Thursday, December 20, 2018 4:36:48 PM
a 510(K) premarket clearance for this class of device is not so difficult to obtain. I would have been very surprised if ARTH had not able to obtain it. Same for CE mark. That is not to imply that obtaining the clearance (not an approval per se, which is much more difficult to obtain)
isn't noteworthy. It's one more step on a long road. It's simply important to keep things in perspective and to have reasonable expectations.
Any increase in the stock price for a pre-revenue company in this market is nothing to sneeze at.
The rubber will meet the road when the AC5 topical product produce unit sales and revenues. ROTH capital is assuming a royalty model in their report, one that assumes that another company will make & sell the device and that ARTH will obtain a royalty stream. That is a 'best guess' as no deal has yet been signed. Wound care is a crowded and price senitive feld, so success woon't be easy regardless of the technology in the device. Let's see the product sales revenues AND understand how much profit (& cash) these will contribute to ARTH. ARTH is counting on these profits to fund future products developments.
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