Sebastian Gabel Chief Executive Officer Dr. Stefan Jockenhövel Inventor anddirectorofr&d Tim Comanns Director of Marketing Daniel Engelbach Director

Transcription

1 Sebastian Gabel Chief Executive Officer Dr. Stefan Jockenhövel Inventor anddirectorofr&d Tim Comanns Director of Marketing Daniel Engelbach Director of Operations

2 Annesuffers froma severe heartvalvedefect

3

4 Past No heart valve replacement perfectly heals children with heart valve defects 135,000 newborns die before reaching adulthood Wordwide annual costs for health care providers to give these children with heart valve replacements exceed $27 Billion Today ProValve a heart valve replacement for newborns and children Reductionof costsforhealthcareprovidersby45% Children: initial market volume of $20 Billion, Newborns: annualmarketsize$2 Billion 4

5 ProValve The only tissue engineered heart valve replacement for babies 100% baby s own body material Created and transplanted within three months after birth Grows with the child

6 Today s heart valve replacements cannot satisfy childrens needs. Mechanical valves Tissue valves Requires anticoagulants Causes clicking noise Doesnot growwithchild Worn out after yrs. Calcifies quickly Doesnot growwithchild 6

7 The ProValve capabilitiesmakeitthe perfectheart valve replacement. Does not cause clicking noises Grows with the patient Doesnot wear out Significant reduction of mortality risk and unrestricted quality of life Does not require anticoagulants Only one surgery necessary Matches the heart perfectly 7

8 The ProValve reducesthe costsforheart valve replacements significantly. Standard tissue valve ProValve First surgery First tissue valve $30,000 $2,000 Second surgery $30,000 Second tissue valve $2,000 Surgery $30,000 Third surgery Third tissue valve Fourth surgery Fourth tissue valve $30,000 $2,000 $30,000 $2,000 $128,000* $32,000 $64,000 $96,000 $? ProValve $40,000 $70,000* $? * Surgery costs do not include follow-up costs. 8

9 Components TwoProteins (Fibrinogen and Thrombin), Calcium Chloride, Water Production Proteins taken from baby Components mixed Gel out of clottingprocess Dr. Stefan Jockenhövel, Inventor & Director of R&D 9 Characteristics Moldablein 3D 100% autologous Cultivated with any cells

10 I Ultrasonic imaging Exact dimensions of the babie s heart determined by ultrasonic imaging On thebasisof US image3d model of theheart valve is created 10

11 Creation of the protein gel II Blood taken from babies umbilical cord. Necessary proteins extracted from blood Protein gel matrix is created and molded 11

12 Cultivation of the heart valve Anykindof musclecells taken from the baby III Cells are multiplied in the laboratory Muscle cells are insertedintothe3d protein gel matrix 12

13 IV 13

14 The financialprognosisforthe ProValve isextraordinarypromising. Children born with heart valve defect every year 80% market coverage 10% market coverage 43,000 children(p.a.) Today 550,000 children living with heart valve defects: Additional potential $22 billion $40,000 per valve $1.7 billion p.a. 14

15 Market entry barriers can be overcome easily. Market entry barriers Technology development Product development Customer awareness Market trust(patients, hospitals, insurances) Distribution network 15

16 A successfulmarketentrywill beachievedin foursteps. Your new life begins here. Initial customers Scientists Surgeons and hospitals Patients and family Heart center at Klinikum Niederrhein Duisburg (Germany) Publications aboutheart valve replacement Publications about studies Presence on fares Talks at conferences Direct dialogue Media advertisement Information material Q&A portal University hospital Aachen (Germany) Goal: Convince scientists of product quality and feasability Goal: Win further hospitals and heart surgeons Goal: Increase product awareness and trust 16

17 A focus on the preperation and cultivation is reasonable for. Hospital Hospital diagnostics withdrawal preparation cultivation surgery prenatal diagnosis of heart valve defect withdrawal of needed body material Creationof heart valve from body material Strengthening of heart valve in bio-reactor Implantation of heart valve 17

18 Eightmajorcompetitorscanbeidentified. Tissue heart valve manufacturers Mechanical heart valve manufacturers Tissue engineered heart valve research groups 18

19 Twopatentsarecrucialelementsofthe knowledgeprotection. Your new life begins here. Bioreactor system Full title: Bioreactor System for strengthening a tissue engineered prosthesis, particularly a heart valve IPC classification: C12M 3/04 Expected approval: third quarter 2010 Production process Full title: Process for manufacturing a tissue engineered prosthesis, particularly a heart valve IPC classification: B29C 41/20 Expected approval: third quarter

20 Research protein gel Animal experiments Animal experiments successful Research heart valves In humans 2000 Research results Shares, Payoff Busincess model Negotiationswith Investors, Patents granted, Product Certification, Production facilities Market entry 20

21 today needed funds Animal experiments Patenting process Certification & approval Studies on humans Capacity Building Staff (Production) Staff (Management) $0 $0 $500,000 $2.5M $1.0M $2.5M $850,000 Investor financing $7.35M 21

22

23 ac life science 2009 Sebastian Gabel, Dr. Stefan Jockenhövel, Tim Comanns, Daniel Engelbach