FDA's move apparently was spurred by the recent case involving Donor Referral Services (DRS) of Raleigh, N.C., in which the agency deemed tissues collected and distributed by the firm were potentially infected with HIV and other infectious diseases. The DRS case follows the highly publicized case last year involving Biomedical Tissue Services, in which similarly risky tissues were distributed.

Q: How does your product work?

A: Basically what we've done is, we've been able to define conditions that allow us to use gamma irradiation to completely sterilize these orthopedic tissue implants from any bacteria or any virus that could be in them. Prior to Clearant coming to fruition with this new sterilization process, no one had been able to give a high enough dose of gamma irradiation energy to achieve a full degree of sterilization from bacteria and viruses because every time someone tried ... you ended up inflicting damage upon the implant and reducing its quality or integrity.

What we've been able to discover are methods that prevent us from inflicting any damage on the implant while at the same time being able to give a dose of energy that's high enough to fully eradicate bacteria and viruses from those implants that come from human cadavers.

Q: How would your product help with the current situation involving Donor Referral Services?

A: Basically, with the use of the Clearant process, you pretty much eliminate any possibility of having any bacteria or any virus from being transmitted to a recipient of a medical implant.

The situation recently is a very typical risk management situation where the risk is clearly identified by the FDA. The risk being that infections can be transmitted. And when you have a situation like this, generally speaking, any kind of textbook risk management situation would tell you that you should design methods to control the risk or eliminate the risk.

I suspect the agency is considering tightening up the regulations around where, and in which settings, the cadavers could be harvested from. In another area that would provide a similar broad positive impact on public health would be requiring that validated sterilization processes be required for these implants.

Q: Is your technology or a similar process required by FDA regulations on tissue collection and distribution?

A: It's not required. Current good tissue practices allow manufacturers to make the implants with a final terminal sterilization step or without.

Q: Do you think there's any resistance from the agency in having something like that in their regulations?

A: No, I don't think so. When the original good tissue practices were written opening the door to methods to sterilizing tissue implants, I have never sensed there was any resistance on the part of the agency for requiring sterilization. It may be something that will come about at some point.

Q: What are your sales now for your sterilization technology?

A: We have a number of tissue banks that have licensed our process and have just begun to use the Clearant process, so our sales are less than $1 million per year, but it's a growing number of people.

Q: Do you know if any of the tissue banks that got some of the tissue in this latest incident used your process? A: None of them (did(.

Q: Can you tell me the names of some of the banks that are using it?

A: Tissuebank International is one. Another one is Donor Community Institute in Nashville, Tenn. Another company is Cryolife. So we have a number of companies that have licensed our technology.

Q: Did you see any increased interest in your technology after the Biomedical Tissue Services incident last year?

A: We did from the surgeons. There was an increased number of phone calls from surgeons to Clearant as of that time, which has led us to now have some tissue implants manufactured by some of our existing partners that we distribute directly to surgeons. That's an effort we launched in the summer of this year, which was largely in response to surgeons in various hospitals who had called and asked us for information at first about the Clearant process.

Once we gave them information, they asked how they could source the implants from us and at the time we were not directly distributing to hospitals and we were referring these leads to our partners. Over time, that situation changed. Now we work with our partners and have a dedicated inventory that we also directly distribute to hospitals and surgeons who want them.

Q: Have you noticed an increase in calls coming in now after the Donor Referral Services incident?

A: Today, I've had several surgeons emailing me. They usually say things like, 'What does it mean, does your process help?'

Q: Are there any other competitors that offers anything similar to your technology?

A: There's one company (that) certainly has a process that seems to work well. They're called Regeneration Technologies Inc., in Florida. It's a different process entirely from ours, but based on claims they've made and presentations of data, it seems that it also eliminates the risk of bacteria from those tissue implants. Now we've never seen data from Regeneration Technologies about elimination of viruses, so I can't comment on their technology regarding virus inactivation. In our case, we do eliminate both bacteria and viruses, such as HIV, hepatitis B, hepatitis C, West Nile virus and other viruses.

Q: How about Creutzfeldt Jakob disease?

A: No. Unfortunately, we don't eliminate the risk of prion or CJD transmission.

Q: What's in the future for your company and your product?

A: Basically, expanding the amount of direct distribution that we're doing. I think the environment is very receptive. Recent events continue to just make surgeons more aware that having a method that sterilizes very broadly against any kind of infectious disease being transmitted while maintaining fully the performance integrity of the tissue is highly desirable. We just started launching this direct distribution program in July of this year and we're already planning to expand it.

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