Tissue Genesis' patented, clinical grade cell therapy processing solutions to be licensed and marketed for commercial applications and medical research in Japan and China.
HOUSTON, Nov. 1, 2017 /PRNewswire/ -- 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, cranio-fascial 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.
To learn more about Human Life CORD Japan, Inc., please visit: http://www.humanlifecord.com/
To learn more about Tissue Genesis and its products, please visit http://www.tissuegenesis.com/
ABOUT HUMAN LIFE CORD JAPAN, INC
Human Life CORD, Japan, Inc.'s underlying corporate mission is "Cords of life, leading the future." Founded in early 2017, HLC Japan is a specialty therapeutics company focused on regenerative medicine and regenerative related medical devices addressing underserved medical needs. Led by President Masamitsu Harata, who also serves as Executive VP of Trim Medical Holdings, Inc., Human Life Cord Japan distributes leading-edge regenerative medical products and therapeutics in Japan and Asian markets, providing expertise and support to research institutions, clinics and hospitals.
ABOUT TISSUE GENESIS
Tissue Genesis LLC, (TG) offers best-in-class, clinical grade cell therapy solutions. Its state-of-the-art Icellator® is a high-performance, point-of-care device that efficiently extracts adult stem cells from a small sample of autologous adipose tissue in a fully enclosed and automated process. Manufactured under cGMP to the highest ISO 13485 and FDA standards, the Icellator® requires no human intervention and provides yields of stromal vascular fraction that is sufficiently pure to allow for intravenous infusion in an hour or less. Founded in 2001 and based in Honolulu, Hawaii, TG is part of the Black Beret Life Sciences, LLC portfolio of companies dedicated to accelerating life sciences through novel therapeutics and commercial innovations. Tissue Genesis' Icellator® is approved for use by medical regulatory authorities in South Korea, the Ukraine and the Bahamas, and is working to obtain regulatory approval for its cell therapy products in the USA, with ongoing FDA-cleared trials for multiple indications of chronic disease.
| Media Contact at Human Life CORD: |
Media Contact at Tissue Genesis: |
| Mai Asao – Public Relations |
Erik Borg – Public Relations |
| 81-3-5511-8660 |
(212) 584-7829 |
SOURCE Tissue Genesis LLC
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