OrthAlign, Inc. Continues Impressive Worldwide Growth in 2016, Including Milestone Achievement 56,000th Joint Arthroplasty Case

Contact: James Young Kim FOR IMMEDIATE RELEASE: January 31, 2017
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OrthAlign, Inc. Continues Impressive Worldwide Growth in 2016, Including Milestone Achievement 56,000th Joint Arthroplasty Case

Aliso Viejo, CA – January 31, 2017 – OrthAlign, Inc., a privately held U.S. based medical device company developing precision technologies for orthopedic surgeons, announced today that it grew sales by approximately 30% in 2016 versus 2015.

Additionally, as of December 31, 2016, OrthAlign technology achieved another major milestone by completing its 56,000th joint replacement case. This milestone reflects the continued rapid adoption of OrthAlign’s precision alignment and positioning technology by surgeons throughout the world.

OrthAlign technology provides a highly accurate handheld computer for surgeons to receive real-time data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasties. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy and simplicity of use.

2016 Key Selected Highlights:

  • OrthAlign’s international business grew by 43% in 2016 versus 2015.
  • OrthAlign Plus® for use in cup placement of direct anterior approach total hip arthroplasties launched in the United States, successfully completing over 500 surgeries. On January 23, 2017, the US FDA 510k cleared the leg length and offset applications for the direct anterior approach. The entire system will be commercially available in the United States Q2 of 2017.
  • OrthAlign Plus for the posterior approach launched in Japan for use in total hip arthroplasty (cup placement, leg length, and joint offset) surgeries.
  • UniAlign® for use in partial knee replacement surgeries received FDA 510k clearance and limited user release commenced. The entire system will be commercially available worldwide as early as Q2 of 2017, based on local regulatory requirements.
  • OrthAlign’s Product Development team grew by over 50% in 2016.
  • OrthAlign announced a multi-country distribution agreement with Smith & Nephew, giving rights for distribution of KneeAlign® technology throughout 21 countries across Asia, India, Africa, the Middle East, Australia, and New Zealand.
  • Eric B. Timko, former President and Chief Executive Officer of Blue Belt Technologies, joined OrthAlign’s Board of Directors.

“OrthAlign’s 2016 sales performance reflects the continued recognition and growth of our unique technology in the global marketplace. In this day and age of bundled payments and the push for lower healthcare costs, the world is seeking a technology that has proven clinical results, is simple for surgeons to use, and is affordable,” said William E. Maya, OrthAlign’s Chief Executive Officer. “OrthAlign addresses each of these requirements and is poised for an even more successful 2017.”

OrthAlign will be showcasing its full portfolio of products, including the recently approved Direct Anterior HipAlign technology at this year’s AAOS meeting in San Diego, CA, March 15-18, 2017 at booth #5615.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical navigation products for precise alignment and positioning. We believe that our technology will raise 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 precision-driven solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit www.orthalign.com.

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