Salutaris Medical Devices (SalutarisMD; Tucson, AZ) has developed an investigational ophthalmic treatment for wet age-related macular degeneration (AMD). The SMD-DA episcleral brachytherapy (placement of a therapeutic radioisotope inside or next to the area requiring treatment) applicator system, which can be performed by a retina specialist in an outpatient setting in approximately 15 minutes, delivers localized tissue irradiation via a fiber-optic light source.
The system will be introduced at the Ophthalmology Futures European Forum on September 8, 2016, in Copenhagen, Denmark. In a presentation, SalutarisMD CEO Dr. Laurence Marsteller will discuss how the system is designed to deliver improved dosimetry to wet AMD lesions and ease of use for retinal surgeons. The company will also display the system at its exhibitor booth.
The company recently received FDA approval for an upcoming clinical study utilizing the new-generation system after completing a previous study with a first-generation version. While that study was not intended to be extrapolated for statistical significance, individual subject results were tracked. In three of the four treatment-naive patients and one of the two chronically treated wet AMD patients, best corrected visual acuity (BCVA) improved at two years following SMD-1 treatment (range: 4 to 25 early treatment diabetic retinopathy study [ETDRS] letters). In addition, two treatment-naive patients did not require any further anti-VEGF injections during the following two years.
ISO audits for certification and CE application are underway, and the company expects to receive ISO 13485 certification and the CE Mark on the commercial product by the end of 2016.
For more information, please visit www.salutarismd.com.