Company Co-Founder and Chief Technology Officer Receives
Distinguished Judith Stitt Best Abstract Award for Data Presented at the
American Brachytherapy Society Annual Meeting
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.
Contacts
Sierra Smith
Health+Commerce
sierra@healthandcommerce.com
408-540-4296