Dry mouth (or xerostomia), a condition affecting hundreds of millions individuals, is a chronic and mostly irreversible condition induced, mainly, as a side effect of hundreds of commonly used medications, by radiation therapy for head & neck cancer, and by auto-immune diseases. Dry mouth affects significantly the patient’s quality of life and hampers chewing, swallowing and speaking, causes bad breath and sleep disturbance and exposes the teeth to a high decay rate.
All treatment methods are typically pharmacological and are either ineffective or induce adverse effects or are contra-indicated to a many patients.
Saliwell has developed a non-pharmacological technological solution for the treatment of xerostomia using electro-stimulation of the salivary gland nerves. A device, called SaliPen, is a patented product with an embedded electronic module that is worn for only a few minutes every day.
SaliPen has two flexible arms that are placed in the mouth. The device treats dry mouth by intraoral electro-stimulation of low-intensity that is barely felt by the patient. The electrostimulation is delivered by electrodes located on the tips of the arms to the nerves that control the salivary gland activity, and causes salivary glands to produce more saliva. When more saliva is produced, the dry mouth sensation declines.
A worldwide post marketing Phase IV trial in 14 clinical centers showed significant improvement in oral wetness over an 11 month period, without significant side effects. The company has achieved FDA (USA), CFDA (China), CE (Europe) and TGA (Australia) clearances.