WINSTON-SALEM, N.C. – When the Wake Forest University School of Medicine scientists who developed a new medical device were ready to partner with an expert in making new technologies available to patients, they didn’t have to go far – just around the corner in Piedmont Triad Research Park.
The scientists are collaborating with SpringMed Group, one of the research park's first tenants, to form a new company – Applied Catheter Technologies Inc. – that will develop and market drug-coated catheters and stents designed to prevent or treat scar tissue that can form after certain medical procedures.
The research is a project of the Department of Urology and part of it was conducted in the Piedmont Triad Research Park at the Wake Forest Institute for Regenerative Medicine. The department and institute are both directed by Anthony Atala, M.D.
“The first application of the technology will be a drug-coated urinary catheter to prevent a condition known as male urethral stricture, but the technology has potential to be used in almost the entire body where strictures or scarring is a problem,” said Steve J. Hodges, lead researcher and an assistant professor in the Department of Urology.
Hodges and colleagues have already expanded applications of the technology to include devices for use in otolaryngology and other surgical fields.
Male urethral stricture, a narrowing of the tube that empties urine from the body, can occur as a result of disease, injury or from scar tissue forming after certain medical procedures, including surgery for prostate cancer or the insertion of a scope into the urethra to treat an enlarged prostate. After these procedures, a Foley catheter is temporarily used to drain urine from the bladder. The physician-scientists’ idea was to coat these catheters with drugs that can prevent the formation of collagen, a protein that is the root cause of scar tissue.
"The idea behind the new device is simple – to combine the Foley catheter that is used as part of these medical procedures with pharmaceuticals that are already being used to inhibit collagen formation," said Jon S. Wilson, CEO of Applied Catheter Technologies. Wilson is also managing partner of SpringMed Group, a company that helps start-up companies develop and launch medical devices.
Douglas Edgeton, M.B.A., M.P.H., president of Piedmont Triad Research Park, said the project is a clear example of how to quickly move ideas from the research bench to patients. He said having it all done in Winston-Salem is an added bonus.
“The research park provides the perfect place for scientists from academia to collaborate with the Office of Technology Management and successful business leaders creating new companies and opportunities to help move the most current medical thinking to patients while at the same time benefiting our local economy,” said Edgeton.
The company's goal is to obtain approval to begin evaluating the new device in patients within 18 months. Foley catheters are currently the most used catheter in the world. Wilson said the current market for urological catheters is about $910 million and that about $250 million is spent each year in the United States treating patients with existing urethral strictures.
The first products of Applied Catheter Technologies will be drug-coated catheters and stents for urologic applications. Under Wilson's direction, Applied Catheter Technologies will further develop the product, including a controlled process for applying the drug coating. The device will also undergo additional testing and will be submitted to the Food and Drug Administration for approval.
Later the company plans to use the same concept in other areas of the body, such as bioabsorbable stents that are used in the gastrointestinal tract.
“What is truly exciting is that we will bring medical device technologies, pharmaceuticals and nanotechnologies together to create new therapies,” said Wilson. “The potential is huge. These devices could be used in virtually any area of the body subject to stricture and there are currently no other preventive treatments.”
Others involved in the technology development were Christopher A. Sullivan, M.D., assistant professor of otolaryngology, James Yoo, Ph.D., associate professor of regenerative medicine and urology, and Atala.
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