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

Revolutionary limb saving procedure set to benefit patients with Chronic Limb-Threatening Ischemia, typically caused by Type 2 Diabetes

SINGAPORE – Media OutReach – 15 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 Kum and together with CLTI expert 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 Conformitè Europëenne (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

Hashtag: #M&LHealthcare #LimFlow #MedTech #Diabetes

The issuer is solely responsible for the content of this announcement.

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.

Cambodian Prime Minister Hun Manet Visits China on His First Official Trip Abroad

Cambodia PM Hun Manet lays a wreath at the Monument to the People's Heroes on the Tiananmen Square in Beijing on Thursday 14 September 2023 on his trip to China. (Photo: AP)

BEIJING (AP) — Cambodian Prime Minister Hun Manet arrived in Beijing on Thursday on his first official trip abroad since taking office last month. The visit demonstrates his country’s warm relations with China, Cambodia’s closest political and economic ally.

Lao Kip Drops to Record Low, Breaches 20,000 to US Dollar

Lao kip
Lao kip

The Lao kip has continued to depreciate against foreign currencies, reaching a historic low today in international markets.

Successful Wolbachia Bacteria Project in Laos Shows Promise for Mosquito Population Control

Successful Wolbachia Bacteria Project in Laos Holds Promise for Mosquito Population Control
FILE: this image is used only for representational purpose (photo: Houston Chronicle)

The Wolbachia bacteria project under the Ministry of Health concluded its five-month experiment earlier this month and will now carry on to its next phase of result evaluation until 2025.

The “Asian Games Letterbox” Singapore Stop Concludes with Success

SINGAPORE – Media OutReach – 15 September 2023 – The “Asian Games Letterbox” is an initiative, under the esteemed guidance of the 19th Asian Games Hangzhou 2022 Organising Committee (hereinafter referred to as “Hangzhou Asian Games Organising Committee”) and the Information Office of the Zhejiang Provincial Government; Phoenix Satellite Television and ifeng.com invite local communities across multiple nations and regions in Asia to handwrite messages of goodwill for the Asian Games personally. The inaugural stop commenced in Hong Kong on June 18th, drawing participation from tens of thousands of individuals, and sparking a significant surge of enthusiasm for the Asian Games Hangzhou 2022.

Less than two weeks before the opening of the 19th Asian Games Hangzhou 2022, a young participant in the “Asian Games Letterbox” Singapore stop wrote down her heartfelt wishes for the Games and the athletes, “I wish the Asian Games Hangzhou 2022 will be successfully organized, and every athlete will achieve triumph on the field.”

As the first Asian stop beyond China, back on July 22nd, H.E. Ms. Sun Haiyan, Chinese Ambassador to Singapore, attended the prelude sports meeting of the “Asian Games Letterbox” Singapore stop, lending her support to this vibrant celebration of the Asian Games Hangzhou 2022.

At present, the “Asian Games Letterboxes” strategically positioned at prominent locales in Singapore, such as Merlion Park, Esplanade – Theatres on the Bay, Clarke Quay, and Gardens by the Bay, have been officially unveiled, swiftly capturing the enthusiastic participation of local residents, overseas compatriots, and Chinese in Singapore.

Every individual who joins this event is adorned with smiles, as they inscribe their heartfelt aspirations and sincere sentiments for the upcoming Asian Games Hangzhou 2022 in both Chinese and English upon postcards. These well-wishes are then placed within the letterboxes, destined to be conveyed back to China.

Amidst the exquisitely designed letterheads adorned with heartfelt blessings, the “Global Insights” microphones were handed to passersby on the streets of Singapore. A local student from Hangzhou, presently enrolled at Nanyang Technological University, Singapore, expressed, “I am delighted to witness my hometown hosting the Asian Games Hangzhou 2022. I hope that through this Asian Games, more friends from different countries will get to know China and Hangzhou.”

Singapore is also brimming with anticipation for this Asian Games. It is reported that Singapore will dispatch its largest-ever delegation, consisting of a remarkable 431 athletes, to participate in the Asian Games Hangzhou 2022 across 32 different sporting disciplines. Of the 431 athletes, 336 athletes will be making their debut at the Asian Games, with the youngest being the 14-year-old synchronized swimmer, Li Jiaxuan, and the most senior participant being the 60-year-old Go player, Kang Zhanbin. This shows Singapore’s profound regard for the Asian Games Hangzhou 2022, and the local residents have conveyed their hopes for the event during interviews.

“The Asian Games Hangzhou 2022 will be an unparalleled celebration, and I hope Singaporean athletes will collaborate with their Chinese counterparts to staging wonderful games for the spectators on the field. While I may not have the opportunity to personally attend and cheer for the athletes at the event, I have already learned on the Internet what a beautiful city Hangzhou is. I hope that one day I can sit by the West Lake, taste the West Lake Fish in Vinegar Gravy, and drink Longjing tea.”

Just as the blessings and aspirations conveyed through the “Asian Games Letterbox”, athletes from various countries, traveling from afar, arrive in Hangzhou not only with a resolute determination to excel but also with a mission of fostering friendly exchanges. Likewise, the spectators from different places worldwide will shower these sportsmen and women with the most heartfelt applause.

The Asian Games Hangzhou 2022 is not just a mere sporting competition; it serves as a bridge that connects China with other nations through the medium of sports. People of different nationalities, ethnicities, and beliefs will be closely connected and united through this event, marching hand in hand towards a brighter future. Through the Asian Games Hangzhou 2022, the world will undoubtedly gain deeper insights into China’s future trajectory, and China, in turn, will contribute its strength to the future of Asia and the globe.

Hashtag: #AsianGamesLetterbox

The issuer is solely responsible for the content of this announcement.

The Beauty of Space

27 September 2023: rare photographic treasures of early NASA space travel from the Victor Martin-Malburet Collection in Dorotheum online auction

VIENNA, AUSTRIA – news aktuell – 15 September 2023 – In the online auction The Beauty of Space – Iconic Photographs of Early NASA Missions, which ends on 27 September 2023, the Austrian auction house Dorotheum offers around 200 historic photographs of the US space agency NASA, dating from the beginning of manned spaceflight in the early 1960s to the mid-1970s. A selection of vintage prints collected over a period of 25 years by French space historian and art collector Victor Martin-Malburet can be purchased at auction – with attractive opening prices, starting at 100 euros, and without reserve.

Buzz Aldrin's gold plated sun visor reflects the photographer and the LM Eagle, Vintage-chromogenetic print on fiber-based, paper, printed 1969 (NASA AS11-40-5903), 20.3 x 25.4 cm DOROTHEUM
Buzz Aldrin’s gold plated sun visor reflects the photographer and the LM Eagle, Vintage-chromogenetic print on fiber-based, paper, printed 1969 (NASA AS11-40-5903), 20.3 x 25.4 cm DOROTHEUM

The colour and black-and-white photographs were originally taken for scientific purposes and most of them were kept under lock and key. The auction includes important visual treasures from the Golden Age of astronautics, such as the first space selfie, the first human-taken photograph of the Planet Earth, and the first human-taken photograph of the surface of another world. An absolute rarity, with an estimate between 15,000 and 25,000 euros, is the only photograph of the first man on the Moon (Neil Armstrong) taken by astronaut Buzz Aldrin during the first lunar landing of the APOLLO 11 mission in July 1969.

The first selfie in outer space, 11 - 15 November 1966, vintage chromogenic print on fiber-based paper, printed 1966, numbered
The first selfie in outer space, 11 – 15 November 1966, vintage chromogenic print on fiber-based paper, printed 1966, numbered “NASA S-66-62926” 20.3 x 25.4 cm DOROTHEUM

Parts of the Martin-Malburet Collection have already been exhibited in renowned museums worldwide, including the Grand Palais in Paris, the Kunsthaus in Zurich, the Museum der Moderne in Salzburg and the Louisiana Museum of Art in Denmark.

View online catalogue https://www.dorotheum.com/en/a/99412/

Hashtag: #Dorotheum #TheBeautyofSpace

The issuer is solely responsible for the content of this announcement.

Hong Kong Science Park Invites French Biotech Innovators to Go Global via Asia’s Booming Markets

HKSTP joins “Think Business, Think Hong Kong” symposium in Paris to boost Hong Kong-French innovation and biotech ambitions

  • HKSTP leads showcase of Hong Kong’s world-class biotech ecosystem as ideal platform to propel startups and big pharma to global scale and success.
  • Asia Pacific is world’s fastest growing biotech region with a 16.9% compound annual growth rate from 2022 to 2030.
  • “Think Business, Think Hong Kong” symposium to feature France’s Minister of Foreign Trade and Hong Kong’s Financial Secretary on 19 September at the Carrousel du Louvre in Paris.

HONG KONG SAR – Media OutReach – 14 September 2023 – Hong Kong Science and Technology Parks Corporation (HKSTP), will join the “Think Business, Think Hong Kong” symposium organised by Hong Kong Trade Development Council (HKTDC) on 19 September, at the Carrousel du Louvre in Paris.

Hong Kong’s largest innovation and technology (I&T) ecosystem and incubator, HKSTP, will lead a contingent of health and biotech leaders to outline how Hong Kong can help biotech start-ups and big pharma in France scale for success and tap into the huge potential of Asia’s healthcare markets. At the same time, French expertise and talent will also advance Hong Kong’s goal to become an international biotech and innovation technology hub.

Mr Olivier Becht, France’s Minister for Foreign Trade, Economic Attractiveness and French Nationals Abroad and Mr Paul Chan, Financial Secretary of the HKSAR Government, will join a cast of business leaders at the event including Dr Peter Lam, Chairman of HKTDC, and Mr Albert Wong, CEO of HKSTP to discuss the collaboration potential between the French and the Hong Kong I&T ecosystems.

Asia Pacific is set to be the world’s fastest growing biotech region with a 16.9% compound annual growth rate from 2022 to 2030, according to Vision Research. The region is also seeing improving healthcare infrastructure, supportive government policies and an increasingly critical aging population challenge. Hong Kong is well located as the ideal hub to both the huge markets in North Asia and diverse fast-growing SE Asian economies.

Fast-rising biotech stars

To discuss these issues and opportunities, HKSTP is hosting a biotech thematic session and pavilion at the “Think Business, Think Hong Kong” symposium, with four leading executives from fast-rising Hong Kong-based biotech ventures showcasing the city’s ability to propel innovation to global success.

The four speakers and biotech companies include:

Dr Ricky Chiu Yin-To, CEO, Co-founder, and lead inventor of Phase Scientific’s underlying diagnostic technology. Amongst his most successful products is OratectXP, the first FDA approved drug-of-abuse diagnostic that utilised oral fluid.

Dr Yiyou Chen, Co-founder, Executive Director and Chief Scientist Officer of New Horizon Health. Chinese cancer screening pioneer New Horizon Health Limited, has gone IPO in Hong Kong in a mission to go global.

Prof Roberto Bruzzone, a renowned cell biologist, recognised for his work on direct cell-cell communication through connexins and their associated human diseases. C2i is a vaccine and therapeutics partnership between global infectious diseases leader the Institut Pasteur and the University of Hong Kong.

Prof Siew Chien Ng, a microbiology expert, Co-founder of GenieBiome, Professor of CUHK Faculty of Medicine, Director of Microbiota I-Center (MagIC). GenieBiome Limited (G-NiiB) is a pioneer in gut health and has launched the world’s first anti-viral gut microbiome formula.

Riding on the upward trajectory of record €13.49 billion funding in 2022, French startups are seeking further growth opportunities, while the French government also launched the Healthcare Innovation 2030 plan in 2021 with a budget of €7.5 billion with a goal to lead biotech innovation in Europe.

“The next potential step for French biotech is to scale up and go global. Asia offers diverse opportunities with Hong Kong the ideal launchpad for French biotech as an engine of funding, partnerships and talent to translate and scale medical innovations to global success. French biotech domain knowledge and innovation will also be a vital boost to Hong Kong’s ambition to become an international innovation hub,” said Mr Albert Wong, CEO of HKSTP.

Ecosystem completeness

Hong Kong is Asia’s leading and the world’s second largest biotech funding hub with Hong Stock Exchange’s biotech-friendly Chapter 18A listing policy, while also ranked 12th in the World Index of Healthcare Innovation, above the likes of the United Kingdom and Canada. The government has also funded the InnoHK initiative with 14 research clusters dedicated to biomedical and health tech, located at Hong Kong Science Park.

HKSTP has built a thriving fully integrated biotech ecosystem that can support ventures through every step of the startup to scale-up journey. Today HKSTP features around 250 biotech ventures supercharged by incubation programmes such as the dedicated Incu-Bio programme, plus attractive subsidies and supportive government policies. World class talent is abundant with Hong Kong’s five top-100 universities as ranked by the Times, plus China’s projected annual output of 77,000 STEM PhDs per year by 2025, compared to 40,000 in the US, as estimated by the Center for Security and Emerging Technology.

HKSTP has forged powerful connections with global pharmaceutical leaders such as Roche, Merck, Boehringer Ingelheim and Shanghai Pharmaceutical, as well as government, public and private hospitals and healthcare institutions. These partnerships support all parties in the ecosystem to expand into the Greater Bay Area (GBA), China, Asia Pacific and global markets.

Hong Kong already features a strong French contingent and community with a total of 800 French businesses, including 373 subsidiaries and 92 regional headquarters based in Hong Kong, according to the French Embassy. Interested parties can join the HKTSP biotech pavilion and the hear from biotech innovation leaders as well as other innovation ecosystem experts at the “Think Business Think Hong Kong” symposium.

Register now: https://thinkbusinessthinkhk-2023.site.digitevent.com/en/

Learn more: https://thinkbusinessthinkhk.com/2023-paris/symposium/en/event-details/programme.html

Hashtag: #HongKongScienceandTechnologParks

The issuer is solely responsible for the content of this announcement.

DigiZag Secures Seven-Figure Funding “Series A” to Boost the Gulf’s Performance Marketing Scene

AMMAN, JORDAN – EQS Newswire – 14 September 2023 – Digital advertising and performance marketing company, DigiZag (www.DigiZag.com), secured a 7-figure “Series A” funding from the SME Investment Fund managed by Al-Arabi Investment Group as part of its expansion strategy, which aims to increase DigiZag’s market presence and digital advancement in the GCC region.

Established in 2015, the Jordanian company, DigiZag offers cutting-edge technology-enabled solutions in the field of performance-based marketing with a business model that focuses on payment based on achieved results. With its advanced platform, DigiZag provides companies and institutions with the opportunity to boost their revenues and increase sales through targeted customer acquisition marketing campaigns that minimize marketing spending and eliminate any associated risks.

With access to DigiZag’s easy-to-use tools, customers can effectively predict and measure the return on their advertising spend, receive real-time performance tracking indicators, grow their brand, and expand target reach by using a network of marketers and expert influencers from across the Arab world.

Saif Atout, the Founder and CEO of DigiZag, expressed his excitement toward the Series A and the company’s future prospects, emphasizing that the “funding will play a pivotal role in expanding the presence of the DigiZag brand and team within the targeted countries. At the current moment, our primary objective is to elevate the standards of digital marketing in the MENA region, focusing on its development and enhancement.” Atout further reiterated DigiZag’s commitment to serving an increased customer base, assisting new regional companies in attaining their marketing objectives, and excelling in the realm of performance marketing.

Furthermore, Raad Fakhoury, Co-Founder and COO of DigiZag, stressed the importance of this milestone, saying, “This partnership will provide us with increased financial flexibility, allowing us to invest in innovative digital solutions to stay ahead in the rapidly evolving digital landscape. Additionally, it will enable us to expand our range of services by introducing new offerings to simplify the performance-based marketing process of our suppliers, which has always been DigiZag’s priority since its inception.”

For his part, Jameel Anz, Managing Director of the SME Investment Fund, commented, “We look forward to partnering with DigiZag. Together, we will expedite the company’s regional expansion, establish strong institutional foundations, and cultivate a proficient and specialized team, elevating its position as a prominent player in the digital marketing field across the Middle East and North Africa markets.”

It is noteworthy that DigiZag has achieved consistent annual growth, with a range of 25 to 30%, over the past three years—attributed to their successful collaboration with over 300 customers and the invaluable support of over 3,000 marketers from various Arab countries.

Hashtag: #DigiZag

The issuer is solely responsible for the content of this announcement.