Just had a look over my previous emails with the company and they were definitely anticipating a device classification previously,
"Dear XXXXXX,
We already have a device classification for VitroGro for topical use in Canada and the EU. We are waiting for a response from the FDA but our US regulatory consultants are confident that we will also be classified as a device by the FDA.
The action of VitroGro for wound healing is essentially that of a biomimetic fusion extracellular matrix protein that replaces an ECM structure that was present prior to the chronic wound developing. It has no chemical or metabolic action.
Dr Steven Mercer CEO Tissue Therapies Ltd"
TIS Price at posting:
59.0¢ Sentiment: LT Buy Disclosure: Held
