(Seal-G Surgical Sealant / Seal-G MIST System)
In millions of surgical procedures on the gastro-intestinal (GI) system, surgical incisions are made and then closed with sutures and or staples. While sutures and staples are the standard of care for surgical wound closure, they are incapable of water-tight or air-tight sealing of wounds. Bowel content leakage from GI incisions is still one of the complications most dreaded by GI surgeons, due to its potential fatal implications.
In addition to and in correlation with the significant morbidity and mortality, GI anastomotic leaks are associated with a 56% increase in the length of stay and with an additional cost of $28,000 per patient on average.
Sealantis develops gastrointestinal (GI) bioresorbable sealants, designed to prevent leakage of bowel content from GI suture- or staple-lines thereby preventing the morbidity and mortality associated with post-surgical leaks. These sealants are intended for use as an adjunctive treatment to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Sealantis has developed the following products:
- Seal-G Surgical Sealant – a CE marked product, designed for open and minimally invasive (extracorporeal) gastrointestinal surgical anastomotic This product has undergone a comprehensive series of preclinical and biocompatibility testing, demonstrating a high safety profile and feasible functional performance, as well as simple and user’s friendly ease of use. Furthermore, the product’s safety and functional usability have been successfully demonstrated in 20 subjects undergoing colorectal resection surgeries, in a single-arm clinical study.
- Seal-G MIST (Minimally Invasive Spray/ Sealant Technology) System – another GI sealant in the Seal-G product family, designed for open and all types of minimally invasive gastrointestinal surgical anastomotic procedures. Seal-G MIST is currently at the advanced development phase. It has undergone a comprehensive series of preclinical and biocompatibility testing, demonstrating a high safety profile and feasible functional performance, as well as simple and user’s friendly ease of use. Seal-G MIST is currently planned to be investigated in a randomized, controlled, clinical trial in 80 subjects.
* Seal-G Surgical Sealant received European CE Mark in December 2017. Seal-G Surgical Sealant is not approved for use outside of the European Union.
** Seal-G MIST System is not approved for market use, at any of countries.