2. INSITU BIOLOGICS
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Jim Segermark, Founder, Inventor, Investor, Owner Operator
- Matrix Technology in 2007 and co-founded InSitu in 2014
- Inventor on over 40 issued patents for medical products
- Total Enterprise: Idea, Design, Manufacturing, To Patient
- BS Carroll University, Wisconsin,
- MBA from Cardinal Stritch University, Wisconsin
Bill Taylor, Scientist, Co-Founder of InSitu Biologics,
- Matrix Technology 2006
- Awarded research grants, authored industry papers in chemical
remediation and demilitarization utilizing biological systems
- BS University of Minnesota, Chemical Engineering and Biology
3. INSITU BIOLOGICS
• Incorporated in 2014
• Product development began in 2007
Molecule Development, Pre-Clinical (animal) Testing
Characterization, Safety, Toxicity
Manufacturing Development
• Hydrogel technology licensed from Cleveland Clinic Foundation
• 25+ US Patents Issued, with matching OUS positions
• Goal is to monetize our product developments through strategic licensing
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4. INSITU BIOLOGICS
• Set a new Standard Of Care and Mitigate Risk for Licensor
• World Class Manufacturing & Supply
• Core hydrogel technology implanted in over 80,000,000 people
• Pre-clinical & Clinical work with best in class institutions
• NAMSA
• Celerion
• Investigator: University of Minnesota
• Auditor: Baker Tilly Virchow Krause
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5. INSITU: TECHNOLOGY OVERVIEW
• Tunability: Create multiple physical forms, viscosities, and absorption
rate by varying the crosslink in Matrix BioHydrogel
• Predictable Elution Rate: Can provide very quick onset of action, and
provide a long elution, and is not subject to gravity, like lipid-based
products
• Safety/Biocompatibility: Matrix BioHydrogel components are made in
the body or metabolized by the body.
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6. ANESTAGEL: PRODUCT OVERVIEW
• AnestaGel: Bupivacaine in Matrix BioHydrogel
• Established Market: Pacira (Exparel) has opened the door into the
$90,000,000,000 annual non-opiate perioperative pain market
• Exparel ~ $450,000,000 million in annual revenues, fifth year
• Developing Market: Pacira licensed Exparel to Aratana for Veterinary
• Nocita around $8,000,000 over 13,500 Veterinarians trained, 1,800 using
• Family of Products: Vary form factor, specific uses, physician
preferences, and targeted length of treatment
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7. ANESTAGEL: PRE-CLINICAL SUMMARY
• Numerous independent studies prove AnestaGel lasts longer, and
provides greater analgesic effect than Exparel (Nocita)
• PharmacoKinetic (PK) results proved presence of bupivacaine in blood
via AnestaGel at 96 hours; far greater than Exparel (Nocita) and just
bupivacaine
• Statistical significance proven at every time point up to 72 hours
• Pathology post-study and six weeks post-study was unremarkable, and
consistent with Exparel (Nocita) findings 5 days post-implant
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8. ANESTAGEL: APRIL 2019
• Pre-Clinical Completed
• Preparing FDA Package for Phase 1 Clinical Study – Safety
• 60 People, Multiple Procedures, Placebo
• Animal Care Market
• Field based study by Licensor
• Manufacturing long lead
• All components meet a higher standard
• Q4 First Batch
• Q1 Clinical Product Run
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9. ANESTAGEL: APRIL 2019
• AMA / Medicare have issued specific codes for non-opiate products
• Hospital and Out Patient
• Multiple Products approaching FDA Clearance
• Many niches within $90Billion Market
• Possibility for FDA Fast Track Designation
• Hyman Phelps & McNamara, DC Based FDA Law Firm
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11. INSITU: APRIL 2019
• Total Investment of $4.4million since inception
• Regulation A+ Offering Opened July 2018
• Raised just over $3million
• $1.5m in bank today
• Spend +$4million ~ 4/19 – Phase 1 Completion
• Continue to sell stock through July 2019
• All Individual Investors
• ComputerShare holds digital certificates
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12. CONFIDENTIAL 12
Implantable Tissue
Matrix
Orthopedic
Space Filler
Tendon Repair
Bone Paste
Orthopedic
Viscosupplement
Cerebral
Deformities &
Transplant
Gastric
Coatings
Catheter
Artificial Heart and
Assemblies
Organ Transplant
Plug & Lumen
Aneurysms
Cerebral
AVM
Cerebral
Lung
Fistula & Diverticula
Aortic
Drug Delivery
Wound Healing
Adhesion Barrier
Oncology
Metobolic Resevoir
Tissue Augmentor
Myocardium
Vocal Fold
Medialization
Aesthetic
Esophogeal Engineered Host
Response
SUI
Surgical
Patch w/
Multifunctional
Facets
Deep Wound /
Trauma
Nerve Repair
Structure Tissue
Remodelling
Tissue Engineering
Engineered ECM
BAP - Islet
In Vivo Combo
ECM
In vitro ECM
In Vivo ECM
Gastrointestinal
Fecal Incontinence
Muscle
Spinal Disc
Pain Management
Antibodies
Vitreal
Replacement
Pediatric Growth
Plate Filler
Cartilage ECM
Pelvic Health
Thyroid
Pituitary
Tissue Culture
Drug Evaluation
Artificial Vessels
Neural Tubes
Spinal Cord Repair
BA Liver
Myocardium
Bone & Marrow
Bladder
Macroscopic Device
Liver
Sensors
Urology
13. INSITU: APRIL 2019
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Many products could be pursued now;
~however~
We remain focused on the tasks at hand:
Prove the Matrix BioHydrogel Safe in
people with a known drug
