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
Updated 13 Jan 2022
US FDA 510(k) Approvals 2021
Updated 4 Jan 2022
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.
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