Medical Polymer Solutions

Confidential. Protected under NDA

• Established in 1994

• Headquartered in SLC, UT

• 75,000 Square Feet

• 24 Hour Operations

• 150+ Active Customers

• Full Service Medical OEM

Manufacturing Capabilities

• ISO 9001:2008

• ISO 13485:2003 recommended

• www.biomerics.com

Confidential. Protected under NDA

• Established in 2004

• Headquartered in Ashaway, RI

• 45,000 Square Feet

– 10,000 Square Ft

Clean Room

• 24 Hour Operations

• 130+ years

Extrusion Experience

• ISO 13485:2003

• www.htpmeds.com

Confidential. Protected under NDA

Vision

MissionPremier Market Based

Customer Service

Operational

Excellence

Technology

and Innovation

S

T

R

A

T

E

G

I

E

S

•Market Focused

Organization

•Superior Quality

Products on Time

•Value Added

Services

•Competitive

Business Systems

•In-house Innovative

Materials Platform

•System Solutions

•Patentable

Technology

Development

Roadmap

•Portfolio

Management

•LEAN Manufacturing

System

•Vertically Integrated

Supply Chain

•ISO and FDA Quality

Systems

•OEM Customer

Partnerships

Vision

Partner with our customers to increase their productivity and

profitability through material technology and innovation,

operational excellence, and market based customer service.

Confidential. Protected under NDA

Quality Assurance

• Quality Statement

– Biomerics manufactures products that meet,

or exceed, our customers expectations. As a

team, we continually strive to perfect our

processes and products to provide superior

service to our customers.

Confidential. Protected under NDA

Quality Registrations

• Salt Lake City, UT

– ISO 9001:2008

– ISO 13485:2003 recommended

• Ashaway, RI

– ISO 13485:2003

Confidential. Protected under NDA

Quality Program Capabilities• Problem Solving Tools:

– Six Sigma Problem Solving Tools (DMAIC, 8D)– Lean Manufacturing Tools (5S, SMED, 7 Wastes)– Value Stream Mapping/Work Flow Diagrams/Process Mapping– Visual Management Systems (VFM)– 5 Why's, Ishikawa Diagrams– Root Cause Analysis

• Product and Process Validation

– Standard Work Documentation– DFMEA / PFMEA– Control Plans/Charts– First Article Layouts and Approvals– Process Capability Studies (CpK)– Real-time Monitoring Systems– IQ, OQ, PQ Validations– Lab testing for Analysis and Compliance– Risk Analysis and Risk Assessment

• Operational Tools:

– Preventative Maintenance Program– Mold Maintenance Program– Clean Room Process– Calibration Program– Risk Assessment Studies– Regular Internal Audits

Confidential. Protected under NDA

Manufacturing Capabilities

• Clean Room Manufacturing– Custom Polymerization

– Custom Compounding

– Pharma-Compounding

– Medical Extrusions

– Polyimide Tubing

– Medical Injection Molding

– Medical Device Assembly

• Other Capabilities– Machining & Tooling

– Support Services

– Quality Testing and Validation

Confidential. Protected under NDA

High Performance Polymers

High temperature and

chemical resistant

thermoplastic polymers

Materials

Thermoplastic Elastomers (TPEs)

Both thermoplastic and

elastomeric properties. The most

common medical grade TPE’s are

TPU & PEBA

Engineered Polymers

Rigid Polymers selected fro their

unique properties such as strength,

transparency, processability,

biocompatibility, and impact

Polyolefin's

Polymers produced from a

single chain carbon to

carbon monomers.

Confidential. Protected under NDA

Custom Polymer Development

• Biomerics has the ability to add the

following to any of our materials to meet

your custom polymer needs:

– Radiopaque Additives

– Specialty Additives

– Color Technologies

Confidential. Protected under NDA

Biomerics’ Proprietary TPUs

Confidential. Protected under NDA

Complete Biomedical Polymer Provider

Quadraflex™

•ARC, Aromatic Polycarbonate•ALC, Aliphatic Polycarbonate•Custom Grades

Quadrathane™

•ARC, Aromatic Polycarbonate•ALC, Aliphatic Polycarbonate•Custom Grades

Quadraplast™

•Rigid Aromatic Polycarbonate•Clear Grades•Custom Grades

Quadraphilic™

•ALC, Aliphatic Polycarbonate•ALE, Aliphatic Polyether•Solution Grades•Extrusion Grades

Quadraban™

•Silver based•Antimicrobial•CHC, Quaternary Ammonium Chloride

Medical Material Compounding

• 6 Medical Compounding Machines

• High Performance Pharma-Compounder

• Clean Room Compounding of:

– Liquids

– Powders

– Fibers

– Pharmaceuticals

Confidential. Protected under NDA

Medical Extrusions• 14 State-Of-The-Art Medical Extrusion Lines

– 3/4” to 2”

– Proprietary Take-Off Equipment

– 11 pullers, 6 bump pullers

– 50+ custom screws, 18+ custom heads

• 2 Dedicated R&D Lines

• Specialty Extrusions– Micro-extrusions

– Multi-lumen extrusions

– Multi material Co-extrusion

– Multi-layer (2,3,4)

– Profile Extrusions

– Coated Wire

– Taper and Bump Tubes

– Fiber Optic Jacketing

Confidential. Protected under NDA

Polyimide Tubing and Coated

Wire• Wire Coating Line and Co-extrusion

– 0.0060-0.080 ID Range

– 0.0005 – 0.010 Wall Thickness

– Colors: Amber, Black, Red, Green

• Specialty Polyimide Tubes– Micro-extrusions

– Multi-lumen co-extrusions

– Multi material co-extrusion (urethane and Pebax)

– Coated Wire

– Braided and Spiral reinforced

• Secondary Operations– Laser Cutting

– Necking

– Drilling

– PTFE LinerConfidential. Protected under NDA

Medical Injection Molding

• 25 Injection Molding Machines

• Clean Room Medical Molding

• Support Capabilities– Closed loop material drying systems

– Centralized plant cooling system

– Full regrind and drying systems

– Robot automation

• Molding Technologies– Hot runner systems

– Insert Molding

– Intrusion Molding

– Master Batch Colorant

– Trim and Deflash

• Process Control– Velocity and positional controls

– Ejection sequences

– Temperature profiles

– Pressure

Confidential. Protected under NDA

Medical Device Fulfillment and

Assembly• Clean Room Capabilities

- Kitting

- Light Assembly

- Ultrasonic Welding

- Packaging In Rigid Trays and Pouches

- Solvent Bonding

- Validation Testing

• Additional Capabilities (not in clean room)

- Pad Printing

• SLC Sterilization Resources- Steris Isomedix – Gamma Sterilization

9 miles away

- Sterigenics – ETO Sterilization 10 miles away

Confidential. Protected under NDA

Machining and Tooling

• Capabilities– 2, 3, 4,5 Axis CNC Milling

– Swiss Machine Turning

– Live Tooling

– Mill from billet

• Plastics Machining Operations

• Precision Metal Turning

• Secondary Operations to

molded parts

Confidential. Protected under NDA

Value Added Support Services

• Product Design and Development

• Patent Services

• Tool Design

• Process Development

• Rapid Prototype Services

• Testing and Validation

• Design for manufacturability

• ISO and FDA regulatory services

• IQ, OQ, PQ validation

Confidential. Protected under NDA

Testing and Validation

• R&D Material Development

• Incoming Raw Material Certification

• In-House Material QC

• Extensive Quality Lab Testing Capabilities

• Inspection and Measurement

Confidential. Protected under NDA

Biomerics Medical – Focus

Peritoneal Dialysis Catheter

Medical Value Chain

End Users:Hospital, Cath Labs, Cardiologist

•3000 Practicing•Application•Cost/Performance•Purchasing Groups

OEM Device Distributor

•Distribution•Packaging•Marketing and Sales•Fulfillment

Medical Device OEM

OEM ManufacturersSemi-Finished GoodsSuppliers

•Thermoset Elastomers•Engineered Plastics•Thermoplastic Elastomers•Fluoropolymers•Performance Metals

•Compounders•Extruders•Molded Shapes•Accessories

•Development•Manufacturing•Testing and Validation•Packaging

•Development•Manufacturing•Trials and Regulatory•Marketing and Sales

Raw Material Suppliers

Confidential. Protected under NDA

Contact Us

• Travis Sessions, President & CEO

• Troy Mohr, VP Business Development

• Amanda Crowell, Customer Service

Biomerics, LLC

2700 S 900 W

Salt Lake City, UT 84119

801-355-2700

www.biomerics.com