Hawthorne Health Delivers Critical Trial Support for Reflow Medical's FDA Approval for Novel Treatment of Peripheral Artery Disease

Hawthorne Health, a leading community site network, announced today its role in providing operational support to Reflow Medical Inc. for the clinical trial that led to U.S. Food and Drug Administration (FDA) clearance for the Spur Peripheral Retrievable Stent System. The first-of-its-kind technology provides a treatment option for patients with infrapopliteal arterial disease, specifically those with below-the-knee chronic limb-threatening ischemia (CLTI).

Hawthorne Health supported the DEEPER REVEAL clinical trial by conducting in-home study protocol visits and facilitating data collection in collaboration with eight sites across the United States. Through its national network of mobile clinicians, Hawthorne enabled high-quality protocol execution and data capture for patients who were unable to travel due to health or distance.

Hawthorne Health provided operational expertise and thoughtful strategic support that helped us successfully gather patient follow up data for the DEEPER REVEAL trial. Their partnership supported efforts to demonstrate the clinical potential of the Spur Stent System and advance progress toward FDA clearance.

Teo Jimenez, Senior Vice President of Research and Development, Reflow Medical

The Spur Stent System, the first retrievable stent with an integrated dilatation balloon catheter, represents a significant advancement in the treatment of peripheral artery disease. Hawthorne Health's operational support helped navigate the complexities of the trial process and facilitated Reflow Medical's FDA approval.

We're proud to have supported Reflow Medical in bringing this novel treatment to patients in need. The success of the DEEPER REVEAL trial demonstrates how expert clinical capabilities, whether delivered at a community site or directly in a patient's home, can drive greater participation, reduce drop-out rates, and ultimately generate high-quality data. Strong clinical partnerships and operational excellence are essential to accelerating and transforming care.

Josh Rose, Chief Executive Officer, Hawthorne Health

The trial highlights Hawthorne Health's role as a key partner in advancing clinical research. As the industry focuses on more complex and underserved patient populations, Hawthorne provides a national network of community trial sites and mobile clinicians to execute trials efficiently and at scale, wherever patients are.