Regenics develops a new wound healing device (Collex™) in addition to Vernex®. Collex™ is a 3D printed all marine ingredient wound healing device.

Collex™ is in exploratory pre-clincial phase. Collex™ is a 3D-bioprinted HTX containing collagen producing alginate patch/bandaid where all components are from marine sources. The 3D construct is made from sea weed alginate and marine tunicate cellulose. The development is supported by a 17.3 mill NOK grant from joint EU commision and national fundors to 2022. Collex™is under development for a CE-marked (EU) wound healing Medical Device, class III, followed by a 510k (US) clearance post CE-marking. 

  

The intended use for Collex™ 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

Collex™  is beeing developed by Regenics jointly with support from a.o. Charfles River Laboratories, (US), RISE AB (Swe).  Collex™The project has reached a bioactive slow - release prototype.  Collex™ is produced by 3D-bioprinting fenestrated surface patches with embedded collagen producing HTX. The product is contemplated to be a sterile patch for hard to heal large wounds. 

For more info on Collex™:

 
Scientifically documented and patented claims in wound healing:

  • COLLEX™ is a registered trademark
  • COLLEX™ will be a collagen producing wound patch 
  • COLLEX™ will be secreting collagen from a 3-bioprinted patch
  • COLLEX™ is in esxploratory development and pilot testing
  • COLLEX™ will be developed as a class III medical device
  • COLLEX™ will be developed for advanced wound treatment

Regenics AS have developed clinical proof of efficacy and safety  in human 2 degree burn wounds for our products Collex® and Vernex®.

The procudts are beeing developed as class III devices. WoundClear® is developed as a BLA/EU CP biotech drug.