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FDA clears IsoRay's and GT's cesium-131 based brachytherapy

por John R. Fischer, Senior Reporter | July 18, 2018
Rad Oncology Operating Room Radiation Therapy
IsoRay's cesium-131 seeds (being
formed here) eliminate residual cancer
while limiting exposure to healthy
tissue during operations to
remove tumors
With FDA clearance now in the bag, IsoRay Inc. is prepping for the inclusion of its cesium-131 seed-based brachytherapy option in the launch of GT Medical Technologies Inc.’s GammaTile solution for the treatment of recurrent brain tumors.

Incorporating proprietary cesium-131 seeds within customizable collagen-based carriers, GammaTile Therapy delivers a highly targeted dose of intense radiation to eliminate residual cancer while limiting exposure to surrounding, healthy tissue, with the procedure taking place during the initial operation to remove the tumor.

“The option they’ve had in the past is whole brain irradiation which damages tissues and the brain structure as it goes through it,” Lori Woods, interim CEO of IsoRay, told HCB News. “Having an opportunity to put the operation in place while the surgery is being done so you don’t have to go back and open them up again, that’s effective for the OR time, it’s effective for the doctor, and it’s effective for patient follow-up.”

Compared to historical forms of permanent brachytherapy, the relatively shorter half life of cesium provides a favorable energy distribution that allows for radiation to be administered into the patient in manner that initiates treatment at a distance of a couple of millimeters, ensuring as little impact as possible on healthy tissue.

The procedure allows patients to avoid returning for an external beam of radiation and acts as an alternative for those that do not have full compliance with other treatments or cannot arrange to receive necessary treatment for residual cancer in the appropriate timeframe.

Its effectiveness has also garnered the solution a new, specific ICD-10-PCS code by the Centers for Medicare and Medicaid Services (CMS).

Michael Krachon, VP of sales and marketing for IsoRay, says its inclusion as a new technology add-on program (NTAP) would qualify for additional payments in inpatient hospital settings under Medicare and beyond what is available now. He adds that its use will spare patients as well as providers from hefty costs associated with expensive external radiation devices.

“Alternative treatments are sometimes delivered with multimillion-dollar pieces of capital equipment that facilities or hospitals have to purchase,” he said. “Being able to do this with these direct seeds that don’t have those incremental costs or capital equipment costs is a more cost-effective way to deliver that radiation therapy.”

However, the date of FDA clearance doesn't qualify for the current NTAP application cycle, requiring that GammaTile be re-submitted for consideration under the NTAP program for the fiscal 2020 year, which begins on October 1, 2019.

GT Medical Technologies plans to launch GammaTile in the fourth quarter of 2018.

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