Salutaris Medical Devices

Salutaris Medical Devices

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Private Company

Total funding raised: $11.5M

Overview

SalutarisMD is pioneering a novel treatment paradigm for challenging retinal diseases with its BetaCurve device, a 510(k)-cleared platform for episcleral brachytherapy. The company is initially targeting polypoidal choroidal vasculopathy (PCV), a subtype of wet-AMD that responds poorly to standard anti-VEGF injections, with a one-time, 10-minute outpatient procedure. By leveraging precision beta radiation from a stable Strontium-90 source, BetaCurve aims to treat the root cause of the disease, potentially eliminating the need for lifelong, burdensome injections. SalutarisMD represents a compelling opportunity to address a significant unmet medical need in a large, underserved global patient population.

OphthalmologyRetinal Diseases

Technology Platform

BetaCurve™: A patented, minimally invasive episcleral brachytherapy device that curves around the eye to deliver precise, low-dose beta radiation from a Strontium-90 source, guided by a fiber optic light for real-time placement.

Funding History

2
Total raised:$11.5M
Series A$10M
Seed$1.5M

Opportunities

The primary opportunity is addressing the large, underserved global population with anti-VEGF-resistant wet-AMD, particularly PCV, which affects millions, especially in Asia.
A successful one-time therapy could disrupt the multi-billion dollar chronic injection market by offering a durable cure with significant value to patients, providers, and payers.
The platform's potential extends to other ocular diseases, enabling a pipeline in targeted ophthalmic radiotherapy.

Risk Factors

Key risks include clinical trial failure to prove efficacy/safety for PCV, slow adoption by retina surgeons accustomed to injections, challenges in securing reimbursement, and competition from next-generation anti-VEGF therapies.
The use of a radioactive source also adds complexity to manufacturing, supply chain, and regulatory compliance.

Competitive Landscape

BetaCurve's direct competitors are other novel therapies aiming to reduce injection burden in wet-AMD, including longer-acting anti-VEGF drugs (e.g., faricimab, high-dose aflibercept), gene therapies (e.g., RGX-314), and port delivery systems (e.g., Ranibizumab PDS). However, as a device delivering radiation directly to the disease site, BetaCurve is mechanistically unique and is positioned as a curative solution for specific subtypes, rather than just a longer-lasting palliative treatment.