Introduction to Carilex Medical. Overview  Manufacturer and designer of OEM and Carilex-branded wound care products o Specializing in therapeutic support.

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Presentation transcript:

Introduction to Carilex Medical

Overview  Manufacturer and designer of OEM and Carilex-branded wound care products o Specializing in therapeutic support surface systems for the prevention and treatment of decubitis ulcers (pressure sores)  Established in 1985 as Suzric Enterprises o Original concentration in textile and garment industry  Today, Carilex Medical has global operations and reach o Corporate office and manufacturing center outside Taipei, Taiwan o European operations based in Karlsruhe, Germany o North American office based in California, USA o Products distributed in over 40 countries

Company History and Milestones  Founded in 1985  Early 1990’s: Shifted industry focus to medical products o Leveraged garment and textile expertise to began OEM manufacturing of mattresses and coverlets 1995: Designed and manufactured first power control unit Collaborated with Industrial Technology Research Institute (ITRI) of Taiwan ( 工研院)  1998: Establishment of R&D team o Integration of in-house capabilities spanning from design and engineering to manufacturing and distribution

Company History and Milestones (cont’d)  2001: ISO certification for quality management systems for medical device  2002: Introduced I.P.S. Technology  2006: Established EU operations center in Germany o R&D, Sales & Marketing, Distribution  2007: Introduced A.R.T. Technology  2007: Established UK operations center in England o Sales & Marketing, Distribution  2012: Established North American operations center in United States o Sales & Marketing, Distribution  2012: Name changed from Suzric Enterprises to Carilex Medical

Our Team  Bringing together PhD’s, mechanical and electrical engineers, bio-engineers, and individuals with strong background in sales, marketing, regulatory, design, manufacturing, and finance  Multi-lingual o Primary language corporate office is Chinese, but bi-lingual English speaking team members work in all departments of the company o EU office able to conduct business in multiple languages  Industry experience includes medical device, IT, textiles, and finance

Our Products  Core focus is therapeutic support surface systems used for the prevention and treatment of decubitus ulcers (pressure sores)  In house design, manufacturing, and testing of entire support surface systems, including: o Many types of power control units that are used to precisely deliver therapeutic modalities to support surface (mattress) Alternating Pressure, Low Air Loss, Combination, Static o Multiple types of mattresses Standard and bariatric  Adding solutions to offer to the wound care market o NPWT systems 510(k) & CE approved, ready to launch in EU and US

Our Facility  Built in 2010 to accommodate growth and replace original factory in Taipei  Located approximately 30 miles west of Taipei in Taoyung County  6 stories  98,000 sq ft  State-of-the-art equipment

Our Quality Assurance System Quality System compliance with FDA 21 CFR 820 and ISO 13485, quality management system certified by DNV Our products certified to meet the safety requirement of CE & UL [EN ] o Critical for products sold throughout EU and the United States

Our Quality Policy  Continuous Innovation  Standardized Quality  Customer’s Satisfaction  Sustainable Business

Quality Validation and Verification All products are tested with strict quality validation and verification processes. To ensure our products’ effectiveness, we check all the key characteristics of the products to make sure that our products’ reliability and durability are up to the standards. In order to assure that the final product’s quality is equivalent to the pilot run, every process from design sample to mass production—including components purchasing, inspection, assembly, and delivery—has to pass through strict and careful validation.

Marketing and Distribution  Building on expertise and industry knowledge as global OEM to expand our efforts to design, build, and sell Carilex-branded products for global markets  Strong presence in Europe, UK, Scandinavia, Australia o Solid network of country dealers and distributors, including Middle East and Asia  Expanding presence in US

Future Direction  Expansion of product portfolio o Leverage expertise in manufacturing and textiles o Target opportunities that are within or tangential to current wound care industry segment and distribution networks o Create Intellectual Property around power unit and system design and performance  Expansion of global reach o Develop and serve additional regions and strengthen presence in current geographic markets o Create true global products

Thank you! SUPPORT SURFACESNPWT Thank You!