As Seen In The Wall Street Journal

SalutarisMD Presents Data for Wet AMD Treatment with Long Term Positive Outcomes at ARVO

May 8, 2013

At the Association for Research in Vision and Ophthalmology, Inc. (ARVO) Annual Meeting yesterday, Kamaljit Balaggan, BSc (Hons), MBBS, MRCOphth, PhD, Vitreoretinal Surgery Fellow at Moorfields Eye Hospital National Health Service (NHS) Foundation Trust in London, presented results from a cohort study evaluating the use of a minimally invasive retrobulbar episcleral brachytherapy device developed by Salutaris Medical Devices (SalutarisMD™) to treat Wet AMD (Age-related Macular Degeneration), the leading cause of vision loss and blindness.

Dr. Balaggan reported the feasibility and tolerability of the SalutarisMD investigational treatment for Wet AMD using a single dose of episcleral brachytherapy in conjunction with intraocular anti-VEGF injections. The 6- subject study produced encouraging results. At 3 months, all patients experienced increases in BCVA (best-corrected visual acuity, mean + ETDRS letters). At 12 months, 2 subjects required no further anti-VEGF injections during follow-up and 3 continued to demonstrate improved or stabilized BCVA (mean +7 letters). Dr. Balaggan observed, “At 12 months all patients demonstrated reduced macular thickness compared with baseline while three patients demonstrated improvement in BCVA.”

“Further, the procedure was readily performed and was well-tolerated with no serious adverse effects. The device allows patient specific targeting of the application of radiation through the posterior sclera. This placement allows for consistent, stable and repeatable control of the distance to the target tissue without violating the intraocular space,” explained Balaggan. This device is distinguished by its precision and lesion-specific targeting, which enable the retina specialist to deliver precisely localized tissue irradiation, customized for each patient.

The SalutarisMD device is designed to enable retina specialists to administer therapy in the same clinical environment (the physician’s office or other outpatient facility) currently used to administer anti-VEGF injections. Placement and treatment are straightforward and performed under local anesthesia in approximately 15 minutes. In this study, 6 patients received 24Gy radiation over 5.5 minutes directly to the macular CNV by positioning the SMD-1 brachytherapy probe adjacent to the macular sclera via a subtenon retrobulbar approach. The probe was then removed. Patients also received concomitant anti-VEGF injections with re-administration as needed. Adverse effects and changes in BCVA and macular thickness were evaluated monthly.

These long term outcomes utilizing SalutarisMD technology show promise for the treatment of Wet AMD. Michael Voevodsky, President and CEO of SalutarisMD said, “We are pleased to present this research at ARVO, the largest eye and vision research organization in the world, whose 2013 theme is Life Changing Research. Our goal is that the SalutarisMD technology will ultimately change the lives of those suffering from this debilitating disease.”

Caution: Investigational Device. Limited by Federal Law to Investigational Use in the United States.

About SalutarisMD
SalutarisMD™ (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) is a privately held, venture capital funded, clinical-stage medical device company dedicated to developing minimally invasive, patient-centric treatments for vision loss. For more information visit www.SalutarisMD.com or www.SalutarisMD.co.uk.

About ARVO
The Association for Research in Vision and Ophthalmology (ARVO) is the largest eye and vision research organization in the world. ARVO encourages and assists research, training, publication and knowledge sharing in vision and ophthalmology. For more information visit www.arvo.org.

Salutaris Medical Devices, Inc.
4330 N. Campbell Ave.
Tucson, AZ 85718
520-638-7518
SalutarisMD.com

Salutaris Medical Devices, Ltd.
Suite B212, Bessemer Building
Imperial College London SW72AZ
+44 (0)203 282 7166
SalutarisMD.co.uk

Contact:
Joanne Vitali, US Communications Director
610-518-5405
jvitali@salutarismd.com

Amanda Thomas, UK Communications Director
+44 (0) 1582 623660/
+44 (0) 7746 708500 mobile
amanda@ajthomas.com