ReGen Biologics seeks to clarify several statements regarding its Menaflex collagen meniscus implant made in a press release that was issued on August 4, by a party unaffiliated with the company. ReGen was unaware of the press release until it surfaced in media reports and on the Internet. The statements made in the release do not represent the views of the company regarding the use of the Menaflex device. ReGen’s Menaflex device is a resorbable collagen scaffold used in arthroscopic surgery to address the most common form of knee injury, a torn medial meniscus. The device is inserted after a partial meniscectomy to reinforce and repair the damaged meniscus by providing a scaffold that is replaced by the patient’s own tissue.
The press release discusses use of the Menaflex device with protein rich plasma and potential use as a carrier for stem cells. Both of these uses are outside of the indications for use of the device that were cleared by the FDA. While surgeons may use a device outside of FDA cleared indications, based upon professional judgment, this sort of “off label” use is not condoned or promoted in any way by ReGen. The company is committed to ensuring that its products are used for their FDA cleared indications and in accordance with best medical practices.
Surgeon acceptance of the Menaflex device has been excellent and is reflected by the fact that in the past few months the company has trained over 120 surgeons in the proper use of the device. The surgeon training course provides background information about the product, hands-on experience in the proper surgical technique and discussion of patient selection in accordance with the FDA cleared indications for use. ReGen’s extensive surgeon training program is designed to prepare surgeons to use the Menaflex device safely and effectively.