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

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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. 16, 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.

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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]

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Fintech PR

Matrixdock Integrates XAUm Gold Token with Binance Wallet to Advance Financial Equality

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SINGAPORE, Dec. 30, 2024 /PRNewswire/ — Matrixdock, Asia’s real-world asset (RWA) tokenization leader, announces the integration of its flagship gold token, XAUm, with Binance Wallet, one of the world’s leading digital asset wallets. This development builds on previous integrations with centralized exchange Web3 wallets like OKX and crypto wallets like MetaMask, reinforcing Matrixdock’s commitment to making gold investments more secure, efficient, and accessible for hundreds of millions of global users.

At the core of this integration is XAUm, a token fully backed by London Bullion Market Association (LBMA)- accredited gold bars with a minimum fineness of 99.99%. Each XAUm token represents one troy ounce of gold. These gold reserves are securely stored in Brink’s vaults in Hong Kong and Singapore, offering token holders the option to redeem XAUm for physical gold.

Purpose-built for Web3 compatibility and the multi-chain ecosystem, XAUm seamlessly blends blockchain innovation with user-centric design. Its robust proof-of-reserve transparency, efficient multi-chain reserve management, and enhanced interoperability inspire trust and elevate gold from a static asset to a dynamic, multifunctional financial instrument in the digital economy.

This integration with Binance Wallet builds on previous developments within Binance’s ecosystem, including decentralized exchanges and lending platforms. The goal is to make XAUm a benchmark for modern gold investments, providing an efficient and trusted solution that redefines asset efficiency and financial equality.

Binance Wallet enhances this vision by offering a secure and intuitive entry point to Web3. Users can manage digital assets, perform cross-chain token swaps, and earn yields effortlessly. With a simple setup process via the Binance app, the wallet eliminates the need for seed phrases or private keys, furthermore, it utilizes Multi-Party Computation (MPC) technology to enhance secure transactions.

Through this integration, individuals worldwide are able to buy, own, and trade gold conveniently with a mobile device. By leveraging Web3 technology and the multi-chain ecosystem, Matrixdock and Binance Wallet set a new standard for modern gold investments, driving financial equality and innovation.

About Matrixdock

Founded in February 2023 by Matrixport, Matrixdock is Asia’s RWA leader that modernizes financial instruments through advanced tokenization technology. As the first in Asia to introduce a tokenized short-term treasury bill product, STBT, earned the Ecosystem Excellence TADS Award in 2023 for Trading & Liquidity Solutions. In 2024, it launched a one-of-a-kind Tokenized Gold token, XAUm, modernizing traditional gold investment into a dynamic, multifunctional digital asset.

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FXGiants Launches Partner Programs to Boost Forex Trading Success

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HAMILTON, Bermuda, Dec. 30, 2024 /PRNewswire/ — FXGiants, a prominent brokerage firm, has opened a new chapter for individuals eyeing opportunities in forex trading. The company has launched new, easy-to-join partnership programs, offering valuable earning opportunities to market participants. Combining effortless integration with substantial revenue potential, these initiatives will arm partners with everything they need to explore today’s forex landscape.

Christopher Oates, a spokesperson for FXGiants elaborated on this development: “Our partner programs are designed to fuel growth for partners by removing unnecessary hurdles. From smooth onboarding to competitive rewards and strong support systems, we aim to provide everything needed for success. Our mission is to help individuals and companies scale their operations, boost their earnings, and tap into new opportunities with confidence.”

Programs Designed for Unique Ambitions

Recognizing that goals differ from partner to partner, FXGiants has shaped three dedicated programs built for varied ambitions. Firstly, the Introducing Brokers (IBs) plan allows users to bring new clients to FXGiants and, in turn, earn competitive commissions. Adding excitement, the IB Monthly Reward Plan offers cash incentives of up to $1,000, determined by client trading activity and volumes.

Secondly, the Affiliate Program is a haven for marketing-focused individuals as it offers forex trading tracking tools and an extensive suite of professional promotional content. Affiliates can easily evaluate their campaigns’ performance and receive earnings based on qualified referrals. Lastly, the White Label Solution is suitable for businesses seeking a fully branded, standalone trading experience. FXGiants delivers a customizable platform that allows businesses to retain control over client offerings.

“At FXGiants, our objective remains straightforward – to give our partners unparalleled possibilities in the forex trading market,” Oates added. “Joining our programs is quick and easy. Interested parties can register on our website or reach out via email to get started. We are committed to building a path for long-term success, one step at a time.”

About FXGiants

FXGiants is an FCA/BMA-regulated broker that gives access to over 300 trading instruments to its clients. Features such as tight spreads, VPS hosting, and Live and ECN/STP accounts, underline its commitment to traders’ convenience and security. With the reliable MT4 platform and PMAM software, FXGiants also ensures swift executions and an intuitive trading environment for beginners and seasoned traders alike. Moreover, around-the-clock, multilingual assistance adds yet another layer of dependability, fostering a confident and efficient forex trading experience.

All trading involves risk. It is possible to lose all of your capital. This offer is made by Notesco Int Limited, registered in Anguilla. FXGiants is a trade name of Notesco Int Limited; a company incorporated in Anguilla with registration number A000001800 and registered address The Valley, AI2640, Cosely Drive, 1338, AI.

https://www.fxgiants.com/

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Bybit and SOLV Protocol Team Up for Explosive bbSOL Maxi Rewards

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DUBAI, UAE, Dec. 30, 2024 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange, today announced a thrilling new campaign in collaboration with SOLV Protocol: the bbSOL Maxi Rewards. This exciting event offers users the chance to win a share of 1,300,000 SOLV tokens via airdrop by staking their SOL.

From December 30, 2024, at 10:00 AM UTC to January 20, 2025, at 10:00 AM UTC, users who stake at least 0.5 SOL to obtain bbSOL through their Bybit Web3 Seed Phrase Wallet on the Bybit Web3 Earn platform are eligible to participate in the campaign and win exciting SOLV rewards.

“We’re thrilled to partner with SOLV Protocol for this exciting campaign,” said Emily Bao, Head of Web3 and Spot at Bybit. “The bbSOL Maxi Rewards presents a fantastic opportunity for users to maximize their SOL holdings and earn substantial rewards. We encourage everyone to participate and experience the power of Bybit Web3.”

How to Participate:

  • Visit the Airdrop Arcade: Head over to the dedicated “bbSOL X SOLV Campaign Page” (Airdrop Arcade).
  • Connect Your Wallet: Connect your Bybit Web3 Seed Phrase Wallet and complete the required tasks.
  • Stake Your SOL: Stake a minimum of 0.5 SOL to obtain bbSOL through Bybit Web3 Earn. The more you stake, the higher your potential rewards in the Ultimate Rewards Pool.

The top 100 stakers with the highest SOL stakes will receive their SOLV rewards directly to their Bybit Web3 Seed Phrase Wallet’s ETH address within three weeks of the event’s conclusion.

To participate, users must deposit SOL and obtain bbSOL on the Bybit Web3 Earn platform using their Bybit Web3 Seed Phrase Wallet. Only new SOL deposits made during the event period are eligible for rewards.

#Bybit / #TheCryptoArk / #BybitWeb3

About Bybit Web3

Bybit Web3 is redefining openness in the decentralized world, creating a simpler, open, and equal ecosystem for everyone. We are committed to welcoming builders, creators, and partners in the blockchain space, extending an invitation to both crypto enthusiasts and the curious, with a community of over 130 million wallet addresses across over 30 major ecosystem partners, and counting.

Bybit Web3 provides a comprehensive suite of Web3 products designed to make accessing, swapping, collecting and growing Web3 assets as open and simple as possible. Our wallets, marketplaces and platforms are all backed by the security and expertise that define Bybit as the world’s second-largest cryptocurrency exchange by trading volume, trusted by over 60 million users globally.

Join the revolution now and open the door to your Web3 future with Bybit.

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For more details about Bybit Web3, please visit Bybit Web3.

About Bybit

Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving a global community of over 60 million users. Founded in 2018, Bybit is redefining openness in the decentralized world by creating a simpler, open and equal ecosystem for everyone. With a strong focus on Web3, Bybit partners strategically with leading blockchain protocols to provide robust infrastructure and drive on-chain innovation. Renowned for its secure custody, diverse marketplaces, intuitive user experience, and advanced blockchain tools, Bybit bridges the gap between TradFi and DeFi, empowering builders, creators, and enthusiasts to unlock the full potential of Web3. Discover the future of decentralized finance at Bybit.com.

For more details about Bybit, please visit Bybit Press

For media inquiries, please contact: [email protected]

For updates, please follow: Bybit’s Communities and Social Media

Discord | Facebook | Instagram | LinkedIn | Reddit | Telegram | TikTok | X | Youtube

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