Innovation in surgery today relies on biomaterials that combine efficacy, safety and ease of use. Among them, self-assembling peptides are attracting increasing attention, particularly RADA16, the active ingredient in the PuraStat® medical device developed by 3-D Matrix. Already validated in several surgical disciplines, this material is opening a new approach to haemostasis and raising strategic issues for its integration into European healthcare systems.
What is a self-assembling peptide?
Self-assembling peptides are synthetic sequences capable of spontaneously organizing into nanofibers when they come into contact with biological fluids at physiological pH. This process results in the rapid formation of a transparent, biocompatible and resorbable hydrogel that mimics the extracellular matrix.
In the case of RADA16, this matrix creates a physical barrier at the bleeding site and induces local coagulation without the need for compression. This simple but powerful mechanism meets several clinical needs:
-Rapid control of bleeding, regardless of the patient’s coagulation status.
-Preservation of surgical field visibility, thanks to the transparency of the gel.
-Complete resorption within about thirty days, without residue or immune reaction.
Clinical data: the example of endonasal surgery
A prospective Australian study involving 167 patients undergoing turbinate surgery showed that PuraStat® achieved effective haemostasis in 98.2% of cases with a low rate of adhesions requiring treatment (4.2%). The frequent absence of nasal packing also improved patient comfort and reduced postoperative complications, see pdf below.
Beyond ENT surgery, published results in gastroenterology and cardiovascular surgery confirm the versatility of self-assembling peptides, with success rates ranging from 72% to 100% depending on the indication.
Towards a new generation of medical devices
Self-assembling peptides represent an innovative alternative to traditional haemostatic agents, often derived from animal or plasma sources. Their fully synthetic nature reduces infectious risks and facilitates regulatory acceptance.
In Europe, PuraStat® holds CE marking as a class III medical device, demonstrating compliance with Regulation (EU) 2017/745. Its approved indications include intraoperative haemostasis of diffuse or low-intensity bleeding in several specialties, including the digestive tract, cardiovascular system and ENT surgery.
More information: EMA – medical devices and regulation
Market access and reimbursement impact
The adoption of self-assembling peptides depends not only on their clinical performance but also on reimbursement decisions.
• In France and Europe: PuraStat® is not yet listed on the LPPR (Liste des Produits et Prestations Remboursables) and does not benefit from specific public reimbursement. Its use is therefore currently financed directly by hospitals, limiting wider deployment.
• In Japan: since December 2021, PuraStat® has been reimbursed by the national health insurance system (MHLW) at an official rate of 13,200 JPY/ml, facilitating adoption in hospitals.
• In other markets (USA, UK): although authorizations exist (FDA, NHS), no specific public reimbursement mechanism has yet been announced.
Useful reference: HAS – evaluation of medical devices
These differences highlight how market access strategy depends on the alignment between clinical evidence, medico-economic value and political willingness to finance innovation.
Perspectives: beyond haemostasis
The unique properties of self-assembling peptides also open the door to other applications:
• Reduction of postoperative adhesions, already observed in abdominal surgery.
• Improvement of wound healing, with promising preclinical results.
• Drug delivery vector, leveraging the porous and modulable structure of the hydrogel.
These perspectives position self-assembling peptides as strategic tools for regenerative medicine and the surgery of tomorrow.
Conclusion
The integration of self-assembling peptides into surgery illustrates a transition towards safer, more effective medical devices that are compatible with economic and regulatory requirements. Between strong clinical evidence and regulatory recognition, the next key step will be obtaining reimbursement in Europe so that these biomedical innovations become widely accessible to patients.
With its expertise in this field, BluePharm is ideally positioned to support manufacturers and healthcare stakeholders in addressing this major challenge.
Article on the same subject : Self-Assembling Peptides: An Emerging Lever for Surgery and Wound Healing
