Supira Medical's FDA Approval for Pivotal SUPPORT II Trial Marks a Significant Step in Ventricular Device Advancement

Supira Medical Achieves FDA Approval for SUPPORT II Trial

Supira Medical, Inc., a clinical-stage company focused on transforming the market for percutaneous ventricular assist devices (pVADs), has recently announced the FDA's approval to commence its pivotal clinical trial known as SUPPORT II. This milestone is crucial as it sets the stage for a future premarket approval (PMA) application, paving the way for Supira's entry into the U.S. market.

What is SUPPORT II?

The SUPPORT II trial aims to evaluate the safety and efficacy of Supira's next-generation pVAD device in patients undergoing high-risk percutaneous coronary interventions (HRPCI). The study is designed as a prospective, randomized, and controlled trial, involving up to 385 patients across approximately 40 sites in the United States. Leading the investigation are esteemed co-investigators: Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons/New York-Presbyterian Hospital, and Dr. David Kandzari, Chief of the Piedmont Heart Institute and Director of the Piedmont Healthcare Research Institute in Atlanta, GA.

Dr. Kandzari emphasized the impact of hemodynamic support systems in the context of high-risk ischemic heart disease, stating, "Deciding whether to use hemodynamic support often depends on accessibility, ease of administration, and the balance between support and procedural efficiency." The new device's potential to provide effective circulatory support while maintaining a smaller profile could expand treatment options for patients in need.

Impact on High-Risk Patients

Dr. Kirtane noted that effectively utilizing a pVAD allows physicians to safely perform complex procedures that were previously not feasible for many high-risk patients. The initiation of this fundamental randomized clinical trial for a smaller hemodynamic support device signifies a remarkable step toward enhancing care for the most vulnerable patients facing significant heart risks.

In addition to SUPPORT II, Supira Medical is exploring new avenues to improve treatment options for patients suffering from cardiogenic shock. Recently, the company has implemented a series of cases using percutaneous axillary access to allow mobility with an active 10 Fr pVAD in patients experiencing shock.

These advancements underscore the next generation's potential for temporary mechanical circulatory support, enhancing access options, facilitating patient mobility, and significantly improving how physicians cater to critically ill patients.

For interventional cardiologists and heart failure specialists, complete hemodynamic support with flexibility in access and the ability for patient mobility during support represents a critical improvement in the overall management pathway for cardiogenic shock.

Appointment of D. Keith Grossman to the Board

Alongside these clinical breakthroughs, Supira Medical has appointed D. Keith Grossman as an independent member of its Board of Directors. Grossman's 40 years of experience in the medical technology industry, particularly in the field of mechanical circulatory assist systems, will bolster the company’s focus on market preparation and growth.

Dr. Nitin Salunke, President and CEO of Supira Medical, remarked, “Keith brings a valuable mix of operational discipline, business vision, and strategic insight. His addition as an independent board member reflects our dedication to building an organization that excels not only clinically but is also ready for large-scale operations.”

Grossman stated, “Supira has established a strong clinical and technological foundation that uniquely positions it to transform the underexplored market of pVADs.” He looks forward to supporting the company's progress in its pivotal clinical trial and its readiness to become a benchmark for treatment options in high-risk ICP and cardiogenic shock patients.

About Supira Medical, Inc.

Supira Medical focuses on developing a next-generation pVAD for high-risk patients undergoing interventional procedures while experiencing cardiogenic shock. To date, the Supira system has been utilized in 99 patients. For further details, visit www.supiramedical.com.

The pVADs are crucial for maintaining cardiovascular function during HRPCI and in patients who suffer from cardiogenic shock—a high-mortality condition where the heart is too weak to pump enough blood to vital organs, often due to a heart attack or heart failure. It is important to note that the Supira system remains an investigational device and is not approved for sale in the U.S. or any other market. Its use is restricted by federal law for investigational purposes only.