Clinical Background & Rationale

Minor salivary gland biopsy is a cornerstone in the diagnosis of primary and secondary Sjögren’s disease, as well as other systemic conditions such as sarcoidosis and amyloidosis. In patients with Sjögren’s disease, salivary gland biopsy plays an important role not only in establishing the diagnosis, but also in assessing disease activity, treatment response, and risk of lymphoma development. Recent Phase III studies have demonstrated the efficacy of immunomodulatory therapies, further emphasizing the importance of accurate and timely diagnosis. Early diagnosis is therefore critical to prevent long-term organ damage and to enable appropriate therapeutic decision-making.

Minimally Invasive Minor Salivary Gland Biopsy

The Saliclick® lip holder was developed to enable minor salivary gland biopsy to be performed in a minimally invasive, standardized manner. The procedure can be carried out by a single operator, typically in under 10 minutes, and is associated with fewer complications compared to traditional open biopsy techniques. This supports broader clinical adoption and facilitates routine use in outpatient settings.

Clinical Experience

The use of the Saliclick® system has been successfully established in leading academic centers across Europe for more than five years, supporting its feasibility and reliability in routine clinical practice.

Key advantages at a glance

• Standardized positioning of minor salivary glands
• Reduced procedure time
• Designed for routine clinical use
• MDR class I medical device