Download Bioabsorbable Surgical Clip & Applicator Commercialization Justin Cetas, MD, PhD Neil Roundy, MD

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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
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.
THE BIG IDEA
Bioabsorbable Clip for Durotomy Closure
▪ Watertight closure
▪ No imaging artifact
▪ Multiple clips applied
quickly
▪ Low-profile applicator
▪ Reduced OR time
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!
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:
1. Metallic/Penetrating (U-Clip by Medtronic)
2. Metallic/Crimping/Non-Penetrating (AnastoClip
by Le Maitre Vascular, Duraclose by Stryker)
3. Bioabsorbable/Penetrating (Vicryl Suture by
Ethicon)
Designs and Prototypes
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
INDICATION EXPANSION
 Colectomy (Ulcerative Colitis): average 19,970/year
(2008-2010) 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
OHSU/OCTRI
FUNDING ($67k)

Prototype Clip & Applicator Designs

Cadaver Testing

Dural Clip tooling

Regulatory Roadmap

Patent Applications
ONAMI GAP
FUNDING ($250k)

Finalize Clip & Applicator Designs

Bench/Cadaver Testing

Small Animal Testing

Large Animal Feasibility Study

FDA Pre-Submission Contact

FDA Documentation & Data
DoD/SBIR/Angel
FUNDING ($750k)

Follow-on Large Animal Study

Sales & Marketing Plan

Patent Prosecution

FDA 510(k) Submission

Engineering Production Tooling

Engineering Documentation

PRODUCT LAUNCH
WE ARE SEEKING:
 NOW: $750k Early-stage seed capital
(Angel & other investment opportunities)
 AT PRODUCT LAUNCH: $4M
(Venture Capital or other funding)
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