FDA Clears Accuray's CyberKnife M6 - Analyst Blog
Renowned radiosurgery systems maker,
) recently received the U.S. Food and Drug Administration ("FDA")
510(k) approval for its new Cybernife M6 Series. This innovative
series is capable of treating large, complicated tumors (which
were rendered untreatable earlier), thereby expanding the number
of patients that can benefit from this treatment.
The CyberKnife M6 FIM and FM Systems feature the unique InCise Multileaf Collimator ("MLC"), specially designed for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments. The flexibility of MLC helps deliver precise and accurate radiation dosages from multiple angles in less time, and thus improves the efficacy and treatment outcomes in the field of radiation oncology.
Its special features include a 3D robot which can revolve around the patient in order to deliver non-isocentric, non-coplanar radiations to match the exact shape of the tumor. The InCise MLC's capability is further enhanced when combined with CyberKnife's Synchrony System, which allows the CyberKnife M6 System to locate tumors while moving and instantly rectifying for their movement during treatment.
California-based Accuray is a global leader in the field of radiosurgery and provides non-surgical treatment option for patients diagnosed with cancer. Globally, more than 200,000 people have been treated with the company's technology. Moreover, the acquisition of rival TomoTherapy has bolstered the company's foothold in the radiation oncology space.
We believe that the FDA clearance of the unmatched CyberKnife M6 Series will further strengthen Accuray's presence in the radiation oncolology market. In addition, the launch of the new TomoTherapy H Series, featuring the TomoHDA System, at the 54th Annual American Society for Radiation Oncology (ASTRO) meeting is also slated to contribute to the company's top-line growth.
However, despite improved sales in Japan and the Asia-Pacific region, the CyberKnife product line is currently facing shipment delays in Europe and a soft demand in the American region. The company reported that Cyberknife revenues in fiscal 2012 were lower by $37.6 million (down 27% year over year) than in fiscal 2011.
Accuray remains susceptible to the weak U.S. and European markets, reimbursement uncertainties and faces stiff challenges from competitive product offerings of Varian Medical Systems Inc. ( VAR ) and Integra LifeSciences Holdings Corporation ( IART ). We are currently Neutral on the stock, which carries a short-term Zacks #3 Rank (Hold rating).
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