bmt corporate presentation

“We are Made in Germany”

Bavaria Medizin Technologie GmbH

MEDICAL DEVICE PRODUCT DEVELOPMENT


BMT - HQ Bavaria Medizin Technologie, GmbH

Munich, Germany




BAVARIA MEDIZIN TECHNOLOGIE

CONTRACT R&D

ENG. SERVICES

PRODUCT DEVELOPM

ENT

PROTOTYPING LAB

MANUFACTURING

OEM DESIGN

FOR MFG

International

We Know How

Ø  VISION – To leave a footprint in the area of innovative product development and be regarded as a competent growth partner for our worldwide clients.

Ø  MISSION – To improve patients’ quality of life through the use of our products.

Ø  CORE VALUES: Ø  Innovative – Out-of-the-box thinking and speed in prototyping Ø  Customer Service – Relationship management through communication Ø  Quality – Deliver just the best no matter what the challenge is.


Bavaria Medizin Technologie GmbH About BMT



Ø  1992 – Founded R&D Group for needle injection catheter

Ø  1997 – Started OEM manufacturing and in-house balloon dev. prog.

Ø  2001 – Development of first Drug Eluting Balloons.

Ø  2004 – Business focus shifted from internal R&D to contract R&D.

Ø  2005 – Sold Drug Eluting Balloon Technology.

Ø  2007 – High volume / Low cost manufacturing facility in ROMANIA

Ø  2009 – BMT – CANADA created as the North American R&D Center

History

SERVICES

We Know How


CONTRACT R&D

Ø  Product Requirement Definition*

Ø  Performance benchmarking

Ø  Concept and prototype development

Ø  Feasibility builds

Ø  Design Freeze

Ø  Design Verification

Ø  Design Transfer to Manufacturing

Ø  Volume Ramp-up * - Applicable to Start-up companies


CONTRACT MANUFACTURING

Ø  High and low volume manufacturing

Ø  Full product traceability

Ø  Cross-functional team for continuous product improvement.

Ø  JIT and Lean manufacturing

Ø  Ship-to-stock program

Ø  Six Sigma implementation**

** - initiative is in progress

PRODUCT DEVELOPMENT

We Know How



Ø  GOAL – USING BMT EXPERTISE TO REDUCE PROJECT RISK AND TIME TO MARKET THROUGH PROOF-OF-CONCEPT (POC) DEVICES AND FIRST GENERATION PRODUCT FOR FIRST-IN-MAN (FIM)

Ø  ADVANTAGES: Ø  Minimize Risk to the project Ø  Professional project management – PMO office Ø  Accelerate development cycle Ø  Contained development cost Ø  Regulatory Approval: CE-Mark, 510(k), PMA Ø  Biocompatibility, Sterilization validation, Animal Studies Ø  OEM manufacturing (packaging, labeling, sterilized finished goods)



l  POC-to-FIM™ Ø  Proof of concept through dedicated hands-on POC staff.

Ø  Generate MRS and PRS

Ø  Access to Key Opinion Leaders in Europe and US.

Ø  Generate Commercialization and Development plans for Fundraising.

Ø  DHF organized as per FDA and ISO regulations

Ø  Organize and lead animal studies.

Ø  Generate first product for FIM.

CATHETER DEVELOPMENT

We Know How


CATHETER SHAFT TECHNOLOGIES

Ø  EXTRUDED TUBING Ø  Single and multi-lumen with & without loading Ø  Single and multi layers Ø  Size Range: .4mm to 10mm – ID & .5mm to 15mm - OD Ø  Tolerances: 0.01mm to 0.03mm Ø  Braided and Non-Braided Ø  “Splittable” tubing.

Ø  CATHETER PROCESSING Ø  Catheter assembly Ø  Stent Crimping Ø  Bonding Ø  OTW and Rx Ø  Catheter reflow Ø  Proximal hub design and bonding


BALLOON DEVELOPMENT PROGRAM Ø  BALLOON SIZES

Ø  Coronary OD – 1.5 to 4.0mm Ø  Coronary Length – 4.0 to 40 mm Ø  Peripheral OD – 3.0 to 15 mm Ø  Peripheral Length – 15 to 220 mm

Ø  BALLOON MATERIALS Ø  Grilamid, Polyurethane, PET, Ø  Vestamid, Pebax, Ø  Rilsane, Silicone

Ø  BALLOON PRESSURES: Ø  Nominal Pressure: 6 & 8 atm. Ø  Average Pressure: based on design. Ø  RBP : based on design.


CUSTOM BALLOON DEVELOPMENT

Ø  BALLOON CUSTOM CHARACTERISTICS Ø  Compliance curve design Ø  Sensor integration in balloons Ø  Balloon-in-balloon design Ø  Tight tolerance for stent retention and delivery Ø  Software simulation of balloon properties** Ø  Balloon folding Ø  Non-Drug Coating on balloon outer surface Ø  Balloon bonding

EXAMPLES

We Know How


Case Study 1 – Drug Eluting Balloon

Ø  Intended Use: Treatment of in-stent restenosis.

Ø  Paclitaxel coated-balloon catheters (Paccocath®) for coronary and peripheral applications.

Ø  Designed product handling performance and emphasized on process development.

Ø  Initiated and sponsored several clinical studies (i.e. THUNDER, ISR I).

Ø  Technology was sold in 2005 as an exit strategy.


Case Study 2: Long Balloons for PAD

Ø  Intended Use: PTA in SFA and BTK

Ø  New range of PTA: Ø  OD: 1.5 to 10 mm Ø  Lengths: 20 to 220 mm

Ø  Technical challenge is to keep this long balloons straight (e.g banana shape)


Case Study – 3: Needle Injection Catheter – GEN II

Ø  Intended Use: Local stem cell injection into the myocardial tissue.

Ø  Designed a three-needle injection system.

Ø  Technical challenges: Ø  Controlled protrusion of needles.

Ø  Sensor to detect vessel apposition. Ø  Catheter maneuverability

FACILITIES


Bavaria Medizin Technologie GmbH Germany

Ø  Cleanroom class 10,000

Ø  Six (6) laminar flow benches

Ø  Safety-work benches available


Bavaria Medizin Technologie GmbH Canada

Ø  R&D CENTER INFRASTRUCTURE IS IN-PROGRESS

Ø  BMT-CANADA OFFICE L6-111 Ø  BMT-CANADA LABORATORIES L6-104/106


Bavaria Medizin Technologie GmbH Romania

Ø  Brand New - 600 m2 facility

Ø  175 m2 cleanroom class 10,000


Feedback from some of North American Clients

Thomas R. Trotter, President and CEO of AngioScore, Inc.: "We were surprised by the tremendous cooperation and attention to detail we received from BMT. Especially when it came to special requirements which have had to be met on short notice BMT's very quick reaction time was extremely helpful for our fast growth in the market.”

Eric Schmid, Vice President, Engineering and Stent Development REVA Medical, Inc.:

"BMT’s expertise, adaptability and speed are matched only by their exceptional customer service and quality. They are truly a valued development partner and ’s success.”

Gera Strommer, former CEO of MediGuide:

"We are very pleased with the expertise, services and know how from BMT, who helped us a lot from an early development stage up to an CE approved product.”

Ben Ewing, Project Manager – MEDRAD, Inc.:

"Despite constantly evolving project requirements and demands, BMT is accommodating, responsive and has exceeded our expectations."
