Aliso Viejo, CA – February 18, 2014 – OrthAlign, Inc., a privately held U.S.-based medical device company, today announced that it has entered into an exclusive distribution agreement with Biomet Japan for its Total Knee Arthroplasty (TKA) technology, KneeAlign®.
Additionally, on December 24, 2013, the Japanese Ministry of Health, Labour, and Welfare (JMHLW) approved KneeAlign® for use with Total Knee Arthroplasty (TKA) surgeries in Japan.
KneeAlign® provides both tibial and distal femoral navigation in a simple, palm-sized, single-use device and is compatible with all implants systems. It is highly accurate for overall mechanical, tibial, and femoral component alignment in TKA, comparing favorably to large-console Computer Assisted Surgery (CAS) systems.
In a recent U.S. study by Denis Nam, MD (Washington University, St. Louis, MO), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively). This study was conducted as a randomized control trial, consisting of five different surgeons.
In another U.S. study by Dr. Nam, significant differences favoring the use of KneeAlign vs. CAS were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mechanical alignment of the limb, with 92.5% of patients within 3° of a neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort. There was no statistically significant difference in tibial component alignment, in this study.
“We are very pleased with the Japanese Ministry’s approval for use of KneeAlign in Japan,” said James Young Kim, OrthAlign’s Vice President of Marketing. “There were approximately 70,000 TKAs in Japan during 2013, and this number will likely increase as the population ages, so this is a very important market for us in our international growth strategy. We are thrilled to be partnering with Biomet Japan in providing full access to OrthAlign technology for Japanese surgeons. Ultimately, we hope it helps to raise the standard of care in Japan for TKAs.”
About OrthAlign, Inc.
OrthAlign is a privately held medical device company committed to providing orthopedic surgeons with user-friendly, cost-effective, surgical navigation products for precise alignment. We believe that our technology raises the standard of care in Total Knee and Total Hip Arthroplasty surgeries by making consistent and measurable results accessible to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precise alignment solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit www.orthalign.com.
“ORTHALIGN®, ORTHALIGN PLUS™, KNEEALIGN® are [registered] trademarks of OrthAlign, Inc.”