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Lexeo Therapeutics Announces Positive Interim Phase 1/2 Clinical Data of LX2006 for the Treatment of Friedreich Ataxia Cardiomyopathy

Coronary/Structural Heart by Comments are Disabled

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

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89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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SAN FRANCISCO, July 12, 2024 (GLOBE NEWSWIRE) — 89bio, Inc. (the “Company” or “89bio”) (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 125,000 shares of the Company’s common stock to six new employees (the “Inducement Grants”) on July 9, 2024 (the “Grant Date”). The Inducement Grants have been granted pursuant to the Company’s 2023 Inducement Plan (the “Plan”). The Inducement Grants were granted as an inducement material to these individuals entering into employment with 89bio in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Grants have an exercise price per share that is equal to the closing price of 89bio’s common stock on the Grant Date. The Inducement Grants will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the employee’s start date, and thereafter the remainder of the shares vest in 12 equal quarterly installments, subject to each employee’s continued employment with 89bio through the applicable vesting dates. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn. Investor Contact:Annie Chang89bio, Inc.investors@89bio.com PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com Media Contact:Sheryl SeapyReal Chemistrysseapy@realchemistry.com

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Sirnaomics Announces Completion of IND-Enabling Studies of Safety and Efficacy for STP125G with NHP Models, Targeting ApoC3 for Treatment of Cardiovascular Diseases

Regulatory by Comments are Disabled

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, July 12, 2024 /PRNewswire/ — Sirnaomics Ltd. (the “Company”, Stock Code: 2257.HK, together with its subsidiaries, the “Group” or “Sirnaomics”), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, announced today that the Group has completed IND-enabling studies for STP125G, an siRNA therapeutics targeting Apolipoprotein C3 (ApoC3), based on its proprietary GalAhead™ mxRNA technology. The safety and efficacy results from the non-human primate (NHP) studies strongly support for an IND filing with the U.S. FDA for initiating a Phase I clinical study of STP125G for cardiovascular disease indications.
ApoC3 is a widely known player in triglyceride metabolism, and it has been recently recognized as a polyhedric factor which may regulate several pathways beyond lipid metabolism by influencing cardiovascular, metabolic, and neurological disease risk. High levels of triglycerides (TG) have been shown to be associated with increased risk of cardiovascular diseases. For severe hypertriglyceridemia (sHTG) patients whose TG level is more than 1000 mg/dL, the risk of developing acute pancreatitis is 5 to 10 times to that in the general population. Down-regulation of ApoC3 using siRNA or antisense oligonucleotides has been shown to be effective in lowering TG in sHTG patients.
During an efficacy evaluation of STP125G with non-human primate model (N = 4), we observed a dose-dependent silencing activity among 1 mg/kg, 3 mg/kg and 10 mg/kg doses with a strong safety profile. The maximum target silencing efficacy was achieved at 10 mg/kg dosage around week 4 and was maintained for an additional 9 weeks (the total length of this 13-week study). The safety evaluation of STP125G using non-human primate model (N = 4) demonstrated an excellent safety readout with a single subcutaneous administration at 50 mg/kg, 100 mg/kg or 250 mg/kg. The maximum target silencing efficacies were like the level of 10 mg/kg for all three high dosages.
“STP125G is the second drug candidate based on our GalAhead™ mxRNA technology that has shown excellent safety and potent efficacy results with the NHP models. Its long-lasting silencing activity against ApoC3 may provide better therapeutic benefit to patients suffering cardiovascular conditions, than those of antisense and other siRNA drugs.” Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics, indicated. “Those data readouts further validated STP125G as a novel siRNA therapeutic candidate for treatment of hypertriglyceridemia and other cardiovascular diseases, using our proprietary GalAhead™-based delivery technology”.
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About ApoC3 and STP125G
ApoC3 is an important emerging target linking hypertriglyceridemia with cardiovascular disease (CVD). ApoC3 is a potent modulator of many established CVD risk factors, and is found on chylomicrons, VLDL, LDL, and HDL particles. Many studies show that in humans, apoC3 levels are an independent risk factor for CVD, and its presence on lipoproteins may promote their atherogenicity. Recent findings of the role of ApoC3 has been implicated in HDL metabolism and in the development of atherosclerosis, inflammation, and ER stress in endothelial cells. ApoC3 has been recently considered an important player in insulin resistance mechanisms, lipodystrophy, diabetic dyslipidemia, and postprandial hypertriglyceridemia (PPT). The emerging evidence of the involvement of ApoC3 in the pathogenesis of Alzheimer’s disease open the way to further study if modification of ApoC3 level slows disease progression. Furthermore, ApoC3 is clearly linked to cardiovascular disease (CVD) risk, and progression of coronary artery disease (CAD) as well as the calcification of aortic valve and recent clinical trials has pointed out the inhibition of ApoC3 as a promising approach to manage hypertriglyceridemia and prevent CVD. Several evidences highlight the role of ApoC3 not only in triglyceride metabolism but also in several cardio-metabolic pathways. STP125G is a single-stranded siRNA therapeutics targeting ApoC3 mRNA, based on Sirnaomics proprietary GalAhead™ mxRNA technology.
About Sirnaomics
Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Group’s GalAhead™ mxRNA technology, is currently in Phase I development. STP125G is the second siRNA therapeutics based on Sirnaomics proprietary GalAhead™ mxRNA technology, targeting ApoC3 mRNA for cardiovascular disease treatment. STP237G is the first dual-targeted drug based on a GalAhead™ muRNA technology and is in the late stage of preclinical evaluation. The Group has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the expansion of the Group’s clinical pipeline and establishment of the Group’s manufacturing facility, Sirnaomics focuses on a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.
SOURCE Sirnaomics

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HeartSciences Announces Allowance of U.S Patent for AI-ECG Assessment of Left Ventricular and Right Ventricular Heart Dysfunction

Rhythm by Comments are Disabled

Southlake, Texas, July 11, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that intellectual property (IP) exclusively licensed to HeartSciences has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for the detection of left ventricular (LV) and/or right ventricular (RV) dysfunction using deep learning, further strengthening the Company’s AI-ECG IP portfolio. Heart failure (HF) is a growing worldwide public health issue affecting 64 million people annually1 and is associated with high mortality, lower quality of life and reduced physical capacity while placing substantial costs on the healthcare system. Low-cost testing for heart failure has not been readily available for front-line physicians. With the development of AI-ECG algorithms, HeartSciences improves the early identification of patients that need additional testing, allowing earlier treatment and improved patient outcomes. Andrew Simpson, Chief Executive Officer of HeartSciences, stated, “This patent allowance further expands our extensive AI-ECG IP portfolio. AI-ECG is set to change the detection of heart disease and this latest patent further bolsters value to HeartSciences and our stakeholders.”  1. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018;392:1789–1858. About HeartSciences Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG’s clinical utility. Millions of ECGs are performed every week and the Company’s objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and is developing AI-ECG solutions to be made available on either a hardware agnostic cloud-based platform or its proprietary MyoVista® wavECG™ device, to help identify cardiovascular disease in any care setting worldwide in a manner to best suit different care providers. HeartSciences’ first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test. For more information, please visit: https://heartsciences.com/. X: @HeartSciences Safe Harbor Statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2023, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 18, 2023, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2024, filed with the SEC on March 14, 2024 and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements. Contacts: HeartSciencesGene Gephart+1-682-244-2578 (US)info@heartsciences.com Investors: Gilmartin GroupVivian Cervantesinvestorrelations@heartsciences.com

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A New Era in Heart Surgery – Israeli Biomed Company TruLeaf Medical’s Two Needle Sticks Procedure for Mitral Valve Replacement

Coronary/Structural Heart by Comments are Disabled

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

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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

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– 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 […]

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Phoenix Cardiology Practice Installs the First and Fastest Cardiovascular CT Scanner in the State, Arineta’s SpotLight Duo

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Caesarea, Israel – July 9, 2024 – Arineta, a leader in advancing cardiovascular imaging solutions through cutting-edge technology, proudly announces the latest installation of its SpotLight™ Duo at Cardiovascular Consultants, Ltd. (CVC) in Arizona. This makes CVC the first and only practice in the southwest region to have the world’s […]

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Adona Medical, a Shifamed Portfolio Company, Raises $33.5 Million in Series C Financing

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Funding to support next stage of product development and early clinical experience of company’s novel interatrial shunt and remote monitoring solution for patients with heart failure LOS GATOS, Calif., July 10, 2024 /PRNewswire/ — Adona Medical, a Shifamed portfolio company that aims to deliver advanced solutions for heart failure, announced today it has secured $33.5 million in Series C financing. The funds will be used to further product development and to initiate clinical use of the company’s adjustable interatrial shunt with integrated bi-atrial pressure monitoring. The financing was led by Cormorant Asset Management and TCP Health Ventures, with participation from Excelestar Ventures, the PA MedTech VC Fund II, Unorthodox Ventures, AMED Ventures, and other new and existing investors.

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The Adona Medical interatrial shunt features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter.

“Heart failure is a complex condition that benefits from an individualized treatment paradigm, yet many of the device-based treatment options available today offer a one-size-fits-all approach,” said Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center, Minneapolis Heart Institute Foundation. “Adona’s innovative shunt and sensor pairing aims to provide a more individualized management strategy and is designed so that shunt flow can be adjusted to best suit the needs of each individual patient, both initially and as their condition evolves over time. I look forward to working with the Adona team as they move into clinical use later this year.”

“Despite advancements in heart failure therapies, challenges remain that limit patient applicability and physician adoption with first-generation devices,” said Bihua Chen, Founder and Managing Member of Cormorant Asset Management. “We are pleased to lead this round as we believe Adona’s technology has the potential to disrupt the field and benefit the millions of patients suffering from heart failure.”
The Adona device includes a shunt that features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter. In addition, the implantable device features integrated sensors designed to capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction. These daily readings can provide physicians with a more complete understanding of a patient’s hemodynamic status and can augment shunt therapy by enabling more informed medical management. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally.1″Adona is committed to improving outcomes for patients with heart failure. We’ve developed multiple innovative technologies that we believe will elevate the impact that is achievable with device-based interventions,” commented Brian Fahey, Co-Founder and Chief Executive Officer of Adona Medical. “The team has made tremendous progress in advancing our solution for heart failure management and we are grateful for the strong ongoing support from our investors as we take the next steps in our journey.”About Adona Medical, Inc.Adona Medical, a privately held portfolio company of Shifamed, LLC, is a pre-clinical stage medical technology company developing next-generation interatrial shunting and remote patient monitoring solutions for patients with advanced heart failure. The Adona Medical heart failure management platform is an investigational device and is not approved for use in the U.S. or anywhere in the world. To learn more, please visit www.adonamed.com.About Shifamed, LLCFounded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.MEDIA CONTACT:Jennie KimSPRIG Consulting, LLC[email protected]References:
Benjamin et al. Circulation 2018.
SOURCE Adona Medical

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CARMAT accelerates its sales momentum and reiterates its confidence in its development outlook

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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 […]

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R3 Vascular Appoints Josh Smale as its Vice President of Global Clinical and Scientific Affairs

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MOUNTAIN VIEW, Calif., July 09, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of Josh Smale as its Vice President of Global Clinical and Scientific Affairs. Prior to joining R3 Vascular, Mr. Smale served as Vice President of Clinical Affairs for the Peripheral Intervention business unit of Becton Dickinson (BD) where he was responsible for all aspects of clinical evidence generation and dissemination for the company’s complex and diverse device portfolio. Prior to his tenure at BD, Mr. Smale served in roles of increasing responsibility for Bard Peripheral Vascular, Inc. (BPV) which was acquired by BD, and as Regulatory Affairs Manager for SenoRX, Inc. which was acquired by BPV. He also served as Regulatory Affairs Manager for Endologix, Inc. and in various roles at BPV. Mr. Smale holds a Bachelor of Science in Engineering with an emphasis on Molecular and Cellular Engineering, and Biochemical Engineering from Arizona State University. He also served on the board of the Peripheral Intervention business unit of BD, has received numerous awards, is the co-author of several publications, and holds five Vena Cava Filter patents. Commenting on the appointment of Mr. Smale, Christopher M. Ownes, President and CEO of R3 Vascular, said, “On behalf of the R3 management team, I am very pleased to welcome Josh Smale as Vice President of Global Clinical and Scientific Affairs. Josh has a proven track record and more than 20 years of relevant medical device experience specializing in clinical and regulatory affairs strategy, clinical evidence generation and dissemination, and physician education. Among other key clinical and scientific affairs programs, Josh will lead our clinical trial efforts, including our pivotal ELITE trial for our next generation Magnitude drug eluting bioresorbable scaffold. We look forward to his contributions as we work towards establishing R3 Vascular as the leader in the development and manufacturing of fully bioresorbable vascular scaffolds.” Mr. Smale said, “I am very excited to join R3 Vascular and work closely with Chris Owens, Kamal Ramzipoor, and the rest of the R3 Vascular team to build upon the success of the company and support the adoption of its breakthrough technology for treating below-the-knee peripheral arterial disease (BTK PAD). R3 Vascular’s novel next generation bioresorbable scaffolds will transform the field of peripheral interventions by providing a new standard of care and improving the health of patients around the world.” Mr. Smale joins R3 Vascular’s leadership team which, among others, includes Christopher M. Owens, President and Chief Executive Officer and Kamal Ramzipoor, R3 Vascular’s Founder and Chief Technology Officer (CTO). In May of 2024, R3 Vascular announced the closing of its $87 million Series B financing round. About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c861cb09-8ed9-4401-8f89-6e69934fd0d3

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