Arlen D Meyers, MD, MBAUniversity of Colorado School of Medicine

CEO, Society of Physician Entrepreneurs

Biomedical and Health InnovationHealth

Digital HealthCare delivery platformsBusiness process innovation

BiomedicalDrugsDevicesDiagnosticsVaccinesCombined products

Why is bioscience different?IP issuesRegulatory hurdlesHigh riskLong time to marketClinical trial issuesReimbursement issuesChanging business modelsThird party payer issues: Who is the

customer?

BioentrepreneurshipThe pursuit of biomedical and health

commercial opportunityGoal is to create customer/user/patient

defined valueBy deploying biomedical and health product,

process, systems and service innovationWith uncontrolled resources

FoundationsIntellectual Property ProtectionRegulatory Affairs and Reimbursement PlanTeamBusiness OpportunitySolution with sustainable competitive

advantage Business model

3 Phases: SOPEPhase 1: Scoping the opportunity (SO)

Opportunity spotting Idea generation High level Opportunity assessment

Phase 2: Planning, vetting, feasibility, validating (P) Feasibility Analysis Validation and testing

Commercialzation StrategyPhase 3: Executing (E)

Life Science Innovation Roadmap

The Capital “Stack”

CapitalValue Advisors, LLC is a registered broker/dealer and member of the Financial Industry Regulatory Authority (FINRA) 8

Type of Capital Pros/ConsSenior Debt - Secured

Non-dilutive, least expensive, but ties up assets – limited amount available

Junior or Mezzanine Debt

May be non-dilutive, more expensive, may not tie up assets

Trade Credit/Credit Cards

More easily available, highest interest rates, non-dilutive

Preferred Equity Allows more debt, more aligned with owners, but dilutive

Common Equity Completely aligned with owners, but most dilutive, possible control issues

drmimi94954@gmail.com

Capital Sources

CapitalValue Advisors, LLC is a registered broker/dealer and member of the Financial Industry Regulatory Authority (FINRA) 9

Amount Growth Buyout

<$1MFriends/FamilySBAHigh Net WorthSmall Local Funds

High Net WorthSmall Local FundsSBA

$1-3MSmall PE FirmsVC FirmsBanks/Mezzanine

Small PE Firms

$3-5MPE FirmsVC FirmsStrategic InvestorsBanks/Mezzanine

PE FirmsStrategic Investors

>$5MPE FirmsVC FirmsStrategic InvestorsBanks/Mezzanine

PE FirmsStrategic Investors

Financing Biomedical ventures Research

Mostly government basic science grantsDevelopment

Family, friends, foolsSBIR/STTRAngels and angel networksProof of concept awardsState development awardsBusiness plan competitionsCollaborative research and development grants

(CRADA)Crowdfunding sites like http://medstartr.comAccelerators like http://www.blueprinthealth.com

Financing Biomedical VenturesCommercialization

IPO’sStrategic partnershipsCorporate Venture FundsVC’sReverse mergers/PIPE’s