Salutaris Medical Devices, Inc. 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) on May 23, 2018.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.
Salutaris Medical Devices, Inc. (SalutarisMD®) 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 utilizes a minimally invasive single-use brachytherapy procedure that can be performed in an outpatient setting in approximately 15 minutes.
For more information, visit www.salutarismd.com
About neovascular Age-related Macular Degeneration
Neovascular age-related macular degeneration (nAMD), often called wet AMD, 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.
Salutaris Medical Devices, Inc.
4340 N. Campbell Ave., Suite 266
Tucson, AZ 85718