SALT LAKE CITY--(BUSINESS WIRE)--Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve. Positive 30-day data for the first 35 patients in the study was presented at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference by Isaac George, M.D., Surgical Director of the Heart Valve Center at Columbia University.

盐湖城-（商业线）-创新型聚合物心脏瓣膜开发的领导者Foldax®公司今天宣布完成印度三联症临床试验注册™ 聚合物外科二尖瓣心脏瓣膜。哥伦比亚大学心脏瓣膜中心外科主任Isaac George博士最近召开的经导管心血管治疗（TCT）会议上介绍了该研究前35名患者的30天阳性数据。

The data showed that TRIA valve implantation resulted in 0% reoperation, 0% blood clotting and 0% bleeding events..

数据显示三瓣膜植入导致0%再次手术，0%凝血和0%出血事件。。

The TRIA mitral valve is designed specifically for the anatomy and pressures of the mitral position. It combines the company’s proprietary polymer – LifePolymer™ – with an innovative valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants..

TRIA二尖瓣专为二尖瓣位置的解剖结构和压力而设计。它结合了公司专有的聚合物-LifePolymer™ – 创新的瓣膜设计旨在抵抗钙化，承受压力和应变而不会失败，并且无需终生使用抗凝剂即可恢复患者的生活质量。。

“We are excited to see early promising results from the TRIA polymer mitral valve,” said Kaushal Pandey, MD, with P.D. Hinduja Hospital in Mumbai, India. “The blood flow dynamics are excellent, and the polymer material properties are formulated to resist calcification, one of the main causes of tissue valve failure.”.

印度孟买P.D.Hinduja医院的Kaushal Pandey博士说：“我们很高兴看到TRIA聚合物二尖瓣早期有希望的结果。”。“血流动力学非常好，聚合物材料的性能可以抵抗钙化，这是组织瓣膜失效的主要原因之一。”。

The Indian TRIA surgical mitral valve study is a prospective multicenter clinical trial. Since commencing in March 2023, the trial has enrolled its target of 66 patients across eight sites in India, making it one of the fastest-enrolling studies of any heart valve and reinforcing the need for a durable mitral valve replacement option.

印度TRIA手术二尖瓣研究是一项前瞻性多中心临床试验。自2023年3月开始以来，该试验已在印度的8个地点招收了66名患者的目标，使其成为任何心脏瓣膜入选研究最快的研究之一，并加强了对持久性二尖瓣置换术的需求。

Patients will be assessed at six months and one year for safety, hemodynamic performance, and durability. Additionally, a registry tracking these patients for five years will be implemented..

患者将在6个月和1年时进行安全性，血液动力学性能和耐久性评估。此外，将实施追踪这些患者五年的注册表。。

India was selected for the clinical trial because approximately two to three million people in the country have rheumatic heart valve disease caused by rheumatic fever, which attacks the mitral valve, and causes it to close improperly and leak. Patients often contract rheumatic disease early in life and their valves begin failing when they are still young..

选择印度进行临床试验是因为该国约有二百万至三百万人患有风湿热引起的风湿性心脏瓣膜病，风湿热会攻击二尖瓣，导致其关闭不当并泄漏。患者通常在生命早期就患有风湿性疾病，并且他们的瓣膜在年轻时就开始衰竭。。

In the Indian TRIA mitral valve trial, the patient age ranges from 19 to 68 years old, with an average age of 39, much younger than the nearly 60-year-old average age for tissue valve replacement in other mitral studies. Sixty-two percent of patients are female, and 60 percent of female patients are less than 40 years old, significantly larger percentages than typically seen in clinical studies..

在印度TRIA二尖瓣试验中，患者年龄为19至68岁，平均年龄为39岁，远低于其他二尖瓣研究中近60岁的组织瓣膜置换平均年龄。62%的患者为女性，60%的女性患者年龄小于40岁，这一百分比明显高于临床研究中的典型百分比。。

“It is especially rewarding to offer the TRIA polymer heart valve to women of child-bearing age,” said Dasari Prasada Rao, M.D., Chief Cardiac Surgeon at Apollo Spectra Hospital in Ameerpret, Hyderabad. “The TRIA polymer valve is designed to last a patient’s lifetime, without the requirement of taking blood thinners indefinitely.

海德拉巴Ameerpret阿波罗光谱医院的首席心脏外科医生Dasari Prasada Rao博士说：“向育龄妇女提供三聚体心脏瓣膜特别有益。”。“TRIA聚合物阀设计用于持续患者的一生，无需无限期地使用血液稀释剂。

With the TRIA valve, women can hold onto the hope of having children without facing repeat surgeries.”.

使用三联瓣，女性可以坚持生育孩子的希望，而不会面对重复手术。”。

The lower average age and high percentage of child-bearing females suggests that both physicians and patients believe the TRIA valve with LifePolymer will not have the limited durability or quality-of-life tradeoffs seen with currently available heart valves.

较低的平均年龄和较高比例的生育女性表明，医生和患者都认为，使用LifePolymer的TRIA瓣膜不会使用目前可用的心脏瓣膜进行有限的耐久性或生活质量权衡。

“Prior to TRIA, patients had to choose between tissue valves made from porcine or pericardial tissue that have limited durability and are not culturally acceptable in India, and mechanical valves that click audibly when opening and closing and require lifelong blood thinning medication,” said Anil Jain, M.D.

“在TRIA之前，患者必须选择由耐久性有限且在印度文化上不可接受的猪或心包组织制成的组织瓣膜，以及在打开和关闭时可听见并需要终身血液稀释药物的机械瓣膜，”Anil Jain博士说。

with Epic Hospital in Gujarat. “With growing positive clinical experience, the TRIA valve has the potential to become the valve of choice for patients of all ages with mitral valve regurgitation.”.

在古吉拉特邦的Epic医院工作。“随着越来越多的积极临床经验，TRIA瓣膜有可能成为所有年龄段二尖瓣返流患者的首选瓣膜。”。

“Treating the final patient in this rapidly enrolled Indian TRIA mitral surgical valve clinical study builds on the exciting phase of innovation and growth at Foldax over the past year,” said Gregory D. Casciaro, CEO of Foldax. “We now have patents in India covering both our LifePolymer material and our valve design, further acknowledging and protecting our innovative polymer and valves.”.

Foldax首席执行官Gregory D.Casciaro说：“在这项快速入选的印度三联二尖瓣手术瓣膜临床研究中，治疗最终患者建立在过去一年Foldax创新和发展的激动人心的阶段。“我们现在在印度拥有涵盖我们的生命聚合物材料和阀门设计的专利，进一步承认和保护我们创新的聚合物和阀门。”。

“Thanks to the expertise and support of our physician partners in both India and the United States, we can continue to clinically implant our ‘designed for mitral’ TRIA valves made with LifePolymer. Across our total clinical experience, over 150 valves have been implanted, making TRIA the most widely studied polymer valve in humans,” Casciaro continued.

“由于我们在印度和美国的医生合作伙伴的专业知识和支持，我们可以继续临床植入我们用LifePolymer制造的'为二尖瓣设计'三瓣膜。在我们的全部临床经验中，已经植入了150多个瓣膜，使TRIA成为人类研究最广泛的聚合物瓣膜，“Casciaro继续。

“We look forward to continuing to follow these patients and validating the robust nature of the TRIA valve.”.

“我们期待继续跟踪这些患者并验证三联瓣的稳健性。”。

The TRIA heart valve is for investigational use only and is not available for commercial sale.

TRIA心脏瓣膜仅用于研究用途，不可用于商业销售。

To learn more about Foldax, visit www.foldax.com.

要了解有关Foldax的更多信息，请访问www.Foldax.com。

About Foldax

关于Foldax

Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve – from material to design to manufacturing – to develop surgical and transcatheter valves designed to last a lifetime addressing historical tradeoffs, between tissue and mechanical valves.

Foldax总部设在犹他州盐湖城，正在重塑心脏瓣膜的各个方面-从材料到设计再到制造-开发外科和经导管瓣膜，旨在持续一生，解决组织瓣膜和机械瓣膜之间的历史权衡。

Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures.

Foldax投资者包括Angel Physicians Fund，Biostar Capital，Caltech，Glenview Capital，Kairos Ventures，Memorial Care Innovation Fund和Sayan Bioventures。