Xeltis - Endogenous Tissue Restoration Heart Valve

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DJM 18

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http://www.xeltis.com

Xeltis is a clinical-stage medical device company developing heart valves that leverage breakthrough science to transform heart valve therapy. Xeltis’ technology enables natural heart valve restoration.

RestoreX, Xeltis’ novel technology platform, is the world’s first polymer-based technology designed to enable restorative heart valve therapy.
 

CazicT

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Anyone know how "Real" this is? I've scoured the web looking for information and it seems like their initial trials with a pulmonary valve were very promising, though it was in like 10 kids, and it hasn't been that long...
Likewise for the Imavalve project... Anyone have opinions on the feasibility? The lady in their youtube video remarked, "In 2020 I think we'll be there..." not exactly sure what there is? Ready for sale??

My wife has Type 1 diabetes and it is quite common for promising new stuff to come along and excite everyone, but then fizzle out... Is it the same deal here?? I've only recently been researching valve related stuff since i am now going in for surgery in a matter of weeks...

If the Endogoneous Tissue Restoration technology is truly feasible and is "just a matter of time", this might have to factor into people's decision for valve choice right now... Mechanical valve is likely not coming out for life once its in place, but if this new ETR heart valve will be readily available in 10 years, maybe going tissue now in anticipating this to be ready in the meantime and then can be implanted via catheter would be a decent bet...

Probably still too early to make that bet though.. Any thoughts?
 

DJM 18

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I think it is very "real' but still a way from demonstrated long term reliability which would make it competitive with current solutions. The fact that it has been implanted in children is quite remarkable, even if only a few. But the Aortic valve is a little more demanding and adults do not regenerate tissue as well as children; So it will be a while before this is a true alternative.

However, others are also working on comparable efforts so tissue engineered valves could in fact gain traction in the years to come...

http://arise-clinicaltrial.eu/home.html

http://www.espoir-clinicaltrial.eu/home.html

https://wyss.harvard.edu/engineering-heart-valves-for-the-many/

Really quite amazing what is being done in this field although I understand how we would all wish it would be available much sooner.
 

DJM 18

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[h=1][/h] Here is another approach which shows great promise that would then be taken to a heart valve scaffold...Not there yet but really all quite amazing.

https://twin-cities.umn.edu/news-events/new-tissue-engineered-blood-vessel-replacements-closer-human-trials

Researchers at the University of Minnesota have created a new lab-grown blood vessel replacement that is composed completely of biological materials, but surprisingly doesn’t contain any living cells at implantation. The vessel, that could be used as an “off the shelf” graft for kidney dialysis patients, performed well in a recent study with nonhuman primates.

It is the first-of-its-kind nonsynthetic, decellularized graft that becomes repopulated with cells by the recipient’s own cells when implanted. The discovery could help tens of thousands of kidney dialysis patients each year. The grafts could also be adapted in the future for use as coronary and peripheral bybass blood vessels and tubular heart valves.

The research was published today as the cover story in Science Translational Medicine, an interdisciplinary medical journal by the American Association for the Advancement of Science (AAAS). The University of Minnesota has also licensed the technology.
 

ottagal

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Some interesting research indeed...always a matter of time etc. before one knows when/if it will be mainstream. Thanks for sharing.
 

DJM 18

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Not there yet but it is great to see them raise this money as it further validates their technology offering; Although there is still A LOT of work before this becomes a viable product.

Xeltis Closes €45 Million in Oversubscribed Series C Financing to Advance Aortic and Pulmonary Valve Programs

The largest investment round for a private medical device company in Europe in 2017

EINDHOVEN, The Netherlands and ZURICH, November 15, 2017 /PRNewswire/ --
Xeltis, a clinical-stage medical device company pioneering a restorative approach in heart valve therapy, today announced the completion of an oversubscribed €45 million ($52 million) Series C financing. The funding round was led by a global strategic investor with participation from venture capital fund Ysios Capital and a number of large private investors. Existing institutional investors (LSP, Kurma Partners and VI Partners) and private investors also participated in the financing.

The Series C financing will support continuation of clinical activities and acceleration of product and market development for the company's novel aortic and pulmonary valve programs. This is the largest investment round for a private medical device company in Europe in 2017.
"Xeltis is eager to provide patients who need heart valve replacement with a new option offered through our restorative technology, to ultimately improve their lives and reduce healthcare system costs," said Xeltis Chief Executive Officer (CEO) Laurent Grandidier. "This robust financing provides us with the resources necessary to catapult our strategy forward - supporting quick expansion of our aortic and pulmonary valve programs and strengthening our quest to redefine heart valve replacement therapy."
Xeltis' heart valves enable the patient's own body to naturally restore a new heart valve through a therapeutic approach called Endogenous Tissue Restoration (ETR). With ETR, the patient's natural healing system develops tissue that pervades Xeltis' heart valve, forming a new, natural and fully functional valve within it. As ETR occurs, Xeltis implants are gradually absorbed by the body. ETR is enabled by bioabsorbable polymers based on Nobel Prize awarded science.
Ongoing Trial Programs
At TCT 2017, Xeltis announced the latest study results from the Xeltis preclinical aortic valve program during a session dedicated to its innovative technology. The 12-month preliminary aortic valve data showed promising results with good hemodynamic performance and fully functional valves in vivo 12 months after implantation.
The first feasibility clinical trial for Xeltis' pulmonary valve, Xplore-I, is underway in Europe and Asia. In January, the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for Early Feasibility Study (EFS) to implant Xeltis' pulmonary valve in 10 patients. Four prominent U.S. centers are now participating in the clinical trial called Xplore-II.
Previously, Xeltis shared up to 31-month data from a pediatric feasibility study of a vascular graft. The study showed positive functionality results with no device-related adverse events, and significant improvement in patients' general conditions.
Xeltis is currently investigating additional applications of its innovative approach to restore other heart valves and blood vessels.
About Heart Valve Replacement
In industrialized countries, heart valve disease is estimated to affect approximately two percent[SUP][1][/SUP][SUP],[/SUP][SUP][2][/SUP] of the population, with hundreds of thousands of patients undergoing heart valve intervention every year.[SUP][3][/SUP][SUP],[/SUP][SUP][4][/SUP] Today, patients with artificial heart valves generally endure the risk of repeated replacement procedures or take long-term medication with potentially severe side effects.
Xeltis' novel restorative approach has the potential to overcome the limitations of current artificial heart valves and to improve the lives of hundreds of thousands of patients requiring heart valve replacements, while reducing overall healthcare system costs.
About Xeltis
Xeltis is a clinical-stage medical device company developing the first heart valves and blood vessels enabling the body's natural restoration of heart valve function through a therapeutic approach called Endogenous Tissue Restoration (ETR).
The company's cardiovascular implants are made of bioabsorbable polymers based on Nobel Prize awarded science.
For more information, please visit http://www.xeltis.com
CAUTION: The Xeltis technology is an investigational device and NOT approved for sale.
 

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