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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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President Emmerson Mnangagwa met this week with Zambia’s former Vice President and Special Envoy Enoch Kavindele to discuss SADC’s candidate for the AfDB

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President Mnangagwa, who is SADC Chairperson, reaffirmed his own country’s and SADC’s enthusiastic support for Zambian candidate Sam Maimbo

LUSAKA, Zambia, Dec. 20, 2024 /PRNewswire/ — Special Envoy Kavindele released the following statement following the meeting:

“I am elated to witness the growing success and momentum of Sam Maimbo’s candidacy to become the next President of the African Development Bank. I am filled with gratitude to our friends across both SADC and COMESA for their continued support and good wishes.

Sam has garnered such wide consensus due to his being uniquely qualified to deliver the transformative change and empowerment our continent needs. Sam’s 30 years in development work is defined by driving outcomes, improving processes, and investing in people. The AfDB needs a hands-on leader who is laser focused on delivering results and who is unafraid of making tough decisions in order to best serve our continent. Sam is that leader. Sam has the track record and experience to drastically enhance the pace, scale, and impact of the Bank’s work in service of the people and governments of Africa.

Our region has a proud history of supporting fellow Southern Africans. For example, we all recall Lusaka’s role in hosting the African National Congress’ headquarters during the dark days of Apartheid oppression.

It therefore gives me no pleasure to observe my South African brothers, who have themselves leant on Zambia’s steadfast friendship over many decades, fail to rally behind both SADC and COMESA’s chosen candidate for the AfDB. Africa’s urgent economic development challenges demand transformational leadership at the AfDB, it is all of our responsibility to put forward the best candidate for the job. This is not the time or place for a government to act with narrow self-interest, we all must act in the continent’s and AfDB’s best interest.

I thank Sam Maimbo for his lifelong service to our entire continent, and I am eager to witness his enormous impact as President of the AfDB.”

View original content:https://www.prnewswire.co.uk/news-releases/president-emmerson-mnangagwa-met-this-week-with-zambias-former-vice-president-and-special-envoy-enoch-kavindele-to-discuss-sadcs-candidate-for-the-afdb-302337613.html

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Stay Cyber Safe This Holiday Season: Heimdal’s Checklist for Business Security

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LONDON, Dec. 20, 2024 /PRNewswire/ — Heimdal Security shares a practical holiday cybersecurity checklist, offering expert insights to help businesses safeguard against cyber threats this festive season.

With reduced staffing, remote work setups, and a surge in online shopping creating heightened vulnerabilities, this guide offers actionable tips to enhance business security.

Going beyond basic advice, the checklist also highlights the most common holiday scams and features videos showcasing real-life examples of Christmas-themed cyber scams and effective prevention strategies.

Key Tips to Protect Businesses This Holiday Season:

  1. Strengthen endpoints: Ensure devices are updated with antivirus and endpoint protection software; consider Endpoint Detection and Response (EDR) and application whitelisting.
  2. Prepare for phishing spikes: Train staff to identify suspicious emails, enforce robust email filters, and establish protocols for reporting unusual activity.
  3. Secure remote access: Mandate VPN usage, monitor unusual logins, and deactivate inactive accounts temporarily.
  4. Segment and shield networks: Isolate sensitive areas, deploy DNS security and advanced firewalls, and maintain full visibility over network traffic.
  5. Apply timely patches: Regularly update all systems and test patches in a controlled environment to minimize disruptions.
  6. Mitigate supply chain risks: Assess vendors thoroughly and limit their access to essential systems.
  7. Have a response plan ready: Tailor incident protocols for the holidays, create an on-call rotation for the IT team, and enable rapid action against suspicious activity.

Cybercriminals thrive on holiday distractions, but with proactive measures like phishing training, secure endpoints, and network segmentation, businesses can stay ahead of potential threats,” said Alex Panait, System Administrator at Heimdal Security.

Common Holiday Scams That Businesses Should Watch For:

Cybercriminals often tailor their tactics to exploit the festive season. The most common scams include:

  • Spear phishing: Emails disguised as holiday bonuses or event invitations that steal credentials or spread malware.
  • Malicious holiday E-Cards: Festive greetings that contain links deploying ransomware or spyware.
  • Fake E-Commerce sites: Fraudulent websites offering discounts to steal payment information.
  • Insider threats: Distracted or disgruntled employees mishandling or exploiting sensitive data.
  • Corporate travel scams: Fake booking platforms targeting business travelers.
  • Business email compromise (BEC): Fraudulent requests for urgent wire transfers during year-end financial rushes.

For more, read the full article here or watch the video on YouTube to see how these threats unfold and learn actionable prevention strategies.

About Heimdal:
Established in Copenhagen in 2014, Heimdal® empowers CISOs, security teams, and IT administrators to improve their security operations, reduce alert fatigue, and implement proactive measures through a unified command and control platform.

Heimdal’s award-winning cybersecurity solutions span the entire IT estate, addressing challenges from endpoint to network levels, including vulnerability management, privileged access, Zero Trust implementation, and ransomware prevention.

For further press information:

Madalina Popovici
Media Relations Manager
[email protected] 

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View original content:https://www.prnewswire.co.uk/news-releases/stay-cyber-safe-this-holiday-season-heimdals-checklist-for-business-security-302337465.html

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According to Tickmill survey, 3 in 10 Britons in economic difficulty: Purchasing power down 41% since 2004

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The people who have the most problems are women (30%) and are between 35 and 49 years old (39%)

ROME, Dec. 20, 2024 /PRNewswire/ — The purchasing power in the UK has dropped by 41% over the last 20 years. Today, £100,000 left in a bank account since 2004 without being invested would now be worth £59,021.

This figure is one of the findings from a study conducted by Tickmill, an international online trading broker that compared the economic situation in the UK and the European Union through the infographic “Purchasing Power and Cost of Living: UK vs EU”.

The analysis reveals a slight decline of 0.4% in the UK’s purchasing power, which currently stands at £41,573. In contrast, the European Union has seen a modest rise of 0.1%, reaching £40,874.

Why is purchasing power declining in the UK? One key factor is the cost of living. If the UK were still part of the European Union, it would rank as the fifth most expensive country, behind Ireland, Luxembourg, Denmark, and the Netherlands.

Unsurprisingly, 3 in 10 Britons are struggling with the cost of living. Women (3 in 10, compared to 25% of men), those aged between 35 and 49 (4 in 10), households earning less than £15,000 (6 in 10), and single parents (1 in 2) are among the most affected groups.

Among UK nations, Northern Ireland is the hardest hit, with 34% of its population facing financial difficulties, followed by Wales (31%), England (28%), and Scotland (22%). In England, the North East has the highest percentage of people struggling, with 4 in 10 residents affected. Even in London, the high costs impact 1 in 4 adults.

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In response to these challenges, Britons are making significant adjustments:

  • 53% have cut back or delayed spending on smaller items like eating out, entertainment, subscriptions, clothing, toys, books, etc.;
  • 52% have reduced household energy consumption;
  • 48% have decreased their grocery spending;
  • 41% have scaled back or postponed major expenditures, such as holidays, cars, and weddings;
  • 26% are working longer hours, taking on overtime, or pursuing additional jobs to earn extra income.

The British also made changes on the financial side. One in four adults has been forced to dip into their savings or investments to cover daily expenses. Moreover, 44% have stopped saving or investing entirely or have reduced their savings and investments—a 4% increase compared to 2023.

The lack of investment is another critical factor contributing to the decline in purchasing power. It is estimated that 13 million UK residents hold £430 billion in cash deposits but do not invest. The reasons? Seventy-four percent say they cannot compare investment products effectively, and 43% are afraid of losing their money.

A lack of knowledge and fear are preventing many savers from taking advantage of an important opportunity: preserving or increasing their purchasing power in the long term.

Photo: https://mma.prnewswire.com/media/2586123/Tickmill.jpg
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