OrthAlign, Inc. Announces Milestone in 25,000th KneeAlign® Total Knee Arthroplasty Case

Contact: James Young Kim FOR IMMEDIATE RELEASE: January 26, 2015
OrthAlign, Inc.
Tel: 949-525-9027

OrthAlign, Inc. Announces Milestone in 25,000th KneeAlign® Total Knee Arthroplasty Case
Aliso Viejo, CA – January 26, 2015 – OrthAlign, Inc., a privately held medical device company, today announced that more than 25,000 KneeAlign® Total Knee Arthroplasty (TKA) cases have been successfully completed, worldwide. This milestone reflects the continuing and rapid adoption of OrthAlign’s palm-sized precision alignment technology, by surgeons throughout the world.

KneeAlign provides both tibial and femoral navigation in a simple, palm-sized, single-use device and it is compatible with all implant systems. KneeAlign is highly accurate for overall mechanical, tibial, and femoral component alignment in TKA and compares favorably to large-console Computer Assisted Surgery (CAS) systems.

Dr. Michael Ries (UCSF Medical Center, San Francisco, CA) states, “KneeAlign is the most reliable and straight-forward navigation system I have used. There is no time added to the surgery and I have full confidence in its accuracy.”

In a published clinical 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 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 neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.

French orthopedic surgeon, Dr. André Ferreira (Ancien Interne des Hôpitaux, Lyon, France) states, “KneeAlign is efficient because it provides accurate information about tibial slope and flexion-extension of the femur, which we did not have so accessible before. Varus-Valgus alignment is also beneficial because, previously, we only did valgus estimation of the femur with x-rays. KneeAlign is like CAS, but all of the data and the accuracy are now in the palm of my hand.”

“KneeAlign has helped bring navigation into the reach of many surgeons, providing precision without added complexity. It is an integral part of all my Total Knees,” said Edwin Su, MD (Hospital for Special Surgery, New York, NY). “25,000 cases is a major milestone and a testament to the rapidly increasing value surgeons are placing on the intra-operative precision that KneeAlign provides. KneeAlign is simply one of those technologies that I truly I believe in.”

• Eliminates intraoperative line of sight issues
• Removes the need to ever invade the intramedullary canal
• Avoids use of reference arrays and additional pin sites in the tibia and femur
• Requires no capital investment
• Provides a significantly lower cost per case
• Promotes greater ease of use

“25,000 successful KneeAlign cases is a truly remarkable milestone for OrthAlign. It definitively validates our approach in designing and developing smart, innovative products that enable precise knee alignment for thousands of patients in orthopedic surgery, worldwide,” said James Young Kim, OrthAlign’s Vice President of Marketing. “This milestone also demonstrates KneeAlign’s repeatability and ease of use, as many surgeons, globally, have begun integrating use of KneeAlign into each of their TKAs.”
KneeAlign technology will be showcased at this year’s AAOS Annual Meeting, March 25-27, 2015, in Las Vegas, NV, Booth #5452.

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®, and KNEEALIGN®2 are [registered] trademarks of OrthAlign, Inc.”