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August 2010

Transforming Critical Care TM. Integrated Medical Systems, Inc. Matthew E. Hanson, Ph.D. Vice President Phone 562-498-1776 ext. 203 Fax 562-597-6423 Email matthewhanson@LSTAT.com. August 2010. Technology: LS-1™. LS-1 “Suitcase Intensive Care Unit” FDA-cleared CE Mark-cleared

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August 2010

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  1. Transforming Critical Care TM Integrated Medical Systems, Inc.Matthew E. Hanson, Ph.D.Vice PresidentPhone 562-498-1776 ext. 203Fax 562-597-6423Email matthewhanson@LSTAT.com August 2010

  2. Technology: LS-1™ • LS-1 “Suitcase Intensive Care Unit” • FDA-cleared • CE Mark-cleared • Airworthiness (pending) • Supplies • Per-Patient Disposable (PPD) packs • Additional batteries • Accessories • Auxiliary infusion pumps • Upgrades • Hardware and Software

  3. Technology: LS-1 Capabilities • Medical • Ventilator • Infusion • One (1) installed low rate pump • Up to four (4) additional low or high rate pumps • Physiological Monitor • SpO2, two temperature, two invasive pressure, one non-invasive pressure, 3/5-lead ECG, EtCO2 • Fluid Warmer • Data • Centralized control and display • Remote control and display (wired or wireless) • Network connectivity • USB port • Greater than 72 hours of continuous data recording from all devices • Utilities • Onboard “hot-swappable” batteries • Accepts off-board sources of power (facility or vehicle, US or EU) • Accepts off-board sources of oxygen (high pressure cylinder/line, or low pressure oxygen concentrator)

  4. Need / Indications: Military Requirements “ En Route Care consists of capabilities for continuing care begun at each echelon while a casualty is moving from echelon to echelon or place-to-place” (Lines 153-156) "Technological advances in attended, compact, self-contained enclosures with embedded diagnostic and interventional therapy features should be aggressively pursued." (line 586-587) As a minimum, alternatives should be included that incrementally increase capabilities (i.e., evolutionary acquisition), especially since medical technologies often advance faster than the time required for fielding a system. (Lines 667-670)

  5. Sustained Vision • LSTAT References In The June 2009 “AMEDD Futures 2039 Final Report”: • "Potential breakthroughs in resuscitative care include full development of the Life Support for Trauma and Transport (LSTAT)…." [Page 54] • "As forecast above, Life Support for Trauma and Transport (LSTAT) systems will be widely utilized." [Page 54] • "Full development of the Life Support for Trauma and Transport (LSTAT) high-tech mobile trauma pods." [Page 60] • Recommendations: "Set shorter term priorities for AMEDD R&D efforts, e.g …accessories for LSTAT system." [Page 60] • Recommendations: "Improve LSTAT so that it is light weight, self-contained, and has an adequate built-in power source." [Page 61] • Among Top Five Listed Major Accomplishments: "Life Support for Trauma and Transport (LSTAT) medical system." [Page 205] • Implications and Recommendations for AMEDD: "Improve LSTAT so that it is light weight, self-contained, and has built-in power source." [Page 205]

  6. Need / Indication:Civilian Status Quo • Critical care patients represent 20% of admissions, and generate 80% of hospital costs, including a substantial amount in capital expenditures • Overarching problems with status quo arrangements for dealing with critical care patients • Dangerous gaps in care reduce safety • Significant inefficiencies increase costs • Military experience is consistent with commercial experience

  7. Key Research • Clinical Studies • Palomar Pomerado Health • Start Fall 2010 • Validation of clinical and economic benefits of LS-1 applied to In-Hospital Transport and continuous care • Major Civilian Trauma Center • Start Fall 2010 • Validation of clinical and economic benefits of LS-1 remote control and continuous care • Applications in Low Resource Environments • Bench Top Studies • Integrated Clinical Environment (MassGen/ CIMIT) - completed • Closed-loop control ventilation (NMRC-SD) - underway • Data system interoperability (Moberg Research) - pending

  8. Connectivity • Port: Universal Serial BusProtocols: USB 1.1, USB2.0, various device classes implemented (e.g., mass storage, wireless, etc.) • Port: LAN Ethernet (RJ-45) TIA/EIA-568BProtocols: IEEE 802.3; 100BaseTX (IEEE 802.3u) , 10BaseT (IEEE 802.3i), TCP/IP, UDP/IP, SSH2, various others • Port: Wireless EthernetProtocols: IEEE 802.11b/g/n, TCP/IP, UDP/IP, SSH2, various others • Port: Auxiliary Port (proprietary)Protocols: proprietary • Company Vision for Interoperability • Standard output adapted to multiple information systems (Cerner, etc)

  9. Key Results • Clearance Status • FDA cleared • CE Mark • Export • Airworthiness (pending) • Market Availability • Ten (10) production units delivered to U.S. Army • Sales to international military medical customers have begun

  10. Key Results • Publications • “Integrated Diagnostic and Treatment Devices for Enroute Critical Care of Patients within Theater”, Palmer, R. RTO-MP-HFM-182, NATO Symposium on "Use of Advanced Technologies and New Procedures in Medical Field Operations“, April 2010, Essen, Germany • “Critical Care on the Go - Military Project Tests Portable Case Containing ICU Equipment”, R-Tech Newsletter, Department of Homeland Security, pp.3-5, Vol 3, Issue 4, April 2010 • “Interoperability through Integration”, MacLaren, R. FDA Workshop on Medical Device Interoperability, January 2010 • “Battlefield Hospitals Re-Envisioned”, Michel, J. Military Medical Technology, p. 7, Vol 13, Issue 8, December 2009 • “Military’s Influence Extends Beyond the Battlefield”, AAMI News, Association for the Advancement of Medical Instrumentation, P. 1, Vol 44, No. 9, October 2009 • “Integrated Medical Systems Puts up the MedEx for Military Testing”, Panaitescu, F., Softpedia, August 2009

  11. Key Results • News Releases • Former Air Force Surgeon General Roudebush Joins Integrated Medical Systems’ Advisory Board, February 2010 • Integrated Medical Systems Receives CE Mark for World's First 'Suitcase' Intensive Care Unit, September 2009 • Former Veterans Affairs Secretary Peake Joins Integrated Medical Systems' Advisory Board, August 2009

  12. LSTAT G6™The Obvious Solution • Initial Capabilities Document for Joint Theater Combat Casualty Care • "Technological advances in attended, compact, self-contained enclosures with embedded diagnostic and interventional therapy features should be aggressively pursued." (line 586-587) • AMEDD Futures 2039 Final Report (June 2009) • "Potential breakthroughs in resuscitative care include full development of the Life Support for Trauma and Transport (LSTAT)…." [Page 54] • Among Top Five Listed Major Accomplishments: "Life Support for Trauma and Transport (LSTAT) medical system." [Page 205] Ground Vehicles Hospital (Fixed or Field / TDA or MTO&E) Air Vehicles (Fixed-Wing/Rotor-Wing) This product is still underdevelopment, is not being offered for sale, and has not yet been cleared for marketing by the U.S. FDA

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