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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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
TEAM NAVER to establish a joint venture with the National Housing Company in Saudi Arabia, building additional foundations for business along with its digital twin platform
– NHC, named “the largest real estate developer in the Middle East” this year, accounts for 70% of real estate transactions in Saudi Arabia
– Leading digital transformation in the real estate sector, including smart cities, plans underway to develop a map-enabled super app for public administration with NAVER
SEONGNAM, South Korea, Nov. 18, 2024 /PRNewswire/ — TEAM NAVER is to establish a joint venture with Saudi Arabia’s National Housing Company (NHC), a state-owned company under the Ministry of Municipalities and Housing. The JV will serve as NAVER’s business unit for the Saudi Arabia region, along with NAVER Arabia (tentative name) which will oversee the company’s business in the MENA region.
TEAM NAVER and NHC signed an MOU to establish a JV at Cityscape Global 2024, held from November 11 to 14 in Riyadh, Saudi Arabia. The MOU signing ceremony was attended by key figures from both companies, including Chae Seon-ju, President of ESG and External Affairs at NAVER, Kim Yuwon, CEO of NAVER Cloud, Majed Al-Hogail, Saudi Arabian Minister of Municipalities and Housing, and Ryan Al-Aql, CSO of NHC.
The JV will operate under NAVER Arabia (tentative name), with the operation and commercialization of the digital twin platform in Saudi Arabia as its core business along with NHC. The JV will also be TEAM NAVER’s first business entity for its technology platform business in the Middle East.
NHC, a key partner of TEAM NAVER in Saudi Arabia, is a state-owned company under the Saudi Arabian Ministry of Municipalities and Housing that is responsible for 70% of real estate transactions in the country. As part of Saudi Arabia’s “Vision 2030” initiative, the company is currently focused on digital transformation such as digital innovation in the real estate sector and smart city development. Since its establishment in 2016, NHC has been in charge of over 380 projects for real estate development projects including public housing provision, and the value of its real estate portfolio is expected to exceed 60 billion USD (80 trillion KRW) as of the end of 2025. The company has also been selected as the largest real estate developer in the Gulf Cooperation Council (GCC) by the Construction Week Middle East in 2024.
TEAM NAVER and NHC will operate and commercialize the digital twin platform in Saudi Arabia through the JV, while also developing other businesses such as a public monitoring platform for urban areas and a map-enabled super app for public administration.
“TEAM NAVER’s global competitiveness in technology and business has been recognized by various ministries and organizations in Saudi Arabia, and we are excited to further discover business opportunities with different partners in the region,” said Chae Seon-ju, President of ESG and External Affairs at NAVER.
Meanwhile, from November 11 to 14 TEAM NAVER attended and exhibited its technologies in Cityscape Global 2024, a prime construction exhibition in Saudi Arabia, to further explore various business opportunities.
About NAVER
Founded in 1999, NAVER is Korea’s largest Internet company. It operates No.1 search engine in Korea ‘NAVER’, along with the e-commerce platform and various global online services such as LINE mobile messenger, Webtoon and Webnovel publishing, SNOW video camera app and ZEPETO metaverse platform.
In addition to its own offerings, NAVER is building a strong global business portfolio through partnerships with industry-leading companies, including Softbank, Poshmark, and Wattpad. NAVER recorded sales of KRW 9.6 trillion (USD 6.9 billion) in 2023. The company invests approximately 25% of its annual sales in R&D projects, pursuing innovation through continuous research and development of future technologies, such as artificial intelligence, robotics and autonomous driving technologies.
To learn more, visit www.navercorp.com/en
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Fintech PR
Setting a New Safety Benchmark for the Industry: Sungrow Achieves Success in the World’s Largest BESS Fire Test
HEFEI, China, Nov. 18, 2024 /PRNewswire/ — In June 2024, Sungrow took the bold step of deliberately combusting the 10MWh of its PowerTitan 1.0 liquid-cooled battery energy storage system (BESS), becoming the first company globally to conduct a large-scale burn test on an energy storage system. Recently, the company invested approximately 4.23 million USD[1] to perform the world’s largest and longest burn test on 20MWh of its PowerTitan 2.0 liquid-cooled BESS.
These two burn tests conducted within six months underscore Sungrow’s commitment to technological innovation, its relentless pursuit of product quality, and its unwavering dedication to ensuring the safety of both personnel and assets at energy storage plants. Meanwhile, the test represents Sungrow’s steadfast commitment to upholding the safety baseline for the energy storage industry.
The 20MWh burn test replicated a real-world power plant fire scenario, completed under the oversight of DNV (Det Norske Veritas) experts and over 100 clients, and delivered results exceeding expectations. The results were clear: there was no fire propagation during the thermal runaway incident. In contrast to conventional industry burn tests, this test was a significant upgrade in terms of combustion duration, testing conditions, and safety standards, establishing a new benchmark for safety through rigorous and extreme testing.
Challenge 1:
Withstanding Over 25 Hours of Combustion, Proving Superior System Protection Capability
Unlike common industry-standard combustion tests within 4 to 8 hours, this challenging test was designed to sustain for 3 to 6 times longer. After continuous burning within 25 hours and 43 minutes, the container structure of the thermal runaway unit remained intact, and the system could still be safely hoisted for removal. Importantly, the fire did not spread beyond the unit, demonstrating the PowerTitan 2.0’s advanced explosion venting, flame retardancy, and impact resistance capabilities.
Challenge 2:
Enduring Temperatures High Enough to Melt Steel, Verifying Thermal Runaway Containment
To simulate extreme operating conditions, four fully-charged energy storage units were arrayed nearby — containers A and B were only 15 cm apart, which is the absolute minimum distance permitted in the industry (most power plant containers are spaced 3 meters apart). Despite the flames from container A reaching 1,385°C — temperatures high enough to melt steel — the fire did not spread to the neighboring container B, which maintained a safe temperature of 40°C. This result validates the PowerTitan 2.0’s superior fire insulation ability, even when the units are placed in extremely close quarters.
Challenge 3:
Testing Fire Resistance and Flame Retardancy Without Firefighting Protection
In this phase of the test, all firefighting systems for the BESS containers were intentionally shut off, leaving the units unprotected and significantly increasing the safety risks. Despite this, the PowerTitan 2.0 performed admirably, with all four storage container doors remaining intact and not burned through. The fire was effectively contained within the container, and the damage was limited. This demonstrated the BESS’s ability to autonomously respond to extreme fire situations, highlighting the robust passive fire protection design that minimizes risk.
Safety is the cornerstone of the energy storage industry. Sungrow’s two consecutive, high-investment, extremely large-scale burn tests on the PowerTitan series reflect the company’s unwavering commitment to safeguarding personnel, assets, and operations at power plants, as well as its dedication to reinforcing the safety standards for the entire industry. The success of this rigorous and high-standard combustion test sets a new benchmark for safety in the energy storage sector, providing valuable real-world evidence for future safety protocols.
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[1] 30 million CNY (approximately 4.23 million USD at an exchange rate of 7.1 CNY to 1 USD). |
About Sungrow
Sungrow, a global leader in renewable energy technology, has pioneered sustainable power solutions for over 27 years. As of June 2024, Sungrow has installed 605 GW of power electronic converters worldwide. The Company is recognized as the world’s No. 1 on PV inverter shipments (S&P Global Commodity Insights) and the most bankable Asian energy storage company (BloombergNEF). Its innovations power clean energy projects in over 170 countries, supported by a network of 490 service outlets guaranteeing excellent customer experience. At Sungrow, we’re committed to bridging to a sustainable future through cutting-edge technology and unparalleled service. For more information, please visit www.sungrowpower.com.
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View original content:https://www.prnewswire.co.uk/news-releases/setting-a-new-safety-benchmark-for-the-industry-sungrow-achieves-success-in-the-worlds-largest-bess-fire-test-302308067.html
QINGDAO, China, Nov. 18, 2024 /PRNewswire/ — A news report from chinadaily.com.cn:
Important in Qingdao’s development strategy, Laoshan district is a city of science and technology that is a fertile ground for innovation and a number of strategic emerging industries and future industries.
In 1994, the initial batch of high-tech enterprises in Qingdao began to congregate in Laoshan. Over the past 30 years, Laoshan has focused on expanding and strengthening the value chains of seven key industries including artificial intelligence, virtual reality, and modern finance.
The district has attracted a large number of innovative enterprises, including nine unicorn companies, 28 nationally recognized specialized and new “little giant” enterprises, 47 provincial-level gazelle enterprises, and 920 high-tech enterprises, all of which are among the top in the city in terms of quantity.
Laoshan district currently has the highest density of scientific and technological innovation in Shandong, with 178 high-tech enterprises per 10,000 companies, 52 national and provincial-level scientific research institutions, and 160 academicians and high-level talents.
By 2023, the proportion of the output value of high-tech industries in Laoshan district to the total output value of large-scale industries reached 86.55 percent, with the leading industry scale exceeding 180 billion yuan ($25.33 billion). Laoshan district has been selected as one of the nation’s top 100 industrial zones for two consecutive years.
Taking virtual reality as an example, as early as 2016, Laoshan district proposed that it become China’s virtual reality industry capital. In 2022, Qingdao constructed an industrial park featuring virtual reality in Laoshan, which has a planned area of over 2,000 mu (133.33 hectares), aiming to create an internationally leading highland for the virtual reality industry.
With the establishment of the industrial park, Laoshan district has vigorously attracted industry-leading enterprises and high-growth companies, as well as top talents in virtual reality. Currently, the park has attracted leading consumer-facing companies such as Douyin Pico and Dapeng VR, as well as core supporting enterprises such as electroacoustic components manufacturer GoerTek and Chinese virtual reality headset maker Pico. Shipments of high-end VR products from leading companies in the park account for over 80 percent of the domestic market.
In 2023, the scale of the virtual reality industry in Laoshan district surpassed 18 billion yuan, a year-on-year increase of 50 percent, and the virtual reality industry cluster was selected as a provincial-level future industry cluster.
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View original content:https://www.prnewswire.co.uk/news-releases/qingdaos-laoshan-district-boosts-innovative-growth-302308048.html
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