If the only news you would consider to be "good news" is FDA Approval, then I can see your disappointment. But I, on the other hand, heard a lot of very very good news in there. Here's the top 10 bits of good news that I took from that call:
1. Regarding the status of the FDA review process, currently the FDA is still reviewing our submission. Dean had a brief call with them a couple of days ago to ask if they had any questions or anything they wanted to discuss, and they simply said: "we're still reviewing your package." In other words, they did not have any more questions. Dean is confident that what was submitted in April (and July) should be enough, especially with the Radiology Review, which obviously he would not have sent in if it had not concluded SE or better. With all that, he is very confident that there is enough there for SE. They could of course come back with more questions, but he feels like we have a much stronger chance than we have ever had. He said, and I quote, "I believe we will have FDA approval very soon."
2. Regarding the recent 10Q, obviously the Company's finances are not as strong as he would like them to be, but he has a personal credit line that he has opened from which he is lending to the Company. It's not on the Company's quarterly reports because it's his personal line of credit. He will continue to execute on that as long as it is needed. He may end up buying back some stock, and he has already invested millions of dollars in the company, and set up a $2 million credit line to lend the company money as long as it is needed. He has 69 Million shares, and he hurts more than anyone when the PPS is down. Today's share price is irrelevant to Dean, because he's looking at the long term.
3. Regarding the Proxy Statement including a request for more authorized (not issued) shares, he said that this mainly started because in California they need to have more members on their Board of Directors. Since they were already putting together a proxy for that, they decided they would also put in a request to issue more shares, but it is NOT about financing, it's a safety net to protect against a hostile takeover.
4. Regarding the value of the Company, Dean stated that as a company, we can carry a $500 M to $1 B market cap easily, and then once the product is born into the market place, even higher because it's going to have a dramatic effect in the market. He said multiple times: "Once we get FDA approval…"
5. Regarding the Radiology Review, Dean confirmed that there were 2 radiologists who confirmed that the image quality from the DViS was at least equal, if not superior, to the predicate devices. He confirmed that the two radiologists were not shareholders, but upon seeing the device function, as with most people who see the product, they were immeidately interested in buying stock.
6. Regarding a live demonstration, Dean confirmed that the FDA would consider a live demo of the 3D functionality of the device to be marketing materials, which could result in more questions and delay. He did the 2D video mainly just to show who they are and that they are not a fly by night operation. After we get approval, there's going to be substantial press and promotion, b/c then they will be free to promote the DViS on real media channels.
7. Dean confirmed, without saying so explicitly, that the "Review Clock" has not restarted. He did this by confirming that the request from the FDA in January was a formal AI request, and that since that time, the FDA has not sent him any formal requests, any "hold" or re-start letters, or anything else in letter form formally requesting information.
8. Regarding the 510(k) vs. PMA issue, Dean said that the FDA would have told him a year ago if they could not see this as a comparative device, and that not only did he not get an indication that PMA was likely or possible, he was told explicitly that the Reviewer believed the DViS application was appropriately filed as a 510(k). He expanded on that by saying that PMA means you have such a completely different device that you have nothing to compare it to. We have comparable devices, so we're not going PMA. B/c we're fluroscopy, b/c we use flat panel detectors, and b/c we use circular gantry, we don't have anything that needs to be reviewed in clinical trials. Finally, he stated definitively that "in my opinion, we'll never go through the PMA process."
9. Dean confirmed that there are no functionality issues with the DViS, it is NOT just a concept and that the DViS is ready to move into production once we get approval. He confirmed, explicitly that "we can generate high res 3D and CT images right now."
10. Dean confirmed that the DViS generates 1/3 less radiation than competitor C-arms both for a single image and for the multiple images that would be generated during a procedure. He gave a detailed technological explanation of this, but more importantly, he stated explicitly: "FDA has not expressed any concern about the radiation dosage."
I'm curious how this can be viewed as anything but good news. I'm feeling more confident than ever. Good luck everybody.
AI
