Raynaud’s Syndrome: A Major Unmet Need in Vascular Health

Clinical Overview

Raynaud’s Syndrome (RS) is a chronic vascular condition marked by recurring vasospastic attacks, primarily affecting the small arteries in the fingers and toes. These attacks lead to temporary ischemia followed by reperfusion, resulting in pain, numbness, and distinctive color changes—white, blue, and red—often triggered by cold exposure or emotional stress. The condition can also affect other extremities such as the nose and ears.

First described in 1862 by Maurice Raynaud, the syndrome continues to affect millions worldwide, significantly impacting quality of life for those affected.

Two Forms of Raynaud’s Syndrome

Primary Raynaud’s Syndrome

is the most common form, typically occurring in otherwise healthy young individuals, particularly women. In the Netherlands, the estimated prevalence is around 10% of the general population. Although not life-threatening, the condition can severely restrict daily activities and social comfort.

Secondary Raynaud’s Syndrome

occurs in association with underlying diseases, particularly autoimmune conditions like systemic sclerosis. These patients often experience more severe symptoms, including digital ulceration, progressive tissue damage, and increased risk of organ failure—substantially lowering life expectancy.

Limited Treatment Options

Despite its prevalence, no EMA or FDA-approved drug currently exists to treat Raynaud’s Syndrome. Current therapeutic options are symptomatic and off-label:

  • Calcium channel blockers (e.g., nifedipine, amlodipine) are commonly prescribed but are only modestly effective and poorly tolerated in up to 50% of patients.
  • Intravenous prostaglandin agonists such as iloprost are sometimes used but are invasive, costly, and impractical for long-term care.

Furthermore, recent shortages of generic calcium channel blockers further highlight the fragile nature of current therapeutic strategies.

This is a thermal camera photo of a patient with Raynaud’s phenomenon. The hand was briefly cooled with water at 15 degrees Celsius (59°F). This causes the small blood vessels in the fingers to go into spasm. In this patient, the blood vessels are extra sensitive to cold. The index finger reacts most strongly to the cold. You can see this in the picture because this finger stays cold (darker color) much longer while the hand warms up again. The fourth finger (ring finger) appears very yellow, indicating it has no vasospasm and good blood flow. The difference in color between the fingers is caused by these spasms in the small arteries of the fingers.

Treatment with STS aims to reduce these blood vessel spasms so that the fingers warm up faster and symptoms improve. This is currently being researched.

A Growing Market with High Unmet Demand

The unmet medical need, coupled with growing awareness of vascular health, creates a significant opportunity:

  • RS affects approximately 5% of the European and North American population, equivalent to over 55 million people.
  • Most affected individuals currently receive no effective treatment.
  • A safe and effective oral therapy would represent a major breakthrough, both clinically and commercially.

At TS Vascular, we estimate the total addressable market (TAM) for a successful oral STS treatment for Raynaud’s Syndrome at approximately €9.5 billion. Our serviceable addressable market (SAM), reflecting those currently seeking treatment, is estimated at €2.3 billion. With the right strategic partner, we believe a serviceable obtainable market (SOM) of over €500 million in Europe and North America is realistically achievable.

Untapped Competitive Landscape

Raynaud’s Syndrome remains largely untapped by major pharmaceutical players:

  • No oral therapies have yet demonstrated robust clinical efficacy in trials.
  • Only a small number of biotech companies are actively developing treatments—most focusing on secondary Raynaud’s associated with systemic sclerosis.

This creates a strong first-mover advantage for TS Vascular and its patented oral STS tablet, which uniquely enables slow-release delivery of sodium thiosulphate for chronic usev—vsomething previously unattainable due to formulation limitations.

The Opportunity Ahead

We believe the successful development of an effective, well-tolerated oral treatment for Raynaud’s Syndrome will not only transform patient care but also unlock a significant new market within the cardiovascular and vasospastic disease space. Our approach is simple, scalable, and backed by robust pharmaceutical technology.

With our Early Development Plan already in motion, TS Vascular is positioned to lead the way in solving one of vascular medicine’s most persistent and underserved conditions.

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