Gyder Surgical Announces Australia’s TGA Regulatory Approval for GYDER® Hip Navigation System

MULGRAVE, Australia, April 21, 2023 (GLOBE NEWSWIRE) — Gyder Surgical, an Australian MedTech company specializing in intuitive, non-invasive orthopaedic navigation solutions, today announced that the Therapeutic Goods Administration (TGA) of Australia 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 National Joint Replacement Registry¹, 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 2003¹. Studies indicate that freehand placement of the acetabular cup during hip replacement is not a reliable method². Sub-optimal positioning of the acetabular cup during total hip replacement can potentially lead to dislocations^3,4, cup loosening – ultimately leading to failures, impingement, limited range of motion, excessive liner wear and osteolysis⁴. These complications are some of the leading causes for revision surgeries⁵, which impact patient experience and contribute to significant increase in healthcare costs⁶.

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 burden⁴. The GYDER^® Hip Navigation System is unique as it does not use invasive metallic pins utilized by most existing navigation products in the market. It also does not rely on pre-operative or inter-operative imaging such as CT ( Computer Tomography ) 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.

About Gyder Surgical

Gyder Surgical is an Australian and US based MedTech company specializing in intuitive, non-invasive orthopaedic navigation products. We believe that every patient should have access to accurate and precise surgery, no matter where they are. We are building smart technologies, in collaboration with surgeons, that work in a wide variety of care settings – Ambulatory / Outpatient Surgery Centers or large ORs in hospitals. The GYDER^® Hip Navigation System, our first product, is designed to assist surgeons to accurately place the acetabular cup during hip surgery.

Forward Looking Statements

This media release may contain forward-looking statements, forecasts, estimates, projections and opinions (“Forward Statements”). Gyder Surgical does not make any representation or warranty, whether express or implied, that such Forward Statements will be achieved or will prove to be correct. A number of factors, many of which are outside the control of Gyder Surgical, could cause actual future results and operations to vary materially from the Forward Statements. No representation or warranty, express or implied, is made that the assumptions on which the Forward Statements are based may be reasonable. No audit, review or verification has been undertaken by Gyder Surgical or an independent third party of any Forward Statements or assumptions, or their reasonableness. As such, undue reliance should not be placed on any Forward Statements contained in this media release.

For more information, please visit https://www.gydersurgical.com.

References:

1. https://aoanjrr.sahmri.com/annual-reports-2022
2. Poor accuracy of freehand cup positioning during total hip arthroplasty, Available at: https://pubmed.ncbi.nlm.nih.gov/17297597/
3. Can some early revision total hip arthroplasties be avoided?, Available at: https://pubmed.ncbi.nlm.nih.gov/31146556/.
4. Current Concepts in Acetabular Positioning in Total Hip Arthroplasty, Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5525519/
5. Causes and Frequency of unplanned hospital readmission after total hip arthroplasty, Available at: https://pubmed.ncbi.nlm.nih.gov/23801061/
6. Treatment patterns and clinical and economic burden of hip dislocation following primary total hip arthroplasty in England, Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9251137/