The salmon roe containing device (VERNEX®) is under development for a CE-marked (EU) wound healing Medical Device, class IIa or IIb (dependant on final claim), followed by a 510k (US) clearance post CE-marking. 

The intended use for VERNEX® is assumed to be:

  • Partial and full-thickness wounds
  • Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
  • Pressure ulcers
  • Chronic vascular ulcers
  • Diabetic ulcers
  • Surgical wound (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
  • Draining wounds

The approval times by a Notified Body for CE marking of a class IIa or IIb product is estimated from 3 to 6 months  for a marketing time of 3 years. This allows marketing of the device across all EU(EEA) member states.

Class Approval Validity Renewal Complexity Costs
Class I NS/NM < 1 Month No expiry N.A.  simple  low
Class I S/M 3-5 Months 3 Years 2 Months  simple  low
Class IIa
3-5 Months 3 Years 2 Months  medium  medium
Class IIb 3-6 Months 3 Years 2 Months  medium  medium
Class III 6-9 Months 3 Years 2 Months  high  high

* NS=non-sterile  **S=sterile

 Regenics development portfolio and contemplated development timeline towards CE marking is shown below:

Figure 1 Product development - regulatory timeline

 

 

The prospective profile of Vernex® will support scientifically documented and patented claims:

  • VERNEX® speeds up reepitelialization of wounds
  • VERNEX® skin safety tested
  • VERNEX® causes no irritation or sensitization
  • VERNEX® delivered as hydrogel formulation
  • VERNEX® increases fibroblast migration
  • VERNEX® increases collagen synthesis
  • VERNEX® enhances hyaluronic acid secretion
  • VERNEX® increases elastin production
 
 

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.