Product News

New Type of Medical Honey Obtains FDA Approval 

The U.S. Food and Drug Administration has approved the following products in the SionBrands, Inc. (Rolling Meadows, IL) L-Mesitran® wound care line, all of which are based on honey: Soft, Tulle, Hydro, Border, and Net. The products were cleared for prescription and over-the-counter use by the 510(k) procedure. These honey-based products use a new, innovative process that enables medical-grade honey products to work effectively at a much lower concentration, according to company officials. 

The products have a proven track record in the European Union and other international markets. They maintain a moist wound care environment. A prospective study published by EWMA Journal in 2013 shows that when used for chronic leg ulcers, L-Mesitran can help speed the wound healing process significantly, reducing the mean time to wound healing. Studies also show a faster reduction in infection, a faster stimulation of tissue growth, and a faster healing time for patients. 

SionBrands, Inc. is launching United States-based company for the L-Mesitran product line. The company has a history of sales and marketing of more than 20 years in the U.S. 

Visit www.sn-medical.com for more information.

Medical Technology Business Acquires First-line Cartilage Repair Product 

Smith & Nephew (St. Petersburg, FL) has announced the acquisition of BST-CarGel,® a first-line cartilage repair product used along with microfracture and other bone marrow stimulation techniques for the initial treatment of most sizes of focal cartilage tears. Through this transaction, an affiliate of Smith & Nephew will acquire ownership of all product and intellectual property assets related to BST-CarGel from Piramal Enterprises Ltd. (formerly Piramal Healthcare Ltd. [Mumbai, India]), officials said. 

Approved for use in a number of countries, including Australia, Canada, and most of Europe, BST-CarGel is a biopolymer-based solution mixed with a patient’s blood and implanted into the joint following a microfracture procedure. BST-CarGel can be delivered arthroscopically and can be used to treat damaged cartilage in synovial joints (such as the knee, hip, ankle, and shoulder). 

Once implanted, it acts as a scaffold, adhering to the cartilage surface to stabilize the blood clot while new cartilage is regenerated. 

Visit www.smith-nephew.com for more information.

Antimicrobal Transparent Film Dressing Recieves FDA Clearance 

Entrotech Life Sciences (San Francisco) has received 510k clearance from the U.S. Food and Drug Administration for ChloraDerm,TM an edge-to-edge transparent film dressing to provide the Chlorhexidine Advantage,TM a safe, colophony- and acid-free chlorhexidine matrix for wound and catheter site protection for up to seven days. Compared to common nonantimicrobial dressings, ChloraDerm demonstrates substantially greater effectiveness against multidrug-resistant organisms at one, three, and seven days, without adding increased cost or complexity. 

Visit www.entrotechlifesciences.com for more information. 

Advanced Wound Management Product Recieves CE Mark

Oculus Innovative Sciences has earned the CE mark for its MucoClynsTM for the treatment of wounds. A Microcyn®-based solution developed through the electrochemical treatment of dilute saltwater, MucoClyns is safe to use on mucous membranes, cuts, abrasions, burns, and body surfaces following an unexpected exposure to infection risk and before receiving professional medical treatment. 

Visit www.oculusis.com for more information. 

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Please email Jaclyn Gaydos at jgaydos@hmpcommunications.com