Acceleration Therapeutics' AT-101 Has Been Reclassified by FDA as Therapeutic Vibrator Requiring 510k Submission.

NORTH BAY VILLAGE, Fla. -- Acceleration Therapeutics Division of Non-Invasive Monitoring Systems, Inc. (OTCBB:NIMU) today announced that the FDA has reclassified the flagship product of the Company, the AT-101 device, from its listed FDA Class 1 (exempt) powered exercise device to a therapeutic vibrator requiring 510(k) submission. The FDA made this determination because the FDA believed that the AT-101 "exceeds the limitations to the exemption in 21 CFR 890.9(a) and (b) because it introduces new indications and new technology for therapeutic vibrators." Accordingly, the Company cannot market the AT-101 device until it has received an allowance letter from FDA. The Company is weighing its options for response to this action and considers this matter of serious concern to its business.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The Statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.