Lescarden said that the approval comes after extensive testing and auditing of the Amcor facilities, which have already begun to package the Catrix Wound Dressing. All regulatory approvals necessary for the delivery of Lescarden’s products to its European distributors are in place.
Catrix Wound Dressing is a specially processed bovine cartilage product in the form of a fine, white powder. The Wound Dressing is approved by the FDA for the management of chronic skin wounds including decubitus ulcers, venous stasis ulcers and diabetic ulcers as well as second degree burns and post-radiation dermatitis.
The clinical studies conducted with Catrix on patients suffering from bed sores have demonstrated its ability to assist patients who had previously been unresponsive to standard wound care treatments. The same studies demonstrated the potential for cost savings for both patient and caregiver in the treatment of such non-healing lesions.
William Luther, president of Lescarden, said: “We are pleased to complete this arduous and time-consuming approval process. Amcor has worked extremely hard to meet the standards required. We expect that our new relationship with Amcor should enable Lescarden to meet future demand more efficiently and more profitably. The immediate effect is that Lescarden will now be able to begin to satisfy a substantial order backlog for its Catrix Wound Dressing.”
