Chitogel wound-healing gel gets FDA approval for sinus surgery

An innovative wound-healing gel developed
by New Zealand 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 percent 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,”
says Professor Hanton.
The US would be the first country to receive
commercial shipments of the gel used postoperatively
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 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 percent 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 postsurgical
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.
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.