Centro de Construcción de Cardioestimuladores

Overview On February 3, 1960, Prof. Orestes Fiandra performed the first effective pacemaker implant in the world. CCC was founded in 1970 dedicated to the development and manufacture of pacemakers We have 30 years of experience in the medical devices field and we are expanding activities to other engineering areas.

A brief history 70’s: Design and manufacture of pacemakers for the domestic market 80’s: Assembly of kits supplied by Exonix 90-94: Development of APEX series 95: Starting international business 97: Starting engineering and OEM business 02: Offices in Europe (i2m)

Today Some years of experience in the global market Two divisions: Pacemakers Engineering

Engineering Division We aim at the development of specific projects through direct agreements with customers, or by participating in agreements with other solution supplier companies. We have developed a substantial set of framework solutions and thoroughly tested modules; so, we can offer short lead times with uncompromising quality. We can offer rapid development of prototypes and new products together with high quality standards and low cost Our work is not limited to the medical devices field

Electronics Design, prototyping and circuit manufacture according to applicable international medical quality standards. Design and manufacture of monitoring devices. Design and manufacture of micro-power implantable circuits. Design of Application Specific Integrated Circuits (ASICs).

Firmware Development of embedded systems software, including real-time systems, signal processing, and communications. Development of complex systems involving real-time parallel processing. Development of microcontroller-based ultra-low power consumption solutions.

High-level Software Development of high-level software, including Graphical User Interfaces and software for the command of embedded systems. Development of special-purpose languages aimed at simplifying maintenance and operation tasks. Development of communications software, used with devices designed by CCC or by third parties Remote operation through the Internet. Integration of Data Base services.

Leads and Encapsulation Design and Manufacture of special purpose, chronically-implantable leads. Medical-grade encapsulations including titanium and epoxy enclosures. Mechanical solutions for medical devices Medical-grade packaging, including blister packs and ETO sterilization.

Project Leadership & Consulting Project management and leadership of mission- critical projects, integrating our capacity and engineering capabilities with the customer’s resources. Wide experience in international multi-center projects. Feasibility studies in areas such as micro-power electronics, real time software development. Consulting services in Software Engineering and SQA.

The innovation path Basic Research Applied Research Customer Services Distribution Manufacture Lab Prototype Industrial Prototype Product Market Pull Technology Push our services

Some clients and partners Illini Group Neurostream

Example From the lab to CE mark and FDA approval Start-up company from US - Israel CCC: 1998: lab prototype 1999: 1st implantable prototype (animals) 2000: refinements, prototypes 2001: clinical trials (Italy) - Starting CE Mark 2002: CE Mark 2003: developing a new model

Pacemaker Division Pacemakers & Leads: Uruguay: direct sales Latin America: Distributors Circuits & Parts: Russia India

Pacemaker Division We are focused in design and manufacture activities We are expanding Sales capabilities We are looking for partners able to promote and commercialize our products

Products Pacemakers ALFA, external APEX series long duration ARGOS series small size TEROS series Based in CCC ASIC Neuro Research centers Cardiomyoplasty LD-PACE II Commercialized by Illini Group Leads Unipolar IS-1 Bipolar IS-1 Cardiomyoplasty

Argos Series SSI – SSIR Hybrid circuits Small size

External Pacemakers Custom Holters Signal acquisition Specific stimulators

Programmer One programmer for all series Easy to use Log ECG display Remote monitoring Custom data base developments

New developments Teros DDD, DDDR 2nd quarter 2004 Teros SSI, SSIR First implant, October 2003 Implantable Defibrillator: starting 4th quarter 2003

Quality Assurance ISO 9000:2000 ISO Inspections and reviews Design reviews Quality Systems Audited by the Client SQA Audited by DHC Associates British Standards Institute Successfully audited in March 2002, March 2003

Strategic Partners and Clients Impulse Dynamics – USA, Israel CNM, Europe (i2m) LMT – Russia Aeromedical, Argentina

Thank you...