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Nrc slides

  1. 1. EVOLUTION of DENTAL IMPLANTS The February 2014
  2. 2. Ti Foam™ is a porous titanium nanotechnology dental implant that is created by a joint research and development project by National Research Council of Canada Industrial Materials Institute a Canadian government supported SME incubator system in conjunction with Dr. Mislav Pavelic Founder/CEO, DDS, FICOI 25 years of Industry experience with over 10,000 real world surgeries 2 previous successful start-ups with industry buyouts 2/11/2014 Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2
  3. 3. 2/11/2014 Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 3
  4. 4. Opencell’s Healing times reduced MONTHS DAYS Candidates 2X with poor bone increased candidate pool 2/11/2014 Technology Structure mimics bone (the scaffold) + (molecular enhancer) Nanotechnology = 3D super charged bone growth bone growth Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 4
  5. 5. BIOMIMETIC SCAFFOLD High porosity (70%-85%) Permeability (i.e. pore size between 50-400 µm) Foaming creates 20X the surface area for attachment BONE Structures and properties mimic those of Trabecular bone facilitating bone growth and grafting Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/2014 5
  6. 6. BONE MORPHOGENIC PROTEINS (BMP-2) INCREASE OSTEOBLAST PROLIFERATION IMBEDDING ANTIBIOTICS (FLAGYL® METRONIDAZOLE) DRASTICALLY REDUCING RISK OF INFECTION Nano surface modifier's of the Ti Foam™ porous titanium scaffold; etching processes, hydrophilic agents, ionizers, hydroxyl apatite's and phosphates Cell BioMed Merging Proprietary Open = super charged bone growth 2/11/2014 Biomedical Materials with Human Cell Biology 6
  7. 7. Video showing 3-Dimensional growth of Bone into Ti Foam™ http://www.youtube.com/watch?v=hdsc nna5r1Q 2/11/2014 Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 8
  8. 8.  The Opportunity  Dental Implant Market  $3.5 BILLION    High growth market over the period 2010–2017, rising from $2.6 billion in 2010 to about $5 billion in 2017, aging population , emerging markets are currently only a bleep in this market Noble, Straumann, Biomet, and Zimmer are all Billion dollar companies Numerous dental implant companies – market is primed for M&A activity In 2010, Danaher purchase of Implant Direct, an innovative fast-growing dental implant company founded in 2004. The value of the deal was $240 mil , or 4x sales. Open 2/11/2014 Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 9
  9. 9. Competition / Customer / Acquirer Company Worldwide % of Implant Market 20 20 19 9 8 Other 24 In 2012, Zimmer Dental Inc., announced the launch of their Trabecular Metal Dental Implant (a product similar to TiFOAM – but not titanium) in the U.S. and select global markets. While segmented numbers are not available for this particular product, the company has said that sales growth has been strong. This product uses a different manufacturing process and does not incorporate nanotech growth inducers or antibiotics. The EVOLUTION of
  10. 10. 2/11/2014 Merging Proprietary Biomedical Materials with Human Cell Biology 1. Proprietary Technology – Strong IP -the foaming process is developed by National Research Council of Canada Industrial Materials Institute and exclusively licensed to our company for the use on dental implants. Additionally the company has patents pending on the manufacturing process for a Titanium foamed surface coated dental implant and a fully Titanium foamed dental implant as well as design patents for a Titanium foamed surface coated dental implant and a fully Titanium foamed dental implant. 2. Process and design –2 Other companies (Biomet-3i and Zimmer) have porous titanium from other manufacturing processes (chemical treatments)but have not been able to utilize it on a dental implant design 3. Strategic Partnerships – Our strategic relationships with National Research Council of Canada Industrial Materials Institute and participating universities build barriers of entry for our competition 4. Proprietary Surgical Technique - Bone Graft Surface Impaction Technique® 5. Low Regulatory Risk – Class 2 Medical Device – gets to market quickly 11
  11. 11. 2/11/2014 Completed Stage 4 in our R&D project namely FDA 510K requirements 1-Development and optimization of the design 2-Validation of the performances (structure, microstructure, composition, implantation, Fatigue Testing ISO14801 Testing completed- Results show the foam holds up to and beyond the forces of mastication* 3-Optimization of the fabrication process  The project cost 1 million to complete with $500,000.00 in seed capital from the principal and The Canadian Government contributed its facilities and Labour force to the tune of $500,000.  The company is now ready to commercialise its unique first product line of Ti Foam™ nanotechnology coated threaded dental implant system. Merging Proprietary Biomedical Materials with Human Cell Biology 12
  12. 12. Near-term Regulatory Clearance • Ti-FOAM™ NT Threaded Implant System is fully developed • U.S. – Class 2 device following 510k Pre-market Notification application process (demonstrate equivalence with approved device – clinical trials NOT required) • Completed: • Development and optimization of design • Validation of performance • Optimized fabrication process • Required: Preparation of Application (estimate) 60 days FDA Clearance Time for Dental Implant (allows for marketing) 90 days ESTIMATED TIME TO “APPROVAL” The EVOLUTION of 150 days
  13. 13. Merging Proprietary Biomedical Materials with Human Cell Biology online worldwide ordering system offer a low cost end user dental implant numerous up sell possibilities Focus on emerging markets Revenue Sources • Dental Implant Systems • Attachments • Surgical Instrumentation • Biologics • Education and Practice growth strategies 2/11/2014 14
  14. 14. POROUS TITANIUM SCAFFOLD  SEM View of the TI-FOAM™ Threaded Dental Implant NANOTECH GROWTH INDUCERS 2/11/2014 15
  15. 15.     TI-FOAM™ Full Foam Design dental implant (designed and tested – undeveloped) TI-FOAM™ Full Foam threaded dental implant Biologics –graft material Hip, knee and shoulder designs Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/2014 16
  16. 16. Merging Proprietary Biomedical Materials with Human Cell Biology Getting the word out Build a Doctor sales force by making their practice a Center for Excellence. Focus on the Ultimate Decision Makers “Patients” Through web based and viral marketing campaigns t Trade Show exhibits and Conferences are the most common and effective forms of getting information and awareness to the Doctors that are using dental implants already or may want to use our product 2/11/2014 17
  17. 17. Direct To Consumer Advertising is the future of Healthcare marketing  Direct to consumer multi-media blitz – emphasis on Ti Foam™ ‘s patient benefits/Patients wants: Fast procedures, Minimally invasive procedures, Long lasting results and Good aesthetics  Medical, pharmaceutical and now dental advertising is on the increase  Consumer awareness of dental implants is increasing  Patients seek more information regarding treatment and they will increasingly use the resources of the internet and social media 2/11/2014 18
  18. 18. Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/2014 Mislav Pavelic Founder/CEO, DDS, FICOI 25 years of Industry experience with over 10,000 real world surgeries 2 previous successful startups with industry buyouts William Simmons COO 30 years operational experience in manufacturing and design of dental implants Stefan Kim VP Marketing /Sales New Media Guru Ragan Mengal CFO 15 years in finance 19
  19. 19.      Capital expenditures Regulatory, documentation /administration Operations Marketing R&D . Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/2014 20
  20. 20. Seeking Funding to commercialize the product line Series A funding of 1.5 million -preferred shares  Distributor – selling rights sold per area – sales Seeking $1.5 million FDA & split Canada Marketing Applications 20% Health on commission basis $500,000 PatentJoint Ventures – negotiable - M&A $100,000  expenses (incl. additional applications)  Packaging and labeling $200,000 Marketing and Sales $200,000 Salaries and Administration $500,000 2/11/2014 21

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