Attached files
file | filename |
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8-K - Isoray, Inc. | v188853_8-k.htm |
EX-10.59 - Isoray, Inc. | v188853_ex10-59.htm |
FOR
IMMEDIATE RELEASE
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Contact: |
Sharon Schultz
|
Tel:
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(301) 351-0109
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email:
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schultzpr@mchsi.com
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ISORAY
AND HOLOGIC SIGN EXCLUSIVE WORLDWIDE LICENSE FOR
CRUCIAL
BRAIN CANCER TREATMENT DEVICE
FDA-Cleared
GliaSite® Balloon Catheter Is World's Only Device
to
Deliver Liquid Radiation Source Therapy
Richland,
WA (June 23, 2010) - - IsoRay, Inc. (Amex:
ISR) announced today that it has completed a license agreement with Hologic,
Inc. (NASDAQ:HOLX) for exclusive worldwide distribution rights to the GliaSite® radiation
therapy system, the world's only FDA-cleared balloon catheter device used in the
treatment of brain cancer. The system’s
balloon catheter is a landmark technology that allows physicians to treat more
patients than ever before with brachytherapy or
internal radiation and provides important benefits over other radiation
treatment options.
Brain
cancer presents unique treatment challenges. Brain tumors are very often
difficult to remove completely because of the need to avoid damaging the
brain. Further, tumors tend to spread to healthy parts of the brain.
Typically, surgeons remove as much as they can of the tumor and then treat the
areas surrounding where the tumor was removed with radiation therapy. They
sometimes use chemotherapy as well. However, most cancerous brain
tumors reoccur shortly following removal, and the cancer tends to return near
the site of the original tumor. Brain cancer is one of the fastest growing
cancers and recurrence often proves fatal.
The
GliaSite system offers a number of advantages in brain cancer
treatment. It places a specified high dose of a liquid radiation
source in the areas most
likely to contain cancer after brain tumor removal and is less likely to damage
healthy brain tissue. It helps eliminate the ability for the tumor to
reoccur, which in turn impacts patient longevity.
In a
related major development, IsoRay is moving forward with the regulatory approval
process for its new liquid form of Cesium-131, an
exciting advance in brachytherapy for the treatment of brain cancer, that would
be delivered using the GliaSite radiation therapy system.
IsoRay
CEO Dwight Babcock said physicians have voiced strong support for the GliaSite
system and liquid Cesium-131 combination because they recognize the benefits
afforded their patients. "In America alone, more than 200,000 men, women, and
children are diagnosed with brain cancers every year. The GliaSite therapy
system and its use to deliver a liquid radiation source is a versatile,
effective treatment for numerous brain cancers," he said.
Cesium-131 brachytherapy is a patented
internal radiation
therapy that has several
advantages over older radioactive isotopes including faster delivery of a
radiation dose that allows less time and opportunity for the cancer cells to
repopulate and has a soft energy that minimizes radiation exposure for the
operating room and support staff as well as the patient's family
members.
Babcock
said this is another step forward in IsoRay's efforts to advance cancer
treatment. "Progress spells hope for patients and the physicians who
help them. The GliaSite system represents further achievement as we work toward
our goal of expanding brachytherapy solutions throughout the entire body and
improving outcomes for cancer patients," said Babcock.
Previously,
approximately 500 GliaSite cases were performed annually at some 40 hospitals
worldwide. GliaSite therapy has established reimbursement for
both in-patient and out-patient settings.
About
IsoRay
IsoRay,
Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of
Cesium-131 brachytherapy seeds, which are expanding brachytherapy options
throughout the body. Learn more about this innovative Richland,
Washington company and explore the many benefits and uses of Cesium-131 by
visiting www.isoray.com.
GliaSite
is a trademark or registered trademark of Hologic and/or Hologic subsidiaries in
the Unites States and/or other countries.
Safe
Harbor Statement
Statements
in this news release about IsoRay's future expectations, including: the
advantages of our Proxcelan Cesium-131 seed, the advantages of the Gliasite
delivery system, whether a liquid form of Cesium-131 will be developed that
receives regulatory approval and can be used successfully with the Gliasite
delivery system, whether IsoRay will be able to expand its base beyond prostate
cancer, whether IsoRay's Cesium-131 seed will be used to treat additional
cancers and malignant disease, whether the use of Cesium-131 to treat brain or
other cancers will be successful in the initial and any future implants, and all
other statements in this release, other than historical facts, are
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the
express purpose of availing IsoRay, Inc. of the protections of the safe harbor
provisions of the PSLRA. It is important to note that actual results and
ultimate corporate actions could differ materially from those in such
forward-looking statements based on such factors as physician acceptance,
training and use of our products, our ability to successfully manufacture,
market and sell our products, our ability to manufacture our products in
sufficient quantities to meet demand within required delivery time periods while
meeting our quality control standards, our ability to enforce our intellectual
property rights, whether additional studies are released and support the
conclusions of early clinical studies, whether initial implants of Cesium-131 to
treat brain or other cancers result in favorable patient outcomes, whether
resources are available as needed to develop a liquid form of Cesium-131 and
whether such liquid form receives and maintains all required regulatory
approvals, whether any liquid form of Cesium-131 is able to be used successfully
with the Gliasite delivery system, patient results achieved when Cesium-131 is
used for the treatment of cancers and malignant diseases beyond prostate cancer
whether with the Gliasite delivery system or in another delivery system,
successful completion of future research and development activities, and other
risks detailed from time to time in IsoRay's reports filed with the
SEC.