Periodic Reporting for period 3 - sFilm-FS (Fibrin sealant for anastomotic leaks and haemostasis)
Période du rapport: 2019-04-01 au 2020-03-31
sFilm-FS is a human body friendly bandage which is used to stop bleeding and body fluid leakage during surgery. The product is much more effective, fast and easier to use than any other standard of care. The product is absorbed by the body allowing full and effective healing of the injured tissue.
sFilm-FS is currently intended to be used to stop soft tissue bleeding during surgery, when control of bleeding by standard surgical methods (such as suture, ligature, cautery) is ineffective or impractical. sFilm-FS is also intended for use for sealing in gastrointestinal (GI) surgical procedures for prevention of leakage following intestinal surgery.
sFilm-FS was tested in various animal models. It was shown to be effective in controlling severe bleeding of soft tissue injuries and was effective in sealing leakage in punctured intestine animal models. Following these encouraging results, Sealantium Medical intends to complete the product's development and test it for safety and efficacy in human clinical trails.
sFilm-FS will improve the world health system helping doctors during complicated surgical procedure and helping patients to recover faster and shortening hospitalization time, significantly reducing risk of post-surgical complications.
The main activities during the last 6 months include the following:
• Production of a preclinical GMP batch which was used to complete a series of ISO10993 bio-compatibility tests including
o Cytotoxisity- Growth inhibition test
o Irritation-Intracutaneous Reactivity test.
o Acute Systemic Toxicity test in mice.
o Hemollysis test
o Bacterial Reverse Mutation Assay (AMES) test
o In vitro Mouse Lymphoma Assay (MLA)
o In vitro Chromosome Aberration Test.
o Biodegradation study in rats.
All tests were completed with excellent results without any toxicity at even the highest tested concentration
• A combined 3-month systemic toxicity, bio-degradation and efficacy study in domestic pig is ongoing and will be completed before the end of 2018.
• The preclinical GMP production batch was also used to start a stability study at 4˚C ans 25˚C. At present the results demonstrate good stability of sFilm-FS at both storage temperatures (6-month data)
• A clinical GMP batch was produced recently and will be used for the IND and CTA applications.
• Preparation of the IND and CTA are ongoing as planned.