General care  

Biofisica receives European clearance for first electric stimulation wound dressing

9 October 2006

Atlanta, USA. Biofisica LLC, a medical device start-up company based in Atlanta, Georgia, has received clearance to market its POSiFECT RD bio-electric wound care product in Europe. Biofisica worked with the British Standards Institute (BSI) throughout the conformity assessment process and has received clearance to affix the European CE Mark to its product.

The company plans to launch its wound care product in the UK within the next three months, followed by staged rollouts in France, Germany and the Nordic region. POSiFECT RD (RD refers to the dressing's round shape) is the first device available that combines two technologies — moist wound-care dressing and electrical stimulation — in a disposable, easy-to-use, sterile dressing that facilitates the normal healing process. Early clinical research has shown that POSiFECT demonstrates healing in many difficult to heal or non-healing wounds.

"We are delighted to have received marketing authorization for POSiFECT, and can now begin to provide this pioneering therapeutic option to tissue viability nurses (TVNs) throughout the UK for the care of their patients," said Rafael Andino, president of Biofisica. "It is intensely satisfying — at both personal and professional levels — to develop a technology that has such a positive impact on patients' lives and has the potential to help heal non- healing chronic wounds instead of simply 'managing the wound' as other products do."

Bio-electric stimulation therapy

The company says that POSiFECT RD bio-electric stimulation therapy is indicated for the management of chronic wounds where conventional therapies have failed. It is designed for use on chronic ulcerated wounds; including venous leg ulcers, pressure ulcers and diabetic foot ulcers.

Patient groups especially prone to these conditions are the elderly, immobile patients and individuals suffering from diabetes. The dressing contains a miniature electrical circuit that delivers a microcurrent to the wound bed. This microcurrent is derived from non-rechargeable coin cell batteries. The dressing remains on the wound for 48 hours and is then replaced with a new dressing.

Clinical studies have shown that when using POSiFECT on difficult to heal chronic wounds, tissue regeneration at the wound bed site occurs within a few weeks.

The process of tissue repair is dynamic and complicated. All living tissue in the human body possesses endogenous bio-electric circuits that contribute to healing once a wound is created. However, with long-term chronic wounds, the body's natural ability to create these "currents of healing" is compromised. Biofisica's breakthrough bio-electric technology associated with POSiFECT, dovetails with normal tissue repair by stimulating the wound bed as would the body's own "current of healing."


To top

To top