Renowned radiosurgery systems maker,
Accuray Incorporated
(
ARAY
) 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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