Product News

Osiris Therapeutics, Inc (Columbia, MD), a leading cellular and regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopedics, and sports medicine, revealed the results of its prospective, multi-center, single-arm clinical trial evaluating the clinical outcomes of Grafix^® in patients with complex chronic diabetic foot ulcers with exposed tendon and bone. The product is a cryopreserved placental membrane intended to be used as a wound cover for patients suffering from chronic wounds. It is a flexible, conforming membrane that is applied directly to acute and chronic wounds.

A total of 31 patients were enrolled, 27 of who completed the protocol (4 early withdrawals). The patient group had significant comorbidity, with more than 80% having hypertension, more than 60% being current or former smokers, 55% having heart disease, and 45% having had a previous partial amputation. The mean wound area at baseline was 14.6 cm², all wounds were present for at least 4 weeks with a mean wound duration of 7.5 months. Per protocol (PP n=27) and Intention to Treat (ITT n=31) analyses were performed. The proportion of patients meeting the primary end-point of complete (100%) granulation at 16 weeks was 96.3% (83.9% ITT). The mean time to 100% granulation was 6.8 weeks with a mean of 6.8 applications of the product. The proportion of patients meeting the secondary endpoint of complete (100%) wound closure at 16 weeks was 59.3% (51.6% ITT). The mean percentage area reduction of all wounds at 16 weeks was 92.3%. There were no product-related adverse events recorded.

Visit www.osiris.com for more information.

UK Wound Care Business Secures Exclusive Use of Technology

Crawford Healthcare (Knutsford, UK), an international advanced wound and skin care company, made a deal with advanced materials developer Exciton Technologies (Edmonton, AB, Canada) for the exclusive rights to its Silver Oxysalt Technology.

The deal helps establish Crawford’s leadership in the global health care market in terms of aggressive antimicrobial wound treatment —a major component in the fight against antibiotic resistance. Also, this transaction enables the company to expand the use of the technology to other wound dressings and formats that are more readily used in the treatment of chronic wounds, such as diabetic ulcers and bedsores.

Visit www.crawfordhealthcare.com for more information. 

New App to Help Caregivers Navigate the Wound Dressing Landscape

DermaRite (North Bergen, NJ) released its Interactive Wound Dressing Selection Guide, a unique interactive catalog app that allows users to input wound information to see which dressings of the company’s are appropriate for that presentation.  Available for iPhone, iPad, and Android, the guide can help for on-the-job reference or to learn more about the available wound dressings.

Designed as an educational resource tool, the app is part of Healing In D.E.P.T.H.^™, DermaRite’s holistic skin and wound care program for facilities. Created to address the primary areas of skin and wound care, each of the program’s 4 steps supports the next, thereby providing caregivers with the tools they need to support healing from without and within.

Visit www.dermarite.com for more information. 

First Human Trials of Liquid to Stop Bleeding Started

Arch Therapeutics (Framingham, MA) has begun the first human tests of a self-assembling molecule designed to conform to the shape of an irregular wound and stop bleeding within seconds. The trial of AC5 Surgical Hemostatic Device will involve 45 patients in Western Europe. The patients will all have at least 2 dermatological lesions to be removed surgically, and one of the wounds will be treated with the product, while the other will receive a control treatment. Ten of the patients will be on blood thinners in order to test how well the device performs in those patients. 

The company decided to target Europe before the U.S. because they believed they could bring the product to market quicker there. The company plans to start the U.S. regulatory process sometime this quarter.

Visit www.archtherapeutics.com for more information.