Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Congrats to Dean and Mike for getting through the first round of questions and a video reply on the Investors Forum. There were some real gems in there, including announcing that the FDA confirmed receipt of the package, describing plans for additional 510K applications after initial approval and reaffirming Dean's confidence that this is the last round with the FDA. I am sure the process on the Forum will only got more and more smooth as we go along. Let's all help enhance the process by asking smart useful questions on the Forum.
Dean's first video on the Investors Forum is now up.
They're loading the first video response now, and they will re-open the Forum for new questions under a new weekly header.
And if you doubt how careful I am in my due diligence, and how well I document the conference calls, here are my notes from the last conference call (note where Dean says "We have literally hudreds if not thousands of orders lined up. They are just awaiting FDA approval. We do have letters of intent, but we stopped asking for them because we don't want to upset the FDA. They do not like to see that you are marketing it for sale before it's approved, and they asked us to stop taking letters of intent (the Act says you shall not market and sell your product)"):
Hosted by Dean Janes, the CEO of Imaging3:
Status of FDA Process:
• Imaging3 filed for a 30-day extension to respond to the FDA, and the request was granted. The extensions are always made in 30-day increments, so it is good through April 5, but Dean expects to file the response package much sooner than that.
• Dean has had two conference calls with the FDA review team, including the Head of the Devices Division and the Reviewer. On the first call, they trimmed down their requests substantially. On the second call, they offered some clarification about the few remaining requests.
• Dean feels really confident with this group. They are both responsive and intelligent. They recognize that the process has taken longer than it should have, but they're new and they weren't comfortable just rubber stamping the work of the prior team, but they are trying to be diligent now.
• Dean believes this was the last round; i.e., their requests/inquiries were exhaustive, and if they are comfortable with everything sent back to them, then they will approve the device. He does not expect new subjects to be addressed. Dean has inquired during the conference calls with the FDA whether FDA has or expects to have any other issues, and they have not identified any.
• FDA's Time Limit: Dean believes he will hear back from the FDA within 30 days of his submission.
• Imaging3 will release a Press Release when the package is submitted to the FDA, and he will also host a podcast on the company's new Investors' Forum on the Imaging3 website.
Status of Radiologist Review:
• Imaging3 retained 2 radiologists and is considering retaining a third medical professional as well, and they are set and ready.
• Imaging3 has accumulated most of the data needed for the review (they need data for each use for which they are requesting approval from FDA, which includes images of multiple body parts from multiple devices, in each mode of operation, set up the same way by all the devices). Dean had mentioned on the previous call that he hoped this would be done by the end of February, but he underestimated how long it would take to get all of this data for each application from all of the machines. The process is going very well, it's just taking longer than he hoped.
• Once all the data is collected and ready, the review by the Radiologists will only take a day or two, and then the report will be drafted.
• The specific opinion they will be providing is that the images are comparable.
• The report will be from the Radiologists to Imaging3, who will in turn submit it to the FDA.
• The process to select the radiologists was to find respected radiologists with more than 5 years experience and experience with both radiation and flouroscopy. Dean went to his pier group and found people easily.
• Until the process is completed, Dean can't identify what the predicate devices are that to which the DViS is being compared, but he can say they are both flouriscopic devices. One has a 3-D fluoro capability, but it is not real time.
• They are using images of phantoms (not humans) for the review.
Images:
• We have no problem creating images of any kind, high resolution or otherwise. The technology we use in the DViS is working perfectly.
• There are two reasons for the delay in posting images to the website:
1. Our priority now is FDA Approval. Our Marketing Material is reviewed by the FDA. The more they have to review, the longer the process will take. Dean is going to conference with the FDA to see if they have any issue with him posting on the website the images used in the Radiologists Review.
2. There is also a conversion issue. We are developing a tech solution for converting the images from their existing form on the DViS hardware, and making them viewable on the website in as high a quality as it is viewable on the device.
Production vs. Sale of the Company:
• We have literally hudreds if not thousands of orders lined up. They are just awaiting FDA approval. We do have letters of intent, but we stopped asking for them because we don't want to upset the FDA. They do not like to see that you are marketing it for sale before it's approved, and they asked us to stop taking letters of intent (the Act says you shall not market and sell your product).
• Deposits for the systems will help us increase our production capability. Currently, there are no plans to raise further funds. If we needed to, we could tap into a credit line in a way that does not dillute share price. Dean has no concern at all about finances.
• We've had conversations with all of the major manufacturers. We've also met with overseas manufacturers to help get ourselves to full production. Can't say we are leaning more towards M&A or partnership. We will move towards production upon approval, but we will certainly continue talks with big players about M&A or partnership.
• For example. we've talked to the head of Toshiba's CT Dept. and they are very interested in our product. Toshiba is so interested because their own device takes 3 or 4 seconds to take the CT slice, and several minutes to create the 3D construct. It is also a large stationary device. Our device creates the construct in less than a second. Application advantages -- Speed (time to acquisition) of 3D construct and Portability.
• About 30 days from approval to have product rolling off the production line. We have the plan in place already. 1 or 2 units per month initially, then hiring people to help sell and manufacture the product. We'll grow at a controlled rate. We have lots of distributors who want to work with us and partner on the sales side.
• Need at least one regulatory body to approve it. When you get U.S. FDA Approval, you are generally good to go in Europe and elsewhere. The U.S. Market is easier to enter and not as many road blocks like customs. Within 6 months, we'll expand into European markets, and then Asia and elsewhare.
• $550,000 for the full product at first, and then we may move up from that number.
• I have relationships with several entities that offer financing for smaller health care markets.
• When we get FDA approval, we can start providing clinical images. We will also start working with Luminary Sites after we have FDA Approval. They have reviewed our product and they will purchase it and they'll market for us.
510K vs. PMA:
• If this was going to go down the PMA route, it would have gone that way already. Dean does not see that as a possibility.
• Worst case scenario from this response is another round of questions, I really don't see the PMA route. The FDA has not even brought it up.
No speculation at all. Dean has signed letters of intent in his possession, or are you calling him a liar? He said on the last Conference Call that Imaging3 had collected numerous letters of intent until the FDA told them to stop accepting them, and from then forward they were accepting verbal committments from medical providers to buy the DViS after approval. He said this LOIs and verbal committment ranged in the hundreds if not thousands. That is fact. What you say is speculation, always.
Again, to appreciate the value of this device, I recommend taking a look at what the experts at Frost & Sullivan had to say when they awarded the DViS the 2008 Medical Imaging Product Innovation of the Year Award.
Quoting Nadim Daher, Frost & Sullivan Research Analyst, "The Dominion combines speed and accuracy to offer fluoroscopic imaging in 3D, that is, real-time 3D imaging. It is the only system capable of 3D imaging in real time, which makes it a valuable clinical tool in a wide array of applications. Its cost effectiveness and versatility make the Dominion an exceptional asset for today's healthcare enterprise."
"3D imaging has become a reality in the medical imaging world. Its clinical utility is further demonstrated every day in radiology, as well as in various specialties, where it provides physicians with a more intuitive depiction of anatomy and function, non-invasively. However, the techniques that today are described as four-dimensional (4D) imaging still require lengthy post-processing times, which limit their clinical utility and hamper their routine utilization."
"Using breakthrough, patented technology, the Dominion can provide 3D images at a rate of thirty frames per second and display them in less than one second - thereby meeting the definition of real-time dynamic imaging. The system combines the speed advantage of high-speed photo fluoroscopy with the benefits of 3D imaging and the precision of computed tomography (CT)."
"The Dominion can be utilized for both diagnostic and interventional procedures, in a variety of clinical areas including trauma, pain management, pediatrics, orthopedics, sports medicine, cardiovascular imaging, and neuro-vascular imaging. During interventional procedures in particular, its dynamic 3D imaging capabilities make the Dominion a useful image guidance tool to assist in placing catheters and medical devices and in performing a broad range of surgical interventions. Current devices used for image guidance - such as ultrasound - are limited to 2D imaging and/or offer poor image quality, which makes them less practical and less reliable."
"Therefore, the Dominion can further enable minimally invasive surgery by providing a more robust modality, with the end-result of improving surgical productivity as well as patient safety. Given its light-weight, small-footprint profile, the Dominion is a truly mobile imaging system that can go through any doorway and be moved around freely to where it is needed. This allows bringing the equipment to the patient at the point of care, thereby offering the flexibility and timesavings that are so critical in an acute care environment."
I guess Dean must have just pulled the wool over the eyes of the hundreds of medical providers who have already signed letters of intent or otherwise committed to buy a DViS after approval. Suckers all of them, right?
Filmed today. Mostly likely available for view later tonight or tomorrow morning.
I think more likely we will get an update in one of his video updates which probably won't be until the end of next week because he will just have given one the end of this week.
LOL. Frost & Sullivan is an "Award Company"? Really? That's what you think Frost & Sullivan is? Classic.
To confirm what my own research showed me, a friend of mine in the medical imaging field wrote to me and stated: "The Frost & Sullivan award can NOT be bought. The firm is very respected in the medical field. They make money on their honesty: good, bad or ugly, they tell the truth."
Where are you getting that I said he had trouble with them? I'm just saying he has more confidence and more comfort with this group. He thinks this group is smarter and gets it better than the prior group. I agree he got along fine with the previous review team, but it's not about becoming friends.
False.
There's a difference between having a good relationship with a group and being much more comfortable with a group. The last team he was cordial with but not as comfortable with. He felt like the last group was not as bright, didn't understand what they were dealing with, and he had to really beat them over the head with information to get them to move the ball. They were also less committed to moving quickly and making progress in live time than the new group. All of this cuts in favor of the new review team getting it done this time around.
Right, nobody has seen the amazing value of this device. Certainly not the hundreds of medical professionals who have signed letters of intent to purchase or otherwise committed to purchase the devices as soon as we get approval. Certainly not the people at Frost & Sullivan who honored the DViS as the Product Innovation of the Year. Certainly not the hosts of RSNA, who run the largest medical convention in the world, and who selected to locate Imaging3 between GE and Toshiba on the main center aisle of the exhibit hall. Certainly not the tens of thousands of shareholders who bought into this company with such a fervor that the share price went from 3 cents to nearly 75 cents in six months. Certainly not the folks at Toshiba, GE and Siemens who are fighting with each other to get a chance to buy this groundbreaking technology.
Borntwice, you are so wrong about this, and you know you are. Arguing with someone who doesn't even believe what they are saying is really exhausting. So strange that someone who thinks the technology is not groundbreaking and will never get approved and will run out of money before it can manufacture any would ever invest in the company. So strange. Pracically UNBELIEVABLE.
This time is different for numerous reasons:
1) We've completed a transition from the old review team to the new review team (it's unfair to criticize Dean for not getting this done during that type of transition).
2) Dean is much more comfortable with this review team, has much more open communications with them, and has been told by this review team, as recently as last month, that it did not have any other subjects to inquire about, and if everything in this submission looked good, they were done.
3) The head of the Devices Division has gone from "interim" to permanent, making the agency more likely to make a final determination on this device.
4) The FDA was clearly just looking for a little CYA by asking for a third party radiologist to give the device a stamp of approval. Having that stamp of approval by at least two radiologists in the file, will give the FDA the comfort it needs to approve.
5) Dean has committed to contacting the FDA about a week after the package is sent back to check on the status and address any concerns immediately and by phone so there isn't another back and forth.
So it absolutely does "stand to reason" that we are much more likely to get approval this time around than before.
I know all of those things to be true because Dean said all of those things over a series of conference calls and public proclamations. He said the Radiologist Review would include at least two, and possibly a third as well. He also described the factors he used in the selection of the three medical professionals, the same general criteria an attorney would use in selecting an expert testifying medical professional at a hearing. I agree, it would be better for that to have been spelled out, and I'm sure that we be detailed in his response video that comes out this weekend, but it is inherent. The package would not go back without the Review, and Dean would not include a Review in the package if it was not a pure endorsement. Therefore, if the package went back, the Radiologist Review was an endorsement, and if you believe Dean to be an honest man, which I absolutely do, I believe he used at least two, and possibly three medical professionals, and and I believe the criterion he used to select them made them all "experts."
There have been all these questions about whether the device actually works, and now we've had at least two independent expert radiologists compare its imagery from various modes of various parts of the body in 2D and 3D, in X-Ray and in CT, etc., etc., and clearly it passed with flying colors or the package would not have gone back to the FDA. In light of literally the best news we've heard since I started following this stock over a year ago, we're down over 20%? Sometime this stock market is a funny business.
Honestly, this makes no sense to me at all.
Agreed, I just mean the questions from this round.
Surprise, surprise. Not a peep out of Sano or Borntwice today? I guess they were too busy trying to cover their shorts.
I agree we'll get a video update on the Forum this week and I do think we will get a couple of general statements from Dean about the Radiologist Review, but we won't get a lot of detail until after approval. There are limits to what can be shared about this confidential process.
One of the primary reasons I'm so confident that we get approval this time is that Dean has asked this review team repeatedly whether the current set of questions is exhaustive, and they have confirmed there are not other open issues. In other words, although there is a possibility the FDA may not like an answer to one of these questions, they are NOT going to ask any questions on a new subject. And since all but the Radiologist Review was described by Dean and team as a piece of cake, and it appears the Radiologist Review, which took a little time, came in with high marks, too, I feel like it's smooth sailing now.
He said by April 5th every time he spoke publicly about this. There has been no mixed signal or inconsistency. Now that doesn't mean a PR is coming out tonight, but I would expect it before the opening bell tomorrow morning.
The emails from Becky that I have with "after hours" PRs usually don't come out until after 6 PM EST.
The results speak for themselves, Sano. From the time Dean started doing the Money TV spots, the share price is up nearly 200x (and sent to double or triple again shortly). That's not to say that the MoneyTV spots are responsible or entirely responsible for that enormous gain, but it would pretty irresponsible to stop doing something that coincided with such an enormous benefit to the Company.
They are "prepared" to start manufacturing right away. That will give Imaging3 much more leverage in M&A discussions. If it is obvious they are just laying there waiting to be bought, you don't get max price. If you demonstrate that you're able and willing to go it alone, you're more likely to draw a higher price from all of the numerous suitors chomping at the bit to buy Imaging3.
Stand by. I'll bet you get your answer soon.
Great point Sano! The first great point you've made in a long time. Why do back to back spots with nothing new to say? I'm guessing he wouldn't. I'm guessing he has something new and marvelous to say. It's the only explanation. The Radiologist Review is complete and we got wonderful marks. The package is ready to go or gone. And Dean is our hero. That's the only explanation. You're right. You nailed it Sano!
You've got to start somewhere. My guess is, as soon as we have a product we are allowed to sell (i.e., after we get FDA approval in the next couple of weeks), we will start getting some more notable coverage.
What difference does it make whether it's a non-trading day? If it's announced no Saturday that the package has been returned to the FDA, is the share price not going to skyrocket on the next trading day? I think it will. Let the word spread over 3 days and let it sink in what it means, and then watch it explode on Monday with no opportunity for the shorts to get out. I can't wait.
That's pretty close in time to his last one. Could mean he's announcing that the package has left the building.
When did he promise a video at the end of the week? They said they would be doing a video once per week after the Forum got started, and the Forum did not get started until mid-week.
Very exciting time. If the package goes back to the FDA this afternoon or any time this weekend, this is the last bit of time to buy in before a massive spike. I suppose that's why the bashers have been out in full force.
Agreed that human imagery will need to follow quickly after FDA approval, and I have no doubt that is exactly what will happen.
"Filing" with the FDA follows the "mailbox rule," which means, it is filed when it is mailed, so he doesn't even need to do same day delivery on Monday. All he needs to do for an "on time" filing is get the package in the mail (any mail service) by the last mail pick-up on the 5th. Regardless, I understand that material is going from Imaging3 to the FDA in two forms, electronic (instantaneous delivery) and a courtesy hard copy by overnight delivery. So he will be emailing it to the FDA on the 5th, which can be done at any time on the 5th and still be on time. Remember also that the FDA is not rigid about deadlines.
Who cares if it had a functioning machine? Not one medical imaging device in that convention hall was powered up and emiting radiation. He had IMAGES with him. Who cares if they were the same images he showed the previous year, they were still images generated by the DViS. That's like saying, Nike showed up at a shoe convention with Air Jordans, the greatest selling shoe of all time, and that the next year's convention, showed up with the same display model of Air Jordans. That doesn't make the Air Jordans fake or phony or non-existent. They also didn't fire up the show making machine and generate a brand new pair in the convention hall. The product is the shoe, the product is the image. The image was of high enough quality to win an award for best new innovation and to earn the praise of everyone who visited the booth, including competitors who entered into NDAs and starting talking buy out.
Many more people than that have seen the images.
The FDA has seen multiple sets. The folks at Frost & Sullivan saw them when they awarded Imaging3 the best new medical device award in 2008. Every single attendee at RSNA for the past 3 years has seen the images. Every visitor to Imaging3's facility has seen the images. At least GE and Toshiba have seen the images and remain very interested in the product. There is at least one set of images on the website right now.
Don't ever fall for the myth spread by bashers, that the images are locked in a vault somewhere and nobody has seen them. It's a blatant lie.
Yawn.
There's a huge difference between trying to predict what the FDA is going to do and when they're going to do it (something for which you have absolutely zero control), and stating when you are personally going to complete a project about which you have complete control and have intimate knowledge of its status.