Medical Device Daily Associate

ReGen Biologics (Franklin Lakes, New Jersey) reported that it has decided to change course, electing to pursue an FDA 510(k) application for its collagen scaffold device called CMI instead of the more rigorous and costly premarket approval (PMA) pathway that it previously indicated it would seek and for which it had, in fact, been conducting a clinical trial.

The 510(k) clearance, the company said during a conference call, would allow it to more quickly advance to the market in the U.S. its family of collagen scaffold products, including an application of the ReGen collagen scaffold for the meniscus a crescent-shaped cartilage pad on the tibial plateau of the knee.

Gerald Bisbee, Jr., PhD, said during the conference call that the rationale for taking the 510(k) route is based on the fact that predicate devices, including surgical patches were recently cleared, including two in 2005, though he declined to name these predicate devices.

“We believe that the test of using this collagen scaffold is that it be at least as safe as these predicates,“ said Bisbee. “The landscape for 510(k)-cleared products in the soft tissue area has evolved over the course of the past few years, including recently cleared products in 2005, providing us the opportunity for this 510(k) submission.“

The company believes the CMI targets a large portion of the estimated 860,000 partial meniscectomies procedures in the U.S. a meniscectomy being a procedure in which the torn or damaged tissue is removed. The company believes that CNI provides an alternative solution which addresses the problems cause by a loss of tissue, such as osteoarthritis of the knee.

Bisbee noted “certain advantages“ of the 510(k) clearance over the PMA approval, chiefly that once the device is cleared, the company could immediately market its collagen core technology beyond just use in the meniscus, where it is currently undergoing clinical trials, into the general surgery space.

Additionally, the company believes it will have a much faster response from the FDA by using the 510(k) path.

“We think we'll probably hear something [from the FDA] in 90 days,“ Bisbee said. “It would therefore be less expensive since we wouldn't have to go through a panel meeting. And after the clearance there would be reduced regulatory oversight. Seen from just a sheer efficiency standpoint, it would be better for the company to do a 510(k) than a PMA.“

As to the clinical data that have already been collected for the PMA some stretching out as far as six years Bisbee said that this data will continue to be a “fundamental asset.“ “It's the only randomized study involving the meniscus,“ he added, noting that there are 300 plus patients involved in the study. “We intend to continue to follow patients in the U.S. clinical trial on the meniscus application, which will provide valuable scientific data on long-term patient outcomes.“

What wasn't clear from the conference call was what affect the FDA warning letter, that the company acknowledged it received in September, had on the decision to pursue the 510(k) route.

The FDA conducted an inspection of the company in 2Q05 and issued a Form 483 covering a number of observations made by agency inspectors concerning procedural issues related to the administration of the CMI clinical trial. The most serious complaint on the Form 483 was failure to provide investigators with information needed to conduct an investigation properly, to ensure proper monitoring and the necessary IRB review and approval.

The company has since said that all of the items in the warning letter were addressed either in its response to the 483 or in follow-on supplemental materials.

The company said it didn't see any fundamental differences in the different approaches to the FDA, since it believes that ReGen's intellectual property is superior to that of competitors. Additionally, it maintains the database from its clinical trial, which it believes will differentiate its product from the competition, when published. And it noted ongoing relationships with “prominent surgeons.“

One analyst argued during the call that a 510(k) would preclude ReGen from making significant, and differentiating, clinical claims from those of competitors, which would generate more interest from surgeons. The analyst also pointed out that the company would not generate the premium pricing and premium Medicare reimbursement for the device that it could garner with a PMA approval.

In response, Bisbee maintained that published data from the meniscus trial will differentiate it from competitors and help to generate better reimbursement.

He also pointed out that other patches are cleared for specific indications via their labeling language, for example in hernia repair or rotator cuff repair, so the company was submitting language that would serve to separate it from the herd.

“This 510(k), if cleared by the FDA, would be cleared as for use in a general surgery situation but also for use in the meniscus,“ he said. “So it would specifically mention the meniscus, at least that's the way we submitted it.“

Bisbee also said he believed that pursuing the 510(k) now would not preclude the company from looking into a PMA in the future. But given the expense of the PMA, he said, “There would have to be some clear benefit to doing that before the company would want to spend the capital to actually get it done.“

He added that if the FDA determines that the CMI device cannot be cleared via a 510(k) and must be done via the PMA “It is possible to get though that process with the current capital. Whether we'd want to do it that way remains to be seen.“