Latest news with #BreakthroughDevice
Fast Company
18-06-2025
- Health
- Fast Company
A revolution in heart disease treatment
Cardiovascular disease affects 315 million people globally and is the world's leading cause of death. For the past quarter-century, it has been standard practice for heart surgeons to treat this by inserting small, mesh tubes called stents to widen or unblock patients' coronary arteries to restore blood flow. Unfortunately, many of those patients experienced additional issues—from blood clots to heart attacks—within years, sometimes months, of the procedure. That's where DynamX, a new vascular technology from Elixir Medical, comes in. Like traditional stents, DynamX is minimally invasive and expands arteries to promote blood flow, but their unique design also enables them to restore arteries' natural defense mechanisms, helping patients avoid life-threatening events or costly and dangerous repeat procedures. The technology's promise to allow cardiac patients to heal more completely and live full, productive lives earned Elixir a spot as one of Fast Company 's 2025 Most Innovative Companies. Novel technology, proven effectiveness Traditional stents solve heart patients' immediate, critical need for restoring arterial blood flow. However, because they don't heal the arteries themselves, about half of patients re-experience an adverse medical event within 10 years, says Motasim Sirhan, Elixir founder and CEO. DynamX is different. After six months, Elixir's implant transforms into an essential part of the artery itself as its mesh tube unlocks, freeing and reinforcing the artery's wall. The implant then gradually restores and adapts to the blood vessel's natural pulsing motion. 'You need to address the disease where it's originating, not the just symptoms of it,' Sirhan says. 'This is the first technology to do that.' In the spring and fall of 2024, Elixir announced the results of a pair of large, international randomized clinical trials that demonstrate DynamX's favorable results. Patients with these implants had 65% fewer serious heart events and 78% fewer issues in the left anterior descending artery—which is critical for heart function as it supplies 50% of blood to the heart—than patients with traditional stent implants. Last year, recognizing DynamX's promise, the U.S. Food and Drug Administration granted Elixir 'Breakthrough Device Designation' (BDD) on two applications of its DynamX technology: to treat heart artery blockage and serious artery blockages in the leg below the knee. BDD accelerates the review and approval process for novel technologies that may provide more effective treatment of life-threatening diseases and conditions. Patient-focused solutions As they developed DynamX, the company's researchers never lost sight of the seriousness and scale of the problem they were addressing. Many people begin to have cardiac issues in their 50s and 60s, requiring them to undergo multiple procedures. Patients often miss a substantial amount of work and sometimes can't participate fully in family activities. As Sirhan puts it, these hardships—on top of the millions or cardiac deaths annually—are 'not acceptable.' Elixir's innovative solution is the product of a multidisciplinary team of experts in physics, biology, chemistry, engineering, and other fields. The researchers addressed the challenge from different perspectives but with a singular mission: serving patients. 'What was important for us,' Sirhan says, 'was being able to make a difference in patient treatment and to not be fazed by the difficulty of the mission.'
Associated Press
18-06-2025
- Business
- Associated Press
Gradient Denervation Technologies Announces Acceptance into FDA's Total Product Life Cycle Advisory Program for Development of its Pulmonary Artery Denervation System
PARIS, June 18, 2025 (GLOBE NEWSWIRE) -- Gradient Denervation Technologies announced today that it has been accepted into the Total Product Life Cycle Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel technology intended to treat patients with pulmonary hypertension and associated heart failure. The TAP Pilot acceptance follows the Company's recent announcement that the FDA granted Breakthrough Device Designation for the Gradient Denervation System. The FDA's Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite patient access to safe and effective, innovative medical devices. To help accelerate development of Gradient's Denervation System, the TAP Pilot will allow the company to have early and frequent interactions with FDA as well as obtain strategic advice from providers, associations, payors and patient organizations. The Gradient Denervation System is a novel technology intended to treat patients with Group 2 pulmonary hypertension due to left-sided heart disease. Treatment is accomplished by ablating nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform was designed specifically for the pulmonary artery anatomy and leverages known interventional techniques. The treatment goal is to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures. 'We're excited to be included in the TAP Pilot as the program will help streamline collaboration with FDA – from initiating our pivotal clinical study to accelerating access to this breakthrough therapy upon approval,' said Martin Grasse, Chief Executive Officer at Gradient Denervation Technologies. 'There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients, which reinforces the need to expedite access to new innovative therapies. We expect that guidance from TAP Pilot advisors will be immensely valuable in developing a targeted therapy intended to improve outcomes and quality of life for these underserved patients.' About Gradient Denervation Technologies Gradient Denervation Technologies is a Paris-based medical device company developing a minimally invasive, ultrasound-based device for the treatment of pulmonary hypertension. Gradient leverages intellectual property developed at Stanford University. The Gradient Denervation System is for investigational use only and is not approved for commercial use. For more information, please visit: Media Contact [email protected]
Business Wire
17-06-2025
- Health
- Business Wire
Mursla Bio Introduces AI Precision Medicine Platform Built on Organ-Specific EV Isolation from Blood
CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to advance precision diagnostics and significantly improve cancer outcomes for at-risk patients, today announced the commercial launch of its AI Precision Medicine Platform, alongside a pre-print¹ reporting the first validated method for isolating hepatocyte EVs from plasma for organ-specific proteomic and miRNA profiling. Mursla Bio is engaging with potential partners to apply its Platform to additional disease areas, biomarker discovery and IVD translation programs. The Platform addresses a major gap in liquid biopsy and precision medicine: enabling non-invasive access to organ-specific molecular information from blood with high spatial and biological resolution. Mursla Bio's Platform is built on its ability to isolate and analyze EVs which are secreted by specific organs into the bloodstream. The Platform reduces non-target background by up to five orders of magnitude compared to standard bulk EV isolation and significantly improves data structure, enhancing prediction model generalization. The pre-print presents the first multi-layered validation of hepatocyte EV isolation in humans, confirming liver origin through proteomic and nucleic acid markers. Key supporting proteomics data was generated in collaboration with Evotec International GmbH. Patient samples were provided by University College London, with Professor Brian Davidson, a global leader in liver disease surgery and clinical research, contributing as a co-author. The study shows that Mursla Bio's method yields robust, organ-specific multi-omics data using minimal blood volume, offering a novel scalable approach for biomarker and AI development. Mursla Bio's Platform incorporates optimized multi-omics workflows, embedded AI pipelines, and IVD translation processes to convert complex biological signals into practical, regulatory-grade assays. These assays are deployable on standard commercial instruments using patented, PCR and ELISA-like steps designed for clinical adoption. The Platform also underpins the development of EvoLiver™, the Company's lead clinical program for liver cancer surveillance in cirrhotic patients. Built on multi-omics data from over 300 patients, EvoLiver achieved 86% sensitivity and 88% specificity on a locked, IVD-compatible assay for early-stage hepatocellular carcinoma detection², and has received Breakthrough Device Designation from the FDA³. Pierre Arsène, Founder and CEO of Mursla Bio, said: "EVs are nature's native signal enrichment system for long-distance communication between cells and organs. Our platform harnesses this biology to non-invasively access organ-specific, multi-omics data from just a small blood sample. It produces structured, biologically labeled datasets that are optimized for AI and ready to support diagnostic translation. EvoLiver is our first proof point of real-world clinical impact, and we are now expanding access to the platform to advance our pipeline and enable partnerships across other disease areas.' Mursla Bio is expanding its pipeline and collaborations, with additional organ programs underway in cardiometabolic, lung, and neurological indications. The Platform will support pharma development through dynamic patient stratification, therapeutic response monitoring, surrogate markers and molecular phenotyping across complex disease biology. For further information on Mursla Bio's AI Precision Medicine Platform, please visit
Cision Canada
20-05-2025
- Business
- Cision Canada
Pulnovo Medical Welcomes EQT as a New Investor Following CE-MDR Approval, with Continued Support from Qiming Venture Partners
HONG KONG, May 20, 2025 /CNW/ -- Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), has received new investment from EQT Group, a top-tier global private equity firm, as a new investor, alongside continued support from Qiming Venture Partners. This latest investment, following Pulnovo Medical's recent CE-MDR certification in Europe, marks a major step forward in expanding treatment options for patients with pulmonary hypertension globally. It is expected to accelerate the company's global expansion by supporting international clinical trials, regulatory approvals, indication expansion, and commercialization. Founded in 2013, Pulnovo Medical addresses a critical unmet need in cardiovascular care by developing a first-in-class medical device based on pulmonary artery denervation (PADN) core technology. It was awarded US FDA Breakthrough Device designation in 2021 and FDA Humanitarian Use Device designation in 2023. Its catheter and generator received China NMPA Approval as a breakthrough device in late 2023, followed by FDA clearance of the 9F sheath in 2024. In March 2025, the company obtained CE-MDR certification, marking a key milestone toward global commercialization. Zoe Zhu, Director in the EQT Private Capital Asia advisory team said: "Globally there is a significant unmet clinical need for patients with pulmonary hypertension and heart failure, Pulnovo's PADN solution offers new hopes for these patients with strong clinical evidence supporting improved outcomes and growing endorsement from the global medical community. EQT is excited to support Pulnovo Medical by leveraging our deep expertise in healthcare and life sciences, along with our global network, to help advance their mission of delivering novel cardiovascular solutions to patients in need worldwide." Cynthia Chen, Chairwoman and Executive Chair of Pulnovo Medical, stated: "We sincerely thank EQT and Qiming Venture Partners for their continued trust and partnership. Since day one, Pulnovo Medical has remained focused on addressing real, unmet clinical needs—developing original, scalable, and evidence-based solutions rooted in frontline care. While the path to transforming clinically driven innovation into global standards is challenging, we remain committed to delivering meaningful, science-based medical value to patients around the world."
Associated Press
17-05-2025
- Health
- Associated Press
Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer's Disease
MALVERN, Pa., & TOKYO--(BUSINESS WIRE)--May 17, 2025-- Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer's disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer's Disease (AD). Alzheimer's disease currently affects an estimated 7.2 million Americans, a number projected to rise to nearly 14 million by 2060. 1 It is a leading cause of disability and death. AD develops over many years, long before symptoms are evident, but the lack of accessible, minimally invasive diagnostics results in many patients remaining undiagnosed until the disease is well advanced, when few effective interventions remain. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test is an accurate, minimally invasive, accessible measurement of pTau 217 and β-Amyloid 1-42 concentrations in plasma as a proxy for the presence of β-Amyloid plaque pathology in the brain. It is intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. In a clinical study population of 499 patients, which closely mirrored the US demographics, and when applying a dual cut point, the test demonstrated a positive predicate value (PPV) of 92%, a negative predicate value (NPV) of 97% with only 20% patients who are uncertain to have amyloid pathology, thus requiring further testing. The Lumipulse pTau 217/ β-Amyloid 1-42 Plasma Ratio test uses Fujirebio's fully automated LUMIPULSE ® G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022. 'The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment,' says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. 'The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective. As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.' About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years' accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio offers a comprehensive line-up of manual and fully automated assays for neurological diseases and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at About Fujirebio Diagnostics, Inc. Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at Reference 1. (2025), 2025 Alzheimer's disease facts and figures. Alzheimer's Dement., 21: e70235. View source version on CONTACT: MEDIA CONTACT:Chris Dague Fujirebio Diagnostics, Inc. Office: 484-395-5556 [email protected] KEYWORD: UNITED STATES NORTH AMERICA ASIA PACIFIC PENNSYLVANIA INDUSTRY KEYWORD: GENETICS HEALTH NEUROLOGY MEDICAL DEVICES SOURCE: FUJIREBIO Copyright Business Wire 2025. PUB: 05/17/2025 02:58 AM/DISC: 05/17/2025 02:57 AM
