SalutarisMD Presents Data for Promising Device to Treat Wet AMD at ASTRO Annual Meeting
At the American Society of Radiation Oncology (ASTRO) Annual Meeting yesterday, Baldassarre Stea, MD, PhD, Professor and Head, University of Arizona Department of Radiation Oncology and The University of Arizona Cancer Center, presented results from a cohort study evaluating use of a minimally invasive retrobulbar episcleral brachytherapy device developed by Salutaris Medical Devices (SalutarisMD™) to treat Wet AMD (Age-related Macular Degeneration), the leading cause of vision loss and blindness.
Dr. Stea assessed the feasibility and tolerability of the SalutarisMD investigational treatment for Wet AMD using a single dose of episcleral brachytherapy in conjunction with intraocular anti-VEGF injections in a cohort of six subjects. The intervention was a minimally invasive retrobulbar episcleral brachytherapy application (24 Gy as a single fraction) to the subfoveal neovascular membrane using a Sr-90 source. The device cannula was positioned through a sub-Tenon episcleral approach over the globe between the sclera and Tenon's capsule. “This simple and robust method allows for a precise therapeutic application of radiation therapy through the posterior sclera to the neovascular target in the subchoroidal space,” explained Dr. Stea.
The device allows the application of radiation therapy through the posterior sclera, avoiding the need for more invasive vitreous surgery. The investigational device is designed to enable retina specialists to administer therapy using a practical procedure that may be performed in the same clinical setting as current anti-VEGF injections (physician's office or other outpatient facility).
Placement and treatment are easily performed under local anesthesia in approximately 15 minutes. Episcleral placement allows for consistent, stable and repeatable control of the distance to the target tissue without violating the intraocular space. This device is distinguished by its precision, lesion-specific targeting, which enables the retina specialist to deliver precisely localized tissue irradiation, customized for each patient.
Dr. Stea reported that “while not an efficacy study, the clinical course of treated subjects revealed measurable and clinically meaningful improvement in visual acuity.” All six subjects showed improvement in vision and 3 subjects required no additional anti-VEGF injections within the 90-day trial period.
Michael Voevodsky, President and CEO of SalutarisMD, said the theme of the 54th Annual ASTRO Meeting, Advancing Patient Care Through Innovation, was the ideal place to present the results of this study. “Our investigational therapy for treating Wet AMD has the potential to improve outcomes and the quality of life for persons suffering from this debilitating disease. We are excited about the prospect of conducting additional clinical trials to further test our approach."
Caution: Investigational Device. Limited by Federal Law to Investigational Use in the United States.
SalutarisMD™ (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) is a privately held, venture capital funded, clinical-stage medical device company dedicated to developing minimally invasive, patient-centric treatments for vision loss. For more information visit www.SalutarisMD.com.
The American Society of Radiation Oncology (ASTRO) is dedicated to improving patient care through education, clinical practice, advancement of science and advocacy. For more information visit www.astro.org.
Salutaris Medical Devices, Inc.
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