OrthAlign, Inc. Announces Multi-Country Distribution Agreement with Smith & Nephew, for Award-Winning KneeAlign® Total Knee Arthroplasty Technology
OrthAlign, Inc., a privately held U.S.-based medical device company, announced today that it has entered into a multi-country distribution agreement with Smith & Nephew, for its award-winning Total Knee Arthroplasty (TKA) technology, KneeAlign®.
Under this agreement, Smith & Nephew has rights to distribute KneeAlign technology as part of its portfolio of products in 21 countries across Asia, Africa, Middle East, Australia and New Zealand.
KneeAlign provides both tibial and distal femoral precision alignment in a simple, palm-sized, single-use device, providing real-time data. It is highly accurate for overall mechanical, tibial, and femoral component alignment in TKA, providing an alternative to conventional large unit Computer Assisted Surgery (CAS) systems, or instrumented methods used with an intramedullary rod. To date, KneeAlign has successfully been used in approximately 40,000 TKA cases throughout the world.
“From the region of the globe where the volume of knee replacement is growing rapidly, OrthAlign adds a critical enabling technology to complement Smith & Nephew’s industry leading knee brands such as JOURNEY II◊, LEGION◊ AND GENESIS◊ II” said David Cook, Director of Knee Reconstruction APAC and Emerging Markets at Smith & Nephew. “We believe this partnership will allow Smith & Nephew to provide further benefits to both healthcare professionals and the patients they serve in this evolving and dynamic geography.”
In a published TKA clinical study by Denis Nam, M.D. (Washington University, St. Louis, MO), significant differences favoring the use of KneeAlign vs. conventional Computer Assisted Surgery 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 mean 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.
In another study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), 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).
“We are extremely pleased to partner with Smith & Nephew in further making available our award-winning KneeAlign technology to surgeons and patients throughout Asia, Africa, Middle East, Australia and New Zealand” said James Kim, OrthAlign’s Global Vice President of Sales and Marketing. “There were approximately 380,000 TKAs in these regions during 2015 and this number will continue increasing at a rapid rate as TKA surgery becomes more of an option for patients in these markets. We recognize Smith & Nephew’s strength in providing cutting-edge products and paving the way for new technologies, like KneeAlign, in these markets, so we have no doubt that our partnership will be successful. As always, our ultimate hope is that OrthAlign technology helps to raise the standard of care for TKAs in these new markets.”