real-time bone drilling monitoring

Real-Time Bone Drilling Monitoring

February 2008

2

The Team

Jacob Halevy-Politch, D.Sc., E.E., CEOTechnion–Israel Institute of Technology, Rafael Israel Armaments Development Authority, Israel Air Force

D. Todd Dollinger, ChairmanJetGuide board, The Trendlines Group

Prof. Dan AdamDepartment 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 RhodesCEO, Misgav Venture Accelerator, and Chairman, The Trendlines Group

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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

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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

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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 andfaster procedures

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The JetGuide Dental System

Implantology

Water container

Pump

Transmitter

Switch Receiver

Signal processin

g

DisplayJetGuide

Electronic Unit

JetGuide cellJetGuide ultrasonic

transducer

Dental implant

drill

Drill tip

Water jet stream

Water stream

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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

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Competition

CompanySystem 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

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Competitive Advantages

Accurate Real-time Simple to use Safe Affordable Compact

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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

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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

Scientific Advisory Committee

Professor Nachum SametAssistant Professor of Restorative Dentistry & Biomaterials Sciences, Harvard School of Dental Medicine

Professor M. SilbermannFormer Chief Scientist, Ministry of Health; Dean, School of Medicine, Technion-Israel Institute of Technology; Chair, Dept. of Anatomy

Professor Peter BirekInternationally recognized expert in dental Implantation and Osseo integration; Dental School, the Univ. of Toronto, Canada.

Professor M. ZaarurChief, 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

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Financial Projections

($000) 2008 2009 2010 2011 2012

Revenues 0 471 5,44716,22

8 29,978

Gross Profit 0 250 3,74611,19

820,37

0

R&D Expenses 287 590 997 1,689 2,855

Sales & Marketing 235 393 703 2,184 3,172

Net Profit (699)(1,030

) 1,505 6,550 13,017

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Opportunity

JetGuide seeks $2 million for:

Advanced product development Clinical trials Initial production Business development JetGuide Ortho – new markets

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JetGuide Ltd.

Jacob Halevy-Politch, CEOJetGuide Ltd. Telephone: +972. 52.353-7294

E-mail: yapo@jet-guide.com

Web: www.jet-guide.com

Development Plan

2006 2007 2008 2009 20101 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

Prototype I completed

Proof of concept testing 

Prepare business plan, revision

Prototype II development 

Seek strategic partners 

Prototype III and beta development

FDA, CE-– partial approval for clinical tests

Evaluation in dental clinics 

Design, engineering – final product

Establish production process 

FDA submission, clearance 

Marketing activities

1st sales activities

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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