Regulatory Status

The CTLM is not approved for sale in the USA. To qualify for permission to sell and market, IDSI must obtain United States Food and Drug Administration marketing clearance. A Pre-Market Approval application is required, supported by extensive data, including pre-clinical and clinical trial data, as well as extensive literature to prove the safety and effectiveness of the device.

Under the Food, Drug, and Cosmetic Act, the FDA has 180 days to review a PMA application, however under certain circumstances the FDA may increase that time period through requests for additional information, panel review or clarification of existing information.

The Company plans to remain involved in the PMA supplement process even if we receive PMA approval as the CTLM® technology platform evolves to expand the range of clinical utility. The Company intends to pursue a rigorous clinical program to discover and commercialize the envisioned applications.

The company has received CE Marking, CMDCAS (Canada), Canadian License, UL listing, ISO 9001:2000 ISO 13485:2003 certification, China SFDA and FDA export certification, enabling sales in international markets.