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Bioabsorbable Surgical Clip & Applicator Commercialization

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Presentation on theme: "Bioabsorbable Surgical Clip & Applicator Commercialization"— Presentation transcript:

1 Bioabsorbable Surgical Clip & Applicator Commercialization
Neil Roundy, MD Neurosurgeon Rachel Dreilinger Biomedical Engineer Eric Hanson, MD, MPH DoD Biomedical Consultant Justin Cetas, MD, PhD OHSU Neurosurgeon NeuraMedica is an Oregon-based LLC and OHSU spinout company.

2 TEAM Neil Roundy, MD (Co-Founder and Chief Medical Officer) is a neurosurgeon with Oregon Neurosurgery Specialists, a private practice group in Eugene, OR. His work interests include skullbase surgery, minimally-invasive intracranial & spinal surgery and neuroendoscopy. Rachel Dreilinger (Co-Founder & CEO) is a biomedical engineering consultant specializing in the design of medical devices with experience in orthopedics, neurosurgery, dentistry, resorbable polymers, mechanical design and all phases of product development. Eric Hanson, MD, MPH (DoD Biomedical Consultant) is a former US Air Force Senior Flight Surgeon and Division Chief of Science & Technology. He has received $68M in funding as a lead PI in DoD research programs and set up over $1.5M in cooperative R&D agreement (CRADA) value in the last two years for NW biomedical companies.

3 THE BIG IDEA Watertight closure No imaging artifact
Bioabsorbable Clip for Durotomy Closure Watertight closure No imaging artifact Multiple clips applied quickly Low-profile applicator Reduced OR time

4 CLINICAL NEED - The Problem
High incidence of durotomy closure (~170k cases/year in the U.S. in 2010) Limited surgical site exposure Long, narrow working channels Prevalence of Minimally Invasive Surgical (MIS) techniques Current suture technique can take up to 60 minutes or more Operative time is very expensive ($29-$133/minute) 30 min case x $80/min = $2400!

5 VALUE PROPOSITION & UNIQUENESS
Vast improvement over current methods of watertight closure (running suture) NO OTHER bioabsorbable clips available for closing the dura Other surgical closure devices: Metallic/Penetrating (U-Clip by Medtronic) Metallic/Crimping/Non-Penetrating (AnastoClip by Le Maitre Vascular, Duraclose by Stryker) Bioabsorbable/Penetrating (Vicryl Suture by Ethicon)

6 Designs and Prototypes

7 MARKET ANALYSIS (Spine Surgery ONLY)
Durotomy closure cases: $80/min x 30 min = $2400 2010: 1.7M spinal surgeries in U.S. ~10% require durotomy closure = 170k cases/year $170k x $2400/procedure = $408M

8 INDICATION EXPANSION Colectomy (Ulcerative Colitis): average 19,970/year ( ) x $2400/case = $48M Ostomy Procedures: 120k/year x $2400 = $288M Cranial Neurosurgery: 250,000 craniotomies performed yearly in the U.S. 250k x $2400/case = $600M Tubal Ligation: 700k procedures/year x $1,000/device = $700M $2B POTENTIAL MARKET

9 OHSU/OCTRI FUNDING ($67k)
Prototype Clip & Applicator Designs Cadaver Testing Dural Clip tooling Regulatory Roadmap Patent Applications Finalize Clip & Applicator Designs Bench/Cadaver Testing Small Animal Testing Large Animal Feasibility Study FDA Pre-Submission Contact FDA Documentation & Data ONAMI GAP FUNDING ($250k) Follow-on Large Animal Study Sales & Marketing Plan Patent Prosecution FDA 510(k) Submission Engineering Production Tooling Engineering Documentation PRODUCT LAUNCH DoD/SBIR/Angel FUNDING ($750k)

10 WE ARE SEEKING: NOW: $750k Early-stage seed capital
AT PRODUCT LAUNCH: $4M (Angel & other investment opportunities) (Venture Capital or other funding)


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