Israel-based developer of protein-free alga-mimetic tissue adhesives, Sealantis, has reported positive results from its first prospective, single-arm, non-randomised clinical study that tested the safety and performance of its protein-free bioresorbable sealant Seal-V.
The latest trial involved 23 patients and 38 vascular reconstruction sites using various types of graft materials and met all primary and secondary endpoints. The study was conducted in three medical centres in Israel.
Following these fruitful results, the company plans to launch the product in European markets later in 2014.
According to the company, Seal-V is a bioresorbable sealant designed to produce haemostasis by mechanically sealing areas of leakage risk for surgical reconstruction of large blood vessels, including bypass procedures and arterio-venous access for haemodialysis.
The study results revealed that the average time to haemostasis (bleeding cessation) using Seal-V was approximately 36 seconds. This demonstrated the benefits in using Seal-V to save blood and time in the operating room.
In addition, no device-related complications or adverse events were reported during the three-month follow-up period.
In August 2013, the company obtained CE Mark approval for its Seal-V and is currently being used in several clinical centres in Germany, towards the coming product launch.
Sealantis CEO Tomer Fuchs said Seal-V performed well in the clinical study.
"We have received positive feedback and increasing interest from surgeons and from the market," Fuchs said. "Our intention is to make Seal-V available to vascular surgeons in Europe later this year."
The sealants are developed based on an alga-mimetic formulation to bind strongly 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 products.
Currently, the company also has other products in the pipeline including gastro-intestinal sealant for preventing leakage of bowel content after surgery, an adhesive for plastic and esthetic surgeries, and innovative adhesive-drug formulations for site-specific drug delivery.
According to GlobalData estimates, the tissue sealants market in Europe valued at $298.7m in 2012 and is expected to grow at a CAGR of 6.7% to reach $470.4m by 2019.