MxBiodevices Develops Diabetic Foot Ulcer Treatment
August 6, 2012
The Daily Reflector
MxBiodevices, a Greenville biotech company, has received a $30,000 company inception loan from the North Carolina Biotechnology Center to aid in completing its business plan.
MxBiodevices is on the fast track to the European marketplace and eventual commercialization in the United States with a revolutionary new treatment for diabetic foot ulcers (DFU).
By 2025, there is expected to be 330 million diabetics worldwide. Every 30 seconds, a lower extremity is amputated due to complications from a DFU.
MxBiodevices is pursuing its commercialization efforts in eastern North Carolina, an emerging hotbed of life science companies, including pharmaceutical, biotechnology and medical product development and manufacturing.
The technology behind MxBiodevices is a synthetic nanofiber scaffold that is injected under the ulcer bed which provides a healing environment for the patient’s cells to initiate tissue regeneration. The technology has proven to be effective in a broad array of applications, including tendon, bone and dermal wound repair, cosmetic surgery and dental applications.
MxBiodevices’ co-founders, Dr. Ronald Hill, Dr. Francis Lamberti and Marilyn Thompson, who have combined nearly 60 years in biotechnology research and product development, were instrumental in the product development, manufacturing, clinical trials, regulatory approval, and successful commercialization for use in orthopedics and spine.
“MxBiodevices will leverage this commercial success in orthopedics and spine to successfully commercialize the technology to treat DFUs,” Hill said. “Greenville is the ideal location for us. There is significant investor support for life science start-ups. The Technology Center provides quality affordable space, and the medical and dental schools at East Carolina University provide expertise and opportunity for collaboration.”
The next step for MxBiodevices will be to gain approval to treat DFUs in the United States and Europe. Manufacturing capabilities are in place, and the technology has been approved for use for several applications in both the United States and Europe.
In place regulatory approvals, DFU clinical data and product manufacturing agreements will speed commercialization. Plans anticipate arrival in the European market in 2013 and in the U.S. market within three years.