Foldax Announces TRIA: World’s First Commercially Approved Polymer-Based Mitral Valve

FoldaxAnnouncing its polymer mitral valve---TRIAApproved for marketing by India's Central Drugs Standard Control Organization (CDSCO) and will be manufactured in India by its Indian partner, Dolphin Life Science India LLP.

Expert Evaluation

"TRIA Mitral Valve Offers New Solution for a Wide Range of Patients, Including Adolescents Aged 18 and Women of Childbearing Age, Who Often Suffer from Mitral Valve Damage Caused by Rheumatic Fever."

---Kaushal Pandey  P.D. Hinduja Hospital

Executive Evaluation

"Approval of the World's First Polymer Heart Valve Marks a Revolutionary Breakthrough in Valve Therapy. Leveraging the LifePolymer material and robotic manufacturing platform, we will expand into transcatheter devices and other valve areas, committed to addressing unmet clinical needs in regions like India."

---Ken Charhut Chairman and CEO of Foldax

Last yearFoldaxPublish the firstHigh Molecular MitralValveTRIAClinical ResearchResearch data, showingIt features excellent safety, stable hemodynamic properties, and can significantly improve the quality of life for patients.。

• The report stated that the all-cause mortality rate was 1.4%, unrelated to the valve;
• Cases without valve re-intervention or valve transplantation;
• One patient experienced an ischemic stroke and was discharged 13 days after surgery, while another patient had a bleeding event. The researchers found no incidence of hemolysis or valve dysfunction.

This study is alsoCDSCO ApprovalTRIAKey to going public. WithTRIAThe listing marks the official entry of valvular disease treatment into the polymer valve era. This is another milestone in valvular disease treatment following the bioprosthetic valve. According toFoldaxDescribe its polymeric valveTRIABy innovating materials, the durability of the product is enhanced, breaking through the limitations of traditional bioprosthetic and mechanical valves, and fundamentally eliminating the need for lifelong anticoagulation therapy in patients.TRIAThe absence of anticoagulation effect was also confirmed in one of its clinical studies (the first patient with aortic valve stenosis implanted with a polymer aortic valve).TRIA, No anticoagulants were taken five years after surgery (except for a few days post-surgery).）。

Of course, in addition to durability and avoiding anticoagulation,TRIACan achieve fully automated production, thereby ensuring a high degree of product consistency and stable, reliable product quality.

TRIAAs a revolutionary product, its market launch signifies the arrival of a new era in valve technology. The future is here!!!

TRIA

• Number-average molecular weight (Mn) is approximately 120,000 Da (GPC tested).
• Glass Transition Temperature (Tg) Below 0°C (Between -4°C and -10°C)
• Ultimate Tensile Strength: ≥30MPa
• Elongation:≥500% 
• Tear Strength:≥50N/mm
• Hardness:~80A Shore A)
• MoveStateModulus:25-35MPa 

• AdoptAn Advanced Biopolymer Material---LifePolymer，The valve is more durable., without the need to apply any animal tissue;
• Will reduce or eliminate the need for lifelong anticoagulant medication；
• Providing a larger opening area than traditional valves, establishingSimilar hemodynamics and blood flow to human heart valves；
• CanVia catheter or surgical procedureMethod for treating heart valve disease;
• AdoptMechanized Production and Manufacturing，Better Precision and Quality Control, while eliminating the uncontrollability of manual production;
• With more competitive economic value;
• EO Sterilization;
• Smaller Profile.