Epitomee®膠囊在RESET研究後獲得美國FDA批準：該研究是一項前瞻性、隨機、雙盲、並進行了安慰劑對照的多中心試驗。該研究招募了279名超重和肥胖的成人參與者，部分伴有前期糖尿病。參與研究的9個試驗點均位於美國9個不同州。符合條件的受試者被隨機分配到測試組或安慰劑組。受試者每天服用兩次試驗設備膠囊或安慰劑，並配合飲食和運動，持續24周。研究顯示，兩項共同的主要目標均已達成。RESET研究表明，與對照組相比，設備組受試者的減重效果更加顯著（P<0.0001）。治療響應者的共同主要目標也已達成：在隨機分配24周後，Epitomee治療組中體重減少至少5%的受試者比例為55.5%（置信區間：46.1-64.6），明顯高於>35%的閾值（P<0.0001）。

研究還表明，在整個研究期間，Epitomee®療法具有良好的安全性。Epitomee®治療組的患者耐受性良好，退出研究的患者人數少於對照組。研究中未發現嚴重的不良設備反應（SADE）。此外，接受Epitomee®治療的受試者在IWQOL-Lite-CT問卷的多個項目中都顯示生活質量得到了更好的改善。

公司還在參與RESET研究的9個試驗site中的3個進行了額外ELECT研究。在這項研究中，設備組和安慰劑組的受試者再繼續服用24周的Epitomee®膠囊。研究顯示，在48周的研究期間，Epitomee®治療設備組受試者的安全性良好。

公司聯合創始人兼董事會主席Shimon Eckhouse博士就獲得FDA批準發表評論：“FDA對Epitomee®膠囊的批準標志著體重管理領域的一個重要裏程碑。其創新方法為患者提供了安全有效的選擇。通過這種簡單、無藥物的膠囊來管理體重，這種療法為那些尋求改善健康和生活質量的人們提供了新的可能性。”

Epitomee Medical Ltd.的CEO Dan Hashimshony博士也表示：“我們為Epitomee®的無藥物口服體重管理方式獲得FDA批準感到自豪。這是我們采取創新方法應對全球肥胖問題的成果。我們的膠囊為數以百萬計、面臨體重管理挑戰的人們提供了一種安全、有效且無藥物的解決方案。展望未來，我們期待將這一突破性產品引入美國市場，並尋求戰略合作夥伴，以充分實現其商業潛力。”

資料來源：

​https://www.prnewswire.com/news-releases/epitomee-medical-announces-fda-clearance-of-its-capsule-weight-management-device-302249169.html

https://epitomeemedical.com/

美國FDA最新核准減重膠囊
Epitomee's Ingestible Capsule, Offers a Safe and Effective Prescription Solution for Adults with BMI of 25-40 looking for Alternative Drug Free Solutions for Their Weight Management Needs alongside diet and exercise.

CAESAREA, Israel, Sept. 17, 2024 /PRNewswire/ -- Epitomee Medical Ltd. (TASE: EPIT), announced that the United States Food and Drug Administration (FDA) has officially cleared the Epitomee® Capsule, a cutting-edge ingestible medical device designed to support weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m² alongside diet and exercise. This novel, drug-free treatment provides a new option for millions of health-conscious individuals in the U.S.

FDA Clears Epitomee® Capsule for Weight Management! The FDA has officially cleared the Epitomee® Capsule, a groundbreaking oral prescription device designed to support weight management in overweight and obese adults with a BMI of 25–40 kg/m² alongside diet and exercise. This innovative, drug-free solution works by promoting a feeling of fullness, empowering a healthier lifestyle.
FDA Clears Epitomee® Capsule for Weight Management! The FDA has officially cleared the Epitomee® Capsule, a groundbreaking oral prescription device designed to support weight management in overweight and obese adults with a BMI of 25–40 kg/m² alongside diet and exercise. This innovative, drug-free solution works by promoting a feeling of fullness, empowering a healthier lifestyle.
The Epitomee® Capsule represents an innovative prescription option in weight management solutions, offering a drug-free alternative that differs from injectable treatments. With FDA clearance extending to adults with a BMI starting at 25, Epitomee® Capsule is accessible to a broader range of patients looking for tolerable and easy to use weight management solutions. The Epitomee® device is encased in a standard size, self-administered ingestible capsule. Once the Epitomee® Capsule is swallowed, and reaches the stomach it absorbs water in the stomach and creates a three-dimensional matrix designed to occupy volume in the stomach creating a sensation of fullness, enabling weight loss. The Epitomee® Capsule mechanism of action is purely mechanical and does not involve any chemical activity. The capsule works directly in the gastrointestinal (GI) tract.

Epitomee® Capsule was cleared by the U.S. FDA following the RESET study: A prospective, randomized, double-blind, placebo-controlled, multi-canter trial. The study enrolled 279 overweight and obese adults with and without prediabetes. All 9 sites enrolled in the study were in the US, located across 9 different states. Eligible subjects were randomized to test or placebo arms. Subjects were to take one capsule of the investigational device or placebo twice daily , alongside diet and exercise, for a period of 24 weeks. The study demonstrated that both co-primary endpoints were successfully met. The RESET study demonstrated significantly better weight loss among the device group compared to the control group (P<0.0001). The co-primary endpoint of treatment responders was also achieved: the rate of Epitomee treatment group subjects whose total body weight was reduced by at least 5% at 24-weeks post randomization was 55.5% (CI; 46.1-64.6), significantly exceeding the threshold of >35% (P<0.0001).

The study demonstrated a favourable safety profile of Epitomee® treatment throughout the study duration. Epitomee® treatment was well tolerated, with fewer patient dropouts in Epitomee® group than the control group. There were no serious adverse device effects (SADEs) in the study. In addition, subjects treated with Epitomee® showed better improvement in quality of life in several items of the IWQOL-Lite-CT questionnaire.

The company also performed an additional study in 3 out of the 9 sites that participated in the RESET study, the ELECT study. In this study subjects from both the device group and the placebo group kept on taking the Epitomee® capsule for an additional 24 week period. The study demonstrated a favourable safety profile of Epitomee® treatment throughout the 48 weeks of the study duration for subjects in the device group.

Shimon Eckhouse PhD co-founder and chairman of the board, commented on the approval: "The FDA clearance of the Epitomee® Capsule marks a significant milestone in the field of weight management. Its innovative approach offers a safe and effective option for patients. The ability to manage weight through a simple, drug free capsule opens up new possibilities for those seeking to improve their health and quality of life."

Dan Hashimshony PhD, CEO of Epitomee Medical Ltd., commented: "We are proud to have received FDA clearance for our Epitomee® weight management Oral, Drug-Free solution. This achievement is the result of the innovative approach we have taken to tackle the global obesity epidemic. Our capsule offers a safe, effective, and drug-free solution to the many millions of individuals struggling with weight management. As we move forward, we are eager to bring this groundbreaking product to the U.S. market and seek strategic partnerships to fully realize its commercial potential."

About Epitomee Medical Ltd.
Epitomee Medical Ltd, a public company (TASE: EPIT), co-founded in 2005 by Shimon Eckhouse, PhD and led by CEO Dan Hashimshony PhD.  Shimon co-founded Syneron Medical Ltd. (Nasdaq: ELOS), Lumenis (formally ESC Medical) and co-founded Ventor Medical Technologies, which was acquired by Medtronic. Dan was the founding CEO of Dune Medical Devices, a surgical oncology company (acquired by Dilon Technologies). Prior to that, Dan was with X-Technologies (acquired by Guidant in 2003) and Sela Semiconductor (acquired by Camtek).

The company is a pioneering health solutions company, committed to advancing innovative therapies. With focus on safety, efficacy, and improving quality of life, Epitomee Medical strives to be at the forefront of transformative healthcare solutions.
The company is advancing two major fields: weight management and biologic drug delivery. In addition to its flagship weight management solution, Epitomee Medical is developing a cutting-edge platform focused on the oral delivery of biologics. This innovative platform is designed to transport drugs to the absorption site with enhanced bioavailability.

For more information about Epitomee Medical Ltd., please visit Epitomee Medical (https://epitomeemedical.com/)

For partnership inquiries and more information about the Weight-management capsule - contact:
Mr. Alon Heth
VP Sales and Marketing
[email protected]
​

資料來源：
​https://epitomeemedical.com/

https://taiwannews.com.tw/news/5937593