The First Effective Spray for Preventing Post-Surgical Adhesions

Professors of Surgery Stig Bengmark and Roland Andersson recognized the unmet clinical need for a product that more effectively prevents surgical adhesions. Together with Professors of Physical Chemistry Björn Lindman and Kåre Larsson, they invented BioBarrier™, now developed by BioActive Polymers.

BioBarrier™ adds two separate polypeptides creating a temporary barrier to the development of fibrous adhesion tissues. The solution is easily sprayed in the abdominal surgical site, targeting injured areas on the peritoneum. The spray solution has a goal-seeking effect based on electrostatic forces that enables a visible accumulation of BioBarrier™ on the desired sites. BioBarrier™ seals the wounded peritoneal areas preventing the risk of organs adhering to each other and the abdominal wall.

BioBarrier™ is a non-toxic, biologically degradable product with amino acids as its only end product. The BioBarries™ matrix
disappears from the target areas and body within 30 days.

BioBarrier™ has been studied in more than 1000 animals (established small animal models) where the product shows excellent anti-adhesion effect. These studies also concluded that BioBarrier™ had no negative impact. They suggest that bleeding areas in parenchymal organs are sealed with deceased bleeding as a result. Pre-clinical BioBarrier™ studies have shown no harm to bowel anastomoses, rather a strengthening of the anastomoses is shown by measured bursting pressure. BioActive Polymers’ research team is headed by surgeon Associate Professor Bobby Tingstedt.

Outstanding Published Data*

Peritoneal adhesions following surgery in mice subjected to different intraperitoneal treatments after 7 days. BioBarrier™ (pL+pG) showed significantly fewer adhesions than controls receiving saline (NaCl) and hyaluronic acid (HA). Earlier published in the Scandinavian Journal of Gastroenterology

Healed anastomosis between ileum and cecum in rat after 8 weeks. No visual matrix remaining. Earlier published in International Journal of Colorectal Disease

White polymer deposits, BioBarrier™, selectively cover the peritoneum at the wound site one week after surgery. It clearly shows the product’s goal-seeking effect. Earlier published in Scandinavian Journal of Gastroenterology

Very promising result with local spray administration

Results of adhesion reduction in rabbits receiving the BioBarrier™ (PLPG). A significant difference in abdominal adhesions could be seen between the experimental and control (saline). In the control group, 100% (8/8) of the rabbits had severe adhesions vs. only 9% (1/8) in the PLPG group had adhesions at all. Earlier published in Journal of Biomedical Science and Engineering.

Cancer cell implantation in vivo. Intra-abdominal implantation of tumor cell as observed as postoperative day 21. BioBarrier™ treated animal (B) and control animal (D). Earlier published in Journal of Surgical Research.

 

* see also “SCIENTIFIC EVIDENCE

Convincing Clinical Advantages

Extensive pre-clinical data for BioBarrier™ indicates convincing clinical advantages:

  • Goal seeking formula that binds to the injured surface, i.e. site specific protection
  • Significant prevention of adhesions (long effect) proven in three different animal models
  • Preventing adhesion reformation after adhesiolysis (surgical removal of adhesions)
  • User-friendly spray administration, easily applied during all types of surgical procedures (also in laparoscopic surgery)
  • Non-toxic
  • Fully biocompatible and biodegradable
  • No side effects observed in more than 1000 animals
  • No interference with healing:
    • Significantly reduced bleeding and inflammation
    • Significantly increased burst pressure in bowel anastomoses
    • Significant decrease in infections in a perforated bowel model
    • No effect on key parameters in fibrosis/fibrinolysis compared to control.
    • Long and lasting effect after biodegradation.
    • Significantly reduced growth of colon cancer cells.