SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036. The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials. Radial artery delivery is a means by which cardiac catheters are advanced through a blood vessel in a patient’s wrist to treat the heart. This approach has significant advantages for patients, enabling them to leave the hospital soon after the procedure with a band aid on their wrist and their arm in a simple sling, allowing them to immediately return to their active lives. In addition, a radial approach permits hospitals and other care centers to greatly reduce costs by eliminating the need for an overnight stay by the patient. For these reasons, trans-radial access is becoming the default approach in many cardiac centers worldwide. Enabling radial access has enormous potential advantages for biotherapeutic delivery to the heart. BioCardia’s Helix system, used in our ongoing clinical trials, is the only known system with patented designs that can enable radial transendocardial biotherapeutic delivery. The issued patent claims further protect this approach and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. Therapeutic cell aggregates have the potential advantage over single cell suspensions by enhancing retention in the heart to maximize therapeutic benefit. However, the delivery of cell aggregates carries greater risks of potentially life-threatening strokes should they leak into the ventricular chamber. As 20% of the blood in the heart chamber goes to the brain, 20% of any cell or cell aggregates released in the heart are expected to obstruct the first cerebral artery that is too small to allow the cell or cell aggregate to pass. The larger the cell aggregate, the larger the vessel they are capable of obstructing, with greater risk of a significant life-threatening stroke. BioCardia’s delivery systems are designed to prevent leakage of therapeutic agents into the ventricular chamber by providing stable and safe engagement to the heart tissue during the delivery process. The issued patent claims further protect this design and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. “Our minimally invasive biotherapeutic delivery platforms enable the successful development of cell and gene-based therapies for the heart,” said Dr. Peter Altman, BioCardia CEO. “The Helix platform underlies BioCardia’s cell therapy clinical programs and this recent patent issuance provides additional protection to our technology and product offerings in the United States for at least another dozen years. This is just one of many patent applications we are advancing to protect our value creation for the benefit of shareholders, which in turn enables these advances to be supported for expected benefit to millions of patients.” About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs. For more information visit: www.BioCardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the benefits and risks of cell aggregates, the benefits of radial artery access, the level and duration of patent protection that the Company’s patents provide to its product candidates, and the expected safety of BioCardia’s delivery device designs. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” And in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Other News
University Hospitals Now Performing Robotic Heart Bypass Surgeries
CLEVELAND – A new, robotic approach to heart bypass surgery is now being offered to patients at University Hospitals (UH) with great success. Two UH Harrington Heart & Vascular Institute providers, Dr. Kelsey Gray and Dr. Pablo Ruda Vega, are currently the only surgeons in Ohio performing this specific type […]
Medtronic chairman and CEO Geoff Martha to speak at Goldman Sachs global healthcare conference
DUBLIN, June 6, 2024 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it will participate in the 45th annual Goldman Sachs global healthcare conference on Tuesday, June 11, 2024.
Geoff Martha, Medtronic chairman and chief executive officer, will answer questions on the company beginning at 10:40 a.m. EDT (9:40 a.m. CDT).
A live webcast of the Q&A session will be available on June 11, 2024, by clicking on the Events link at http://investorrelations.medtronic.com. An archive of the Q&A session will be available on the same webpage later in the day.
About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Erika Winkels Ryan WeispfenningPublic Relations Investor Relations+1-763-526-8478 +1-763-505-4626
SOURCE Medtronic plc
AVS Receives IDE Approval from FDA for Pivotal Intravascular Lithotripsy Study
June 06, 2024 07:58 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today that it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its pivotal […]
Hypertrophic Cardiomyopathy 101
What every student-athlete should knowMISSION, Kan., June 6, 2024 /PRNewswire/ — (Family Features) You may find it difficult to wrap your mind around the idea of an energetic student-athlete with a cardiac diagnosis. Heart conditions may be more often associated with older individuals, but you might be surprised to learn hypertrophic cardiomyopathy is the most common condition responsible for sudden cardiac death in young athletes. In fact, it’s the cause of 40% of sudden cardiac death cases.
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Photo courtesy of Shutterstock
Photo courtesy of Shutterstock
It’s estimated 1 in every 500 adults living in the United States has hypertrophic cardiomyopathy, according to the American Heart Association, but a significant percentage are undiagnosed. More than 80% of individuals who experience this condition show no signs or symptoms before sudden cardiac death. While sudden cardiac death is rare, it can occur during exercise or in its aftermath. That’s why it’s important for student-athletes and their loved ones to learn more about this condition and talk to a doctor about their risk.
With proper knowledge and the support of a skilled care team, it’s possible to manage hypertrophic cardiomyopathy with heart-healthy actions to prevent complications or worsening cardiovascular conditions like atrial fibrillation (a quivering or irregular heartbeat), stroke or heart failure. Hypertrophic cardiomyopathy awareness and education for athletes by the American Heart Association is made possible in part by a grant from the Bristol Myers Squibb Foundation.
What is hypertrophic cardiomyopathy?Hypertrophic cardiomyopathy is the most common form of inherited heart disease and can affect people of any age. It’s defined by thickening and stiffening of the walls of the heart. The heart’s chambers cannot fill up or pump blood out adequately, so the heart is unable to function normally.There are different types of this condition. Most people have a form of the disease in which the wall that separates the two bottom chambers of the heart (the septum) becomes enlarged and restricts blood flow out of the heart (obstructive hypertrophic cardiomyopathy).However, sometimes hypertrophic cardiomyopathy occurs without significant blocking of blood flow (nonobstructive hypertrophic cardiomyopathy). The heart’s main pumping chamber is still thickened and may become increasingly stiff, reducing the amount of blood taken in then pumped out to the body with each heartbeat.What are possible symptoms?Symptoms can include:
shortness of breath
chest pain
heart palpitations
fatigue
The severity of symptoms can vary, but if you experience them or if you have a family history of hypertrophic cardiomyopathy or sudden cardiac death, it may be a good idea to speak to your doctor about whether you have this condition.For some people, symptoms can get worse and new symptoms can appear over time, resulting in people dealing with harsher effects and a diminished ability to do the activities they love. This decrease in functions can be one of the most challenging aspects of the disease. Keeping your health care team aware of any new or changing symptoms allows them to work with you to develop a plan to manage these symptoms and reduce their impact.How is hypertrophic cardiomyopathy diagnosed?Medical history, family history, a physical exam and diagnostic test results all factor into a diagnosis. A common diagnostic test is an echocardiogram that assesses the thickness of the heart muscle and observes blood flow from the heart.If anyone in your family has been diagnosed with hypertrophic cardiomyopathy, other heart diseases or has been told they had thick heart walls, you should share that information with your doctor and discuss the need for genetic testing. Because this condition is hereditary, first-degree relatives, which include siblings and parents, should be checked.Learn more at heart.org/HCMStudentAthlete.Photos courtesy of ShutterstockMichael French[email protected]1-888-824-3337editors.familyfeatures.comAbout Family Features Editorial SyndicateA leading source for high-quality food, lifestyle and home and garden content, Family Features provides readers with topically and seasonally relevant tips, takeaways, information, recipes, videos, infographics and more. Find additional articles and information at Culinary.net and eLivingToday.com.SOURCE Family Features Editorial Syndicate
MiRus Siegel™ TAVR: First in Human Results Presented at New York Valves
Five sequential patients with severe, symptomatic aortic stenosis (AS) were treated at the Instituto Nacional Del Torax in Santiago, Chile by Drs. C. Dauvergne, J. Sandoval and P. Yadav. Three patients had bicuspid aortic valves and two were tri-leaflet. Three patients had peripheral arterial disease with vascular access < 5.5 mm. There was no mortality or stroke at 30 days and no patients required a permanent pacemaker (PPM) or suffered vascular complications. At 30 days, the mean echo gradient was 6.7 mmHg; four of the five patients had no peri-valvular leak (PVL) and one bicuspid patient had trace PVL. "The ease of use and hemodynamics were impressive" commented Pradeep K. Yadav, MD. "On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning. The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love. Also the frame strength and virtually no recoil, allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability." The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon.The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil."This initial data is striking and potentially heralds a new age for TAVR," stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute. "The ability to treat such complex patients with an 8 French system and without Nickel exposure should make TAVR safer and more broadly accessible. From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients. We are truly on the precipice of surgical-like outcomes with the Siegel THV!!"About MiRus, LLC.MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved.* MiRus® , Siegel™ are all trademarks of MiRus, LLC. Contact:Pam CowartVP of Clinical Affairs[email protected]770-861-4804SOURCE MiRus
CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath
BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years. While vascular access for hemodialysis can be initiated in an inpatient setting, ambulatory surgical centers or vascular access centers offer a less-invasive, outpatient-based alternative for patients. The company estimates that up to 100,000 HD-CVC placements occur each year, and pass-through status ensures that providers are reimbursed separately for administration of DefenCath in this setting of care. Given that approximately 50% of catheter-related bloodstream infections, or CRBSIs, can occur within the first 90 days that a catheter is inserted, it is critical to protect the line beginning at the time of placement. DefenCath® (taurolidine and heparin)IMPORTANT SAFETY INFORMATION These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath. LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients. DefenCath is contraindicated and has warnings and precautions in patients with: Known heparin-induced thrombocytopenia (HIT).Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products. If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures. To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Please see the full Prescribing Information. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisors(617) 430-7576
Anthos Therapeutics Announces ~84% of Eligible Patients Have Transitioned to Abelacimab in the AZALEA-TIMI 71 Extension Study of Atrial Fibrillation Patients at a Moderate-to-High Risk of Stroke
75% of patients in the rivaroxaban arm voluntarily switched from the once-daily oral anticoagulant to once-monthly abelacimab Landmark AZALEA-TIMI 71 Study previously stopped early due to an overwhelming benefit favoring abelacimab relative to rivaroxaban across all bleeding endpoints Data Monitoring Committee (DMC) recommended an open-label extension for all eligible patients to benefit from abelacimab treatment Abelacimab is a once-monthly, highly selective, fully human monoclonal antibody that achieves a near complete 99% inhibition of Factor XI CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today provided an update on the transition of patients in the open-label extension (OLE) portion of the AZALEA-TIMI 71 study. When the independent data monitoring committee (DMC) recommended that the study be stopped early because of the substantially greater than anticipated reduction in bleeding events favoring abelacimab over rivaroxaban, they also recommended that an optional open-label extension be made available so that all eligible patients could potentially benefit from abelacimab treatment. “The impressive bleeding reductions with abelacimab in the AZALEA-TIMI 71 study represent a potential game changer for how we treat patients with atrial fibrillation in the future, so it was no surprise when almost 84% of eligible patients, including the vast majority who had been on rivaroxaban during the trial, voluntarily decided to enter the open-label extension to receive abelacimab,” said Dr. Christian T. Ruff, MD, MPH, Principal Investigator of AZALEA-TIMI 71, the Director of General Cardiology at Brigham and Women’s Hospital, Senior Investigator of the TIMI Study Group, an Associate Member of the Broad Institute of MIT and Harvard, and an Associate Professor of Medicine at Harvard Medical School. The initial results of the AZALEA-TIMI 71 study1 of patients with atrial fibrillation at moderate-to-high risk of stroke were presented at the American Heart Association 2023 scientific congress during a late-breaking session. For the primary endpoint, abelacimab 150 mg dosed once-monthly, demonstrated a highly significant 67% reduction in major or clinically relevant non-major bleeding.1 In addition, there was a substantial 74% reduction in major bleeding alone and a 93% reduction in gastrointestinal (GI) bleeding, all favoring abelacimab over rivaroxaban, a standard-of-care anticoagulant.1 “We are very pleased that the open-label extension of the AZALEA-TIMI 71 study has completed its transition phase and that the vast majority of eligible patients voluntarily opted to receive abelacimab 150 mg once-monthly moving forward,” said Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. “Too many patients with diagnosed atrial fibrillation are not receiving an anticoagulant today or are taking an inappropriate dose, due to the risk or fear of bleeding, the possibility for drug-drug interactions, dosing complications due to age or renal status or just because they forget to take their daily medication. If approved, it is our hope that abelacimab will provide patients with the protection they need against blood clots, but with a placebo-like bleeding profile.” Atrial fibrillation, or AF, is the most common type of irregular heart rhythm. The most severe complication of AF is stroke,2 which can be prevented by taking an anticoagulant, or “blood thinner.” The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.3 However, data from multiple patient registries and claims-based data analyses highlight that approximately 40% to 60% of patients with atrial fibrillation are either not on an anticoagulant or are receiving a sub-therapeutic dose and are thereby not benefiting from the protection that anticoagulants provide. This underuse of anticoagulants has been cited as one of the greatest public health issues facing cardiovascular patients.4 About Abelacimab Abelacimab is a highly selective, fully human monoclonal antibody that binds to FXI and locks it in the inactive state, preventing the formation of activated FXI (FXIa). As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low. There is no need to adjust the dose based on age or renal/hepatic status. Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.5 Abelacimab is the only Factor XI inhibitor being studied for both conditions. In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.1 In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.6 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.7 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. About the AZALEA-TIMI 71 Phase 2 Study The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluated the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The primary endpoint of the AZALEA-TIMI 71 study was the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint was major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily. With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant. Summary of Results as Presented During the American Heart Association 2023 Scientific Sessions:1 Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P
RapidAI Wins 2024 MedTech Breakthrough Award For “Best Care Coordination Platform”
LOS ANGELES, June 06, 2024 (GLOBE NEWSWIRE) — MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies, and products in the global digital health and medical technology market, today announced that RapidAI, the global leader in developing Artificial Intelligence (AI) and clinical workflow solutions to combat life-threatening neurovascular, cardiac, and vascular diseases, has been selected as the winner of the “Best Care Coordination Platform” award in the 8th annual MedTech Breakthrough Awards program. The 2024 MedTech Breakthrough Award recognizes the breakthrough innovation of the RapidAI Clinical Platform, a proven solution that provides clinicians from thousands of hospitals in over 100 countries with deep clinical context to make faster and more informed treatment decisions while also enhancing their confidence in diagnosis. By opening up the care pathway through the power of AI and enhanced connectivity, RapidAI transforms the quality of care delivered to patients by facilitating faster, more informed decision-making. “RapidAI’s Clinical Platform moves the needle by pairing together the most clinically validated deep AI algorithms with workflow efficiencies that take the friction out of the healthcare system, making it our ‘Best Care Coordination Platform’ for 2024,” said Steve Johansson, managing director of MedTech Breakthrough. “The workflow efficiencies and connectivity that RapidAI enables ensures that every patient, no matter where they go for care, has access to the most trusted technology and clinical specialists – all while delivering measurable financial and operational impact.” According to the World Stroke Organization (WSO), over 100 million people in the world have experienced a stroke, of which over half will die as a result. On top of this, the WSO estimates 143 million healthy years of life are lost for those who do survive. For stroke patients alone, RapidAI’s technology has been shown to reduce both length-of-stay and non-fatal complications, increase mechanical thrombectomy procedure volume, reduce the number of costly futile transfers, and give radiologists and hospital staff valuable time back through its cutting-edge AI and workflow solution. “We are honored that the RapidAI Clinical Platform has been recognized by MedTech Breakthrough for the care orchestration and workflow efficiencies that it enables,” said Karim Karti, CEO of RapidAI. “By enhancing cross-department collaboration and team communication, the RapidAI Clinical Platform benefits care teams by fostering prompt collaboration and mitigating wasted time and resources. Our commitment to delivering clinical, financial, and operational excellence in advanced artificial intelligence distinguishes our platform from other healthcare AI imaging solutions in neurology, cardiology, and beyond. ” The mission of the MedTech Breakthrough Awards is to honor excellence and recognize innovation, hard work, and success in a range of health and medical technology categories, including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices, Medical Data & Privacy, and many more. This year’s program attracted thousands of nominations from over 18 different countries throughout the world. About MedTech BreakthroughPart of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com. Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose. About RapidAIRapidAI is the global leader in AI imaging analysis and clinical decision support, leading the next evolution in patient workflow technology and clinical decision-making. The company has helped set a new standard for stroke care with its presence in over 2,200 hospitals across more than 100 countries. Its clinically deep AI technology has played a pivotal role in over 25 clinical trials worldwide, 350 publications, and 11 NEJM articles, and was instrumental in changing the guidelines for stroke care. Today, the company continues to transform the clinical landscape by enhancing operational efficiency for improved patient outcomes in stroke care and beyond. This includes empowering healthcare professionals to make confident decisions, driving better operational performance, and providing tangible financial ROI – all while ensuring that every patient, regardless of their entry point into the healthcare system, has access to world-class technology and clinical expertise.
ECHO IQ TECHNOLOGY CHAMPIONED IN INDEPENDENT SCIENTIFIC REVIEW
Echo IQ’s EchoSolv-AS decision-support software for cardiology delivers significant potential benefits to hospital networks according to independent scientific presentation at prestigious New York Valves scientific conference.
NEW YORK, June 6, 2024 /PRNewswire/ — At the Structural Heart Summit New York Valves earlier today, Dr. Pedro Covas (Baylor Scott & White, The Heart Hospital Plano TX) delivered the scientific presentation: AI-Powered Cardiac Ultrasound Improves Identification of High-Risk Aortic Stenosis (Echo IQ).
Dr. Covas highlighted the unmet need for an AI system for aortic stenosis – a form of heart valve disease characterised by high rates of mortality when untreated. He revealed that the condition is underdiagnosed and undertreated worldwide, partly due to the complexity in the diagnosis of severe aortic stenosis (including low-flow states), and that there is a need for assistance to improve rates of diagnosis. As backed up by the research presented by Dr. Covas, Echo IQ uses artificial intelligence to aide in identifying a high-risk phenotype of aortic stenosis, to ultimately help with timely diagnosis and treatment.
LEARN HOW ECHO IQ USES AI TO SUPPORT ENHANCED DISEASE DETECTION:
The independent research presented by Dr. Covas considered whether artificial intelligence could improve accuracy and reproducibility of diagnosis of severe aortic stenosis in a real-world hospital setting. To test this, Echo IQ’s technology (EchoSolv) was applied to the echocardiographic report data of one of Baylor Scott & White’s leading academic heart hospitals over a 7-month period with a subset of the assessments adjudicated via comprehensive image review by expert cardiographers.
The findings showed EchoSolv to be successful in identifying more patients at risk of aortic stenosis than human-only diagnosis. Specifically,
EchoSolv accurately identified 15% more patients with severe aortic stenosis than human-only diagnosis
Where initial underdiagnosis occurred, patients were found to have a “low flow” state of disease in 30% of cases (subsequently identified by EchoSolv)
The research concluded that:
Echo IQ’s technology can automatically identify aortic stenosis patients at-risk using only echocardiographic measurement data.
Echo IQ’s technology has the potential to improve diagnostic rates of severe aortic stenosis, particularly in low flow states.
There are important implications for less specialized cardiology centers, where echocardiographers are likely to benefit the most from automated diagnosis of severe AS.
Echo IQ Chief Medical Advisor, Professor David Playford said: “This kind of independent research demonstrates exactly how Echo IQ’s artificial intelligence can help healthcare professionals identify patients with severe cases of aortic stenosis as well as those with significant risk of disease. Diagnosing aortic stenosis accurately, and in a timely fashion, is extremely complex and the findings shared by Dr. Covas show clearly how Echo IQ’s artificial intelligence can help improve clinical performance.”
About Echo IQ
Echo IQ uses artificial intelligence for decision support in structural heart disease. The company’s first fully AI-enabled solution has been submitted for final FDA clearance. The company is headquartered in Sydney, Australia and is publicly listed on the Australian Securities Exchange (ASX:EIQ). Don Fowler is President, Echo IQ USA, and is based in Austin, TX.
SOURCE Echo IQ Limited
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