Local medtech secures TGA approval of its orthopaedics technology

MedTech & Diagnostics News: An Australian MedTech company specialising in orthopaedics announced that the Therapeutic Goods Administration (TGA) has granted regulatory approval for the GYDER Hip Navigation System, a non-invasive (pin-less) and image-less smart navigation system for total hip replacement surgery using the Anterior Approach.

“We are excited to receive the regulatory approval from Australia’s TGA for the GYDER Hip Navigation System. It’s a major milestone and an important step forward in our journey to bring our patented Pin-less and Image-less technology to orthopaedic surgeons in Australia and for improving patient care”, said Sujit Dike, CEO of Gyder Surgical.

“We believe that there is a strong appetite for fast, easy-to-use and cost-effective enabling technologies that improve surgical accuracy during orthopaedic surgery”.

According to the Australian Orthopaedic Association (AOA) National Joint Replacement Registry, 52,787 hip replacement surgeries were performed in 2021 in Australia. Primary total hip replacement increased by 7.0% in 2021 compared to 2020, and there has been a 125.2% increase since 2003. Studies indicate that freehand placement of the acetabular cup during hip replacement is not a reliable method. Sub-optimal positioning of the acetabular cup during total hip replacement can potentially lead to dislocations, cup loosening – ultimately leading to failures, impingement, limited range of motion, excessive liner wear and osteolysis. These complications are some of the leading causes for revision surgeries, which impact patient experience and contribute to significant increase in healthcare costs.

Hydrix applauded its long-term client and venture investee company, Gyder Surgical, on the TGA registration.

Gavin Coote, Executive Chairman of Hydrix, said “It is very rewarding to have developed this world first product and technology innovation for Gyder Surgical, and to have successfully managed the TGA regulatory application process. We look forward to supporting Sujit and the Gyder Board with future product developments and as investors through our Hydrix Venture investment.”

The GYDER Hip Navigation System is a computer controlled, non-invasive surgical tool to aid navigation during Total Hip Arthroplasty via the Anterior Approach. It is designed to provide real-time guidance to assist the surgeon in positioning the acetabular cup in the intended orientation during primary or revision Total Hip Arthroplasty. Improved cup placement accuracy has significant potential to reduce post-surgery complications, thereby improving patient outcomes and lowering health system cost burden.

The GYDER Hip Navigation System is unique as it does not use invasive metallic pins utilised by most existing navigation products in the market. It also does not rely on pre-operative or inter-operative imaging such as CT or X-ray technology. Calibration takes only one minute, and registration is quick, making the GYDER Hip Navigation System fast and easy-to-use. It has a small footprint, seamlessly integrates into existing workflow, and is an open platform that provides surgeons flexibility to use their preferred implants. Gyder Surgical plans to commercialize the GYDER Hip Navigation System later this year.