Currently, regenerative medicine has shown a tremendous potential to revolutionize medicine by being able to produce human cells for use in a wide-array of novel and important therapies.
TCA-CT is focused to commercialize the use of proprietary cell products in regenerative medicine, specifically oriented to the treatment of a group of cardiovascular diseases, with special emphasis in the management of patients suffering critical limb ischemia (CLI).
There are an estimated 10 – 12 million people with Peripheral Artery Disease (PAD) in the United States and over 1 million people with CLI. Results obtained, after completion of phase II of clinical trial IND BB-IND 13139, have shown that TCA-CT stem cell product is safe and effective in increasing blood flow in the ischemic legs of CLI and thus to significantly improve quality of life. In addition, the therapeutic effect proved to be sustained (J Thorac Cardiovasc Surg. 2012; 144:377-82). Initiation of phase III studies will represent an outstanding opportunity for investors.
Clinical trial BB-IND 13729 (Infusion of ex vivo expanded stem cells in patients with Amyotrophic Lateral Sclerosis) has been designed by the FDA as an Orphan Drug.
In the US and in Europe it is easier to gain marketing approval for an orphan drug, which in addition has other financial incentives, such as extended exclusivity periods, all intended to encourage the development of a drug which might otherwise lack a sufficient profit motive. Orphan drugs have great commercial potential despite small markets because they can dictate high prices where they are the only drug therapy available.
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