Exactech Gets FDA Nod for Optetrak Logic CC Prosthesis

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Producer of bone and joint restoration products, Exactech Inc. EXAC recently received FDA clearance to market its Optetrak Logic Constrained Condylar (CC) Prosthesis. The system has been approved for revision knee arthroplasty cases.

Notably, Exactech has a clinically recognized knee system that offers advanced approaches to knee replacement. The FDA clearance of Optetrak Logic CC further expands the Exactech Knee system offerings for surgeons who desire predictable and reproducible outcomes.

The recently cleared Optetrak Logic CC is a surgeon-focused, patient-driven innovation, which offers a modern solution for reproducibility in the most complex and challenging knee arthroplasty cases. It is an advanced implant system with precision tools to consistently achieve optimized implant placement and bone coverage.

Optetrak Logic CC is indicated for use in patients undergoing total knee replacement surgery due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. The device is also indicated for use when previous devices have failed.

We believe that this new addition to Exactech’s clinically recognized knee system will help knee surgeons treat complex revision knee anthroplasty cases. It will offer additional options to surgeons to treat patients with revision total knee surgery including challenges like significant bone loss.

The Optetrak Logic CC system will have limited availability in 2015, ramping up to a full market launch in 2016. We feel that this will give a significant boost to top-line growth across the company’s knee implant segment, which continues to be impacted by unfavorable foreign exchange rates.

However, management expects the currency fluctuations to continue affecting the company’s results over the next couple of quarters. Moreover, pricing pressure remains a serious concern in the near term.

Stocks to Consider

Currently, Exactech carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the medical instruments industry include Cepheid CPHD, Masimo Corp. MASI and LDR Holding Corp. LDRH. While both Cepheid and Masimo sport a Zacks Rank #1 (Strong Buy), LDR Holding carries a Zacks Rank #2 (Buy).

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