Salutaris Medical Devices

What Salutaris Medical Devices does

Salutaris Medical Devices (SalutarisMD) is a clinical-stage medical device company developing the BetaCurve, a globally-patented, FDA 510(k)-cleared episcleral brachytherapy device that delivers precision beta radiation to treat ophthalmic diseases. The device uses a strontium-90 source to emit beta radiation with limited and predictable penetration, is placed on the outer surface of the eye, curves around to the back of the eye, and is positioned using a fiber optic light source. The procedure is designed as a 10-minute outpatient intervention requiring only one treatment and using a common surgical technique that retina surgeons can perform without additional methodological training.

The company's clinical focus is wet age-related macular degeneration (wet-AMD) and, in particular, polypoidal choroidal vasculopathy (PCV), a subtype that responds poorly to the standard-of-care anti-VEGF injection regimen and that disproportionately affects pigmented populations such as Asians and Blacks. SalutarisMD cites that 20+ million people globally suffer advanced wet-AMD and that roughly half of patients treated with anti-VEGF injections still achieve inadequate results, positioning BetaCurve as a one-time, potentially curative alternative rather than a palliative lifelong injection schedule.

The business model is hardware sales of the BetaCurve device to hospitals and eye clinics via direct enterprise sales, with the website footer openly stating 'Available for partnership' and noting the company is 'Managed by an affiliated LLC.' The company holds 73 utility patents, 13 design patents, and 6 trademarks granted in 50+ countries, has disclosed approximately $7.5M in cumulative equity funding across ten rounds between 2009 and 2018, operates with 1–10 employees from Tucson, Arizona, and has not yet announced a pivotal trial start, commercial launch, or strategic transaction.

Name

Salutaris Medical Devices

Legal name

SalutarisMD

Website

https://salutarismd.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

1–10 employees

Short description

SalutarisMD is a clinical-stage medical device company developing BetaCurve, an FDA 510(k)-cleared episcleral brachytherapy device that delivers a one-time, 10-minute precision beta radiotherapy treatment to wet-AMD and PCV patients who respond poorly to anti-VEGF injections.

Ownership category

akta.pro rank

Product category

Ophthalmic Medical Devices

NAICS

Ophthalmic Goods Manufacturing (339115), Irradiation Apparatus Manufacturing (334517), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845), X-Ray Apparatus & Tubes & Related Irradiation Apparatus (3844)

akta.pro primary industry

Retina & Vitreous Specialists (HLAKAKAE)

akta.pro secondary industries

Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB), Glaucoma Diagnostics & Surgical Devices (Tonometry, Gonioscopy, MIGS, Drainage Implants, Laser Trabeculoplasty) (HLAHAJAI)

Keywords

• Ophthalmology medical devices
• Episcleral brachytherapy devices
• Radiation therapy equipment
• Retinal disease treatment
• Wet-AMD treatment devices

Headquarters

HQ city

Tucson

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Medical device sales: Clinical stage medical device company with FDA 510(k)-cleared BetaCurve device for treating ophthalmic diseases. Revenue likely generated through device sales to hospitals and eye clinics, with a one-time treatment approach rather than recurring injection model.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

SalutarisMD develops and sells the BetaCurve, an FDA 510(k)-cleared episcleral brachytherapy device that delivers precision beta radiotherapy (strontium-90) to treat ophthalmic diseases including wet age-related macular degeneration (wet-AMD) and polypoidal choroidal vasculopathy (PCV). The device curves around the back of the eye and is guided by a fiber optic light source, enabling a 10-minute, one-time outpatient procedure targeting lesions that respond poorly to anti-VEGF injections.

Product overview

SalutarisMD is a clinical-stage medical device company offering a single unified product: the BetaCurve precision radiotherapy delivery platform. The BetaCurve is an FDA 510(k)-cleared medical device that delivers therapeutic beta radiation (strontium-90) to treat ophthalmic diseases, specifically targeting wet age-related macular degeneration (wet-AMD) and polypoidal choroidal vasculopathy (PCV). The device is placed episclerally (on the outer surface of the eye) and curves around to reach the back of the eye, using a fiber optic light source for placement guidance. The procedure is outpatient, takes approximately 10 minutes, requires only one treatment, and uses a common surgical technique that retina surgeons do not require additional training to perform.

Differentiator

Problem solved

Functional benefit

Brands

• BetaCurve: FDA 510(k)-cleared device that curves around the back of the eye to precisely deliver therapeutic beta radiation to diseased areas, using a fiber optic light source for placement guidance. Designed to treat ophthalmic diseases including PCV (polypoidal choroidal vasculopathy) and wet-AMD.

Products and services

• BetaCurve An FDA 510(k)-cleared, globally-patented episcleral brachytherapy device that delivers precision beta radiotherapy (strontium-90) to treat ophthalmic diseases including wet age-related macular degeneration (wet-AMD) and polypoidal choroidal vasculopathy (PCV). The device curves around the back of the eye and is guided by a fiber optic light source, enabling a 10-minute, one-time outpatient procedure for retina surgeons without requiring additional methodological training.

Quantifiable outcome

• 20+ million people affected by advanced age-related macular degeneration (wet-AMD) globally
• +2 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• NeoVista: NeoVista developed the Epi-Rad90, an episcleral brachytherapy device using strontium-90 for wet-AMD, the most direct historical competitor to SalutarisMD's BetaCurve. Both pursued radiation-based approaches to address anti-VEGF resistance in retinal disease.
• Oraya Therapeutics: Oraya developed the IRay system, a stereotactic radiosurgery device delivering low-energy X-ray to treat wet-AMD. Pursued a similar radiation-based strategy for anti-VEGF-resistant AMD, making it a directly comparable peer in mechanism and indication.

Broad incumbents

• Alcon: Alcon is a major ophthalmic medical device and pharmaceutical company with a broad portfolio covering retinal surgery, vision care, and surgical equipment. As a large diversified ophthalmic player, Alcon could be a strategic acquirer of SalutarisMD and competes broadly in the ophthalmic device space.
• Carl Zeiss Meditec: Carl Zeiss Meditec is a leading global ophthalmic device company with surgical ophthalmology and diagnostic imaging products for retina specialists. Its installed base and relationships with retina surgeons make it a relevant comparable in the ophthalmic device channel.
• Topcon Healthcare: Topcon manufactures ophthalmic diagnostic and surgical equipment, including retinal imaging and surgical microscopy used by retina specialists. As a broad ophthalmic device incumbent with retina-focused offerings, Topcon is a relevant comparable for the surgical ophthalmology channel SalutarisMD targets.
• Genentech (Roche): Genentech/Roche markets Lucentis (ranibizumab) and Vabysmo (faricimab), the foundational anti-VEGF therapies for wet-AMD. As the originator of anti-VEGF therapeutics, Roche represents the incumbent standard of care that SalutarisMD must displace with BetaCurve.
• Regeneron Pharmaceuticals: Regeneron manufactures Eylea and Eylea HD, the dominant anti-VEGF therapy for wet-AMD and the standard of care SalutarisMD is positioning BetaCurve against. As the entrenched incumbent in the wet-AMD treatment paradigm, Regeneron represents the primary competitive threat to radiation-based alternatives.

Emerging players

• Kodiak Sciences: Kodiak Sciences is developing novel antibody-based therapies for retinal diseases, including longer-duration anti-VEGF agents. As an emerging AMD therapeutic developer, it represents the next-generation pharmacological competition to SalutarisMD's radiation approach.
• Adverum Biotechnologies: Adverum is developing gene therapies for wet-AMD (e.g., ADVM-022/ixoberogene soroparvovec) as a one-time alternative to anti-VEGF injections. It pursues the same anti-treatment-burden value proposition as SalutarisMD's BetaCurve but via gene therapy rather than radiation.
• Iridex Corporation: Iridex develops laser-based systems for ophthalmology, including transscleral cyclophotocoagulation and retinal laser treatment. While not radiation-based, it serves the same retina specialist customer base and competes for treatment slots in retinal disease management.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/salutaris-medical-devices

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds10 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Salutaris Medical Devices