Coronary/Structural Heart

MiRus Siegel™ TAVR: First in Human Results Presented at New York Valves

Coronary/Structural Heart by Comments are Disabled

Five sequential patients with severe, symptomatic aortic stenosis (AS) were treated at the Instituto Nacional Del Torax in Santiago, Chile by Drs. C. Dauvergne, J. Sandoval and P. Yadav. Three patients had bicuspid aortic valves and two were tri-leaflet.  Three patients had peripheral arterial disease with vascular access < 5.5 mm. There was no mortality or stroke at 30 days and no patients required a permanent pacemaker (PPM) or suffered vascular complications.  At 30 days, the mean echo gradient was 6.7 mmHg; four of the five patients had no peri-valvular leak (PVL) and one bicuspid patient had trace PVL. "The ease of use and hemodynamics were impressive" commented Pradeep K. Yadav, MD.  "On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning.  The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love.  Also the frame strength and virtually no recoil, allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability." The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment  and with the valve pre-mounted on the balloon.The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil."This initial data is striking and potentially heralds a new age for TAVR," stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute.  "The ability to treat such complex patients with an 8 French system and without Nickel exposure should make TAVR safer and more broadly accessible.  From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients.  We are truly on the precipice of surgical-like outcomes with the Siegel THV!!"About MiRus, LLC.MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease.  Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved.* MiRus® , Siegel™  are all trademarks of MiRus, LLC. Contact:Pam CowartVP of Clinical Affairs[email protected]770-861-4804SOURCE MiRus

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ECHO IQ TECHNOLOGY CHAMPIONED IN INDEPENDENT SCIENTIFIC REVIEW

Coronary/Structural Heart by Comments are Disabled

Echo IQ’s EchoSolv-AS decision-support software for cardiology delivers significant potential benefits to hospital networks according to independent scientific presentation at prestigious New York Valves scientific conference.
NEW YORK, June 6, 2024 /PRNewswire/ — At the Structural Heart Summit New York Valves earlier today, Dr. Pedro Covas (Baylor Scott & White, The Heart Hospital Plano TX) delivered the scientific presentation: AI-Powered Cardiac Ultrasound Improves Identification of High-Risk Aortic Stenosis (Echo IQ).
Dr. Covas highlighted the unmet need for an AI system for aortic stenosis – a form of heart valve disease characterised by high rates of mortality when untreated. He revealed that the condition is underdiagnosed and undertreated worldwide, partly due to the complexity in the diagnosis of severe aortic stenosis (including low-flow states), and that there is a need for assistance to improve rates of diagnosis. As backed up by the research presented by Dr. Covas, Echo IQ uses artificial intelligence to aide in identifying a high-risk phenotype of aortic stenosis, to ultimately help with timely diagnosis and treatment.
LEARN HOW ECHO IQ USES AI TO SUPPORT ENHANCED DISEASE DETECTION:
The independent research presented by Dr. Covas considered whether artificial intelligence could improve accuracy and reproducibility of diagnosis of severe aortic stenosis in a real-world hospital setting. To test this, Echo IQ’s technology (EchoSolv) was applied to the echocardiographic report data of one of Baylor Scott & White’s leading academic heart hospitals over a 7-month period with a subset of the assessments adjudicated via comprehensive image review by expert cardiographers.
The findings showed EchoSolv to be successful in identifying more patients at risk of aortic stenosis than human-only diagnosis. Specifically,

EchoSolv accurately identified 15% more patients with severe aortic stenosis than human-only diagnosis
Where initial underdiagnosis occurred, patients were found to have a “low flow” state of disease in 30% of cases (subsequently identified by EchoSolv)

The research concluded that:

Echo IQ’s technology can automatically identify aortic stenosis patients at-risk using only echocardiographic measurement data.
Echo IQ’s technology has the potential to improve diagnostic rates of severe aortic stenosis, particularly in low flow states.
There are important implications for less specialized cardiology centers, where echocardiographers are likely to benefit the most from automated diagnosis of severe AS.

Echo IQ Chief Medical Advisor, Professor David Playford said: “This kind of independent research demonstrates exactly how Echo IQ’s artificial intelligence can help healthcare professionals identify patients with severe cases of aortic stenosis as well as those with significant risk of disease. Diagnosing aortic stenosis accurately, and in a timely fashion, is extremely complex and the findings shared by Dr. Covas show clearly how Echo IQ’s artificial intelligence can help improve clinical performance.”
About Echo IQ
Echo IQ uses artificial intelligence for decision support in structural heart disease. The company’s first fully AI-enabled solution has been submitted for final FDA clearance. The company is headquartered in Sydney, Australia and is publicly listed on the Australian Securities Exchange (ASX:EIQ). Don Fowler is President, Echo IQ USA, and is based in Austin, TX.
SOURCE Echo IQ Limited

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Prevencio Selected for Prestigious MedTech Innovator 2024 Accelerator Cohort

Coronary/Structural Heart by 0 comments

KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., a leader in AI-powered blood tests for cardiovascular diagnostics, has been selected to join the 2024 Accelerator Cohort of MedTech Innovator, the world’s largest accelerator for medical technology companies. This honor places Prevencio among the top 5% of 1,300 applicants, reflecting the company’s innovative approach to […]

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Deep integration of proven AI tools into Philips cardiovascular ultrasound systems to better diagnose more cardiac disease patients

Coronary/Structural Heart Radiology by Comments are Disabled

June 4, 2024 New FDA-cleared AI-enabled applications include the industry’s first automated tool for segmental wall motion scoring of the heart to quickly and objectively identify disorders including coronary artery disease and cardio-oncology issues in secondsFirst fully automated 3D quantification of mitral regurgitation (MR) volumes* designed to provide reproducible, efficient analysis helps clinicians make better-informed decisions for patients with heart valve disease Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced its next-generation AI-enabled cardiovascular ultrasound platform to help speed up cardiac ultrasound analysis with proven AI technology and reduce the burden on echocardiography labs. Integrated into the company’s EPIQ CVx and Affiniti CVx ultrasound systems, the new FDA 510(k) cleared AI applications significantly advance Philips’ cardiovascular imaging and diagnosis solutions, automating measurements and speeding workflows to increase productivity. Heart failure is a rapidly growing health issue that affects an estimated 64 million people worldwide [1]. It’s also associated with high mortality and poor quality of life, and is a substantial burden on healthcare systems globally [2]. As the most common and least invasive way to check the structure and function of the heart, cardiovascular ultrasound has played a key role in diagnosing cardiac disease earlier. “As clinical cases get more complex and patient volumes increase, we read hundreds of echocardiography exams daily with thousands of data points,” said Roberto Lang, MD, Director of the Noninvasive Cardiac Imaging Lab, University of Chicago Medicine, USA. “With the integration of AI into echocardiography solutions, we can now automate some of the steps to support clinicians’ decision-making, allowing them to detect, diagnose, and monitor various cardiac conditions with greater confidence and efficiency in seconds.” Dr. Lang will join other clinicians to share the results of a new scientific abstract being presented at the American Society of Echocardiography (ASE2024) annual meeting (June 14 – 16, Portland, US), demonstrating how first-of-kind AI algorithms co-developed with Philips provide highly accurate detection of regional wall motion abnormalities (RWMA) on echocardiography. RWMAs can be an independent indicator of adverse cardiovascular events and death in patients with cardiovascular diseases like myocardial infarction (MI) and congenital heart disease. Automated machine learning-based assessment of RWMA has the potential to improve the efficiency of all readers. “An advantage of AI methods over conventional visual analysis is that it can be performed in seconds, providing rapid and accurate information to help augment expert reads by quickly highlighting areas of concern for RWMA, improving the ease and efficiency of interpretation,” Lang added. “By harnessing the power of AI into our echocardiography solutions, we empower clinicians with enhanced diagnostic capabilities, to ultimately improve patient care and outcomes in the management of coronary and valvular disease, while enhancing overall efficiency in cardiac practice,” said David Handler, VP and Business Leader for Global Cardiovascular Ultrasound at Philips. “For patients, this means consistent image interpretation which can lead to fewer re-scans, shorter and more effective interventional procedures, and potentially faster recovery times.” Integration of proven AI applications from Philips DiA Imaging Analysis Trained on anonymized patient data sets from real-life clinical environments, the AI features integrated across Philips cardiovascular ultrasound systems help improve the quality and reproducibility of cardiac imaging and enhance operator and departmental efficiency. These include FDA-cleared and CE-marked software solutions from DiA Imaging Analysis, a Philips company. Together, these AI features automate how users interpret ultrasound images, so clinicians with varying levels of ultrasound experience can automatically analyze images with increased speed, efficiency, and accuracy in real time. In addition to integrating these latest advanced AI features into the company’s cardiovascular ultrasound systems, Philips’ new mini ultrasound transducer X11 4t, introduced earlier this year, is fully compatible with the EPIQ CVx and Affiniti CVx systems. The innovative transducer allows interventional cardiologists to provide enhanced care to a wider range of patients, including pediatric patients as small as 5kg in weight. Through breakthrough innovation and collaborations with technology leaders including NVIDIA**, Philips continues to rapidly integrate AI into its cardiovascular ultrasound portfolio to help improve efficiency and productivity and mitigate staff shortages while delivering high-quality cardiology care to an increasing number of patients. These third-party solutions complement Philips’ proprietary AI-enabled solutions, integrating AI to enhance diagnostic confidence and decision-making. For more information, join Philips in Booth #441 at ASE2024 and visit Philips Cardiovascular Ultrasound for the latest AI-powered echocardiography applications. *Clinical performance and safety have not been established for some features which have 510(k) pending. Not available for sale in the USA.**NVIDIA MONAI for medical imaging AI and NVIDIA Holoscan for building software-defined medical devices. [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10398425/  [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10398425/   For further information, please contact: Kathy O’ReillyPhilips Global External RelationsTel.: +1 978 221 8919E-mail : kathy.oreilly@philips.com About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring, and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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Orchestra BioMed Announces Further Details on In-Person R&D Day in New York Featuring Key Opinion Leaders to Discuss AVIM Therapy Program in Hypertensive Pacemaker Patients on June 11, 2024

Coronary/Structural Heart by Comments are Disabled

NEW HOPE, Pa., June 04, 2024 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced further details on its in-person R&D day at the Lotte New York Palace Hotel on Tuesday, June 11, 2024, at 10:00 AM ET. To register, click here. The R&D day will feature in-depth presentations focused on the Company’s lead program, atrioventricular interval modulation (AVIM) therapy, including: The high unmet need for treatment of uncontrolled hypertension in pacemaker-indicated patients and other older high-risk patientsThe AVIM therapy mechanism of action and supporting clinical and non-clinical mechanistic dataThe robust existing body of clinical evidence from the MODERATO I and II studiesDesign of and rationale for the BACKBEAT global pivotal study In addition to Orchestra BioMed management presentations, the event will include esteemed key opinion leading physicians: David Kandzari, M.D., FACC, FSCAI, Chief of the Piedmont Heart Institute and Cardiovascular Service Line; Director, Interventional Cardiology of the Piedmont Heart Institute; Chief Scientific Officer for Piedmont Healthcare in Atlanta, Georgia; and co-principal investigator on the BACKBEAT global pivotal study Dr. Kandzari specializes in cardiovascular disease, peripheral arterial disease and interventional cardiology. Board certified by the American Board of Internal Medicine and its subspecialty Board of Cardiovascular Disease and Board of Interventional Cardiology, Dr. Kandzari has held national and international leadership roles in clinical trials in cardiovascular disease and has participated in national and international program committees in cardiology. He has authored and coauthored more than 400 studies, book chapters and scientific reviews, and has delivered more than 800 lectures, both nationally and internationally, on a variety of issues related to both interventional and general cardiology. Dr. Kandzari has been consecutively voted as one of Atlanta’s Top Doctors by Atlanta Magazine from 2011 to 2024 and is peer-nominated in the top 1% of cardiologists by U.S News and World Report. Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and the Mount Sinai Health System; Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn School of Medicine at Mount Sinai; and Clinical Steering Committee Advisor for the BACKBEAT global pivotal study Dr. Reddy is one of the nation’s premier cardiac electrophysiologists, leading a team of physician-scientists who are developing and testing advanced therapies for cardiac arrhythmias – including atrial fibrillation and ventricular tachycardias, the most common cause of sudden cardiac death. Dr. Reddy’s pioneering clinical research is changing the way cardiac patients are treated and cured. Under his leadership, Mount Sinai is the lead site on several multinational clinical trials exploring new arrhythmia procedures and technologies. In 2014, Dr. Reddy implanted the world’s first miniature leadless pacemaker in a patient’s heart in the United States at The Mount Sinai Hospital. A live question and answer session will follow formal presentations. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for the development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About Hypertension and the Risk of High Blood Pressure in the Pacemaker Population Hypertension (“HTN”) is characterized by elevated blood pressure, which increases the force of blood pushing against blood vessels, requiring the heart to work harder and consume more oxygen. HTN accelerates the progression of atherosclerosis and leads to increased risk of major cardiac events like heart attack, heart failure, kidney disease and other end organ damage. HTN is the leading global risk factor for death, affecting an estimated 1.28 billion adults worldwide. In the United States, 122 million adults, or approximately 47% of all adults, are estimated to have HTN. While many patients do not notice high blood pressure, cardiovascular risk doubles for every 10-mmHg increase in systolic blood pressure and the mortality rate doubles with an increase of 20 mmHg in systolic blood pressure.1 It is estimated that more than 70% of the approximately 1.1 million people globally who are implanted with cardiac pacemakers each year are also diagnosed with HTN. Based on updated American College of Cardiology/American Heart Association guidelines, we estimate that an even higher percentage (approximately 80%) of U.S. patients who are indicated for a pacemaker implant have HTN. Pacemaker patients tend to be elderly and are more likely to suffer from co-morbidities, such as atherosclerosis, hyperlipidemia, diabetes mellitus and chronic kidney disease, and harder to treat effectively with medical therapy for many reasons, including co-morbidities and a high prevalence of isolated systolic HTN. About AVIM Therapy (BackBeat CNT™) AVIM therapy, also known as BackBeat CNT™, is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized, pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. The IDE approved BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker. References: 1. Benjamin EJ, Blaha MJ, Chiuve SE, et al., Heart Disease and Stroke Statistics – 2017 Update: A Report from the American Heart Association. Circulation. 2017; 135: e146. Investor Contact:Bob YedidLifeSci Advisors(516) 428-8577Bob@lifesciadvisors.com Media Contact:Kelsey Kirk-EllisOrchestra BioMed(484) 682-4892Kkirkellis@orchestrabiomed.com

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BridgeBio Announces Durable Month 12 and 18 Phase 2 Cohort 5 Results of Oral Infigratinib in Achondroplasia, and First Participant Consented in ACCEL for Hypochondroplasia

Coronary/Structural Heart by Comments are Disabled

– In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015) – At Month 18, there was a statistically significant improvement in body proportionality (p-value of 0.001). The mean upper to lower body segment ratio was 1.88 at Month 18, as compared to 2.02 at baseline – Infigratinib continues to be well-tolerated as a single daily oral therapy with no adverse events (AEs) assessed as treatment-related in any participant in Cohort 5 – PROPEL 3, the global Phase 3 registrational study of infigratinib in achondroplasia, continues to enroll on schedule, with completion estimated by end of 2024 – BridgeBio announces first child consented in ACCEL, the observational run-in study for infigratinib in children living with hypochondroplasia, a skeletal dysplasia closely related to achondroplasia and similarly driven by FGFR3 gain-of-function variants PALO ALTO, Calif., June 04, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced sustained positive results from PROPEL 2, a Phase 2 trial of the investigational therapy infigratinib in children with achondroplasia, demonstrating continued potential best-in-class efficacy and an encouraging safety profile. Infigratinib is an oral small molecule designed to inhibit FGFR3 signaling and target achondroplasia and hypochondroplasia at their source. BridgeBio will also host an investor call on June 4, 2024, at 8:00 am ET with Ravi Savarirayan, M.D., Ph.D., of Murdoch Children’s Research Institute in Melbourne, Australia, and the global lead investigator for PROPEL 2, to discuss the results from the Phase 2 study. To date, key results from the Cohort 5 dose escalation cohort in PROPEL 2 trial include: Sustained and statistically significant mean increase in AHV of +2.51cm/year from baseline at 12 months, and +2.50 cm/yr at 18 months (p=0.0015)Statistically significant improvement in body proportionality (mean upper to lower body segment ratio), from 2.02 at baseline to 1.88 at Month 18 (mean change from baseline, p=0.001)A continued well-tolerated safety profile, with no treatment-related adverse events assessed as related to infigratinib “These data indicate that treatment with infigratinib is continuing to show increased growth velocity and improvements in body proportionality in children with achondroplasia. This is encouraging and suggests that infigratinib has the potential to enhance functionality for people living with achondroplasia in addition to increasing growth. We hope to see these improvements reflected in the ongoing PROPEL 3 pivotal study that will build toward providing a safe and effective oral therapy to those in the achondroplasia community who are seeking treatment,” said Dr. Savarirayan. PROPEL 3, the global Phase 3 registrational study of infigratinib in achondroplasia, continues to enroll on schedule, with completion of enrollment anticipated by the end of the year. Given the promising results from PROPEL 2, BridgeBio is committed to expanding the FGFR3-related skeletal dysplasias franchise for infigratinib by accelerating development in hypochondroplasia. Positive interactions with both the U.S. FDA and EMA support development in children with hypochondroplasia, with a small open-label Phase 2 portion testing a single dose of 0.25 mg/kg/day, leading into a double-blinded, placebo-controlled Phase 3 study. ACCEL, the observational lead-in program for hypochondroplasia, was initiated with the first participant consented in May 2024. The interventional program, ACCEL 2/3, will be a global Phase 2/3 multicenter, single-dose study, to evaluate the efficacy and safety of 0.25mg/kg/day of infigratinib in children living with hypochondroplasia. The open-label Phase 2 portion in children aged 5 to 11 years old will be followed by a pivotal Phase 3, one-year, 2:1 randomized, double-blinded, placebo-controlled study in children aged 3 to < 18 years old with growth potential. In addition to changes from baseline in AHV measurements, the study will evaluate changes in other indicators of growth, body proportions, medical complications associated with hypochondroplasia, and changes in quality-of-life measures. BridgeBio has previously presented promising preclinical data for hypochondroplasia at ENDO 2023 and ASHG 2022. “We are very excited to see a persistence of response to infigratinib in linear growth. We are especially encouraged by the promising effect on body proportions, which supports infigratinib’s potential to provide benefits that could impact the lives of children with achondroplasia. These results motivate us to continue evaluating infigratinib in other FGFR-related skeletal dysplasias and genetic conditions. The initiation of our observational study in hypochondroplasia and the obtainment of FDA and EMA alignment on the interventional study underlie our excitement for the potential of infigratinib as a treatment option for children with hypochondroplasia,” said Daniela Rogoff, M.D., Ph.D., Chief Medical Officer, Skeletal Dysplasias at BridgeBio. “The journey of living with skeletal dysplasia varies from person to person, but many are impacted by functional limitations, social stigma and medical complications due to their condition and the way their bones develop. We are encouraged to see infigratinib’s potential to improve body proportionality, which could help address functional complications meaningful to people living with skeletal dysplasia. The Chandler Project values the collaborative partnership we’ve developed with BridgeBio and QED, to ensure that the community’s true needs are prioritized throughout the discovery and development process. We are also thrilled for the launch of an observational study in hypochondroplasia, a community that has been eager for further research and development of treatment options,” said Chandler Crews, founder of The Chandler Project, a patient advocacy organization based in Baltimore, MD. Information about PROPEL 3 (NCT06164951) can be found here on clinicaltrials.gov. Information about PROPEL (NCT04035811), BridgeBio’s observational lead-in study in achondroplasia for PROPEL 3 and other studies, can be found here on clinicaltrials.gov. Information about ACCEL (NCT06410976), BridgeBio’s observational lead-in study in hypochondroplasia can be found here on clinicaltrials.gov. BridgeBio is committed to exploring the potential of infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasias, which hold significant unmet needs for families. Webcast InformationBridgeBio will host an investor call and simultaneous webcast to discuss the Phase 2 data at Months 12 and 18 of infigratinib in children with achondroplasia on June 4, 2024 at 8:00 am ET. A link to the webcast may be accessed from the event calendar page of BridgeBio’s website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event. About AchondroplasiaAchondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the United States (US) and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia impacts overall health and quality of life, leading to medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis. The condition is uniformly caused by an activating variant in FGFR3. About HypochondroplasiaHypochondroplasia is also an FGFR3-associated skeletal dysplasia and is a rare condition with similar prevalence in achondroplasia. Hypochondroplasia presents with a wide spectrum of phenotypes including disproportionate short stature, mild joint laxity and macrocephaly. Currently, no treatments for hypochondroplasia are approved in the United States. About BridgeBio Pharma, Inc.BridgeBio Pharma (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter. BridgeBio Pharma, Inc. Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the clinical, therapeutic and market potential of our programs and product candidates, including our clinical development program for infigratinib in achondroplasia, the timing and success of our clinical development programs, the progress of our ongoing and planned clinical trials of infigratinib in achondroplasia and in hypochondroplasia , our planned interactions with regulatory authorities, the availability of data from our clinical trials of infigratinib, and the timing of these events, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, difficulties with enrollment in our clinical trials, adverse events that may be encountered in our clinical trials, the FDA or other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, potential adverse impacts due to global health emergencies, including delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and rising interest rates, on our business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Contact:Vikram Balicontact@bridgebio.com(650)-789-8220 Medical Information Contact:MedInfo@QEDTx.com1-877-280-5655

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Program Announcement for Annual ASPC Congress on CVD Prevention August 2024

Coronary/Structural Heart by Comments are Disabled

Detailed Program Agendas Released for Pre-conference Course and Scientific Sessions
KINGWOOD, Texas, June 4, 2024 /PRNewswire/ — The ASPC announces details of a full program of events to be held at their annual Congress on Cardiovascular Disease Prevention, scheduled for August 1-4, 2024, at the Hyatt Regency hotel in Salt Lake City, UT.
A new pre-conference MasterClass focused on lifestyle medicine is being offered Thu., August 1 – Hot Topics in Preventive Cardiology and Lifestyle Medicine:  Implications for Patient Counseling and Management. This program is being Co-Chaired by Barry Franklin, PhD, FASPC and Heather Johnson, MD, MS, FASPC. They shared, “Americans have a shorter life expectancy compared with residents of almost all other high-income countries.  We also have the most expensive healthcare system in the world. It’s simply not sustainable! Accordingly, readily accessible preventive health interventions should be a top priority. This unique and timely Masterclass will address these issues – and more.”
Features of the 2024 Scientific Sessions program include diverse content with many international experts joining the program, honorees in the field of prevention, and a record number of abstracts in the poster hall!
The three ASPC honorees are:

Honorary Fellow Award: Dr. Chris Cannon, Professor of Medicine at Harvard University. His award lecture will focus on “Lipid Lowering 2024 and Beyond”.
Nanette Wenger Award: Dr. Noel Bairey Merz, Director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Heart Institute. She will present a lecture titled, “Where are We Now? – From WISE to Chest Pain Guidelines and Improving CVD Care for Women.”
Joseph Stokes III, MD Pioneer in Prevention Award:  Dr. Sergio Fazio, VP/Chair, Scientific Council, Global Clinical Development at Regeneron Pharmaceuticals and the first Editor-in-Chief of the American Journal of Preventive Cardiology. Dr. Fazio’s award lecture topic is to be announced.

ASPC is looking forward to honoring these awardees during the opening session of the Congress on Friday, August 2 from 8:00 – 9:30 AM.
Throughout the weekend, the Scientific Sessions will collaborate with societies from around the globe, including:

Society of Cardiovascular Computed Tomography (SCCT)
Korean Society of Lipid and Atherosclerosis (KSoLA)
Korean Society of Cardiovascular Disease Prevention (KSCP)
European Atherosclerosis Society (EAS)

Three rousing debates will be featured during Session 7 on Saturday, August 3, from 9:00-11:00am:

Reducing Residual CVD risk: Adding Colchicine vs. Aggressive Lipid Lowering

Mike Wilkinson, MD vs. Daniel Soffer, MD

CAC/CCTA is the Imaging Modality of Choice in Refining ASCVD Risk in Primary Prevention

Seamus Whelton, MD, MPH vs. Matthew Budoff, MD, FASPC

Lp(a) in Primary Prevention is Actionable Today

Vera Bittner, MD vs. Roger Blumenthal, MD, FASPC

Detailed program agendas for both the Congress on CVD Prevention and the Lifestyle MasterClass are available at www.aspconline.org.  
The ASPC’s mission is to promote the prevention of cardiovascular disease, advocate for the preservation of cardiovascular health, and disseminate high-quality, evidence-based information through the education of healthcare clinicians and their patients.
SOURCE The American Society for Preventive Cardiology

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HeartFlow AI Plaque Analysis Achieves Major Milestone Towards Medicare Coverage

Coronary/Structural Heart Financial by Comments are Disabled

MOUNTAIN VIEW, Calif., June 03, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in cardiovascular healthcare technology, is pleased to announce a key Medicare policy development, which should allow for future expanded patient access to their Plaque Analysis product. Five Medicare Administrative Contractors (MACs), CGS, NGS, Noridian, Palmetto GBA, and WPS, released draft Local Coverage Determinations (LCD) for Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA). These draft LCDs recognize the importance of quantifying coronary artery plaque, which underscores the pivotal role HeartFlow technology plays in diagnosing and managing treatment for patients in need of cardiovascular care. HeartFlow’s accurate and actionable Plaque Analysis aligns with the Centers for Medicare & Medicaid Services (CMS) commitment to supporting technologies that enhance diagnostic accuracy and patient care: HeartFlow Plaque Analysis is the only FDA cleared plaque analysis with a reported 95% agreement prospectively compared to the gold standard, IVUS.¹Two out of three patients had their medical management changed and more precisely tailored with HeartFlow Plaque Analysis.² Plaque Analysis is a major function of the HeartFlow portfolio, which offers the only comprehensive, AI-driven, precision coronary care solution based on the guideline-directed cardiac CT pathway, backed by robust clinical evidence and guidelines. HeartFlow FFRCT has an established reimbursement pathway which is covered for 99% of people in the US with health insurance. Leveraging our expertise and proven success creating new AI reimbursement categories as done with HeartFlow FFRCT, similar coverage and adoption for Plaque Analysis is anticipated, ensuring it becomes an integral part of coronary care. “We are excited about this milestone, as it highlights the critical importance of accurately quantifying plaque in cardiovascular disease management,” said John Farquhar, chief executive officer at HeartFlow. “This recognition by the MACs in the draft policies is a testament to the clinical value of Plaque Analysis and its potential to revolutionize how cardiovascular disease is diagnosed and treated, for all.” The release of these draft LCDs mark the first step in integrating accurate plaque measurement into standard clinical practice. Next steps toward coverage include a period for input from clinicians and other stakeholders before policy is finalized and released. “We are confident that Plaque Analysis will not only meet but exceed the rigorous standards of Medicare,” added Cara Santillo, Senior Vice President of Market Access and Reimbursement at HeartFlow. “This nod of support from the MACs underscores the importance of access and equity in cardiovascular care by ensuring that all patients, regardless of background, receive the critical insights needed for treatment for cardiovascular disease.” About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media Contact Linly Ku Digital Marketing Manager media@heartflow.com Investor Contact Nick Laudico VP of Business Development and Investor Relations nlaudico@heartflow.com 1 Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound EHJ 2024. ² Rinehart et al. JSCAI 2024. https://doi.org/10.1016/j.jscai.2024.101296

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Cadrenal Therapeutics Highlights Presentation of New Trial Data at ISHLT Conference Demonstrating the Importance of Anticoagulation Quality in LVAD Patients

Coronary/Structural Heart by Comments are Disabled

Tecarfarin, which recently received Orphan Drug Designation from the FDA for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, has the potential to improve the time in therapeutic range a factor correlated in the ARIES-HM3 trial with better patient outcomes
PONTE VEDRA, Fla., June 3, 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, today highlighted a groundbreaking presentation at the International Society for Heart & Lung Transplantation (ISHLT) 44th Annual Meeting & Scientific Sessions.
These new findings from secondary analyses of the ARIES-HM3 trial were released in a presentation titled, “Impact of Vitamin K Antagonist (VKA) Therapy On Outcomes In a Randomized Controlled Trial of Aspirin Removal In Left Ventricular Assist Device (LVAD) Patients – A Pre-Specified Analysis From the Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure, or the ARIES-HM3, Randomized Clinical Trial.”
The ARIES-HM3 trial data demonstrated that lower time in therapeutic range, or TTR, translated directly to excessive bleeding events. The “average” patient in the ARIES-HM3 study had a 30% rate of serious bleeding events even after aspirin was eliminated as part of the antithrombotic regimen, and persistent bleeding was inversely correlated with TTR.
The ARIES-HM3 clinical study was sponsored by Abbott (NYSE: ABT), which evaluated a new clinical approach to patient management that included removal of aspirin as part of the antithrombotic regimen warfarin. The data is currently under review by the FDA. Labeling changes related to the antithrombotic regimen have not been approved by the FDA at this time.
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital, commented, “This comprehensive analysis identifies adequacy of VKA use (as measured by TTR) as a significant risk marker for bleeding events and provides new clinical direction for further mitigation of bleeding to enhance hemocompatibility with the HeartMate 3 LVAD.” Mehra continued, “Each incremental improvement of 10% above the median of 56% TTR trends in a significant further reduction in bleeding rate. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anti-coagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”
“The ARIES-HM3 trial data underscores the deficiencies of warfarin and the need for a new VKA therapy for patients with LVADs. We believe our drug candidate, the next-generation VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation than warfarin, is the much-needed replacement therapy. We intend to pursue a pivotal trial evaluating tecarfarin effectiveness for LVAD patients,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Cadrenal commends Abbott’s commitment to LVAD patients in sponsoring this important trial and analyses.”
On April 9, 2024, Cardenal Therapeutics announced that the United States Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD).
The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with LVADs due to a lack of evidence of benefit, while the level of anticoagulation achieved with warfarin was achieved in the target range only 56% of the time in the ARIES-HM3 trial. Patients whose level of anticoagulation was in the therapeutic range > 56% had better outcomes than those with lower levels. This highlights the potential role for investigating new VKA agents in improving clinical outcomes in LVAD patients.
VKA anticoagulation is prescribed for the prevention of LVAD-related clotting. However, the only available VKA is warfarin, which was approved for human use in 1954. Tecarfarin has been shown to improve TTR, particularly in patients taking multiple medications, and be more stable in patients with renal dysfunction which is common in LVAD patients.
ABOUT CADRENAL THERAPEUTICS, INC.Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is a next-generation Vitamin K Antagonist (VKA) specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.  
Safe Harbor StatementAny statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding tecarfarin having the potential to improve the time in therapeutic range which analysis of the ARIES-HM3 trial reveals is associated with better patient outcomes. TTRs as predicting increased risk for bleeding events, the VKA tecarfarin, filling the market void for a next-generation VKA, the Company pursuing a pivotal trial evaluating tecarfarin effectiveness for LVAD patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve the time in therapeutic range, the ability of the Company  to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics:Matthew Szot, CFO858-337-0766[email protected] 
Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700[email protected] 
SOURCE Cadrenal Therapeutics, Inc.

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HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation

Coronary/Structural Heart by Comments are Disabled

HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation Paris, June 3rd 2024 – HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe Mitral Regurgitation (MR), announced today that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a US Pivotal Study with its technology. The Pivotal Study is a single-arm, multicenter, prospective study assessing the safety and effectiveness of the HighLife TSMVR solution in patients with moderate to severe Functional Mitral Regurgitation (FMR), unsuitable for surgery or transcatheter repair treatment. This patient population lacks approved therapeutic options, leading to a poor prognosis with many recurrent hospitalizations and reduced life expectancy. The pivotal study is expected to enroll patients at clinical sites in the United States, Europe and APAC. Over 100 patients have been treated with the HighLife technology within different clinical programs in the USA, Europe and APAC. Study results have been presented at conferences globally and published in JACC (Journal of the American College of Cardiology) – Cardiovascular Interventions1. Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai (New York, USA) will be the Principal Investigator of the Pivotal study. “I am honored to lead the HighLife pivotal study. There is still a significant unmet clinical need for patients suffering from mitral regurgitation and TMVR is a promising treatment option. The HighLife TMVR solution offers the potential to provide important clinical benefits for these high-risk patients. We are gratified that FDA has granted approval for this pivotal study that will further advance the management of patients with MR” commented Prof. Stone. Georg Börtlein, Founder and Chief Executive Officer of HighLife, said, “We are extremely pleased with the FDA IDE approval for our US pivotal study, marking a significant milestone in our US clinical strategy. This approval aligns with the maturity of our extensive clinical dataset generated over multiple sites across three continents. We are also making great progress towards CE mark readiness, eagerly anticipating the market introduction of our technology in Europe.” The HighLife technology will be featured at NY Valves annual meeting on Thursday, June 6th   at 11am in the session “Innovation at NYV: Transfemoral TMVR – Technology and Clinical Updates” – Room: Innovation & FDA, 504, Level 5, Jacob K. Javits Convention Center, North. About HighLife HighLife SAS, headquartered in Paris, France, with facilities in Irvine, California, is a pre-commercial stage company. It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation. The TSMVR solution developed by HighLife consists of a valve-in-ring concept, both ring and valve being implanted percutaneously. The technology is implanted in a simple, 3-step procedure. The valve is deployed in a beating heart, reducing trauma to the patients. It is currently evaluated in clinical studies across three continents. For more information, visit https://www.highlifemedical.com/ Caution: The HighLife Valves are investigational devices and not for sale in any geography. About Mitral Regurgitation Mitral Regurgitation is a growing public health concern, affecting over 2% of the total population2. It refers to a condition in which the valve between the heart’s left chambers (the mitral valve) does not close completely, allowing blood to leak back across it, rather than continuing to supply the organs with oxygenated blood. Without proper treatment, severe Mitral Regurgitation can cause major heart problems or even lead to heart failure. Limited treatment options are available for many patients at high surgical risk, TSMVR solutions offer a less invasive alternative to traditional open-heart surgery. Contact: HighLife MedicalAmina Benkabouabenkabou@highlifemed.comTel : +33 (0)1 72 32 21 25 1 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study. J Am Coll Cardiol Intv. 2023 Dec, 16 (23) 2854–28652Burden of valvular heart diseases: a population base study. Nkomo VT et al.
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