Salutaris Medical Devices, Inc. announces first subject treated in a clinical trial investigating the SMD-DA ophthalmic device for the treatment of neovascular Age-related Macular Degeneration (nAMD)
TUCSON, AZ. – May 23, 2018 – Salutaris Medical Devices, Inc. today announced the first subject was treated in a multi-center clinical trial investigating the use of its ophthalmic brachytherapy device to treat neovascular Age-related Macular Degeneration (nAMD).
Dr. Gregg Kokame, Principal Investigator (PI) at the clinical site in Honolulu successfully performed the first procedure using the SMD-DA device on May 9, 2018. The procedure was performed without complication and well tolerated by the subject.
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 provide improved outcomes to the growing number of patients suffering from neovascular Age-related Macular Degeneration, many of whom do not respond well to existing treatments. There is great potential for real quality of life improvements.”
Retina Consultants of Hawaii’s Dr. Gregg Kokame, Principal Investigator, and Drs. Raymond Wee and James Lai, sub-investigators, are currently recruiting subjects.
In Chicago, Illinois, University Retina’s Dr. Rama Jager, Principal Investigator, is currently recruiting subjects with the first procedure anticipated later this month.