SUNNYVALE, Calif., Oct. 26,
2022 /PRNewswire/ -- Accuray Incorporated (NASDAQ:
ARAY) announced today that the Japanese Ministry of Health, Labor
and Welfare (MHLW) has approved reimbursement for the
CyberKnife® System for the treatment of trigeminal
neuralgia (TN). The system provides an important new option for
people living with this chronic pain disorder, described by some
patients as the most excruciating pain human beings can
experience1.
TN affects the trigeminal or 5th cranial nerve which carries
sensation from the face to the brain, triggering pain in the lower
face and jaw, in areas above the eyes or around the nose. One of
the most common causes of TN is compression of the nerve by a blood
vessel, but there are multiple other causes including a tumor
constricting the nerve, surgical injury or stroke. The
unpredictable, intense pain patients experience can make living
with TN challenging and can lead to weight loss, depression and
isolation2.
"Trigeminal neuralgia has the potential to significantly disrupt
patients' daily lives if left untreated or inadequately treated.
That's why the health insurance reimbursement approval for the
CyberKnife System is so important," said Suzanne Winter, president of Accuray. "Our
high-precision system provides a unique radiosurgery treatment
alternative to surgery supported by long-term data. Importantly,
the system's precision makes it possible to deliver radiation
typically in just one out-patient procedure without a fixed frame
secured to the patient's head to prevent movement, as required with
other devices."
People diagnosed with TN require long-term medical care that
usually starts with medication to lessen or block the pain signals
sent to the brain. Over time, the pain control provided by these
drugs diminishes for some patients and others experience unpleasant
side effects. For these patients, injections, surgery, or
radiosurgery may be necessary.
"Although trigeminal neuralgia is a rare disease with an
incidence of about 5 out of 100,000 people, or approximately 5,000
people in Japan, the pain these
people experience is significant and more options are needed that
can improve their care. CyberKnife radiosurgery offers new hope for
people living with this difficult to treat medical condition," said
Hiroshi Onishi, M.D., , Chairman of
the Health Insurance Committee at the Japanese Society for
Radiation Oncology (JASTRO), and Professor and Chairman, Department
of Radiology and Vice-director of School Medicine, University of
Yamanashi. "Until now, Gamma Knife has been the only device
approved to deliver radiosurgery for the treatment of trigeminal
neuralgia. I believe insurance coverage for the CyberKnife System
to treat this condition is great news for patients, as there will
be more opportunities for treatment and better accessibility to
treatment facilities."
The CyberKnife System was initially designed by a neurosurgeon
for neurosurgeons to treat diseases in the head, the skull base and
the spine such as benign and malignant primary tumors, brain
metastases, meningiomas, trigeminal neuralgia, acoustic neuromas
and arteriovenous malformations (AVMs). The platform's unique
robotic technology, non-coplanar beam delivery and
Synchrony® motion adaptation technology enable the
delivery of radiation with sub-millimeter accuracy, meaning minimal
radiation is delivered to the surrounding healthy tissue. Since its
introduction the CyberKnife® System has evolved into a
full-body radiosurgery system that enables consistent delivery of
extremely precise treatments to tumors throughout the body,
including those in the kidney, liver, lung, pancreas, prostate,
bone metastases and oligo metastases.
Important Safety Information
For Important Safety Information, please refer to
https://www.accuray.com/safety-statement.
About Accuray
Accuray is committed to expanding the powerful potential of
radiation therapy to improve as many lives as possible. We invent
unique, market-changing solutions designed to deliver radiation
treatments for even the most complex cases—while making commonly
treatable cases even easier—to meet the full spectrum of patient
needs. We are dedicated to continuous innovation in radiation
therapy for oncology, neuro-radiosurgery, and beyond, as we partner
with clinicians and administrators, empowering them to help
patients get back to their lives, faster. Accuray is headquartered
in Sunnyvale, California, with
facilities worldwide. To learn more, visit www.accuray.com or
follow us on Facebook, LinkedIn, Twitter, and YouTube.
Safe Harbor Statement
Statements made in this press release that are not statements of
historical fact are forward-looking statements and are subject to
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements in this press
release relate, but are not limited, the CyberKnife platform's
potential for the treatment of trigeminal neuralgia, clinical
applications, clinical results, patient experiences and outcomes,
and Accuray Incorporated's leadership position in radiation
oncology innovation and technologies. These forward-looking
statements involve risks and uncertainties. If any of these risks
or uncertainties materialize, or if any of the company's
assumptions prove incorrect, actual results could differ materially
from the results expressed or implied by these forward-looking
statements. These risks and uncertainties include, but are not
limited to, the company's ability to achieve widespread market
acceptance of its products, including new product offerings and
improvements; the company's ability to develop new products or
improve existing products to meet customers' needs; the company's
limited long-term clinical data supporting the safety and efficacy
of its products, including product improvements, for certain users;
and such other risks identified under the heading "Risk Factors" in
the company's Annual Report on Form 10-K, filed with the Securities
and Exchange Commission (the "SEC") on August 17, 2022, and as updated periodically with
the company's other filings with the SEC.
Forward-looking statements speak only as of the date the
statements are made and are based on information available to the
company at the time those statements are made and/or management's
good faith belief as of that time with respect to future events.
The company assumes no obligation to update forward-looking
statements to reflect actual performance or results, changes in
assumptions or changes in other factors affecting forward-looking
information, except to the extent required by applicable securities
laws. Accordingly, investors should not put undue reliance on any
forward-looking statements.
Media Contact
Beth Kaplan
Public Relations Director, Accuray
+1 (408) 789-4426
bkaplan@accuray.com
1
https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Trigeminal-Neuralgia
2
https://www.nhs.uk/conditions/trigeminal-neuralgia/
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