Target Indications

Incontinence is a benign condition, and treatment typically follows a stepwise approach—starting with the least invasive methods and progressing only if necessary. In medical terms, "invasiveness" refers to the intensity of intervention, ranging from non-invasive therapies to complex surgical procedures involving incisions, implanted devices, or medications with potential side effects.

For mild symptoms, conservative treatments such as lifestyle guidance, pelvic floor muscle training, biofeedback, and medication are commonly recommended. However, when these approaches fail to deliver sufficient improvement, surgical options may be considered.

Despite their effectiveness, existing surgical treatments—such as anal sphincteroplasty and sacral nerve stimulation—are highly invasive and often not preferred by patients seeking less disruptive solutions. This underscores the need for innovative therapies that offer meaningful outcomes with minimal intervention.

In other words, there is a exceptional unmet need for less invasive treatment options for patients who do not achieve sufficient results from conservative therapies.

in·con·tin·ence [ɪnˈkɒntɪnən(t)s], noun: the inability to control the leakage of feces or urine, resulting in involuntary or unconscious loss that raises mental, social, and hygiene-related concerns.

Incontinence is a condition that significantly impacts daily life; however, patients visit healthcare facilities relatively infrequently to seek examination or treatment. This phenomenon is sometimes referred to as "Silent Affliction." Factors contributing to this include the benign nature of the condition, patients' feelings of embarrassment that make them reluctant to discuss it with others, and the fact that the potential for symptom improvement through treatment is not widely recognized, not only among patients but also among healthcare professionals.

In Japan alone, it is estimated that there are approximately 5 million patients with fecal incontinence, and more than 11 million people are reported to have urinary incontinence symptoms. For the US and EU these numbers rise to a combined 100 million across all incontinence types. However, many of those suffering from incontinence may not be receiving adequate treatment. As such, there are many patients who could benefit from treatment and yet have not, or do not, seek it out.

All of our cell therapy candidates are treatment methods involving the injection of cells into the affected area – a minimally invasive procedure unlike existing surgical treatments that involve significantly more invasive procedures. Currently, there are no approved surgical treatment options for patients who do not show improvement with conservative therapies that are as minimally invasive as our therapeutic candidates.