BIOMATERIALSPOLYMER SOLUTIONS FOR THE MEDICAL DEVICE MARKET

ABOUT USBiomerics is a vertically integrated leading mid-market medical device contractmanufacturer in the attractive interventional medical device market.

Key Metrics:• 6 Locations • 418,000 square feet of facilities• 150,000 square feet of cleanrooms• 1100+ employees • ISO 13485:2016, FDA, CE Registered

3 Phase Design & Development Plan

Our world-class process ensures complete alignment at every step.

Forging strategic partnerships through execution

Value Streams

35%Engineered Components & Sub-Assemblies

14%Design & Development

51%Finished Device

BIOMATERIALS BALLOONS& BALLOONCATHETERS

We manufacture more than 20,000 medical balloons each week and play an integral role in designing and developing medical balloons and balloon catheters that push

the envelope of performance, including highly engineered

materials and customize techniques.

ADVANCED EXTRUSION

INJECTION MOLDING

MICRO METALS

Biomerics molds a wide range of components and medical

devices for the leading medical device companies. Operating over 40 molding presses, with

both vertical and horizontal molding capabilities, in low

and high volume capabilities.

Biomerics specializes in developing innovative, custom medical-grade polyurethanes to solve many of the unique applications required by the medical device industry. We know

and understand the specific details that go into manufacturing a material that performs within various medical

devices.

We combine our expert knowledge of laser processing capabilities, with

vertically integrated machining capabilities to create small and micro-type components used in

medical devices, in a wide range ofmaterials, tolerances, and configurations.

Biomericsproduces thermoplastic extrusions thatmeet the most

precise speci cations.From single lumen,dual or multi-lumentubing, includingco-extrusions,jacketing,

and tapered, our teamof professionals help movethe needle to manufacture

quality products.

QUALITYThe Biomerics Quality Management System is fully compliant with medical device design and manufacturing requirements. The system is flexible enough to allow our experienced Quality Engineers to use our customers’ requirements or leverage Biomerics’ internal requirements.

TECHNOLOGY CENTERS OF EXCELLENCEBiomerics uses a vertically integrated approach to manufacturing medical devices.Our 9 centers of excellence work seamlessly with one another to produce today’s medical device products.

SHAFTS, SHEATHS & STEERABLES

ASSEMBLY, PACKAGING

& STERILIZATIONWe have the ability to see a product

through from design and developmentinto production, to complete assembly, packaging,

sterilization management, and distribution.We pride ourselves on our ability to

provide a one-stop, hassle-free contract manufacturing source for our customers.

ULTRASONIC ENERGY,

SENSORSUsing high-end ultrasonic technology,

our dedicated teams provide exceptionalultrasonic solutions to our customers by leveraging industry knowledge and

experience to create world-class, customized products for our customers.

NEW PRODUCT DEVELOPMENT

We specialize in the design, development and the production of medical devices. Our services include braiding, coiling,

steerable and deflectable configurations, including SMART catheters.

Customers benefit from working with a cross-functional and committed team

of engineers, to support and guide them through a complete and

vertically integrated process, making medical devices a reality.

IR/CARDIOVASCULAR NEUROVASCULAR STRUCTURAL HEART CARDIAC RHYTHM MANAGEMENT

ENDOSCOPY

PERIPHERAL ACCESSVASCUALR ACCESS GI & UROLOGY LIFE SCIENCESROBOTIC SURGERY

MARKETSLeading companies in various medical segments partner with us to developand manufacture their devices. Our vertically integrated structure and specialized market focus provides our customers with unparalleled expertise and accountabiliity throughout the design, development and production processes.

TECHNOLOGY CENTERS OF EXCELLENCE

BIOMATERIALSWe offer the broadest portfolio of medical grade polyurethane chemistries,as well as specialize in developing innovative, custom medical-grade polyurethanes. Our Quadra™ family of medical-grade thermoplastic polyurethanes (including ElastEon) are engineered to meet the medical device market's demanding quality and biocompatibility requirements. In addition to offering products that can be used in applications from short term disposable to long term implantable, Biomerics’ vertical integration allows us to offer our customers more than just resin. Our range of in-house processing capabilities include custom compounding (colorants, radiopacifiers, lubricants, antimicrobials, etc.), extrusion, balloons, films, and injection molding.

Quadrathane™ALC & ARC

Family of polycarbonate-based, thermoplastic polyurethanes

Quadraflex™ALE & ARE

Family of polyether-based, thermoplasticurethanes

Quadrasil™ARES & ARCS

Family of co-polymer thermoplastic silicone polyurethanes

QUADRA™

Quadraplast™

Family of aromatic rigid thermoplastic polyurethanes

Quadraban™

Technology Platform for incorporating antimicrobial performance into any product in the Quadra Family

Quadraphilic™

Group of aliphatic, hydrophilic, ether based thermoplastic polyurethanes

Family of siloxane segmented polyurethanes

Family of carbonate silicone polyurethanes

Elast-Eon™

ECSil™

COMPOUNDINGAt Biomerics, we provide custom biomedical polymer compounding for the medical device market. Within our ISO 13485 certified facilities, we utilize our expertise in formulation development to produce custom compounds such as radiopaque fillers, coloring, and other specialty additives. Leading medical device companies choose Biomerics for our ability to deliver specialty compounds and formulations in an efficient and high quality manner.

MEDICAL-GRADE POLYMERS

Our compound manufacturing capabilities include:• Multiple Custom Compounders• Underwater Pelletization Line• Strand Pelletization Lines• Belt Air Cooled Pelletization Line• Controlled Feed Systems• Proprietary Water Treatment Systems• Integrated Material Drying and Handling System• Various Pellet Sizes Available

Commonly requested polymer and additive technologies include:

Thermoplastic Elastomers (TPE)

Florinated Polymers

Pharma Compounds

Engineered Thermoplastic Polymers

Commodity Grade Plastics

PVC & Non-DEHP PVC

1

2

3

5

4

6

• UV Stabilizers• Antioxidants• Flame Retardants• Impact Modifiers• Anti-static Agents• Lubricants• Fillers

• Nanocomposites• Radiopacifiers• Antimicrobials• Elastomeric Compounds• High Performance Polymers• Implantable Formulations• Fluoropolymer Compounds

Our highly trained technicians formulate, manufacture, and test critical polymercompounds in a controlled environment. We also maintain a full service qualitylab and we have the ability to characterize and certify each customer’s materialutilizing validated test methods.

HEADQUARTERS6030 W Harold Gatty Dr.Salt Lake City, UT 84116

SIX LOCATIONS TO BETTER SERVE YOU

SALT LAKE CITY, UT BROOKLYN PARK, MN ATHENS, TX

MONROE, CT CARTAGO, COSTA RICA PLYMOUTH, MN

Biomerics Advanced Catheter

10351 Xylon Ave. N., Suite #100 Brooklyn Park, MN 55445

Biomerics FMI

1605 Enterprise St.Athens, TX 75751

Biomerics NLE

246C Main St. Monroe, CT 06468

Biomerics Costa Rica

Edificio 22-23D Zona France Zeta

Guadalupe, Cartago, Costa Rica

Biomerics NLE

10005 51st Ave. N.Plymouth, MN 55442