A Medical Device Daily
Pegasus Biologics (Irvine, California), a developer of collagen scaffolds for soft-tissue repair, reported receiving the CE mark certification for its Unite Biomatrix collagen wound dressing for treatment of diabetic foot ulcers.
The privately held company said Unite Biomatrix has "uncompromised strength" to support the natural healing environment. It said Pegasus Biologics' stabilization and sterilization technologies make Unite Biomatrix "pliable, but durable, safe and biocompatible," a wound dressing that can "easily be secured by the physician to the wound."
The product was launched in the U.S. early this year, and the company said it "continues to gain attention from ... wound-care specialists."
"Receiving CE mark approval for Unite ... opens the door for a tremendous opportunity for our company," said Michael Will, CEO of Pegasus. "European surgeons have been looking for new options for the treatment of diabetic foot ulcers and have greatly anticipated the release of the Unite Biomatrix outside of the U.S."
He said that according to the World Health Organization (Geneva, Switzerland), the incidence of diabetes is expected to more than double by 2030. "With this, the prevalence of diabetic ulcers and other disease-related complications continues to rise," Will said. "We are pleased that we can now offer diabetic patients outside the U.S. this new treatment."
Earlier this year, Pegasus received the CE mark for its OrthAdapt Bioimplant product line, which is cleared for the repair, augmentation and reinforcement of ligaments and tendons.
Biofisica names UK/Ireland distributor
In other wound-healing sector news, Biofisica (Duluth, Georgia), a developer of bio-current therapy wound-healing technology, said it has named Sumed International UK (Hadfield, UK) as exclusive distributor of its POSiFECT bio-electric stimulation therapy product line in the UK and Ireland markets.
Sumed is a private manufacturer and distributor of a medical products for the maintenance of healthy skin. The deal with Biofisica will enable Sumed to enter the wound-healing market.
POSiFECT is a wound dressing that produces small bio-electric currents around the site of a wound, which mimics naturally occurring bio-currents. Biofisica said these currents "can help wounds to heal and enable clinicians to treat non-healing wounds."
The company said hundreds of thousands of patients suffer from leg, foot and pressure ulcers that are categorized as non-healing. Failure to treat them can lead to further medical complications and in severe cases, result in limb amputation.
It is estimated that the management of non-healing wounds consumes around 4% of the UK National Health Service's annual budget each year.
Rafael Andino, president/CEO of Biofisica, said, "The strength of Sumed's team and reputation will allow us to expand significantly our penetration into the UK market and ensure that this groundbreaking technology is available to patients via the public healthcare system."
VeinViewer gets CE mark, ISO clearance
Luminetx (Memphis, Tennessee) said its lead product, VeinViewer, has received CE-mark and ISO 13485:2003 certifications, allowing shipment to European countries and continuing the expansion of the Luminetx global strategy.
The VeinViewer vascular imaging system allows physicians, nurses and other healthcare professionals to clearly see accessible vasculature or a lack thereof in real time.
The device uses a combination of near-infrared light and proprietary technologies to image vascular structures and project their location directly on the surface of the skin, providing clinicians with what the company terms "a safe, non-invasive adjunct technology for clinical treatments and procedures including, but not limited to IV insertions, PICC line insertions, routine venipuncture (blood sampling), blood and plasma donations and treatment for varicose and spider veins."
"The VeinViewer is changing the standard of compassionate care, and now with these new certifications we are able to ship [the system] to Europe," said Mark Darty, executive VP of operations at Luminetx. "Patients around the globe will have access to this leading-edge technology and all the benefits it allows."
He added: "This is ... the summation of tireless efforts and the judicious development of a quality program from the ground up."
Pilot manufacturing of the VeinViewer began in spring 2006, with its FDA clearance as a Class I Exempt Medical Device granted and full U.S. commercial rollout following in the fall of last year.
More than 400 VeinViewers are currently in use, according to Luminetx.
USPM and UK firm near agreement
U.S. Preventive Medicine (USPM; Dallas), which describes itself as "building the first network focused on prevention in the United States and internationally," said it has signed a letter of intent with iHealth UK (London) to jointly develop three preventive medicine businesses in the UK.
The U.S. firm said iHealth "brings together leading clinicians, advanced modalities, electronic integration and a holistic perspective to support enhanced wellbeing through its health screening and assessment services."
iHealth initially will market preventive medicine services in the greater London area, broader UK and other international markets in collaboration with USPM by leveraging USPM's systems, operating procedures, and branding and marketing materials.
In addition, iHealth will jointly develop and operate USPM's services and products in England, including The Prevention Plan, a personalized wellness program delivered online to individuals.
The Prevention Plan is primarily sold to employers to help manage future health costs. USPM said the program "helps individuals determine their top health risks and provides a step-by-step plan for improving and tracking their health."
The agreement also enables iHealth to jointly develop and operate USPM's chronic disease management business in England.
Christopher Fey, CEO and chairman of U.S. Preventive Medicine, said, "This expansion into Europe is the first step in [our] plan to provide practical solutions at every point in the healthcare continuum, both nationally and internationally."