Publisert 10.08.2016

Vernex™ Medical device non-binding opinion by SLV

The Norwegian Medicines Agency (SLV) has on August 10th 2016 preliminary reviewed the regulatory status of Vernex™. 

The Norwegian Medicines Agency (SLV) has on August 10th 2016 preliminary reviewed in a non-binding opinion the regulatory status of Vernex™. The review was requested by the Norwegian Health Directorate for initiation of patient inclusion into the clinical safety programme (REG002) approved by the Regional Ethical Commitee on June 9th. The  Medicines Agency has issued the opinion that Vernex™ is not a pharmeceutical substance/entity and thus the Company can progress its planned CE-marking programme under the Medical Device Directive (Council Directive 93/42/EEC). Approval from the Norwegian Health Directorate is still pending, but is expected shortly. First patient in (FPI) in the study is expected during Q4 2016. The REG002 study will enroll 20 subjects for a safety evaluation of Vernex™ in small 2nd degree skin burns.

 

 

Regenics AS has developed a number of assays and techniques to study effects of various substances on skin cells both in vitroin vivo and in the clinic. Our focus is to develop products and techniques for therapeutic skin applications and to improve skin appearance.