VahatiCor Submits IPO Prospectus Highlighting 100% Procedural Success and Zero Device-Related Adverse Events with A-FLUX™ Recapturable Angina Reducer

Dec 28, 2025 22:10 CST Updated 22:10

VahatiCor

Medical Device Developer

VahatiCorPublished in the journal "Journal of the Society for Cardiovascular Angiography & Interventions" regarding itsRecyclable Angina Stent---A-FLUXThe first set of clinical research data.

This study enrolled 12 symptomatic patients (mean age 66.8 years, 58% male) who underwent A-FLUX treatment, among whomSix patients with coronary microvascular dysfunction (CMD),Obstructive Epicardial Coronary Artery Disease (CAD)Six patients were enrolled. Patients were followed up at approximately 1, 3, and 6 months post-procedure to assess safety and symptom improvement (using the Canadian Cardiovascular Society Angina Grading [CCS] and Seattle Angina Questionnaire [SAQ] scores). Additionally, after A-FLUX implantation in seven miniature pigs, tissue healing responses were evaluated via coronary sinus angiography and intravascular ultrasound, with histological assessments performed at 3 and 6 months.

Specific Research Results

Clinical Research

Among 12 clinical patients, 11 successfully received CSR implants, with one case aborted due to the complex anatomy of the coronary sinus.

No adverse events related to surgical instruments occurred.

At 6-month follow-up, compared with baseline, both CCS grade (3 vs 1; P < 0.001) and SAQ score (33.6 ± 13.4 vs 84.5 ± 10.2; P < 0.001) were significantly improved.

Preclinical Studies

The success rate of preclinical experimental surgery was 100%, with no perioperative or long-term complications.

Histological evaluation showed good local tissue response around the CSR, with ideal healing characteristics, and a fully endothelialized, mature neointima had formed.

All CSRs remained patent at the time of animal sacrifice, with no evidence of thrombosis.

Conclusion

A-FLUXIt has demonstrated good procedural safety in both preclinical and clinical studies and shown promising short-term clinical efficacy in patients with CMD and persistent symptoms of obstructive CAD.

A-FLUX

A-FluxIs aNew self-expanding, retrievable, and repositionable anginaStent, designed to restore natural blood flow and alleviate chest pressure, heaviness, and tightness.

A-FluxByWoven from nickel-titanium alloy, designed in an hourglass shape.Adopting SwiftCell design, its design features:

Variable Cell Structure

Optimized to immediately redistribute cardiac blood flow post-implantation;

Hourglass Shape

Design with a narrow middle and wide endsAiming to provide stable performance that can adapt to any type of physiological anatomical structure;

Shape Memory Materials

Designed to seamlessly fit with the coronary sinus for proper implantation and long-term clinical outcomes.

A-FLUXThere are four sizes (9, 11, 13, and 15 mm) for treating target coronary sinus diameters ranging from 6.4 to 12.5 mm; the neck diameter (central constriction zone) of all sizes is 3 mm.

Its delivery system features two radiopaque markers: one at its distal tip and the other at the center of the loading device; additionally, the proximal and distal edges of the device are each outlined by three small radiopaque markers.

A-FLUXCan be retrieved when not more than 50% is released, and can be repositioned after retrieval.

VahatiCor

VahatiCorVahatiCor, Inc. is an innovative medical device company and a member of T45 Labs. It is committed to advancing the field of medical technology by creating innovative solutions to address unmet clinical needs and improve care standards.