IRVINE, Calif., June 17 NeoMend, Inc. today announced thatits ProGEL(TM) Surgical Sealant has received a recommendation for approvalfrom the U.S. Food and Drug Administration's (FDA) Anesthesiology andRespiratory Therapy Devices Advisory Panel.
The panel's recommendation will be considered by the FDA during completionof its review of the Premarket Approval (PMA) for ProGEL. The panel'srecommendation for FDA approval was conditioned principally on NeoMendconducting a post approval study to gather more safety data.
The panel's decision was based on the results of a multi-center,prospective, randomized clinical trial, which demonstrated ProGEL's success insealing intra-operative air leaks after lung resection surgery. NeoMendestimates that over 100,000 lung resection surgeries are performed annually inthe U.S., with lung cancer comprising the majority of cases.
Post-surgical air leaks represent the most common complication followinglung surgery. These air leaks can lead to serious complications prolongedhospitalizations, and increased costs as a direct result of the continuouscontamination of the chest cavity. To date, surgical options to control orreduce these air leaks have been limited.
During the ProGEL clinical trial 161 patients were enrolled at five of theleading lung cancer treatment centers in the U.S. At the end of surgery inwhich a portion of the lung is removed, the surgeon would use standardtechniques, suturing or stapling, to seal any air leaks that were present.Patients were then randomized to either a control group, who received nofurther treatment, or they were randomized to the treatment group forapplication of ProGEL to the air leaks. In this study, ProGEL was not usedprophylactically to prevent air leaks.
As presented to the panel, 35% of the 103 ProGEL treated patients werefree of air leaks through one month follow up compared to only 14% of the 58patients randomized to the control group. Also presented to the panel was thebenefit of using ProGEL to keep patients free of air leaks, as the trialdemonstrated that the mean average of hospital stay was nearly two daysshorter for the ProGEL patients.
"Lung cancer is the leading cause of cancer deaths of both men and womenin the U.S. Improved surgical tools and techniques to successfully treatthese patients will significantly reduce perioperative morbidity andmortality," said Garrett Walsh, M.D., Professor of Surgery at the Universityof Texas, MD Anderson Cancer Center and a study investigator. "The results ofthis trial clearly show the benefit to our patients offered by this product."
Jerry Mezger, President and CEO of NeoMend added, "The panel's decisionbrings us one step closer to allowing us to provide ProGEL to surgeons in theU.S."
NeoMend is a privately held company in Irvine, California developing afamily of advanced wound care products. NeoMend's first product, theProGEL(TM) Surgical Sealant used in this trial, is a bioabsorbable hydrogelcapable of sealing challenging surgical injuries such as air leaks on thesurface of a lung, which is constantly expanding and contracting. NeoMend isalso developing a similar product, ProGEL-AB, for sealing surgical wound siteswhile also helping prevent the formation of post-surgical adhesions. Moreinformation about NeoMend can be found at its web site,http://www.neomend.com.
SOURCE NeoMend, Inc.