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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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UltraSight collaborates with Mayo Clinic to advance next generation cardiac care with AI

Financial by Comments are Disabled

New collaboration formed to enhance detection and diagnosis of cardiovascular disease
TEL AVIV, Israel , June 3, 2024 /PRNewswire/ — UltraSight, a pioneer in digital health transforming cardiac imaging with artificial intelligence, is collaborating with Mayo Clinic on a new endeavor with the goal of enhancing cardiac care by harnessing the power of AI in point-of-care ultrasound.UltraSight and Mayo Clinic will jointly develop algorithms for analyzing and interpreting cardiac ultrasound images. This collaboration aims to create a new end-to-end solution and decision support to help healthcare providers make more informed diagnoses and treatment decisions using point-of-care ultrasound (PoCUS) devices. By gaining access to Mayo Clinic’s team of researchers, clinicians and data, UltraSight will be best positioned to enhance and scale its introduction of new cardiac solutions to the market.
With cardiovascular disease affecting approximately 130 million people globally, according to the American Heart Association, the demand for timely cardiac diagnosis and access to consistent cardiac care is on the rise.
“According to the American Heart Association, the prevalence of cardiovascular disease is more than 75 percent in individuals over 60,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota. “Early detection may prevent the progression of heart disease or stroke.  The addition of AI to point-of-care ultrasound, widely available and inexpensive, stands to eliminate significant barriers to adoption by guiding users in image acquisition and supporting image interpretation – making the approach highly scalable for early diagnosis and periodic cardiac monitoring.”
“UltraSight Real-time Guidance software harnesses the power of AI to allow more medical practitioners to capture images with confidence,” said Davidi Vortman, CEO of UltraSight. “However, obtaining diagnostic quality cardiac images at the patient point of care is only the first step needed to increase patient access to quality care. We firmly believe that point-of-care ultrasound, when enhanced by the capabilities of AI, holds potential to optimize patient care. Through this collaboration, we plan to enhance our solution to detect and manage cardiac conditions in a more scalable and cost-effective way, ultimately helping more patients receive timely treatment.”
“We know that over the next decade, training programs around the world will not graduate enough specialists and technologists to meet the demands of an aging population,” said John Halamka, M.D., President of Mayo Clinic Platform. The best option in our toolkit is to embrace AI in a way that democratizes access to knowledge. Mayo Clinic and UltraSight will work together to enable a wider spectrum of caregivers to obtain cardiac ultrasound data and understand the results, serving many more patients globally.”
Mayo Clinic is now an investor at UltraSight and has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
For more information about UltraSight, visit www.ultrasight.com. For more information about Mayo Clinic, visit www.mayoclinic.org
About UltraSightUltraSight’s mission is to make diagnostic imaging more accessible by empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. UltraSight’s AI-driven software offers real-time guidance, making cardiac ultrasound accessible and efficient, which may lead to quicker diagnoses and improved patient care. The company was awarded a patent for its real-time guidance solution for ultrasound devices. UltraSight’s software has FDA 510(k) Clearance, is UKCA and CE Marked, and has Israeli AMAR Clearance to assist medical professionals in performing cardiac ultrasound scans. For more news and information, visit our website or follow UltraSight on LinkedIn and Twitter
SOURCE UltraSight

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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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Microbot Medical Has Received FDA Approval to Proceed with its Pivotal Human Clinical Trial

Peripheral/Endo Regulatory by Comments are Disabled

BRAINTREE, Mass., June 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces that it has received the U.S. Food and Drug Administration’s (“FDA”) approval to proceed with its pivotal human clinical trial as part of its Investigational Device Exemption (“IDE”) application for its LIBERTY® Endovascular Robotic Surgical System. The study will be conducted in the U.S., and the Company has already signed a clinical trial service agreement with a leading academic medical center. The Company is also in the process of engaging additional leading centers to participate in the trial. In parallel to commencing the pivotal human clinical trial, the Company is completing its biocompatibility tests as required by its IDE application. “The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” commented Harel Gadot, CEO, President and Chairman. ”It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe”. 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, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the 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)52-3044404IR@microbotmedical.com

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