TEMPE, Ariz. & MIAMI--(BUSINESS WIRE)--GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, today announced the presentation of clinical data from a prospective study of GammaTile® Therapy in patients with previously irradiated intracranial neoplasms (brain tumors) at the American Brachytherapy Society (ABS) 2019 Annual Meeting in Miami. These data reinforce the safety profile of GammaTile Therapy, a surgically targeted radiation therapy (STaRT) that is designed to delay tumor regrowth for patients with recurrent intracranial neoplasms (brain tumors).
The company also announced that David Brachman, M.D., co-founder and CTO of GT MedTech, received the prestigious Judith Stitt Best Abstract Award for his abstract Surgically Targeted Radiation Therapy: Safety Profile of Collagen Tile Brachytherapy in 79 Recurrent, Previously Irradiated Intracranial Neoplasms on a Prospective Clinical Trial. Only four abstracts every year – out of hundreds of submissions – are selected by the ABS’s scientific committee for this recognition.
GammaTile is an FDA-cleared therapy for patients with recurrent intracranial neoplasms (brain tumors) including primary (benign or malignant) and metastatic tumors. Placed directly at the site of the tumor cavity during the last few minutes of excision surgery, GammaTile Therapy is a new approach that immediately begins targeting residual tumor cells, before they can replicate. Designed to help protect healthy brain tissue and facilitate rapid, accurate placement during the procedure, the therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source.
The prospective, single-arm study evaluated the safety profile of GammaTile Therapy in combination with tumor resection surgery in 79 recurrent brain tumors of various types, including gliomas, meningiomas, and brain metastases. Results from the study showed that GammaTile Therapy improves local tumor control compared to currently available treatments. The study also showed a low rate of adverse events, with wound infection occurring in 2.5% of tumors and radiation-related brain changes occurring in 8% of treated patients during the follow-up period. These findings suggest that GammaTile Therapy is a viable radiation therapy option for the challenging cohort of patients with recurrent brain tumors.
“These data further support the safety profile and efficacy of GammaTile Therapy for patients with brain tumors,” said Dr. Brachman. “This therapy is designed to meet a significant unmet need for patients who may not be candidates for other forms of radiation therapy, or for whom surgery is not a viable option without effective adjuvant therapy. We are encouraged by these data, which build on our body of evidence supporting the safety and efficacy of this therapy.”
GammaTile Therapy offers advantages over the most common treatment for patients undergoing surgery for recurrent brain tumors: a course of External Beam Radiation Therapy (EBRT), which requires daily treatments for up to six weeks. Some patients may not be candidates for EBRT. Once the disease has returned, many people with recurrent brain tumors have already received levels of radiation therapy that make the risk of additional external beam radiation outweigh the potential benefits. Additionally, those patients who are potentially candidates for EBRT typically have to wait two weeks or more for surgical wound healing before beginning treatment, giving any residual tumor cells a chance to replicate.
Initial data from this study were published this year in the Journal of Neurosurgery (JNS) demonstrating that GammaTile therapy is a safe and effective new option proven to delay tumor progression in patients with previously treated, aggressive meningiomas, the most common type of primary brain tumor. Additional data from this study supporting the safety and efficacy of GammaTile Therapy for various tumor types were presented in April at the American Association of Neurological Surgeons Annual Meeting, affirming that this therapy could help expand options for brain tumors that are challenging to treat.
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. Featuring a bioresorbable, conformable, 3D-collagen tile and uniform radiation source, GammaTile Therapy is placed at the end of excision surgery so that it immediately begins to target residual tumor cells while limiting the impact of radiation on healthy brain tissue. Because the therapy is implanted at the end of surgery, patients treated with GammaTile Therapy require no additional trips to the hospital or clinic for radiation therapy.
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 recurrent 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.