Sealantium Medical
Developer of next-generation biosurgical materials focused on biodegradable polymeric films that combine mechanical sealing and fibrin-based hemostasis for use in open and minimally invasive surgery. Activities include preclinical testing, randomized multicenter Phase I/II clinical trials with peer-reviewed publication, and preparation for GMP manufacturing through CDMO partnerships.
Industries
Nr. of Employees
small (1-50)
Patents
Method for determining the adhesive force of a hemostatic tissue sealant patch
US-11662299-B2
View Details
Method for determining the adhesive force of a hemostatic tissue sealant patch
US-11662299-B2
View DetailsProducts
Biodegradable polymeric hemostatic and sealing film
Flexible, biodegradable polymer film that incorporates a fibrin-based hemostatic agent to provide both mechanical tissue sealing and accelerated coagulation for open and minimally invasive surgery.
Biodegradable polymeric hemostatic and sealing film
Flexible, biodegradable polymer film that incorporates a fibrin-based hemostatic agent to provide both mechanical tissue sealing and accelerated coagulation for open and minimally invasive surgery.
Services
Design and execution of preclinical studies to evaluate usability and efficacy of surgical sealing/hemostatic materials.
Management of randomized multicenter clinical studies and preparation of peer-reviewed clinical publications.
Quality assurance and regulatory planning to support clinical progression and GMP readiness.
Design and execution of preclinical studies to evaluate usability and efficacy of surgical sealing/hemostatic materials.
Management of randomized multicenter clinical studies and preparation of peer-reviewed clinical publications.
Quality assurance and regulatory planning to support clinical progression and GMP readiness.
Expertise Areas
- Tissue sealant development
- Hemostatic agent development
- Minimally invasive surgical delivery
- Preclinical animal models
Key Technologies
- Biodegradable polymeric film platforms
- Fibrin-based hemostatic systems
- Dual-acting hemostatic-sealing biomaterials
- Minimally invasive delivery adapters
News & Updates
Publication of a randomized controlled multicenter Phase 1/2 trial reporting faster median time-to-hemostasis (2 minutes) and 100% success rate within 10 minutes, with favorable safety and tolerability.
Signed quality agreement with a biologics CDMO marking completion of initial manufacturing preparation and laying groundwork for GMP manufacturing and scale-up.
Completed enrolment of 32 patients in a randomized, open-label multicenter Phase I/II study comparing the film to a market comparator for control of liver bleeding; interim analysis suggested safety and efficacy.
Successful proof-of-concept porcine study demonstrating an adapter device enabling use of the film in minimally invasive surgery.
Peer-reviewed article reporting clinical trial outcomes comparing the film to a leading hemostatic agent in elective liver surgery.
Awarded an EU 'Seal of Excellence' and a €1.4M grant from the European Commission.
Publication of a randomized controlled multicenter Phase 1/2 trial reporting faster median time-to-hemostasis (2 minutes) and 100% success rate within 10 minutes, with favorable safety and tolerability.
Signed quality agreement with a biologics CDMO marking completion of initial manufacturing preparation and laying groundwork for GMP manufacturing and scale-up.
Completed enrolment of 32 patients in a randomized, open-label multicenter Phase I/II study comparing the film to a market comparator for control of liver bleeding; interim analysis suggested safety and efficacy.
Successful proof-of-concept porcine study demonstrating an adapter device enabling use of the film in minimally invasive surgery.
Peer-reviewed article reporting clinical trial outcomes comparing the film to a leading hemostatic agent in elective liver surgery.
Awarded an EU 'Seal of Excellence' and a €1.4M grant from the European Commission.