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HeartSciences Regains Compliance with Nasdaq Listing Requirements

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Southlake, TX, June 04, 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 on June 3, 2024, the Company received formal notice from the Listing Qualifications Staff of the Nasdaq Stock Market LLC indicating that HeartSciences has regained compliance with bid price requirement as set forth in Listing Rule 5550(a)(2), and that the Company is therefore in compliance with the Nasdaq Capital Market’s listing requirements and the scheduled hearing has now been cancelled. 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 InvestorsGilmartin GroupVivian Cervantesinvestorrelations@heartsciences.com

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OBVIUS Robotics™ Announces Growth Into New Development and Operations Facility

Financial by Comments are Disabled

SUNRISE, Fla., June 4, 2024 /PRNewswire/ — Obvius Robotics, a medical device company developing an innovative technology platform for democratizing vascular access, today announced its move into a new development and operations facility. The South Florida facility will enable Obvius Robotics to support its growth as the company prepares for clearance and commercialization.
Obvius Robotics has developed technology that can be used with minimal training or experience, initially targeting central venous catheterization (CVC) procedures. The CERTA Access System is a hand-held, image guided device that enables clinicians to single-handedly target anatomical structures and access them with the push of a button using a proprietary targeting system and needle assembly. Early clinical use of the CERTA has demonstrated a 100% access success rate (link).
As the most common interventional procedure performed in the United States, CVC is a key platform from which to launch critical medical interventions for acutely ill patients and patients requiring surgery. The procedure involves gaining access to one of the great veins (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid replacement of blood volume, administration of emergency medicines and analgesics, and hemodynamic monitoring. Despite the broad use of CVC, these procedures carry a complication rate between 4% and 11% due to a lack of training and experience.
“The goal of Obvius Robotics is to democratize access, improve outcomes, and become the new standard of care in CVC,” said Russell Seiber, president and CEO of Obvius Robotics. “The new facility will not only support development and production of the CERTA Access System for CVC, but will also be a center of innovation to expand the CERTA platform into new applications”.
The CERTA Access System is not approved for clinical use at this time, but the company is currently preparing its submission to the U.S. Food and Drug Administration (FDA) for market clearance.
About Obvius Robotics
Obvius Robotics is a privately held medical device company based in South Florida with clinical offices in the Center for Device Innovation at the Texas Medical Center, Houston, that is developing technology for image-guided access of structures within the body. The platform technology, the CERTA Access System, incorporates robotics and imaging to improve the accuracy, safety, and consistency of accessing targeted anatomy.  The company’s first clinical application is central venous catheter placement, a high-volume procedure in which CERTA has the potential to aid clinicians of varying levels of training and experience in safely and effectively achieving vascular access. Note: The CERTA Access System is not approved or cleared for use in patients in any geography at this time.
SOURCE OBVIUS Robotics, Inc.

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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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Amarin Board of Directors Announces CEO Transition

Financial by Comments are Disabled

— Board Appoints Aaron Berg as President & CEO — — Patrick Holt to Step Down as President & CEO to Pursue Other Opportunities — DUBLIN and BRIDGEWATER, N.J., June 04, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company’s Board of Directors has appointed Aaron Berg, currently Amarin’s Executive Vice President and President of the U.S. Business, as President and Chief Executive Officer (CEO). The appointment of Mr. Berg follows the resignation of Patrick Holt as President & CEO of the Company. “On behalf of the Company’s Board of Directors, I thank Pat for his contributions to Amarin, and I welcome working closely again with Aaron as President & CEO,” said Odysseas Kostas, MD, the Chairman of the Board. “No one knows the company better than Aaron, and we look forward to him contributing meaningfully as CEO.” “As I begin this new role, my focus is clear – to find ways to deliver value for investors, and to maximize the potential of VASCEPA®/VAZKEPA for patients,” said Aaron Berg, President & CEO, Amarin. “I look forward to continuing to work with our Board of Directors and our tremendous team focusing on these priorities for the Company as we move forward.” Mr. Berg joined Amarin in November 2012 and has more than 30 years of biopharmaceutical industry experience. Mr. Berg initially served as Amarin’s Vice President, Marketing and Managed Care. He was promoted to Senior Vice President, Marketing and Sales in February 2014, and to the position of Senior Vice President and Chief Commercial Officer in April 2018. Before joining Amarin, Mr. Berg served as President and Chief Executive Officer for Essentialis, Inc., a development stage pharmaceutical company where he led the company’s work on triglyceride management. Prior to joining Essentialis, Mr. Berg served as Vice President of Marketing and Sales at Kos Pharmaceuticals (Kos), where he was instrumental in driving annual revenues approaching $1 billion. Mr. Berg worked at Kos until it was acquired by Abbott Laboratories in December 2006 for $3.7 billion. About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.   Forward-Looking Statements   This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and  potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.    Availability of Other Information About Amarin Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.  Amarin Contact Information    Investor & Media Inquiries:    Mark Marmur  Amarin Corporation plc    PR@amarincorp.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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Shape Memory Medical Announces First Patient Treated in the AAA-SHAPE Randomized Controlled Pivotal Trial

Peripheral/Endo by 0 comments

SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first patient treated as part of the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm […]

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Microbot Medical Announces $2.35 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules

Financial by Comments are Disabled

HINGHAM, Mass., June 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 1,566,669 shares of the Company’s common stock at a purchase price of $1.50 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series F preferred investment options. The series F preferred investment options to purchase up to 3,133,338 shares of common stock have an exercise price of $1.50 per share and are immediately exercisable following issuance for a period of two years thereafter. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 4, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings. The gross proceeds to the Company from the offerings are expected to be approximately $2.35 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offerings for the continued development, commercialization and regulatory activities for the Company’s LIBERTY® Robotic System, expansion and development of additional applications derived from the Company’s existing IP portfolio, and for working capital and other general corporate purposes. The shares of common stock described above (but not the series F preferred investment options issued in the concurrent private placement or the shares of common stock underlying such series F preferred investment options) are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-275634) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on December 4, 2023. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at placements@hcwco.com. The series F preferred investment options described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the series F preferred investment options, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the series F preferred investment options and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, the completion of the offerings, the satisfaction of customary closing conditions related to the offerings, the intended use of proceeds from the offerings, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty +972-(0)52-3044404 IR@microbotmedical.com

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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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