Multi-Institutional Study Data Presented at ASTRO 2023 Builds Upon Growing Evidence of GammaTile for Patients with Brain Tumors

October 3, 2023 — Medical device company GT Medical Technologies, Inc. announced interim findings of a multi-institutional study that demonstrates high local control for the treatment of recurrent brain metastases in patients. The findings add to the growing evidence of the efficacy and safety of its FDA-approved GammaTile Therapy, and were presented during an Oct. 2 poster presentation at the American Society for Radiation Oncology’s (ASTRO) 65th Annual Meeting, ASTRO 2023, being held this week in San Diego, CA.

“Surgically Targeted Radiation Therapy (STaRT) for Brain Metastases: Initial Experience from a Prospective Multi-institutional Registry” was presented by study author David Brachman, MD, Co-founder and Chief Technology Officer at GT Medical Technologies.

A statement published on the presentation of data reported that, at this interim timepoint, 48 patients with 51 brain metastases at 14 U.S. sites were treated with GammaTile, a treatment that provides immediate radiation where it is needed most after brain tumor removal surgery. None of the patients experienced adverse effects from the radiation treatment in follow-ups, which had a median time of four months post-surgery. GammaTile is a Surgically Targeted Radiation Therapy (STaRT) for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms, including primary (benign or malignant) and metastatic tumors.

“We could not have achieved these interim clinical results without the support of the doctors and patients who were part of this registry study from across the nation,” said Brachman. “This robust emerging scientific data reinforces the impact GammaTile Therapy has on local control for patients with brain metastases. It builds upon an already strong body of evidence that shows just how effective and safe GammaTile is for patients with brain tumors.”

“As an enrolling institution in the GTM-101 registry, we are excited by these initial  interim results demonstrating the feasibility of GammaTile brachytherapy for patients with brain metastases – with a median implantation time of 3 minutes – and no patients experiencing any radiation-attributed adverse effects,” said Rupesh Kotecha, MD, lead study author and Chief of Radiosurgery for the Department of Radiation Oncology at Miami Cancer Institute, Baptist Health South Florida, Miami, FL.

In addition to the poster presented at the ASTRO Annual Meeting, according to the GT Medical Technologies statement, three recently published clinical studies from Memorial Sloan Cancer Center, Barrow Neurological Institute and Miami Cancer Institute further demonstrated that GammaTile leads to durable local control for the treatment of recurrent brain metastases.

Among these three publications, it further noted, Miami Cancer Institute’s findings were recently published in Brachytherapy on September 16, 2023. The results showed that GammaTile for operable recurrent brain metastases was associated with superior local control compared to the first course of external beam radiotherapy in the series. Study authors found the initial clinical experience demonstrated that GammaTile is associated with a high local control rate, modest surgical complication rate, and low radiation necrosis risk in the reirradiation setting.

Since its initial FDA clearance in 2018 for recurrent brain tumors and subsequent FDA clearance in 2020 for newly diagnosed brain tumors, GammaTile Therapy has helped more than 1,000 people with operable brain tumors, reported the company in the statement released during ASTRO 2023.

FDA-cleared GammaTile Therapy is a Surgically Targeted Radiation Therapy (STaRT) for patients undergoing brain tumor removal surgery of newly diagnosed malignant and recurrent brain tumors, reports the company, adding: This “one-and-done” treatment eliminates the need for one to six weeks of daily external beam radiation therapy, allowing patients to go about their daily lives without the burden of additional trips to the hospital or clinic for ongoing treatment. The latest interim findings announcement also noted that since its full market release in the United States in March 2020, GammaTile has been offered in more than 95 hospitals, with more centers being added each month. A Tempe, AZ-based med tech company, GT Medical Technologies, Inc., was founded by a team of brain tumor specialists.

The incidence of brain metastasis is increasing with an estimated 98,000 to 170,000 cases each year.  The company noted this is likely increasing as a result of patients with systemic metastatic disease are surviving longer as a result of new innovations like immunotherapy.1

More information: www.gtmedtech.com 

Reference:

1Mark J. Amsbaugh; Catherine S. Kim (2023). Brain Metastasis. NIH, National Library of Medicine. mAccessed on September 25, 2023: https://www.ncbi.nlm.nih.gov/books/NBK470246/#:~:text=In%20the%20United%20States%2C%20an,a%20result%20of%20several%20factors