Latest news with #BreakthroughDevice
Associated Press
5 days ago
- Health
- Associated Press
BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology
WINSTON-SALEM, N.C., Aug. 4, 2025 /PRNewswire/ -- BMI OrganBank, a pioneering leader in organ assessment and preservation, proudly announces that its revolutionary organ preservation device has received the prestigious Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation, granted for their kidney preservation device, underscores BMI OrganBank's commitment to advancing transformative technologies that will significantly improve outcomes for transplant patients. With current kidney perfusion technologies, which use cold storage temperatures, it is difficult to evaluate the function of kidneys before transplant. Furthermore, they are vulnerable to significant injury during the storage period before transplantation. As such, a large proportion of donated kidneys remain unused. BMI OrganBank's groundbreaking room temperature machine perfusion (RTMP) platform, developed in collaboration with leading transplant surgeons and academic medical centers, shows great promise to facilitate kidney quality assessment and extend preservation times. BMI OrganBank intends to increase the number of kidneys available for transplant and address stubbornly long kidney transplant waitlist times. A clinical study is planned for early next year. 'We are incredibly honored to receive this significant designation from the FDA and look forward to working with them as we prepare for clinical studies' stated Carrie DiMarzio, Chief Executive Officer and Co-Founder. David A. Gerber, MD, abdominal transplant surgeon and Chief Medical Officer stated 'We are energized by our promising preclinical data. The timing of this news is outstanding as my colleagues and I participate in the World Transplant Congress this week.' About BMI OrganBank® BMI OrganBank specializes in developing transformative perfusion systems for organ and tissue evaluation and preservation. With facilities at the Innovation Quarter in Winston-Salem, NC, and Research Triangle Park, NC, the company is advancing multiple medical devices that use its patented and proprietary technologies. Its flagship product, the portable OrganBank kidney device, was co-developed with leading transplant surgeons and is set to begin clinical studies soon. Learn more at View original content to download multimedia: SOURCE BMI OrganBank
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."
