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Luke Helm: Director

of Business Development

Scott Castanon:

CEO Biomedical

Engineer

Contact:luke@symbientpd.comPhone: +1 760 687 4030 ext. 2www.SymbientPD.com

1061 La Mirada CourtVista, CA 92081 U.S.A.

Focus: Developing medical devices that use plastics.

Experience: 300+ successful designs since 2004. Highly experienced engineering team.

Speed: Internal prototyping, prototype mold fabrication and injection molding create efficiencies.

Flexibility: Large or small projects in a variety of phases.

Overview

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Our facility is specifically designed for the rapid design, development of medical devices that use plastics.

3Facility Located in Vista, CA

Joe Baker Director of Engineering, OperationsB.S. Mechanical Engineering7 years experience developing medical products *Life Technologies (now Thermo Fisher Scientific)

Engineering Team

Scott Castanon Founder/CEOB.S. Biomedical Engineering20 years in the industry*Hudson RCI and Dura Pharmaceuticals

Vince SoSenior Product Development EngineerM.S. Mechanical EngineeringVince has 10 years of experience designing and developing medical and life science devices. *ViaCyte, Applied Medical, Life Technologies (now Thermo Fisher Scientific) and Boston Scientific

Dylann Ceriani Director of Engineering Product Development M.S. Biomechanical Engineering20 years in medical product development *Breg, DJO Global

Michael WilliamsIndustrial Designer | M.S. Industrial Design14 years of experience, that includes extensive work in anthropometrics, human factors engineering and usability

Bob EiseleSenior Product Development Engineer | B.S. Mechanical EngineeringBob has 35 years of medical product development and engineering experience *Integra Life Sciences, Iapyx Medical, Reva Medical, Elan Pharmaceuticals and Shiley Laboratories

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Espir Kahatt Principal EngineerB.S. Mechanical Engineering20 years experience including 14 in biotech.*Life Technologies (now Thermo Fisher), Sequenome, Aurora Biosciences.

DEVELOPMENT PROCESSOverviewPhase 1

Define Product Requirements

Develop Concepts

Phase 3

Develop Detailed Design

Individually Prototype Critical Functions

Develop Integrated Prototype

Phase 2

Fabricate Prototype Molds

Mold and Assemble

Phase 4

Design Verification Testing

Phase 5

Transfer to ManufacturingTest and Iterate

Development Tools

CNC Machining 3 full time expert

machinists 4 Haas CNC mills

and 2 lathes. Precise machining

tolerances and fabrication of complex geometry.

Stereolithography (SLA)

Rapid design iterations; SLAs in

hours vs days.

Enables efficient high-risk function

development.

Transparent material with

mechanical properties of ABS

plastic, making it ideal for functional

testing.

Most accurate SLA available –

tolerance .003” (75 microns). High

quality prototypes yield valid test

results.

SLA is an invaluable development

tool to have in-house and our team

uses daily.

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PROPRIETARY PROTOTYPE MOLDING SYSTEM

Steel Mold Base – MUD Compatible | Brass Inserts – Easily Modifiable | Stainless Steel Core Pins – Robust

Benefits:• Closely replicates

production• Robust – 100K + parts• Quickly fabricated –

1-2 weeks• Quickly iterated –

1 day

• Transferrable – to any molder

• Bridge tooling –continue molding

• Learning – for production tooling

• Mitigates scale up risk• Inexpensive to fabricate

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DEVELOPMENT TOOLS: INJECTION MOLDING

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Production grade molding machines replicate manufacturing

Production quality parts Quantities:100’s to low 1000’s Invaluable for design verification

testing, user studies, clinical trials

Arburg 55 Ton Vertical

Arburg 38 Ton Horizontal

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INTERNAL ASSEMBLY, TESTING, TEST METHOD DEVELOPMENT Fully Equipped

Engineering Lab

Ultrasonic welding,

UV Bonding, Heat sealing

– all in house.

Experts in all plastic

assembly methods.

Custom Test

Methods and

Fixture

Development

Inspection and

Imaging CMM for

measuring critical

dimensions for

product release

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COMMITMENT TO QUALITYISO 13485:2003 CERTIFIED

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ISO 13485 is a set of international standards published in 2003 that specifies requirements for a quality management system that demonstrates our ability to provide medical devices development services that consistently meet customer and regulatory requirements.• Enables us to maintain the documentation required for FDA and CE

regulatory submission.• Critical for non-ISO certified clients who plan to seek regulatory approval.• For clients with a quality system, we can provide the needed inputs.

• Annual audits by BSI Group to ensure compliance.• Calibrated equipment• Continuously improved standards and procedures for every process.

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ACON LANCET DEVICE

• Achieved all functions with fewer components (lower cost) than competitive products.

• Patented and sold with ACON glucose tests.

• Uses two springs, whose force we optimized to create the puncture needed for a wide variety of patients, from people who bleed easily to those people who have thick calluses. Accomplished through research of anthropomorphic data, force testing and user studies.

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AUTO INJECTOR• Aspirates water, re-suspends a powdered drug• Button deploys the needle, injecting the

medication automatically • Uses 2 - 27 gauge insert molded needles • One needle was used to pierce a drug vial

septum. The second needle that automatically deploys for patient injection

• Resolved challenges to complete design for manufacturing, including excessive actuation force, latching and release of shield, needle occlusion

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GAS CELL POWERED SAFETY SYRINGE 13

See Videos of It In Action: http://www.symbientpd.com/portfolio-item/gas-cell-powered-safety-syringe

• Retractable-needle safety syringe that uses a gas-cell technology that provides a low-cost, disposable power source for medical products.

• Uses the stored energy in the gas-cell to propel the needle back into the body of the syringe.

• Key features include: • Usage procedures that mimics those of a

regular syringe• Cost competitive with other safety

syringes• Superior safety and lower actuation force

than other safety syringes• Creative, readily-manufacturable features that

accomplish a five-step needle retraction operation that is actuated in a single step when the user depresses the plunger at the end of travel.

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SAFESHOT – SAFETY SYRINGE

• From an early prototype, designed a fully functional 3 mL auto-retracting safety syringe

• Unique pressure driven retraction (no spring)• Plunger engages needle hub at end of travel

• Disengages the braking mechanism.

• Uses vacuum to retract needle into barrel

• Developed braking mechanism.

• Developed a custom non-coring needle with external texture at the blunt end, allowing for insert molding

• Developed a 1 mL version using same IP

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SAFESHOT – SAFETY SYRINGE

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PRESSURE-SENSING URINARY CATHETER16

Passive Sensor

Squeeze Valve

Insertion Device

Extraction Device

• Designed to enable spinal cord injured patients to know when their bladder is full and relieve it without need of intermittent catheterization.

• Wireless transducer transmits pressure to smart phone.

• Normally closed valve enables patient to relieve empty bladder on demand.

• Expected service life of 2 months.

CONFIDENTIAL

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CLOSED SUCTION CATHETER - HUDSON RCI

• Designed entire system and coordinated development through launch.

• Patented Closed Suction Catheter design.

• Safeguard that prevents inadvertent suction.

• Easy-to-operate suction control with filter.

• Duckbill valve isolates catheter from patient circuit.

CONFIDENTIAL

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BAXTER – NEEDLELESS IV VALVE

• Positive fluid displacement during disengagement to prevent blood coagulation occlusion.

• Currently on the market with annual volume in excess of 10 million units.

• Patent #: 6,755,391 and Patent App. # 10/844,785

BRAIN CHILLER PAD - SILICONE19

Inlet

OutletThermocouple location #1

Thermocouple location #2

• Reduces temperature of the brain tissue during surgery (found to improve surgical outcomes)

• Input and output port for coolant

• Insert molded soft aluminum sheet captured inside silicone enabled pad to be bent to conform to surface of the brain.

• Thermocouples are insert molded for measuring coolant temperature.

• Bottom of chiller pad sealed using a thin sheet of material.

Bottom View

Top View

WEARABLE DRUG PUMP

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• For delivery of low molecular weight heparins

• Medical grade adhesive for securing to skin.

• Automatic insertion and retraction of 30 ga.curved needle to 3.5 mm depth.

• Pinch valve to open fluid path to drug reservoir.

• Low profile (>5MM thick)• Drug driving mechanism

is a wave spring with pressure plate against flexible pouch.

Split septum port for filling with drug

Skin adhesive with peel-off backing

Fill-level indicator

Pulling actuation pin releases the needle and starts the drug flow.

Needle-retraction button

SKIN CANCER SCREENING DIAGNOSTIC

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• Custom medical adhesive / bandage assembly collects skin cell sample from a lesion.

• Adhesive is removed and bandage is placed into the cartridge.

• Top housing closed and buffer is dispensed through the bandage to deliver sample to a lateral flow test strip.

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ALKERMES – INSULIN DELIVERY SYSTEM

• Developed aerosol functionality and confirmation of performance for insulin dry powder inhaler in collaboration with Eli Lilly

• Resolved issues within 5 months that others anticipated would take a minimum of 16 months to resolve

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EZ-EKG

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• Disposable product allows for rapid application of EKG leads by paramedics in the field using a single pad

• Most significant challenge was the ergonomics to fit a large percentage of all patients, men, women and children in just three sizes

• Researched and specified optimal medical adhesive for the product.

EYE SPRAY DEVICE

CONFIDENTIAL24

• Eliminates the need for users of eye drop to tilt their head back to deliver liquid medication.

• Atomizes the liquid medication for delivery to the eye.

• User depresses overmolded elastomeric ‘button’ to create positive pressure and spray the medication.

SLEEP APNEA DEVICE DESIGN CONCEPTS

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