With no FDA on-label treatment for PCV available, SalutarisMD is the first company to seek FDA market approval to treat PCV.
20+ MILLION PEOPLE SUFFER FROM WET-AMD
15+ BILLION IN ANTI-VEGF SALES
UP TO 60% EXPERIENCE INADEQUATE RESULTS
WET AGE-RELATED MACULAR DEGENERATION
THE ESTIMATED NUMBER OF INDIVIDUALS WITH AMD FOR 2020 IS 196+ MILLION
20+ MILLION SUFFER FROM THE ADVANCED FORM OF AMD
WE ESTIMATE THAT UP TO 8+ MILLION ARE RESISTANT TO ANTI-VEGF THERAPY
THE INJECTION INDUSTRY FOR
ANTI-VEGF IS A $15+ BILLION INDUSTRY
THE MARKET LANDSCAPE
Currently, we estimate the majority of afflicted seniors go untreated or under treated.
Of those treated, up to 60% suffer inadequate results due to their subtype, which is often PCV.
SMD plans to address this treatment failure with BetaCurve.
Our upcoming pivotal study will establish efficacy for PCV.
In addition, BetaCurve's one-time, 10-minute procedure may prove to be the only alternative for those who can't afford or access frequent and ongoing injections.
A different approach that changes the outlook
In early 2022, SalutarisMD will commence a pivotal study to receive FDA on-label approval for the indication of PCV, the first of several indications that can be treated with our device.
Disease activity is charaterized by abnormal fluid and blood leakage at the back of the eye from undesirable capillary growth.
The first year requirement is 8-12 anti-VEGF injections and continues indefinitely. Up to 60% suffer inadequate results after the first year and will stop treatment altogether.
The arteriolized vessels are largely unaffected by anti-VEGF. Repeated injections never fully eliminate the root cause.
White people typically suffer from classic wet-AMD that can be treated effectively with ongoing anti-VEGF monotherapy.
HIGH RISK EYES
Asian and Black people are more likely to suffer from the PCV sub-type of wet-AMD that does not respond well to anti-VEGF monotherapy.
BETACURVE GIVES HOPE
The BetaCurve™ is designed to treat all types of patients. The mechanism of action of beta radiation on neovascularization has been studied for over 50-years.