Haemacure reports positive results of fibrin sealant preclinical study

The study was conducted on 16 rabbits that underwent open gynaecologic surgery in a uterine horn model. In preclinical testing, company’s fibrin sealant was found to be significantly superior to the control group in preventing the formation of post-surgical tissue adhesion. These preclinical results are strategically significant as company’s current fibrin sealant haemostasis formulation was used in this study. Initial analysis indicates that no change in the formulation or the manufacturing of company’s fibrin sealant will be required to pursue an adhesion prevention indication.

The safety and manufacturing information applicable to an IND to conduct adhesion prevention trials using company’s fibrin sealant is identical to the information that will be included in the IND amendment to be filed later this year for the haemostasis indication. It is likely that adhesion prevention-specific preclinical data, clinical protocols and programs will also be required.

Joseph Galli, Chairman and CEO of Haemacure, said: “We are very excited with the results of this study, as it opens a new market with a significant unmet medical need and allows Haemacure to leverage to leverage its technology, past clinical data and experience in a timely manner.”