Sealantis Announces Successful Results of First Clinical Trial Results advance the launch of Seal-V™ in Europe
HAIFA, Israel, March 6, 2014 /PRNewswire/ --
Sealantis Ltd. has announced positive results from its first clinical trial that tested the safety and performance of Seal-V, a vascular sealant that helps rapidly control bleeding during vascular surgery. The results pave the way to a product launch in European markets intended for later this year.
Seal-V works by mechanically sealing areas of potential leakage during surgical reconstruction of large blood vessels including bypass procedures and arterio-venous access for hemodialysis. It is adjunctive to standard surgical procedures for bleeding control.
The results show that the average time to hemostasis (bleeding cessation) using Seal-V was approximately 36 seconds, which demonstrates the benefits in using Seal-V to save blood and time in the operating room. No device related complications or adverse events were reported during the three-month follow-up period.
Seal-V received the CE Mark last July and is currently being used in several clinical centers in Germany, towards the coming product launch.
"Seal-V performed extremely well in the clinical study and consistently demonstrates exceptional performance in current clinical use," said Sealantis CEO Tomer Fuchs. "We have received positive feedback and increasing interest from surgeons and from the market. Our intention is to make
Seal-V available to vascular surgeons in Europe later this year."
The product represents a new generation in tissue sealing technology that imitates the properties of algae, giving it an inherent ability to strongly bind to both native blood vessels and synthetic grafts, even in wet and moist conditions. In addition, the protein-free composition relieves Seal-V from risks associated with the use of protein-based sealants.
Sealantis is also developing a pipeline of advanced solutions for a variety of clinical needs. Among them is a gastro-intestinal sealant to prevent leakage of bowel content after surgery, an adhesive for plastic and esthetic surgeries, and innovative adhesive-drug formulations for site-specific drug delivery.
The latest prospective, single-arm, non-randomized clinical trial involved 23 patients and 38 vascular reconstruction sites using various types of graft materials and met all primary and secondary end-points. The study was conducted in three medical centers in Israel.
About Sealantis Ltd.
Sealantis Ltd. develops a proprietary platform of alga-mimetic tissue adhesives, for a variety of applications and clinical needs. The Sealantis adhesives are protein-free and have an extraordinary ability to adhere strongly to internal tissues even in wet environments. These adhesives have applications in surgical leakage control, tissue adhesion and drug delivery. Sealantis was founded in 2010 by the Alfred Mann Institute at the Technion (AMIT) and Prof. Havazelet Bianco-Peled. For more information, visit http://www.sealantis.co.il.