North Carolina Federal Advanced Technologies SymposiumMay 9, 2013Medical Technologies ForumHosted by:Office of Senator Ric...
CONFIDENTIAL
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 ...
Why Nitric Oxide?Your body is making nitric oxide every second of every day.Nitric oxide plays an important role in:• Woun...
BURN INJURIES DIABETIC FOOT ULCERS~4 million in the US per yearCost of ~$8,000 per episode“Someone, somewhere, loses a leg...
Department of Defense, US Army• Topical Nitric Oxide for the Treatment of Acute Military Wound Infections (SBIRPhases I/II...
Novan Topical Nitric OxideCurrent Status• Clinical trial materials (drug substance and drug product) aremanufactured and p...
- CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.OVERVIEW OF ADHEZION BIOMEDICALPage  13ADHEZION BIOM...
- CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.14WHAT IS CYANOACRYLATE?Page  14• Today’s commercial...
- CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.Page  15WOUND CLOSURE OVERVIEWWound Closure OptionsS...
- CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.SURGISEAL® TOPICAL SKIN ADHESIVE: KEY ATTRIBUTESPage ...
- CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.SURGISEAL® TOPICAL SKIN ADHESIVE: KEY ATTRIBUTESPage ...
One Step Wound TestTM
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....
Medical Technologies
Medical Technologies
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Medical Technologies

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Medical Technologies

  1. 1. 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:
  2. 2. CONFIDENTIAL
  3. 3. CONFIDENTIALCorey RussMay 9th 2013Combat Medical SystemsNC Advance Technology Symposium
  4. 4. Phases ofTactical Care• Care Under Fire• Tactical Field Care• Tactical Evacuation
  5. 5. Early Lessons• Standardize techniques• Simple devices• Command responsibility• Train-as-you-fight
  6. 6. THANK YOUCombat Medical Systems5845-D Yadkin RoadFayetteville, NC 28303910.426.0003www.combatmedicalsystems.com
  7. 7. • 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.
  8. 8. 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
  9. 9. 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.
  10. 10. 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
  11. 11. 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.
  12. 12. - CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.OVERVIEW OF ADHEZION BIOMEDICALPage  13ADHEZION BIOMEDICAL BRINGS INNOVATION TO CYANOACRYLATE-BASED MEDICAL DEVICESAdhezion Biomedical, LLC is a privately held medical devicecompany focused on the development, manufacturing andcommercialization of highly differentiated and proprietarycyanoacrylate-based surgical, wound management andinfection prevention products.Surgical SolutionsImprove clinicaloutcomes in the surgicalspecialties with anemphasis on the O.R.and E.R. settings.Infection PreventionReduce or eliminate theincidence of HealthcareAssociated Infections(HCAIs).
  13. 13. - CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.14WHAT IS CYANOACRYLATE?Page  14• Today’s commercially available cyanoacrylate tissue adhesives can be segmented into two distinct product categoriesbased on the product’s chemical structure.Practical comparison of 2-octyl cyanoacrylate (OCA) and n-butyl cyanoacrylate (BCA) FormulationsProperty OCA(SURGISEAL, Dermabond, Derma+Flex QS)BCA(Histoacryl, Indermil, LiquiBand, GluStitch)Chemical CompositionFilm Flexibility Higher ModerateWound-Breaking Strength1,2 Stronger StrongHeat released Less MoreSetting time Short (minimizes clogging) ShorterWater Resistance Patient may shower immediately Patient may not shower for 24-48 hours3Incision LengthClinically proven to close longincisions4Clinically proven to close up to 4-5 cm3,5Microbial Protection CoverageAreaGreater ModerateBO8-carbon side chain 4-carbon side chain[1] Perry LC. An evaluation of acute incisional strength with traumaseal surgical tissue adhesive wound closure. Findings by: Dimensional Analysis Systems, Inc., Leonia, NJ. 1995.[2] Singer AJ, et al. Comparison of wound-bursting strengths and surface characteristics of FDA-approved tissue adhesive for skin closure. J Adhes Sci Technol. 2004;18:19-27.[3] HISTOACRYL [package insert]. B. Braun; 2009.[4] Blondeel P, et al. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive vs. commercially available methods. Am J Surg. 2005; 188:307-13.[5] INDERMIL [package insert]. Norwalk, CT: United States Surgical/Syneture; 2002.
  14. 14. - CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.Page  15WOUND CLOSURE OVERVIEWWound Closure OptionsSutures• Traditional method• Easy, safe, cheap• All internal layers arenormally sutured• Large incisions• Deep layers• Delicate areas (eyes, lips,etc)• 95% of incisions are stillsuturedStaples• Large wounds in areasrequiring extra holdingstrength• Speed is main advantage• Cosmesis is okay• Painful to remove staples• Staple removal is an extraprocedure/costAdhesive Strips• For small wounds only• No tension• Poor holding strength• Not waterproof• Limited applicationsLiquid Adhesive• No needles• Reduced anxiety• Quick closure• Secure closure• No removal of sutures orstaples• No dressings required• Waterproof closure• Cost advantage• Wide applicationsSURGISEAL® TOPICAL SKIN ADHESIVE: MARKET ASSESSMENT
  15. 15. - CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.SURGISEAL® TOPICAL SKIN ADHESIVE: KEY ATTRIBUTESPage  16TEARDROP APPLICATOR2-octylcyanoacrylateFormula containsembedded activator(consistent ratio)No glass in applicatorSponge can be utilizedwith broad or narrowstrokesApply 2 layersLasts 5-7 dayson skin
  16. 16. - CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.SURGISEAL® TOPICAL SKIN ADHESIVE: KEY ATTRIBUTESPage  17APPLICATION INSTRUCTIONS
  17. 17. One Step Wound TestTM
  18. 18. Protease Activity in Normally- and Non- Healing Wounds
  19. 19. One Step Wound TestTMBefore (left) and AfterReaction With Protease
  20. 20. 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

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