ROCKVILLE, Md., March 16, 2018 /PRNewswire/ -- TissueGene, Inc. ("the Company"), a leader in advanced cell and gene therapies targeting osteoarthritis (OA), announced today the completion of the change of its corporate name to "Kolon TissueGene, Inc." The name change signifies the Company's renewed purpose in moving rapidly to regulatory approval of a first-in-class cell and gene therapy for treating OA of the knee, with a global focus on bringing to market medicines addressing serious and debilitating diseases. By adding the name "Kolon," the new corporate identity recognizes the patient but committed support and effort by its parent company and major shareholder, the Kolon Group, since the founding of the Company in 1999.
Founded in 1954, the Kolon Group is a South Korean conglomerate consisting of 40 domestic companies and 26 overseas subsidiaries in a broad range of strategic industries, including chemicals, materials, construction, fashion, and more recently, biotechnology.
"Through its development of innovative biopharmaceuticals, the Company will continue to expand on a global basis the values of the Kolon Group's vision of 'Lifestyle Innovator' through its ongoing research on cutting-edge biopharmaceutical products," said Mr. Woosok Lee, President and CEO of TissueGene. "
The Company has focused its efforts on developing Invossa™, a first-in-class cell and gene therapy drug designed to conveniently and effectively treat osteoarthritis of the knee through a single intra-articular injection. Clinical trials completed in Korea and on-going in the US have demonstrated pain relief, increased mobility, and potentially game-changing improvements in joint structure – offering substantial relief and convenience for osteoarthritis patients who would otherwise be in need of surgery.
Through its national US Phase III clinical trials, the Company will be using the results to seek a DMOAD designation for Invossa™ from the US Food and Drug Administration (FDA), potentially making Invossa™ the first and only cell and gene therapy for osteoarthritis of the knee. In July 2017, Kolon Life Science, Inc., TissueGene's exclusive licensee for Asia, received marketing approval from the South Korea Ministry of Food & Drug Safety (MFDS) for Invossa-K Inj.
Other than the Company name, all other aspects and structures of the Company will remain unchanged.
About TissueGene, Inc.
TissueGene, Inc., is an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting OA of the knee. TissueGene's lead product, Invossa™, is an allogeneic cell and gene therapy. The Company is preparing for Phase III clinical trials in the U.S. under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA). Information about the trials can be found at the National Institutes of Health registry, www.clinicaltrials.gov. For additional information about TissueGene, Inc., please visit www.tissuegene.com.
In November 2017, TissueGene, Inc. successfully completed an offshore initial public offering and was listed on the Korean stock market (KOSDAQ: 950160). TissueGene's securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act") and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons except in certain transactions exempt from the registration requirements of the Securities Act.
The information made available in this press release does not constitute the giving of investment advice or an offer to sell or the solicitation of an offer to buy any security of TissueGene, Inc. (the "Company") in any jurisdiction. The securities of the Company have not been and will not be registered under the United States Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons except in certain transactions exempt from the registration requirements of the Securities Act.
SOURCE TissueGene, Inc.