Supira Medical Receives FDA Approval for SUPPORT II Study and Advances in Cardiogenic Shock Treatment

Supira Medical Achieves Key Milestones in Cardiovascular Treatment

Supira Medical, Inc., a clinical-stage company focused on transforming the market for percutaneous ventricular assist devices (pVAD), has recently announced the FDA's approval for the launch of its pivotal study, SUPPORT II. This represents a critical advancement for the company as it aims to enter the American market for cardiac interventions.

Overview of SUPPORT II Study

The SUPPORT II study (SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention) is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of the new generation pVAD among patients undergoing high-risk percutaneous coronary intervention (HRPCI). The study will engage up to 385 patients across 40 sites in the United States, led by esteemed national principal investigators, Dr. Ajay Kirtane from Columbia University and Dr. David Kandzari, head of the Piedmont Heart Institute in Atlanta, Georgia.

Dr. Kandzari stated, "In HRPCI, the decision to use hemodynamic support is often influenced by availability and the balance between support and procedural efficiency. A system that can provide effective circulatory support with a smaller profile has the potential to widen the range of patients eligible for treatment while improving its effectiveness."

Dr. Kirtane added, "The appropriate use of pVAD allows physicians to safely perform the most complex procedures and offer HRPCI to patients who previously had limited options. The initiation of this pivotal randomized study of a smaller-profile hemodynamic support device represents an important leap towards improving care for some of our most at-risk patients."

Advances in Treating Cardiogenic Shock

Apart from the SUPPORT II study, Supira Medical is exploring opportunities to enhance treatment options for patients recovering from cardiogenic shock. This includes recent cases outside the United States, where a series of patients with cardiogenic shock were treated using a percutaneous axillary approach, allowing patients to ambulate with an active 10Fr pVAD.

These milestones collectively underscore the potential benefits that the next generation of temporary mechanical circulatory support can offer, including expanded access options, enhanced mobility, and improved methods for treating critically ill patients. For interventional cardiologists and heart failure specialists, full hemodynamic support with flexibility in the point of percutaneous access and patient mobility represents significant advancements in the overall management of cardiogenic shock.

Appointment of D. Keith Grossman to the Board

In conjunction with these clinical milestones, Supira Medical has announced the appointment of D. Keith Grossman as an independent board member. With 40 years of leadership experience in the medical technology industry, including a pivotal role in mechanical circulatory support, Mr. Grossman is expected to enhance the company's focus on market preparation and growth.

Dr. Nitin Salunke, president and CEO of Supira Medical, remarked, "Keith brings a valuable combination of operational discipline, business insight, and strategic perspective. His appointment as an independent member of our board reflects our commitment to building an organization that is not only clinically differentiated but also prepared to operate at scale."

Mr. Grossman stated, "Supira has built a compelling clinical and technological foundation that uniquely positions it to transform the burgeoning and often underexplored area of pVAD. I look forward to supporting the company in advancing the pivotal study and preparing to become a leading provider of treatment options for high-risk PCI and cardiogenic shock patients."

About Supira Medical, Inc.

Supira Medical is dedicated to developing a next-generation pVAD for high-risk patients undergoing interventional procedures and those suffering from cardiogenic shock. To date, the Supira system has been employed in 99 patients. To learn more about Supira Medical, visit www.supiramedical.com.

As vital components to support cardiovascular functions during HRPCI and for patients recovering from cardiogenic shock, pVAD play an essential role. Patients undergoing HRPCI face complex coronary anatomy, compromised hemodynamics, and multiple comorbidities, while cardiogenic shock is a condition with high mortality rates, often resulting from heart attacks or heart failure.

The Supira system is a research device and is not approved for sale in the U.S. or anywhere else in the world. Its use is restricted to investigational purposes under federal law.