First multi-national study to challenge surgical sealant safety and application in high-risk low anterior resection (LAR) anastomosis procedures
24 February 2014
Uppsala, Sweden – LifeBond Ltd., a leading developer of absorbable biosurgical products for tissue repair, announced enrollment of the first patient in the second clinical trial for its LifeSeal™ Surgical Sealant product. LifeSeal™ is designed to form a robust reinforcement layer and to minimize staple-line leakage in bariatric and colorectal anastomosis procedures. Colorectal anastomosis leakage presents an urgent clinical need since leakage rates can reach 15-20% and are associated with high morbidity and mortality. The study, currently underway in Europe and Israel, is intended to evaluate the safety and usability of LifeSeal™, as well as support the potential of LifeBond’s technology as a wound closure platform.
The commencement of this study follows the successful completion of a preliminary, clinical study at multiple sites in Sweden that evaluated the safety and the application technique of LifeSeal™. The current study, being conducted at seven hospital sites in Sweden, Belgium, and Israel, is the first to focus solely on the application of a surgical sealant to low anterior resection (LAR) anastomoses, procedures associated with the highest risk for developing staple-line leaks. LifeSeal™ will be applied in both open and laparoscopic procedures using its ergonomic Applicator and Laparoscopic Applicator.
“Anastomotic leak is a distressing concern for every colorectal surgeon” said Prof. Lars Pahlman of the Uppsala University Hospital, Uppsala in Sweden. “We were pleased with the simplicity of LifeSeal™ application in the preliminary study and are looking forward to expanding the clinical experience with the product in this study.”
“LifeSeal™ Surgical Sealant was developed to have specific properties that make it uniquely suited for colorectal staple-line reinforcement,” said Gideon Sturlesi, President and CEO of LifeBond. “We were thrilled with the positive response from the surgeons during the Investigator Meeting and are confident regarding the potential of this product to improve their patient outcomes.”
About LifeBond Ltd.
LifeBond is a leading developer and manufacturer of medical device products in the rapidly growing field of biosurgical tissue repair. LifeSeal™ Surgical Sealant is designed to provide surgeons with a safe and effective solution to provide staple line reinforcement to prevent postsurgical leakage in bariatric and colorectal operations. LifeMesh™ Self-Fixating Mesh is designed to deliver secure mesh fixation without tacks or sutures. The Company’s other products in development include tissue adhesives and absorbable hemostats. LifeBond’s products are based on its proprietary platform technology that mimics the body’s natural wound healing processes. LifeSeal™, LifeMesh™ and other LifeBond™ products are investigational and have not yet been approved for sale in the US or in any other market. For more information, please contact us at:
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company’s future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.