An innovative wound-healing gel developed by NZ medical science company Chitogel and involving University of Otago scientists will soon be used to treat sinus patients in the United States following regulatory clearance from the US Food and Drug Administration (FDA).
A team of Otago and Adelaide researchers have been associated with the project since its beginning. One of the research team and Professor in Chemistry at Otago University Lyall Hanton, says with FDA approval, Chitogel can now move forward with its goal to capture 20-30% of 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,” says Professor Hanton.
The US would be the first country to receive commercial shipments of the gel used post-operatively in sinus surgery, and which is produced at the company’s new manufacturing plant situated outside of Wellington, within Lower Hutt’s Gracefield Innovation Quarter.
Chitogel’s early development was the brainchild of two award-winning researchers: the late New Zealand chemical scientist, Marsden medallist, and Otago University Professor Brian Robinson, who was Chitogel’s previous Chair before he passed away last year; and the University of Adelaide’s Professor PJ Wormald, who is a leading ENT surgeon.
Chitogel represents a significant medical advancement to endoscopic sinus surgery, which is one of the most common surgical procedures, performed approximately 500,000 times each year in the US alone.
The gel is a topical medical treatment that extensive tests have shown will significantly reduce bleeding, and almost completely eliminate the scarring resulting from sinus operations. These post-operative complications lead to 15 % of sinus surgeries needing to be repeated.
Further, placing the dissolvable clear gel dressing within the sinus cavity after surgery replaces the need for uncomfortable gauze bandages to be inserted to stop wounds bleeding, thereby improving a patient’s post-surgical recovery experience.
Executive Chair and CEO Phil Royal says he expects the first commercial shipments of Chitogel to begin the middle of next year, noting a number of pharmaceutical companies are currently trialling the product as part of advanced negotiations around its distribution.
“This FDA clearance represents a huge milestone for our young company and the medical world, says Mr Royal. “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.
“It’s a very exciting time for the advancement of ear, nose and throat surgeries.”
Mr Royal acknowledges the many years of hard work leading up to the FDA milestone. This includes developing partnerships with Callaghan Innovation, the New Zealand government through MBIE, world-leading clinicians, and scientists in New Zealand.
With FDA approval to use Chitogel as a medical device for ear, nose and throat surgeries, the company will next be submitting applications to secure FDA clearance for post-surgery use in spinal and abdominal surgeries. The company will also look to seek regulatory clearance in other markets beyond the US.