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One Year Into Kabir Nath’s Leadership, Compass Pathways’ (NASDAQ: CMPS) Phase 3 Trial For Innovative Treatment Resistant Depression Progressing

COMPASS Pathways

By Faith Ashmore, Benzinga Treatment-resistant depression, also referred to as TRD, is a subset of depression that poses significant challenges for clinicians, patients and those closest to patients. It is characterized by persistent symptoms of depression that do not respond adequately to at least two different standard antidepressant treatments. This debilitating condition often leaves individuals grappling with feelings of despair, hopelessness and a diminished quality of life. Unlike some forms of depression that may improve with pharmacological interventions or talk therapies, TRD tends to persist, leading to a multitude of negative consequences. The unyielding nature of this condition can contribute to increased rates of disability, higher suicide risk and significant financial burden due to the need for repeated treatments. Psilocybin treatment is emerging as a potentially effective approach to the treatment of TRD. Although further research is still needed to establish its efficacy and safety, initial findings are promising. While there are a number of companies developing psilocybin treatments, Compass Pathways (NASDAQ: CMPS) is setting itself apart from its contemporaries with its phase 3 program in TRD. The company’s innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the U.K. for their investigational COMP360 psilocybin. Moreover, in late 2021, Compass Pathways announced the completion of a randomized, controlled double-blind phase 2b study of COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America. In August of 2022, Compass Pathways brought on Kabir Nath as CEO to help navigate its transition from a start-up to an established phase 3 biopharma company. Nath is a seasoned healthcare executive with over two decades of experience leading global pharmaceutical companies. He has held several leadership positions at multinational corporations, including Bristol Meyers Squibb (NYSE: BMS), GlaxoSmithKline (NYSE: GSK) and Otsuka Pharmaceutical (OTCMKTS: OTSKY). Nath has a track record of success in developing new products and creating commercial strategies to make medicines available to patients on a global scale. He is skilled in identifying unmet patient needs and working collaboratively with stakeholders to develop targeted and effective treatment options. He also has considerable experience in psychiatric drug development. Under Nath’s leadership, Compass Pathways has made significant progress in advancing the development of its investigational drug, COMP360 psilocybin. One notable accomplishment was the initiation of their phase 3 clinical trials, which are pivotal in determining the safety and efficacy of the treatment. These trials consist of two key studies: Pivotal Trial 1 (COMP005) and Pivotal Trial 2 (COMP006). COMP005 is studying a single dose (25mg) of COMP360 psilocybin as monotherapy, comparing it with a placebo. The aim of this trial is to replicate the positive treatment response observed in the company’s phase 2b study, which included 233 patients with treatment-resistant depression. COMP006 is a fixed repeat dose monotherapy study that examines the effects of three different dose arms: 25mg, 10mg and 1mg. The objective of this trial is to investigate whether a second dose can enhance the number of responders and further improve the response observed in the phase 2b study. Additionally, this trial explores the potential for a meaningful treatment response from the repeat administration of COMP360 10mg. Both pivotal trials have the change from baseline in MADRS (Montgomery-Åsberg Depression Rating Scale) total score at week six as their primary endpoint. This measure allows researchers to evaluate the effectiveness of COMP360 psilocybin in reducing depressive symptoms compared to baseline. In addition to driving the company forward into phase 3, Nath has supported the development of the company’s digital platforms that accompany its psilocybin treatment, has led a successful private placement fundraising that extends the company’s runway into late 2025, and claims to have one of the most talented and experienced leadership team among psychedelic companies in the space. Nath's global experience in the pharmaceutical industry and his expertise in developing and commercializing treatments for unmet needs uniquely position him to lead Compass Pathways toward the successful development and commercialization of their investigational drug COMP360 psilocybin, subject to FDA approval. Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Stephen Schultz stephen.schultz@compasspathways.com

September 19, 2023 09:25 AM Eastern Daylight Time

AmeriLife Wealth Announces New Distribution Growth and Wealth Transformation Division

AmeriLife

AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, today announced the formation of Distribution Growth and Wealth Transformation, a newly created division within AmeriLife Wealth designed to support business development and organic growth, and accelerate the integration of its network of leading distribution companies and wealth advisory firms. “As we break through traditional distribution models and provide holistic solutions to the market we serve, it’s critical that we focus the right talent and resources to help us fundamentally transform the way in which we deliver value,” said Mike Vietri, Chief Distribution Officer of AmeriLife Wealth. “This team will spearhead our strategic focus and enhance our Wealth Distribution Platform, while also capitalizing on selling synergies and opportunities to leverage best-in-class solutions across our platform, better supporting those we serve.” Andrew “Andy” Sheen, most recently senior vice president and head of AmeriLife’s BizRev Group (BRG), will lead the Distribution Growth and Wealth Transformation team, reporting to Vietri. In this newly created role, Sheen will also leverage his considerable industry experience to lead all efforts surrounding AmeriLife Wealth’s market positioning while collaborating with AmeriLife Wealth leaders to deliver best practices, business development strategies, and sales and resource synergies. Sheen joined AmeriLife in December 2020 from Saybrus Partners, where he oversaw product development for the company’s annuity and life distribution. Prior to Saybrus, from 2009 to 2012, Sheen served his first stint with AmeriLife as its director of Financial Services, managing annuity and life product development for the company with its carrier partners. He began his career at CDA of America in various, and increasingly senior, product development, sales, and marketing roles. “I’m thankful to Mike for this opportunity and excited to bring my nearly 20 years of experience on the both carrier and distribution side to this new endeavor,” said Sheen. “‘Growth’ and ‘transformation’ are two sides of the same coin and essential to both accelerating the success of our affiliated partners, but also ensuring they remain one step ahead of consumer demands and the constant changes in our industry.” AmeriLife Wealth Continues to Grow Its Leadership Ranks The establishment of the new division and Sheen’s elevation builds upon significant strategic changes to AmeriLife’s Distribution structure as well as leadership changes within both its Wealth and Health Distribution organizations. In addition to Sheen’s appointment, the following senior roles within AmeriLife Wealth were also announced: Kelly Atkinson has been named Senior Vice President of Distribution Operations and Chief of Staff for AmeriLife Wealth, an expansion of her current role with a strategic focus on supporting Wealth’s growing executive leadership team and priority initiatives. In this expanded role, Atkinson will also continue to support enterprise campaigns and initiatives that span AmeriLife’s Wealth and Health distribution organizations. With Atkinson’s elevation, Crystal Santillanes has assumed an expanded role as Vice President of Distribution Operations. With a focus on driving action and alignment with Distribution goals, Santillanes is accountable for overseeing a variety of enterprise-wide Distribution initiatives and campaigns, in partnership with various functional areas across the company. Santillanes and her team is also responsible for Distribution meetings, events, and incentive programs. Bob Yates has been named Vice President, Distribution Business Analytics. In his new role, Yates will focus on partnering with Wealth and Health Distribution leadership and AmeriLife’s affiliates to maximize the value of available data, providing financial and market analysis, interpreting production results, and forecasting and developing business trend insights to support data-driven strategic planning, business development, and decision making. Yates will continue to collaborate with AmeriLife’s Enterprise Data and Analytics (EDA) team to support enterprise level data collection and reporting as well as ad hoc Distribution analysis needs. Lastly, Christy Appleang, CPA, joins the organization as Vice President, Financial Operations, responsible for leading all budgeting processes as well as developing strategic budgetary policies and guidelines to help meet short and long-term financial goals. Appleang brings 20 years of financial planning and analysis experience to AmeriLife Wealth, most recently serving as Senior Director of Finance for national grocer, Kroger, in its Health & Wellness Specialty Pharmacy Retail Division. Prior to Kroger, she served as Chief Financial Officer for Northwestern Mutual’s Southeast region. “We’re incredibly grateful for Andy’s, Kelly’s, Crystal’s and Bob’s continued dedication to our business, and are excited to welcome Christy to our team, as we continue our mission of transforming Wealth distribution for our affiliated agents and advisors,” added Vietri. “The growth of our team is a testament to what we’re building here at AmeriLife, and I look forward to working with each of them in their new roles.” ### About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For more than 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers served through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com, and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado +1 321-297-1112 jmaldonado@amerilife.com Partnership Inquiries Patrick Nichols +1 727-726-0726 pnichols@amerilife.com Company Website https://amerilife.com/

September 19, 2023 09:00 AM Eastern Daylight Time

Genflow Biosciences CEO says human healthspan has not kept up with lifespan

Genflow Biosciences PLC

Genflow Biosciences PLC (LSE:GENF) CEO Dr. Eric Leire speaks to Thomas Warner from Proactive about the gene therapy company's work in the field of extending human longevity. He notes that the amazing advances made in advancing human lifespans over the last century have not been matched by a similar increase in people's healthspans, with many people spending the second half of their life plagued with various debilitating illnesses and conditions. "The purpose of our company is to increase the healthspan, that's the primary objective. If we can also increase the lifespan, fine... so we are a longevity company that's trying to extend healthspan and secondly maybe lifespan." The company's central asset is a centenarian version of the sirtuin six gene, which plays a crucial role in aging. They've identified a rare mutation of this gene found exclusively in centenarians, offering a promising avenue for intervention. Genflow's approach is supported by a strong team and close collaboration with a distinguished Scientific Advisory Board. He goes on to explain how Genflow Biosciences is going about its mission, revealing its most promising leads, before concluding by saying who else in the sector he admires. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 19, 2023 03:00 AM Eastern Daylight Time

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News Release

Avricore Health announces HealthTab now supporting first Rexall Pharmacy walk-in clinic

Avricore Health

Avricore Health CEO Hector Bremner joined Steve Darling from Proactive to share news regarding the company's flagship health-data management platform, HealthTab. The company has made a significant move by partnering with Rexall Pharmacy, one of Canada's largest pharmacy retailers, to integrate HealthTab into its walk-in clinic services. Bremner revealed that patients can now access testing through HealthTab at the first Rexall Pharmacy Walk-In Clinic located in Sherwood Park, Alberta. This collaboration enables HealthTab to offer both the Afinion 2™ blood-chemistry analyzer and the ID Now™ molecular platform by Abbott Rapid Diagnostics. This means that patients can receive rapid test results and immediate consultation with their pharmacist, facilitating timely healthcare interventions. HealthTab has played a crucial role in the last year by assisting pharmacists in screening patients for diabetes and cardiovascular conditions, as well as supporting those already diagnosed in better managing their health. With Rexall Pharmacy joining the HealthTab network, patients now have more accessible care options, empowering them to make meaningful and impactful changes to their health. This partnership underscores Avricore Health's commitment to leveraging technology to improve access to healthcare services, particularly within the pharmacy setting. The integration of HealthTab into Rexall Pharmacy's walk-in clinics not only enhances patient convenience but also contributes to early detection and management of health conditions, aligning with the broader goal of improving healthcare outcomes in Canada. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

September 18, 2023 02:03 PM Eastern Daylight Time

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News Release

Perimeter Medical Imaging new CEO makes key improvements in personnel and technology

Perimeter Medical Imaging AI

Perimeter Medical Imaging CEO Adrian Mendes joined Steve Darling from Proactive to discuss the strategic developments and innovations the company has undertaken since his appointment as CEO. Mendes highlighted several key initiatives aimed at driving Perimeter's growth and advancing its technology in the medical field. One notable addition to the team is Adam Hodges, a seasoned medtech sales executive with over 20 years of experience. Hodges has taken on the crucial role of overseeing the strategy and execution of sales-related goals, bringing valuable expertise to the company's efforts. Another significant advancement Mendes shared is the enhancement of Perimeter's AI capabilities. This involves leveraging additional training data and the latest AI advancements to improve the sensitivity, specificity, precision, and recall of their ImgAssist AI technology. This updated version is expected to significantly enhance the accuracy of image classification, reducing the incidence of false positives and negatives. Moreover, Mendes touched upon the positive interactions with the FDA in relation to the clinical development program for Perimeter's B-Series OCT medical imaging technology with ImgAssist AI. This collaborative engagement with regulatory authorities reflects the company's commitment to advancing its next-gen AI technology, ultimately aimed at improving clinical and economic outcomes in the field of breast surgical oncology. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

September 18, 2023 01:58 PM Eastern Daylight Time

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Futura Medical "on track for a profit in 2025" after strong first half

Futura Medical PLC

Futura Medical PLC (AIM:FUM, OTC:FAMDF) CEO James Barder speaks to Thomas Warner from Proactive London after the pharmaceutical company announced its interim results for the six months to 30 June 2023. Barder gives an overview of what he describes as a "pretty tremendous 2023 for Futura so far", highlighting the progress made in multiple markets with the company's topical erectile dysfunction treatment MED3000. He starts with a look at the enormously prospective US market where Futura secured both FDA approval for the product as well as a distribution deal with Haleon, who are responsible for the future launch and ongoing regulatory, development, marketing, and commercialisation of MED3000 in the USA. Barder also talks about the strides the company made in Europe during the first half and noted minimal complaints with over 200,000 packs sold. Financially, the company reported £1.7 million in revenue and a gross profit of £900,000, with Barder saying that he expects Futura to reach breakeven in 2024 and "is on track for a profit by 2025". Barder acknowledged the importance of production expansion to meet rising demand and highlighted efforts to strengthen distribution networks, particularly in Asia. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 18, 2023 11:20 AM Eastern Daylight Time

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September is Cholesterol Education Month

YourUpdateTV

September is Cholesterol Education Month and for people with unsafe levels of high LDL (bad) cholesterol, there are many options in the treatment toolbox. Recently, Preventive Cardiologist Dr. Seth Baum participated in a nationwide satellite media tour to discuss high LDL cholesterol, best treatment options, and tips for patients navigating challenges with their health coverage. A video accompanying this announcement is available at: https://youtu.be/rcUk4OWkpD4 Heart disease remains the leading cause of death in the United States and LDL-cholesterol, what we call the “bad” cholesterol, is a major risk factor which can lead to a heart attack or a stroke. While many can lower their LDL cholesterol with a heart healthy diet, some will need medication to reach their Safe Zone. Statins are often the first-line of treatment for individuals with high LDL cholesterol, not all patients reach their recommended LDL cholesterol levels with statins alone. In these cases, lipid-lowering medications, known as PCSK9 inhibitors, are often recommended to help lower cholesterol levels. Unfortunately, individuals who are prescribed PCSK9 inhibitors are facing significant hurdles in accessing and using these potentially life-saving drugs, despite their proven efficacy in reducing LDL cholesterol. One major obstacle is insurance company denials or rejections. Data published in the November 2022 Journal of the American Medical Association found that for commercially insured patients prescribed a PCSK9 inhibitor, only 42% of initial rejections were overturned. Sadly, nearly 75% of patients rejected for a PCSK9 inhibitor ended up on no therapy, which is not a win for anyone. Research from the Family Heart Foundation shows that compared to individuals who were able to obtain their prescribed PCSK9 inhibitor, those whose prescription was rejected or abandoned experienced more heart attacks, strokes, and other cardiovascular events within 12 months. For more information and resources that can help, visit LDLSafeZone.org About Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC Dr. Seth J. Baum is Chief Scientific Officer at Flourish Research, and clinical affiliate professor of Cardiology at FAU Medical School. He actively consults in Clinical Lipidology and Cardiovascular Disease Prevention and continues to offer lipoprotein apheresis for patients in southeast and central Florida. Dr. Baum has practiced Preventive Cardiology and Clinical Lipidology since 2000. He is a fellow of the American College of Cardiology, the American Heart Association, the American College of Preventive Medicine, the National Lipid Association, and the American Society for Preventive Cardiology. Dr. Baum is a past President of the American Society for Preventive Cardiology (ASPC). He currently serves on both the ASPC and Family Heart Foundation Advisory Boards. He has published over 100 peer reviewed papers and abstracts as well as two books. In 2013, he was awarded Cleveland Heart Lab’s “Heart Award” for lifelong dedication to Preventive Medicine. In 2019, Dr. Baum received Mended Hearts’ biennial Dwight Emary Harken Award. Dr. Baum is the Founder of Excel Medical Clinical Trials, LLC, a consortium of clinicians dedicated to the safe and professional conduct of high-level scientific trials. He has served as Principal Investigator in over 100 clinical trials covering a broad range of disease states. Dr. Baum is the Chief Scientific Officer of Flourish Research, a leading national clinical research company. Dr. Baum is a graduate of Columbia College and Columbia College of Physicians and Surgeons, and completed training in Internal Medicine, Cardiology, Interventional Cardiology, and Electrophysiology Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

September 18, 2023 10:27 AM Eastern Daylight Time

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Arecor Therapeutics expecting a busy end to the year after solid first half progress

Arecor Therapeutics PLC

Arecor Therapeutics PLC (AIM:AREC) CEO Sarah Howell speaks to Thomas Warner from Proactive after the globally-focused biopharmaceutical group released its interim results for the six months to 30 June 2023. Howell gives an overview of recent progress, highlighting the initiation of the second Phase One clinical study for their concentrated rapid-acting insulin, with positive recruitment in type 2 diabetes patients. She also highlights fruitful partnerships, such as the one with Hikma, which obtained FDA confirmation for an accelerated regulatory pathway during the reporting period. Arecor's acquisition of Tetris Pharma led to successful commercialisation of their lead product, Ogluo, for severe hypoglycemia. Looking ahead, Arecor anticipates passing some significant milestones, including the launch of a biosimilar product and pivotal study progress for a partner's novel medicine. She says she's expecting "A busy end to the year and its really testament to the great work of Arecor and the team there and also the support from our shareholders and investors that we're very grateful for." Howell attributes the company's achievements to a dedicated team and supportive investors. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 18, 2023 09:13 AM Eastern Daylight Time

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

M&L Healthcare

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 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 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 amorais@klarecocomms.com

September 18, 2023 06:39 AM Eastern Daylight Time

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