North Carolina Federal Advanced Technologies SymposiumMay 9, 2013Medical Technologies ForumHosted by:Office of Senator Richard BurrNC Military Business CenterNC Military FoundationInstitute for Defense & BusinessUniversity of North Carolina SystemReception Sponsor:Bronze Sponsor:
CONFIDENTIALCorey RussMay 9th 2013Combat Medical SystemsNC Advance Technology Symposium
Phases ofTactical Care• Care Under Fire• Tactical Field Care• Tactical Evacuation
Early Lessons• Standardize techniques• Simple devices• Command responsibility• Train-as-you-fight
THANK YOUCombat Medical Systems5845-D Yadkin RoadFayetteville, NC 28303910.426.0003www.combatmedicalsystems.com
• Exclusively devoted to developing nitric oxide-basedtherapies• Founded by Drs. Mark Schoenfisch and Nathan Stasko• Core platform technology licensed from the University ofNorth Carolina at Chapel Hill• Began operations in 2008• Raised ~$20M in equity financing from high-net-worthindividuals• Awarded ~$7.5M in federal contracts and grants from DOD,NIH and NSFNovan, Inc.
Why Nitric Oxide?Your body is making nitric oxide every second of every day.Nitric oxide plays an important role in:• Wound healing• Blood pressure control• Immune functionNitric oxide has antimicrobial activity:• Targets gram positive and gram negative bacteria, fungi, andviruses• Disrupts mature biofilms and kills bacteria embedded inbiofilms• Non-antibiotic strategy; no known mechanisms of drugresistanceNitric oxide is a gas which is difficult to store and deliver
BURN INJURIES DIABETIC FOOT ULCERS~4 million in the US per yearCost of ~$8,000 per episode“Someone, somewhere, loses a legbecause of diabetes every 30 secondsof every day.” (Lancet, 2005)$35.6B cost to UShealthcare system~2.4 million burn injuries peryear in the U.S.650,000 are treated by medicalprofessionals2/3 of patients experiencingmore than 40% TBSA die as aresult of sepsis or othercomplications.
Department of Defense, US Army• Topical Nitric Oxide for the Treatment of Acute Military Wound Infections (SBIRPhases I/II and Option - 2011-2014)• Effects of Topical Nitric Oxide Formulations on Sulfur Mustard and Thermal BurnInjuries (Cooperative Research & Development Agreement - 2010)• Evaluation of Antimicrobial Wound Dressings on Infected and Non-infectedWounds in a Swine (sus scrofa) model, Amendment 5 (Cooperative Research &Development Agreement - 2013)National Institutes of Health• Nitric Oxide-Releasing Wound Dressing for Treating Chronic Wound Infections(SBIR Phases I/II – 2008-2013)• Use of a Nitric Oxide-Loaded Gel to Improve Healing Outcomes of Burn Injuries(SBIR Phase I – 2012-2013)Novan Topical Nitric OxideWound Care Contracts and Grants
Novan Topical Nitric OxideCurrent Status• Clinical trial materials (drug substance and drug product) aremanufactured and packaged at Novan’s facilities under GMP.Drug Substance Drug Product• Intellectual property portfolio includes >50 patents andapplications with worldwide coverage and 15-20 years of patentlife.• IND for a topical wound care ointment to be submitted in 2013 tosupport future clinical studies.
Protease Activity in Normally- and Non- Healing Wounds
One Step Wound TestTMBefore (left) and AfterReaction With Protease
The One Step Wound TestTMis:1. Non-invasive—using a drop of Wound fluidas a diagnostic fluid;2. Inexpensive--less than $0.05 CGS;3. Rapid--< 10 min in total;4. One step--a passive separation;5. Colorimetric--red-to-grey color change;6. Sensitive--detection limit approaching ~15nanogram of a model protease;7. Selective--only gelatinase activity isdetected;8. Instrumental Readout--using an inexpensive$200 turbidimeter;9. Easy to use-- No training needed;10. Room Temperature—where the reactiontakes place; it’s stable at room temperature.11. Quantitative--kinetic analysis providesnanogram resolution for an improvement overa yes/no result