Tissue Genesis LLC, and Human Life CORD Japan, Inc., Announce Exclusive Agreement to Advance Adult Stem Cell Therapies in Asia

Human Life CORD Japan, Inc., (HLC) a group company of Nihon Trim (Cord No. 6788, Tokyo Stock Exchange 1st Section) is pleased to announce a strategic agreement with Tissue Genesis, LLC (TG) to distribute its proprietary stem cell processing products in commercial clinics, research institutions, and hospitals in Japan and China. The 10-year agreement marks a major leap forward in advancing the field of regenerative medicine through state-of-the-art point-of-care platform technology, to meet the broad needs of a growing, global healthcare market.

Under the agreement, HLC will hold exclusive rights to license and market Tissue Genesis’ high-performance Icellator machine, a highly efficient, fully automated stem cell isolation system utilizing autologous adipose tissue for human use. The Icellator has already been approved for commercial use in Korea as a Class III medical device by the Korean FDA (KMFDS) and has been used in more than 1,200 commercial applications. The Ukraine and the Bahamas have also given regulatory approval for the Icellator. Clinical trials registered with the FDA using the Icellator are underway for indications including osteoarthritis, diabetic leg pain, amputation site pain, craniofascial trauma, and erectile dysfunction.

Through this unprecedented alliance venture, HLC and TG will work together to obtain the necessary regulatory approvals to maximize the potential benefits of adult stem cells for the patients in Asia. The first targeted indication is breast reconstruction through an on-going clinical research trial at Kansai Medical University in Hirakata, Japan.

“We are very excited to add Icellator into our medical device portfolio. This device can improve patient outcomes and add value in the management of tissue repair,“ said Human Life CORD President Masamitsu Harata. “We hope to take full advantage of an accelerated path to regulatory approval so that use of the Icellator receives reimbursement coverage for Japanese patients given that Icellator has already navigated the regulatory process and launched in multiple countries.”

“At Tissue Genesis, we believe excellence and innovation is a continual process,” said Tissue Genesis CEO Anton Krucky. “Our scientists and engineers are currently working on next generation innovations to match an aggressive product development plan. We believe we can achieve tremendous success as this whole industry begins to grow.”

CEO Dr. Marc Penn of Black Beret Life Sciences (BBLS), which oversees the investment and management of Tissue Genesis, said: “This is an exciting partnership that will foster a robust exchange of scientific research and data. The teams at Tissue Genesis and Human Life Cord will be working together to enhance the outcomes of patients seeking to treat chronic conditions or to improve their wellness and healthy living. Through this valuable collaboration, we can offer the other highly novel technologies within the BBLS portfolio access to the Japanese market.”

The Tissue Genesis Icellator requires no user intervention once in operation, providing simple and efficient processing while simultaneously eliminating the potential for human error. Through a completely sterile single-use processing pathway, it isolates a consistent yield of stromal vascular fraction (SVF), which include multiple types of adult stem cells, from a small sample of adipose tissue in about one hour, using a patented purification process.

Tissue Genesis will provide training on the Icellator machine in both commercial and clinical settings for a range of indications from plastic surgery to orthopedics, heart failure and erectile dysfunction. Other propriety Tissue Genesis products include the Icellator kits and Adipase enzyme blend used to improve cell isolation yields from human adipose tissue.