Myocardial Ischemia

TAMPA, Fla., Jan. 20, 2025 /PRNewswire/ -- Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled. Continue Reading Concept Medical proudly announces that over 1,250 patients have successfully enrolled in the SirPAD Trial. The SirPAD (Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated or uncoated balloon) randomised controlled trial is the world's largest study evaluating the treatment of Peripheral Artery Disease (PAD) using the MagicTouch PTA Sirolimus Coated Balloon (Concept Medical Inc.) versus uncoated balloons and one of the largest device studies ever performed for PAD. More than 1,250 patients have been enrolled and will be followed up at 12 months to assess the primary outcome of major adverse limb events (MALE). Final results are expected by Q1-Q2 2026. SirPAD is an investigator-initiated, multi-centre, randomized, open-label trial that aims to determine whether the MagicTouch PTA sirolimus-coated balloon is non-inferior to plain old balloon angioplasty (POBA). The trial will also explore the potential for superiority. Principal Investigators Prof. Dr. med. Nils Kucher and Prof. Dr. med. Stefano Barco, from the University Hospital Zurich, who leads this ambitious study, said, "Sirolimus-coated balloons represent a promising technology in treating symptomatic PAD, supported by evidence primarily from studies with surrogate endpoints. While trials like SIRONA and ongoing studies such as SirPAD are expanding knowledge, robust data from randomized controlled trials with clinical outcomes are needed to guide treatment and shape future guidelines. This result, having been able to randomize so many patients in a PAD device study, is unprecedented and we are very thankful to all investigators and patients for having supported the trial" on achieving the significant milestone of enrolling 1,250+ patients and successfully completing this phase of the study. With sirolimus-coated balloons gathering global momentum and MagicTouch PTA at the forefront, SirPAD is a crucial milestone in expanding the evidence for PAD treatment options. While patients with PAD have limited therapeutic avenues, SirPAD aims to bolster data supporting sirolimus-coated balloon technology. This large RCT was critical to evaluating treatment alternatives, and its year-long follow-up will provide much-anticipated answers. "At Concept Medical, we are committed to generating robust clinical evidence to support our innovative technologies. Following the successful completion of SIRONA—the largest superficial femoral artery (SFA) trial comparing our device against paclitaxel drug-coated balloons (DCBs), which demonstrated non-inferiority—we are proud to announce the completion of enrollment for another historical milestone: the largest randomised clinical trial for peripheral all-comers patients, completed enrolment of 1250+ patients. With this achievement, Concept Medical continues to lead the way with the most extensive and advanced clinical trial program in the field, reinforcing our position as a global pioneer in patient-centric vascular innovations," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. About Concept Medical Concept Medical Inc., headquartered in Tampa, Florida, has a global presence and is dedicated to enhancing patient care through cutting-edge research and development of drug-delivery technologies. Its proprietary platforms are designed to deliver pharmaceutical agents across vascular luminal surfaces with unparalleled precision. Concept Medical is the developer of the MagicTouch family of Sirolimus Coated Balloons (SCBs)—the world's first and most utilized SCB technology—well recognized for its versatility and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have been used to treat over a million patients globally, setting a new standard for vascular therapy. For more information, please visit Photo: Logo: SOURCE Concept Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LIVERMORE, Calif., Jan. 17, 2025 /PRNewswire/ -- Advanced Bifurcation Systems Inc. (ABS), a leader in innovative solutions for bifurcation lesions in coronary angioplasty, announces the successful closure of a $20.8 million Simple Agreement for Future Equity (SAFE) financing round. The round was oversubscribed, reflecting strong demand from high-net-worth individuals and family offices across the United States and internationally. The company is also pleased to welcome two distinguished members to its expanded Board of Directors: Malia Chui: Representing Brandon Holdings, LLC, ABS's largest investor through the recent SAFE financing. Malia brings decades of expertise in investment management, with a specialization in healthcare, including hospital ownership and operations. Her strategic vision and leadership in navigating complex healthcare investments will be instrumental as ABS scales its operations. Susan Yashar: A seasoned executive and legal expert, Susan recently retired as Deputy Global CEO and General Counsel of Deloitte Global, the world's largest professional services firm. Prior to Deloitte, she served in senior roles at the Securities & Exchange Commission and the Public Company Accounting Board. Among other things, Susan brings deep experience in regulatory compliance, corporate governance and managing international business. Her background will provide ABS with unparalleled insights as the company navigates regulatory approvals and expands globally. Mehran Khorsandi, MD, CEO of ABS, stated: "We are honored by the strong support shown by our investors in this oversubscribed financing round. Many of them are industry experts who recognize the transformative potential of our technology. We are equally excited to welcome Malia Chui and Susan Yashar to our Board of Directors. Their expertise, alongside guidance from Willie Lawrence, MD, as a new member of our Scientific Advisory Board and Advisor to the CEO, will be instrumental as we advance through U.S. FDA and international regulatory processes and prepare for the commercialization of the ABS device." This milestone builds on the company's receipt of the FDA's coveted Breakthrough Device Designation in October 2023, underscoring the device's potential to address a critical unmet need in interventional cardiology. For more information about Advanced Bifurcation Systems and its groundbreaking approach to coronary artery bifurcation disease, visit . Contacts: Advanced Bifurcation Systems, Inc. Mehran Khorsandi, MD, Chairman & CEO [email protected] Henry Bourang President & COO [email protected] Ken Richards CAO/CFO [email protected] SOURCE Advanced Bifurcation Systems WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The Company’s oncology aPKCi inhibitor is a novel, first in class drug candidate Jan. 15, 2025 -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the issuance of a patent in Japan for “Inhibitors of atypical protein kinase C (aPKCi) and their use in treating hedgehog pathway-dependent cancers.” The patent number is 7603605 and expires in 2040. The aPKCi inhibitor platform is a novel, potential high-potency, specific, drug candidate with applications in oncology, particularly in hedgehog pathway-dependent cancers. Such cancers include basal cell carcinoma, medulloblastoma, rhabdomyosarcoma, small cell lung cancer and other malignant diseases. The asset platform includes two formulations (topical and oral) that have been in development in partnership with Cancer Research UK and top academic research centers. The claims also include combination therapies comprising use of the hedgehog pathway inhibitors along with an HDAC inhibitors enhancing anti-cancer efficacy. “Issuance of the new patent for our oncology preclinical aPKCi inhibitor pipeline is an important part of our development strategy,” said Jed Latkin, CEO of Windtree Therapeutics. “We will continue with our intellectual property work to expand our patent portfolio in key markets throughout the world.” The drug candidate is a novel, potential high-potency, specific, azaquinazoline ATP-competitive atypical PKC iota (aPKCi) inhibitor efficacy for the treatment of skin cancer and other rare malignant diseases. The asset platform includes two formulations (topical and oral) of the aPKCi inhibitor. Windtree Therapeutics also has an additional pending PCT application directed to crystalline forms of these inhibitors, also for use in cancer treatment. Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. The content above comes from the network. if any infringement, please contact us to modify.