Study Shows CyberKnife® System Provides Long-Lasting Pain Relief for Trigeminal Neuralgia Patients

Sunnyvale, California (ots/PRNewswire) -

CyberKnife Frameless Radiosurgery Offers a Precise and
Non-Invasive Technique with Clinical Outcomes Similar to Gamma
Knife Frame-Based Invasive Radiosurgery

Accuray Incorporated (NASDAQ: ARAY) announced today that data from
a study of 138 patients with trigeminal neuralgia (TN) showed
stereotactic radiosurgery (SRS) delivered with the CyberKnife® System
resulted in rapid and long-lasting pain relief, with minimal side
effects. The study, titled "Image-Guided Robotic Radiosurgery for
Trigeminal Neuralgia," was published in the December 2017 issue of
the peer-reviewed journal Neurosurgery and provides robust clinical
data supporting the efficacy and safety of the system for TN
patients. It is the largest single-center study of TN patients
treated with the CyberKnife technology reported to date.

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"This study is important because it reinforces that CyberKnife SRS
provides unique benefits in the treatment of TN. Pain management
goals were achieved and bothersome complications were rare even
though a less invasive approach to delivering radiation was used,"
said Professor Pantaleo Romanelli, M.D., Centro Diagnostico Italiano,
Milan, Italy. "Importantly, we used a consistent treatment protocol
for each patient that resulted in reproducible outcomes. This should
provide confidence to other clinicians that they, too, can achieve
similar clinical results."

TN is a disease often characterized by severe pain, with some
patients describing it as the most atrocious pain human beings can
suffer. Techniques like CyberKnife SRS may provide new hope for
people living with this severe and challenging-to-treat medical
condition.

Significant Pain Control

- Pain relief was achieved in 93.5 percent of patients after a median
delay of three weeks after treatment
- Stable pain control was maintained by 76 percent of patients three
years after the first treatment. The remainder of the patients
attained pain control after a second treatment

Elimination of Pain Medication

- 78.9 percent of patients were completely pain- and medication-free
within six months after treatment
- 93.5 percent of patients were able to decrease the dose of
medications intended to control pain throughout follow-up and
finally cease pain medication

Manageable Toxicity

- Overall, 18.1 percent of patients developed some sensory
disturbance. Of these patients, 68 percent experienced the onset of
complications after their second treatment; this is a typical side
effect following re-irradiation

"The frameless CyberKnife Robotic Radiosurgery System delivers
radiation beams from multiple unique angles (non-isocentric approach)
with sub-millimeter accuracy. The reproducibility of the delivery
technique resulted in excellent clinical outcomes for the patients
with a non-invasive technique, unlike Gamma Knife. This study
confirms the long lasting effect of one single fraction treatment
delivered with the CyberKnife system," said Fabienne
Hirigoyenberry-Lanson, PhD, Vice President Global Medical and
Scientific Affairs, at Accuray.

Importantly, the CyberKnife® technology's unique image guidance
and automatic beam correction capability enabled the precise dose
targeting necessary to treat TN. No head frame was required to obtain
the pain control and side effect profile achieved with Gamma Knife,
as reported in other studies.[1],[2].

About Trigeminal Neuralgia

Trigeminal neuralgia is a chronic pain disorder affecting the
trigeminal or 5th cranial nerve. The condition requires long-term
medical treatment which usually starts with medications to lessen or
block the pain signals sent to the brain. Over time some patients
stop responding to medications or suffer from unpleasant side
effects. For those patients, injections, surgery, or radiosurgery are
alternative treatments.

About the Study

In this study, 138 patients with TN were treated with the
CyberKnife System. A prescription dose of 60 Gy was delivered in a
single fraction to a 6-mm segment of the nerve. The minimum and
median follow-up was 36 and 52.4 months, respectively. All patients
had taken medications for an average of 4.3 years before treatment
with radiation. The primary study objective was to evaluate the
safety and effectiveness of CyberKnife SRS in TN patients.

Important Safety Information

For Important Safety Information please refer to
http://www.accuray.com/safety-statement.

About Accuray

Accuray Incorporated (Nasdaq: ARAY) is a radiation oncology
company that develops, manufactures and sells precise, innovative
treatment solutions that set the standard of care with the aim of
helping patients live longer, better lives. The company's
leading-edge technologies deliver the full range of radiation therapy
and radiosurgery treatments. For more information, please visit
http://www.accuray.com or follow us on Facebook, LinkedIn, Twitter
and YouTube.

[1] Young B, et al: Long-term outcome of high-dose Gamma Knife
surgery in treatment of trigeminal neuralgia. Journal of
Neurosurgery. Published online April 19, 2013; DOI:
10.3171/2013.1.JNS12875.

[2] Regis J, et al: Long-term safety and efficacy of Gamma Knife
surgery in classical trigeminal neuralgia: a 497-patient historical
cohort study. Journal of Neurosurgery. 124:1079-1087, 2016.

ots Originaltext: Accuray
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+ 33 1 86 21 50 80 charline.lejust@elanedelman.com

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