Duke Medical Center

FDA-Approved US study intended to evaluate pulmonary artery denervation in heart failure patients with WHO Group 2 Pulmonary Hypertension PARIS, March 6, 2024 /PRNewswire/ -- Gradient Denervation Technologies, a Paris-based medical device company developing a minimally-invasive, ultrasound-based device designed to treat pulmonary hypertension patients with associated heart failure, announced today that the Food and Drug Administration (FDA) has approved the initiation of the PreVail-PH2 Early Feasibility Study in the United States. The company also announced the successful enrollment of the first patient in the study at Duke University Hospital, Durham, NC. The PreVail-PH2 study is enrolling patients with pulmonary hypertension due to left-sided heart disease, classified by the World Health Organization (WHO) as Group 2 Pulmonary Hypertension. As many as half of heart failure patients around the world have elevated pulmonary vascular resistance, which is shown to lead to an increased risk of mortality and hospitalization. There are no approved drug or device therapies for this group of pulmonary hypertension patients. The procedure under investigation uses the Gradient Denervation System to ablate nerves around the pulmonary artery using therapeutic ultrasound energy. This is intended to down-regulate the sympathetic nervous system's input into the pulmonary vascular tree to reduce vascular resistance and lower pulmonary pressures. The Gradient device may provide a treatment option for patients with this debilitating condition on a platform designed for the pulmonary artery anatomy using known interventional techniques. The patient was enrolled by Marat Fudim, MD, MHS, Advanced Heart Failure Specialist, Duke Cardiology Center, and Richard Krasuski, MD, Adult Congenital Heart Failure Specialist and Director of the Adult Congenital Heart Center, Duke University Medical Center. "We are excited to enroll the first US patient in this important study," noted Dr. Fudim. "Completion of this study is a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients." "New technologies are needed to treat patients with pulmonary hypertension," said Dr. Krasuski. "We are actively screening for additional patients and will continue to work closely with our study collaborators to complete enrollment in this important trial." "We are thrilled to initiate this study and bring our technology to patients in the United States," says Martin Grasse, Gradient's CEO. "We look forward to continuing to work with the FDA and our clinical partners as we enroll this study." About Gradient Denervation Technologies Gradient Denervation Technologies is developing a minimally invasive device for the treatment of pulmonary hypertension in patients with heart failure. Gradient leverages intellectual property developed at Stanford University. The Gradient device is for investigational use only and is not approved for commercial use. For more information, please visit: . Logo: Media Contact info@gradientdenervation.com SOURCE Gradient Denervation Technologies

Phase 1 studies planned for both WISP1 and EphrinB2 candidates in 2024 Company enters strategic collaborations with Pfizer Ignite and WuXi Biologics to accelerate IND-enabling studies and drug product manufacturing Jeffrey D. Bornstein, M.D. joins as Chief Medical Officer, bringing fibrosis expertise and more than 20 years of clinical development experience CAMBRIDGE, Mass., Oct. 25, 2023 /PRNewswire/ -- Mediar Therapeutics Inc., a biotechnology company advancing a portfolio of first-in-class therapies that halt fibrosis progression, today announced several milestones that support clinical advancement of its portfolio of novel antibodies: the nomination of two clinical candidates, key strategic collaborations with Pfizer Ignite and WuXi Biologics, and the appointment of Jeffrey D. Bornstein, M.D., as Chief Medical Officer. Mediar's first candidate, MTX-463, is a first-in-class monoclonal antibody designed to neutralize the WISP-1 signaling that is elevated in and contributes to fibrosis progression. Its second candidate, MTX-474, is a first-in-class monoclonal antibody designed to neutralize the EphrinB2 signaling that causes fibrosis advancement and may play a role in defining the fibrotic niche. Both candidates offer therapeutic potential across multiple indications, including fibrosing diseases of the lung and liver, and are supported by a compelling suite of preclinical in vivo and ex vivo data demonstrating specific anti-fibrotic effects and selective neutralization of their respective targets. Mediar plans to advance both MTX-463 and MTX-474 into Phase 1 clinical development in 2024. The company has also entered a strategic collaboration with Pfizer Ignite, a new end-to-end service for biotech companies with high potential science that leverages Pfizer Inc.'s significant R&D capabilities, scale and expertise to accelerate the development of breakthrough therapies. Research and development efforts, assay development, and IND-enabling studies for MTX-463 and MTX-474 will be conducted with support with Pfizer Ignite. Mediar will retain ongoing decision-making autonomy and rights to all programs throughout the collaboration. In addition, the company has entered a partnership with WuXi Biologics, wherein WuXi Biologics will provide fully integrated CMC development and cGMP manufacturing of clinical supply for drug substance and drug product to support IND-enabling and initial clinical studies for MTX-463 and MTX-474. The appointment of Jeffrey D. Bornstein, M.D., as Chief Medical Officer further supports Mediar's focus on moving its novel pipeline of biologics towards the clinic. "We are excited by this progress and believe that approaches that pinpoint fibrosis progression may be the key step in improving outcomes for patients," said Mediar's Chief Executive Officer Rahul Ballal, Ph.D. "In addition, Jeff's wealth of experience in driving clinical development of fibrosis treatments will be instrumental as we continue to advance our portfolio of first-in-class antibody treatments. We look forward to leveraging his deep insight and KOL connections across a variety of indications to design effective and efficient studies." "Fibrosis is the final common pathway for chronic diseases in multiple organ systems, contributing to a significant number of deaths each year, and creating a large global unmet need that must be addressed," said Dr. Bornstein. "Mediar's novel approach of targeting of fibrotic mediators holds exciting potential offering opportunities to address fibrosis at the later stages of progression either on its own or added to therapies that do not target fibrosis directly or sufficiently. I'm thrilled to join this talented team and advance these candidates into clinical studies." Dr. Bornstein joins Mediar with more than 20 years of clinical development expertise in the biopharmaceutical industry, with deep experience overseeing clinical studies of fibrosis treatments across multiple indications, including idiopathic pulmonary fibrosis (IPF), primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH). Dr. Bornstein previously served as Chief Medical Officer of Eledon Pharmaceuticals and Vice President, Head of Clinical Sciences, Gastroenterology at Takeda Pharmaceuticals. In addition, he directed development programs, including those focused on fibrosis, at Biogen, Gilead Sciences, Elan Pharmaceuticals and other early-stage biotechnology companies. After earning his M.D. and completing a residency in internal medicine at McGill University, Dr. Bornstein completed a fellowship in gastroenterology at Duke Medical Center, where he joined the faculty, conducting clinical research in hepatitis C and providing clinical care in gastroenterology and hepatology as a practicing physician. About Mediar Therapeutics Mediar Therapeutics is a biotechnology company pioneering a new approach to fibrosis treatment that halts the disease at a different source – the fibrotic mediators that drive disease progression. Mediar was founded based on a deep understanding of the complex science underlying fibrosis onset and progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar is derisking the path forward for fibrosis therapies in clinical development. For more information, contact [email protected] or follow us on LinkedIn. SOURCE Mediar Therapeutics

BAROguard is a next-generation donor lung preservation system, designed to provide optimal temperature range and a clinically recommended inflation pressure range to donor lungs, throughout the journey, from donor to recipient patient Paragonix gets FDA approval for BAROguard system. (Credit: Robina Weermeijer on Unsplash) US-based organ transplant company Paragonix Technologies has received the US Food and Drug Administration (FDA) approval for BAROguard, its next-gen donor lung preservation system. BAROguard is designed to deliver an optimal temperature range and a clinically recommended inflation pressure range to donor lungs, throughout the journey, from donor to recipient patient. The system combines the company’s existing advanced hypothermic preservation technology with automated continuous and active airway pressure control. The combination of advanced technologies will further help improve and redefine the standard of care within transplant medicine, said the medical device company. Paragonix CEO and president Lisa Anderson said: “The BAROguard Donor Lung Preservation System was designed to address these critical issues with an automated and easy-to-use active pressure management system.” According to the organ transplant company, current clinical practice involves the preservation and transportation of donor lungs in an inflated state from donor to recipient site. However, current organ recovery techniques lack reliable maintenance and control over lung inflation pressures within the clinically recommended range of 12-15cmH2O. The changes in ambient pressure may expose the lungs to elevated pressure, which may increase the risk of pulmonary barotrauma, according to respiratory management studies. Paragonix said that its BAROguard System provides automated active control over donor lung airway pressures and automated donor lung temperature control, which is continuously reported to the transplant team in real time. Duke Medical Center lung transplant program surgical director Jack Haney said: “Manually inflating donor lungs can be a highly variable process during lung donation. “There is the belief that maintaining a consistent donor lung airway pressure can be useful for optimizing static preservation, especially when recovering organs overextended times or distances. “BAROguard offers the potential for significant advancement of lung preservation that we will be studying via the GUARDIAN registry.” Earlier this year, Paragonix announced the first paediatric use of its LUNGguard Donor Lung Preservation System in the Time Shift lung transplantation case.