TUCSON, AZ. – August 1, 2017 – Salutaris Medical Devices, Inc. today announced the start of a clinical trial investigating the use of its ophthalmic brachytherapy device to treat neovascular Age-related Macular Degeneration (nAMD)
Photo: Source: http://salutarismd.com/
Dr. Reid Schindler, Principal Investigator, and Dr. Leonard Joffe of Retina Specialists of Southern Arizona are currently recruiting subjects. Expertise in medical physics is provided by Dr. Russell Hamilton of the University of Arizona with Dr. Baldassarre Stea as the consulting radiation oncologist.
The trial, “A prospective study of episcleral brachytherapy for the treatment of neovascular age-related macular degeneration”, has the primary objective to determine the safety, including surgeon ease of use and subject tolerability, of the SMD-DA system concomitant with an anti-VEGF treatment regimen.
Further details are posted on www.clinicaltrials.gov (identifier NCT 02988895)
“The goal of this trial is to explore the safety and feasibility of our technology,” remarked Ryan Lohrenz, SalutarisMD® CEO. “Our hope is to present a new option for the growing number of patients suffering from neovascular Age-related Macular Degeneration, many of whom do not respond well to existing treatments.”
About neovascular Age-related Macular Degeneration
Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness in persons age 50 and older in the Western world, afflicting approximately 5 million people. Because older adults represent an increasingly larger percentage of the general population, vision loss associated with nAMD is a growing problem; nAMD has a profoundly negative impact on quality of life and imposes a considerable financial burden on healthcare systems. There is therefore an urgent and compelling need for new therapies that improve visual outcomes and lower the burden of care.
About the Clinical Trial of the SMD-DA ophthalmic device
The subjects in this trial are adults age 50 years or older who have been diagnosed with nAMD and are within the first 18 months of receiving the standard of care administration of intraocular anti-VEGF.
This is designed as a multicenter, prospective, single arm, open-label trial involving 20 subjects. The trial includes a single episcleral brachytherapy treatment and 52 weeks of follow-up.
Subjects will concomitantly receive the standard of care administration of anti-VEGF during the trial.
Further details of the study are posted on www.clinicaltrials.gov (identifier NCT 02988895)
About Salutaris Medical Devices, Inc.
Salutaris Medical Devices, Inc. is a pre-revenue, venture capital funded, clinical-stage medical device company developing a minimally invasive investigational ophthalmic product for neovascular Age-related Macular Degeneration (nAMD). The SalutarisMD® patented technology incorporates a minimally invasive single-use brachytherapy procedure that can be performed in an outpatient setting in approximately 15 minutes. The SalutarisMD® technology is being engineered to deliver improved outcomes for nAMD.
For more information, visit www.SalutarisMD.com
About Retina Specialists of Southern Arizona
Retina Specialists of Southern Arizona is a comprehensive retinal specialty practice that provides retinal evaluation, diagnostic testing, and therapeutic treatments for all retinal diseases and treats patients of all ages.
For more information, visit https://tucsonretinaspecialists.com