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“Dealing with sudden cardiac death: We are taking the next step in extracorporeal resuscitation.”

Thomas Kraft has been Chairman and CEO of Resuscitec GmbH since the beginning of October 2022 and took functional responsibility for Sales, Marketing and the Medical Alliance. He has twenty years of experience in medical technology and previously held management positions at international medical technology companies. We spoke to him about his first months at the company, CARL’s unique selling points and his vision for the future of Resuscitec GmbH.

Mr. Kraft, you have been CEO of Resuscitec GmbH for two and a half months. How have you experienced this time?

Thomas Kraft: Fast-moving, multi-faceted and very enriching. Unbelievable how time goes by (laughs). For me personally, it was first of all important to get to know our employees and our customers as well as the processes around resuscitation care for patients. Both in the company and in the healthcare sector, it is the people and synchronised processes that make the difference.

In this respect, I think it is important to understand the perspective of all those involved along the patient care chain, in our case the rescue chain. Who interacts with whom, when and how? For example, I can’t get out of my mind the importance of lay resuscitation in the first minutes of sudden cardiac death. Without this, survival is not very likely, and we all know how heterogeneous and sometimes poorly developed our social knowledge is in this regard. This is followed by the deployment of the emergency physicians: What are the everyday challenges they face in the event of resuscitation on site? How and why does which patient come to the hospital? How do the processes in the interdisciplinary competence centers work, where are their strengths with regard to a possible application of CARL and what can we do to enable the medical staff in the best possible way to implement CARL?

However, as a result of many discussions at congresses, in expert committees and in hospitals on site, it has also become very clear to me that the current framework conditions in the healthcare system in general, and in cardiac emergency medicine in particular, are very challenging: Be it the availability and qualification of staff, keeping response teams available for 24 hour emergencies, financial conditions or the coordination of interdisciplinary emergency teams – the aspects that need to be considered are manifold. In this respect, I was very pleased to have already met many users and parties interested in CARL. They are all joined by the impulse to provide patients suffering from sudden cardiac death the chance of neurologically intact survival.  

The CARL System and its components comprise a lot of technical features. In your opinion, what are the most important unique selling points of the system?

Thomas Kraft: The development of the CARL System is based on findings from both medical research and clinical application practice. Technological solutions were then sought or newly developed to meet these therapeutic requirements. We call it “Therapy guides Technology”.

One example is the supply of oxygen to the vessels after a prolonged period of reduced blood flow, which can lead to so-called reperfusion damage due to the formation of free oxygen radicals, among other things. Our solution is based on an automated mixing of ambient air with oxygen from an external source in order to precisely control oxygenation and decarboxylation. A second example is the establishment of a natural pulsatile blood flow, which is achieved within the CARL System by a powerful and automated dual pump in the extracorporeal circuit. Thirdly, I would like to mention the extensive measurement sensors with venous and arterial blood gas analysis as well as intra-aortic blood pressure monitoring by means of an optionally integrable fibre optic catheter. The listed technological examples and others are unique, but it is only their integration and automation in the overall system enabling users in emergency operations to implement a patient-specific therapy.

In summary: CARL Technology can improve the neurological survival of emergency patients after cardiac arrest through controlled reperfusion. Our mission is to facilitate lifesaving in any location, both in-hospital and out-of-hospital. For this purpose, CARL was developed as a mobility concept.

Das CARL. System mit seinen Komponenten

What do you currently see as the biggest challenge in your work for Resuscitec GmbH?

Thomas Kraft: We are a young, fast-growing company with an unleashed brand awareness.  With CE approval and the market launch at the beginning of the year, we have already been able to win well-known reference clinics and are currently focused on winning further centres for our clinical trials. Internationalization is certainly a challenge, as our clear goal is to work with leading reference clinics in 15 European countries within the next 12-18 months. Despite the EU-wide MDR guidelines, there are still local approval procedures and the inclusion of new therapy concepts in the country-specific financial reimbursement options are lengthy and costly, especially for small companies in the medical technology industry.  

In addition, we also encounter the post-Corona reality in the health sector, which complicates both the testing and the training of potential users. Through our CARL Academy, we have therefore set up a special program that includes both simulation training and e-learning modules. The training and empowerment of healthcare professionals is the key factor for interdisciplinary teams, especially in emergency situations.   

What are your future visions for CARL?

Thomas Kraft: Considering that currently a maximum of 10% or 20% of resuscitation patients survive a cardiovascular arrest outside or inside a hospital, and the few survivors often exhibit serious neurological sequelae, we derive from this our daily incentive to make CARL available to as many users and patients as possible. On the one hand, this is accompanied by the integration of CARL into regional care networks in order to optimise the critical factor of time along the rescue chain. For example, we are working on the possibility of using CARL in air rescue as well. On the other hand, we are continuing our internationalization, and, after Europe, we also want to access new markets for us overseas. After all, lifesaving with CARL in the event of sudden cardiac arrest should be possible anywhere in the world. 

In addition, we are continuously working on the further development of our technology platform in order to incorporate continuous improvements on the one hand and, on the other hand, to develop new indication fields in future.

Next year you are expecting the results of the PMCF registry study. What relevance will these results hold for you?

Thomas Kraft: Clinical evidence is highly relevant in the health care system and thus also for us as a company. Only based on clinical results it appears that a new procedure and/or a new technology has the potential to become a new “standard of care” within the health care system. In addition to a registry study on CARL, which was set up for monitoring and is currently still running, we have a portfolio of different studies and projects underway to investigate various questions from research and clinical application.

Just as important for us are presentations and publications from application centers that document and discuss the first clinical experiences with CARL. For example, the Regensburg University Hospital, one of the first CARL users in Germany, has just published its first case series. The Regensburg results are a first indicator of the potential that CARL may offer for resuscitation patients in terms of neurological survival.

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