Pipeline R&D

Research & Technology

The company’s preclinical strategy has been to explore and validate a robust list of indications utilizing the FibriSEAL technology platform in a broad range of hemostasis applications.

Updated summary of preclinical studies for SurgiCLOT®

St. Teresa Medical updated summary of Pre-Clinical studies for SurgiCLOT® including applications for dural repair and sternotomies.

The Company has completed a total of nineteen (19) pre-clinical studies, performed to both Good Laboratory Practices (GLP) and non-GLP standards. The program was focused in three basic medical areas: (1) spine and orthopaedic procedures; (2) control of high-volume arterial/venous bleeding; and (3) soft tissue / liver & spleen coagulation. The goals of the studies were to determine ideal product configurations and formulations, to develop and hone proper surgical techniques and to determine initial market focus and form the basis for regulatory strategy and filings. Summaries of the more important studies are described below.

Pre-Clinical Studies of Arterial
Hemorrhage in Combat Shock Model

Clinical Question:  How effective is a SurgiCLOT prototype at controlling fatal arterial hemorrhage?

  • 20 subjects
  • Control: Standard U.S. Army field dressing
  • Design: 60% of blood volume depleted, Hextend administered, hypothermia, coagulopathy, shock
  • Injury: 6mm arteriotomy in proximal femoral artery with 45 seconds free-bleeding
  • Results: 90% survival with SurgiCLOT prototype, 20% survival with field dressing, 78% restoration of distal limb blood flow
  • Conclusion: SurgiCLOT prototype highly effective at controlling bleeding in combat trauma model and at restoring blood flow to extremity

Pre-Clinical Study of
SurgiCLOT vs. Gelfoam in Corpectomy Model

Clinical Question:  How does SurgiCLOT compare to Gelfoam without Thrombin in controlling bleeding from a spinal corpectomy (partial vertebrectomy) model?

  • 6 subjects
  • Injury:  38 partial corpectomy injuries 
  • Results: Hemostasis achieved with SurgiCLOT in 89% of injuries vs. 11% with Gelfoam, p = 0.006
  • Conclusion: SurgiCLOT was superior to Gelfoam at controlling bleeding in corpectomy model

Use of SurgiCLOT to Control Spinal CSF Leaks

Clinical Question: Does SurgiCLOT seal the dura in spinal durotomies?

  • 5 subjects in pilot study
  • Site: dorsal dural injury in lumbar spine
  • Injury: 5mm durotomy
  • Results: 80% control of CSF leak without suture
  • After 30 days survival no pseudomeningocoele, minimal fibrosis, no arachnoid adhesions, repair withstood 200cm H20 pressure
  • Conclusion: SurgiCLOT appears to control CSF leak in linear spinal durotomy

Use of SurgiCLOT to Control Cranial CSF Leaks.

Clinical Question: Does SurgiCLOT seal the dura in cranial durotomies?

  • 6 subjects
  • Site: 4 sites in parietal dura
  • Injury: 14mm durotomy with initial suture repair followed by Valsalva maneuver
  • If suture did not control CSF leak, SurgiCLOT was applied followed by Valsalva maneuver
  • Results: 13% control of CSF leak with suture alone; 100% control of CSF leak with addition of SurgiCLOT, p < 0.0001
  • Conclusion: Addition of SurgiCLOT to suture in larger cranial durotomies is highly effective at controlling CSF leak

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