VahatiCor Reports Positive Results From Its A-Flux Reducer System Compassionate Use Cases

Demonstrated a Reduction of Symptoms with Short Procedural and Recovery Times

Leading Coronary Physiology Experts Appointed Co-Principal Investigators for Planned U.S. Early Feasibility Study

VahatiCor News

SANTA CLARA, Calif.-- VahatiCor announced the successful completion of its compassionate use study treating patients with the A-FLUX Reducer System™ for either obstructive coronary artery disease with persistent symptoms or symptomatic coronary microvascular dysfunction (CMD). The study, in which ten patients were implanted with A-FLUX (four with CMD and six with obstructive epicardial disease), marks a significant milestone in demonstrating the safety and early efficacy of a promising therapeutic option for patients suffering from these challenging and debilitating conditions.

Based on the positive results from the compassionate use study, the Company plans to commence SERRA-I, its U.S. early feasibility study (EFS) exclusively focused on CMD patients. Coronary physiology experts Samit Shah, MD, PhD, FACC, FSCAI, an interventional cardiologist from the Yale School of Medicine, and Tim Van de Hoef, MD, PhD, FESC, an interventional cardiologist from University Medical Center Utrecht, the Netherlands will lead the trial as co-principal investigators. The A-FLUX Reducer System offers a novel, minimally invasive approach to directly improve flow within the coronary microvasculature and relieve anginal symptoms in patients with CMD.

"Our compassionate use study demonstrated the safety of the implant and a sustained therapeutic potential for the A-FLUX Reducer System with significant reductions in anginal symptoms," said Marwan Berrada-Sounni, Founder and Chairman, VahatiCor. "We are excited to address the unmet clinical needs of CMD patients and delighted to take the next step in initiating the SERRA-I EFS, upon FDA IDE approval, with Dr. Shah and Dr. Van de Hoef so that we can bring this important therapy to patients."

Patients treated with the A-FLUX Reducer System reported rapid symptom improvements and returned to their daily activities with minimal recovery time. The short nine-minute average implantation procedure time and clinical outcomes highlighted the implant's potential to become a frontline device therapy for patients with persistently symptomatic CMD.

"Patients with CMD, which is more common in women, experience significant symptoms that can happen at rest and during exertion," noted Dr. Shah. "There is a real need for an effective treatment for these patients. The A-FLUX Reducer System has innovative properties, including its atraumatic expansion and repositionable design. I look forward to supporting the development of clinical evidence for this novel therapy."

The A-FLUX Reducer System is engineered with SwiftCell Technology™, a small-cell proprietary design based on computational modeling, to redistribute oxygen supply to the sub-endocardium layer of the heart muscle. As Dr. Van de Hoef explained, "About half of the patients undergoing an invasive angiography are found not to have obstructive coronary artery disease but, in fact, have coronary microvascular disease. Increasingly, more patients are likely to be identified as centers begin adopting the strong guidelines recently published by the European Society of Cardiology. These patients have no dedicated treatment available. Coronary sinus reduction and the advanced features of the A-FLUX device carry significant potential to help these patients return to normal daily activities."

CMD occurs when the small coronary arteries within the heart muscle (coronary microvasculature) fail to dilate properly upon exertion, reducing blood flow to the heart muscle and creating discomforting angina symptoms. Millions of CMD patients worldwide suffer from persistent chest pressure, tightness, and chest pain, with no current viable options for symptom relief. Left untreated, diagnosis of CMD results in a fourfold elevated mortality risk compared to the general population.[1]

About VahatiCor
VahatiCor, Inc., a T45 Labs portfolio company, is committed to revolutionizing the treatment of coronary microvascular dysfunction through cutting-edge technologies and minimally invasive therapies to provide rapid relief and empower patients to reclaim their daily lives.

To learn more, please visit https://vahaticor.com/.

Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.
Not available for sale.

[1] Gdowski MA, Murthy VL, Doering M, Monroy-Gonzalez AG, Slart R, Brown DL. Association of Isolated Coronary Microvascular Dysfunction With Mortality and Major Adverse Cardiac Events: A Systematic Review and Meta-Analysis of Aggregate Data. J Am Heart Assoc. 2020 May 5;9(9):e014954. doi: 10.1161/JAHA.119.014954. Epub 2020 Apr 29. PMID: 32345133; PMCID: PMC7428565.