510(k) for ReGen Biologics' Collagen Scaffold Rejected
BY HUYEN NGUYEN, AUGUST 9, 2006
On Monday, ReGen Biologics announced that it had received a letter from the FDA rejecting to approve the ReGen® collagen scaffold technology to be classified as a Class II medical device. In its exact words, the collagen scaffold technology, "is not substantially equivalent (NSE) to existing Class II devices already in receipt of FDA clearance." In late December 2005, the Company submitted a 510(k) premarket notification for the ReGen® collagen scaffold family of products, for use in general surgical procedures for the reinforcement and repair of soft tissue. The Company hopes that by gaining FDA clearance, it would allow ReGen to market this technology in the U.S., including an application for the meniscus.
510(k) Process
Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify the FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). It allows the FDA to determine whether the device is equivalent to a device already placed into one of three categories: Class I, II or III. Class I device is subject to general controls, such as quality standards. Class II device is subject to special controls such, as performance standards and FDA guidelines as well as general controls. Class III is requiring premarket approval (PMA), the most stringent process fo the three.
In this case, the Company stated in its annual report that if they are unsuccessful getting a 510(k) approval as a Class II device for the collagen scaffold, it will pursue a PMA for the CMI™ in the U.S. The CMI™ is a type I collagen implant intended for patients with a meniscus tear or meniscus loss. This product is currently being distributed in Europe and selected regions worldwide. With extensive data of more than 300 patients on its scaffold product, and success marketing this product in Europe, the latest announcement came as a big disappointment for the Company. It has stated that it will vigorously pursue an appeal to the FDA. We believe that the Company will defend its data to achieve its goal.
On the day of this announcement, ReGen's stock plummeted 50% and closed at $0.30.
