a "stentless stent"

[Cece]

http://www.technologyreview.com/news/40 ... d-vessels/

I want to hear more about this. This is from 2007 so there may be more recent information.

"The blood-vessel wall is a complicated structure," says Elazer Edelman, director of the Harvard-MIT Biomedical Engineering Center and cofounder of Pervasis. When the endothelium is damaged, it leads to a condition called intimal hyperplasia--an abnormal growth of smooth muscle cells. The vessel walls then scar and thicken, leading to restenosis.

The Pervasis product contains endothelial cells grown from culture. The factors released by the cells "send the signal that the endothelium is okay, that it's in control," says Pervasis CEO Steve Bollinger. It gives the endothelium time to heal itself. The gel biodegrades after 30 to 60 days.

It was being tested in patients with kidney dialysis, which might mean it was being tested in jugular veins. The product wraps around the outside of the blood vessel, so there would be a cut into the neck to get it there.

the company is still around, five years later: http://www.pervasistx.com/

[Cece]

http://www.pervasistx.com/clinical-development/pipeline
Here's the pipeline. It's also being tested in grafting, and we've been talking lately about grafting of jugular veins. Maybe a use for it there someday.

http://www.pervasistx.com/clinical-deve ... l-overview
Here's the results of phase II trials in the dialysis patients. It is not being tested in jugulars. It is being tested in arteriovenous fistulas, which are commonly on the arm. Good results with enhanced primary and secondary patency.

This could work in CCSVI. There's nothing on the market yet like it, and it serves an unmet need to support the healing of the blood vessel after angioplasty. Intimal hyperplasia or smooth muscle cell overgrowth, which is a healing response, reduces the size of the lumen after venoplasty. This product could potentially prevent that.

[MarkW]

Hello Cece,
After 5 years I would expect to find more info on this product if was going to make it to market. Over 90% of life science ideas never get to market or have a limited use. It is the risk of development in life sciences................
MarkW

[Cece]

I thought too that it would be gone after five years, but then I found their website (my second post). In April 2012 they were acquired by a company named Shire. In Feb 2011 they received FDA fast track status.

Vascugel has demonstrated proof of concept in two Phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous (AV) access in order to undergo hemodialysis. In these trials, Vascugel exhibited an excellent safety profile, and encouraging efficacy trends were observed, including improved duration of patency (or unimpeded blood flow) and a delay in time to first intervention as compared to placebo.

In 2009, Pervasis received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Vascugel in patients with ESRD. Pervasis announced last month that the FDA had granted Fast Track review status for Vascugel. Last year, Pervasis reached an agreement with the FDA for a Phase 3 clinical trial of Vascugel under the Agency’s Special Protocol Assessment (SPA) procedure, whereby FDA formalized its agreement that the design
of the Phase 3 trial was acceptable to support a regulatory submission seeking new drug approval.

http://www.pervasistx.com/userfiles/EMA ... 11%20FINAL(1%29.pdf

To receive Fast Track designation, a product must address a serious unmet medical condition, and be supported by strong results from pre-clinical or clinical testing demonstrating the product potential.

http://www.pervasistx.com/userfiles/Per ... 11%20FINAL(1%29.pdf

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has signed an agreement to acquire substantially all the assets of Pervasis Therapeutics. Shire will provide Pervasis with an upfront payment, plus potential post-closing milestone payments that are dependent on Shire’s achievement of certain clinical development, regulatory and sales targets.

http://www.pervasistx.com/sites/default ... 0FINAL.pdf
Is it good news or bad news that they were acquired?

[MrSuccess]

I still think a stent custom made from -plaque - could achieve desired results .

A : It's already in your body B: It's already in your Artery's. C: No rejection issues and thus no need for a lifetime on anti-rejection drugs D: It can be removed .

MrSuccess offers his idea free of charge ..... and hopes that some brilliant young mind finds a way to make this happen.

Why not put mother natures " cement " to good use ? It's already on your teeth.


Who knows ...... it might work .


MrSuccess