Medical Technologies

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:

CONFIDENTIAL

CONFIDENTIAL

Corey Russ

May 9th 2013

Combat Medical Systems NC Advance Technology Symposium

Phases of

Tactical Care

• Care Under Fire

• Tactical Field Care

• Tactical Evacuation

Early Lessons

• Standardize techniques

• Simple devices

• Command responsibility

• Train-as-you-fight

THANK YOU

Combat Medical Systems

5845-D Yadkin Road

Fayetteville, NC 28303

910.426.0003

www.combatmedicalsystems.com

• 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.

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

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.

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

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.

- CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved.

OVERVIEW OF ADHEZION BIOMEDICAL

ADHEZION BIOMEDICAL BRINGS INNOVATION TO CYANOACRYLATE-BASED MEDICAL DEVICES

Adhezion Biomedical, LLC is a privately held medical device

company focused on the development, manufacturing and

commercialization of highly differentiated and proprietary

cyanoacrylate-based surgical, wound management and

infection prevention products.

Surgical Solutions

Improve clinical

outcomes in the surgical

specialties with an

emphasis on the O.R.

and E.R. settings.

Infection Prevention

Reduce or eliminate the

incidence of Healthcare

Associated Infections

(HCAIs).

- CONFIDENTIAL - ©2011 Adhezion Biomedical, LLC. All Rights Reserved. 14

WHAT IS CYANOACRYLATE?

• Today’s commercially available cyanoacrylate tissue adhesives can be segmented into two distinct product categories

based on the product’s chemical structure.

Practical comparison of 2-octyl cyanoacrylate (OCA) and n-butyl cyanoacrylate (BCA) Formulations

Property OCA (SURGISEAL, Dermabond, Derma+Flex QS)

BCA (Histoacryl, Indermil, LiquiBand, GluStitch)

Chemical Composition

Film Flexibility Higher Moderate

Wound-Breaking Strength1,2 Stronger Strong

Heat released Less More

Setting time Short (minimizes clogging) Shorter

Water Resistance Patient may shower immediately Patient may not shower for 24-48 hours3

Incision Length Clinically proven to close long incisions4

Clinically proven to close up to 4-5 cm3,5

Microbial Protection Coverage

Area

Greater

Moderate

B O

8-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.


WOUND CLOSURE OVERVIEW

Wound Closure Options

Sutures

• Traditional method

• Easy, safe, cheap

• All internal layers are normally sutured

• Large incisions

• Deep layers

• Delicate areas (eyes, lips, etc)

• 95% of incisions are still sutured

Staples

• Large wounds in areas requiring extra holding strength

• Speed is main advantage

• Cosmesis is okay

• Painful to remove staples

• Staple removal is an extra procedure/cost

Adhesive Strips

• For small wounds only

• No tension

• Poor holding strength

• Not waterproof

• Limited applications

Liquid Adhesive

• No needles

• Reduced anxiety

• Quick closure

• Secure closure

• No removal of sutures or staples

• No dressings required

• Waterproof closure

• Cost advantage

• Wide applications

SURGISEAL® TOPICAL SKIN ADHESIVE: MARKET ASSESSMENT


SURGISEAL® TOPICAL SKIN ADHESIVE: KEY ATTRIBUTES

TEARDROP APPLICATOR

2-octyl

cyanoacrylate

Formula contains

embedded activator

(consistent ratio)

No glass in applicator

Sponge can be utilized

with broad or narrow

strokes

Apply 2 layers

Lasts 5-7 days

on skin


SURGISEAL® TOPICAL SKIN ADHESIVE: KEY ATTRIBUTES

APPLICATION INSTRUCTIONS

One Step Wound TestTM

Protease Activity in Normally- and Non- Healing Wounds

One Step Wound TestTM Before (left) and After Reaction With Protease

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

Medical Technologies

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