Clinical Study Results of LifeBond’s LifeSeal™ Surgical Sealant for GI Surgeries Announced at the ESCP’s 9th Scientific & Annual Meeting
We anticipate LifeSeal™ will become an essential part of the next generation surgical toolbox. It has the potential to make a significant and welcomed impact. Professor Lars Påhlman, Professor of Surgery at the University of Uppsala, Sweden
Caesarea, Israel, September 29, 2014 – LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that it presented the results of the preliminary clinical study of the company’s flagship product, LifeSeal™, in a poster at the European Society of Coloproctology’s (ESCP) 9th Scientific & Annual Meeting in Barcelona. The title of the poster: INITIAL CLINICAL EXPERIENCE WITH LIFESEALTM SURGICAL SEALANT IN SUBJECTS UNDERGOING LOW ANTERIOR RESECTION.
The LifeSeal™ surgical sealant is specifically designed to help surgeons performing GI and bariatric surgeries minimize post-operative complications such as staple-line leakage and potentially save lives by providing staple-line reinforcement.
Lars Påhlman, Professor of Surgery at the University of Uppsala, Sweden and principal investigator of the LifeSeal™ study, said, “As described in the poster, between January and May 2013, ten patients with rectal cancer enrolled in the LifeBond study. The patients were randomized to either the LifeSeal™ group or the standard of care (SOC) group. In the LifeSeal™ group, one unit of the sealant was applied on the staple line re-connecting the rectum. No safety concerns were raised relating to LifeSeal™. And, no leaks were identified along the surgical connection where LifeSeal™ had been applied. LifeSeal™ was also convenient to use, easy to prepare and performed accordingly with the requirements of the instructions for use.”
LifeBond also announced today that is has completed enrollment of seventy patients in a larger, multi-national pilot study of LifeSeal™ at seven colorectal surgery centers of excellence in Europe. This study seeks to further confirm safety and usability of the sealant as well as to assess the performance of LifeSeal™ in reinforcing the anastomotic staple-line during open or laparoscopic lower anterior resection (LAR) procedures. Results are expected by the end of 2014.
Professor Påhlman continued, “Should the results of the pilot study be as positive as the first study, LifeSeal™ is likely to change how we do things in the operating room and become an essential part of the next generation surgical tool box. LifeSeal™ has the potential to make a significant and welcomed impact.”
“LifeBond’s product pipeline is like no other on the market or in development for the market today. Our products combine the unique properties of bio-surgical implants with the regulatory benefits of a medical device. This is beneficial as, comparative to the overall market, manufacturing processes are shorter, delivery is simpler and the products are generally less expensive,” said LifeBond president and CEO Gideon Sturlesi. “We have made great progress in the last year and the industry has noticed, both in the clinic and in the board room. We are engaged in several high level discussions with leading companies regarding market introduction.”
Anastomotic (point of surgical connection) leakage after a colorectal resection is associated with significant mortality and morbidity with anastomotic leakage occurring in as many as 15-19% of patients. LifeSeal™ is designed to address the unmet surgical need for a sealant that provides a protective layer that can improve a patient’s recovery and quality of life by reducing leakage associated complications and the need for repeat operations.
LifeSeal™, like in all of LifeBond’s products, is uniquely comprised of natural origin bio-surgical materials with established safety profiles. Designed for application in both open and laparoscopic procedures, LifeSeal™ uses a special ergonomic applicator designed to easily and efficiently apply the sealant to tissues, including in very low, hard-to-reach locations. The sealant is comprised of two components which combine real-time inside the applicator. The resulting sealant is then applied in a gel form to the staple-lines. Once applied, LifeSeal™ transforms into a durable, elastic and transparent protective layer designed to conform well to tissue and imitate its natural properties. LifeSeal™’s adhesive properties are intended to enable it to remain in place long enough to create an environment that supports the body’s natural healing and tissue repair processes, before it naturally degrades into the body.
LifeBond is a leader in the development and manufacturing of bio-surgical medical devices for tissue repair that are intended to improve the recovery of patients and to create an environment that supports the body’s natural healing process and promotes tissue repair. Of natural origin, elastic, adhesive, durable and yet absorbable, the company’s devices can be used to fill a long list of unmet surgical needs. LifeBond’s first product, LifeSeal™, is designed to provide staple-line reinforcement in bariatric and colorectal operations. It was recently studied in an international pilot clinical study in Europe. The company’s second pipeline product, LifeMesh™, a self-fixating hernia mesh, is in pre-clinical development. Other pipeline products include tissue adhesives and absorbable hemostats. 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 visit www.life-bond.com