In 1999, two scientists from Aalborg University and three doctors from Aalborg Hospital founded the company CardioTech Aps (former name for Mermaid Care) and discovered the unique benefits of ALPE, Mermaid Care’s core technology. They filed a patent for the ALPE technology and method, and continued the development of the technology through the University of Aalborg.
The two main areas of interest with ALPE technology were:
1) Using ALPE technology prior to the “intelligent” ventilator (ICU Ventilation Assist System), in order to automatically set the most appropriate level of inspired oxygen (FiO2) for the patient, based on measurements of arterial saturation and end-tidal expiratory oxygen.
2) Using ALPE technology as a stand-alone product, in order to measure the Pulmonary V/Q mismatch non-invasively.
No other products on the market could offer this functionality, making ALPE technology unique.
From 1999-2005 intensive research and several clinical trials were performed to generate proof-of-concept for ALPE technology. A simple product-prototype for using ALPE technology was built by the university to generate the clinical evidence needed, in order to create the proof-of-concept for ALPE technology.
In late 2005, new investors joined CardioTech. They provided the necessary funding to make ALPE technology a commercial product.
In 2006, CardioTech Aps changed the name to Mermaid Care A/S, signalling a new era for the company.
Between 2006 and 2010, a development project was initiated at Mermaid Care to establish ALPE technology as a stand-alone product for the pre- and post-surgery stages of anaesthesia, in order to diagnose and monitor patients with reduced respiratory capabilities (expected pulmonary V/Q mismatch). The target was to develop the product ‘ALPE Essential’, and make it a commercial product, CE marked, and ready for marketing and sales – all of which was achieved in this period.
In 2010, a new CEO joined the company and a new strategy was developed and executed. The overall strategy was to:
1) Penetrate the European market with ALPE Essential.
2) In addition use ALPE technology as a stand-alone product for the pre-operative stages of anaesthesia as well as in ICU.
3) Strategize the process and enable the development of ALPE technology as an “intelligent ventilator system”, to be used as an integrated part of mechanical ventilators in ICU (Ventilation Management System).
The strategy was executed in the period 2010-2013:
- The product, ALPE Integrated, was developed and launched to the European ICU market in 2012. ALPE Integrated is a diagnostic device, which can measure the pulmonary V/Q distribution.
- Both ALPE standalone products (ALPE Essential and ALPE Integrated) were rolled out to key opinion leaders in Europe.
- Market and distribution channels were established in Italy, Austria and Switzerland in the period 2011-2013, utilizing partners with key competences in the ICU sector and a proven track record in customer relations.
In mid-2013, our vision started to come to life. Based on market requirements, commercial attention and support from our shareholders, we kick-started the process to complete the R&D for our Physiological Based Ventilator Assist and Intelligent Monitoring System, the BEACON Caresystem.
We strongly believe that the BEACON Caresystem will change how ICU patients are managed while receiving ventilatory support.
The BEACON Caresystem will be introduced to the European market throughout 2014.
Our mission is to create value for the healthcare market, our employees, and the shareholders of the company by developing, manufacturing, marketing and servicing innovative medical devices for ventilator management in compliance with international standards.
We want to be recognized globally amongst key opinion leaders and commercial partners as the most innovative company providing leading technology, care systems and solutions for optimizing ventilation management during the anaesthesia process and in Intensive Care Units.
Chief Executive Officer: Jørgen Hansen
Jørgen Hansen’s 20-year career encompasses pioneering efforts in medical devices and executive roles in healthcare corporate development, strategy, fundraising, and general management. His expertise is in imaging, oncology and respiratory care devices.
Prior to his current position, Jørgen was Managing Director of Byrum Healthcare, Business Unit Manager Nordic at Philips Healthcare and Managing Director of ADAC Laboratories A/S.
He is a member of the Advisory Board of Biomed Community, a cluster organization for medtech firms in northern Denmark, and is a board member of MedicQA, a firm specializing in medtech quality assurance processes and consultancy.
Jørgen’s qualifications include an MBA with specialization in International Management. He joined Mermaid Care in February 2010.
Chief Technical Officer: Claus Lindholt
Claus holds a BSc in Electronic Engineering from Aalborg University. He has a lifetime of experience in business management and project management in areas such as product development (electronics, mechanics and software both in telecommunication and medical devices), technology transfer, patenting, production and testing technology.
Claus is also a specialist in the regulatory requirements and standards for medical devices. He has extensive experience with CE-marking and has until now moved four medical devices from concept to certification.
Besides the responsibility for R&D, Claus is responsible for order handling and quality management. Claus joined Mermaid Care in April 2006.
Søren Svenningsen, Chairman
CEO SDS Holding A/S
Mette Vagner Johannesen
Managing Director of Investeringsselskabet af 30.04.1992 A/S
CEO Mermaid Technology A/S
Professor of RCare at Aalborg University
Mermaid Care’s employees and research partners have specific and advanced skills and competences in the following areas:
- Physiological based Ventilation Management, Intelligent Monitoring and Pulmonary Diagnostics
- Decision Support and Mathematical model building
(Pulmonary Gas Exchange, Lung Mechanics, Respiratory Drive, Acid-Base chemistry of blood, Oxygen and Carbon Dioxide transport in the lungs and blood, etc.)
- Fast time-to-market development process
(Customer requirement driven V-Model development model with room for iteration, agile methods and rapid prototyping including quality management and design control certified to EN/ISO13485, integrated ISO14971 risk management process and requirement specifications to SW-unit level in compliance with IEC/EN62304 and IEC/EN62366)
- Business development
(BtG and BtB sales management, organisational development, Commercial, Clinical and Research Partnerships and IPR strategy)
Mermaid Care applies and maintains a quality management system based on the EN ISO 13485:2003 standard and in compliance with Annex II of the European Medical Device Directive (MDD 93/42/EEC).
The EN ISO 13485 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The scope of the EN ISO 13485 certificate is: “Design, development, production and servicing of equipment for measuring gas exchange impairment.”