Dental Plaque

MOUNTAIN VIEW, Calif., May 15, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced that the data from its REVEALPLAQUE study, highlighting the accuracy of its Plaque Analysis, was published in the European Heart Journal Cardiovascular Imaging. REVEALPLAQUE aimed to evaluate HeartFlow’s non-invasive plaque technology, an automated, deep learning-based method for identifying, characterizing, and segmenting plaque in the coronary arteries. Understanding the volume and composition of plaque allows physicians to ensure appropriate medical treatment, which could be life changing for patients. Key Results: HeartFlow Plaque Analysis is highly accurate in determining total plaque volume and plaque volume by type vs. invasive imaging (IVUS)1 Total Plaque Volume vs. IVUS: 95% agreementCalcified Plaque Volume vs. IVUS: 95% agreementNon-Calcified Plaque Volume vs. IVUS: 93% agreement HeartFlow Plaque Analysis is the only FDA cleared, AI-enabled plaque quantification tool validated in a prospective, international trial against the gold standard of invasive imaging (IVUS) using blinded core lab adjudication.1 Heart disease is the leading cause of death for both men and women.² Four out of five of the deaths may be preventable with nutrition, lifestyle, and medication therapy changes for patients identified early.³ Now with HeartFlow Plaque Analysis, physicians can measure confidently and accurately, the volume by type. Ultimately, this supports patients in a technology forward way that hasn't previously been possible. “I’m thrilled to see such an overwhelming result showcasing that CT angiography, coupled with automated AI-driven Plaque Analysis is an effective way to assess plaque burden,” said Jagat Narula, M.D., Ph.D., co-principal investigator and and K. Lance Gould Distinguished University Chair of Coronary Pathophysiology at UTHealth Houston. “This is a futuristic step forward for patients and clinicians to have an accurate, non-invasive test that gives insights into their total plaque volume, and is every bit as good as the invasive reference standard. It will allow clinicians to feel more informed to deliver the best treatment recommendations possible for each patient.” The REVEALPLAQUE trial was a large, global prospective study which enrolled 258 patients across 15 sites in the U.S. and Japan. This was an independent, blinded, core lab adjudicated study to determine the accuracy of HeartFlow’s AI Plaque Analysis compared head-to-head with IVUS. “HeartFlow continues to be the clear market leader in developing clinically useful AI-powered tools for non-invasive diagnostic testing for coronary artery disease. What’s more, we continue to support clinicians by providing an overwhelming body of clinical evidence attesting to their utility and accuracy,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of HeartFlow. “With the addition of the REVEALPLAQUE data, we’re pleased to highlight that we are the only platform that has conducted and published a head to head comparison vs. IVUS using the most rigorous approach possible. Our plaque assessment technology is highly accurate, giving clinicians confidence in the product to support their clinical decision making.” The HeartFlow Plaque Analysis technology is an automated method which analyzes coronary computed tomography (CT) scans and enables clinicians to visualize, characterize, and quantify plaque. The plaque technology is based on HeartFlow’s proprietary deep learning-enabled algorithms, which have been trained on more than 15 million coronary CT images. This critical information is delivered seamlessly to physicians in the HeartFlow platform, and when paired alongside anatomy and physiology of the patient, enhances decision-making for the clinician. HeartFlow’s Plaque Analysis is FDA cleared and is commercially available. HeartFlow has been adopted by over 1,000 institutions globally and continues to strengthen its commercial presence to make cutting-edge solutions more widely available to an increasingly diverse patient population worldwide. 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. Reference: 1 Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound EHJ 2024. ² CDC.org ³ Wang et al. JAHA 2020 Media Contact: Linly KuHeartFlowmedia@heartflow.com

Elucid also said that it is developing its FDA-cleared PlaqueIQ software toward a new indication, for calculating fractional flow reserve from CT scans—an analysis of the flow of oxygenated blood through the various branches of the cardiac muscle’s coronary arteries. The cardiovascular imaging company Elucid has made it clear they mean to deliver on their promise of artificial intelligence-powered exams to chart the insides of blocked arteries. And now they’ve raised $80 million to do so. Financially speaking, the startup has kept up its momentum since last year’s venture capital fundraising—with a $27 million series B in June 2022, which just about tripled its $8 million round from the year before. The most recent series C continues that trajectory, for a total of $121 million since Elucid’s founding. With green lights in the U.S. and Europe, the company’s diagnostic software takes CT angiography scan data and uses AI algorithms to build 3D models of the build-ups of plaque within the blood vessels—giving clinicians a much more detailed view into the key drivers of strokes and heart attacks, by simulating what a pathologist might see under a microscope with a physical sample. This can also include objective analyses of the make-up and stability of the arterial plaque itself, not just its geometry, to help predict the chances it may break apart and cut off blood flow down the line to the brain, heart or other organs of the body. Elucid also said that it is developing its PlaqueIQ software toward a new indication, for calculating fractional flow reserve from CT scans—an analysis of the flow of oxygenated blood through the various branches of the cardiac muscle’s coronary arteries. The company’s series C funding round was the first major public outing by Elevage Medical Technologies, a medtech-focused fund launched this past May with a $300 million investment from Patient Square Capital.  Elevage led the round with additional backing from Elucid’s previous investors, which have included Biovision Ventures, IAG Capital, Bold Brain Ventures, BlueStone Venture Partners and MedTex Ventures. Elevage’s CEO, Evan Melrose, and senior advisor Kelly Huang joined the company’s board of directors as part of the financing.

FreedomFlow orbital atherectomy peripheral platform is designed to clear the plaque blockages formed in the arteries of the legs, using an advanced mechanism of action, and supports a broad range of vessel diameters, from 2mm in the ankle to 8mm in the hip FreedomFlow Orbital Atherectomy Platform. (Credit: Business Wire) US-based medical devices firm Cardio Flow has received the US Food and Drug Administration (FDA) 510(k) approval for its FreedomFlow orbital atherectomy peripheral platform. The FreedomFlow platform is designed to incorporate an advanced mechanism of action to clear the blockages formed in the arteries of the legs, due to the accumulation of plaque. Its unique catheter-based design uses angular momentum to create a spiral geometry that enables the five diamond-coated spheres to be in contact with the vessel wall. The FreedomFlow platform also features a diamond-coated tip that enables the driveshaft to easily navigate through tight blockages, said the medical device maker. Cardio Flow CEO Michael Kallok said: “Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development. “Many of the existing atherectomy devices on the market have various design constraints and capital equipment costs. “With FreedomFlow, we strove to provide physicians with the freedom to treat complex PAD hip to heel with a simple yet sophisticated device that would answer the call for flexible treatment options and cost savings for healthcare systems.” Cardio Flow said that the unique approach of the FreedomFlow platform provides physicians with an effective and flexible way to treat complex peripheral arterial disease (PAD). It supports a broad range of vessel diameters, from 2mm in the ankle to 8mm in the hip and is flexible in treating multiple arteries and blockages in the same vessel, with a single device. The FreedomFlow platform enables time savings and cost efficiencies, with rapid and simple device setup, requires no capital equipment, or lubricant, and reduced inventory needs. It also provides quicker run times, consistent treatment outcomes, and a nearly flat learning curve for physicians, and is suitable for hospitals, ambulatory surgical centres, and office labs. Ascension St. John’s Hospital cardiovascular research director Thomas Davis said: “The incidence of patients presenting with multi-level PAD has increased dramatically in my practice, so having a flexible, efficient, and easy-to-use device that can treat PAD in a broad range of vessel sizes is a key advantage for physicians and patients as we seek to reduce the number of PAD-related amputations.”