Revolutionary Diabetic Ulcer Treatment Headed to Market

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MxBiodevices, a Greenville, NC 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 US with a revolutionary new treatment for diabetic foot ulcers (DFU). By 2025 there is expected to be 330 million diabetics worldwide and every 30 seconds a lower extremity is amputated due to complications from a DFU.

MxBiodevices, a Greenville, NC 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 US with a revolutionary new treatment for diabetic foot ulcers (DFU). By 2025 there is expected to be 330 million diabetics worldwide and every 30 seconds a lower extremity is amputated due to complications from a DFU.  

MxBiodevices is pursuing its commercialization efforts in the fertile ground of 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 own cells to initiate tissue regeneration. In contrast, current wound care products are topical applications that do not treat the underlying tissue. 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’ cofounders, 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. Dr. Hill stated, “MxBiodevices will leverage this commercial success in orthopedics and spine to successfully commercialize the technology to treat DFUs. 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 (ECU) provide expertise and opportunity for collaboration.” Home to the Metabolics Institute at East Carolina, the University is renowned for its research into obesity and diabetes.

The next steps for MxBiodevices will be to gain approval to treat DFUs in the United States and Europe. Manufacturing capabilities are already in place and the technology has previously been approved for use for several applications in both the US and Europe. In place regulatory approvals, DFU clinical data and product manufacturing agreements will speed commercialization; current plans anticipate arrival in the European market in 2013 and in the US market within 3 years.

North Carolina’s Eastern Region is an economic development agency representing 13 counties in Eastern North Carolina. For more information visit www.nceast.org or contact, Steven Pearce, Marketing & Communications Coordinator at pearce@nceast.org.