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A wound-healing gel developed by Kiwi scientists has been cleared for use by the US Food and Drug Administration.
The gel, developed by NZ medical science company Chitogel and involving University of Otago scientists, will be used after endoscopic sinus surgery to reduce bleeding and almost entirely eliminate scarring.
Placing the dissolvable clear gel dressing within the sinus cavity after surgery would replace the need for uncomfortable gauze bandages to be inserted to stop bleeding, thereby improving a patient's post-surgical recovery experience.
Those post-operative complications lead to about 15% of the operations being repeated but the gel could significantly reduce that.
Endoscopic sinus surgery is one of the most common surgical procedures performed with more than 500,000 carried out each year in the US alone.
The US would be the first country to receive commercial shipments of the gel which is produced at the company's new manufacturing plant in Lower Hutt's Gracefield Innovation Quarter.
One of the research team and University of Otago chemistry professor Lyall Hanton said the company aimed to capture 20-30% of the US market by the end of 2020.
"I am delighted that something we have worked so long and hard on, is finally able to make a fundamental difference to people recovering from this type of sinus surgery. It is fantastic to finally get this to the market," he said.
Chitogel's early development was the brainchild of two award-winning researchers: the late New Zealand chemical scientist, Marsden medallist, and University of Otago professor Brian Robinson, who was Chitogel's previous chairman before he died last year; and the University of Adelaide's Professor PJ Wormald, who is a leading ear, nose and throat surgeon.
Executive chairman and chief executive Phil Royal said he expected the first commercial shipments of Chitogel to begin in the middle of next year.
A number of pharmaceutical companies were trialling the product as part of advanced negotiations around its distribution, he said.
"This FDA clearance represents a huge milestone for our young company and the medical world. Outcomes for surgeons and their patients will be significantly improved from using Chitogel, which was developed over the course of the past 12 years using innovative Kiwi research and technology," he said.
"It's a very exciting time for the advancement of ear, nose and throat surgeries."
The company would next be submitting applications for FDA approval for post-surgery use in spinal and abdominal surgeries and seek approval for use in other countries.
About Chitogel Ltd (pronounced kyto-gel):
• Chitogel produces an eponymous clear topical medical gel which has been scientifically proven to provide cost-effective wound healing solutions that significantly reduce the bleeding, scarring and infection resulting from sinus operations.
• Its patent-protected formula is made from two chemical compounds (chitosan succinamide and dextran aldehyde) produced from chitosan, a natural sugar polymer derived from high-grade crab shells.