Real-Time Bone Drilling Monitoring
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  • Founders bring knowledge from all fields relating to our product, paired with solid business development experience
  • Dangers of drilling into bone during dental implant surgery: Drilling too far into mandible, or lower jaw, can allow drill to enter nerve canal. Not only is there danger of infection, severe pain, and numbness in cheek, lips and tongue, but the nerve can be damaged irreversibly. When drilling into upper jaw, drill can enter sinuses, again causing infection and great pain. Without guidance, only way to assess location of drilling is to stop during surgery and take X-ray – more exposure to radiation and loss of time Solutions: CT can only be performed prior to surgery; oral surgeon does not have equipment in clinic X-ray: radiation and loss of time Add: other competing solutions are bulky, expensive and complicated Our system: simple, easy to use
  • The spine market is over $3.5 billion (Devicelink). The orthopedic implant market is expected to reach $11.6 billion in 2012 as the baby boom population ages (Freedonia). Growth rate – 15% is minimum growth rate $1.2K/implant operation More dentists are performing implants Number of patients wanting implants is growing at this rate annually Reflects on ability to sell disposables, not just system E. Europe – patients coming from W. Europe to have implant surgery – no hard data
  • Number of drill through incidents will go down and will have effect of reducing insurance claims
  • System for dental implant surgery – explain existing system From cell containing transducer, our extended water pipe – standard for all types of hand pieces No additional equipment in the mouth of the patient Display monitor on patient’s shoulder, in surgeon’s field of vision No distractions during surgery, can see display while drilling Display - stoplight
  • Transducer sends out signal – ultrasonic waves are guided in pipe and once out, by jet stream 1 st reflection from water at the drilled surface 2 nd reflection from water at bottom of drill surface Wave continues to propagate within the bone 3 rd reflection from mandible canal 3 surfaces of measurement Main interest in measurement from bottom to mandible canal – accurate results in tests over last year SHOW ANIMATION AFTER THIS SLIDE
  • Fits on handpiece – small footprint and out of surgeon’s way Simple to learn to use and to use Low energy ultrasonic waves for diagnostic purposes
  • Timeline: Marketing efforts – underway FDA clearance – Q2 2008
  • SHOW NAHUM SAMET VIDEO AFTER THIS SLIDE
  • Commence sales H2 2008
  • FDA & CE $250K Prototype $1.25M Patents >$100K Clinical >100K Business Development > $200K

Transcript

  • 1. Real-Time Bone Drilling Monitoring February 2008
  • 2. The Team
    • Jacob Halevy-Politch, D.Sc., E.E., CEO Technion–Israel Institute of Technology, Rafael Israel Armaments Development Authority, Israel Air Force
    • D. Todd Dollinger, Chairman JetGuide board, The Trendlines Group
    • Prof. Dan Adam Department of Biomedical Engineering, Technion-Israel Institute of Technology
    • Andrei Craft, D.D.S. Oral and maxillofacial surgeon, formerly Rambam Medical Center (Israel) and Toronto University Dental School
    • Dr. Nahum Rosenberg, M. Ortho. Orthopedic Department, Rambam Medical Center
    • Steve Rhodes CEO, Misgav Venture Accelerator, and Chairman, The Trendlines Group
  • 3. Blind Man’s Bluff The Problem Bone drilling: an inexact and, often, blind art. Surgeons risk damaging nerves, blood vessels, and cartilage Current Solutions CT, panoramic and X-ray imaging pre-surgery; inaccurate manual gauges, and expensive real-time options The JetGuide Solution Affordable real-time monitoring with feedback during surgery
  • 4. Vision and Markets Safe and Accurate Bone Drilling
    • Orthopedic/spine :
      • >6% growth
      • >$30 billion
    • Other surgical growth rates up to 15%
      • ENT : ~$5 billion
      • Neurosurgery : spine and skull ~$6 billion
      • Plastic surgery : ~$5 billion
    • Oral surgery
      • 2 million implants performed annually; $2.4 billion
      • Growth: 15-18%
      • Untapped market: implants 10% of tooth replacements
  • 5. Value Proposition Surgeons Healthcare payors Real-time intraoperative feedback during surgery builds confidence and raises comfort levels. More surgeons can perform procedures. Patients Reduction in complications for decreased costs Improved outcomes and faster procedures
  • 6. The JetGuide Dental System
    • Implantology
    Water container Pump Transmitter Switch Receiver Signal processing Display JetGuide Electronic Unit JetGuide cell JetGuide ultrasonic transducer Dental implant drill Drill tip Water jet stream Water stream
  • 7.  
  • 8. How It Works
    • Water-Guided Ultrasonic Waves
    Bone Jet stream (water) Transmitted ultrasonic waves Reflected ultrasonic wave Bore Mandible canal & nerve JetGuide-measured distance to sensitive tissue a
  • 9. Competition Company System price Disposable price Characteristics JetGuide $3,500 $30
    • In development
    • Easy to use, intuitive
    • Follows existing protocols and techniques
    • Real-time intraoperative information
    DenX Inc. +$50,000 $500
    • In advanced development
    • CT images and complicated image reconstruction
    • Targeting teaching centers and large dental institutions
    • Reportedly difficult to use
    Tactile Technologies +$15,000 $150
    • In development
    • Invasive system based on tactile sensing technology, three-dimensional radiological visualization and miniaturized robotic control
    Imadent +$30,000 $300
    • In development
    • Ultrasound imaging for pre-procedure planning and real-time monitoring of maxillofacial surgeries
    • Equipment is bulky and hard to use
    Dentosonic Ltd. $20,000 $100
    • Development discontinued due to technological obstacles
  • 10. Competitive Advantages
    • Accurate
    • Real-time
    • Simple to use
    • Safe
    • Affordable
    • Compact
  • 11. Business Development Target Market First market: maxillofacial and dental surgeons, dental implantologists Revenue Model Sale of device and per procedure disposables Marketing Strategy Reach end-users with established distributors and OEM manufacturers, provide strong support FDA 510(k) class II
  • 12. Achievements
    • IP
      • Patents strategy – patents applied for; continuing applications
    • Technology/Science
      • Operating system, algorithms, display, ultrasound cell operational
      • Successful experiments on phantoms and ex-vivo fresh animal bones
      • IRB and Ministry of Health approvals for human trials
      • Clinical trials under way – Rambam Medical Center, Haifa
    • Business Development
      • Established Scientific Advisory Board
      • On-going talks with leaders in ortho and dental markets
    • Regulatory
      • FDA pre-ruling received
      • Regulatory strategy, filing in process
  • 13. Scientific Advisory Committee
    • Professor Nachum Samet Assistant Professor of Restorative Dentistry & Biomaterials Sciences, Harvard School of Dental Medicine
    • Professor M. Silbermann Former Chief Scientist, Ministry of Health; Dean, School of Medicine, Technion-Israel Institute of Technology; Chair, Dept. of Anatomy
    • Professor Peter Birek Internationally recognized expert in dental Implantation and Osseo integration; Dental School, the Univ. of Toronto, Canada.
    • Professor M. Zaarur Chief, Dept. of Neurosurgery, Rambam Hospital; School of Medicine, Technion
    • Dr. Micha Peled, M.D., D.D.S. Chief, Oral and Maxillofacial Surgery, Rambam Hospital; School of Medicine, Technion-Israel Institute of Technology
  • 14. Financial Projections 13,017 6,550 1,505 (1,030) (699) Net Profit ($000) 2008 2009 2010 2011 2012 Revenues 0 471 5,447 16,228 29,978 Gross Profit 0 250 3,746 11,198 20,370 R&D Expenses 287 590 997 1,689 2,855 Sales & Marketing 235 393 703 2,184 3,172
  • 15. Opportunity
    • JetGuide seeks $2 million for:
        • Advanced product development
        • Clinical trials
        • Initial production
        • Business development
        • JetGuide Ortho – new markets
  • 16. JetGuide Ltd.
    • Jacob Halevy-Politch, CEO
    • JetGuide Ltd.
    • Telephone: +972. 52.353-7294
    • E-mail: [email_address]
    • Web : www.jet-guide.com
  • 17. Development Plan 1 st sales activities Marketing activities   FDA submission, clearance   Establish production process   Design, engineering – final product   Evaluation in dental clinics   FDA, CE-– partial approval for clinical tests   Prototype III and beta development   Seek strategic partners   Prototype II development   Prepare business plan, revision   Proof of concept testing Prototype I completed 4 3 2 1 4 3 2 1 4 3 2 1 4 3 2 1 4 3 2 1 2010 2009 2008 2007 2006
  • 18. About JetGuide
    • September 2005: joined Misgav Venture Accelerator
    • Funding to Date
      • The Office of the Chief Scientist of the Israel Ministry of Industry, Trade & Labor
      • The Trendlines Israel Fund
      • Founders