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Jon J. Snyder OVA 4.17.09. Background. Management Morning Read…. The Plain Dealer ‘Ohio leads Midwest in health-care investments’ - October 30, 2007. BioEnterprise – CEO IR. CEO IR is an important new strategy to continue to build NEOhio region’s expanding bioscience sector
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Jon J. Snyder OVA 4.17.09 CONFIDENTIAL
Background CONFIDENTIAL
Management Morning Read… The Plain Dealer • ‘Ohio leads Midwest in health-care investments’ - October 30, 2007 CONFIDENTIAL
BioEnterprise – CEO IR • CEO IR is an important new strategy to continue to build NEOhio region’s expanding bioscience sector • Funded by the State of OH ESP Program • Lend expertise in clinical application to start up companies - OR – • Find technology, form Company, secure funding, lead and grow the Company CONFIDENTIAL
BioEnterprise – CEO IR • First CEO IR in the Program (new ground) • By Day 3 – Strategic Plan Drafted • Measurable Objectives (stay on track) • Quarterly Focused • Goal • Find neurostimulation technology to form a company around • Establish company • Secure funding • Commercialize technology and grow opportunity CONFIDENTIAL
CEO IR Plan • CY08 - Q1 • Review neurostimulation technologies and research projects • Interface with tech transfer departments/key contacts and researchers • Understand status and timing of research underway/planned • Value Proposition and IP position review • Gather/review VC feedback of previously presented neurostimulation opportunities (e.g. VC firms) • Understand local neurostimulation company history • Introduction to area seed funding sources (e.g. JumpStart, Case Tech Ventures, NorthCoast Angels,...) • CY08 – Q2 • Continue interface with tech transfer departments/key contacts and researchers • Identify most promising neurostimulation technology opportunities • Confirm value proposition, investibility, and IP status • Understand technology licensing capability • Define competitive technology/application • Conduct market opportunity review CONFIDENTIAL
CEO IR Plan • CY08 – Q3/Q4 • Identify key ‘next steps/milestones’ in technology development process (e.g. proof of concept) • Create and shape business model concept • Develop business plan, including funding requirements to meet milestones • Target funding sources (equity, non-equity/grants, strategic partnerships) and secure CONFIDENTIAL
Est. October 22, 2008 CONFIDENTIAL
Problem: Residual Limb Pain Large Unmet Medical Need: 1.7 million patientshave undergone limb amputation (U.S.) Projected to double by year 2050 to 3.6 million patients 900,000 patients with no proven treatment for their chronic residual limb pain due to severed limb = $14b total market ($16k ASP) 95,000 new residual limb pain patients each year = $1.5b new annual potential market Current Treatments Inadequate: Pharmacological polytherapy, injectable pain medication, pain pumps, peripheral nerve stimulation, spinal cord stimulation, and surgical ablation Only 30% effective in total Source: Amputee Coalition of America, Arch Phys Med Rehabil Vol. 89, March 2008, The Lancet, Neurology July 2002 CONFIDENTIAL
Solution: Neuros Medical Nerve Block Technology • Nerve Block is a rapid, completely reversible, neurostimulation therapy which blocks pain, without systemic adverse effects • Blocks action-potential of the nerve (sensory + motor signal) Implantable Programmable Generator Implantable Stimulating Electrode/lead Source: ANS – A St. Jude Company Product Example CONFIDENTIAL
Neuros Medical Neurostimulation Technology Differentiation CONFIDENTIAL
Intellectual Property - Regulatory – Reimbursement Patent Protection/Differentiation- Neuros technology is unique and has been protected with: • 1 issued United States Patent • 1 Patent Cooperation Treaty (PCT) application • 1 continuation in part application • Additional patent applications under discussion with targeted filing date of Q4 2009 Regulatory: • Class II device, requiring FDA 510k Market Clearance – OR - PMA Reimbursement: • Nerve Block will follow precedent of peripheral nerve stimulation (PNS) which currently exists and is neutral to positive for providers and physicians. • Payer Mix: 81% Medicare and Private; 10% Medicaid CONFIDENTIAL • (source: HCUPNet: US Health and Human Services)
Management Team Jon J. Snyder: Founder, President, and CEO • CEO In Residence at BioEnterprise and Venture Partner at Arboretum Ventures. • Over 20 years of domestic and international management experience in biomedical and healthcare sales, marketing, and operations at Cyberonics, Cardinal Health, Imalux, and STERIS. Kevin L. Kilgore, Ph.D.: Inventor, Technical Consultant • Over 20 years of experience with upper extremity neuroprosthetic systems. • Multiple appointments and positions at MetroHealth Medical Center, CWRU, Cleveland Functional Electrical Stimulation (FES) Center and VA Advanced Platform Technology (APT) Center. Niloy Bhadra, M.D., Ph.D. Technical Consultant • Orthopaedic Surgeon - Biomedical Engineer. • Over 14 years of experience with various aspects of functional electrical stimulation research, CWRU, and Cleveland FES Center. To Be Added 2010 – 2011: • CTO, CSO, VP Sales and Marketing, Support Personnel CONFIDENTIAL
Continuum of Care Neuros ADVANCED PAIN THERAPIES SECOND TIER PAIN THERAPIES PNS SCS SURGICAL ABLATION FIRST-TIER PAIN THERAPIES OPIOIDS DIAGNOSIS NSAIDS INJECTIBLE NERVE BLOCKS CONFIDENTIAL
Business Model Combination of Direct Sales Force and Strategic Partnerships for Selected Target Specialties Anesthesiologists, Interventional Pain Physicians, Physiatrists, Rehabilitative Medicine Supported by Consumer and Clinician Marketing/Education: Direct to Patient via Amputee Coalition of America and National Pain Foundation Peer to Peer Marketing Education efforts Grand Rounds, Symposia, Annual Medical Conferences $16,000 Purchase Price 75% Gross Margin CONFIDENTIAL
Platform Technology Sources: HCUP Utilization Report 2006, NEJM - USA Today January 9th, 2009, National Center for Health Statistics; Joint Implant and Research Foundation; Musculoskeletal Report - msk.com • Within the Chronic Pain Category, technology provides for other applications forChronic Post Surgical Pain including: • Hernia • Thoracotomy • Knee/Hip • Mastectomy • ~ 170,000 – 400,000 patients a year = $2.7b – $6.4b annual market CONFIDENTIAL
Milestones - Investment Requirement $1.5mm $5-7mm • Safety Testing • First In Man Test • FTO • IDE – Quality Plan • Feasibility (5-10 patients) • US/Intl Patent Submissions • Product Refinement • Mgt Team Expansion • FDA Submission • Post Market Study (40 pts) • Launch 2009 2010 2011 CONFIDENTIAL
Fundraising Status • $1.5m Seed Round: $1.5m Pre-Money • $600k committed • JumpStart • Case Tech Ventures • NCAF • $900k Being Pursued • OTAF, QCA • Other investors • State of OH BRCP $750,000 Apr. 2009 • US Army Med Rsch $1.5m Sep. 2009 • SBIR $275,000 Nov. 2009 • $5 - $7 m A-round : Q2-2010 CONFIDENTIAL
Pro-Forma Financials CONFIDENTIAL
Exit Opportunities NOTE: Transneuronix, Northstar Neuroscience, Enteromedics, and NDI activity were pre-FDA approval CONFIDENTIAL
Neuros MedicalNerve Block - Summary Large and growing market Treatment of chronic pain in market with significant unmet needs Future opportunities in other chronic pain applications Extensive NIH and BRTT funded research to date confirming proof of concept Enables financially efficient and timely commercialization path Excellent revenue and profitability potential Neutral to positive reimbursement precedent IP protection Experienced Management Team Strong exit opportunities (Clinical Trial, FDA Approval, Launch) CONFIDENTIAL
Thank You… CONFIDENTIAL
Jon J. Snyder 11000 Cedar Avenue Cleveland, OH 44106 Tel: 216-658-3989 Fax: 216-658-3998 Mobile: 440-487-7515 jsnyder@bioenterprise.com CONFIDENTIAL