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Title: A1256655907zUgxW


1
American Innovation Forum March 31st, 2008
2
History
  • On February 3, 1960, Dr. Orestes Fiandra
    performed the first effective pacemaker implant
    to a human being in the world.
  • In 1970, Dr. Orestes Fiandra founded CCC, to
    develop and manufacture pacemakers.
  • So up to date this means 48 years working with
    implantable medical devices in Uruguay and 38
    years of experience in manufacturing.

3
Pacemakers
  • Products
  • TEROS pacemakers
  • ALUS Programming System
  • Leads
  • Circuits Parts
  • We sell in Uruguay to the FNR and export to few
    countries. Our pacemakers have the CE mark. We
    are not interested in expanding our exports.
  • Today sales of pacemakers represent less than 10
    of the total sales.
  • Development of this sector is not a priority.

4
Today
  • CCC is mainly an engineering company dedicated
    to the development and manufacturing of medical
    systems including active implantable devices.

5
Current Main Business Lines
  • Contract design and low scale manufacture CCC
    designs and manufactures medical systems
    including implantable devices for third parties.
  • Know how transfer CCC sells know-how for
    implantable devices manufacturing.
  • IP licensing CCC sells licenses to other
    companies to use some of its technologies.

6
Design and Manufacture under Contract
  • It is our main business. Our customers are
    companies that conceived an original method to
    treat a disease that implies using a new active
    implantable device. They contract us to design
    the device and complementary accessories
    according to their requirements and to
    manufacture the needed units for animal
    experiments and clinical trials.

7
Design and Manufacture under Contract
  • Customers companies that conceived a treatment
    for any disease involving the use of an active
    implantable device.
  • They contract us to
  • design the device and its accessories,
  • build breadboards, prototypes and small series,
  • elaborate the documentation required for
    regulatory purposes.

8
Expertise Areas
  • Electronics
  • Firmware
  • High-level software
  • Mechanical design
  • ASIC design
  • Leads and encapsulation
  • Communications
  • System integration

9
Implantable Medical System
Patient wand
ID Leads
Programmer System
Logger
PSA
Battery charger
10
Implantable Devices (ID)
  • They have two main functions
  • Applying a therapy, usually by delivering
    electrical signals to some organs or tissues.
  • Monitoring relevant parameters or signals in
    order to avoid risks to the patient or to
    optimize his treatment.
  • They usually are capable of measuring and
    analyzing electrical and mechanical physiological
    signals. They transmit this information
    (monitoring function) or use it as input data for
    the therapy.

11
Development Platform
  • Communication protocols and modules
  • Sensing modules
  • Pacing modules
  • Wireless battery recharge module
  • Lead impedance measurement modules
  • Accelerometer modules
  • FW download module
  • RTC module

12
Design Process
Customer
Idea / Concept
Research
13
Application Fields of Some Systems Developed by
CCC
  • Heart Failure
  • Obesity
  • Diabetes
  • Neurostimulation
  • Blood pressure control
  • Foot drop correction
  • Urinary incontinence
  • Patient monitoring
  • Sleep apnea

14
Implantable Systems Market
  • 5 big companies
  • share more than 98 of the market (mainly
    pacemakers and ICDs).
  • design and manufacture their products but do not
    act as contract designers or manufacturers.
  • buy patents and technology from small companies
    in the field or eventually buy the companies.
  • Start up companies created to check the
    feasibility of treating a disease using an
    implantable device implementing a therapy
    conceived by themselves
  • few per year, mainly from US, Israel and Canada
  • without capacity to develop and manufacture the
    devices

15
Implantable Systems Market
  • To develop and produce the systems, they usually
    have two options
  • hiring independent persons or companies (for
    example, electronics and mechanical designers,
    contract manufacturers, etc.) with expertise in
    one or several tasks necessary to develop and
    produce the system,
  • contracting CCC, which is the single company
    working as contract designer and manufacturer
    with the capability of developing and
    manufacturing (in small quantities) the whole
    system.
  • The quantity of implantable devices developed per
    year for the start up companies grew
    significantly in the last two years but it is
    still very small.
  • CCC designs more than the 50 of these devices.

16
Know-how Transfer and IP Licensing
  • CCC signed agreements involving the transference
    of its implantable devices manufacturing know-how
    to companies from India and from US.
  • CCC sold licenses to use some protocols and
    modules that it developed to some start ups that
    opted by developing their devices themselves.

17
Strengths and Uruguay factor
  • Which are CCCs competitive strengths?
  • Single source ? Single responsibility
  • Speed and lead times compliance
  • Experience and very good references
  • Is being located in Uruguay a disadvantage?
  • Yes, to sell pacemakers and at the beginning to
    sell projects. This has been reverted now.
  • Conference calls, Internet, etc. allow good and
    cheap communications.
  • Components supply is not a problem.
  • It is an advantage in order to hire highly
    qualified personnel and a difficulty to get
    specialized consultants.

18
Certifications
  • ISO 90002000 (BSI)
  • ISO 134852003 (BSI)
  • CE Mark for design and manufacture pacemakers and
    accessories
  • CE Mark for TEROS family pacemakers
  • CE Mark for ALUS Programming System
  • CE Mark for several customers devices

19
FDA
  • IDE for several implantable devices designed for
    our customers
  • Quality System compliance with FDA 21 CFR Part
    820 (QSR)
  • Near future
  • 2008 Q2 GMP facility authorized by the FDA
  • 2008 Q3 PMA of an implantable device designed
    and manufactured by CCC.

20
People Facilities
  • Number of Employees 125
  • Number of Engineers 45
  • Facility surface 2000 m2
  • Class 100.000 clean area 132 m2
  • Class 10.000 clean area 12 m2

21
Our People
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