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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

M&L Healthcare

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Seattle Injury Law PLLC Is Reputed for Knowing How to Approach Wrongful Death Claims and SettlingTraumatic Brain Injury Cases

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Everett, WA – Seattle Injury Law PLLC has represented many accident victims seeking compensation. It has won several cases for its clients, amassing millions of dollars in compensation for accident victims. The legal team’s experience and knowledge play an important role in how they approach tough cases and direct such cases toward a favorable end.

As an experienced attorney in settling personal injury claims, Seattle Injury Law PLLC has handled many wrongful death claims for families who have lost their loved ones due to another person’s negligence. The wrongful death lawyers offer a free initial consultation service to help clients better understand their case, their chances, and the legal strategies to adopt. Clients going up against insurance companies can rely on the law firm and its lawyers’ experience in managing a wrongful death claim, as well as their resources to investigate and collect relevant evidence to prove fault and demand compensation.

Other than representing clients whose loved ones have been killed due to another person’s negligence, Seattle Injury Law PLLC also handles traumatic brain injury cases. The law firm understands that the approach to such cases differs and can make all the difference. They explain their approach and how to appropriately settle a traumatic brain injury case to the client and their loved ones while carrying them along throughout the entire claim process.

Seattle Injury Law PLLC understands how emotionally painful and financially disturbing situations around these cases are. They, therefore, offer clients a no-win, no-fee arrangement. This contingency agreement allows clients to waive any upfront legal costs as they grieve or seek improved medical care for loved ones who have suffered traumatic brain injuries. The lawyers leverage their firm’s resources from start to finish, calculating the client’s losses to the nearest dollar and demanding the highest possible compensation from insurance companies.

Encouraging Washington residents to speak out and fight for their rights to be compensated, the law firm’s lead attorney, Rob Sears, said: “Our office is experienced in taking the burden off of the family and doing everything related to handling wrongful death claims, including setting up trust accounts, structured settlements, and being sure all loved ones are compensated at the highest level for the loss to their family. If this is you, we extend our most heartfelt condolences to your family. Remember, talking to us is free, and we are happy to lend any help we can. Reach us now to connect.”

Families affected by wrongful deaths or traumatic brain injury can contact Seattle Injury Law PLLC via phone at (425) 450-7544. The attorneys can also be reached via their website or visit the office at 1000 SE Everett Mall Way, Suite 203, Everett, WA 98208 US.

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Seattle Injury Law PLLC
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InfusionMD Redefines Patient Care Excellence in The Woodlands with Innovative, Evidence-based Ketamine Infusion Therapy

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The Woodlands, TX – However undesired, health complications are a sad reality of existence. While specific lifestyles, including healthy dieting and regular exercising, positively impact health and wellness, some complications occur from unforeseeable circumstances, such as injuries and accidents. This is not to mention the natural decline that accompanies aging. As usual, the rule of thumb in maintaining optimal health is prevention rather than cure. However, the inevitability of health complications makes access to effective treatments a critical necessity. Enter InfusionMD, a highly recommended clinic whose patient-centered therapies continue to touch the lives of many in The Woodlands, TX, and beyond.

Despite the tremendous advancements in contemporary medicine, some health complications tend to respond better to other evidence-based treatment alternatives. InfusionMD, an outlier among regular clinics, specializes in Ketamine infusion therapy, a revolutionary treatment approach with numerous proven health benefits, notably pain relief. Individuals struggling with mild, acute, or chronic pain conditions with no end in sight can sigh in relief, as a few sessions at the clinic may be just what they need to retake control of their lives. InfusionMD’s physicians can help with severe pain conditions such as Complex Regional Pain Syndrome (CRPS) and Reflex Sympathetic Dystrophy (RSD).

Besides pain relief, InfusionMD’s Ketamine therapies have shown promising results in addressing various mental health issues, including but not limited to depression, obsessive-compulsive disorder (OCS), PTSD, and anxiety. In addressing these conditions, the clinic’s infusions heal damaged or blocked neural pathways without impairing thinking or concentration.

In addition to remedying existing health complications, The Woodlands Ketamine Therapy is a tried-and-proven preventative remedy that bolsters overall health and wellness. Rather than wait to fall sick before seeking care, discerning, health-conscious individuals can visit InfusionMD for health-boosting vitamin infusions.

The treatment providers at InfusionMD work tirelessly to administer highly individualized remedies. They subject every new patient to exhaustive medical tests and examinations to pinpoint the root cause of their problems and ascertain their Eligibility for Ketamine Therapy. Demonstrating an unwavering dedication to patient wellness, they employ an educational approach during treatments, enriching patients with practical, everyday-use tips for optimal health whenever applicable. To improve access to its increasingly popular therapies, InfusionMD accepts most insurance covers and offers affordable payment plans whenever needed.

“Dr. Mukalel takes time to explain your options and the best treatment plan to help decrease or relieve your pain. Joseph & Ashley do an excellent job with physical therapy, which works too! If you’ve struggled with chronic pain, anxiety, depression, or PTSD, I’d highly suggest visiting Dr. Mukalel; it could change your life as it has changed mine!” admitted one impressed patient.

More information regarding InfusionMD’s game-changing Ketamine infusion therapies is available on its website. One of its representatives is always reachable at (281) 204-8993 for queries or appointment scheduling. The clinic is conveniently located at 10857 Kuykendahl Rd Suite 120B, The Woodlands, Texas, 77382, USA.

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InfusionMD
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Jessen Mukalel, MD
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State
Texas
Postal Code
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United States
Website
https://ketamine4u.com/

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Experience Unsurpassed Outdoor Elegance with Green Scapes Landscapes: Redefining Landscaping Services in Fayetteville, GA

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Fayetteville, GA – Green Scapes Landscapes is a distinguished landscaping company, locally owned, offering its artistic creativity and innovative solutions to transform outdoor spaces. The company combines time-tested practices and cutting-edge techniques to bring unparalleled beauty to properties. In addition, the team stands out for its prompt communication and environmentally-conscious approach to landscaping.

Green Scapes Landscapes provides an extensive range of services, including landscape design and installation, meticulous selection and installation of plants and trees, and sophisticated hardscaping. Their hardscaping solutions encompass outdoor paving and stonework, along with professional outdoor lighting installation to enhance the elegance and functionality of outdoor spaces.

Green Scapes Landscapes understands that every beautiful landscape begins with a well-thought-out design. The Fayetteville landscaping company takes a scientific and artistic approach to landscape design, carefully analyzing each property’s unique features and contours and then merging this knowledge with their artistic flair to create stunning outdoor spaces. This balance between the practical and the aesthetic ensures that each project not only looks spectacular but is also perfectly suited to the local climate and the lifestyle of the property owner. The result is a harmonious blend of beauty and functionality that enhances the overall layout and adds value to any property.

Green Scapes Landscapes also excels in the careful selection and planting of trees and shrubs. Drawing from its deep-rooted knowledge and understanding of different species and varieties, the team will transform mundane yards into vibrant canvases splashed with nature’s hues. With a discerning eye for detail, the team will consciously select flora that enhances the aesthetic appeal of a property and thrives in the local climate and soil conditions.

From planning to execution, the seasoned professionals at Green Scapes Landscapes carefully map out the placement of each plant, ensuring a pleasing composition that balances color, texture, and size. Their meticulous approach and passion for nature result in lush outdoor spaces that offer a visual treat throughout the year.

“As a homeowner, I couldn’t be more thrilled with the transformation Green Scapes Landscapes has brought to my property. The selection and placement of trees and plants have created a mesmerizing aesthetic appeal and a vibrant, eco-friendly environment. My yard has blossomed into a visually captivating outdoor oasis perfectly suited to our climate.

Green Scapes Landscapes is located at 781 Goza Road, Fayetteville, Georgia, 30215, USA. Clients looking for landscaping services can contact the company at (678) 329-8214 for inquiries. For more information on the company’s services, visit their website.

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781 Goza Road
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