Fintech PR
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. 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.
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]
Photo – https://mma.prnewswire.com/media/2506355/Epitomee_Medical.jpg
Logo – https://mma.prnewswire.com/media/2506356/Epitomee_Medical_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/epitomee-medical-announces-fda-clearance-of-its-capsule-weight-management-device-302249169.html
Fintech PR
Droit Launches Dedicated Product for Exchange Traded Derivatives Reporting
Pioneering ETD Reporting product to enhance regulatory transparency for listed derivatives
NEW YORK, Nov. 18, 2024 /PRNewswire/ — Droit, a leading technology firm in computational law and regulation, today announces the launch of its Exchange Traded Derivatives (ETD) Reporting product—designed to enhance regulatory transparency and ensure compliance with global reporting requirements for listed derivatives.
Recent scrutiny of position-based reporting obligations to clearing agencies and exchanges has increased pressure on clearing firms to upgrade their reporting infrastructure. Both internal and external audits are pushing clearing firms to adopt stricter controls, ensuring completeness and accuracy akin to OTC transaction reporting standards.
ETD Reporting from Droit provides precise identification and management of reporting obligations for seamless quality assurance of reports pre- or post-submission. Initially focusing on high-risk clearing, collateral, and margin reports, the ETD Reporting product is set to expand beyond futures and options to support a broader range of listed instruments.
With regulators stepping up enforcement and issuing fines for misreporting, clearing firms face the dual challenges of handling vast volumes of trade and position data daily while navigating complex, diverse global regulatory requirements. Senior executives are also pressured to ensure a cohesive quality assurance process exists across their enterprise. Yet, many clearing brokers still rely on outdated, opaque systems that lack transparency and auditability.
Droit’s ETD Reporting delivers a comprehensive quality assurance platform to provide a consistent approach to regulatory compliance. With complete insight into each decision made and the ability to trace the logic through to the underlying source text, the product ensures clarity and accuracy in complex regulatory interpretations.
“Our new ETD Reporting product establishes a unified quality assurance process across Exchange Traded Derivative reports,” said Blythe Barber, Head of Business Development, Americas of Droit. “By using Droit for completeness and accuracy checks, clearing firms can adopt a single global process, significantly reducing the operational burden of current manual methods. Front and middle office teams can fully focus on client opportunities, confident that reporting obligations have been fulfilled.”
“ETD Reporting marks a key step in our strategy to expand our regulatory reporting products to listed derivatives,” said Brock Arnason, Founder and Chief Executive Officer of Droit. “Our clients have many regulatory reporting obligations across departments within their firms. By adding ETD Reporting to our product suite, we aim to provide one platform to advance global compliance and real-time controls, helping our clients navigate these challenges with confidence.”
About Droit
Droit is a technology firm at the forefront of computational law and regulation within finance and other domains. Founded in 2012, Droit counts many of the largest financial institutions as its clients. Its award-winning, patented platform Adept provides an implementation of regulatory rules reflecting industry consensus. The Adept platform processes tens of millions of inquiries a day, deciding in real-time which interactions are legally permissible across the globe. Adept is used by institutions to evaluate, with sub-millisecond latency, the full regulatory implications of any given interaction within their transactional infrastructure.
For more information visit droit.tech. To obtain more information about Droit’s products, please contact [email protected].
Logo – https://mma.prnewswire.com/media/2016603/Droit_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/droit-launches-dedicated-product-for-exchange-traded-derivatives-reporting-302307548.html
Fintech PR
Quantinuum together with Mitsui advance unforgeable quantum tokens over fibre network in first ever trial
- First successful delivery of quantum tokens using commercial QKD hardware, demonstrating fast transaction verification at the point of exchange – a crucial step toward quantum-enhanced financial security and a major advance for QKD.
- Quantum tokens are designed to provide unforgeability, privacy, and fast settlement, in a single financial instrument. No previous technology can deliver these three combined benefits.
- In the world’s first implementation using off-the-shelf hardware, quantum tokens were transmitted across 10km of fibre in Tokyo, using commercial quantum key distribution (QKD) devices provided by NEC*.
- This is a pivotal step towards the deployment of ultra-high-security quantum tokens in use cases such as tokenized asset security and high-speed trading.
TOKYO and BROOMFIELD, Colo., Nov. 18, 2024 /PRNewswire/ — In a long anticipated trial, Quantinuum (“Quantinuum”, Head Office: Broomfield, Colorado, U.S.A., CEO: Rajeeb Hazra), together with Mitsui & Co., Ltd. (“Mitsui”, Head Office: Tokyo, President and CEO: Kenichi Hori) and NEC (“NEC”, Head Office: Tokyo, President and CEO: Takayuki Morita) today announced the successful delivery of quantum tokens across a 10km fibre-optic network in Japan. This is the first time such a delivery has been accomplished.
Quantum tokens are a new financial instrument that take advantage of the properties of quantum physics to meet the robust demands of asset trading without the communication overheads required by traditional financial systems. Quantum tokens are transmitted across fibre-optic quantum key distribution (QKD) networks, which are rapidly expanding around the globe. Today’s announcement with Mitsui demonstrates growing industry recognition of quantum tokens’ potential in financial services.
Ilyas Khan, Founder and Chief Product Officer at Quantinuum, said: “The original motivation for quantum communications was the exchange of money, as envisaged by Stephen Wiesner. Today, we have demonstrated real-world security enhancements for financial systems using off-the-shelf quantum communications hardware. This opens the door to a new era in quantum-enhanced security with wide applicability, providing commercial organisations with something concrete to utilise.”
Koji Naniwada, Deputy General Manager, Quantum Innovation Dept. at Mitsui, said: “Quantum tokens will increase the security of digital assets, while improving transaction performance and maintaining privacy. These topics are critical for our customers and partners in the financial sector and this demonstration is a valuable outcome of our partnership with Quantinuum.”
Naoki Ishida, Director with the Trading and Service Solution Department at NEC, said: “We are the first to provide a platform for realizing a quantum token system using NEC’s quantum key distribution (QKD) devices. Based on the results of this trial between Mitsui & Co. and Quantinuum, we will continue to work towards the social implementation of quantum cryptography technology.”
Quantum tokens are designed to use quantum physics to prevent forgery, while ensuring transactions can be settled near-instantly, whereas traditional payments systems rely on double-entry bookkeeping to prevent double-spending of funds. This adds time, overhead and risk to every transaction, as digital systems are consulted to confirm funds are available and to settle transactions.
Quantum tokens instead rely on the no-cloning theorem of quantum physics to prevent forgeries and double-spending. Only the intended recipient will receive the correct token data, which can only be spent at one location in the future. This enables near-instant transaction settlement by removing the need to check multiple systems or wait for network confirmations.
As demonstrated in Quantinuum’s recent work with HSBC, securing digital assets in the quantum-age is growing in urgency. The financial sector is increasingly looking to quantum technology to solve these complex problems with the power of nature.
Note:
(*) The equipment provided by NEC was partially supported by results from Japan’s Ministry of Internal Affairs and Communications’ (MIC) “Research and development for construction of a global quantum cryptography network”(JPJ008957) under “R&D of ICT Priority Technology Project” (JPMI00316) and Japan’s Cabinet Office’s “Photonics and Quantum Technology for Society 5.0” project under the Cross-ministerial Strategic Innovation Promotion Program (SIP).
Mitsui & Co. is a global trading and investment company with a presence in more than 60 countries and a diverse business portfolio covering a wide range of industries.
The company identifies, develops, and grows its businesses in partnership with a global network of trusted partners including world leading companies, combining its geographic and cross-industry strengths to create long-term sustainable value for its stakeholders.
Mitsui has set three key strategic initiatives for its current Medium-term Management Plan: supporting industries to grow and evolve with stable supplies of resources and materials, and providing infrastructure; promoting a global transition to low-carbon and renewable energy; and empowering people to lead healthy lives through the delivery of quality healthcare and access to good nutrition.
Visit https://www.mitsui.com/jp/en/index.html for more information.
Quantinuum, the world’s largest integrated quantum company, pioneers powerful quantum computers and advanced software solutions. Quantinuum’s technology drives breakthroughs in materials discovery, cybersecurity, and next-gen quantum AI. With over 500 employees, including 370+ scientists and engineers, Quantinuum leads the quantum computing revolution across continents. http://www.quantinuum.com/
NEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of “Orchestrating a brighter world.” NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at http://www.nec.com.
View original content:https://www.prnewswire.co.uk/news-releases/quantinuum-together-with-mitsui-advance-unforgeable-quantum-tokens-over-fibre-network-in-first-ever-trial-302307746.html
Fintech PR
Strategic Value Partners Acquires Blanchardstown Centre, one of Ireland’s Leading Retail Destinations
DUBLIN, Nov. 18, 2024 /PRNewswire/ — Strategic Value Partners, LLC and its affiliates (together, “SVP”), a global alternative investment firm with approximately $19 billion of assets under management, today announced that SVP-managed funds have agreed to acquire Blanchardstown Centre, a prime retail and leisure destination in Ireland.
Blanchardstown Centre is a major retail complex in north-west Dublin, covering 1.2 million square feet and housing over 180 shops and restaurants. With an annual footfall of approximately 17 million visitors and 5,500 parking spaces, it is one of Ireland’s leading shopping destinations. Strategically connected to Ireland’s major motorways, Blanchardstown Centre is well-positioned to continue serving as a premier retail hub for Dublin and beyond.
SVP plans to make significant investments in Blanchardstown Centre, including enhancements to its food and beverage offerings. SVP will work closely with Fingal County Council, existing tenants, and Falcon Asset Management to elevate the centre’s appeal and strengthen its position as a premier retail destination for visitors and tenants alike.
“As a centrepiece in Dublin’s retail sector, we’re excited by the opportunities Blanchardstown Centre presents” said Mike Ungari, Global Head of Real Estate at SVP. “Our goal is to build on the facility’s strengths, and we are committed to ensuring Blanchardstown continues to set the benchmark for retail and leisure excellence in the region.”
With an extensive real estate portfolio built over the past two decades across U.S. and European markets, supported by a dedicated team of 10 professionals, SVP has established itself as a seasoned real estate investor with deep expertise in retail assets and shopping centres. In 2021, SVP funds led the restructuring and subsequent acquisition of Washington Prime Group, a U.S. REIT with a portfolio of approximately 90 retail properties. In 2023, SVP became the largest investor in Intu SGS, a portfolio of four large UK shopping centres, and played a leading role in its restructuring earlier this year. Led by Anders Hemmingsen, SVP’s London-based team is actively seeking to invest in European real estate, and believes it is well positioned to leverage the firm’s differentiated sourcing, investing and operating expertise in the sector this cycle.
The acquisition is expected to complete prior to year-end, subject to regulatory approvals.
For media enquiries:
Greenbrook – James Madsen / Ksenia Galouchko
[email protected]
About SVP
SVP is a global alternative investment firm that focuses on special situations, private equity, opportunistic credit and financing opportunities. The firm uses a combination of sourcing, financial and operational expertise to unlock value in its portfolio companies. Today SVP manages approximately $19 billion in assets under management, and since inception, has invested more than $48 billion of capital, including more than $18 billion in Europe. The firm, established by Victor Khosla in 2001, has over 200 employees, including more than 100 investment professionals, across its main offices in Greenwich (CT) and London, and a presence in Tokyo. Learn more at www.svpglobal.com.
View original content:https://www.prnewswire.co.uk/news-releases/strategic-value-partners-acquires-blanchardstown-centre-one-of-irelands-leading-retail-destinations-302307771.html
-
Fintech7 days ago
Fintech Pulse: Industry Innovations and Partnerships Drive Global Fintech Forward
-
Fintech6 days ago
Fintech Pulse: Evolving Fintech Investments and Partnerships Signal Industry Transformation
-
Fintech PR5 days ago
Cayman Enterprise City Receives Two Prestigious Awards from the Financial Times’ fDi Intelligence Global Free Zones of the Year 2024
-
Fintech PR4 days ago
Universal Consulting Opportunities (UCO), a Stellar MLS Subsidiary, Signs Agreement with NAR India As Advisor to Develop a National MLS
-
Fintech PR2 days ago
Sustainable Infrastructure Holding Company (“SISCO”) Q3FY24 revenue (excluding accounting construction revenue) increases by 23.8% to 341.8 million
-
Fintech PR4 days ago
DC to VC – NatWest Cushon and Future Planet Capital Lead the Charge in UK Pension Access to British Innovation
-
Fintech PR4 days ago
Noble Corporation plc announces submission of request for removal from trading and official listing on Nasdaq Copenhagen
-
Fintech PR4 days ago
Blockchain for Good Alliance Hosts Web3 Oscar, Celebrating Innovators Advancing UN’s Sustainable Development Goals