Dosimetry data from SalutarisMD episcleral brachytherapy device clinical study on wet AMD

At the American Association of Physicists in Medicine (AAPM) Annual Meeting yesterday, Russell J. Hamilton, PhD, Professor and Physics Section Head, University of Arizona Department of Radiation Oncology, reviewed dosimetry data for a minimally invasive episcleral brachytherapy device developed by Salutaris Medical Devices, Inc. (SalutarisMD™) to treat Wet AMD (Age-related Macular Degeneration), the leading cause of vision loss and blindness.  

Dr. Hamilton described dose rate data for the Sr-90/Y-90 source used in the SalutarisMD investigational medical device, which permits accurate delivery of a therapeutic radiation dose for the treatment of Wet AMD. Dr. Hamilton explained the potential advantages: "The device provides a simple and robust way to reliably deliver a therapeutic dose of radiation to treat Wet AMD with very low complication risk. Furthermore, the procedure may be expeditiously performed in an office-based setting."

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 the present standard of care (a physician's office or other outpatient facility) and potentially reduces the need for anti-VEGF injections.

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. Utilizing this minimally invasive technology, the retina specialist delivers an accurate dose of radiation through the sclera to the neovascular target in the subchoroidal 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.

Michael Voevodsky, President and CEO of SalutarisMD, said, "We are pleased that we were selected to present our technology in this forum. Our investigational therapy and its effective use of radiation for treating Wet AMD have the potential to improve 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."