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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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WSPN and dtcpay Introduce Zero-Fee On-Ramp for WUSD, Marking New Era for Stablecoins 2.0

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SINGAPORE, Oct. 11, 2024 /PRNewswire/ — Worldwide Stablecoin Payment Network (WSPN), a leading provider of next-generation stablecoin infrastructure, and dtcpay, a leading regulated digital payment platform, are making history with a strategic partnership that will revolutionize access to stablecoins. For the first time ever, users will have the ability to on-ramp WUSD, a fiat-collateralized stablecoin pegged 1:1 to the US dollar, through dtcpay with zero fees, marking a paradigm shift in the accessibility and affordability of digital assets.

This groundbreaking move marks a new era for stablecoins, breaking down barriers to entry and empowering individuals and businesses worldwide. Now, with a more inclusive and cost-effective way to utilize stablecoin solutions, WSPN and dtcpay are making WUSD a truly borderless and accessible digital currency. By eliminating fees, the partnership will save users significant amounts annually in transaction fees. WUSD will be gradually rolled out to the many merchants supported by dtcpay, including high-end establishments such as 35A Scotts Whisky Club and Capella Hotel Group’s flagship properties, Capella Singapore and Patina Maldives, Fari Islands. This practical implementation demonstrates the immediate impact and versatility of WUSD in everyday transactions, from luxury experiences to hospitality services.

“This zero-fee WUSD on-ramp with dtcpay is a game-changer for Stablecoin 2.0,” said Raymond Yuan, Founder & CEO of WSPN. “This partnership embodies our vision of making digital assets truly accessible to all, accelerating the adoption of stablecoins in the world. WSPN is proud to lead this financial revolution, reshaping the future of borderless transactions.”

“Partnering with WSPN to offer a zero-fee on-ramp for WUSD is a monumental step in making digital assets more accessible and affordable for dtcpay’s users. At dtcpay, we are excited to lead this charge toward a more i­nclusive financial future, breaking down barriers and creating new opportunities”, said Anson Zeall, Chief Strategy Officer & Head of Compliance, dtcpay.

By eliminating fees for on-ramping WUSD, WSPN and dtcpay are democratizing access to stablecoins, fostering greater adoption and paving the way for a more efficient, transparent, and equitable financial system globally.

About WSPN

WSPN is a leading provider of next-generation stablecoin infrastructure, committed to building a more secure, efficient, and transparent payment solution for the global economy. Their flagship product, WUSD stablecoin, is pegged 1:1 to the U.S. Dollar and aims to optimize secure and licensed digital payments for Web3 users. WSPN ‘s Stablecoin 2.0 approach prioritizes user-centricity, community governance, and accessibility, paving the way for widespread stablecoin adoption.

Learn more: www.wspn.io | X | LinkedIn

About dtcpay

dtcpay is a regulated Major Payment Institution (MPI) licensed by the Monetary Authority of Singapore (MAS) to conduct Digital Payment Token (DPT) services and other payment services under the Payment Services Act (PSA).

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As a leading provider of digital payment solutions, we pioneer the integration of cryptocurrency acceptance into traditional financial systems. With a vision to make global transactions seamless and sustainable, dtcpay empowers individuals and businesses to embrace the future of payments. 

Learn more at dtcpay.com.

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XA NETWORK EXPANDS TO AFRICA WITH LAUNCH OF XA AFRICA, BACKED BY TECH VETERANS

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An exclusive investment network founded by tech alumni in Southeast Asia expands to support and fuel the vibrant African startup ecosystem.

SINGAPORE, Oct. 11, 2024 /PRNewswire/ — XA Network, a leading investment network founded by tech alumni in Southeast Asia, today announced its expansion into Africa with the launch of XA Africa. The move underscores the network’s vision and commitment to fostering innovation and supporting promising startups globally.

XA Africa is founded by a trio of experienced tech professionals:

  • Nitin Gajria, former MD of Google Sub-Saharan Africa
  • Jason Scott, venture capitalist and an architect of the Black Founders Fund at Google
  • Marek Dawidowicz, current Marketing Director at YouTube and South African native

“Founders of technology startups in Africa are uniquely placed to solve some of Africa’s most profound challenges and unlock its greatest opportunities. We see the foray of XA Network into Africa as a natural progression, allowing us to connect amazing founders to experienced and expert operators from the tech industry”, says Nitin Gajria, Co-Founder of XA Africa.

XA Africa aims to connect exceptional African tech founders with seasoned investors and industry experts, primarily from global and regional technology companies, to provide not just capital but also the guidance and support needed to scale their ventures. The newly established XA Africa has already made notable investments in promising African startups, including:

“We are excited to have XA network on board because of their strong network of experts who are open to listening and helping. They’ve introduced us to advisors from Expedia and truly understand the dynamics of emerging markets, making them a valuable investor.” – Sonia Kabra & Wyclife Omondi – Founders of BuuPass

“Partnering with XA Network has been a game-changer for our company. Their strategic guidance and network have opened doors to new opportunities, and we’re excited to see the impact of our collaboration continue to unfold. We’re grateful for their trust in our vision.” – Michael Ogundare – CEO of Crop2Cash

Since its inception six years ago, XA Network has established itself as a significant player in the Southeast Asian startup ecosystem, making nearly 100 investments in the region, and consistent ranked as #1 investment network in the region. XA Network comprises senior leaders from prominent global and regional technology companies and notable company founders. This approach distinguishes XA Network, enabling it to offer portfolio companies unparalleled guidance and support from experienced industry operators.

We also see an opportunity to build a stronger bridge between ecosystems in Africa and Southeast Asia along the way. In fact, this investment hypothesis has already been proven across some of the African founders we are currently supporting.”, Mr Gajria added.

The XA Africa team will be hosting their first public Demo Day webinar on Thursday November 7, 1-2pm GMT+1, where Africa focused investors can meet and invest in four founding companies and learn more about XA Africa. Click here to register for the event.

For more information, please visit https://xanetwork.co/

For media queries, please contact: 
Carmelita Lumempouw-Didoné
[email protected]

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Arta Finance partners with Abu Dhabi’s Wio Invest to launch Wealth-as-a-Service for banks globally, unveils Arta AI Copilot

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  • MAS-licensed Arta Finance launches in Singapore and internationally
  • Arta announces partnerships with Wio Invest for its Wealth-as-a-service offering for banks and financial institutions globally
  • Arta unveils Arta AI Copilot – a number of AI-enhanced experiences on its wealth platform
  • Arta welcomes Ralph Hamers as external advisor

SINGAPORE, Oct. 11, 2024 /PRNewswire/ — Fast-growing digital wealth management platform Arta Finance today launched globally. Arta’s platform is now open to accredited investors in Singapore and to international investors open to managing their wealth in Singapore – a global wealth hub where an expected 1.6 million offshore investors are expected to manage $4.8 trillion in assets by 2028. The international launch follows Arta’s successful debut in the US in October 2023.

Arta today also took a major step on its B2B journey with the announcement that Abu Dhabi’s Wio Invest would be the first of many to integrate the Arta wealth-as-a-service platform into their digital platform, to create a new wealth management offering for its clients in the Middle East, pending regulatory approval. Wio Invest, a forward-thinking Middle Eastern fintech, is regulated by the Securities and Commodities Authority (SCA) and backed by Abu Dhabi Development Company (ADQ), a prominent institution.

Arta’s wealth platform offers a curated deal flow that includes private investments from exclusive fund managers, intelligent public market strategies, and innovative structured products, without the sales pressure, opaque pricing and manual processes found in many other financial institutions.

Commenting on the international launch, Arta CEO Caesar Sengupta said: “Arta is at the intersection of some powerful trends, including the personalisation and democratisation of wealth management, the huge growth and opportunity in private market investing, and the use of AI to create capabilities that have previously only been the preserve of the ultra-wealthy. We are now taking a major leap forward with our international launch and can’t wait to bring the Arta wealth platform and AI Copilot to the global community in the months and years ahead.”

The ‘wealth-as-a-service’ platform for banks and financial institutions is a new B2B offering by Arta. It was done with support from the venture building team of the Singapore Economic Development Board (EDB), which worked closely with Arta to incubate this offering during the early stages of the concept. This cloud-based platform empowers partner banks to serve their clients better and meet evolving demands with faster time-to-market for innovative wealth management products, services, and technology. Banks can choose from integrating Arta AI Copilot capabilities, to embedding Arta’s investment solutions into their platforms, to fully white-labelling the Arta platform — enhancing their digital capabilities and unlocking growth in new wealth segments.

To help integrate a cloud and AI-native wealth platform into legacy systems at partner banks, Arta is also announcing partnerships with leading cloud provider Google Cloud and global management and technology consultancy Capco to provide solutions for banks looking to adopt Arta’s technology.

Amanda Ong, Head of International Expansion commented: “The launch of the B2B business is an extension of Arta’s mission, enabling us to partner with banks and financial institutions in a way that is wholly complementary to their current offering. We are proud to welcome Wio as our launch partner and look forward to growing together.”

AI drives leap in wealth tech

Arta also launched the first-of-its-kind AI Copilot, purpose-built for wealth management and finance. This patent-pending technology empowers Arta’s members to make smarter investment decisions – ideate, analyse, and monitor their portfolios with the tools and insights that usually require large teams of relationship managers, private bankers, and investment analysts.

Unlike commonly available AI chatbots or apps, Arta’s AI systems are purpose-built for applications in wealth and finance and exploit the reasoning capabilities of the latest large language models. Arta’s AI stack employs several models that work in conjunction with each other – including commercially available closed source models, fine-tuned open source LLMs and several custom built AI/ML models created by Arta’s researchers. These models have access to high-quality public and proprietary data including large financial and risk data sets for training and inference. This enables Arta to combine the fluency of LLMs with the time sensitivity, hard mathematical rigour and explainability necessary for investment and financial applications. Its AI stack, like the rest of Arta’s infrastructure, is highly privacy-preserving and uses encryption at rest and in transit for all user data.

Singapore Minister of State for Trade and Industry and MAS board member, Alvin Tan was on hand to help launch Arta in the City State, alongside investors, fund managers, partners, and clients. The company has established key functions in Singapore including engineering, marketing, product, design and operations and a number of its global leads including its CEO are based in Singapore.

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Arta welcomes Ralph Hamers as external advisor

Arta also today welcomes Ralph Hamers as an external senior advisor, providing strategic guidance as the company grows internationally. Ralph Hamers is an advisor to established and new players in the global financial sector. He developed a special knowledge in digitalisation of processes and client offerings. Hamers previously was CEO with UBS and ING

Commenting on his role as senior advisor to Arta, Mr Hamers said:

“A central focus of my leadership has been to take legacy businesses and digitalise, integrating front-to-back technology to drive efficiencies and make the lives of clients and colleagues easier. This often needs major and multi-year transformations in well-established organisations. With Arta, I see the enormous opportunity of having incredibly smart people from the worlds of technology and finance coming together to build a platform that is more than ready to take its place amongst the world’s leading wealth managers.”

Mr. Hamers becomes part of a distinguished group of early investors in Arta, which includes more than 140 technology and finance leaders, such as ex-Google CEO Eric Schmidt and Mastercard CEO Michael Miebach.

The Arta wealth platform is now available globally to all accredited investors on desktop and mobile. Early members will get their first investment up to $100K managed free for life by Arta (terms and conditions apply). To learn more about Arta, please visit artafinance.com.

Important Disclosures
Arta Wealth Management Pte. Ltd. (“Arta Finance”) is licensed by the Monetary Authority of Singapore (“MAS”) whose products and services are only available to Accredited Investors.

Investing in securities involves risk, and there is always the potential of losing money. Certain investments are not suitable for all investors. The content provided herein is for informational purposes only and is not investment or financial advice, tax or legal advice, an offer, solicitation of an offer, or advice to buy or sell or hold securities or investment products. This material has not been reviewed by the Monetary Authority of Singapore. For additional disclosures related to Arta Finance, please visit https://artafinance.com/sg/disclosures.

About Arta Finance:
Founded by ex-Google executives, Arta Finance is a digital wealth platform for the savvy that enables more people to access the “financial superpowers” of the ultra-wealthy. The platform provides access to private market investments from elite fund managers, intelligent public market strategies and structured products, and sophisticated financial services such as insurance and estate planning. Headquartered in the US and Singapore, Arta serves its members directly as well as empowering partner financial institutions to expand wealth management to new clients. Arta is backed by Peak XV, Ribbit Capital, Coatue, EDBI, and over 140 luminaries in tech and finance.

Learn more at artafinance.com

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