Foldax Continues

[Jmprosser.lab]

Foldax continues to have encouraging advancements in multiple trials, gain FDA approval, and large funding. They spoke about the very high potential of this valve in a recent Cleveland Clinic Q&A. Still a ways to go, but the first human patient for the Aortic Valve is apparently doing well. Will continue to monitor the study results. But wow they are now moving to 15 human patients now. Some details below. Will be fun to monitor over the next few years, hopefully the data is positive.

Redirect Notice

Foldax Receives FDA Approval to Expand Clinical Study of Novel Biopolymer Aortic Heart Valve

The FDA approves an expanded U.S. clinical study of the Tria biopolymer heart valve. The valve is designed to resist calcification and stresses.

www.businesswire.com

Foldax Named Cardiovascular Device Company of the Year by MedTech Outlook

Foldax named cardiovascular Company of the Year by MedTech Outlook.

www.businesswire.com

Foldax® Completes Enrollment in Tria LifePolymer™ Early Feasibility Study | BioSpace

Foldax® Completes Enrollment in Tria LifePolymer™ Early Feasibility Study - read this article along with other careers information, tips and advice on BioSpace

www.biospace.com

 

[rich01]

I'm hopefully at least 5 years from needing my valve replaced, so I sure hope this pans out. I don't think I'll make it to 90, but I wouldn't want to have valve replacement at that age.

 

[Protimenow]

Hey, Rich -- you're not already in your '80s now, are you? If you were, you'd probably hit 90 without too many complications.

The way things are feeling now, I'll be surprised to make it to my next birthday (July).

 

[rich01]

Hey, Rich -- you're not already in your '80s now, are you? If you were, you'd probably hit 90 without too many complications.

The way things are feeling now, I'll be surprised to make it to my next birthday (July).

No, I'll be 72 next month and had TAVR a little over a year ago. I'm hoping it will be my late 70's before needing this valve replaced, so if the Foldax is available then that should mean I won't have to worry about replacing it again.

 

[Protimenow]

That's IF the Foldax proves to be as good as their marketing makes it sound.

 

[rich01]

That's IF the Foldax proves to be as good as their marketing makes it sound.

Hopefully, it will be several years before I need it, so I expect some major advances to take place. I don't know if it will help or not, but I am taking vitamin K hoping that might reduce calcification.

 

[Jmprosser.lab]

This is at least reason for optimism! Hopefully it does match the marketing enthusiasm, though only further studies will tell. Looking forward to that data.

 

[BillDaThrill]

Jm - do you have a link to that Cleveland Clinic Q&A or know more about any upcoming studies with the Tria valve at the Cleveland Clinic? Tried to search for it but could not find further info. Thanks!

 

[Jmprosser.lab]

Hey Bill— I couldn’t find it online yet but I assume they will post it soon. I attended a live version. The trials aren’t happening at Cleveland Clinic, their cardios just found the approvals and studies encouraging and said they’d anxiously be following the trials as they continue. My links above have the info on that but we will deff know a good bit in the next 2-5 years as they continue to expand human trials. 15 more were enrolled during COVID.

 

[rich01]

Something I hadn't picked up on is the transcatheter aortic valve is only in the preclinical testing phase. The surgical aortic valve is furthest along, then the mitral valve, and transcatheter is far behind.

 

[Jmprosser.lab]

That’s correct. As someone who has regurgitation and not stenosis, TAVR is a bit behind for me anyway. The JennaValve gives some hope for us regurgitation patients to get TAVR, but I’m not sure how far away that technology is from being used in low risk patients.

 

[Jmprosser.lab]

Jenna valve update from this year is super encouraging with the FDA labeling it a breakthrough device and wanting to expedite the trials. Not sure how that affects low risk patients, though.

 

[Jmprosser.lab]

JenaValve Transcatheter Aortic Valve Replacement (TAVR) System Designated by FDA as Breakthrough Device

JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic Regurgitation Indication

www.cathlabdigest.com

 

[nobog]

Something I hadn't picked up on is the transcatheter aortic valve is only in the preclinical testing phase. The surgical aortic valve is furthest along, then the mitral valve, and transcatheter is far behind.

The transcatheter is probably farthest behind as they try to crunch those polymer leaflets into a tube without damage.

 

[Jmprosser.lab]

Agreed that may be a ways away based on the links/studies I’ve read. Good thing is good or bad we will get data on all of this in the next couple years as they begun human trials.

 

[Chuck C]

Foldax continues to have encouraging advancements in multiple trials, gain FDA approval, and large funding. They spoke about the very high potential of this valve in a recent Cleveland Clinic Q&A. Still a ways to go, but the first human patient for the Aortic Valve is apparently doing well. Will continue to monitor the study results. But wow they are now moving to 15 human patients now. Some details below. Will be fun to monitor over the next few years, hopefully the data is positive.

Redirect Notice

Foldax Receives FDA Approval to Expand Clinical Study of Novel Biopolymer Aortic Heart Valve

The FDA approves an expanded U.S. clinical study of the Tria biopolymer heart valve. The valve is designed to resist calcification and stresses.

www.businesswire.com

Foldax Named Cardiovascular Device Company of the Year by MedTech Outlook

Foldax named cardiovascular Company of the Year by MedTech Outlook.

www.businesswire.com

Foldax® Completes Enrollment in Tria LifePolymer™ Early Feasibility Study | BioSpace

Foldax® Completes Enrollment in Tria LifePolymer™ Early Feasibility Study - read this article along with other careers information, tips and advice on BioSpace

www.biospace.com

Thanks for sharing this. I'll be watching the Foldax data closely as it is published.

 

[Warrick]

Not sure if this ones been posted yet-

New heart valve could transform open heart surgery

A new polymeric heart valve with a life span potentially longer than current artificial valves that would also prevent the need for the millions of patients with diseased heart valves to require life-long blood thinning tablets has been developed by scientists at the universities of Bristol and...

healthcare-in-europe.com

 

[Humboldtgrrl]

As of early April, a surgeon involved with Foldax surgical AVR trials (so can access their private database), related there were 18 implanted. As of late April, this surgeon did their first Foldax implantation & related that it a certain seemed to require a minimum diameter hole to suture in (e.g. not a good match for a patient with a small heart). All these updates are only Points in Time events, so keep listening.

 

[Paleowoman]

New heart valve could transform open heart surgery

A new polymeric heart valve with a life span potentially longer than current artificial valves that would also prevent the need for the millions of patients with diseased heart valves to require life-long blood thinning tablets has been developed by scientists at the universities of Bristol and...

healthcare-in-europe.com

Following the link in that article for more information about the Polivalve: https://pubs.rsc.org/en/content/articlepdf/2020/bm/d0bm00412j it mentions testing 19mm valves: "Four valves of the latest prototype J6 (two 19 mm and two 21 mm ID) have been tested for durability.”
"the EOA of the valves remained well above the minimum required by ISO standards (0.85 cm2 for 19 mm and 1.05 cm2 for 21 mm)”

Certainly worth keeping an eye on this one. There's a link to check on updates too.

 

[ATHENS1964]

Foldax Gets Indian Approval to Start Clinical Trial of Tria Biopolymer Surgical Aortic Valve

December 13, 2021 - Foldax Inc. announced that the Drugs Controller General of India (DCGI), India’s regulatory body for medical devices, has approved initiation of a clinical trial of the Tria biopolymer surgical aortic heart valve. The Tria valve reimagines the heart valve by combining the...

www.dicardiology.com