Trisol Medical Announces Positive Early Feasibility Study Results for TRISOL VALVE, a Novel Transcatheter Tricuspid Valve Replacement System Featuring an Integrated Dome-Shaped Leaflet Design

Trisol MedicalAnnouncement of its Transcatheter Tricuspid Valve Replacement System---TRISOL VALVEResults of the Early Feasibility Study in the United States. This study aims to evaluateTRISOL VALVEIn the treatment of patients with severe to very severe tricuspid regurgitation.

This study was conducted at multiple top medical centers in the United States, where treatment was successfully completed for 22 patients with severe to extremely severe tricuspid regurgitation who were at high risk for traditional surgery via a transjugular approach. Clinical research using a transfemoral venous approach is currently underway.

Specific Research Data

• Safety: The need for permanent pacemaker implantation was less than 5% during the 30-day follow-up.

• Effectiveness: Tricuspid regurgitation significantly reduced after implantation.

• Functional Improvement: At the 30-day and 12-month follow-ups, patients showed significant improvements in quality of life (KCCQ score), heart failure symptoms (NYHA classification), 6-minute walking distance, right ventricular function, and cardiac output.

• Technical Performance: The devices were successfully deployed without any displacement events.

Notably, these encouraging results encompass high-risk subgroups of patients with right ventricular dysfunction. This subgroup typically has a poor prognosis, and neither existing nor emerging therapies have adequately met their treatment needs. Early clinical experiences with current emerging therapies indicate that unmet medical needs persist within this patient population.TRISOL VALVEIs expected to fill this critical gap.

PI Evaluation

“TRISOL VALVEWith multipleInnovative features, including ease of operation, retrievable anchoring structure, wide range of size applicability, lower pacemaker implantation rate, and excellent performance in dysfunctional right ventricles. We look forward to the next phase of research and pivotal trials for its femoral artery delivery system.”

---Pradeep Yadav

Executive Evaluation

"These positive outcomes are highly encouraging and further validate the potential of our leading technology to improve treatment for patients with severe tricuspid regurgitation. We sincerely thank the clinical researchers and the entire team for their dedication and excellent patient care."

---Ron Davidson  CEO of TriSol Medical

"Millions of people across the U.S. suffer from tricuspid regurgitation, and despite significant recent medical advancements, effective treatment options for severe cases remain very limited."TRISOL VALVE"The development is precisely to address this significant unmet need and is expected to redefine the standard of care."

---Shimon Eckhouse Trisol MedicalChairman

• Eliminate Tricuspid Regurgitation While Preserving Right Ventricular Function
• Can match with annuloplasty rings of any size
• Delivery is simple and intuitive.
• Totally Percutaneous Surgery
• Can be fixed on any shaped annulus

TRISOL VALVE DEMONSTRATION

Trisol Medical