1. ARTICULARIS INC. presents SynchroTalus TM Developed by Tanya Hauck Karyn Ho Rohin Iyer Joon Lee Jorge Torres Derek Watt Change is afoot!

2. Presentation Outline Need for prosthetic foot Existing technology Our product Regulatory issues Other applications Target market Commercialization Economic plan Conclusions

3. Need for Prosthetic Foot 1.55 amputees per 1000 in most developed countries 91.7% are lower limb amputations In the UK, only 5% of lower limb amputees have both limbs amputated Most amputees wear a prosthesis for about 70 hr/week Some amputees use crutches or wheelchairs instead FIGURE ADAPTED FROM: http://amputee-online.com/amputee/newamp.html

4. Ankle Amputations: Prosthesis Goals Easy to use Preferable to wheelchair or crutch use Appearance of “normal” walking Maximize social, vocational interaction Require same energy to walk Reduce stress on the healthcare system Prevent additional stress or injury

5. Existing Ankle Prosthetics: Options 1. Solid ankle 2. Flexible material, with solid ankle 3. Single Axis 4. Multiple Axis 5. Energy Storing (dynamic elastic) “amputees continue to expend 35% more energy compared to normals” IEEE TRANSACTIONS ON REHABILITATION ENGINEERING, VOL. 6, NO. 2, JUNE 1998 Source: Arimed http://www.arimed.com/prosthetics.htm

6. Existing Ankle Prosthetics: Concerns Often discarded for crutches or a wheelchair Normal walking motion not considered Emphasis on cosmetics over function Many do allow motion (“Flex Foot”, “Springlite”) and energy recovery GOAL: To provide a foot and ankle prosthetic that completely mimics the motion of the non-amputated limb and permits “normal” mobility.

7. Gait Analysis Gait analysis = study of a person’s gait/locomotion Typically using cameras, in a gait analysis lab on a large sensor-equipped platform Forces/angles/position of each joint/limb measured to generate force/moment vs. time curves Photo Credits: http://www.sportsci.com/adi2001/adi/services/support/tutorials/gait/chapter2/2.3.asp Hansen et al. J Biomech. 2004 Oct;37(10):1467-74.

8. Our Product – SynchroTalus TM Pressure/tilt/proximity/gyro-scopic sensors built into sole of “gait shoe.” Unique feature: gait symmetry mode (emulates motion of unaffected ankle). Gait analysis data wirelessly transmitted to built-in CPU CPU actuates motors in ankle joint of prosthesis to emulate normal locomotion Conveniently fits over/interfaces with any conventional prosthesis! Media Credits: http://www.marlbrook.com/medical.htmlhttp://www.marlbrook.com/medical.html http://www.media.mit.edu/resenv/GaitShoe/ http://www.ifr.mavt.ethz.ch/research/prosthesis/http://www.media.mit.edu/resenv/GaitShoe/http://www.ifr.mavt.ethz.ch/research/prosthesis/

9. Superior design standards FDA regulations  Classification: External limb prosthetic component  Requires failure and complaint reporting  Exempt from pre-market notification  Exempt from good manufacturing practice

10. Superior design standards Fail-safe mechanisms  Powers off when shoe or prosthesis detached  Control or sensor failure defaults to passive mode  Can be switched manually to passive mode  Simple battery replacement and testing  Self-diagnostic program allows easy calibration and testing at home

11. Additional applications Other joints for symmetrical prostheses PHOTO CREDITS: http://health.allrefer.com; http://www.waramps.ca; http://www.ksaria.com; http://www.allaboutmydoc.com Robotics Automation Total joint replacement Real-time measurements for rehabilitation Other symmetric joints for prosthetics

12. Target Market Approximately 60,000 new patients in need of a lower limb (transtibial) prosthesis annually Diabetes  5% of Canadians suffer from diabetes, rate is currently increasing by over 1% every five years  15% will develop a foot ulceration  10% will require amputation  over 50% of all leg amputations are performed on diabetics  market will continue to grow for many years as population ages This product would be ideally suited for the young and the active

13. Market Share and Competitors Most widely available foot prostheses products have little, if any, functionality besides aesthetics Foot prostheses products generate approximately $500 million annually in North America, and currently cost anywhere between $7,000 and $20,000 Minimum 5-10% market share at 5 years, revenue of approximately $25-50 million annually Plan to approach Canadian government for possible subsidization or coverage for patients to increase availability and revenues

14. Product Life Cycle Currently reaching end of stage III Product will be reaching profitability in near future

15. Development Times – Gantt Chart TODAY

16. Business case - Investment ConceptCost (USD) / 2 years Patent 1 8,000 Research & test phase 100,000 Prototype250,000 Prod. Plant set-up500,000 Miscellaneous (pub., reg., etc.) 80,000 Prod cost per unit (inc. packaging, etc) 1,920,000 Prod cost fixed (rent, utilities, salaries, etc.) 2,400,000 1. http://www.patents.com/cost.htm PHASECOST USD Initial108,000 Prototype250,000 Plant set-up580,000 Production4,320,000 Total (2 Yr.)5,258,000 USD

17. Investment Analysis Market analysis gives approximate Time to Revenue (TTR) of 2 years. Partnership with existing industries can extend market share and reduce TTR. Possibility to acquire external investment sources (Capital growth, dilution). Estimated time to investment recovery from 4 to 6 years

18. Conclusions Novel product that will improve more than just walking for lower limb amputees Not much regulatory concern Promising consumer market Flexibility for alternatives Staged product development plan INVEST NOW!

19. Questions?