OrthAlign, Inc. Receives Australian Therapeutic Goods Administration (TGA) Approvals for Direct Anterior Total Hip and Partial Knee Arthroplasty Precision Technologies

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OrthAlign, Inc., a privately held U.S.-based medical device and technology company, announced today that the Australian Therapeutic Goods Administration (TGA) has approved OrthAlign's advanced precision technologies for Direct Anterior Approach Total Hip (DAA HipAlign®) and Partial Knee Arthroplasty (UniAlign®) surgeries to be included on the Australian Register of Therapeutic Goods.

"Based on its well-established KneeAlign® platform for total knees, availability of OrthAlign's technology in Australia for direct anterior hip arthroplasty and partial knee replacement surgeries is an exciting development, said Dr. Price Gallie of Gold Coast University Hospital.

OrthAlign, Inc., a privately held U.S.-based medical device and technology company, announced today that the Australian Therapeutic Goods Administration (TGA) has approved OrthAlign's advanced precision technologies for Direct Anterior Approach Total Hip (DAA HipAlign®) and Partial Knee Arthroplasty (UniAlign®) surgeries to be included on the Australian Register of Therapeutic Goods.

Dr. Price Gallie, orthopaedic surgeon at Gold Coast University Hospital in Queensland, Australia, commented, "Based on its well-established KneeAlign® platform for total knees, availability of OrthAlign's technology in Australia for direct anterior hip arthroplasty and partial knee replacement surgeries is an exciting development. The use of handheld navigation within the surgical field enhances surgical accuracy with minimal disruption to the surgical workflow, as demonstrated by my regular use of KneeAlign. I'm particularly excited about DAA HipAlign, as it will allow improved accuracy of cup placement and restoration of leg length, ultimately leading to better outcomes for my patients."

Recent global statistics have shown that the direct anterior approach for total hip arthroplasty is growing, as it arguably leads to quicker recovery, less pain, and more normal function for patients after hip replacement. DAA HipAlign does not require any pre-operative imaging or intraoperative fluoroscopy, while providing more clinically relevant positioning for cup placement and leg length measurement. Early clinical data from the United States demonstrates that surgeons can expect to reduce fluoroscopy exposure time by about 45%. Early clinical data from Japan shows cup placement (for both inclination and anteversion) accuracy of ±10°, with at least 95.9% confidence.

Unicompartmental knee arthroplasty procedures are also growing in market share, worldwide. UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. UniAlign has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth, with at least 90% confidence.

“Australia is one of the world's most important navigation and technology markets for joint arthroplasty," said James Young Kim, OrthAlign's Vice President and General Manager of International. "We are pleased that DAA HipAlign and UniAlign are now available in the Australian market and are confident that surgeons will be impressed by its ease of use and accuracy."

DAA HipAlign and UniAlign will be included in OrthAlign Plus® handheld navigation devices, along with OrthAlign's award-winning KneeAlign® and Posterior HipAlign® technologies. To date, OrthAlign technology has successfully been used in over 65,000 cases, in over 25 countries, with more than 15 published international clinical studies demonstrating its accuracy.

OrthAlign will be showcasing its full portfolio of products at this year’s Australian Orthopaedic Association meeting in Adelaide, Australia, October 9-13, 2017 at booth #10.    

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

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