College Park, Maryland.And January 12, 2023 /PRNewswire/ — Medcura, Inc. announces: Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, today announced that the U.S. Food and Drug Administration (FDA) has awarded the Prestigious Device Innovator Designation to LifeGel™ Absorbable Surgical Hemostat. LifeGel™ is the first and only hemostatic agent to receive an advanced device rating seeking a new, highly distinctive indication: In surgical procedures (excluding ophthalmology and urology) as an adjuvant hemostatic device when controlling minor, mild, and moderate bleeding by conventional procedures is ineffective or impractical. Due to its non-swelling properties, LifeGel can be used in surgical procedures where swelling cannot be tolerated.
The FDA’s Breakthrough Device Program is available for therapeutic devices that demonstrate they have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. The super designation provides several important benefits, including faster and more collaborative review of future regulatory submissions with greater opportunity to interact with FDA experts throughout the review process.
“We are very pleased with the opportunity to continue working closely with the FDA to improve the surgeon’s ability to control and stop the wide variety of bleeding scenarios for which we have been awarded the Breakthrough Designation Award,” said Medcura President and CEO. Jim Buck. “This designation provides a more collaborative partnership with the FDA that should accelerate patient access to LifeGel as a new, game-changing solution for the management of surgical bleeding.”
Other hemostatic agents swell after application. When used in confined spaces such as the spinal canal, where up to 60% of these products are applied, hemostatic agents have been documented to cause nerve compression that can lead to severe adverse events including paralysis. Medcura’s proprietary and patented formula is designed not to swell upon use, eliminating the chance of spinal cord compression caused by hemostatic swelling agents. Unlike many other thinning agents, LifeGel does not contain human or animal proteins, including thrombin, and does not require pre-mixing, preparation, or cold-chain storage. Being ready-to-use, LifeGel can help avoid costly delays, risks and complications associated with uncontrolled bleeding and reduce wastage of expensive materials for hemostasis in the operating room. These distinct features, combined with the platform’s disruptive cost advantage, position Medcura’s LifeGel to become the future standard of care for the management of surgical bleeding.
Medcura’s chief medical officer, neurosurgeon Dr. Ken Renkins. “With experience gained through extensive pre-clinical testing, LifeGel has proven to be easy and intuitive to use while demonstrating an impressive ability to reliably control a wide range of challenging bleeding conditions that the surgeon often encounters.”
Medicura, Inc. is a phase-to-market medical device company that develops versatile hemostatic products that serve significant opportunities in the surgical, medical and consumer market. The company’s proprietary technology platform combines the use of safe, inert ingredients with patented chemicals, all aimed at delivering devastatingly low-cost products capable of safely and effectively controlling bleeding across a broad range of clinical applications. Learn more about Medcura’s growing product line at www.medcurainc.com.
Inspiration Agency on behalf of Medcura, Inc.
Source: Medcura, Inc.