Organizational Structure Running A Successful Business
Medical Technologies
1. North Carolina Federal Advanced Technologies Symposium
May 9, 2013
Medical Technologies Forum
Hosted by:
Office of Senator Richard Burr
NC Military Business Center
NC Military Foundation
Institute for Defense & Business
University of North Carolina System
Reception Sponsor:
Bronze Sponsor:
7. THANK YOU
Combat Medical Systems
5845-D Yadkin Road
Fayetteville, NC 28303
910.426.0003
www.combatmedicalsystems.com
8. • Exclusively devoted to developing nitric oxide-based
therapies
• Founded by Drs. Mark Schoenfisch and Nathan Stasko
• Core platform technology licensed from the University of
North Carolina at Chapel Hill
• Began operations in 2008
• Raised ~$20M in equity financing from high-net-worth
individuals
• Awarded ~$7.5M in federal contracts and grants from DOD,
NIH and NSF
Novan, Inc.
9. 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 function
Nitric oxide has antimicrobial activity:
• Targets gram positive and gram negative bacteria, fungi, and
viruses
• Disrupts mature biofilms and kills bacteria embedded in
biofilms
• Non-antibiotic strategy; no known mechanisms of drug
resistance
Nitric oxide is a gas which is difficult to store and deliver
10. BURN INJURIES DIABETIC FOOT ULCERS
~4 million in the US per year
Cost of ~$8,000 per episode
“Someone, somewhere, loses a leg
because of diabetes every 30 seconds
of every day.” (Lancet, 2005)
$35.6B cost to US
healthcare system
~2.4 million burn injuries per
year in the U.S.
650,000 are treated by medical
professionals
2/3 of patients experiencing
more than 40% TBSA die as a
result of sepsis or other
complications.
11. Department of Defense, US Army
• Topical Nitric Oxide for the Treatment of Acute Military Wound Infections (SBIR
Phases I/II and Option - 2011-2014)
• Effects of Topical Nitric Oxide Formulations on Sulfur Mustard and Thermal Burn
Injuries (Cooperative Research & Development Agreement - 2010)
• Evaluation of Antimicrobial Wound Dressings on Infected and Non-infected
Wounds 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 Oxide
Wound Care Contracts and Grants
12. Novan Topical Nitric Oxide
Current Status
• Clinical trial materials (drug substance and drug product) are
manufactured and packaged at Novan’s facilities under GMP.
Drug Substance Drug Product
• Intellectual property portfolio includes >50 patents and
applications with worldwide coverage and 15-20 years of patent
life.
• IND for a topical wound care ointment to be submitted in 2013 to
support future clinical studies.
20. One Step Wound TestTM
Before (left) and After
Reaction With Protease
21.
22. The One Step Wound TestTM
is:
1. Non-invasive—using a drop of Wound fluid
as 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 ~15
nanogram of a model protease;
7. Selective--only gelatinase activity is
detected;
8. Instrumental Readout--using an inexpensive
$200 turbidimeter;
9. Easy to use-- No training needed;
10. Room Temperature—where the reaction
takes place; it’s stable at room temperature.
11. Quantitative--kinetic analysis provides
nanogram resolution for an improvement over
a yes/no result
