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

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

Foldax Inc. today announced a manufacturing agreement with Dolphin Life Science India LLP to enable incountry manufacturing of the TRIA polymer mitral surgical heart valve outside of the U.S. for the first time. ....

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

SALT LAKE CITY (BUSINESS WIRE) #TRIAheartvalves Foldax® Inc. today announced that it has executed an agreement with Australia’s national science agency, CSIRO, for full ownership of a polymer ....

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Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve

Published: Dec 14, 2020
SALT LAKE CITY (BUSINESS WIRE) Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.
The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and addresses a large unmet clinical need based on the prevalence of rheumatic fever worldwide.
The first of the company’s products – an aortic surgical heart valve – is currently enrolling a U.S. clinical study as a result of FDA approval of an expanded study last October. The third valve product is a transcatheter aortic valve replacement (TAVR), which is in the pre-clinical testing phase. ....

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Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve - Press Release

Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve
SALT LAKE CITY (Business Wire) Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.
The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and addresses a large unmet clinical need based on the prevalence of rheumatic fever worldwide. ....

Salt Lake City , United States , Michelle Mcadam , Frank Maguire , Frank Shannon , Sayan Bioventures , Angel Physicians Fund , Memorial Care Innovation Fund , Drug Administration , Chronic Communications Inc , Business Wire , Cardiovascular Surgery , Beaumont Hospital , Royal Oak , Foldax Medical Advisory , Biostar Capital , Kairos Ventures , Chronic Communications , உப்பு ஏரி நகரம் , ஒன்றுபட்டது மாநிலங்களில் , மைக்கேல் மக்யாடம் , வெளிப்படையான மக்வைர் , வெளிப்படையான ஶ்யாநந் , தேவதை மருத்துவர்கள் நிதி , நினைவகம் பராமரிப்பு கண்டுபிடிப்பு நிதி , நாள்பட்ட தகவல்தொடர்புகள் இன்க் ,