Nrc slides

20
The EVOLUTION of DENTAL IMPLANTS February 2014

Transcript of Nrc slides

  • 1. EVOLUTION of DENTAL IMPLANTS TheFebruary 2014

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 2/11/2014Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology2 3. 2/11/2014Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology3 4. Opencells Healing times reducedMONTHSDAYSCandidates 2X with poor bone increased candidate pool2/11/2014TechnologyStructure mimics bone (the scaffold) + (molecular enhancer) Nanotechnology = 3D super charged bone growth bone growthOpen Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology4 5. BIOMIMETIC SCAFFOLD High porosity (70%-85%) Permeability (i.e. pore size between 50-400 m) Foaming creates 20X the surface area for attachmentBONE Structures and properties mimic those of Trabecular bone facilitating bone growth and graftingOpen Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/20145 6. BONE MORPHOGENIC PROTEINS (BMP-2) INCREASE OSTEOBLAST PROLIFERATIONIMBEDDING 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 growth2/11/2014Biomedical Materials with Human Cell Biology6 7. Video showing 3-Dimensional growth of Bone into Ti Foamhttp://www.youtube.com/watch?v=hdsc nna5r1Q2/11/2014Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology8 8. The OpportunityDental Implant Market$3.5 BILLIONHigh growth market over the period 20102017, 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 Biology9 9. Competition / Customer / Acquirer CompanyWorldwide % of Implant Market20 20 19 9 8Other24In 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. 2/11/2014 Merging Proprietary Biomedical Materials with Human Cell Biology1.Proprietary Technology Strong IP -the foaming process isdeveloped 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 design3.Strategic Partnerships Our strategic relationships with National Research Council of Canada Industrial Materials Institute and participating universities build barriers of entry for our competition4.Proprietary Surgical Technique - Bone Graft Surface Impaction Technique5.Low Regulatory Risk Class 2 Medical Device gets to market quickly 11 11. 2/11/2014Completed 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. 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 daysFDA Clearance Time for Dental Implant (allows for marketing)90 daysESTIMATED TIME TO APPROVAL The EVOLUTION of150 days 13. Merging Proprietary Biomedical Materials with Human Cell Biologyonline worldwide ordering system offer a low cost end user dental implant numerous up sell possibilitiesFocus on emerging marketsRevenue Sources Dental Implant Systems Attachments Surgical Instrumentation Biologics Education and Practice growth strategies2/11/201414 14. POROUS TITANIUM SCAFFOLDSEM View of the TI-FOAM Threaded Dental ImplantNANOTECH GROWTH INDUCERS 2/11/201415 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 designsOpen Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/201416 16. Merging Proprietary Biomedical Materials with Human Cell BiologyGetting the word outBuild a Doctor sales force by making their practice a Center for Excellence. Focus on the Ultimate Decision Makers Patients Through web based and viralmarketing 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 2/11/201417 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 aestheticsMedical, pharmaceutical and now dental advertising is on the increaseConsumer awareness of dental implants is increasingPatients seek more information regarding treatment and they will increasingly use the resources of the internet and social media2/11/201418 18. Merging Proprietary Biomedical Materials with Human Cell Biology2/11/2014Mislav 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. Capital expenditures Regulatory, documentation /administration Operations Marketing R&D . Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology2/11/201420 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$200,000Marketing and Sales$200,000Salaries and Administration$500,0002/11/201421