BetaCurve - Model SalutarisMD (SMD) - Clinical Stage Medical Device
SalutarisMD [SMD] is a clinical stage medical device company. SMD's BetaCurve is a globally-patented, 510(k)-cleared device designed to treat various ophthalmic diseases with precision beta radiotherapy, including PCV. The BetaCurve™ curves around the back of the eye to precisely deliver therapeutic beta radiation to the diseased area using a fiber optic light source for placement guidance. The procedure is a outpatient, takes 10-minutes, and requires only one treatment. Utilizing a common technique, retina surgeons do not require additional methodological training.
Cutting Edge Design Features
SAFE TREATMENT
BetaCurve applies the well-established, therapeutic approach of low-dose beta radiation.
MINIMALLY INVASIVE
Our episcleral brachytherapy is an outpatient procedure using twilight anesthesia with minimal discomfort.
ACCURATE DOSIMETRY
The individualized treatment time ensures an accurate dose of beta radiotherapy.
PRECISION TARGETING
The retina surgeon targets the offending lesion with a precision beta radiotherapy delivery platform
A Promising Alternative for Those Patients Who Do Not Respond Well to Anti-VEGF
CURRENT TREATMENT: Anti-VEGF
- Effective against classic wet-AMD, the type that primarily affects lightly pigmented individuals, especially Whites.
- Improvement in vision is palliative due to underlying persistent disease activity
- Requires a lifetime of injections (monthly for recalcitrant subtypes)
- A temporary solution as patients often quit injections as early results fade or they develop drug resistance over time
- Tremendous treatment burden due to needle anxiety, requisite frequent visits and scheduling logistics
NEW PROSPECTIVE TREATMENT: BetaCurve
- Future pivotal trial to show efficacy against PCV, the type that primarily affects pigmented individuals, especially Asians and Blacks
- Designed to reduce or eliminate underlying disease
- One-time treatment may reduce or eliminate injections altogether for all subtypes
- Radiotherapy may prove to be durable and last a lifetime
- Minimally-invasive, one-time procedure
Betacurve Highlights
- Outpatient
- One-time treatment
- 10-minute procedure
- No seed left behind
- Cost-effective
- Accurate dosing
- Precision targeting
- Extraocular
The Location of Disease Activity (Wet-AMD Type) Determines The Effectiveness of the Treatment
- Patients who do not respond well to anti-VEGF treatment typically suffer from occult and minimally classic lesions, located below the retinal pigment epithelium (RPE).
- BetaCurve curves around the back of the eye and precisely delivers therapeutic beta radiation to the diseased area guided by a fiber optic light source.
- Upper layer disease activity above the RPE (classic type) responds well to anti-VEGF injections.
- Lower layer disease activity below the RPE (occult, minimally classic, and PCV) responds poorly to anti-VEGF injections.
The BetaCurve is designed to target the occult and PCV disease from the nearest location with precision delivery.
- Radiation oncologists affirm SMD's choice of strontium-90 (beta radiation) due to its reliable performance.
- Strontium-90 is a stable source of beta radiation.
- Beta radiation is ideally suited to treat diseased tissues due to its limited and predictable penetration.
- BetaCurve is designed to enable a retina surgeon to deliver the appropriate dose of therapeutic radiation at the precise location.
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