Kolon TissueGene, Inc. announced that Clinical Hold issued by the FDA has been lifted effective July 5, 2018 and that the company now has FDA Approval to move forward with its clinical trials involving patients diagnosed with knee osteoarthritis (OA). The pivotal phase III trials for US approval of Invossa will enroll close to 1,020 patients at over 50 clinical sites across the United States. In addition to demonstrating significant pain and functional improvements, the company has designed the trials for Invossa™ to achieve a Disease Modifying Osteoarthritis Drug or 'DMOAD' designation. A DMOAD designation would be a unique designation in the armamentarium towards treatment of knee OA. Current OA patients suffer through many years of debilitating pain and reduced quality of life. A single injection of Invossa could lead to more than 2 years of productive and pain free mobility, without the immediate need for surgery, and fill in this significant treatment gap.