Supira Medical Receives FDA Approval for Groundbreaking SUPPORT II Clinical Trial in Cardiogenic Shock Treatments

Supira Medical Receives Key FDA Approval for SUPPORT II Trial

Supira Medical, Inc., an innovative clinical research company focused on transforming the market for percutaneous ventricular assist devices (pVAD), recently announced a significant milestone in its journey. The U.S. Food and Drug Administration (FDA) has granted approval for the initiation of the SUPPORT II clinical trial. This pivotal study aims to support the company's pre-market approval (PMA) application and signals a crucial step towards entering the American healthcare market.

Understanding the SUPPORT II Trial

The SUPPORT II trial, which stands for "SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy Intervention (HRPCI)," is designed as a prospective, randomized, controlled study. It seeks to evaluate the safety and effectiveness of Supira's next-generation pVAD device in patients undergoing high-risk coronary procedures. Up to 385 patients across a maximum of 40 sites in the United States will participate in this landmark study. Leading the research efforts are Dr. Ajay Kirtane, a professor at Columbia University Vagelos College of Physicians and Surgeons, in collaboration with New York-Presbyterian Hospital, and Dr. David Kandzari, the head of the Piedmont Heart Institute in Atlanta, Georgia.

Dr. Kandzari highlighted the importance of hemodynamic support in HRPCI procedures, where vascular access, device introduction, and balancing support levels are critical considerations. He emphasized that a system providing effective circulatory support with a smaller profile could potentially expand the pool of eligible patients, thereby enhancing treatment outcomes.

"Optimal pVAD deployment allows physicians to safely perform the most complex procedures, offering HRPCI options to patients who previously had limited treatment alternatives," stated Dr. Kirtane. The commencement of this key randomized trial for a novel hemodynamic support device represents a significant progression in care for high-risk patients.

Advancements in Cardiogenic Shock Treatments

Alongside the SUPPORT II trial, Supira Medical is actively enhancing therapeutic options for patients experiencing cardiogenic shock. Recent clinical experiences outside of the United States included a preliminary case series involving patients with cardiogenic shock treated via a minimally invasive access point through the axillary artery. This approach allowed for patient mobility while actively supported by a 10 Fr pVAD device.

The milestones achieved so far illustrate the potential that next-generation mechanical circulatory support can offer—expanding access options, improving patient mobility, and advancing treatment methodologies for critically ill patients. Comprehensive hemodynamic support with flexible access point options significantly enhances the overall treatment pathway for those suffering from cardiogenic shock.

Strengthening Leadership with D. Keith Grossman

In tandem with these clinical achievements, Supira Medical announced the appointment of D. Keith Grossman to its board of directors. Grossman, who boasts over 40 years of leadership experience in the medical technology industry, particularly in the field of mechanical circulatory support, is expected to bolster the company’s focus on scaling operations for market readiness and growth.

"Keith brings a valuable blend of operational discipline, commercial insight, and strategic perspective," commented Dr. Nitin Salunke, CEO of Supira Medical. His role as an independent board member reflects the company's commitment to building an organization that excels clinically while also preparing for large-scale operations.

D. Keith Grossman also mentioned, "Supira has laid a compelling clinical and technological foundation that uniquely positions it to disrupt the rapidly expanding and underserved pVAD market. I look forward to supporting the company through this pivotal study and positioning it as a leader in treating high-risk PCI patients and those with cardiogenic shock."

About Supira Medical, Inc.

Supira Medical is dedicated to innovating a next-generation pVAD device for patients at high risks during intervention procedures and for those experiencing cardiogenic shock. To date, the Supira system has been used in 99 patients. For more information about Supira Medical, please visit www.supiramedical.com.

As pVAD devices play a crucial role in supporting cardiovascular function during HRPCI procedures, they are invaluable to patients facing cardiogenic shock. This condition is characterized by high mortality rates, with the heart being unable to pump sufficient blood to vital organs, often following a heart attack or heart failure. It is important to note that the Supira system is currently an investigational device and has not been approved for sale in the United States or any other country. Under federal law, this device is only to be used for research purposes.