Epitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device

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.

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
alon@epitomeemedical.com

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Epitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device

Customer's Product to Hit the Market in Q1 2025
Enhancing Consumer Headset Speech Quality to Professional Grade 

ZHUBEI, Dec. 30, 2024 /PRNewswire/ -- Airoha Technology announces the launch of its flagship wireless audio chip, AB1595. This groundbreaking chip integrates essential functions that currently require multiple chips into one single system-on-chip (SoC) and achieves Microsoft Teams Open Office certification level, setting a new industry standard. The AB1595 significantly enhances speech noise reduction through AI algorithm and the collaborative processing of up to 10 microphones. It also improves the depth and bandwidth of environmental noise cancellation, enabling real-time filter adaptation to achieve consistent noise cancellation experience across various users' wearing behaviors. The AB1595 has been adopted by customers, with products expected to be available in Q1 2025.

The AB1595 leverages Airoha Technology's extensive expertise in wireless communication, AI audio, and hearing aid audio technologies, overcoming numerous challenges to meet diverse customer needs. AB1595 accelerates the development of AI audio products that offer consumers a more comfortable, natural conversation experience and higher quality.

First Flagship Wireless Audio SoC with Built-in AI Hardware Accelerator

Airoha Technology's Senior Vice President, Yuchuan Yang, stated, "The AB1595 is not only Airoha Technology's first flagship AI audio chip with a built-in AI hardware accelerator but also the fifth-generation chip on the same development platform provided to our customers. Airoha Technology offers a comprehensive Software Development Kit (SDK) solution that allows customers to reuse components developed in previous generations and quickly integrate them with the AB1595, reducing development costs and time to market. Additionally, Airoha Technology's platform includes complete acoustic design recommendations, including customized software, hardware application notes, and tools to help customers accelerate the development of differentiated end products."

Significant Enhancement in "Speech Noise Reduction" Performance with Up to 10 Microphones

The flagship AB1595 chip from Airoha Technology brings the stringent speech quality standards of professional-grade boom microphones with Microsoft Teams Open Office certification to consumer-grade boomless, omnidirectional headsets. By collaborating with up to 10 microphones for ambient sound capture and using AI algorithms to accurately identify and distinguish user voice and environmental sounds, it achieves professional-grade speech quality.

Compared to consumer-grade headsets, the AB1595 can enhance "voice noise suppression" from 10 dB to as low as 40 dB, especially in noisy environments like offices and cafes, significantly optimizing speech quality and bringing professional-grade teleconference functionality to consumer headsets.

Full Adaptive Active Noise Cancellation (ANC): The AB1595 chips feature real-time adaptive ANC significantly enhancing the depth and bandwidth of environmental noise attenuation. They can further detect the user's wearing condition (i.e., good fit or loose with leakage), performing adaptive compensation. The internal filter settings automatically adjust based on the user's wearing conditions and different environmental noise types, balancing the best noise cancelling effect with the comfort of reduced ear pressure, providing the most comfortable wearing, and listening experience.

AI Conversation De-Noising: Even in noisy environments, users can clearly hear the speech from the audience they are speaking to while wearing the headset, such as on airplanes, in stadiums, or on subways.

Achieving Low Power Consumption with 6-Core Architecture

The AB1595 flagship chip is the industry's first 6-core architecture design supporting Bluetooth transmission and AI audio processing. By distributing computing tasks across multiple cores and lowering operating voltage, it optimizes power consumption. Given the high computational power required for intense AI audio data processing and the need to extend usage time despite the trend towards miniaturization that battery size need be reduced in headsets, power-saving technology is crucial for overall energy efficiency. Additionally, it could last 12 hours of the usage time while hearing aid function is activated.

Airoha Technology adheres to the core development philosophy of enabling users to "hear clearly, speak clearly, and move freely" in the most natural way. We continuously explore technological breakthroughs to provide users with a more natural and comfortable experience. Senior Vice President Yang further noted, "The launch of the AB1595 not only brings technological innovation to the wireless audio industry but also, driven by user needs across various scenarios, breaks down the deep technical barriers that previously existed in consumer, gaming, enterprise, and hearing aid fields. Airoha Technology, already a leader in these areas, will lead the trend of integrated compatibility, allowing consumers to enjoy professional-grade speech experiences in different scenarios."

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Airoha Technology Launches Latest Flagship Wireless AI Audio SoC AB1595