TRIA

Foldax, Inc. Signs Manufacturing Agreement with Dolphin Life Science India LLP to Expedite Upcoming Commercial Availability

Retrieved on: 
Tuesday, February 27, 2024
Research, Medical Devices, Engineering, Chemicals, Plastics, Health Technology, Cardiology, Manufacturing, Biotechnology, Health, Science, Anticoagulant, Cardiovascular disease, CDSCO, Sale, RHD, Calcification, Mitral valve, Patient, Anatomy, LLP, Failure, DCGI, TRIA, Medical device

Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.

Key Points: 
  • Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.
  • The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position.
  • Dolphin Life Science India LLP is an expert in manufacturing medical devices.
  • The company is registered with India’s regulatory bodies, the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).

Foldax Completes Enrollment in India Clinical Trial Evaluating TRIA™ Polymer Surgical Mitral Heart Valve

Retrieved on: 
Monday, November 27, 2023
Health, Hospitals, General Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Sale, Woman, Calcification, Safety, Hope, Anatomy, Heart, Surgery, Clinical trial, Patient, Anticoagulant, Casciaro, Rheumatic fever, MD, TRIA, Human, Growth, TCT, Columbia University, Mitral valve, Failure, Female, Physician, Life, Medical device, Medical imaging

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.

Key Points: 
  • 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.
  • The TRIA mitral valve is designed specifically for the anatomy and pressures of the mitral position.
  • “We are excited to see early promising results from the TRIA polymer mitral valve,” said Kaushal Pandey, MD, with P.D.
  • “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.”
    The Indian TRIA surgical mitral valve study is a prospective multicenter clinical trial.

First Patients Outside of U.S. Treated with TRIA Polymer Surgical Mitral Heart Valve

Retrieved on: 
Tuesday, August 1, 2023
Surgery, Medical Devices, Clinical Trials, Health Technology, Cardiology, Biotechnology, Health, Pharmaceutical, General Health, Workforce, Surgeon, Failure, Noise, Calcification, Cardiovascular disease, Anatomy, Rheumatic fever, Clinical professor, Clinical trial, Woman, Sale, Anticoagulant, TRIA, Patient, Tricuspid valve, Developing country, Family, Disease, Medical device, Medical imaging

Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced that the first 30 patients have been treated outside of the U.S., in the Indian clinical trial of the TRIA™ surgical mitral heart valve.

Key Points: 
  • Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced that the first 30 patients have been treated outside of the U.S., in the Indian clinical trial of the TRIA™ surgical mitral heart valve.
  • The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position.
  • This polymer valve holds the promise of being a lifetime valve, without the negative quality-of-life implications of other types of prosthetic valves.”
    The Indian trial is a prospective surgical mitral valve study that will enroll up to 70 adult patients with mitral valve disease from 10 sites and will support commercialization in India.
  • “We are excited to be able to offer our novel TRIA mitral surgical valve to patients in India,” said Foldax CEO Gregory D. Casciaro.

Foldax, Inc. Receives Full Ownership Rights to Proprietary Polymer Patent Portfolio

Retrieved on: 
Thursday, May 11, 2023
Biotechnology, Medical Devices, Health, Health Technology, Cardiology, Failure, Calcification, Elective surgery, Cell, Heart, Sale, Protein, TRIA, Electrophysiology, Blood, CSIRO, FDA, Economics, Medical device, Medical imaging, California Institute of Technology

Foldax® Inc. today announced that it has executed an agreement with Australia’s national science agency, CSIRO, for full ownership of a polymer technology patent family.

Key Points: 
  • Foldax® Inc. today announced that it has executed an agreement with Australia’s national science agency, CSIRO, for full ownership of a polymer technology patent family.
  • This LifePolymer material characteristic makes it highly biocompatible with the human body and extremely durable, which may be ideal for certain medical devices.
  • The LifePolymer technology has undergone extensive biological safety testing that has been included in Foldax’s regulatory filings to the FDA.
  • The TRIA biopolymer heart valve is the first polymer valve ever to receive FDA approval for human studies in both aortic and mitral positions.

LBank Exchange Will List TRIA (TRA) on February 17, 2023

Retrieved on: 
Thursday, February 16, 2023
Metaverse, AR, Non-fungible token, TRA, TRIA, Blockchain-based database, Acquisition, AI, NFT, VR, Blockchain, History, Certification, Sale, Science, Cryptocurrency

Road Town, British Virgin Islands--(Newsfile Corp. - February 16, 2023) - LBank Exchange, a global digital asset trading platform, will list TRIA (TRA) on February 17, 2023.

Key Points: 
  • Road Town, British Virgin Islands--(Newsfile Corp. - February 16, 2023) - LBank Exchange, a global digital asset trading platform, will list TRIA (TRA) on February 17, 2023.
  • For all users of LBank Exchange, the TRA/USDT trading pair will be officially available for trading at 6:00 UTC on February 17, 2023.
  • After being registered via the TRIA NFT Exchange, assets marked as TRIA may be exchanged by auction, sale, or exchange.
  • The public NFT exchange may be used to trade, and the TRIA NFT Wallet is used to store and exchange NFTs.

First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

Retrieved on: 
Tuesday, May 3, 2022
Medical Devices, Health, Hospitals, Surgery, Clinical Trials, Cardiology, Bleeding, New York Heart Association Functional Classification, Failure, Anticoagulant, Death, Hemodynamics, Patient, Calcification, Aortic valve, Clinical trial, EOA, TRIA, Workforce, NYHA, Quality of life, Sale, JACC: Cardiovascular Interventions, DCGI, Drugs Controller General of India, Medical imaging, Medical device, California Institute of Technology

Foldax , Inc. today announced that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA biopolymer surgical aortic heart valve.

Key Points: 
  • Foldax , Inc. today announced that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA biopolymer surgical aortic heart valve.
  • We are honored to be the first center outside of the U.S. to implant the TRIA heart valve.
  • We look forward to completing enrollment in the study in the next few months and seeing how this novel biopolymer heart valve can improve the lives of our patients.
  • The trial is studying the ability of the TRIA biopolymer aortic valve to surgically treat patients with aortic valve disease and is designed to support commercial approval in India.

TRIA Transcatheter Biopolymer Heart Valve Shows Promise in Pilot Animal Study

Retrieved on: 
Monday, February 28, 2022
Medical Devices, Health, Surgery, General Health, Cardiology, Biotechnology, Workforce, Human, Riverside Methodist Hospital, NYHA, Thrombosis, Failure, Anticoagulant, Heart, New York Heart Association Functional Classification, Company, Sale, Life expectancy, Calcification, CRT, TRIA, TAVR, Patient, Â, Hemodynamics, MD, Face, EOA, Medical imaging, Medical device, Hydraulic machinery, California Institute of Technology

Foldax , Inc. today announced the presentation of results from the first animal study of its transcatheter valve from the TRIA biopolymer heart valve portfolio this past weekend at the Cardiovascular Research Technologies (CRT) annual conference.

Key Points: 
  • Foldax , Inc. today announced the presentation of results from the first animal study of its transcatheter valve from the TRIA biopolymer heart valve portfolio this past weekend at the Cardiovascular Research Technologies (CRT) annual conference.
  • Investigators for the pilot study of four ovine subjects reported the TRIA TAVR (valve) demonstrated satisfactory deployment, function and good hemodynamic results.
  • On the basis of this pilot study, Foldax plans to conduct a larger pre-clinical study of its transcatheter valve in 2022 intended to support a first-in-human study.
  • In this small animal study, we found that the TRIA transcatheter biopolymer valve showed promising hemodynamic results with encouraging durability, said Dr. Yakubov.

Distinguished Programs Announces Additional Cities and New Umbrella Coverage in City Insurance Program

Retrieved on: 
Wednesday, February 23, 2022
Umbrella, National Communication Association, Insurance, City, Growth, Real estate, CA, Multimedia, Distinguishing, CO, TRIA, Fort Collins, Colorado, Program, Terrorism, Restaurant

NEW YORK, Feb. 23, 2022 /PRNewswire/ --Distinguished Programs ("Distinguished"), a national insurance program manager,today officially announces the expansion of its City Insurance program to select cities in CA and CO.

Key Points: 
  • NEW YORK, Feb. 23, 2022 /PRNewswire/ --Distinguished Programs ("Distinguished"), a national insurance program manager,today officially announces the expansion of its City Insurance program to select cities in CA and CO.
  • Distinguished also revealed new umbrella coverage eligibility for condos and rentals with underlying City Insurance policies.
  • Distinguished covers 23 cities across the U.S.
    "We are excited to be expanding our presence in CA and CO," said Katie Vespia, Managing Vice President of City Insurance program at Distinguished.
  • In addition, Distinguished announced umbrella coverage availability for condos and rental properties with underlying City Insurance policies in select cities*.

First Clinical Study on TRIA Biopolymer Heart Valve Shows Excellent One-Year Performance

Retrieved on: 
Tuesday, December 21, 2021
Medical Devices, FDA, Health, Surgery, General Health, Cardiology, TRIA, Review, FDA, Trial of the century, FACC, EOA, Failure, Hemodynamics, Journal, Aortic valve, NYHA, New York Heart Association Functional Classification, Safety, TAVR, American College, Calcification, Classification, Heart, Anticoagulant, Economics, Human, Sale, JACC, Patient, Bleeding, Medical imaging, MD, Tria, California Institute of Technology

Foldax , Inc. today announced publication of the first clinical results for its TRIA biopolymer heart valve - the first polymer valve to be implanted in humans.

Key Points: 
  • Foldax , Inc. today announced publication of the first clinical results for its TRIA biopolymer heart valve - the first polymer valve to be implanted in humans.
  • The TRIA valve reimagines the heart valve by combining the companys proprietary biopolymer LifePolymer with an innovative valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without requiring lifelong use of anticoagulants.
  • Summarizing the study results, Dr. Kereiakes said, The TRIA valve demonstrated marked and sustained improvements in transvalvular gradients, valve EOA and NYHA clinical class out to one-year following valve implant.
  • The Tria heart valve is considered investigational in the U.S. and is not available for commercial sale in the U.S.
    To learn more about Foldax, visit www.foldax.com .

Foldax Receives Approval for Clinical Trial of TRIA Biopolymer Surgical Aortic Heart Valve in India

Retrieved on: 
Tuesday, December 7, 2021
Biotechnology, Medical Devices, Health, Clinical Trials, Cardiology, Bleeding, Aortic valve, TRIA, Technology, Calcification, Drugs Controller General of India, Failure, Quality of life, Death, Patient, Anticoagulant, Trial of the century, Clinical trial, DCGI, Sale, Medical imaging

Foldax , Inc. today announced that the Drugs Controller General of India (DCGI), Indias regulatory body for medical devices, has approved initiation of a clinical trial of the TRIA biopolymer surgical aortic heart valve.

Key Points: 
  • Foldax , Inc. today announced that the Drugs Controller General of India (DCGI), Indias regulatory body for medical devices, has approved initiation of a clinical trial of the TRIA biopolymer surgical aortic heart valve.
  • The trial will study the ability of the TRIA biopolymer aortic valve to surgically treat patients with aortic valve disease and lead to commercial approval in India.
  • Today, 70 percent of aortic valve replacements being performed in India implant mechanical valves.
  • After promising outcomes from our U.S. early feasibility study, we are excited to expand our clinical study of the TRIA biopolymer valve globally, beginning in India.