InSitu Biologics Corporate
•
1 like•1,251 views
This document summarizes a presentation by InSitu Biologics given in April 2019. It introduces the founders and history of the company, which was incorporated in 2014 and develops drug-eluting hydrogel technologies licensed from the Cleveland Clinic Foundation. It provides an overview of their lead product AnestaGel, a bupivacaine-eluting hydrogel for post-operative pain management, which has shown longer-lasting analgesic effects than competitors in pre-clinical studies. The company is preparing for a Phase 1 safety trial and manufacturing scale-up to target the large non-opioid pain market. It also lists other potential medical applications of their tunable hydrogel platform and strategic focus on proving safety with Anest
Recommended
More Related Content
What's hot
What's hot (9)
Similar to InSitu Biologics Corporate
Similar to InSitu Biologics Corporate (20)
Recently uploaded
Recently uploaded (20)
InSitu Biologics Corporate
- 1. Information Presentation April 2019 INSITU BIOLOGICS, INC
- 2. INSITU BIOLOGICS Confidential 2 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 Confidential 3
- 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 Confidential 4
- 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. 5
- 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 6
- 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 Confidential 7
- 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 Confidential 8
- 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 Confidential 9
- 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 Confidential 11
- 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 Confidential 13 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