SensaMove ArmSensaMove Technologies

Irena Barbulovic-NadStefanie Blain

Geneviève GaviganRohini Gupta

Jennifer KohlenbergGolnaz Vahedi

November 30th, 2005

Where’s my change? Problems with current prosthetics (suggested from literature

and by individual who uses four prosthetic limbs)

Weight Audible noise Unnatural appearance Durability Temperature Speed of arm’s movement Ease of Use Functionality

Objective Develop a prosthetic that improves upon:

Functionality

Weight

Audible noise

Ease of use

Outline Highlights of technology Biopsychosocial implications FDA approval Commercialization Questions

The SensaMove Arm

MMG electrodes

Artificial muscles

90º ROM elbow

Electroactive Polymer sensors

Supinating / pronating wrist

Open / close hand

User-trainedMicroprocessor

Sensors

Finger pressure sensors

Grip pressure sensor

EAP locationsGrip

Artificial Muscles

E.A. Moschou et al. / Sensors and Actuators B xxx (2005) xxx–xxx

Hydrogel

Artificial muscle

Muscle conformation

Training

Artificial Neural Network

User

Elbow

HandWrist

ICF Model

Get to Market: FDA Approval

Step 1defined by 201(h) in FD&C Act

Step 2no substantially equivalent PMA $90,910“de novo” process as Class II under 513(f)(2) 510(k) $3,066

Step 3performance standardsclinical performance datapatient registriespost market surveillanceguidelines

Step 1 Step 2 Step 3“Medical Device”

Classify Device

Data for Market

Submission

Competitors:

Motion Control, Inc.

Otto Bock HealthCare

T.R.S., Inc

Variety Ability Systems Inc.

Can we commercialize?

Commercialization: Market (USA data)

350,000 amputees - 30% upper limb loss

50,000 new amputations/yr - 20% upper limb

Target Clients: 100,000

Market increase from $5.2 billion in 2005 to $6.8 billion in 2010 (AAGR of 5.5%)

Source: BCC, Inc

Commercialization: The ‘So-So’ R&D:

New techniques in preliminary research

Legal: Concepts: Artificial muscle, MMG, EAP

Commercial: Acceptance – New training

Commercialization: The ‘Good’ Legal:

Patentable: Pressure Sensor, Complete arm People:

Dynamic team Skilled and Resourceful

Commercial: Address unmet needs for prosthetics Reach market in 3 yrs High market potential

Start Up Company

SensaMove Prosthetics

Lead Product: SensaMove Arm Platform Technology: Feedback Sensors Timeline:

Phase Milestone 6 mnth 1 yr 2 yr 3 yr

Research and Design Detail Design        

Prototype construction Prototype arm        

Testing Client use        

Commercial Production capability        

Total Units Sold 637Cost of Capital 8%Net Present Value $7,514,471.41

Year 1 2 3 4 5 … 10

Growth Rate 50% 50%No. of People Mng. 6 6 6 8 8 10Units Sold 0 0 0 20 30 225Patent Costs -$50,000Legal Fees, Insurance -$20,000 -$20,000 -$20,000 -$20,000 -$20,000 -$20,000Rent & Oprt. Cost -$100,000 -$100,000 -$100,000Equipment -$500,000 -$10,000 -$10,000 -$10,000Material -$50,000 -$280,000 -$420,000 -$3,150,0001 Prototype, 2 Demos -$100,000Marketing -$20,000 -$20,000 -$40,000 -$40,000 -$40,000R&D (subcontracting) -$20,000 -$20,000 -$20,000 -$20,000 -$20,000FDA Approval -$100,000Total Sale* $0 $0 $0 $1,400,000 $2,100,000 $15,750,000

Salaries $0 $0 $0 -$960,000 -$960,000 -$1,200,000Sales Cost (%10) -$140,000 -$210,000 -$1,575,000Tech. Support (%5) -$70,000 -$105,000 -$787,500Training (%3) -$42,000 -$63,000 -$472,500Warranty (5%) -$70,000 -$105,000 -$787,500Net Cash Flow -$120,000 -$160,000 -$660,000 -$352,000 $47,000 $7,587,500

*Price/Unit $70,000; Material Cost/Unit 20%;

Money Money Money

NPV = $7.5 MInvestment = $1.5 M

Technology that FeelsQuestions ?