GT Medical Technologies Announces FDA Clearance of Expanded Indication for GammaTile Therapy

Patients with Newly Diagnosed Malignant Brain Tumors Now Eligible for Surgically Targeted Radiation Therapy

TEMPE, Ariz. — GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for GammaTile® Therapy. Patients with newly diagnosed malignant brain tumors are now eligible to receive the FDA-cleared surgically targeted radiation therapy (STaRT).

“We are pleased to offer GammaTile Therapy to patients who are newly diagnosed with malignant brain tumors, in addition to patients with recurrent brain tumors,” said Matthew Likens, president and CEO of GT Medical Technologies. “This is a significant step forward that expands our ability to improve the lives of patients with brain tumors. Patients receiving GammaTile Therapy immediately after the removal of a brain tumor will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumor cells where treatment is most needed to help prevent recurrence.”

Approximately 700,000 Americans are living with some type of brain tumor each year.1 Despite the efforts of the most skilled brain tumor specialists throughout the world, outcomes for patients with brain tumors have improved very little over the past 30 years. During this time, there have been only four FDA-approved drugs and two FDA-cleared devices available to patients and physicians for the treatment of brain tumors. GammaTile Therapy, which became available to patients with recurrent brain tumors in January 2019, is the most recent treatment cleared or approved by the FDA for the treatment of brain tumors.

GammaTile Therapy is the only radiation therapy specifically designed for use in the brain and offers advantages for patients undergoing surgery for brain tumors. GammaTile begins targeting residual tumor cells immediately at the time of tumor removal surgery, rather than waiting several weeks for surgical wound healing before beginning treatment. GammaTile protects healthy brain tissue while delivering a targeted dose to any remaining tumor cells. The unique design also limits side effects typically associated with radiation therapy, including hair loss. Additionally, the burden of radiation treatment is reduced for patients treated with GammaTile Therapy. These patients receive their course of radiation while going about their daily lives, requiring no additional trips to the hospital or clinic for radiation therapy.

In a clinical study, GammaTile Therapy gave the average patient approximately ten extra months without a local recurrence with extended overall survival.Clark C. Chen, M.D., Ph.D., head of the Department of Neurosurgery at the University of Minnesota Medical School, presented data from his first patients treated with GammaTile at the 2019 Society of Neuro-Oncology (SNO) Annual Meeting. Consistent with data published in a peer-reviewed article, Chen reported that local control was achieved in approximately 90% of patients who underwent gross total resection. This impressive result was achieved without an increase in wound complications or length of hospital stay. “GammaTile Therapy is an important addition to the armamentarium of treatments available against brain cancer,” said Dr. Chen. “It has the potential to improve the quality of life as well as clinical outcome. I am encouraged by the FDA’s decision to expand the indications for this therapy.”

GammaTile Therapy became available to patients in January 2019 and is being used in top cancer treatment centers across the United States. Dr. Vincent DiNapoli, neurosurgeon and director of the Brain Tumor Center at The Jewish Hospital in Cincinnati, Ohio, has been treating patients with GammaTile Therapy since August 2019. “Having been encouraged by the outcomes for recurrent brain tumor patients treated with GammaTile Therapy in my practice, I am excited by the FDA’s decision to expand this technology to the many patients who can benefit from the treatment during their initial diagnosis,” Dr. DiNapoli said. “This could potentially create a more meaningful impact on patient outcomes, treatment compliance, and quality of life.”

About GammaTile Therapy

GammaTile Therapy is an FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) that is designed to delay tumor regrowth for patients with brain tumors. Roughly the size of a postage stamp, GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source, Cesium-131, provided by Isoray, Inc. (NYSE: ISR). GammaTile Therapy is placed at the end of excision surgery to immediately target residual tumor cells while limiting the impact of radiation on healthy brain tissue.

About GT Medical Technologies, Inc.

Driven to overcome the limitations of current treatments for recurrent brain tumors and raise the standard of care, a team of brain tumor specialists joined forces and formed GT Medical Technologies with a purpose to prevent disease progression and improve quality of life for patients with brain tumors. GammaTile Therapy received FDA 510(k) regulatory clearance for the treatment of all types of recurrent brain tumors in July 2018 and has an established CMS code for Medicare reimbursement. Extensive clinical expertise informed the design of GammaTile Therapy, and deep medical device experience guides the company. The company is headquartered in Tempe, Arizona. For more information, visit https://www.gtmedtech.com/ and follow @GTMedTech on Twitter and on LinkedIn.


1 https://www.abta.org/about-brain-tumors/brain-tumor-education/

2 Nakaji P, Youssef E, Dardis C, Smith K, Pinnaduwage D, Brachman D. Surgically targeted radiation therapy: a prospective trial in 79 recurrent, previously irradiated intracranial neoplasms. Poster presented at: 2019 AANS Annual Scientific Meeting; April 2019; San Diego, CA.

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Amy Cramer
Health+Commerce
Amy@healthandcommerce.com
650-391-3714

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