Supira Medical Receives FDA Approval for SUPPORT II Study, Marks Breakthrough in Cardiogenic Shock Treatment

Supira Medical's Major Breakthrough in Cardiogenic Shock Treatment

Supira Medical, Inc., a clinical-stage company dedicated to transforming the market of percutaneous ventricular assist devices (pVAD), has announced significant milestones in its journey towards improving cardiovascular care. Recently, the company received FDA approval for its critical SUPPORT II study, a pivotal development that signals progress in treating cardiogenic shock, alongside the appointment of industry veteran D. Keith Grossman to its board of directors.

FDA Approves the SUPPORT II Study

On April 8, 2026, Supira Medical revealed that it has been granted FDA approval to commence its SUPPORT II study, designed to evaluate the safety and effectiveness of its next-generation pVAD systems. This study is pivotal as it not only facilitates future premarket approval applications but also marks a critical step towards entry into the U.S. market. The SUPPORT II study will be a randomized controlled trial that aims to enroll up to 385 patients across 40 sites in the U.S., overseen by lead investigators Dr. Ajay Kirtane and Dr. David Kandzari, who are esteemed authorities in the fields of interventional cardiology and cardiovascular research.

Dr. Kirtane, affiliated with Columbia University and New York-Presbyterian Hospital, mentioned that the decision to utilize hemodynamic support in high-risk procedures often hinges on various factors such as availability and feasibility. He emphasized the potential of Supira's system to provide effective circulatory support with a smaller profile, which could broaden patient eligibility and enhance procedural efficacy.

Dr. Kandzari highlighted that the appropriate use of pVAD systems allows healthcare professionals to safely perform complex procedures, availing high-risk percutaneous coronary intervention (HRPCI) to patients who previously had limited treatment options. The initiation of this key randomized study represents a significant advancement in care for some of the most critically ill patients.

Advancements in Treating Cardiogenic Shock

Alongside the SUPPORT II study, Supira Medical is actively seeking innovative solutions for patients suffering from cardiogenic shock. This condition, characterized by the heart's inability to pump sufficient blood to vital organs, typically arises from a heart attack or heart failure and is associated with a high mortality rate. The company has reported successful initial applications using a percutaneous approach from the axilla, allowing patients on active pVAD to maintain mobility while receiving treatment.

These advancements underscore the potential of the next-generation temporary mechanical circulatory support systems to expand access, enhance mobility, and improve treatment methodologies for critically ill patients.

With hemodynamic support systems like pVAD, interventional cardiologists and heart failure specialists can deliver top-tier care to patients in cardiogenic shock more effectively than ever, thanks to flexible access points and enhanced patient mobility during treatment.

Appointment of D. Keith Grossman to the Board

In a parallel development, Supira Medical has strengthened its leadership by welcoming D. Keith Grossman to its board as an independent member. Mr. Grossman brings over 40 years of experience in the healthcare technology sector, including a pivotal role in mechanical circulatory support systems, which will bolster the company's preparation for market entry and expansion.

According to Dr. Nitin Salunke, Supira Medical's president and CEO, Grossman's blend of operational expertise, business acumen, and strategic vision aligns perfectly with the company’s goals. His appointment reflects a commitment to building an organization that not only excels clinically but is also poised for substantial market impact.

Mr. Grossman acknowledged Supira's impressive clinical and technological foundation and its unique positioning to revolutionize an underrepresented market for pVAD systems. He expressed enthusiasm about supporting the company in its key study and growth initiatives as it aims to emerge as a leader in treatment options for high-risk PCI patients and those experiencing cardiogenic shock.

About Supira Medical, Inc.

Supira Medical is dedicated to advancing a new generation of pVAD designed specifically for high-risk patients undergoing interventional procedures and suffering from cardiogenic shock. To date, the Supira system has been utilized in 99 patients, showcasing its potential in clinical settings. For more information about Supira Medical, visit www.supiramedical.com.

The use of pVAD is crucial in supporting cardiovascular functions during HRPCI and in patients with cardiogenic shock, enhancing recovery prospects and quality of care. It's essential to note that Supira's system is an investigational device and is not approved for commercial sale in the U.S. or any other country, with its usage strictly limited to research purposes as per federal law.