About us
Re5 ApS is a Danish privately owned MedTech development company which was founded in 2000. The company has developed a new and innovative technology by which neurons in the brain can be activated by use of electric pulses with a particular shape, intensity and duration.
The Re5 Treatment System takes advantage of the fact that coils can create pulsed electromagnetic fields that consequently gives rise to such pulsed electric fields in the brain. The pulses as well as the coil configuration are patented by Re5 Aps and is unique for the treatment concept. Research in the Re5 company is aiming at defining new treatment concepts for other neurological diseases based on this technology.
Management
Peter Schøller-Larsen
Peter Schøller-Larsen, former and from 1985-2008 CEO of K.V. Tjellesen A/S - Denmark's second largest pharmaceutical wholesaler.
Peter, who established his first company more than 47 years ago, is an innovator and has been the initiator to and architect behind the development of several companies. He has an international education and background.
Peter joined Re5 full time as CEO in April 2008.
The Board
The Board of directors consists of chairman Nicolai Mallet, lawyer and partner in one of Denmark's largest law firms, Dahl, Mads Brydegaard, Partner in the IT company Bosco A/S and Peter Schøller-Larsen, head of Re5 ApS.
Nicolai Mallet
Mads Brydegaard
Peter Schøller-Larsen
Patents
- European Patent EP 1 216 076 B1
- United States Patent US 6,561,968
- United States Patent US 8,911,342 B2
CE approval
Marking
Re5 is a CE-marked medical device and thus meets the European guidelines for medical equipment (products for the diagnosis, treatment and alleviation of disease, injury and disability).
CE marking requires that the medical device is safe to use, is appropriate for its approved purpose and that the benefits of using the equipment is not disproportionate to its disadvantages.
The Norwegian Ministry of Health and Care Services notified body DNV Product Assurance AS (NB 2460) has issued the EC certificates to Re5.
Classification
Re5 is classified as a medical device Class IIa and consequently belongs to the electro-medical equipment - a subset of medico-tecnical equipment. Medical device equipment allows physical or electrical contact with the patient and / or transfers energy to or from the patient and / or detect such energy transfer to or from the patient.
Legislation
Basic & Clinical Research
Professor, Dr. Sc. Steen Dissing, Department of Cellular and Molecular Medicine, Faculty of Health, University of Copenhagen, Denmark.
Professor, dr. med. Per Bech and his research team at the Psychiatric Research Unit, Psychiatric Centre, North Zealand, Copenhagen University Hospital, Hillerød, Denmark, in collaboration with the University Hospital (Rigshospitalet, Copenhagen) and associate professor, dr. med. Erik Roj Larsen at the Department of Affective Disorders, Mood Disorders Research Unit, Aarhus University Hospital, Denmark have been the doctors conducting the two clinical trials that have been the basis for the CE approval for the treatment of Resistant Major Depression.
Professor, dr. med. Per Bech passed away in May 2018.
Production
Re5 cooperate with a leading northern European EMS manufacturing company, with an international platform for manufacturing electronics-based products that require high technology competence and flexibility through product lifecycles. The EMS supplier provides services for complete product lifecycles, with engineering, pre-production, industrialization, flexible serial production, box build and aftermarket services.
The company has several facilities including Northern Europe, Asia and Eastern Europe.
Their quality standards include ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, Workmanship IPC-A-610, UL and ATEX.
Re5 ApS contact information:
Re5 ApS
Niels Ebbesens Vej 31
1911 Frederiksberg
Phone: +45 50 531 410
E-mail: info@re5.com