Menu

amputation prevention

FDA APPROVES LIMFLOW SYSTEM IN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA AND NO SUITABLE ENDOVASCULAR OR SURGICAL REVASCULARIZATION OPTIONS

New Therapeutic Option Has Potential to Reduce Rate of Major Limb Amputation in U.S.

PARIS AND SAN JOSE, CALIF. – 09/12/2023 — LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation.

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients. The therapy is designed to save patients’ legs from major amputation, as limb loss is associated with significant complications, mortality, and deterioration of quality of life. CLTI affects up to four million Americans1 and disproportionately impacts minority and underserved patients,2 resulting in more than 150,000 major amputations per year in the U.S.3 FDA approval of the LimFlow System will enable these patients to have access to a minimally invasive treatment giving them a chance to save their limbs and improve their quality of life.

“With LimFlow, we now have an option for the sickest patients who were previously consigned to limb loss and the downward spiral that accompanies it,” said Daniel Clair, MD, PROMISE II/III Co-Principal Investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “Using this new treatment, we have seen many patients whose limbs have been saved, whose pain has been reduced or resolved, whose chronic wounds are healed or healing, and who can now look forward to happier and more active lives.”

FDA approval was based on successful outcomes seen in the PROMISE II pivotal trial, recently published in The New England Journal of Medicine, and from positive clinical results seen in earlier studies. In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment.4

The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.

“At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI. We developed a novel way to make a vein function as an artery with the goal of saving limbs, and by doing that, saving patients’ lives,” said LimFlow CEO Dan Rose. “We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the U.S.”

The LimFlow System is indicated for patients who have chronic limb-threatening ischemia (CLTI) with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in Canada or Japan.

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from diabetes, coronary artery disease, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

About LimFlow and the LimFlow System

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally invasive LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) bypasses permanently blocked arteries in the leg and foot and delivers oxygenated blood back into the foot via the veins. Restoring perfusion in the lower limbs may help resolve chronic pain, improve quality of life, enable wound healing, and prevent major amputation. Click here to view a video of how the LimFlow System for TADV works.

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease and an aging population. For more information, visit www.limflow.com.

  1. Yost ML. CLI U.S. epidemiology supplement 2016. THE SAGE GROUP.
  2. Kalbaugh CA, Witrick B, Sivaraj LB et al. Non‐Hispanic Black and Hispanic Patients Have Worse Outcomes Than White Patients Within Similar Stages of Peripheral Artery Disease. JAHA.2022 Jan 4;11(1): https://doi.org/10.1161/JAHA.121.023396.
  3. Creager MA, Matsushita K, Arya S, Beckman JA, Duval S, Goodney PP, Gutierrez JAT, Kaufman JA, Joynt Maddox KE, Pollak AW, Pradhan AD, Whitsel LP. Reducing Nontraumatic Lower-Extremity Amputations by 20% by 2030: Time to Get to Our Feet: A Policy Statement From the American Heart Association. Circulation. 2021 Apr 27;143(17):e875-e891.
  4. Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martínez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023 Mar 30;388(13):1171-1180.

MEDIA CONTACTS:
Tim Baker, for Chronic Communications Inc.
Tim.baker@mrnacommunications.com, +1 919-969-3492

Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274

LANDMARK NEW ENGLAND JOURNAL OF MEDICINE PUBLICATION REPORTS POSITIVE RESULTS FROM PROMISE II PIVOTAL TRIAL SHOWING THAT LIMFLOW SYSTEM SAVES MOST PATIENTS WITH END-STAGE PERIPHERAL ARTERY DISEASE FROM MAJOR AMPUTATION

  • PROMISE II Trial Met Primary Endpoint
  • Therapy Demonstrates 76% Limb Salvage in Patients with Chronic Limb-Threatening Ischemia Who Otherwise Faced Amputation

PARIS – March 30, 2023 — LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that results from the PROMISE II U.S. pivotal trial were published in today’s issue of the New England Journal of Medicine (NEJM). The results demonstrated that the LimFlow System achieved 66% amputation-free survival (patients were alive and amputation-free) at six months. This exceeded the FDA’s Performance Goal with statistical significance.

The LimFlow System for TADV (Transcatheter Arterialization of Deep Veins) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients who have exhausted all other treatment methods and face major amputation of their lower limb. The therapy is designed to prevent amputation, which is associated with significant complications, mortality, and deterioration of quality of life. CLTI affects up to four million Americans and disproportionately impacts minority and underserved patients, resulting in more than 150,000 major amputations per year in the U.S.

“The publication of PROMISE II in the New England Journal of Medicine reinforces the transformational value of TADV for a patient population in great need,” stated Mehdi Shishehbor, DO, MPH, PhD, PROMISE II Co-Principal Investigator, President of the Harrington Heart and Vascular Institute, University Hospitals, and lead author of the NEJM paper. “The introduction of this therapy provides the possibility of limb salvage for a no-option CLTI population previously consigned to primary amputation, potentially reducing the suffering, mortality, and economic burden in this ever-growing segment of patients.” “These results establish TADV as a real alternative to major amputation for patients facing inevitable limb loss from no-option CLTI,” said Daniel Clair, MD, PROMISE II Co-Principal Investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “This therapy will enable us to redefine the concept of a ‘no-option’ CLTI patient by giving us a treatment that offers patients limb salvage and hope.”

The PROMISE II Trial also demonstrated:

  • 76% limb salvage rate, where more than three-quarters of patients kept their leg and avoided amputation
  • 76% of patients had wounds that were completely healed (25%) or in the process of healing (51%)
  • Patient pain was substantially reduced, with average pain scores dropping from 5.3/10 prior to treatment to 3.0/10 six months after treatment
  • 99% technical success of the procedure, indicating a reproducible procedure across diverse sites and investigators

PROMISE II is a landmark trial of the most severe CLTI patient group ever studied in a vascular device pivotal trial, with 100% of patients suffering from end-stage peripheral artery disease (classified as Rutherford Stage 5 or 6), 77% with diabetes, and 57% with chronic kidney disease, many of whom were on dialysis. The multi-center, prospective, single-arm study encompassed 105 no-option CLTI patients treated at 20 U.S. sites. PROMISE II was designed to be representative of a broad patient population, with 43% of subjects being Black, Hispanic, or Latino, and 31% female. Subjects will be followed out to three years. The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat their CLTI.

“Too often, patients are confronted with the limits of traditional interventional options and must undergo a major amputation, which often leads to severe complications, greatly reduced quality of life, and an early death. The LimFlow System demonstrated remarkable success in relieving patients’ pain and healing their wounds, diverting them from amputation and putting them on a path towards a better life,” said LimFlow CEO Dan Rose. “We want to thank the clinical investigators and their research teams for their commitment to this important research. As this is a large and growing patient population in great need of a new therapeutic option, we look forward to engaging further with the FDA as we seek regulatory approval.”

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons

About LimFlow and the LimFlow System

LimFlow SA is a private, venture-backed medical device company, transforming the treatment of CLTI, a severe condition, for which there is a growing clinical need in light of high mortality rates. The minimally-invasive LimFlow System 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.

The LimFlow System received the Conformitè Europëenne (CE) Mark in October 2016 and is currently only commercially available in Europe. The PROMISE II study is currently enrolling patients at up to across 22 sites in the U.S. and Japan. For more information, please visit: add link.

For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
Follow us on: LinkedIn, Facebook and Twitter.

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

MEDIA CONTACT:

Michelle McAdam, Chronic Communications Inc.

michelle@chronic-comm.com, +1 310-902-1274

LIMFLOW APPOINTS MIKE MATHIAS AS VICE PRESIDENT, COMMERCIAL OPERATIONS

PARIS-December 6, 2022-LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), today announced the appointment of Mike Mathias as Vice President of Commercial Operations.

Mr. Mathias has spent his 30-year career successfully leading sales organizations in the cardiovascular space, including playing a seminal role in the launch of Medtronic’s transcatheter aortic valve replacement (TAVR) business as head of the company’s $1.2 billion Heart Valve Therapies U.S. sales operation. Most recently, Mr. Mathias was Vice President of U.S. Commercial Operations for the Medtronic Structural Heart division, leading sales, marketing, training, and sales operations. Prior to this, he held sales management roles across Medtronic’s cardiology, endovascular, cardiac surgery, peripheral, perfusion and cardiac rhythm businesses, as well as a variety of sales roles in the cardiology franchise for Pfizer. He earned a B.S. in Arabic and French Studies at the U.S. Military Academy at West Point and holds a master’s degree in Business Administration from the University of Minnesota.

“Mike is an extraordinary leader with deep experience building successful sales teams and commercializing innovations such as TAVR, where he introduced a transformational new device and therapy into a complex market development setting in the U.S.,” said LimFlow CEO Dan Rose. “The magnitude of our opportunity at LimFlow has enabled us to attract the highest level of talent to our team and we look forward to benefitting from Mike’s insights and sales leadership as we build our commercial organization and prepare for the future launch of the LimFlow System in the U.S.”

“I see many parallels between LimFlow and the groundbreaking solution that TAVR represented for both patients and physicians. LimFlow can be an equally revolutionary therapy with the potential to significantly reduce amputations due to end-stage vascular disease and change the course of patient care,” said Mr. Mathias. “The patient-centric culture of execution at LimFlow combined with the collaborative nature of the skilled team provides a strong foundation to build the U.S. commercial organization at LimFlow.”

In line with LimFlow’s broader growth strategy, Theo Mastrokostopoulos, currently Vice President of Global Sales and Market Development, is being appointed to General Manager, International to lead all commercial activity outside of the U.S.

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

About LimFlow and the LimFlow System

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease, and an aging population.

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation.

Click here to view a video of how the LimFlow System for deep vein arterialization works.

For more information, visit www.limflow.com.

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
Follow us on: LinkedIn, Facebook and Twitter.

LIMFLOW APPOINTS JENNY GAFFNEY AS VICE PRESIDENT, HEALTH ECONOMICS AND REIMBURSEMENT

PARIS-August 23, 2022-LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), today announced the appointment of Jenny Gaffney as Vice President, Health Economics and Reimbursement. Ms. Gaffney brings to LimFlow over 15 years of rich experience designing and executing global reimbursement strategies for medtech innovations that accelerated patient access to critical therapies.

Prior to joining LimFlow, she worked with Medtronic for more than seven years, most recently as the global lead for reimbursement and health economics for the coronary and renal denervation division. In this role, she led a team that gained and maintained public and private coverage, coding, and payment in the U.S. and other key geographies for novel devices. She also provided counsel on evidence programs and conducted analyses to demonstrate the economic value of therapies. Prior to Medtronic, she served as a healthcare policy and reimbursement consultant at Avalere Health, a premiere Washington, DC-based firm. She earned an A.B. in government, economics and health policy from Harvard University, and holds an executive master’s degree in health management and policy from the University of Michigan School of Public Health.

“We look forward to benefitting from Jenny’s deep understanding of global reimbursement and experiences gained from working with some of the world’s largest medtech companies,” said LimFlow CEO Dan Rose. “Her direct experience influencing reimbursement for novel renal denervation technology and other important cardiovascular technologies will be extraordinarily valuable in the next year and beyond as we move closer to commercialization of our innovative LimFlow System to help patients suffering from CLTI.”

“I am excited to join LimFlow at this critical time, as the company completes its pivotal study and ramps up to make this life-saving therapy accessible to more patients,” said Ms. Gaffney.

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons

About LimFlow and the LimFlow System

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease, and an aging population.

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation.

Click here to view a video of how the LimFlow System for deep vein arterialization works.

For more information, visit www.limflow.com.

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
Follow us on: LinkedIn, Facebook and Twitter.

LIMFLOW RAISES $40 MILLION (€36 MILLION) IN SERIES D FINANCING

Funds to Support Completion of Clinical Program Through Commercialization of Novel Device Designed to Prevent Amputations in Patients with Chronic Limb-Threatening Ischemia

PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), today announced it has closed a $40 million (€36 million) oversubscribed Series D financing round. New investors Longitude Capital, Soleus Capital Management and an undisclosed strategic investor joined the round along with current major shareholders of the company: Sofinnova Partners, through its Crossover Strategy fund; Bpifrance, the French sovereign investment bank; and Balestier, a Singaporean family fund.

The LimFlow System, designated by the FDA as a Breakthrough Technology, uses a minimally-invasive family of transcatheter products designed to optimize perfusion of the critically ischemic foot, potentially avoiding major amputation, resolving pain and promoting wound healing. Proceeds from the Series D financing will fund follow-up for the PROMISE II U.S. pivotal trial necessary to obtain FDA approval and will support the commercialization of the LimFlow System for deep vein arterialization.

The company recently completed enrollment in PROMISE II, the U.S. pivotal trial of the LimFlow System. It also completed enrollment in CLariTI, a natural history study of high-risk and no-option CLTI patients, intended to shed light on outcomes from patients treated with the current standard of care. Over the last year, the company also integrated the second-generation of its LimFlow System into its clinical program, and reported positive two-year data from its PROMISE I U.S. feasibility study.

“We are thankful for the support of so many industry-leading investors, both new and existing, who recognize the potential of the LimFlow System to address a major clinical need in saving patients from amputation,” said LimFlow CEO Dan Rose. “We look forward to sharing results from our pivotal trial later this year, and to the prospect of being able to make the LimFlow system commercially available as early as next year to the patients in the U.S. and Europe who desperately need it.”

“We are truly impressed by the clinical results LimFlow has delivered for patients who have exhausted all other treatment options. We are excited about the technology’s potential to transform the way CLTI patients are treated, and in turn, transform the quality of their lives,” said Maxwell Bikoff, Principal at Longitude Capital.

“The LimFlow management team has achieved key milestones and Series D financing needed to successfully bring the LimFlow System to market. We are enthusiastic about continuing to work with the company to help make this game-changing technology accessible to patients in the near future,” said Kinam Hong, MD, Partner at Sofinnova Partners.

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons

About LimFlow and the LimFlow System

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease, and an aging population.

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation.

Click here to view a video of how the LimFlow System for deep vein arterialization works.

For more information, visit www.limflow.com.

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
Follow us on: LinkedIn, Facebook and Twitter.

US PIVOTAL STUDY AND CLARITI COMPLETE ENROLLMENT

LimFlow Completes Enrollment in PROMISE II U.S. Pivotal Trial of Breakthrough Device Designed to Prevent Amputations in No-Option Patients with Chronic Limb-Threatening Ischemia

PARIS- March 15, 2022 — LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that it has completed patient enrollment in the PROMISE II pivotal trial of the LimFlow System. The LimFlow System is designed to reestablish arterialization in deep veins for patients who have exhausted other methods and  face major amputation of their lower limbs.

PROMISE II is a multi-center, prospective, single-arm study being conducted at multiple sites in the U.S. Using an adaptive statistical design, the study enrolled 105 no-option CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, and subjects will be followed out to three years. The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat CLTI.

“The PROMISE II investigators are very encouraged by our experience using the LimFlow System to treat CLTI patients with no other options. These are likely the sickest patients ever to have been enrolled in a limb salvage trial,” said Daniel Clair, MD, PROMISE II principal investigator and Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “Major amputations have a devastating effect on the lives of patients and their families. We are excited about the prospect of helping improve the lives of more of these patients once this novel technology becomes broadly available.”

LimFlow also announced completion of enrollment in the CLariTI study of approximately 200 high-risk and no-option CLTI patients. The prospective, observational, multicenter CLariTI study will track the clinical progression of CLTI and incidence of death, amputation, and revascularization attempts in patients undergoing standard medical management for the disease over a one-year period.

“Despite suffering from the most advanced form of CLTI, these no-option and high risk patients have been excluded from other trials,” said Anahita Dua, MD, MS, MBA, FACS, CLariTI principal investigator, vascular surgeon at Massachusetts General Hospital, and Assistant Professor of Surgery at Harvard Medical School. “Our hope is that the CLariTI study gives us better insights into the reintervention, amputation and death rates in no-option and high-risk patients treated with the current standard of care.”

“It is tremendous to see the clinical community’s enthusiasm for the PROMISE II pivotal trial and the prospect of a new option for these desperate patients,” said LimFlow CEO Dan Rose. “While PROMISE II will demonstrate the progress of patients treated with LimFlow, CLariTI will tell us more about outcomes for high risk and no-option patients being treated with today’s interventional options. Running these studies concurrently gives us a wealth of data in order to learn about the progress of disease and quality of life in both treated and untreated patients. It will also highlight the gap between what is achievable with today’s FDA-approved therapies and what is possible with our transformational approach to CLTI using the LimFlow System.”

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons

About LimFlow and the LimFlow System

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease, and an aging population.

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation.

Click here to view a video of how the LimFlow System for deep vein arterialization works.

For more information, visit www.limflow.com.

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
Follow us on: LinkedIn, Facebook and Twitter.

LATE-BREAKING DATA FROM PROMISE I STUDY ON LIMFLOW SYSTEM CONFIRM EXCELLENT SUSTAINED OUTCOMES IN PATIENTS WITH NO-OPTION CHRONIC LIMB-THREATENING ISCHEMIA

Limb salvage in 77 percent of patients at 2 years with “no-option” for revascularization via traditional techniques

24-Month Results Presented Wednesday at VIVA 2021 Conference

SAN JOSE, Calif. and LAS VEGAS – LimFlow SA, the pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), on Wednesday announced 24-month results from the PROMISE I Study of the LimFlow Percutaneous Deep Vein Arterialization System (“LimFlow System”), confirming excellent and sustained outcomes for both amputation-free survival and wound healing. The late-breaking data was presented on Wednesday at the Vascular Interventional Advances (VIVA) Conference in Las Vegas, Nevada.

“The presentation of the PROMISE I 24-month results validate the benefits of the LimFlow System,” said Daniel Clair, MD, PROMISE I principal investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “The high percentage of no-option CLTI patients that remained amputation free at 24-months is a major positive step forward for a condition characterized by high amputation and mortality rates.”

PROMISE I is a multi-center, prospective, single-arm study of the LimFlow System, conducted at seven study centers across the U.S. All of the 32 patients enrolled in the study had non-healing wounds on the target foot. The primary endpoints were freedom from amputation (FFA), amputation-free survival (AFS), and survival overall. There were no amputations after day 75 in the study.  At 24-months, FFA remained at 77 percent with an AFS of 59 percent. Three additional deaths within the second year of study resulted in 77 percent survival (two non-limb-related deaths; one from sepsis due to a non-healing wound in the non-treated foot). 92 percent had all wounds classified as healed or healing as adjudicated by an independent core lab. Technical success was reported at 97 percent.

“The 2-Year data from PROMISE I US feasibility study is highly encouraging and sends a strong signal about the potential of the LimFlow System to strengthen our mission of no limb left behind,” said LimFlow CEO Dan Rose. “We are swiftly advancing our study of the LimFlow System in the ongoing PROMISE II US pivotal study in a patient population which is facing a very poor overall prognosis in terms of mortality and quality of life after major limb amputation. The LimFlow System is designed to help heal wounds and avoid major limb amputation, and we are proud of our mission of ‘No Limb Left Behind.'”

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons

About LimFlow and the LimFlow System

LimFlow SA is a private, venture-backed medical device company, transforming the treatment of CLTI, a severe condition, for which there is a growing clinical need in light of high mortality rates. The minimally-invasive LimFlow System 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.

The LimFlow System received the Conformitè Europëenne (CE) Mark in October 2016 and is currently only commercially available in Europe. The PROMISE II study is currently enrolling patients at up to across 22 sites in the U.S. and Japan. For more information, please visit: add link.

For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
Follow us on: LinkedIn, Facebook and Twitter.

Limb salvage in 77 percent of patients at 2 years with “no-option” for revascularization via traditional techniques

24-Month Results Presented Wednesday at VIVA 2021 Conference

SAN JOSE, Calif. and LAS VEGAS – LimFlow SA, the pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), on Wednesday announced 24-month results from the PROMISE I Study of the LimFlow Percutaneous Deep Vein Arterialization System (“LimFlow System”), confirming excellent and sustained outcomes for both amputation-free survival and wound healing. The late-breaking data was presented on Wednesday at the Vascular Interventional Advances (VIVA) Conference in Las Vegas, Nevada.

“The presentation of the PROMISE I 24-month results validate the benefits of the LimFlow System,” said Daniel Clair, MD, PROMISE I principal investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “The high percentage of no-option CLTI patients that remained amputation free at 24-months is a major positive step forward for a condition characterized by high amputation and mortality rates.”

PROMISE I is a multi-center, prospective, single-arm study of the LimFlow System, conducted at seven study centers across the U.S. All of the 32 patients enrolled in the study had non-healing wounds on the target foot. The primary endpoints were freedom from amputation (FFA), amputation-free survival (AFS), and survival overall. There were no amputations after day 75 in the study.  At 24-months, FFA remained at 77 percent with an AFS of 59 percent. Three additional deaths within the second year of study resulted in 77 percent survival (two non-limb-related deaths; one from sepsis due to a non-healing wound in the non-treated foot). 92 percent had all wounds classified as healed or healing as adjudicated by an independent core lab. Technical success was reported at 97 percent.

“The 2-Year data from PROMISE I US feasibility study is highly encouraging and sends a strong signal about the potential of the LimFlow System to strengthen our mission of no limb left behind,” said LimFlow CEO Dan Rose. “We are swiftly advancing our study of the LimFlow System in the ongoing PROMISE II US pivotal study in a patient population which is facing a very poor overall prognosis in terms of mortality and quality of life after major limb amputation. The LimFlow System is designed to help heal wounds and avoid major limb amputation, and we are proud of our mission of ‘No Limb Left Behind.'”

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons

About LimFlow and the LimFlow System

LimFlow SA is a private, venture-backed medical device company, transforming the treatment of CLTI, a severe condition, for which there is a growing clinical need in light of high mortality rates. The minimally-invasive LimFlow System 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.

The LimFlow System received the Conformitè Europëenne (CE) Mark in October 2016 and is currently only commercially available in Europe. The PROMISE II study is currently enrolling patients at up to across 22 sites in the U.S. and Japan. For more information, please visit: add link.

For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
Follow us on: LinkedIn, Facebook and Twitter.

LIMFLOW RECEIVES JAPAN PMDA APPROVAL FOR CLINICAL STUDY OF MINIMALLY-INVASIVE TECHNOLOGY DESIGNED TO PREVENT AMPUTATIONS IN CHRONIC LIMB-THREATENING ISCHEMIA PATIENTS

PARIS – March 23, 2020 — LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Clinical Trial Notification (CTN) for the Japanese cohort of the ongoing PROMISE II pivotal trial of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. 

PROMISE II is a multi-center, prospective, single-arm study being conducted in the U.S. and Japan as part of the Medical Device Harmonization by Doing (HBD) regulatory collaboration between the two countries. Using an adaptive statistical design, the study plans to enroll 60 to 120 “no option” CLTI patients at 25 sites, four of which will be in Japan. The primary endpoint is amputation-free survival at six months; additional endpoints include limb salvage and wound healing. Subjects will be followed out to three years. The “no option” patients who are candidates for the PROMISE II study are no longer eligible for conventional endovascular or surgical therapy for CLTI, as determined by an independent physician committee.

“Late-stage CLTI patients have a terrible quality of life, where they live with pain and limited mobility. Treatment success with these patients is defined by wound healing and amputation-free survival. The investigational LimFlow therapy has the potential to achieve both – by restoring oxygen-rich blood flow to the ischemic foot, it may create the conditions for chronic wounds to heal, which may enable patients to avoid amputation and keep their limb,” said Hiroyoshi Yokoi, MD, PROMISE II Japanese Principal Investigator and Director, Cardiovascular Center, Fukuoka Sanno Hospital. “We recently received Investigational Review Board approval to begin the PROMISE II trial at Fukuoka Sanno Hospital and I am enthusiastic about being able to offer a promising new option to my no-option patients.”

Nobuyoshi Azuma, MD, Professor of Vascular Surgery at Asahikawa Medical University and a PROMISE II investigator said, “In Japan’s aging society, arteriosclerosis of the lower limbs is increasing, and severe lower limb ischemia encompassing foot pain, ulceration and necrosis due to impaired blood flow associated with diabetes and dialysis is becoming a major problem. We hope that pDVA with the LimFlow System will be a viable option and we look forward to starting the trial in Japan soon.”

“We are excited about the momentum that adding several Japanese centers will bring to patient enrollment in our important PROMISE II trial,” said LimFlow CEO Dan Rose.

“Participating in the HBD program allows us to leverage the clinical data from all patients enrolled in the U.S. and Japan towards Shonin approval in Japan. It also complements our acceptance in the FDA’s Breakthrough Device program, which is expected to accelerate our regulatory and reimbursement pathways. This is another promising step in our mission to bring our groundbreaking technology to CLTI patients who need it as soon as possible, wherever they may be in the world.”

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol and high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

The pivotal PROMISE II clinical trial of the LimFlow System is currently enrolling patients at centers in the U.S. and Japan. Click here for more information about the trial.

About LimFlow SA

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia (CLTI), a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease and an aging population. For more information on the company and the LimFlow pDVA System, visit www.limflow.com

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

###

MEDIA CONTACT

Michelle McAdam, Chronic Communications, Inc.

michelle@chronic-comm.com, +1 310-902-1274