Management

Dr Niels Katballe and senior mechanical engineer Peter Heydorn founded Pleuratech ApS in collaboration with Oestjysk Innovation A/S, who offered support in the form of expertise in business development and financing via the Danish Ministry of Science.

The result of collaboration among experts

The Pleuratech KatGuide is the result of a process involving a large number of collaborating companies, hospitals and authorities.
Collaboration with experts in various aspects of the process resulted in a unique, high quality product – one which could have an incredible impact on the future treatment of patients in need of a large bore chest tube.

• Business development advice: MTIC (Med Tech Innovation Center) in Aarhus and the Technology Transfer Office, Aarhus University
• Regulatory aspects of developing a medical device: Greendale Medical.
• Choosing and testing materials with ideal specifications for the KatGuide: Danish Technological Institute
• Design according to Pleuratechs’ specifications: Made by Makers
• High quality medical device production standards: Knudsen Plast A/S and Recon
• Provision of plastic material: Dupont
• Sterilization procedures: Sterigenics in Wiesbaden, Germany

Clinical trial

The clinical trial follows all principals for good clinical practice and is approved by The Local Ethical Commity, The Danich Data Protection Agency and The Danish Medical Board of Health. The clinical trial is a prospective randomized parallel group controlled trial, where the KatGuide technique is compared to the conventional method of chest tube insertion.
The clinical trial is reported to ClinicalTrial.gov. In order to conduct a high quality clinical trial, Pleuratech ApS collaborated
with Biostata ApS, who has the statistical expertise and long time experience in data handling.

Biostata ApS delivered the randomization. Klifo A/S supported with communication to the authorities concerning the approval of the clinical trial and also delivered the packaging of kits. Collaboration with Biostata Aps and Klifo A/S ensures that Pleuratech has had no influence on or knowledge of the randomization. The clinical trial is monitored by the GCP-unit of Aarhus University Hospital. The multi center trial is conducted on three university hospital units in Denmark (Aarhus, Aalborg and Odense). Collaboration with the above-mentioned companies, hospitals and authorities ensures high quality research in testing the KatGuide.