I wonder why they are only going to try their scaffold device in the first human trial instead of combining the structure with their hydrogel? I don't know a lot of the medical details, but has InVivo said when they plan to test the gel on humans as well? From the investor presentation, it looks like they had given the primates the full treatment, and I'm sure the gel was probably a big success factor in the primate trials... Anyone have any insights?
Fizz, I think if I remember the timeline correctly, the data to support human clinical trials, on the hydrogel, was not out yet when they first submitted the scaffold for IDE with the FDA.
Weitz is correct. The original primate data and the most complete and data was done using only the scaffold. They do have primate data with hydrogel and scaffold + cells but this isn't as complete although it looks VERY promising.
That being said doing simply the scaffold by itself is easier in terms of FDA approval. The scaffold is made with materials that are already approved by the FDA and KNOWN to be safe. InVivo uses a specific manufacturing technique to create the scaffold that guides the neurons and supports their survival and regeneration. So a simple scaffold device will be MUCH easier to gain FDA approval and with the cash flow from the sales of this device the hydrogel and stem cell based devices can be tested and approved as well as the peripheral nerve hydrogel which could be absolutely HUGE.
Very exciting stuff. Glad to see others following it!
