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M&L Healthcare’s First MedTech Investment Receives FDA Approval Following Successful US Trials

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–News Direct–

SINGAPORE – Media OutReach – 18 September 2023 – M&L Healthcare, in its first major MedTech investment, has announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the LimFlow System – a revolutionary therapy providing limb-saving treatment for patients with Chronic Limb-Threatening Ischemia (CLTI). The approval comes after successful outcomes in the PROMISE II Pivotal trial in the United States, recently published in the New England Journal of Medicine.

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is designed to re-establish blood flow in deep veins for "no-option" CLTI patients. It is the first and only FDA-approved device for TADV and provides no-option CLTI patients with access to a minimally invasive treatment.

Type 2 diabetes is a major cause of CLTI, a condition that affects millions of people globally. The United States alone witnesses approximately 150,000 ischemic amputations each year, resulting in healthcare costs of over US$95 billion. LimFlow's therapy was developed to offer a limb-saving procedure to patients with incurable CLTI. The minimally invasive LimFlow is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in CLTI patients who are facing major amputation and have exhausted all other therapeutic options. Given the high personal and social implications of amputation, as well as the alarming mortality rate of CLTI patients (approximately one in five amputees die within one year*), the availability of the LimFlow System marks a significant milestone.

Dr. Steven Kum, Chief Medical Officer for M&L Healthcare, and a Vascular Surgeon, shared his thoughts on this achievement:

"We are thrilled that the LimFlow System has received FDA approval for the LimFlow System this week. This breakthrough therapy has already achieved several significant milestones out of the work done in US, Europe and Singapore including the first-in-man procedure which was performed by the Vascular Team in Changi General Hospital Singapore. LimFlow has revolutionized the treatment of CLTI, aiding in wound healing and preventing debilitating amputations. It grants patients a second chance and potentially enhances their life span and quality of life. Considering Type 2 diabetes is the major cause of CLTI globally, the availability of LimFlow is crucial for improved patient outcomes."

LimFlow overcame numerous hurdles, navigating the complexities of conducting clinical trials during the COVID-19 pandemic. Recognizing the significance of bringing this life-changing therapy to fruition, M&L Healthcare proactively provided the clinical support and necessary funds to mitigate the unexpected additional costs to ensure the clinical trial stayed on track.

Reflecting on the achievement, Ms. Jocelyn Kum, Executive Director of M&L Healthcare, expressed her confidence in M&L Healthcare's capabilities as an investment partner, stating, "Our contribution to LimFlow's success is a testament to the dedication and business acumen that M&L Healthcare brings to the table."

"Statistics show that only 1% of MedTech devices cleared for the US market in 2021 were novel and required pre-market approval, with the rest cleared via the 510(k) pathway. M&L recognized the early clinical and investment value of LimFlow and established itself as a reliable partner, demonstrating the financial stability and determination required to support investments throughout the challenging journey to success."[1]

The LimFlow journey to date

Established in Germany in September 2012, the LimFlow System was supported by Paris-based accelerator fund, MD Start I. By November 2012, LimFlow embarked on its first animal study under then-acting CEO, Mr. Tim Lenihan, a partner in MD Start I.

MD Start approached Dr. Steven Kum and together with co-inventor Dr. Martin Rothman and CLTI expert Dr. Roberto Ferraresi, the team sought to develop a percutaneous procedure for Deep Venous Arterialization, leveraging their extensive clinical and engineering experience.

Dr. Kum played a critical role in the development of the LimFlow technology and procedure, performing one of many cadaver studies in Singapore. In July 2014, he performed the first-in-human trial in Singapore with the purpose built Crossing Catheters and Valvulotome and subsequently completed a seven-patient pilot study with a 100% technical success rate. The results of the pilot study were promising with all primary safety endpoints met. 6 of 7 patients had avoided major amputations at 6 months and their wounds healed by an average of 4 months.

In September 2014, LimFlow closed its Series A funding round, with M&L Healthcare as the lead investor. Now, a decade later, LimFlow stands apart as a game-changer in the field of medical technology. Having participated in all financing rounds since Series A, M&L Healthcare and Dr. Steven Kum have been integral to LimFlow's successful journey, pioneering a life-changing solution for CLTI. Unlike many medical devices which optimize existing solutions, LimFlow has addressed a significant, unmet need in CLTI, an area historically considered as a graveyard for technological advancements.

What's Next for LimFlow

In March 2023, a significant milestone was reached when LimFlow's US pivotal trial results were published in the New England Journal of Medicine. The six-month outcomes exhibited a limb salvage rate of 76% where over three-quarters of participants kept their leg, avoided amputation, and experienced progressive wound healing LimFlow previously received Breakthrough Designation from the FDA and the results substantially surpassed the FDA's performance target. This publication in the prestigious New England Journal of Medicine underscores the transformational potential of the LimFlow System for patients desperately in need.

LimFlow successfully obtained Conformit Europenne (CE) Mark in October 2016 and is currently available commercially in Europe. FDA pre-market approval on 11 September2023.

Building on these outstanding trial results and regulatory approvals in major markets, LimFlow is now gearing up for commercialisation in the US, the EU, and the UK, with plans for subsequent worldwide distribution.

For more information about LimFlow, visit www.limflow.com

Patient testimonies

Case study 1

Case study 2

Case study 3

[1] US FDA Premarket Approvals 2021

Updated 13 Jan 2022

US FDA 510(k) Approvals 2021

Updated 4 Jan 2022

About M&L Healthcare

M&L Healthcare Investments is a wholly owned subsidiary of the Singapore-based Kum family, one of the pioneers in the Singapore shipping sector and a global investor in hospitality. Leveraging off over 40 years of business experience and entrepreneurial spirit spanning across several different sectors, M&L Healthcare aspires to be a leading life sciences company of the future.

Led by Executive Director, Ms Jocelyn Kum, and Chief Medical officer, Dr Steven Kum, M&L Healthcare made its first investment in LimFlow Medical Technology in 2014. M&L Healthcare Investments has since participated in various financing rounds with investments in Europe, United States and Asia Pacific valued in excess of US$150 million.

M&L Healthcare Investments is a subsidiary of the diversified M&L Group, which is valued at approximately US$2.5 billion. The group includes M&L Hospitality, M&L Shipping, and M&L Healthcare and Alternatives. With growing investments across various sectors, M&L Healthcare is poised to benefit from the group's extensive international network and strong investment acumen. This positions M&L Healthcare for significant growth.

Contact Details

M&L Healthcare

Alina Morais

[email protected]

View source version on newsdirect.com: https://newsdirect.com/news/mandl-healthcares-first-medtech-investment-receives-fda-approval-following-successful-us-trials-213489341

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Ripmex Debuts RPX Tokens PreSale: Commission-Free Trading for a New Financial Era

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Ripmex Announces PreSale of Commission-Free RPX Tokens – The Native Token of Its Currency Exchange Market

Washington, United States, 20th Jul 2024, King NewsWireRipmex is excited to announce the presale of its innovative real-time gross settlement token, RPX. Designed to transform global currency exchange, RPX facilitates secure, low-cost transactions for banks, payment providers, digital asset exchanges, and businesses. By eliminating commission fees, RPX enhances potential profitability and provides seamless, instant transfers across various networks. The presale offers a unique opportunity for early investors to engage with Ripmex’s cutting-edge technology and be part of a revolutionary financial ecosystem.

What is Ripmex?

Ripmex aims to enable banks, payment providers, digital asset exchanges, and companies to send money and value globally, securely, and with low transaction fees. Utilizing advanced blockchain technology, Ripmex offers a commission-free currency exchange network that allows users to exchange, buy, and sell funds without incurring fees.

Key Features of RPX

Commission-Free Transactions

RPX operates entirely commission-free, allowing investors worldwide to save money and increase their potential profit margins. Whether trading on centralized exchanges (CEX) or decentralized exchanges (DEX), RPX ensures users pay zero commission fees.

Real-Time Gross Settlement

In the crypto industry, RPX will be known as a real-time gross settlement token. This designation underscores its capability to facilitate instantaneous transactions across different networks, providing unmatched efficiency and security in currency exchange.

Staking and Blockchain Development

RPX represents a comprehensive ecosystem. With plans to establish its own blockchain, RPX offers staking opportunities, allowing users to earn rewards while supporting the network’s security and operations.

Advanced AI Technology

Ripmex is also at the forefront of integrating artificial intelligence (AI) to enhance user experience and investment strategies. The upcoming RPX application, powered by AI, will:

Determine Optimal Trading Points: The AI technology will analyze market conditions to provide users with opportunities for buy and sell points for cryptocurrencies.

Assess Presale Projects: The app will evaluate new token projects, distinguishing reliable investments from potential risks, thereby helping users make informed decisions.

Provide Real-Time Insights: With comprehensive data analytics, users can evaluate presale opportunities based on key metrics such as project stage, funding targets, and token economics.

PreSale Details

The RPX presale is now live, offering an opportunity for early investors to acquire tokens at a favorable rate. By participating in the presale, investors can leverage the innovative features of RPX, gain early access to the platform’s benefits, and contribute to the development of a revolutionary financial ecosystem.

Ripmex is set to redefine currency exchange and trading with its innovative RPX token, offering zero commission fees and advanced AI-driven tools.

About Ripmex

RPX technology allows users to trade on CEX and DEX exchanges without paying commission. RPX has an infrastructure where companies and individuals can save money in their commercial lives.

In quick buy and sell transactions, users can convert RPX tokens into cash without paying commission or obtain RPX without paying commission. The RPX chain token, built on agreements with CEX and DEX exchanges, can be used worldwide. Aiming to establish its own blockchain, RPX can be staked.

In the Blockchain technology era, RPX provides convenience to investors with launch panels. RPX has signed a new era in Blockchain with its expert team and various encrypted parameters in the field of Blockchain technology. 

For more information and to participate in the presale, users can visit:

Presale: https://sale.ripmex.com 

Website: https://ripmex.com 

Twitter(X): https://x.com/RipmexOfficial 

Telegram: https://t.me/Ripmex

Contact email: [email protected]

Media Contact

Organization: Ripmex

Contact Person: Tyrone

Website: https://ripmex.com

Email: Send Email

City: Washington

Country: United States

Release Id: 20072414516

The post Ripmex Debuts RPX Tokens PreSale: Commission-Free Trading for a New Financial Era appeared first on King NewsWire. It is provided by a third-party content provider. King Newswire makes no warranties or representations in connection with it.

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Unlock Ultimate Health with the Nation’s Top Alkaline Diet Series, Flip McGyver’s Alkaline Life Diet

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United States, 20th Jul 2024, King NewsWireIn the fast-paced world we live in, maintaining optimal health often feels like an uphill battle. But what if the secret to vitality, energy, and longevity was as simple as choosing the right foods? Enter Flip McGyver, the seven-time best-selling, award-winning author behind the transformative “Alkaline Life Diet” series, which is now the #1 selling alkaline diet book in the country! 

Why the Alkaline Life Diet Series is a Game-Changer 

Flip McGyver’s groundbreaking journey into the world of alkaline diets began with his first book, “The Alkaline Life,” published in 2018. This book quickly garnered worldwide acclaim, inspiring a series of follow-up volumes that have captivated readers across the globe. But what makes this series stand out in the crowded field of diet and health books? 

Proven Success: The Alkaline Life Diet series isn’t just popular—it’s the best-selling alkaline diet book in the nation. Thousands of readers have experienced life-changing health benefits, from increased energy levels to significant weight loss and improved overall wellness. 

Comprehensive Approach: Whether you’re reading “The Alkaline Life Diet: Health is Wealth Cookbook Edition” or “The Alkaline Life Silenced By The System: The Dr. Sebi Story,” each book provides a deep dive into the science behind alkaline foods, practical recipes, and actionable advice that make transitioning to an alkaline lifestyle easy and enjoyable. 

Holistic Health: Flip McGyver’s philosophy goes beyond mere dieting. His motto, “It’s not just a diet; it’s a new way of life,” reflects a commitment to holistic health that nurtures the body, mind, and spirit. His books empower readers to make informed choices that lead to lasting health and vitality. 

The Alkaline Life Diet Series – A Reader’s Perspective 

What do readers have to say about the Alkaline Life Diet series? Testimonials pour in from across the country, with readers sharing incredible stories of transformation: 

“I never knew I could feel this good just by changing my diet. Flip’s books are a lifesaver!” – Maria J. 

“The recipes are not only delicious but have also helped me lose 20 pounds and keep it off!” – James T. 

“Flip McGyver’s insights into the healthcare system are eye-opening. This series is a must-read for anyone serious about their health.” – Linda K. 

Take Control of Your Health Today 

Are you ready to join the health revolution? With the Alkaline Life Diet series, you’re not just buying a book; you’re investing in a brighter, healthier future. Flip McGyver’s proven methods and inspiring guidance will help you unlock the secrets to ultimate health and well-being. 

Don’t wait—take the first step towards a healthier, more vibrant life today. Visit TheAlkalineLifeDiet.com or find Flip McGyver’s books on Amazon and other major retailers. Discover why the Alkaline Life Diet series is the #1 choice for health-conscious individuals nationwide. 

Special Offer 

For a limited time, get exclusive access to Flip McGyver’s latest book, “The Alkaline Life Trilogy,” which combines three of his best-selling books into one comprehensive guide. Order now and take advantage of this special offer to kickstart your journey to optimal health. 

Media Contact

Organization: The Alkaline Life Diet

Contact Person: Flip Mcgyver

Website: http://thealkalinelifediet.com/

Email: Send Email

Country: United States

Release Id: 20072414524

The post Unlock Ultimate Health with the Nation’s Top Alkaline Diet Series, Flip McGyver’s Alkaline Life Diet appeared first on King NewsWire. It is provided by a third-party content provider. King Newswire makes no warranties or representations in connection with it.

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Tektronic in Central Scotland Revives Classic Porsche Engines for Enthusiasts across the UK

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Tektronic, based in Central Scotland, is making waves in the classic car community by specialising in restoring and rebuilding classic Porsche engines. Serving Porsche enthusiasts from all over the UK, Tektronic has established itself as a premier destination for those looking to preserve the performance and heritage of their beloved vehicles. The company focuses on iconic models such as the Porsche 911, the pioneering 356, and the performance-centric 944, offering expert services that ensure these classics continue to deliver the driving experience they were designed for. Tektronic’s commitment to quality and meticulous attention to detail set them apart in a niche market, providing a valuable alternative to traditional manufacturer services.

The need for specialised restoration services for classic Porsches is significant. Owners of these iconic vehicles often face high costs and limited service options when seeking engine restorations through manufacturers. Independent garages like Tektronic fill a crucial gap in the market by offering cost-effective and reliable alternatives. Tektronic specialises in rebuilding engines with a detailed and efficient process that involves sourcing high-quality, genuine parts and applying advanced restoration techniques. Each project is tailored to the vehicle’s specific needs, ensuring that every component is either restored or replaced to maintain the engine’s performance and reliability. This personalised approach enhances the vehicle’s longevity and preserves its authenticity and value.

One of the major challenges in restoring classic engines is sourcing authentic parts, a task that Tektronic excels at. The company goes to great lengths to find high-quality, genuine parts that are essential for maintaining the integrity of the original engine. This dedication to authenticity ensures that the restored engines are as close to their original condition as possible, preserving the legacy of these classic vehicles. The rebuilding process requires a deep understanding of each component involved, and Tektronic’s team possesses the specialised knowledge necessary to perform these intricate restorations. Their expertise covers a wide range of models, and they employ advanced techniques to ensure that the engines not only perform at their peak but also retain their historical significance.

Tektronic also prioritises client experience, inviting potential customers to visit their workshop in Central Scotland to witness firsthand the professional care and sophisticated environment where classic Porsche engines are restored. Visits are by appointment only, allowing clients to engage in detailed discussions about their specific needs and to tour the workshop. This personalised service underscores Tektronic’s commitment to building strong relationships with their clients and ensuring that their expectations are met or exceeded. Continuous innovation and expansion of services are central to Tektronic’s mission. The company is not only dedicated to maintaining high standards of quality and reliability but also looks forward to introducing future projects and services that will further enhance their restoration capabilities. This forward-thinking approach ensures that Tektronic remains at the forefront of the classic car restoration market, setting industry standards and making classic Porsche engine restoration accessible to a wider range of enthusiasts.

In conclusion, Tektronic is setting a new standard in the classic car restoration industry by offering Porsche owners a trusted and cost-effective alternative for engine restorations. The company’s dedication to preserving the performance and heritage of iconic Porsche models, combined with their meticulous attention to detail and commitment to quality, ensures that these vehicles continue to provide the driving experience they were designed for. Tektronic’s role in the classic car community is significant, as they provide services that are essential for the preservation of these historical vehicles. For more information, or to schedule a visit to their workshop, potential clients can contact Tektronic online or call 01786 625 624. Tektronic remains committed to innovation and excellence, continually striving to meet the evolving needs of classic Porsche enthusiasts across the UK.

Contact details

1. Company name: Tektronic Prestige Car Specialist

2. Website link: https://www.tektronic.co.uk/independent-porsche-specialist/classic-porsche-engine-rebuilds/

3. Contact email: [email protected]

4. Country: United Kingdom

5. City: Unit 1a, Alva Industrial Estate, Alva FK12 5DQ

6. Contact person name: Ewan Montgomer

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