Mallinckrodt’s Stratatech Earns National Honor for Contributions to Small Business Innovation Research

Stratatech skin tissue image

Stratatech, a Mallinckrodt company, recently earned recognition as a 2016 Tibbetts Award winner, recognized for its unique contributions to the Small Business Innovation Research (SBIR) Program, as coordinated by the U.S. Small Business Administration. Stratatech received its award at a White House Ceremony on Jan. 10, 2017

Stratatech, a leader in regenerative medicine, is developing novel cell-based therapeutic products for the treatment of severe burns and other complex skin defects to reduce or avoid the need for painful skin harvest and transplantation, and has the potential to create a paradigm shift in cutaneous wound healing. Mallinckrodt acquired Stratatech in September 2016.

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Dr. Lynn Allen-Hoffmann

“The field of regenerative medicine may have seemed like something out of a science fiction novel a few years ago, but for our team, we have been developing a first-in-class regenerative medicine pipeline since 2000,” said Dr. Lynn Allen-Hoffmann, Senior Vice President of Regenerative Medicine, who founded the company in 2000 as the first spinout by a woman faculty member at the University of Wisconsin-Madison. The Small Business Innovation Research (SBIR) program is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R&D) that has the potential for commercialization. Named after Roland Tibbetts, who is credited with starting the SBIR program, the Tibbetts Awards recognize individuals, organizations, firms or projects that have made a visible technological impact on the socioeconomic front and exemplify best-in-class achievements. Award winners are selected based on the economic impact of their technological innovation, and the extent to which that innovation served federal R&D needs, encouraged diverse participation and increased the commercialization of federal research.

Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. Stratatech received its first SBIR award in March 2001, when the company had fewer than five employees; today, there are more than 50 employees who support the business.

“Support from SBIR and the similar Small Business Technology Transfer (STTR) program was critically important to Stratatech, supporting development of StrataGraft® skin tissue from early stage research through Phase 2 clinical development,” says Lynn, who adds that the funding received was especially important for a woman-owned company. “Funding from the SBIR/STTR programs also provided for the development of ExpressGraft™ skin tissue, the first genetically enhanced, human cell-based therapy product to receive approval for clinical assessment in humans.” These successes enabled Stratatech to secure additional funding, including support from the U.S. Department of Defense and a series of contracts with the Biomedical Advanced Research and Development Authority. Stratatech has also cultivated research relationships with various universities and research institutions including the University of Wisconsin-Madison, Wake Forest University, The Arizona Burn Center, the U.S. Army Institute of Surgical Research, Harvard Medical School, and industry.

As a small business, Stratatech generated the most SBIR/STTR funding of any biotech company in the state of Wisconsin and its evolution and growth have served as a model for other small, high-tech businesses located in the Midwest.