Innovacell (TYO:504A) said it will focus on commercializing its lead regenerative therapy ICEF15 after its listing on the Tokyo Stock Exchange Growth Market, backed by late-stage data and in-house manufacturing, according to a Tuesday filing on the Tokyo Stock Exchange.

ICEF15, an autologous skeletal muscle cell therapy for urge fecal incontinence, is in Phase III trials in Japan and Europe. Phase IIb results showed statistically significant reductions in incontinence episodes versus placebo.

The company estimates about 120,000 eligible patients in Japan, 430,000 in Europe and 320,000 in the U.S. It projects annual market potential of 70 billion yen to 120 billion yen in Japan, 240 billion yen to 420 billion yen in Europe and 180 billion yen to 310 billion yen in the U.S., based on a 10% penetration assumption.

Innovacell plans to position ICEF15 as an alternative to invasive surgical options such as sphincteroplasty and sacral nerve stimulation.

A second program, ICES13 for stress urinary incontinence, has completed Phase IIb trials and is preparing for Phase III, while ICEF16 for passive fecal incontinence remains in early development.