ARTICULARIS INC. presents TM SynchroTalus Developed by Change is afoot! Tanya Hauck Karyn Ho Rohin Iyer Joon Lee Jorge Torres Derek Watt 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: Options 1. 2. 3. 4. 5. Solid ankle Flexible material, with solid ankle Single Axis Multiple Axis Energy Storing (dynamic elastic) Source: Arimed http://www.arimed.com/prosthetics.htm “amputees continue to expend 35% more energy compared to normals” IEEE TRANSACTIONS ON REHABILITATION ENGINEERING, VOL. 6, NO. 2, JUNE 1998 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 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. Our Product – TM SynchroTalus 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 Other symmetric joints for prosthetics Total joint replacement Robotics Automation Real-time measurements for rehabilitation PHOTO CREDITS: http://health.allrefer.com; http://www.waramps.ca; http://www.ksaria.com; http://www.allaboutmydoc.com 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 TODAY Initial research & devel. Devel. of Prototype Test phase Regulatory Plant opening Time to market Time to revenue Investment recovery 2003 2004 2005 2006 2007 2008 2009 2010 2011 Business case - Investment Concept 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. 1,920,000 packaging, etc) Prod cost fixed (rent, utilities, salaries, etc.) 1. http://www.patents.com/cost.htm 2,400,000 Fixed prod. Cost 46% Patent 0% Previous Research & 1% test 1% Prototype 3% Unit prod. Cost 38% Prod. Plant 10% Misc. 2% 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?