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]
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Australian property developer and operator to utilise innovative cloud platform for construction and investment accounting
SYDNEY, Sept. 18, 2024 /PRNewswire/ — Apt.Residential, an owner, developer and operator of residential properties in Australia, has chosen Yardi’s single connected platform to support growth, connect teams and manage capex projects and build.
With Yardi®, Apt.Residential can manage its funds and simplify complex financial processes, mitigate risk and deliver real-time insights into projects. The platform provides more visibility from investor to asset and delivers enhanced and accurate reporting. The company can access live data for costing, expenses, and revenue on all projects, from ground-up development to single-unit improvements and will allow Apt.Residential to grow the volume of units within BTR once they have operational units.
“We wanted to find the best platform for BTR that would support growth, streamline management of capex projects and handle our complex accounting,” said Michael Hogg, co-founder & head of operations for Apt.Residential. “Yardi’s single integrated platform was the best solution as it ensures our team can connect on one system and not worry about integrations or using multiple platforms.”
“We’re excited to work with Apt.Residential and support its growth as the company expands its BTR projects,” said Neal Gemassmer, vice president and general manager for Yardi. “Our connected platform will help Apt.Residential enhance communication and set them up so they’re ready to operate once development has completed.”
See how Yardi’s end-to-end technology can help drive your digitalisation strategies.
About Apt.Residential
Apt.Residential is a leading vertically integrated owner, developer, and operator of residential properties in Australia backed by global institutional capital. The company develops residential communities where wellbeing and connectedness come first. Its human-centric approach allows Apt.Residential to shape places for people who crave comfort, community, and elevated living. For more information, please visit aptresidential.au.
About Yardi
Celebrating its 40-year anniversary in 2024, Yardi® develops industry-leading software for all types and sizes of real estate companies across the world. With over 9,500 employees, Yardi is working with our clients to drive significant innovation in the real estate industry. For more information on how Yardi is Energised for Tomorrow, visit yardi.com.au.
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Fintech PR
NewCo Capital Group Continues Global Expansion as 2024 Milestones Set The Stage for an Ambitious Q4
NEW YORK, Sept. 18, 2024 /PRNewswire/ — As Q4 fast approaches, NewCo Capital Group (“NewCo”) and Australia-based Bizcap are finalizing year-end initiatives to strategically position both companies for an ambitious expansion in 2025.
Both companies have celebrated a highly successful 2024, marked by remarkable and accelerated growth. This momentum has been driven by Bizcap’s unique Line of Credit product, NewCo’s introduction of their “Line of Capital” product and the launch of NewCo’s new mobile app. CEO Albert Gahfi emphasized the importance of closing 2024 on a high note to set the stage for future growth. “We’ve had an exceptional year so far, but our focus is on what comes next. We’re building the foundation for 2025 and beyond, ensuring that NewCo and Bizcap are positioned for continued global expansion.”
The plan for Q4 includes deepening their presence in existing markets while making calculated moves into new territories, including Singapore, Germany, and Luxembourg. “There are new opportunities in emerging markets that are currently underserved, where we believe we can make a significant impact. As a result, 2025 promises to be an exciting year for SMB financing globally.”
By reinforcing their operational and technological infrastructure, the companies are preparing to meet the demands of a rapidly evolving global financing landscape. “2024 has been a year of strong growth, but we’re not stopping here,” Gahfi said. “We are focused on delivering innovative financing solutions that not only meet the needs of today but also anticipate the demands of tomorrow. As we head into 2025, we’re ready to expand our reach and provide even more businesses with the capital they need.”
Part of a multinational collaboration, NewCo and Bizcap have successfully deployed over $1.5 billion to over 35,000 businesses worldwide. Gahfi commented, “We’re moving capital faster and more effectively than any other sector and our clients are benefiting from that growth.”
NewCo’s strength lies in its ability to adapt quickly, using a unique mix of proprietary technology, nuanced underwriting, and an experienced risk management team. The companies’ hybrid approach is challenging outdated financing models, making NewCo a preferred partner for SMBs looking for custom capital solutions that truly fit their needs.
“We’re not just growing; we’re leading,” Gahfi added. “As we expand globally, our goal remains the same—helping small businesses scale, create jobs, and thrive.”
With a clear strategy and a relentless focus on delivering value, NewCo Capital Group is primed to deepen its market influence and capitalize on emerging opportunities. As the company prepares for its next wave of market entries, Q4 will serve as a pivotal launchpad for an even more ambitious 2025, setting the stage for continued growth and global leadership.
For more information, visit www.NewCoCapitalGroup.com.
Contact:
NewCo Capital Group
Email: [email protected]
Website: www.NewCoCapitalGroup.com
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Fintech PR
Zulu Ecosystems and Severn Trent Water secure Innovate UK funding to pioneer catchment-scale Nature-based Solutions
- Partnership aims to develop innovative funding model for nature-based solutions that enhance water resilience in the Idle and Torne catchment, a priority area for environmental improvement
- Project will aggregate supply and demand for ecosystem services across the 1,200km2 catchment, benefiting both nature and local communities
- Led by Zulu Ecosystems, the collaboration seeks to accelerate private investment in nature recovery while addressing critical water challenges
LONDON, Sept. 18, 2024 /PRNewswire/ — Zulu Ecosystems and Severn Trent Water have been awarded funding from Innovate UK, the UK’s innovation agency, for a £580,000 project to develop a groundbreaking catchment system operator model for unlocking private investment in nature. The project aims to enhance water resilience and deliver multiple benefits for both nature and local communities in the Idle and Torne River catchment.
The Idle and Torne catchment, identified as a priority catchment by the Environment Agency, faces significant challenges including drought risk, flood vulnerability, and water quality issues. Approximately 60% of water bodies in the catchment currently fail to meet good ecological status. However, the area also presents substantial opportunities for nature recovery, with potential to restore over 5,000 hectares of priority habitats and significantly improve water resources management.
This innovative partnership will leverage Zulu Ecosystems’ cutting-edge natural capital assessment capabilities and Severn Trent Water’s expertise in water management to create a scalable approach for funding and delivering nature-based solutions. The project will focus on interventions such as woodland creation, wetland restoration, and riparian woodland to address the catchment’s pressing environmental challenges. The project will engage local stakeholders, including farmers, landowners, and community groups, to ensure that interventions reflect local needs and knowledge.
Ed Asseily, CEO of Zulu Ecosystems, said:
“This funding from Innovate UK is a game-changer for how we approach local nature recovery and water resilience. By developing a catchment-scale model that aggregates both the supply of and demand for ecosystem services, we can accelerate the flow of private capital into nature-based solutions.”
Severn Trent Water will play a key role as the project’s System Operator, strategically coordinating plans and aligning stakeholder priorities to maximise outcomes for water services and the environment.
Richard Smith, Strategic Asset Planning Manager at Severn Trent Water, commented:
“We’re excited to partner with Zulu Ecosystems on this transformative project. By adopting a system operator approach, we can ensure that investments in nature-based solutions deliver the greatest possible benefits for our customers, local communities, and the environment.”
This project has been funded by Innovate UK as part of the ‘Integrating Finance and Biodiversity for a Nature Positive Future’ programme, a joint initiative between the Natural Environment Research Council (NERC) and Innovate UK. This £7 million programme aims to develop solutions that embed the values of biodiversity into financial decision-making.
By bridging the gap between nature recovery and water resilience, this project has the potential to create a replicable model for sustainable landscape management across the UK. Innovate UK’s support underscores the national significance of developing new approaches to environmental management that can deliver multiple benefits, including improved water security, enhanced biodiversity, climate resilience, and potential new income streams for landowners.
Over the next 9 months, the project team will work closely with local stakeholders to identify priority interventions and develop a portfolio of investable nature-based solutions. The project aims to demonstrate how multi-stakeholder nature-based projects can be developed, funded, and delivered at catchment-scale to address climate adaptation and reverse biodiversity loss. Findings will be published to help scale similar initiatives across the UK and beyond.
For more information, please contact:
[email protected]
[email protected]
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