To me the FDA approval is a tick in the box exercise. It will happen. The product works much better than Thoratec's Heartmate II, who even with their 5 patient deaths due to a faulty device still have FDA approval. Ventrassist is a proven product. Plus it will be compared to the older Heartmate XVE, which is ancient technology now and nowhere near as good as Ventrassist.
It will just take time (and money) to jump through the hoops.
I think the main challenge for VCR is having investor sentiment and funding to keep it alive until FDA approval and profitability.
VCR Price at posting:
8.6¢ Sentiment: LT Buy Disclosure: Held
