Biofisica receives European clearance for first electric stimulation
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
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
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."