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AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

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World’s First AI to Detect 35 Cardiac Determinations, Including Heart Attack, Using a Reduced LeadsetPowered by this AI, the Pocket-Sized Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac ConditionsMOUNTAIN VIEW, Calif., June 25, 2024 /PRNewswire/ — AliveCor, the global leader in AI-powered cardiology, today announced the U.S. Food & Drug Administration (FDA) clearance and commercial launch of KAI™ 12L AI technology and the Kardia™ 12L ECG System. This is the world’s first AI that can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System, featuring a game-changing patented technology, is the world’s first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.

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Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions Using Reduced Leadset

Pocket-Sized Kardia 12L ECG System

KAI 12L employs multiple deep neural network algorithms, trained and validated on more than 1.75 million ECGs from leading US medical centers. This AI technology can detect 35 cardiac determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI) and the most common types of cardiac ischemia, using a reduced leadset. KAI 12L can seamlessly integrate with compatible devices, including the Kardia 12L ECG System, expanding critical access to accurate heart data within a broad range of healthcare settings.

“Not only is it the first FDA-cleared AI that can detect a heart attack on a reduced leadset, but it also returns determinations for our broadest range of conditions yet,” said Priya Abani, CEO of AliveCor. “Paired with our pocket-sized Kardia 12L ECG System, this offering is poised to disrupt traditional care pathways and represents a leap forward in cardiac care.”
Kardia 12L ECG System is an innovative solution that requires only a single cable with 5 electrodes to acquire 8 high quality diagnostic bandwidth leads. Conventional 12-lead ECG machines are the standard of care for detecting and diagnosing many heart conditions, but their availability can be limited due to their size and complexity. Using advanced KAI 12L and a reduced leadset, Kardia 12L offers outstanding clinical efficiency and performance substantially equivalent to state-of-the-art ECG analysis solutions. Its speed and simplicity assists healthcare providers in rapid disease detection and enhancing patient experience. “The AI innovations in the Kardia 12L ECG System offer healthcare providers a clinically-validated handheld 12-lead ECG system and expands this critical technology into more resource-limited settings,” said Dr. Stavros Stavrakis, MD, PhD, Professor of Medicine, Division of Cardiology at the University of Oklahoma Health Sciences Center. “By streamlining the process of recording a 12-lead ECG, Kardia 12L has significant implications for rapid ECG diagnosis in clinical practice.”Kardia 12L is battery-operated, weighs just 0.3 pounds and can fit in a pocket – making it significantly smaller, more portable and more convenient than conventional 12-lead ECG machines. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler to use than standard 12-lead ECG machines. These features put 12-lead ECG data within reach of more healthcare providers than ever before in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and other under-resourced or rural venues.For healthcare providers interested in purchasing a Kardia 12L, please visit alivecor.com/products/kardia12L.About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L to detect 35 cardiac conditions (14 arrhythmias and 21 morphologies), was designed exclusively for use by healthcare providers. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook.Media ContactsSu Leeslee191@alivecor.com(562) 544-4634Ben Rickles[email protected](404) 502-6766SOURCE AliveCor, Inc.

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Heart Hospital of New Mexico at Lovelace Medical Center and GE HealthCare Collaborate to Install the First Allia IGS Pulse Electrophysiology Lab in the United States for Minimally Invasive Cardiovascular Procedures

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ALBUQUERQUE, N.M.–(BUSINESS WIRE)–Today Heart Hospital of New Mexico at Lovelace Medical Center (HHNM) and GE HealthCare (Nasdaq: GEHC) announced HHNM as the first location in the United States to install GE HealthCare’s latest Allia Image Guided System (IGS) Pulse, which was designed to provide […]

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Vizient examines pulsed field ablation, wearables for women’s cardiovascular health in latest Medical Device Tech Watch

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IRVING, Texas–(BUSINESS WIRE)–Vizient, Inc. examines pulsed field ablation technologies for atrial fibrillation and the role wearable monitoring devices can play in women’s cardiovascular health in the latest Medical Device Tech Watch. “By working closely with providers, we have developed best practices for […]

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Haemonetics Launches Limited Market Release for New VASCADE MVP XL Vascular Closure Device

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BOSTON, June 18, 2024 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions to drive better patient outcomes, has launched a limited market release of its new VASCADE MVP® XL mid-bore venous closure device. The VASCADE MVP XL system expands Haemonetics’ VASCADE® portfolio of vascular closure systems featuring an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis.
Haemonetics’ current VASCADE portfolio includes the VASCADE system, designed for “small-bore” femoral arterial and venous closure with standard 5-6/7F procedural sheaths, and the VASCADE MVP® system, designed for “mid-bore” multi-access femoral venous closure with 6-12F procedural sheaths. The upsized VASCADE MVP XL system utilizes 58% more collagen and a larger disc than the current VASCADE MVP system, providing a robust closure solution for procedures requiring 10-12F sheaths (up to 15F in outer diameter) such as cryoablation and left atrial appendage closure for atrial fibrillation patients.
“With VASCADE MVP XL, Haemonetics continues to expand its presence and broaden its reach in the $2.7 billion total addressable market for vascular closure solutions,” said Stew Strong, President of Global Hospital at Haemonetics. “The introduction of VASCADE MVP XL underscores our commitment to innovation and improving patient care, as we enhance our range of vascular closure solutions to address increasing demand for catheter-based ablation technologies. We are enthusiastic about the initial launch of VASCADE MVP XL and anticipate a full market release later this year.”
The VASCADE MVP XL system earned pre-market approval from the U.S. Food and Drug Administration this spring. The limited market release follows the first procedure performed using VASCADE MVP XL by Dr. Tom McElderry, Section Chief, Electrophysiology and Co-Director Heart & Vascular Center at the University of Alabama at Birmingham.
About Haemonetics
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services. Haemonetics’ Global Hospital business provides a range of solutions to address the needs of hospitals, including Interventional Technologies for electrophysiology and interventional cardiology, and Blood Management Technologies that include diagnostics to help inform treatment decisions, technologies to help avoid unnecessary allogeneic transfusions and solutions to help optimize management of blood products. To learn more about Haemonetics, visit www.haemonetics.com.
Cautionary Statement Regarding Forward-Looking Information 
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the Vascade MVP XL vascular closure device and Haemonetics’ plans or objectives related to the commercialization of such product. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics’ current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of global economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics’ periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.

Investor Contacts:  

Olga Guyette, Vice President-Investor Relations & Treasury 
David Trenk, Manager-Investor Relations

(781) 356-9763
(203) 733-4987

[email protected] 
[email protected]

Media Contact:

Josh Gitelson, Senior Director-Global Communications

(781) 356-9776

[email protected]

SOURCE Haemonetics Corporation

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Elutia Announces FDA Clearance of EluPro®: The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators

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EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the $600 million U.S. implantable electronic device protection market EluPro also granted clearance for indications beyond CIEDs, including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting BioEnvelope, EluPro® (referred to as CanGaroo®RM during development), has received clearance from the U.S. Food and Drug Administration (FDA). Specifically designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that over time regenerates into a protective pocket of the patient’s own tissue. Infection, migration, and skin erosion are some of the most frequently encountered complications of pacemaker surgery, occurring in up to five to seven percent of cases. These cause significant patient morbidity and mortality, increase the length of hospitalization, and can add more than $50,000 to healthcare costs per event. In development since 2019 and protected by intellectual property extending beyond 2032, EluPro is the only biologic offering in the $600 million U.S. implantable electronic device protection market. The Company also announced that EluPro was granted clearance for indications beyond the cardiac implantable electronic devices (CIEDs), including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea. These additional markets, estimated to be $8 billion worldwide, have not previously been served by a drug-eluting biomatrix and present significant additional growth opportunities for EluPro. “When I implant a pacemaker or defibrillator, minimizing the risk of any future complications is crucial,” said Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center. “However, the body’s natural immunity can treat the device like a foreign object contributing to inflammation, causing device migration, potentially eroding through the skin, or sometimes causing a serious infection. Those are the specific problems EluPro was designed to solve. It combines the remodeling properties of regenerative medicine through extracellular matrix along with long-acting antibiotic delivery to create a healthy environment for every device implantation.” The EluPro BioEnvelope is constructed from reinforced layers of natural extracellular tissue matrix and designed to create a conforming envelope with optimal stability for implantable electronic devices. The walls of EluPro are embedded with powerful antibiotics rifampin and minocycline, engineered for extended delivery directly into the surgical site long after closure. This unique combination of drug and biomatrix supports the regeneration of a healthy, vascularized pocket from the patient’s own tissue, mitigating a long-term foreign body response. “Post-operative infection, migration and erosion can result in significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That is why we developed the antibiotic-eluting BioEnvelope,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. “While the approval of EluPro is a major value inflection for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body response that can inevitably develop with any long-term implantable device. We intend to rapidly extend our product offering to other indications as we fulfill our mission to humanize medicine so patients can thrive without compromise.” EluPro represents a significant opportunity in the $600 million U.S. implantable electronic device protection market, previously served by a single competitor. With over 600,000 devices implanted in the U.S. annually, EluPro addresses significant complications arising from these procedures. Elutia plans to launch EluPro into the CIED market nationwide in the second half of 2024 and is prioritizing adjacent markets in the neurostimulation and modulation space, where implantable medical devices result in high rates of addressable complications. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise,” “opportunity” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements regarding EluPro’s potential future success in the CIED protection market or in device protection for other types of implantable devices, like neurostimulators or neuromodulators, and statements regarding market size. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to continue as a going concern; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits; our ability to achieve or sustain profitability; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; the continued and future acceptance of our products by the medical community; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com

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FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials

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With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.

Clario’s SpiroSphere® integration with the wireless COR-12 is now FDA 510(k) cleared, allowing for consecutive collection of spirometry and ECG data during a single site visit.
The flexibility of the wireless COR-12 ECG enables integrated respiratory and cardiac safety trials for on-site, hybrid or remote trial design considerations.
The wireless feature of the SpiroSphere® ECG improves patient experience by removing the need for lead wires while maintaining high-quality data collection and accelerating trial timelines.

PHILADELPHIA, June 13, 2024 /PRNewswire/ — Clario, a leading provider of technologies and endpoint data solutions for clinical trials, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This technological advancement allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario’s SpiroSphere® platform, consolidating all data into a single, unified database. This streamlines the clinical trial process and eliminates the need for separate ECG devices or multiple databases for a study.
Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, initially did not include ECG functionality. Now, the introduction of the SpiroSphere® ECG features the wireless COR-12 ECG device. This advancement enables customers to run integrated respiratory and cardiac safety trials on a single device and single database, simplifying the clinical trial process.
“The launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology,” said Tom Stuckey, Senior Vice President, Respiratory & Precision Motion at Clario. “This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety.”
Ellen Street, Executive Vice President, Cardiac, Respiratory & Precision Motion at Clario added, “Our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining the high-quality data collection standards as our wired ECG model. With this wireless technology, site clinicians can now comfortably record both ECG and spirometry data in a single session on a single device, which can reduce the necessity for multiple devices, reduce burden, and accelerate trial timelines.”
This new product not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience. For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com.
About ClarioClario is a leading healthcare research and technology company that generates high clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.
Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.
For more information, go to Clario.com or follow us on LinkedIn.
Media Contact:Alexis NavratilCommunications Manager[email protected] 
SOURCE Clario

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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

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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

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ACSD Granted Significant Telemedicine Patent

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IRVINE, Calif., June 5, 2024 /PRNewswire/ — ACS Diagnostics, Inc. of Irvine CA, with executive offices in Chattanooga TN, has been granted U.S Patent No. 11,980,452. The patent relates to ACSD’s Cardiac Monitoring CORE technology, specifically ambulatory ECG. The patented CORE device provides for multiple telemedicine related tests , including ECG/EKG, Holter, Event, and Mobile Cardiac Telemetry. The Core monitor integrates a cell phone module to alleviate the necessity for a companion phone for patient transmissions.
This is the fifth CORE technology patent, and relates to a single cardiac monitoring device offering to perform more than one of the above mentioned test modalities. The Core monitor is the only telemedicine device that is patented to offer the worldwide cardiology community all these tests within a one device. With this patent, the days of a provider needing to purchase a different monitor for each test are over.
This technology, and all related test modalities, are being successfully used by thousands of US customers, transmitting ECG patient data 24/7 to our California based IDTF laboratory. The ACSD IDTF laboratory is completely staffed with cardiac technicians to monitor patients and alert physicians to significant cardiac events.
A number of companies provide products for this market, including GE Healthcare, Medtronic, BioTelemetry / Philips, Boston Scientific, Samsung, Hill-Rom, IRhythm Technologies, Johnson & Johnson, OSI/Spacelabs, and a host of smaller players.
ACSD respects intellectual property rights and has a growing portfolio of patents, which are listed at www.ACSD4u.com/patents. ACSD firmly believes in innovation through research and development, and it will vigorously enforce its intellectual property rights.
SOURCE ACS Diagnsotics

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AliveCor’s AI-backed ECG Offerings Featured in New Film Series on Innovative Technologies Presented by the Consumer Technology Association

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The Human Component series, produced by BBC StoryWorks Commercial Productions, is now available to stream 
MOUNTAIN VIEW, Calif., June 5, 2024 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced its participation in The Human Component, a new online branded series developed for the Consumer Technology Association (CTA) and produced by BBC StoryWorks Commercial Productions, the commercial content division of BBC Studios.
The series showcases innovative technologies that are supporting healthier communities, stronger societies and a more resilient planet. Through compelling, human-led films, The Human Component celebrates global efforts to maximize the full potential of technology.
“We are incredibly proud to take part in The Human Component alongside innovators who are just as committed to introducing game-changing ideas to improve lives as we are,” said Priya Abani, CEO of AliveCor. “The series beautifully depicts the real-life impacts of technologies like our AI-backed ECG solutions and services, and how they are helping transform society for the better.”
AliveCor’s film shares the story of Dr. Cleveland Francis, a cardiologist and musician who was diagnosed with a heart condition after collapsing at home. After his episode, Dr. Francis used one of AliveCor’s FDA-cleared Kardia™ devices to take a real-time, clinical-grade ECG that he shared with his doctor, leading to a definitive diagnosis. Capable of remotely identifying six of the most common arrhythmias in just 30 seconds, Kardia personal ECGs place the power of advanced AI technology directly into users’ hands. They also offer healthcare providers a way to capture patients’ elusive arrhythmias, contributing to earlier diagnoses and improving clinical decision-making.
This is the second series that BBC StoryWorks has created for CTA, a trade association that brings together companies that improve lives through technology. By highlighting how innovators across industries are advancing groundbreaking new technologies, The Human Component explores how we can solve some of the most pressing challenges facing the world today.
To learn more, watch AliveCor’s full film at alivecor.com/cleveland-cardiology-ai.
About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook.
SOURCE AliveCor, Inc.

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