OrthAlign, Inc. Announces JMHLW Approval for use of Direct Anterior HipAlign®and UniAlign™ in Japan

OrthAlign, Inc. Announces JMHLW Approval for use of Direct Anterior HipAlign®and UniAlign™ in Japan

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OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today that the Japanese Ministry of Health, Labour, and Welfare (JMHLW) has approved Direct Anterior HipAlign® for use in supine position Total Hip Arthroplasty (THA) surgeries and UniAlign™ for use in Unicompartmental Knee Arthroplasty (UKA) surgeries in Japan.

“I am very excited that OrthAlign technology will be available for use in Japan for supine position THAs and UKAs,” said Yukihide Minoda, MD, PhD of Osaka City University in Osaka, Japan. “I already use KneeAlign® for my TKAs and have found it to be a very important part of my surgeries. Clinically, it has been very valuable for my patients in Japan and I am very happy with the excellent outcomes. I expect the same with these new technologies.”

Recent statistics have shown that the direct anterior (supine position) approach is growing in popularity amongst Japanese surgeons as it arguably leads to quicker recovery, less pain, more normal function for Japanese patients after a hip replacement, and is more minimally invasive. HipAlign provides accurate cup placement positioning and does not require any pre-operative imaging, intraoperative fluoroscopy, or additional personnel in the operating room to control components outside of the sterile field.

Based on FDA cleared bench test data, HipAlign technology provides cup placement accuracy of ±3°, with at least 97% confidence. The system accounts for pelvic tilt when measuring the abduction and anteversion angles of the acetabular cup.

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. The system 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. This accuracy has been validated with at least 90% confidence.

Just as KneeAlign and Posterior Approach HipAlign have been distributed in Japan through OrthAlign’s partner ZimmerBiomet Japan, so too will Direct Anterior HipAlign and UniAlign.

“We are very pleased with the Japanese Ministry’s approval for use of Direct Anterior HipAlign and UniAlign in Japan,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “There were approximately 20,000 supine position THAs and 8,000 UKAs completed in Japan during 2016, and these are the fastest growing procedures in joint replacement in the country. Japan is extremely important for OrthAlign’s international growth strategy and we will continue providing new technologies that address the market’s needs, following the successes of KneeAlign and Posterior Approach HipAlign. We are thrilled to be expanding our partnership with ZimmerBiomet Japan and hope we can continue our contribution in raising the standard of care for Japanese joint replacement surgeries.”

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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