ARTICULARIS INC.presents

SynchroTalusTM

Developed by

Tanya HauckKaryn HoRohin IyerJoon LeeJorge TorresDerek Watt

Change is afoot!Change is afoot!

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

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

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

Existing Ankle Prosthetics: Options1. 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

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.

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 ofeach joint/limb measured togenerate force/momentvs. 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.

Our Product – SynchroTalusTM 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.html

•http://www.media.mit.edu/resenv/GaitShoe/ •http://www.ifr.mavt.ethz.ch/research/prosthesis/

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

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

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

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

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

Product Life Cycle

Currently reaching end of stage III

Product will be reaching profitability in near future

Development Times – Gantt Chart

2003 2004 2005 2006 2007 2008 2009 2010 2011

Initial research & devel.

Devel. of Prototype

Test phase

Regulatory

Plant opening

Time to market

Time to revenue

Investment recovery

TODAYTODAY

Patent 0%

Research & test 1%

Prototype 3%

Unit prod. Cost 38%

Fixed prod. Cost 46% Previous

1%

Prod. Plant 10%

Misc. 2%

Business case - InvestmentConcept Cost (USD)

/ 2 years

Patent1 8,000

Research & test phase

100,000

Prototype 250,000

Prod. Plant set-up 500,000

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

PHASE COST USD

Initial 108,000

Prototype 250,000

Plant set-up 580,000

Production 4,320,000

Total (2 Yr.) 5,258,000 USD

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

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!

Questions?