Tuesday, May 01, 2012 9:27:34 AM
Approach to Market Entry
We have delayed the hiring of key staff positions and making certain preparations for market entry prior to FDA approval of the ProUroScan System in order to conserve cash during the prolonged FDA review period. Once we have obtained FDA approval and sufficient funding (see “Management’ Discussion and Analysis”), we plan to take the following actions over the next few months in advance of our product rollout.
· Hire the key staff needed to execute our commercialization plans. We have identified outstanding candidates in the marketing, operations, engineering, and medical reimbursement fields.
· Install ProUroScan Systems in the facilities of approximately six members of our Scientific Advisory Board to begin formal training in the use of the system, and to perform studies. We expect the work done by these respected scientists to provide the important market validation of key opinion leaders that will help facilitate market acceptance.
· Establish the internal quality control systems and capabilities required to enter the highly regulated U.S. medical device market.
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM