Pulmonary Vascular Disease

44% reduction in total heart failure event rate and ongoing improvements in quality of life in responder group patients implanted with shunt TEWKSBURY, Mass., Oct. 25, 2024 /PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced impressive three-year results from its REDUCE LAP-HF II randomized clinical trial confirming safety and sustained efficacy of the Corvia® Atrial Shunt in selected heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. The results were published in The American Heart Journal. REDUCE LAP-HF II is the world's first phase III trial to evaluate safety and efficacy of an atrial shunt in heart failure patients. The study of 626 patients previously identified a responder group representing half of all study participants. This group consisted of patients without latent pulmonary vascular disease or a cardiac rhythm management device. At three years, the 161 responder patients receiving the Corvia Atrial Shunt experienced 44% fewer combined inpatient and outpatient heart failure events compared to the control group of 152 patients. The shunt group also reported a clinically meaningful 2.5 times greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, indicating improved quality of life with less fatigue, reduced shortness of breath, and fewer activity restrictions. No significant safety concerns have been identified with the Corvia Atrial Shunt. "What we've learned from this three-year data set is that the Corvia shunt results are not only strongly positive but demonstrably durable," said Sheldon Litwin, MD, Alicia Spaulding-Paolozzi Professor of Cardiology at Medical University of South Carolina and a lead researcher in the trial. "The absolute risk reduction for total heart failure events actually improves year by year over the two-year and one-year statistics. And with a majority of patients emphasizing quality of life even over reduced hospitalizations, the importance of the sharply improved KCCQ scores is magnified." "We are confident that the strong three-year results will generate continued enthusiasm for atrial shunting among referring physicians, positioning it as a promising treatment option for eligible HFpEF patients," said Jan Komtebedde, Chief Medical Officer at Corvia Medical. "We are actively driving toward completion of RESPONDER-HF, a randomized, sham-controlled, confirmatory trial conducted at up to 80 centers worldwide," added George Fazio, Chief Executive Officer at Corvia Medical, "which we expect to generate the final data set needed for FDA approval of the Corvia Atrial Shunt." About heart failure (HF) and the Corvia Atrial Shunt More than 26 million people worldwide have HF, and the majority have HFpEF, making it the largest unmet clinical need in cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated left atrial pressure (LAP), the primary contributor to HF symptoms in HFpEF patients, by creating a passage between the left and right atria, reducing HF events and improving quality of life. About Corvia Medical, Inc. Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. Visit . For information regarding RESPONDER-HF study eligibility, please visit . MEDIA CONTACT: Lisa Ensz +1 978-654-6120 [email protected] SOURCE Corvia Medical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Collaboration to focus on RS BioTherapeutics’ first-in-class, steroid-free, therapeutic platform in the treatment of deadly lung diseases and use as a chemical countermeasureCUMBERLAND, Md., July 08, 2024 (GLOBE NEWSWIRE) -- RS BioTherapeutics, whose mission is to develop life-changing medicines for the millions of people suffering from deadly lung diseases characterized by pulmonary inflammation, is pleased to announce a collaboration agreement with the University of Colorado School of Medicine to evaluate use of its first-in-class, steroid-free therapeutic platform in the treatment of deadly lung diseases as well as a chemical countermeasure. RS BioTherapeutics is collaborating specifically with the lab of Dr. Tom Hu, an Associate Professor in the Division of Pulmonary and Sleep Medicine and Associate Director for the Center for Advanced Drug Development, Department of Pediatrics, at the University of Colorado School of Medicine. The University of Colorado School of Medicine is home to numerous seminal discoveries in pulmonary and critical care medicine, including advances in tuberculosis, interstitial lung disease, airway disease, cancer, pulmonary vascular disease, and critical care. Commenting on the collaboration, RS BioTherapeutics’ Chief Medical Officer, Dr. Michelle L. Shuffett said, “We are very pleased to have established this collaboration with Dr. Hu’s lab and the University of Colorado School of Medicine to evaluate RSBT-001, our first-in-class, steroid-free therapeutic platform for deadly lung diseases characterized by pulmonary inflammation and as a chemical countermeasure for terrorist activities. Dr. Hu’s academic credentials coupled with his extensive experience in both the private and government sectors, makes him the ideal partner to help evaluate these important use cases for RSBT-001.” Dr. Tom Hu said, “RSBT-001 is currently in development for Chronic Obstructive Pulmonary Disease (COPD), the third leading cause of death in the world as well as Idiopathic Pulmonary Fibrosis (IPF), a rare disease with no cure and a 3-5 year survival rate. In addition, the anti-inflammatory properties of RSBT-001 demonstrated in preclinical trials underscore its potential to be an effective chemical countermeasure. I am very excited to collaborate with Dr. Shuffett and the rest of the RS BioTherapeutics team to evaluate and advance the development of RSBT-001.” Dr. Hu joined the University of Colorado in 2023 after 14 years of federal services as a Project Officer in the Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Countermeasures at the Biomedical Advancement Research and Development Authority (BARDA), U.S. Department of Health and Human Services (HHS). Dr. Hu received a bachelor’s degree in chemistry, Magna Cum Laude, with an emphasis in Biology from the University of Pittsburgh in 1996. Dr. Hu went on to earn his M.S. and Ph.D. in Chemistry from Carnegie Mellon University in 1999 and 2001, respectively. Following his doctoral work, Dr. Hu moved to the National Institutes of Health as an Intramural Research Training Award (IRTA) Fellow. He subsequently went on to GlaxoSmithKline PLC as a Principal Scientist. During this period, he also completed an MBA at Villanova University. Dr. Hu then established the Small Animal Imaging Program at the Medical College of Georgia. During his most recent position as a Project Officer for the past 14+ years, Dr. Hu was responsible for oversight of technical progress for the Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Countermeasures. He has managed more than 20+ company contracts for the Federal Government, developing medical countermeasures in the Chemical, Radiological/Nuclear, Biodosimetry, and Thermal Burn areas, where total contractual values total over $186+ million. Currently, he serves as an associate editor and ad hoc reviewer for more than 20 peer-reviewed journals, has published 29 peer-reviewed articles and made presentations at over 60 national and international conference presentations. Dr. Hu has 5 U.S. patents and has been certified as a Diplomate by the American Board of Medical Physics in Magnetic Resonance Imaging Physics. About RS BioTherapeuticsThe mission of RS BioTherapeutics is to develop life-changing medicines for the millions of people suffering from deadly lung diseases characterized by pulmonary inflammation. RS BioTherapeutics is developing a first-in-class, steroid-free, multi-targeted immune modulator (RSBT-001) with Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF) targeted as first indications. RS BioTherapeutics owns the exclusive, global license for RSBT-001 and is projecting filing an Investigational New Drug Application for RSBT-001 and initiating human trials in 2026. More information on RS BioTherapeutics can be found at www.rsbiotherapeutics.com. Media Contact: David Gutierrez, Dresner Corporate Services for RS BioTherapeutics, (312) 780-7204, dgutierrez@dresnerco.com

SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), will present updated seralutinib TORREY open-label extension data at the American Thoracic Society 2024 International Conference, which takes place May 17-22 in San Diego, California. Details for the oral presentation related to seralutinib, an inhaled, PDGFR, CSF1R and c-KIT inhibitor, designed for the treatment of pulmonary hypertension, are as follows: Session: A14: Building Lego(Land): Lessons Learned From Large Scale Clinical Trials In PAH Session Date & Time: Sunday, May 19th, 9:15 a.m. - 11:15 a.m. PT Talk Title: Interim Results from the Phase 1B and Phase 2 TORREY Open-label Extension Study of Seralutinib in Pulmonary Arterial Hypertension (PAH) Location: San Diego Convention Center, Room 29A-D (Upper Level) Presenting Author: Olivier Sitbon, MD, PhD Gossamer also will present additional data on seralutinib via poster. Details for those posters are as follows: Poster Board Number: 424 Poster Session: D105 Balboa Park Explorers: Translational Science and Epidemiology in PH Session Date & Time: Wednesday, May 22nd, 11:00 a.m. – 1:00 p.m. PT Poster Title: TORREY Phase 2 Study of Seralutinib in Pulmonary Arterial Hypertension (PAH): Circulating Biomarkers of Proliferation, Inflammation, and Fibrosis Improve with Treatment Location: San Diego Convention Center, Room 25A-C (Upper Level) Poster Board Number: 318 Poster Session: D109 Now We Got Bad Blood: RSF/PC Joint Session on Pulmonary Vascular Disease Session Date & Time: Wednesday, May 22nd, 11:00 a.m. – 1:00 p.m. PT Poster Title: Cardiac Effort Is Less Variable Than Six-minute Walk Distance, Correlates with Hemodynamics and Is Consistent with REVEAL 2.0 Risk Score in a Sub-study of the TORREY Phase 2 PAH Trial Location: San Diego Convention Center, Room 28C-E (Upper Level) About Gossamer Bio Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. View source version on businesswire.com: Contacts For Investors and Media: Bryan Giraudo, Chief Operating Officer and Chief Financial Officer Gossamer Bio Investor Relations ir@gossamerbio.com Source: Gossamer Bio, Inc. View this news release online at: