pp-091 Injection

Indication: Fecal urge incontinence from weakened external anal sphincter, often post-childbirth, causing sudden uncontrollable bowel movements; for patients not controlled by conservative or device therapies. Clinical stage: Multiple Phase I/II trials with long-term data; late-phase study in Japan; EU Phase III in preparation; approvals targeted for Japan, EU, and U.S. Modality: Autologous cell therapy. Mechanism / Target: Local injection of expanded skeletal muscle cells to regenerate sphincter function. Route / form: Local injection into the external anal sphincter. Differentiation: First regenerative therapy targeting the underlying cause of fecal urge incontinence; addresses major unmet need in a population underserved by medications, biofeedback, neuromodulation, or artificial sphincter implantation; supported by extensive multicenter clinical data from 19 clinics across eight European countries with sustained functional improvement demonstrated in early-phase trials.