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

SINGAPORE – Media OutReach – September 15, 2023 –
M&L Healthin its first major investment in medical technology, announced that the United States Food and Drug Administration (FDA) has granted premarket approval (PMA) of
LimFlow system – a revolutionary limb-saving therapy for patients with chronic limb-threatening ischemia (CLTI). This approval follows positive results from the pivotal PROMISE II trial in the United States, recently published in the New England Journal of Medicine.

The LimFlow System for Transcatheter Deep Vein Arterialization (TADV) is designed to restore blood flow in deep veins for “no options” CLTI patients. It is the first and only FDA-approved device for TADV and provides option-free CLTI patients with access to minimally invasive treatment.

Type 2 diabetes is a major cause of CLTI, a disease that affects millions of people worldwide. The United States alone experiences approximately 150,000 ischemic amputations each year, resulting in healthcare costs of more than $95 billion. LimFlow therapy was developed to provide a limb-saving procedure for patients with incurable CLTI. The minimally invasive LimFlow is designed to bypass blocked arteries in the leg and return oxygenated blood to the foot via veins in CLTI patients who are facing a major amputation and have exhausted all other treatment 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 a year*), the availability of the LimFlow system marks an important milestone.

Dr. Steven KumChief Medical Officer of M&L Healthcare and Vascular Surgeon, shared his thoughts on this achievement:

“We are pleased that the LimFlow System received FDA approval for the LimFlow System this week. This revolutionary therapy has already reached several important milestones thanks to work carried out in the United States, Europe and Singapore, including the first procedure in humans that has been performed. by the vascular team at Changi General Hospital, Singapore. LimFlow has revolutionized the treatment of CLTI, helping wound healing and preventing debilitating amputations. It gives patients a second chance and potentially improves their lifespan and quality of life. Considering that type 2 diabetes is the leading cause of CLTI globally, the availability of LimFlow is crucial to improve patient outcomes.

LimFlow has overcome many obstacles, navigating the complexities of conducting clinical trials during the COVID-19 pandemic. Recognizing the importance of bringing this life-changing therapy to fruition, M&L Healthcare proactively provided the necessary clinical support and funding to mitigate unexpected additional costs and ensure the clinical trial remained on track.

Reflecting on success,
Ms. Jocelyn KumExecutive Director of M&L Healthcare, expressed 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.

“Statistics show that only 1% of MedTech devices authorized for the US market in 2021 were new and required pre-market approval, with the remainder authorized 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 necessary to support investments throughout the challenging journey to success. »[1]

LimFlow’s journey to date

Created in Germany in September 2012, the LimFlow system was supported by the Paris-based accelerator fund MD Start I. In November 2012, LimFlow embarked on its first animal study under the leadership of its interim CEO, Mr. Tim Lenihan, MD Start partner. I.

MD Start contacted 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 technical experience.

Dr Kum played an integral role in the development of the LimFlow technology and procedure, performing one of several cadaver studies in Singapore. In July 2014, it conducted the first human trial in Singapore with specially designed crossover catheters and valvulotome, and then carried out a pilot study on seven patients with a 100% technical success rate. The results of the pilot study were promising, with all key safety endpoints met. 6 out of 7 patients had avoided major amputations at 6 months and their wounds had healed in 4 months on average.

In September 2014, LimFlow closed its Series A funding round, with M&L Healthcare as lead investor. Now, a decade later, LimFlow stands out as a revolutionary in medical technology. Having participated in every funding round since Series A, M&L Healthcare and Dr. Steven Kum have been an integral part of LimFlow’s successful journey, pioneering a life-changing CLTI solution. Unlike many medical devices that leverage existing solutions, LimFlow addressed a significant, unmet need in the CLTI space, an area historically considered a graveyard for technological advancements.

What’s next for LimFlow

In March 2023, an important milestone was reached when the results of LimFlow’s US pivotal trial were published in the New England Journal of Medicine. Six-month results showed a limb salvage rate of 76%, where more than three-quarters of participants kept their leg, avoided amputation and experienced progressive wound healing. LimFlow has already received FDA Breakthrough Designation and results far exceeded the FDA’s performance goal. This publication in the prestigious New England Journal of Medicine highlights the transformational potential of the LimFlow system for patients who desperately need it.

LimFlow successfully obtained Conformité Européenne (CE) marking in October 2016 and is currently commercially available in Europe. Pre-market approval by the FDA on September 11, 2023.

Building on these exceptional trial results and regulatory approvals in major markets, LimFlow is now preparing for commercialization in the US, EU and UK, with plans for subsequent global distribution.

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