Innovacell K.K., a biotech aiming to improve the quality of life (QOL) of patients with fecal/urinary incontinence through the development of innovative cellular therapies, today announced that with investments from SBI Investment Co., Ltd. and MEDIPAL HOLDINGS CORPORATION cumulative funds raised by the Company have topped 11.5 billion JPY. The investments are part of the Company’s ongoing Series C round where it looks to raise a minimum of 2.0 billion JPY.

■Background & Overview

In this round, Innovacell, currently in the final phase of clinical development and IPO preparation, is focused on raising funds from investors with whom mutual strategic benefits can be obtained and to-date has attracted investments totaling over 1.1 billion JPY. Investments include a follow-on investment from Ci:z Investment (a fund headed by one of Japan’s leading medical entrepreneurs) alongside new investments from SBI 4&5 fund of SBI Investment (who positions biotechnology as a key next-generation industry and have a wealth of experience in supporting biotech firms), corporate venture capital fund MEDIPAL Innovation Fund of Medipal Group (a major Japanese wholesaler of prescription pharmaceuticals), and Moroto Capital Management (a company backed by one of Japan’s wealthiest families).

The capital raised during this round will be used to further the Company’s commitment to deliver innovative treatments to patients suffering from incontinence. In particular, funds will cover the clinical development of the Company’s cellular therapy for urge FI (ICEF15), IPO preparatory work, and pre-clinical/clinical development of the Company’s cellular therapy for passive FI (ICEF16).

Innovacell has already successfully completed a European phase IIb study (STEFFI study) for ICEF15 and is currently taking steps to initiate a Phase III validation study (fidelia study) of ICEF15 with the aim of obtaining market authorization following the successful conclusion of the trial.

■Comments from Innovacell K.K. CEO, Ekkehart Steinhuber

Building upon the long-standing work of its Austrian predecessor, Innovacell K.K. is a newly established company that looks to capitalize on the favorable regenerative medicine environment that exists in Japan and to IPO in the country. As such, I am honored by the interest we have garnered thus far from high-quality and strategic Japanese investors.

I would also like to take this opportunity to express my sincere gratitude to the many people/entities who have supported the implementation of the ICEF15 validation study, and to the members of the Innovacell team, in both Japan and Austria, who have worked tirelessly in the pursuit of this goal.

■Comments from Innovacell K.K. COO, Jason David Sieger

As someone who has worked in the regenerative medicine industry in Japan for many years, I am convinced that these investments will serve to advance our desire to be the first to provide minimally invasive and innovative treatments to patients suffering from incontinence.

With their proven track record in ultra-low temperature cold chain logistics for regenerative medicine products and their focus on health promotion, we believe that future collaboration with the Medipal Group will prove to be of great strategic significance to our efforts here in Japan. Furthermore, together with SBI Investment, who have an extensive track record of investment in life science/healthcare/biotechnology fields, we intend to further strengthen our cap table with like-minded investors.

■Comments from ID Pharma (existing shareholder) CEO, Toyotaka Mori

As the contract manufacturer of ICEF15 here in Japan, in addition to being a long-standing shareholder of Innovacell, we are very pleased with the investments from SBI, Medipal and other investors during this round. Manufacturing and distribution are especially important for the successful delivery of regenerative medicine products to patients, and ID Pharma is happy to have the opportunity to work alongside Medipal in support of Innovacell in Japan.

About Fecal Incontinence (FI)

FI is defined as involuntary or uncontrollable loss of feces.1 The indication is a serious social and hygienic problem that can lead to a loss of self-esteem, social isolation, and reduced QOL. It is estimated that there are more than 5 million2 patients with FI in Japan.

Current surgical options are such that there is a long-standing need for a less invasive, safe treatment option preferably with long-lasting efficacy.

1　Japanese Practice Guidelines for Fecal Incontinence (2017)

2　SURGERY Vol. 79 No. 3, pg. 212~219, 2017

About Innovacell K.K.

Innovacell K.K. is a Japanese regenerative medicine biotech established in 2021 as the parent company of a long-standing Austrian cellular therapy venture spun out of the Medical University of Innsbruck.

The Innovacell Group aims to improve people's health and QOL through the commercialization of regenerative therapies for the treatment of various forms of incontinence: fecal incontinence (urge & passive) and stress urinary incontinence.

ICEF15, the Group’s most advanced clinical development program, consists of local administration of a patient’s own myoblasts and aims to cure/treat urge fecal incontinence through muscle regeneration. To date, the Group has successfully completed multiple clinical trials in Europe including two Phase IIb studies: one for ICEF15 and another for ICES13 (a cellular therapy for stress urinary incontinence). A Phase III study for urge FI is currently in preparation.

Website : https://www.innovacell.co.jp

[Media Contact]

Public Relations, Innovacell K.K.

TEL: +81-(0)3–6555–4437

E-mail: PR@innovacell.co.jp