Company: Stratatech Corporation

Products: Stratatech is a regenerative medicine company focused on the commercialization of proprietary skin substitute products for therapeutic and research uses. The company has a portfolio of therapeutic skin substitutes to treat severe burns, non-healing ulcers and other complex skin defects. Its flagship product, known as StrataGraft® tissue, is a full-thickness human skin substitute being developed as a treatment for severe burns. It is designed to mimic natural human skin. Stratatech’s ExpressGraft® skin substitute products are genetically enhanced to produce elevated levels of natural, human wound-healing factors that fight infection, improve blood flow and increase the rate of healing. The company is also developing its progenitor cell line as an alternative to animal testing with novel, three-dimensional cellular models that can evaluate the effects of new chemicals and compounds on human skin.

Location: Madison, Wis.

Employees: 38

Founded: Stratatech was founded in 2000 to commercialize the discovery of NIKS® cells—a human keratinocyte cell line that produces living tissue nearly identical to native human skin. The discovery was made at the University of Wisconsin-Madison.

Leadership: Lynn Allen-Hoffmann, Ph.D., is the founder, CEO and chief science officer at Stratatech. Allen-Hoffmann received her doctorate from Cornell University and trained with Dr. James Rheinwald at Harvard Medical School. She has been professor of pathology at the University of Wisconsin Medical School since 1988 and has received ongoing funding from the National Institutes of Health for her research program.

Operations/Market: The discovery of NIKS cells has profound implications. Currently, patients with severe burns go through painful skin transplants called autografts and are often treated with cadaver skin as a temporary wound covering prior to the autograft procedure. Stratatech’s StrataGraft tissue has the potential to provide a safer, less painful and more effective alternative in a single surgical procedure.

“There is an urgent need for new treatment options for burns,” Allen-Hoffmann said. “Severe burns and other major skin trauma are life-threatening injuries that require immediate surgical intervention. Stratatech’s extensive product line has the potential to limit the many serious drawbacks to current burn treatment.”

StrataGraft offers important prospective benefits, including:

• Reduced patient pain, discomfort and infection risk.
• Elimination of, or a reduction in the size of, painful skin transplant (autograft) donor sites.
• Increased patient safety due to the virtual elimination of infection risks associated with cadaver skin currently used as a temporary covering.
• Potentially faster overall healing timeframes.
• Shorter hospital stays and fewer surgeries resulting in lower costs to healthcare providers and payers.

The American Burn Association estimates that 1.1 million people suffer burns annually in the United States with approximately 45,000 patients requiring hospitalization. In addition, the Government Accountability Office reports that in the case of a mass-casualty situation, more than 10,000 patients might require thermal burn care. The limited number of specialized burn centers and related medical infrastructure in the U.S. creates a public health need for readily available therapies in these and other care sites.

“There is an increased interest in the StrataGraft product since the positive results of our second round of clinical trials were released in January. Our recent federal contract with the Biomedical Advanced Research and Development Authority (BARDA) will accelerate clinical development and ensure that Stratatech has the resources it needs to get StrataGraft through all the remaining clinical trials, and bring it to market within the next five years,” Allen-Hoffmann added.

Business Successes: In 2011, Stratatech was awarded $4.6 million by the National Institute of Diabetes and Digestive and Kidney Diseases to support the first human clinical trial of ExpressGraft tissue, an antimicrobial skin substitute, to treat patients with non-healing diabetic foot ulcers. Allen-Hoffmann felt that the competitive, peer-reviewed award signified the compelling value of Stratatech’s genetically enhanced skin substitutes.

In January 2013, Stratatech released results from a proof of concept trial of StrataGraft in patients with deep partial-thickness burns. The results showed that of the 20 patients treated, 17 patients’ wounds had fully closed within three months, and 19 had avoided painful grafts of their own skin. Allen-Hoffmann said it was “the first skin substitute to ever achieve this level of efficacy, potency and consistency in severe burns.”

Based on the data, Stratatech was awarded a major government contract worth up to $47 million by BARDA this past July. Stratatech is the first company to be awarded a contract like this in the state of Wisconsin. The funding will allow the company to add 10 to 20 employees over the next five years. It will also enable the company to conduct a clinical trial with pediatric burn patients during the contract’s five-year term.

Stratatech has been awarded more than $30 million in research grants from the National Institutes of Health, the Department of Defense, and the federal Small Business Innovation Research (SBIR) program to support its research programs.

Wisconsin Business Environment Benefits:  Stratatech has received significant support from the Wisconsin-based angel investment community throughout the past 13 years. The Department of Commerce has certified Stratatech as a Qualified New Business Venture, a designation that provides investors access to important investment tax credits.  In addition, the department has supported the company with technology development loans.

“No matter how many times an investor tries to persuade me to move the company to California or the East Coast, I’m firm in my belief that Stratatech belongs in Madison,” Allen-Hoffmann said. “It’s where we began; it’s where we received the funding and resources we needed to grow; and it’s where we’ll continue to develop groundbreaking products for the patients who need them most.”

To learn more: www.stratatechcorp.com

(October 2013)