As marketing will be performed by Nestle, the company is not expected to burn through large amounts of cash and can use funds to develop other products.
Published by Globes, Israel business news - en.globes.co.il - on September 4, 2023.
© Copyright of Globes Publisher Itonut (1983) Ltd., 2023.