VahatiCor Kicks Off Patient Enrollment for Study of its A-FLUX Reducer System

VahatiCor Inc. has enrolled the first U.S. patient in its SERRA-I early feasibility study of the A-FLUX Reducer System. The induction builds on early human experience from SERRA-I and ongoing enrollment in the SERRA-I European (EU) study.

SERRA-I is evaluating initial use of the A-FLUX Reducer System in patients with symptomatic coronary microvascular dysfunction (CMD). The study is part of the broader SERRA clinical program, with centers across the United States and European Union. The first U.S. patient was enrolled at Yale-New Haven Hospital, with Samit Shah, M.D., Ph.D., an interventional cardiologist with Yale New Haven Hospital Heart & Vascular Center and assistant professor of medicine at Yale School of Medicine, serving as SERRA-I’s co-principal investigator.

“Treating our first U.S. patient brings the A-FLUX Reducer System into U.S. clinical investigation,” VahatiCor CEO Harry D. Rowland, Ph.D., said. “Cardiology is moving toward treating microvascular disease as a frontline condition, and the A-FLUX Reducer System is built for this shift. I’m grateful to the SERRA-I investigators and to the patients who are making this study possible.”

Appointed CEO in late May, Rowland previously served as president/CEO of Endotronix, where he led the development and commercialization of the Cordella Pulmonary Artery Sensor and Heart Failure System. Under his leadership, Endotronix raised more than $150 million and grew to 150-plus employees. He also supervised the PROACTIVE-HF pivotal trial from execution through U.S. Food and Drug Administration premarket approval and commercial launch. Following its acquisition by Edwards Lifesciences in 2024, Rowland stayed on to support key CMS national coverage and CE Mark milestones.

CMD affects millions of patients who experience persistent angina (chest pain) and related symptoms without blockages in the large coronary arteries. The A-FLUX Reducer System is a self-expanding nitinol device, delivered by catheter to the coronary sinus, that influences blood flow through the heart’s smaller vessels and addresses the underlying microvascular dysfunction.

“Patients with CMD are highly symptomatic and underserved by current therapies, with no approved option in the United States that directly targets microvascular disease,” Dr. Shah said. “Enrolling our first U.S. patient is an important step in generating the evidence these patients need.”

VahatiCor Inc., a T45 Labs portfolio company, is developing interventional therapies for CMD, a condition affecting millions of patients who experience persistent chest pain despite no obstruction in their major coronary arteries. The A-FLUX Reducer System is the company’s lead technology, a self-expanding, repositionable coronary sinus reducer currently under clinical evaluation in the SERRA clinical program. The company is based in Santa Clara, Calif. The A-FLUX Reducer System is an investigational device and has not been approved by the U.S. Food and Drug Administration for commercial use.