ITMR unites off-the-shelf Travel Manager (TM) relocation software package developed by Gelco Information Network, GSD, Inc.
ITMR is fully compliant with the CFO Act, Federal Travel Regulations, and Internal Revenue Service (IRS) regulations as they apply to allowable moving expense deductions and other legal requirements.
Clinical results with the company's ITMR and PMR Systems encouraging
Hill continued, "Our modular Pre-Market Approval (PMA) submission of data to the Food and Drug Administration (FDA) on the surgical ITMR System is progressing according to schedule.
received treatment with the ITMR System achieved approximately a two
tolerance in study patients who did not receive the ITMR therapy.
Hill commented, "Preliminary data on approximately 90 'no option' patients from one investigation site participating in our pivotal, prospective randomized trial, presented at a recent medical conference indicate that 70 percent of patients treated with our ITMR
System reported a two class reduction in angina score versus no major change in angina pain class for patients who continue to be treated with only anti-anginal drugs.
The Phase II ITMR
System clinical trial is a multi-center, controlled, prospective, randomized study which is designed to provide the data necessary to establish the safety and efficacy to support a Premarket Approval Application (PMA) for the Company's ITMR
system in "no option" patients.
NOTE: Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risk and uncertainties, including reliance on Boston Scientific Corporation, effect of possible pricing changes, the impact of indirect sales on operating results, the timely availability and acceptance of new products, the impact of competitive products and pricing, approval for and final results of clinical studies, timing of regulatory approvals, potential third-party patent infringement claims, the management of growth and the effectiveness of ITMR
, TTMR and PMR.