Vivos Inc (RDGL)

[MilkWai]

Just because two companies "beat them to the punch" doesn't mean ADMD cannot succeed. Ultimately the deciding factor on which device comes out ahead is cost. I'm talking about everything. How much does it cost to manufacture? Is the administration quick and easy? Is there a big hassle afterwards?

One big downside to TheraSphere is that it is NOT biodegradable[1]. That is a huge concern because how would the body remove it? Is there a danger of accumulation? What happens if there is an accumulation?

The fact that TheraSphere is NOT biodegradable separates it from SIR-Sphere and Radiogel. But I can't comment any further on SIR-Sphere and Radiogel because I don't know what polymers it's made of. The formulation of the polymer composite matrix is probably considered reasonably different than the resin used for SIR-Sphere although function is probably still about the same. And now it comes down to cost. All of the things mentioned above.

So in my opinion, would this get FDA approval? Very likely. There is no reason why SIR-Sphere would be approved and Radiogel won't be especially if ADMD can demonstrate to the FDA that the matrix it uses can hold up and is biocompatible with the body. At the end of the day, SIR-Sphere and Radiogel are probably doing the same thing with reasonably close efficacy and safety levels. Think MSFT vs AAPL sort of competition.


[1] http://www.accessdata.fda.gov/cdrh_docs/pdf/H980006b.pdf