CARL. Year 1: Successful start into the marketing
After many preparations and the successfully passed CE certification, the CARL System was launched at the beginning of 2022. In addition to setting up study centers to implement the multicenter PMCF registry study, renowned reference hospitals could already be gained as CARL users in this first year. Their initial clinical expertise was already presented and published at various congresses and symposia at the end of the year. And talking about presentations: The CARL. Design and the trade fair presentations were praised by all customer-relevant emergency teams as “Strong. Technological. For rescue.”
“As a company, we have grown strongly, increased our number of employees by about a third and set up our processes and procedures for the coming years,” reports Jörg Ronde, CFO of Resuscitec GmbH. “Particularly in production, purchasing and supplier management, it was also necessary to absorb the uncertainties due to the external framework conditions and to secure our added value, which the entire team managed to do very well. In addition, we were also able to achieve the annual goals in the administrative area, which form the building blocks of the company’s future development. Thus, for example, we have established a compliance system, expanded the communication processes via website, social media and intranet, and professionalised investor relations.”
Nonetheless, after certification is before certification: At the end of the year, TÜV Süd comes for MDR certification. “We are very confident and have prepared ourselves very well to overcome this regulatory hurdle, which is particularly challenging for small companies like us,” emphasises Christoph Benk, CTO. “Likewise, we have submitted FDA pre-submission, as FDA approval is just as important to us as the further technological development of our CARL products,” says Benk. “In addition, we have successfully implemented in-house developments this year, especially in the area of production automation.”
“We as the management are proud of our team and its performance this year,” sums up Thomas Kraft, CEO. “The achievements this year give us the confidence and energy to master new challenges in the new year and to actively shape the establishment of CARL in the European area.”