HCB News: Carestream already has a cone beam CT solution for dentistry. Did that influence the development of this solution?

JB: We are utilizing the same basic X-ray detector technology, but because it’s look at much larger body parts it requires a larger field of view. We also spent a tremendous amount of our R&D resources on developing the 3-D reconstruction algorithms for image processing and we started that many years ago to develop our dental product and we leveraged that work into this orthopedic product as well.


HCB News: For ultrasound, Caresteam recently entered the market from the top with a high end system. Will this cone beam solution also be a top of the line product or will it cater more to facilities on a tight budget?

JB: It doesn’t really apply as much. I look at this as more of a new solution. It’s certainly going to be much lower in cost than a conventional CT. In terms of costs for a physician’s office it will be on the higher end of the equipment they would have.

HCB News: Is there anything comparable on the market?

JB: There are some things on the market now, another company from Europe has a device that is somewhat similar. It does extremity exams. In our opinion it is somewhat limited because of some of the design they’ve utilized. There is another device that is similar to this that does not offer the size of an image that we offer, it’s much less accommodating for patient access.

There’s another cone beam CT device from a U.S. company that is exclusively for feet. My understanding is that has some reasonable acceptance but it’s limited to the one body part. Then there’s a variety of cone beam used in dental as you’ve already indicated.

HCB News: What can you tell me about the clinical trials in progress?

JB: We have clinical trials we’ve been conducting on three different levels of prototypes at Johns Hopkins in Baltimore for about four years now. We currently have a trial underway with our near-final design. It’s very broad and covers hands, feet, ankles, knees, various trauma for long bones in both the upper and lower extremities. That’s going quite well.

The other one is a fairly recent start-up at the University of Buffalo Orthopedics looking at some pathology in the knee. We just got approval from the site to begin a much broader study that will probably begin next month that will look at all extremities.

We haven’t applied for 510(k) yet so we aren’t making any claims with that yet but so far the researchers are validating that the image quality is very good and they are excited about the type of imaging that’s going on here.

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