California-based medical device Harbor MedTech has gained FDA marketing approval for its first product, Architect, an advanced collagen matrix for treatment of partial and full thickness skin wounds.
Harbor president and founder Jerry Mezger said the company is happy to gain FDA clearance for its Architect, which helps to treat a wide variety of serious skin wounds, including diabetic foot ulcers, venous leg ulcer, pressure ulcers, and many other trauma or surgery related skin wounds.
"These serious wounds affect about 6 million Americans each year," Mezger added.
"They not only are a leading cause of infection, hospitalization and even amputation, but the cost of today's therapies is a major burden on the healthcare system."
According to Mezger, the FDA's approval allows the company to provide a unique wound treatment alternative to hospitals and wound care clinics that offer not only earlier and more aggressive therapy, but at a substantially lower cost than today's leading products.
