1. Section Editor(s): Hess, Cathy Thomas BSN, RN, CWOCN

Article Content

CLOSURE Medical Corporation, Raleigh, NC, has received FDA clearance to market LIQUIDERM liquid adhesive bandage as an over-the-counter (OTC) product. This is the first cyanoacrylate medical device approved by the FDA for the OTC market.


LIQUIDERM uses the same proprietary technology as CLOSURE Medical's DERMABOND Topical Skin Adhesive. LIQUIDERM is painted on a wound, sealing it from dirt and germs and creating a moist healing environment. As the wound heals, the adhesive sloughs off naturally.


CLOSURE Medical is currently negotiating with a marketing partner for rights to its OTC wound care platform.


Ortec International, Inc, New York, NY, has received FDA approval to market its Composite Cultured Skin (CCS) for use in patients with recessive dystrophic epidermolysis bullosa (RDEB) undergoing hand reconstruction and to cover donor sites created during the surgery. RDEB is the most severe form of epidermolysis bullosa, a congenital skin disorder characterized by painful ulcerations and widespread, permanent scarring, resulting in deformity of the hands and feet.


The approval was granted under the Humanitarian Device Exemption provision, which allows medical devices that provide safe treatment to be available for patients with rare medical conditions that affect fewer than 4000 individuals in the United States per year.


Organogenesis Inc, Canton, MA, and Novartis Pharma AG, Basel, Switzerland, a subsidiary of Novartis AG, have signed an amendment to their 1996 agreement granting Novartis the right to purchase an exclusive option to license the Organogenesis product VITRIX, which is scheduled to begin pivotal trials soon. VITRIX is a living dermal replacement product that contains only 1 layer-a fibroblast-populated dermal layer-enabling it to be folded and inserted into deep wounds.