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Breakthrough wound-healing gel from Wellington approved for use in USA

Press Release – Chitogel Ltd
A ground-breaking wound-healing gel developed by the Wellington medical science company Chitogel will be used to treat sinus patients in the United States now that that regulatory clearance from the US Food and Drug Administration (FDA) has been approved.

Chitogel represents a significant medical advancement to endoscopic sinus surgery, which is one of the most common surgical procedures globally, and is performed approximately 500,000 times each year in the US.

The company’s eponymous gel is the only topical medical treatment in the world that has been scientifically proven to significantly reduce bleeding, and almost completely eliminate scarring resulting from sinus operations*. This is significant given 15 % of sinus surgeries need to redone due to complications arising from bleeding, scarring and infection.

Further, applying the clear gel dressing within the sinus cavity after surgery replaces the need for gauze bandages to be used, thereby improving a patient’s comfort during recovery.

With FDA approval, Chitogel can now move forward with its plans to capture 20-30% of the US market by the end of 2020. The US will be the first market to receive commercial shipments of the gel, which is produced at the company’s new manufacturing plant at Callaghan Innovation’s Gracefield Science Quarter in Wellington.

Chair Phil Royal says he expects the first bulk commercial shipments of Chitogel to be exported by the middle of next year, and notes pharmaceutical companies are currently trialling the product as part of advanced negotiations on potential distribution agreements.

“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 by using Chitogel, which has been 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, world-leading clinicians, and some of the best scientists in New Zealand.

Other uses and markets:

With FDA approval to use Chitogel as a medical device for sinus surgeries, the company will next be submitting applications to secure FDA clearance for post-surgery use in spinal and abdominal surgeries, once extensive testing of the these products is complete. The company will also look to seek regulatory clearance in other markets beyond the US.

The early brains behind Chitogel
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 Wormwald, who is one of the world’s foremost Ear, Nose and Throat surgeons.

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. The company maintains an extensive portfolio of patents covering innovative treatments based on a formula involving highly complex carbohydrate chemistry.

Initially developed by researchers at Otago and Adelaide universities, Chitogel opened a manufacturing plant in 2016 near Wellington, where the gel will be produced and then shipped to the United States. Its patent-protected formula is made from two chemical compounds: chitosan succinamide, derived from high grade shrimp; and and dextran aldehyde, a natural sugar polymer. See http://www.chitogel.com/

BusinessDesk report by Rebecca Howard
Wellington medical science company Chitogel has signed a heads of agreement with a US-based pharmaceutical multinational after getting greenlit by the US Food and Drug Administration for its wound-healing gel.

“We just signed the deal on Tuesday. They are the largest or second largest in the US in the ears, nose and throat space,” chief executive Phil Royal told BusinessDesk. He declined to name the company but said it would be Chitogel’s distributor for the ENT gel in the US. Chitogel is aiming to capture 20 percent to 30 percent of the US market by 2020 and Royal said he was confident that was possible. Now the company has regulatory approval from the FDA, he expects the first commercial shipments to begin in the middle of next year.

Royal said the company currently has the capacity at its new manufacturing plant in Lower Hutt’s Gracefield Innovation Quarter to meet demand from the US but would then have to expand as it moves into other markets and other products.

The gel, which has been 12 years in the making, is used post-operatively in endoscopic sinus surgery, performed approximately 500,000 times each year in the US alone. The clear gel is a topical medical treatment that reduces bleeding, scarring and infection resulting from sinus operations, according to the company. Among other things, the dissolvable clear gel dressings replace the need for gauze bandages, improving the recovery.

“It’s very effective material,” said Lyall Hanton, a chemistry professor at Otago University and one of the developers of the project. While Chitogel does have some competition in the ENT space he is confident the gel offers a better outcome for patients.

Hanton said the company is submitting applications to secure FDA clearance for post-surgery use in spinal and abdominal surgeries, likely focusing on spinal use first. According to Royal, human testing just kicked off today in Adelaide for spinal use.

The company also has global patents in place and will look to get regulatory approval in several markets outside the US. “Every market is slightly different in terms of how you approach it and the cost of approaching it,” said Hanton.

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