Chitogel Limited is excited to announce that they have received approval of its first wound healing product within the UK and European community to add to their FDA approval in 2018.
Receiving CE Mark certification for our Endoscopic Sinus Surgery Kit is a highly significant strategic milestone on our journey to international expansion.
The CE Mark indicates that a medical device complies with the applicable EU regulations for medical devices and perceived as the leading international benchmark of proven quality and efficacy for medical devices.
Chitogel Chairman Phil Royal says while the European approval process can take years, it’s well worth the wait as it unlocks many key markets and has flow on benefits in further establishing our international credibility.
“The platform has been set for a focused and ambitious international expansion plan and we are proud and excited to share the exceptional clinical benefits of our Chitogel technology with many more patients around the world in the next stage of our growth.” Mr Royal says.
Chitogel is poised to expand into Europe and Australia, and has treated more than 7,000 patients since its 2019 launch in the US and NZ.
Chitogel Limited is a medical device company offering a scientifically proven chitosan-based hydrogel that improves patient outcomes following sinus surgeries and other potential applications.
Chitogel is the 2003 brainchild of the late University of Otago professor Brian Robinson, New Zealand ENT surgeon Simon Robinson, and world-renowned sinus surgeon and University of Adelaide professor Peter-John Wormald.
The multi-million dollar project has involved numerous researchers and scientists from Otago and Adelaide universities working together over the years to develop the product as it’s known today.
World-renowned sinus surgeon and University of Adelaide professor Peter-John Wormald says Chitogel is a unique product that significantly improves patient outcomes and reduces the need for further surgeries.
“It’s really exciting to be taking Chitogel to the rest of the world to increase patients’ comfort post-surgery and significantly improve their recovery,” he says.
In a little over three years, Chitogel Limited has transitioned from a company largely focused on research and development into achieving commercial expansion.
Chitogel has also recently completed a highly successful capital raise to support sales growth and expansion into new markets and products.
Over $6 million was raised from a variety of New Zealand and Australian investors including individuals, medical professionals and institutions and look forward to their support during the next phase of the journey.
Backed by compelling clinical evidence, Chitogel is already well positioned to gain a significant share of the global market. They are firmly focused on their key objectives of growing sales, entering new markets and developing their wound care product pipeline.
