RAMAT GAN, Israel – July 15, 2024 – ARC Innovation at Sheba Medical Center, Israel’s largest medical center announced today another successful startup exit from within its innovation ecosystem with the acquisition of Innovalve Bio Medical Ltd by Edwards Lifesciences Corporation (NYSE: EW), a global leader in patient-focused medical innovations […]
Coronary/Structural Heart
Lexeo Therapeutics Announces Positive Interim Phase 1/2 Clinical Data of LX2006 for the Treatment of Friedreich Ataxia Cardiomyopathy
Achieved mean reduction in left ventricular mass index (LVMI) of 11.4% at 12 months and 18.3% at 18 months in participants with elevated LVMI at baseline >10% reduction in LVMI at 12 months in 75% of participants with elevated LVMI at baseline Sustained and consistent improvements in other key measures of cardiac status, including left ventricular wall thickness and troponin I, in majority of participants at 12 months Increased post-treatment frataxin expression above baseline in all participants evaluated via myocardial biopsy to date LX2006 was well tolerated with no treatment-related serious adverse events to date; proceeding to Cohort 3 in SUNRISE-FA, with one participant dosed in this cohort to date Company to host webcast today at 8:00 AM ET NEW YORK, July 15, 2024 (GLOBE NEWSWIRE) — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced positive interim data of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. Across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the Weill Cornell Medicine investigator-initiated Phase 1A trial (NCT05302271), LX2006 was well tolerated with no treatment-related serious adverse events, and clinically meaningful improvements in cardiac biomarkers were observed with increasing improvement over time. “We are very encouraged by these data and the potential of LX2006 to treat FA cardiomyopathy, a devastating and fatal condition with no currently approved therapies,” said Dr. Eric Adler, Chief Medical Officer and Head of Research at Lexeo Therapeutics. “Based on the favorable safety profile and clinical benefits observed to date, we are excited to explore expedited clinical development of LX2006, including potential for accelerated approval of this possibly life-saving treatment.” “The interim data shared today demonstrate clinically meaningful improvements across multiple cardiac biomarkers of hypertrophy, a hallmark of FA cardiomyopathy,” said Dr. Sandi See Tai, Chief Development Officer at Lexeo. “Together with the increases in frataxin protein expression observed in SUNRISE-FA cardiac biopsies to date, these results further highlight the potential of LX2006 to positively impact outcomes for people with FA cardiomyopathy. I would like to thank the participants, caregivers, and investigators participating in these trials who have helped to achieve this important milestone.” FA cardiomyopathy is a devastating, rare, and progressive disorder caused by loss of function mutations in the frataxin gene. Thus far in participants in the SUNRISE-FA trial with cardiac biopsies, low levels of frataxin have been found in the heart at baseline, estimated to be 2% or less of normal. In terms of clinical presentation, FA cardiomyopathy is typically characterized by left ventricular hypertrophy ultimately progressing to heart failure, and cardiac dysfunction is the cause of death in up to 80% of individuals with FA. A new natural history subset analysis conducted by Lexeo showed elevated left ventricular mass index (LVMI) in adults with FA cardiomyopathy, and LVMI remained stable or increased with age without spontaneous improvement. Elevated LVMI is an indicator of left ventricular hypertrophy and correlated with mortality in multiple cardiovascular conditions including FA cardiomyopathy. Interim Safety Results LX2006 was well tolerated with no treatment-related serious adverse events to date in either studyNo signs of complement activation or other immunogenicity observedNo cardiac or hepatic safety signals observedAll adverse events were transient and resolvedNo participants discontinued from either study Interim Clinical Results (from 8 participants with > 6-months of follow-up) Left ventricular mass index (LVMI): Of participants with elevated LVMI at baseline, 75% achieved >10% reduction at 12 months (n=4). Of all participants, 50% achieved >10% reduction in LVMI at 12 months (n=6). Among the participants with elevated LVMI at baseline, mean reduction in LVMI was 11.4% at 12 months (n=4) and 18.3% at 18 months (n=2). Left ventricular (LV) lateral wall thickness: wall thickening, an early indicator of left ventricular hypertrophy, was reduced by 13.6% on average in all participants at 12 months (n=6).High-sensitivity Troponin I (hsTnI): troponin I, a biomarker of myocardial injury, was reduced by 53.3% on average in all participants at 12 months (n=5).Frataxin protein expression evaluated via myocardial biopsy: observed increased frataxin levels compared to baseline following treatment with LX2006 in all participants evaluated to date utilizing two distinct measurements: LCMS: frataxin increase observed in 3 of 3 evaluable participants.IHC: frataxin increase observed in 2 of 2 evaluable participants. Dosing Update and Next Steps As of July 15, 2024, 13 participants dosed to date across two trials: Cohort 1 (1.8x1011vg/kg): n=6Cohort 2 (5.6×1011 vg/kg): n=6Cohort 3 (1.2×1012 vg/kg): n=1 SUNRISE-FA independent Data and Safety Monitoring Board endorsed proceeding to Cohort 3 dose level (1.2x1012vg/kg). This cohort has started enrollment with 1 participant dosed to date and will include at least 3 participants.The Weill Cornell investigator-initiated trial is currently enrolling in Cohort 2.Lexeo expects to share further details of these interim results, including an additional cardiac biopsy from Cohort 2, at a scientific conference in Fall 2024. Corporate Webcast DetailsLexeo Therapeutics will host a webcast at 8:00 AM ET today, July 15, 2024. Analysts and investors can participate by accessing the webcast live here or on the News & Events page in the Investors section of Lexeo’s website, www.lexeotx.com. The webcast will be archived on the company’s website following the completion of the call. About the Clinical Studies SUNRISE-FA is a Lexeo-sponsored, multicenter, 52-week, open-label trial evaluating the safety and preliminary efficacy of LX2006 in people who have FA cardiomyopathy, with three ascending-dose cohorts. Investigators at Weill Cornell Medicine are conducting a Phase 1A study of AAVrh.10hFXN, known as LX2006 at Lexeo, in a single-site, 52-week, open-label trial evaluating the safety and preliminary efficacy in people who have FA cardiomyopathy, in two ascending-dose cohorts with five participants per cohort. About LX2006LX2006 is an AAV-based gene therapy candidate delivered intravenously for the treatment of FA cardiomyopathy, the most common cause of mortality in individuals with FA affecting approximately 5,000 people in the United States. LX2006 is designed to target the cardiac manifestations of FA by delivering a functional frataxin gene to promote the expression of the frataxin protein and restore mitochondrial function in myocardial cells. In preclinical studies, LX2006 reversed the cardiac abnormalities in FA disease models and showed improvement in cardiac function and survival while demonstrating a favorable safety profile. The FDA has granted Rare Pediatric Disease designation, Fast Track designation, and Orphan Drug designation to LX2006 for the treatment of FA cardiomyopathy. About Lexeo Therapeutics Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs. Cautionary Note Regarding Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations and plans regarding our current product candidates and programs, including statements regarding the potential benefits of LX2006 for the treatment of Friedreich ataxia cardiomyopathy and the timing for receipt and announcement of data from its clinical trials, and the timing and likelihood of potential regulatory approval. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward-looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources; and other risks and uncertainties identified in Lexeo’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, filed with the SEC on May 9, 2024, and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Media Response:Janine Bogris (201) 245-6838 janine.bogris@inizioevoke.com Investor Response:Stephen Jasper(858) 525-2047stephen@gilmartinir.com
A New Era in Heart Surgery – Israeli Biomed Company TruLeaf Medical’s Two Needle Sticks Procedure for Mitral Valve Replacement
AllMeD Solutions (TASE:ALMD) subsidiary TruLeaf Medical receives Helsinki Ethics Committee’s approval in Uzbekistan to conduct clinical trial in human subjects, paving the way for minimally invasive heart valve treatmentsCAESAREA, Israel, July 11, 2024 /PRNewswire/ — AllMeD Solutions announced subsidiary TruLeaf Medical’s receipt of the Helsinki Ethics Committee’s approval in Uzbekistan to conduct clinical trial in human subjects. As part of the trial, a prosthetic mitral valve will be implanted via two needle sticks in the groins in a two-stage catheterization procedure without the need for open-heart surgery (transcatheter mitral valve replacement, TMVR). The implantation of the innovative platform (the RoseDoc) developed by TruLeaf, which replaces the patient’s leaky heart valve, will be carried out in two stages. In the first stage, a docking station will be implanted in the left atrium, followed a few weeks later by implantation of an artificial ‘biological’ mitral valve prosthesis.
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Trueleaf’s Medical Device
Today, there are tens of millions of patients with severe, life-threatening mitral valve regurgitation (leaky valve) across the world. This leak causes heart failure, heart arrhythmia, brain strokes leading to high mortality. About 10% of the world’s population over the age of 75 suffer from a leaky mitral heart valve. In the U.S. alone there are about 4 million patients.
These patients experience a substantial decrease in their functional capacity manifesting, such as fatigue, shortness of breath on exertion with lower and lower exertion and arrhythmias, progressively impairing their daily routine. Today, the most effective treatment for these patients is complex open-heart surgery to repair or replace the leaky heart valve. However, it is only offered to about 2% of patients due to the high surgical risk.
The unique RoseDoc platform developed by TruLeaf is the first-of-its-kind technology allowing implantation of a biological bioprosthesis to replace the diseased valve through catheterization only. This ground-breaking procedure is minimally invasive, performed on a beating heart via two needle punctures without surgery or the use of a heart-lung machine. As such, it is associated with substantially lower risk compared to the traditional open-heart mitral valve surgery. As a result, millions of patients around the world, who until now were deemed inoperable, will be able to get receive a new valve and experience a significant improvement in their functional capacity, quality of life and life expectancy, allowing them to resume normal life.As part of the preparations for human implantations in clinical trials in Uzbekistan, TruLeaf conducted additional implantations in large animals with the participation of Dr. Horst Sievert, one of the world’s leading interventional cardiologists, who is expected to lead TruLeaf’s clinical trials.TruLeaf Medical, Ltd was founded in 2017 by three Israeli entrepreneurs – Benjamin Spencer, Nathaniel Benisho and the late Dr. Uri Rosenstein. Benjamin and Nathaniel’s played a seminal role in the development of the first ever transcatheter aortic bioprosthesis, the Sapien valve, initially within the Israeli company PVT, that was later acquired by the medical technology giant Edwards Lifesciences. Today, the aortic valve that Benjamin and Nathaniel developed saves thousands of lives of patients with aortic stenosis every year all over the world.Benjamin Spencer, TruLeaf Medical CEO, explains, “The main challenge with existing transcatheter TMVR technologies is achieving optimal anchoring of the valve prosthesis to the heart, given the complex anatomy and physiology of the native mitral valve. The RoseDoc TMVR platform is technically simple, safe, and has proven effective in long-term animal testing. Completely eliminating the leak prevents the progressive dilation of the heart, which otherwise worsens the leak in a vicious cycle, leading to further weakening of the heart muscle and intractable heart failure. Currently, patients with severe mitral valve leaks that are unresponsive to maximal medical treatment have no effective options. The vast majority of these patients are declined surgery due to prohibitive risk. The unique RoseDoc TMVR platform provides a potential lifeline for these patients.”Professor Oz Shapira, AllMeD Solutions CEO, adds, “As a heart surgeon who has performed hundreds of open-heart surgeries to treat leaky heart valves, the possibility of replacing the mitral valve through a simple and quick needle puncture operation is a true revolution that may offer a solution to millions who currently have no other option.””The first-in-human trial is both exciting and mission-critical for TruLeaf’s success. Given the outstanding results of the preclinical experiments, I am confident that TruLeaf’s innovative RoseDoc TMVR platform will perform exceptionally well in humans and eventually save countless lives of patients who currently have no alternatives. AllMeD Solutions will continue to demonstrate its ability to identify early-stage startups and leverage its vast knowledge, experience, and expertise in the med-tech space to lead these companies to engineering, clinical, and business success.”Photo: https://mma.prnewswire.com/media/2459133/AllMeD_Solutions.jpgLogo: https://mma.prnewswire.com/media/2459132/AllMeD_Solutions_Logo.jpgSOURCE AllMeD Solutions
XyloCor Therapeutics and SmartCella Enter into License Agreement for Use of the Extroducer Infusion Catheter System to Administer Novel Gene Therapy XC001 to the Heart
– The Extroducer® Infusion Catheter System ® enables local delivery of XC001 to the heart without the need for surgery. – XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and […]
CARMAT accelerates its sales momentum and reiterates its confidence in its development outlook
20 implants of the Aeson® artificial heart performed in the first half of 2024 Pace of 4 implants per month in the second quarter Half-year sales at €3.2 million, higher than the 2023 full-year sales Unique safety and performance profile of Aeson® confirmed, based on more than 70 implants made since inception […]
Pulnovo Medical Announces Joining PHA’s (Pulmonary Hypertension Association) Corporate Committee
SHANGHAI, July 9, 2024 /PRNewswire/ — Pulnovo Medical, a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure, has recently announced its partnership with the Pulmonary Hypertension Association (PHA). This partnership not only underscores Pulnovo Medical’s growing global influence but also empowers PHA’s mission to extend and improve the lives of those affected by pulmonary hypertension (PH) worldwide.
Pulnovo Medical and the PHA are united by a collective vision to a future where pulmonary hypertension is better understood and more efficiently treated. Pulnovo Medical’s PADN technology, an innovative interventional therapy in the field of pulmonary hypertension, provides a new and beneficial solution for patients troubled by traditional drug treatments. Currently Pulnovo Medical is conducting global trials in US and Europe. This strategic partnership aims to combine Pulnovo Medical’s cutting-edge PADN therapies for Pulmonary Hypertension with PHA’s extensive network to enhance public awareness and improve the care of PH patients globally. As a member of PHA, Pulnovo Medical will actively participate in PHA’s educational programs, research projects and advocacy campaigns. Our collaboration will harness the urgency of our shared mission to make a lasting impact on pulmonary hypertension patients worldwide.
About PHA
The PHA was founded in 1991 in Florida and evolved into an international community of more than 16,000 people with PH, caregivers, family members and health care professionals. As one of the largest and oldest pulmonary hypertension association in the world, the PHA acts as a trusted liaison between the pulmonary hypertension community and industry and academic partners.
About PADN
Pulmonary Artery Denervation (PADN) is a percutaneous pulmonary artery intervention procedure that uses a PADN catheter to deliver radiofrequency energy to the sympathetic nerves in the outer membrane of the pulmonary artery, resulting in the disappearance of the myelin sheath of the nerves and the fusion of the axons, which inhibits sympathetic activity, increases cardiac output, reduces pulmonary artery pressure, inhibits the pathologic remodeling of the pulmonary arteries, improves the patient’s exercise endurance and cardiac function, and achieves long-term benefits from a single minimally invasive procedure.
About Pulnovo Medical
Pulnovo Medical Limited, is a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure, is committed to leveraging our deep expertise in the science of breakthrough technologies with the goal to market our innovative therapeutic solutions and benefit patients around the world.
For more information, please visit: www.pulnovomed.us
Reflow Medical Enrolls First Patients in Pilot Study of Coronary Sirolimus-Eluting Retrievable Scaffold System (Spur Elute)
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a developer of innovative devices focused on cardiovascular disease, announces the first patient enrollments in “A pilot study of the Drug-Eluting Coronary Spur™ StEnt as a Primary trEatment for in-stent Restenosis (ISR) of the CORONARY arteries” (DEEPER CORONARY, NCT06117150). ISR is a common clinical problem that can generate significant […]
Vectorious Medical Technologies Reports Novel Findings From VECTOR HF Trials: Self-Management of Heart Failure Patients Using Left Atrial Pressure
TEL AVIV, Israel, July 8, 2024 /PRNewswire/ — Vectorious Medical Technologies Ltd. announces the publication of a breakthrough pilot clinical study, which evaluated the V-LAP system and a novel therapeutic approach for heart failure, in the European Journal of Heart Failure.
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Vectorious: Self-Management of Heart Failure Patients Using Left Atrial Pressure via V-LAP to Prevent Disease Deterioration and Repeated Hospitalizations
Vectorious has developed a miniature digital pressure sensor (V-LAP) that measures left atrial pressure and is implanted in the heart’s interatrial septum using a minimally invasive catheterization procedure. The sensor transmits data that allows physician-directed, patient self-management of chronic heart failure, a prevalent and complex form of heart disease affecting approximately 1-2% of the population. Through a dedicated mobile application and based on daily data transmitted from the left atrium, patients self-adjust their diuretic dosage with the aim of preventing disease deterioration and repeated hospitalizations.
The study demonstrated for the first time that self-management of heart failure based on left atrial pressure (LAP) is both safe and feasible. At 12 months of follow-up, no complications or side effects related to the system were reported. Additionally, patient adherence to treatment was high, and significant improvements were observed in quality-of-life measures, coupled with a reduction in hospitalizations due to heart failure.
“This groundbreaking study marks a significant milestone in heart failure management by placing control directly in the hands of patients. This approach, akin to the empowerment seen in diabetes management, enables heart failure patients, under the guidance of their heart failure management team, to monitor and manage their condition safely with ease and confidence. By fostering greater patient autonomy, this innovative shift is set to dramatically enhance care quality and outcomes for this vulnerable population.” Said David Meerkin, MBBS, Interventional Cardiologist participating in the pilot VECTOR-HF study.To date, 55 V-LAP sensors have been successfully implanted in patients across Europe and Israel, accumulating over 40,000 days of LAP monitoring. This summer, implantations are planned to begin in leading heart centers in the United States, marking the next phase in the expansion of Vectorious’ clinical trials.”This study marks another significant step in realizing the transformative potential of patient self-management guided by left atrial pressure monitoring. By empowering patients with real-time hemodynamic data and decision-making tools, this innovative approach may not only enhance patient-centered outcomes but also shift the paradigm towards proactive and personalized heart failure care.” Said William T Abraham, Professor of Medicine from The Ohio State University Wexner Medical Center and one of the pioneers in implantable hemodynamic monitoring systems for heart failure patients.Eyal Orion, co-founder and CEO of Vectorious, added: “Publishing the research in a top-tier scientific journal is a historic milestone for the company, which has been developing not only one of the most complex medical systems but also a new therapeutic approach for over a decade. Transferring part of the responsibility to patients requires advanced, reliable, and accurate technology, and this is a challenge that requires perseverance and patience. We still have a way to go to fundamentally change the way the most common heart disease is understood and treated, but together with the amazing Vectorious team, physicians, and our partners, we are getting closer step by step.”About Vectorious Medical Technologies Ltd.Vectorious is a privately held company based in Tel Aviv, Israel, founded in 2011. The company’s V-LAP System enables heart failure patients to better control their disease by monitoring the heart’s Left Atrial Pressure (LAP) and detecting fluid accumulation in the earliest stages of the disease, prior to physiological symptoms. A mobile app further empowers patients to self-titrate medication in real-time based on data extracted from the heart. For more information, please visit the company website.Contact:Lili Arbely-ElbazVectorious Medical Technologies.+972-(0)525909192[email protected]Photo – https://mma.prnewswire.com/media/2455810/Vectorious_V_LAP.jpgSOURCE Vectorious Medical Technologies Ltd.
Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)
— VASCEPA Approved by the National Medical Products Administration (NMPA) To Reduce the Risk of Cardiovascular Events as an Adjunct to Statin Therapy in Adult Patients with Elevated Triglyceride (TG) Levels (≥150 mg/dL) and Other High-Risk Characteristics as Studied in REDUCE-IT — — EddingPharm Now Working to Prepare for National Reimbursement and Drug Listing (NRDL) and Enhance the Commercial Launch of VASCEPA Across Mainland China — DUBLIN and BRIDGEWATER, N.J., July 08, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in Mainland China (“China”), EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated and high triglycerides (≥150mg/dL) and established cardiovascular disease or diabetes mellitus with ≥2 other cardiovascular disease risk factors, combined with hypertriglyceridemia. Following approval by NMPA, EDDING is working to include VASCEPA on the National Reimbursement Drug Listing (NRDL) and augment the ongoing commercial launch of VASCEPA in China to include the CVRR indication. The NRDL is updated annually and serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. Inclusion on the NRDL provides full or partial reimbursement at the national level. Products included in this listing can be prescribed from public hospitals in China. According to a recent report on cardiovascular health and disease in China,i cardiovascular disease (CVD) accounted for 44-47% of all death in urban and rural areas in China, meaning two out of every five deaths were due to CVD. It is estimated that 330 million patients suffer from CVD in China,i and that China has one of the highest CVD death rates in the world.ii According to the World Heart Federation, cardiovascular events, such as ischemic heart disease and stroke, are projected to increase by 50 percent among the population in China between 2010 and 2030 (based on population aging and growth alone).ii “We congratulate our partner, EDDING, on the regulatory approval of VASCEPA for cardiovascular risk reduction in China, as this marks an important step in helping broaden access to this novel treatment for patients across that country,” said Steven Ketchum, Ph.D., President, Research & Development and Chief Scientific Officer, Amarin. “This milestone is a major step forward to help ensure that the unique benefits of VASCEPA are accessible to patients throughout the world. We look forward to EDDING’s continued progress in introducing VASCEPA to patients at-risk for a cardiovascular event across China.” “The approval of the CVRR indication will allow many patients with atherosclerotic disease (ASCVD) in China to benefit from this innovative drug,” said EDDING. “In the future, we will continue to expand the application of VASCEPA® in the management of cardiovascular diseases to meet the unmet clinical needs of more Chinese patients.” As part of the approval, NMPA has requested that EDDING conduct a post-approval study after the product is marketed to further verify the efficacy of the product to reduce the risk of cardiovascular events in Chinese patients and provide a post-approval study report to conduct a life-cycle benefit-risk assessment at the time of product renewal. Product renewal is required five years post the approval of the product. Under the partnership agreement, EDDING is responsible for development and commercialization activities in the China territory and associated expenses. Amarin provides development assistance and is responsible for supplying finished bulk product. Based upon the NMPA approval for the CVRR indication, Amarin will earn a regulatory milestone payment in the amount of $15 million. EDDING will also pay Amarin tiered double-digit percentage royalties on net sales of VASCEPA in the territory. Amarin will supply product to EDDING under negotiated supply terms. About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than 20 million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. VAZKEPA is being commercialized in multiple European countries, including England, Wales, Spain, Sweden and Finland. United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur. VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin. Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%). Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%). Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here. Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the regulatory approval of VASCEPA in China and the potential impact in that territory; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2022. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact Information Media & Investor Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com ______________________________ i The Writing Committee of the Report on Cardiovascular Health and Diseases in China. Report on Cardiovascular Health and Diseases in China 2021: An Updated Summary[J]. Biomedical and Environmental Sciences, 2022, 35(7): 573-603. doi: 10.3967/bes2022.079ii World Heart Federation Fact Sheet: Cardiovascular Disease in China. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://world-heart-federation.org/wp-content/uploads/2017/05/Cardiovascular_diseases_in_China.pdf
Ultromics granted Category III CPT reimbursement code for EchoGo® Heart Failure
OXFORD, England, July 2, 2024 /PRNewswire/ — Ultromics announced today that the American Medical Association (AMA) has issued a Category III Current Procedural Terminology (CPT) code for EchoGo® Heart Failure, a crucial advancement in enhancing the accessibility of Ultromics’ ground-breaking technology in hospital outpatient settings.
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The American Medical Association (AMA) has issued a Category III CPT® code (0923T) for reimbursing EchoGo® Heart Failure.
EchoGo® Heart Failure uses AI to detect heart failure with preserved ejection fraction (HFpEF) from a single, routinely acquired echocardiographic video. The technology leverages large datasets and advanced algorithms to identify patterns and correlations that may go undetected by traditional diagnostic methods. The AI insights aid clinicians in diagnosis, monitoring, and expediting treatment responses, significantly enhancing the detection and management of patients with this challenging subtype of heart failure.
This is the only artificial intelligence CPT code specific to supporting HFpEF diagnosis through echocardiography and was released on July 1st this year on the AMA’s website, becoming effective January 1st, 2025. The new CPT code, 0923T, will replace the previous HCPCS outpatient code for EchoGo® Heart Failure, C9786. EchoGo® Heart Failure is also covered in the hospital inpatient setting, using the New Technology Add-on Payment (NTAP) code XXE2X19.
Ross Upton, PhD, Chief Executive Officer and founder of Ultromics, stated, “This recognition by the AMA underscores the significant impact our technology is having in the field of heart failure care. HFpEF represents a significant and growing patient population, accounting for 50% of heart failure cases worldwide, and may go undiagnosed in up to 64% of cases.1 We believe that EchoGo® Heart Failure will transform diagnostic pathways for these patients, enable earlier intervention, improve quality of life, and deliver benefits to payors and healthcare systems.”In the US, CPT codes are used by public and private health insurance programs and offer doctors and healthcare professionals a method to identify medical services and procedures for reimbursement. Category III CPT codes are temporary codes assigned to new and developing technologies, procedures, and services.Additional Data on EchoGo® Heart FailureEchoGo® Heart Failure was granted FDA 510(k) clearance in December 2022 and has been awarded FDA Breakthrough Device Designation.2Recent data on the tool was published last year in JACC: Advances, showing superior efficacy of EchoGo® Heart Failure in identifying HFpEF over the current clinical standard.Specifically, the AI-based system was able to correctly assign a diagnosis to 74% of patients who had returned non-diagnostic results on the commonly used HFA-PEFF and H2FPEF clinical scores.3 This improvement could translate to more patients receiving accurate and timely diagnoses and management.EchoGo® Heart Failure demonstrated high sensitivity and specificity, detecting 88% of patients who had HFpEF, and 82% of patients that did not.3 These results exceed what is usually observed in routine clinical practice.For the study, investigators retrospectively assessed independent data on 6,756 patients who underwent a comprehensive TTE at Mayo Clinic in Rochester, Minnesota, between January 2009 and December 2020. It was then independently tested in geographically distinct areas within Mayo Clinic Enterprise sites across the United States on a dataset that included 1,284 patients.The authors concluded, “EchoGo® Heart Failure’s exceptional discrimination capabilities, combined with its ability to identify patients with higher mortality risks, hold great promise for improving patient outcomes and enabling faster access to treatment.”References:1. Borlaug et al., Heart Failure With Preserved Ejection Fraction: JACC Scientific Statement. J Am Coll Cardiol 2023;81:1810–1834.2. Ultromics receives FDA Clearance for its Breakthrough Device EchoGo Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction. News release. Ultromics. December 2, 2022.3. Akerman AP, et al. Automated Echocardiographic Detection of Heart Failure with Preserved Ejection Fraction Using Artificial Intelligence. JACC Adv. 2023:1;2(6):100452–2.About Ultromics:Ultromics is a pioneer in precision heart failure detection. Our ground-breaking platform, EchoGo®, is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality. The technology empowers clinicians to make precise, efficient, and accurate assessments of heart failure, leveraging the largest known heart disease dataset in echocardiography. The model was trained on thousands of patients to accurately detect disease and was validated against 5-year patient outcomes. The technology has been built in collaboration with Mayo Clinic and the NHS England. Ultromics’ mission is to stop heart failure in its tracks with its precision detection platform.Photo – https://mma.prnewswire.com/media/2452704/Ultromics.jpgSOURCE Ultromics



