IRVINE, Calif.--(BUSINESS WIRE)--Harbor MedTech, Inc. announced today notification of FDA marketing clearance for their first product, Architect™, an advanced collagen matrix for treatment of partial and full thickness skin wounds.
“We are very excited that the FDA has cleared Architect for treating 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,” said Jerry Mezger, Harbor’s President and Founder.
“These serious wounds affect about 6 million Americans each year,” added Mezger. “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. With this approval, we can now provide a unique wound treatment alternative to hospitals and wound care clinics that offers not only earlier and more aggressive therapy, but at a substantially lower cost than today’s leading products.”
Mezger explained that part of the inspiration for Architect came from another product that was sold by a venture capital-backed company that no longer exists. “We know there is a built-in and enthusiastic group of clinicians eager to use Architect, so we will hit the ground running when shipments begin in April,” said Mezger. “These clinicians know that Architect offers a better therapy for many of their patients, and our patented technology enables Architect to heal many difficult wounds with just one application. This is truly unique, because, by comparison, today’s leading products require up to 12 applications, costing the healthcare system thousands of dollars more to treat each patient.”
Harbor MedTech is an Irvine, California based medical device company founded in 2010 to develop and market advanced biologic medical devices for regenerating tissue lost from disease, injury, or surgery. Harbor’s proprietary technology, called BriDGE™, transforms animal-sourced tissues into biologic medical products that can be used in a broad spectrum of medical conditions, including serious and chronic skin wounds, hernia, sports injury surgery, breast reconstruction, and urological/gynecological repairs.
Harbor acquired BriDGE from Edwards Lifesciences and obtained its initial funding in late 2011. Mezger added, “We are extremely proud of what we have accomplished in just 15 months after our initial funding. In today’s medical device world, it is almost unheard-of that a company with only a handful of dedicated people could develop, test, and obtain FDA approval of its first product in that short of time. It really is a testament to the strength of the technology and our team.”
Advanced Collagen Matrix
Diabetic Foot Ulcers
Venous Leg Ulcers