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OrthoSensor Announces One-Year Results, 97% Patient Satisfaction in VERASENSE Multicenter Study

February 20, 2014

Patients with VERASENSE Quantifiably Balanced Knees Continue to Show Significant Improvements in Pain, Function, Activity Level, Satisfaction

DANIA BEACH, FL -- OrthoSensor Inc. announced one-year clinical results from an ongoing prospective multicenter evaluation using the VERASENSE Knee System. The one-year results showed that patients with quantifiably balanced knees scored higher on pain and functional assessments and reported higher overall patient satisfaction compared to patients with non-quantifiably balanced knees.

The one-year results also yielded statistically significant improvements in Activity Level and the Knee Society Score (KSS). Most notably, non-quantifiably balanced patient scores at one year failed to achieve the level of improvement of the quantifiably balanced patient scores at six months.

"Knee replacement is one of the most common surgeries performed in the United States today, yet current literature shows 1 in 5 patients are not happy with the outcome of their new knee," said Kenneth Gustke, a lead investigator in the multicenter evaluation and Orthopaedic Surgeon at Florida Orthopaedic Institute in Tampa, FL. "VERASENSE allows surgeons to quantifiably balance the patient's knee, resulting in a significant increase in patient satisfaction, as well as improvements in all patient-reported pain and functional outcomes. When patients whose knees were balanced with VERASENSE were asked to rate the outcome of their knee replacement procedure, 97% said they were 'satisfied' to 'very satisfied.' This is a marked improvement in patient satisfaction levels, which historically have been reported at 81%, and underscores the value of the VERASENSE Knee System."

Patient satisfaction is becoming increasingly important for surgeons and hospitals, as Center for Medicare & Medicaid Services (CMS) and payor performance initiatives are incentivizing doctors and hospitals for improving the quality of care they provide to their patients. As reimbursement is further aligned to patient satisfaction, incentive payments will be eliminated and physicians who do not satisfactorily report quality data will see their payments from Medicare reduced.

VERASENSE utilizes an intelligent sensor technology during knee surgery that enables evidence-based decisions regarding component positioning, limb alignment and soft-tissue releases. The technology helps surgeons achieve balance and stability through a full range of motion during primary and revision knee surgery.

Jay Pierce, CEO and President of OrthoSensor said, "We are exceptionally pleased by the results shown by the clinical study and what it may mean to enhancing a patient's quality of life after total knee replacement surgery. Clinical research is demonstrating what we intuitively know: patients with balanced knees function at higher levels. This data shows that quantifying a balanced knee may contribute to more favorable biomechanics, decreased pain, improved post-operative function, increased activity levels and higher patient reported satisfaction."

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