First we had smart skin patches from Power Paper, Vyteris, Alza, BirchPoint (recently renamed Travanti Pharma) and others that deliver a few volts to the skin to make it porous for accelerating and controlling the absorption of drugs and cosmetics. The Power Paper version has a printed battery and electrodes and is complete in itself, while the others are connected to drug reservoirs and power sources via catheters.
Next, IDTechEx reported on diagnostic skin patches being developed by Gentag and the CORE Institute. Now we have smart skin patches that heal wounds by restoring the natural electrical signals in the skin at the site of a wound thanks to BIOFiSICA. It is a world leader in using innovative technology to treat hard-to-heal wounds. The smart patch has a button battery driving an integrated circuit which delivers a specific customized voltage pattern to the wound area using a hydrogel that is biocompatible. Clearly, as volumes increase there is scope for these components to be printed therefore reducing bulk and cost.
Here is how it works. Adherent to the outer tan adhesive part of the dressing is a flexible metal ring (the anode). This is one of two contacts which are used to maintain and deliver the bio-current to the wound. The second contact (the cathode) is on the end of a soft, insulated medical grade wire that is attached to the power unit under the dressing flap. This contact is placed on the wound bed during use. Both the anode and cathode are covered in a sodium-rich hydrogel to ensure good electrical contact.
The POSiFECT® monitor attached to the dressing contains a low voltage battery supply and a tightly controlled microcurrent delivery system. This system continuously and automatically adjusts the microcurrent to levels clinically shown to initiate the wound healing process. Each dressing has enough battery life to continue working for at least 48 hours. An adhesive-backed 'lid' is fitted to cover the wound and maintain a moist wound environment. It can also be used to secure additional absorbent dressing material if required, along with the cathode, on the wound surface.
Smart electronics creates continuous adjustments to ensure constant current flow throughout the stages of wound healing. The lid allows easy access to additional absorbent dressings and to check on cathode placement. It also allows the clinician to visually monitor wound healing progression. The Form fitting dressing is hypoallergenic and extremely oxygen permeable.
The company says, "At BIOFiSICA, we understand the lives of patients and the needs of the clinicians who manage them. Our mission is to develop, manufacture and supply medical devices that trigger the healing process in wounds that fail to heal on their own. These exclusive devices use bio-electric stimulation therapy (bio-current) to restore the conditions which promote natural healing. Founded in 2000, our company headquarters are in Georgia, USA, and our European office is in Hampshire, England.
At present our unique devices are available for commercial sale in the European Union, with arrangements being made for launches further afield."
In one example of its impressive service, BIOFiSICA is currently following over 100 patients in 20+ UK clinic sites, who are enrolled in a 16 week Outcome Assessment Program (OAP). These patients were those who had the most intractable wounds - with an average history of 4 1/2 years using standard of care treatment. Clinicians have reported over 75% of patients completing treatment have shown improvements within the first 8 weeks of therapy. Pain reduction has been a key feature since the initiation of this POSiFECT® therapy.
An earlier case study reported, "Mr A is a 56 year old gentleman with recurrent ulceration of his right lower leg. He is an insulin dependent diabetic who has had ulceration over an 18 month period. He has had vascular screening and is known not to have any large-vessel arterial disease in his lower limbs. Despite this he has had significant constant pain which he described as 7 on a scale of one to ten (10 being totally unbearable). Following treatment with POSiFECT®, Mr A said his pain levels fell. Within 3 months he had no pain and no longer took any of his previous pain-killers. Spectacularly, his ulcer completely healed within 4 months."
BIOFiSICA estimates the 2005 global wound care market at $12 billion with advanced wound care products representing 11% of the total or $1.3 billion. Advanced wound care is one piece of the total wound care market which is divided into four broad segments: wound closure (sutures, staples, and professional fees), wound management (gauze, tape, and solutions), advanced wound care products (alginates, films, foams, gels) and grafts.
Frost & Sullivan reports the majority of the advanced wound care market resides in Europe due to Europe's aging population accounting for a disproportionate number of chronic wounds and a higher penetration of advanced wound care products versus the United States. Figure 2 depicts the market geographically. BIOFiSICA estimates 50 percent of the advanced wound care market is in the European community with the remainder split equally between the United States and the rest of the world (ROW).
Chief Executive Rafael Andino tells us that he sees the future of medical treatment in this realm, with customizing of the therapeutic effects of medication. He is now raising money to expand his business beyond the US and the new venture in the UK.
He founded BIOFiSICA Inc. with the vision of developing breakthrough products to expedite wound healing and regeneration of connective tissue in humans and has successfully led the biotechnology company through five rounds of fundraising. In late 2006, Mr. Andino and his management team launched the first wound care product of its kind, POSiFECT®, in the United Kingdom. The product will be subsequently marketed throughout Europe in 2007 and beyond. In addition, the company has begun early stage submission and filing processes for POSiFECT® with the FDA in the United States.
For more attend Printed Electronics USA 2007
Source top image: BIOFiSICA
