COLLEGE PARK, Md. — gel-e Inc., announces the 510(k) clearance of gel-e FLEX by the U.S. Food and Drug Administration (FDA) for the over-the-counter (O-T-C) use of its first flowable hemostat.
This new clearance expands the Company’s label that now includes the use of gels and bandages in the local management of bleeding, such as lacerations and minor bleeding. These products are specifically designed to create rapid hemostasis through easy-to-use applications for professional healthcare providers, parents, coaches, adult caregivers and even patients themselves. gel-e FLEXalso complements the company’s already FDA cleared vascular closure device, Vascular gel-e, as it can be worn home by patients to manage any residual bleeding from an out-patient diagnostic or interventional procedure, see http://www.gel-e.co/products.html.
“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit,” said Dr. Matthew Dowling chief scientific officer at gel-e. “We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery.”
gel-e’s line of high-performance first aid products is enabled by a technology platform which enhances the natural characteristics of highly abundant natural polysaccharides. Through proprietary modifications, this advanced biopolymer is designed to be durable, biocompatible, and highly functional. It can also be infused into, or onto, complementary products to improve their hemostatic performance.
You can learn more about our technology, gel-e FLEX and other tools the company is developing including an overview by Stephen Hawking at http://www.gel-e.co/overview.html.