IT TAKES A SPECIAL PERSON to invent something revolutionary, and Aubrey Woodroof is one of those people. In the academic and medical community Dr. Woodroof is known for his pioneering treatment of patients with burns and chronic wounds.

Dr. Woodroof is the inventor of PermeaDerm, a groundbreaking acellular biosynthetic skin substitute. He and Paul Butorac, Principal Development Engineer at Trelleborg Sealing Solutions, have spent the past three years working to transform his dream into a market-ready range of products. In addition to Butorac, a key team of specialists at Trelleborg in Tustin, California, have worked together to make PermeaDerm a reality – including: Sean McPherson, Sales Engineer, Healthcare and Medical, and Mark Gordon, Product Manager for Trelleborg Sealing Solutions in Tustin.

“When Dr. Woodroof first called us in 2014, he was hoping that we would be able to provide just the silicone element of his proposed wound dressing system,” McPherson says. “Little did he know that we would actually be able to bring a whole range of capabilities to the table, including raw material research and selection, equipment design, process development, packaging, validation and sterilization management.”

While Dr. Woodroof had a theoretical concept and some basic handmade prototypes, Trelleborg Sealing Solutions was able to provide formal drawings, material controls, work instructions, certification of active ingredients, a quality control system and a world-class manufacturing system. This would ultimately produce a high-quality marketable product while securing global regulatory acceptance for a complete combination drug-and-device solution – in other words, the entire framework that would make his product a success.

While Dr. Woodroof had a winning concept, the manufacturing strategy involved in bringing it to market was complex. “It was quite a challenge to develop and optimize a manufacturing process that would make this whole project feasible,” Butorac says. “At the beginning, the work was very manual – for example, we were sizing product with scissors. This was never sustainable. We systematically applied our quality management framework and manufacturing expertise to help PermeaDerm achieve clinical success and commercialization of their products.

“It was very gratifying to see how excited our operators were to come on board for PermeaDerm production. Extensive training was conducted to educate and motivate the operators, to ensure the process was consistent and to help continuously improve quality while reducing manufacturing times. By providing a complete manufacturing solution we helped Dr. Woodroof focus on writing critical scientific publications, identify new investors, promote PermeaDerm and develop new ideas.”

Butorac continues, “Working with such a significant yet elegant solution designed to help patients recover from their wounds and change their lives makes for rewarding work and a great sense of fulfillment. This is especially pleasing now that the first two products have been released – PermeaDerm B for burns and PermeaDerm C for chronic wounds – with very positive results.”

“We have observed the remarkable healing process in patients after treatment with PermeaDerm, often with reduced pain and scarring as a result. Having seen the results of this work, it feels really good to collaborate with and contribute to Dr. Woodroof’s success.”

Dr. Woodroof commends the Trelleborg team’s effort, support and manufacturing expertise. “I have been fortunate to play a role in advancing the art of medicine for the successful management of acute and chronic wounds (such as diabetic ulcers) and burns with PermeaDerm,” he says.

The demand for biosynthetic wound and burn care solutions is significant, with burn centers and long-term wound-care providers always on the lookout for new, effective forms of treatment.

The team is now busy developing PermeaDerm G – the “G” is short for glove. People’s hands are more susceptible to burn wounds, and the demand for an effective treatment solution is currently overwhelming.

Trelleborg’s collaboration with Dr. Woodroof is the perfect symbiosis. While PermeaDerm Inc. owns, markets and sells its products, it relies on Trelleborg’s backing and support resources.

“If Dr. Woodroof can get to a point where his products are not only being used in hospitals and burn centers but become available over the counter like Elastoplast, we’re looking at high-volume sales,” Butorac says. “Let’s face it: if I had a child with a wound or burn that could cause pain and permanent scar tissue, I would happily use this product. What parent wouldn’t?”