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Innovative Aiming Device for Long Bone Fixation

Innovative Aiming Device for Long Bone Fixation. LRS Ortho Ltd. Medical Device Projects Conference March 2008. Problem and Solution. Long bones Fixation – The Problem. Insertion of distal locking screws The IM Nail may be bent &twisted in the course of implantation.

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Innovative Aiming Device for Long Bone Fixation

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  1. Innovative Aiming Device for Long Bone Fixation LRS Ortho Ltd. Medical Device Projects Conference March 2008

  2. Problem and Solution

  3. Long bones Fixation – The Problem Insertion of distal locking screws The IM Nail may be bent &twisted in the course of implantation

  4. Current solution- Free Hand Technique • Continuous X-Ray radiation, posing dangers to the surgeon from cumulative exposure. • Different ancillary sighting jigs are used to place the drill bit in correct position

  5. Current solution drawbacks • Time consuming • Radiation exposure • Residual of metal fragmentation • Need expertise • Inaccuracy of the procedure Surgeons and hospitals are looking for an aiming device

  6. LRS solution PCT application was published as WO 2008/001386 • Three-part system: • Instrument– unique jig for aiming the driller • Image Processing Software • laser inside nail

  7. System Advantages • Shortens total procedure time significantly • Reduces X-ray exposure levels – from about 50-100 images per procedure to only three images! • Improves procedure quality and drilling accuracy • Lower the overall cost • Designed to be used with common types of cannulated IM nails • Enables less experienced surgeons to perform procedure with better results Saves time + reduces radiation + improves outcome with similar protocol 7

  8. Market Opportunity/Potential • Opportunity • No device to date has provided a good solution • Radiation is a concern for surgeons • Large players are acquiring small companies for new technologies • AO organization searching for suitable devices • DRG is high enough to cover LRS solution • Potential • IM nails = 15%-18% of worldwide trauma market • Trauma market estimated at $3.8 billion to $4 billion/year • LRS potential market is $600M annually

  9. ProjectStatus • Achieved Milestones • working prototype • Successful Lab trials • Negotiating with one of the largest strategic company • Patent - PCT Application filed, registered and published • Next Milestones: • Clinical trials • FDA- 510K and CE 9

  10. Entrepreneurs • M.D. Alex Lerner– Chief Medical Advisor. Senior Surgeon and an Orthopedic expert (Thousands of surgeries), Orthopedics Dept. of RAMBAM Hospital, Haifa, Israel. Author of “Severe injuries to the Limbs” (Springer). Russia, Israel • M.Sc. Alex Nassonov – Chief Engineer. Physicist and Engineer with extensive experience withnew products development. Over 20 years experience in R&D activities for a range of industries; co-author of 21 patents.Canada, Israel 10

  11. Management • Mr. Giora Bernat – Active Chairman. Senior Executive and entrepreneur. Extensive experience in fund raising, business development, medical devices and R&D. Former founder and CEO of Sightline (acquired by Stryker in 2006 for $150M). Israel, USA • Mr. Yaron Bar-Ilan – CEO. Senior Executive and entrepreneur with technical and management leadership and experience. Singapore, India, USA, Israel • PhD. Lev Diamant– CTO. Physicist with extensive experience in R&D and new products inventions, numerous publications and patents in his name. Russia, Israel 11

  12. Senior Advisory Board • Prof Michael Soudry – Chairman. Chairman, Orthopedic Division, Director, department of Orthopedics A of RAMBAM Hospital, Haifa, Israel. • Doctor Alexander Chelnokov - Member Uralski Institute of Trauma and Orthopedics, Ekaterinburg, Russia 12

  13. Funding LRS Ortho is seeking to raise US$3 million for: • Completing product development • Regulatory approval • In-hospital trials • Initial production • Marketing activities

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