FDA Clears Bioshield Silicone Film
Press Release, San Antonio, TX / October 17, 2019 / Rochal Industries LLC.
Based in San Antonio, Texas, Rochal Industries LLC., a global leader in commercializing technology innovations in natural and synthetic polymers, antimicrobials, and biological systems, announces FDA 510(k) approval of its new medical device, Bioshield Silicone Film, as well as the previous FDA approvals of three of the company’s other medical devices: Antimicrobial Wound Cleanser, No Sting Skin Protectant, and Antimicrobial Barrier Film.
Dr. Rebecca McMahon, the President of Rochal Industries stated, “The FDA clearance of Bioshield Silicone Film adds another exciting product to the Rochal portfolio. Paired with the previous FDA Barrier Film, this clearance marks a significant step forward for not only Rochal Industries, but also the greater healthcare and medical research communities in the San Antonio region.”
Bioshield Silicone Film is a first in-class, 100% silicone, breathable spray-on bandage that can be used for both incisions and excisions. The polymer used in this product mimics the transport and mechanical properties of human skin including tensile strength, elasticity, and flexibility. Due to these properties, it performs exceptionally well when used to protect surgical sites in areas of the body that experience movement or in areas where scarring is of significant concern (such as the face). Additionally, Bioshield Silicone Film can be used to protect against medical adhesive-related skin injury and maceration when used in conjunction with negative pressure wound therapy.
Rochal’s Antimicrobial Wound Cleanser safely and gently kills planktonic microbes in addition to immature and mature biofilm, creating an environment conducive to wound healing. It is a non-cytotoxic, non-irritating product that is effective against Gram-negative bacteria, Gram-positive bacteria, and fungi. It is suited for stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first- and second-degree burns, and both grafted and donor sites.
No Sting Skin Protectant is a spray-on bandage designed to protect against and prevent incontinence-related dermatitis, colostomy-related dermatitis, and medical adhesive-related skin injuries. It is also applied to reduce friction over bony prominences and is ideally suited for use in skin-folds as it does not self-adhere.
Antimicrobial Barrier Film is a first in-class antimicrobial spray-on wound dressing that kills microbes while protecting the underlying tissue, helping to remediate damage and prevent further infection. This product can be used to heal macerated skin after which a clinician could use the No Sting Skin Protectant to help prevent further tissue damage.
Ann Beal Salamone, Chairman of the Board and Co-Founder of Rochal Industries, states, “Rochal continues to be at the forefront of product development and commercialization in the wound care industry. These exciting products not only represent an important development for our company, but also the opportunity to bring relief to thousands of patients suffering from difficult and debilitating conditions.”
About Rochal Industries LLC.
Rochal Industries is a global leader in commercializing technology innovations in natural and synthetic polymers, antimicrobials, and biological systems. As a research-oriented company focused on wound and skin care, Rochal created the field of non-stinging liquid bandages in the 1990’s. The company’s current pipeline contains transformative products for mitigation of opportunistic pathogens and biofilm, wound re-epithelialization and closure, necrotic tissue debridement, cell compatible substrates and transdermal drug delivery. Rochal drives its pipeline from concept to preclinical and clinical development through product validation, FDA clearance and lifecycle management, while retaining its core competency in scientific innovation.