Deployable Closed-Loop Anesthesia System

Award Information
Agency: Department of Defense
Branch: Defense Health Program
Contract: W81XWH-11-C-0078
Agency Tracking Number: O2-1239
Amount: $3,798,658.00
Phase: Phase II
Program: SBIR
Awards Year: 2012
Solicitation Year: 2010
Solicitation Topic Code: OSD10-H05
Solicitation Number: 2010.3
Small Business Information
NeuroWave Systems Inc.
2490 Lee Blvd Suite 300, Suite 300, Cleveland Hts, OH, 44118
DUNS: 607075160
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Stephane Bibian
 VP, Engineering&Clinica
 (216) 472-6338
Business Contact
 Tatjana Zikov
Title: President
Phone: (216) 472-6338
Research Institution
The AutoTIVA system, to be developed under this program, comes as an answer to the Army requirement for a "deployable automated analgesia and anesthesia system". The AutoTIVA device concept is akin to that of an autopilot for anesthesia and sedation, where the administration of both intravenous analgesics and hypnotics are adjusted continuously in real-time, to drive and maintain patients in a pre-defined cortical activity level. This system integrates a clinical-grade 2-channel electroencephalographic device to acquire the patient brainwaves, and our proprietary WAVcns analysis to calculate the level of cortical activity from the acquired signals. The proprietary WAVcns index is used as a feedback quantity to regulate the infusion rates of both analgesics and hypnotics. Drug delivery is ensured via two off-the-shelf syringe infusion pumps directly connected to the AutoTIVA platform. The proposed Phase II program builds on our Phase I results, transitioning from a prototype-level system to a first commercial device deployable at the outset of the program. In addition, further enhancements of the system user interface and control mechanism will be made to address some of the limitations identified in the Phase I, and based on the feedback from our Clinical Advisory Board.

* information listed above is at the time of submission.

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