articularis inc. presents synchrotalus tm developed by tanya hauck karyn ho rohin iyer joon lee...
TRANSCRIPT
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?