Demonstrating safety and efficacy in a high-dose treatment of a first flowable formulation
Demonstrating safety and efficacy in a high-dose treatment of a first flowable formulation
COLLEGE PARK, Md., April 3, 2019 /PRNewswire/ -- gel-e Inc., announces publication of recent study results in the Journal of Surgical Research entitled “Expanding Hydrophobically-Modified Chitosan Foam for Internal Surgical Hemostasis: Safety Evaluation in a Murine Model.” The paper describes the successful use of a flowable hemostatic product in a standard surgical model, followed by 6 weeks of observation; see the article here via Science Direct.
The study, led by researchers at the Regenerative Bioscience Center at the University of Georgia, involved delivery of a high dose of hydrophobically-modified chitosan (HM-CS) foam into the abdomen of a rat after a non-lethal liver excision. The HM-CS group (n = 16), was compared to a commercial fibrin sealant, Tisseel® (n =16), an unmodified chitosan formulation (n =16) and no treatment controls (n = 16). In each cohort, half of the animals were evaluated at 1 week, while the balance of the cohorts were evaluated at 6 weeks, all via gross necropsy (upon sacrifice) and histopathology. All subjects treated with HM-CS in the study achieved rapid hemostasis and went on to survive to their designated endpoints with no clinical signs of morbidity or mortality. There was almost complete reabsorption of the HM-CS material at the 1-week timepoint. These results suggest that certain formulations of gel-e may be effective during routine surgical applications, especially where flowable formats are most useful.
“These results from an in vivo survival study are significant, demonstrating the capability of gel-e’s core material” said Dr. Grant Bochicchio, MD, Clinical Advisory Board member at gel-e and Chief of Acute and Critical Care Surgery at Washington University in St Louis School of Medicine. “With any new biomaterial, there is always a risk to leave foreign substances inside the body to degrade over extended periods. This study provides a foundation from which to build an internal surgical hemostat that may not require compression and can be safely left behind without risk of post-surgical complications.”
gel-e is developing a line of high-performance surgical products based on a technology platform which enhances the adhesive characteristics of abundant and inexpensive natural polysaccharides. Through proprietary modifications, advanced biopolymers can be designed that are durable, biocompatible, bioresorbable and highly functional. The versatility of gel-e’s approach allows our products to be delivered to the OR for open, or laparoscopic procedures and even incorporated, or coated onto, complimentary product platforms. You can learn more about surgical gel-e and other tools being developed for advanced hemostatic applications by visiting http://www.gel-e.co/products/.
About the Company
gel-e is a clinical-stage medical device company developing versatile hemostatic products for surgical, medical, and consumer applications. With an initial focus on external wounds, gel-e combines the use of safe, inert ingredients with proprietary chemistry that can be designed for use across a broad spectrum of clinical applications, including vascular closure and during surgery. gel-e is based in College Park, Md.
For additional information, please visit http://www.gel-e.co.
Contacts:
Larry Tiffany, gel-e, Inc.
(301) 529-4943
pr@gel-e.co
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SOURCE gel-e, Inc.
