American Biotech Labs has announced that it has obtained clearance by the FDA to market its ASAP Antibacterial Silver Wound Dressing Gel as a prescription 510(k) medical device throughout the United States. The FDA 510(k) medical device clearance enables ABL to market its ASAP Antibacterial Silver Gel “for use in the management of 1st and 2nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears and surgical incision sites.

IP2Biz has announced that a prototype wound measurement camera is being tested by wound specialty nurses at the Shepherd Center in Atlanta, Georgia. The handheld device determines and captures wound boundaries and wound area using proprietary software and low-cost hardware. The device provides fast, accurate and repeatable digital documentation of wound progression, a necessary component to validate payment from insurance and government agencies. Nurses using the device say that the device easily fits in hands, can be operated with just a click and gives confidence that the measurements can be repeated consistently.

Oculus Innovative Sciences, Inc., has launched Microcyn Wound Care product into the U.S. podiatry market. The product has received three FDA 510(k) clearances for use in moistening, lubricating, cleaning and debriding wounds. It is available to podiatrists for treatment of, and distribution to, their patients in 8 oz. and 500 ml. bottles. Oculus is also pursuing a U.S. drug approval using a different formulation of the Microcyn Technology. The company intends to secure a partner that will assume clinical, regulatory, and commercial responsibilities along with costs for the drug formulation approval.

Smith & Nephew’s Advanced Wound Management division has announced the launch of its new product, ACTICOAT Flex, to expand the ACTICOAT range. Designed to support physicians dealing with injuries at high risk of infection, the product utilizes the Silcryst(R) nano-crystalline silver technology. It is highly conformable – ideal for awkward anatomical areas such as face and hands to improve patient comfort during wear. The product will be available in the markets of USA and EU by early 2009.

A clinical study has found Derma Sciences, Inc.’s key product, MEDIHONEY(TM), Wound & Burn Dressing with Active Leptospermum Honey, to be significantly beneficial in healing stalled venous leg ulcers, a first of its kind development in standard treatment ( compression therapy) of the ulcers. This will be extremely helpful in giving relief to patients suffering from chronic wounds for long periods.

Angiotech Pharmaceuticals Inc. has received 510(k) clearance from the FDA for sizes 3–0 and 4–0 of its Quill Self-Retaining System (SRS) Polydioxanone (PDO) product offerings, which are longer lasting absorbable suture typically used for deeper tissue closures. The company indicated that these smaller diameter sizes incorporate a new design for better holding strength and expand the number and scope of procedures that can be done with the Quill SRS product.

OMRIX Biopharmaceuticals has received FDA approval to start the Phase II clinical trial for its Fibrin Patch product candidate in the U.S. The patch is used for patients suffering from mild to moderate bleeding. According to the company, the trial is likely to start in the second quarter of 2008.