Subjects: TRI, FDA
LifeBond's Multi-Center International Pivotal Study of the LifeSeal Surgical Sealant for GI Resections is Enrolling Patients in the US and Europe
CAESAREA, Israel, February 22, 2017 /PRNewswire/ --
LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that 20 leading medical centers in the United States and Western Europe are now recruiting for the company's international pivotal study of its LifeSeal® Surgical Sealant. An additional 20 clinical sites in the U.S. are expected to follow in the coming months. LifeSeal is currently in commercial use in several Western European countries, following the receipt of a CE Marking in April 2016.
(Logo: http://photos.prnewswire.com/prnh/20140929/708770 )
The pivotal prospective, multi-center, multi-national, randomized, IDE clinical trial, compares patients undergoing colorectal anastomosis with and without LifeSeal. The LifeSeal Surgical Sealant is a unique gastrointestinal (GI) sealant specifically designed to provide reinforcement and minimize staple-line leakage. It is the only GI sealant CE marked in Europe to help reduce leaks as an adjunct to sutures or staples.
"LifeBond achieved several milestones in 2016. To begin, the FDA granted permission to the company to commence the LifeSeal IDE study as part of the EAP (Expedited Access Pathway) program. We are deeply appreciative of the FDA's responsiveness and designation of LifeSeal as part of the EAP program, as well as the medical community's strong support and participation in validating LifeSeal's clinical value," said LifeBond CEO Gideon Sturlesi. "We began our pivotal study initially in Europe, to build on the completion of a successful CE study, and then recently expanded to multiple centers in the US. Last year also marked the start of the commercialization of LifeSeal in Europe. We have established strong momentum clinically and commercially, and we intend to build on this in the coming year and beyond."
"LifeBond's team is committed to bringing LifeSeal and other high quality surgical tools to the market, and to providing surgeons worldwide with access to easy-to-use solutions for reducing leaks in GI surgery. We are very pleased with LifeBond's progress clinically and commercially, and are confident that LifeSeal is the first of a number of novel products the company will introduce in the next few years," said Ittai Harel, Managing General Partner at Pitango.
About LifeBond
LifeBond, a 2016 Frost & Sullivan 2016 European New Product Innovation Award winner, is a leader in the development and manufacturing of bio-surgical medical devices for tissue repair intended to improve patient outcomes and support the body's natural healing process. The company's devices have the potential to fill a long list of unmet surgical needs. LifeBond's LifeSeal® surgical sealant is designed to provide staple-line reinforcement in GI surgery. Reducing leakage has the potential to save patient lives, improve patient recovery, and avoid re-admissions and repeated surgeries. LifeSeal® has a CE marking for sale in the European Union (EU). In the US, LifeSeal® is available only for use as experimental device in the approved IDE study. LifeBond's LifeMeshtm, a self-fixating hernia mesh, is in pre-clinical development. Other pipeline products include tissue adhesives and absorbable hemostats. LifeMeshtm is an investigational device and has not yet been approved for sale in the US or in any other market. For more information please visit http://www.life-bond.com.
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.
Press Contact:
Marjie Hadad
MH Communications
+972-54-536-5220
[email protected]
SOURCE LifeBond
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