Faculty Park, Maryland.And January 12, 2023 /PRNewswire/ — Medcura, Inc. pronounces: Inc., a medical gadget firm devoted to transformatively bettering the administration of surgical bleeding, as we speak introduced that the U.S. Meals and Drug Administration (FDA) has awarded the Prestigious System Innovator Designation to LifeGel™ Absorbable Surgical Hemostat. LifeGel™ is the primary and solely hemostatic agent to obtain a complicated gadget ranking looking for a brand new, extremely distinctive indication: In surgical procedures (excluding ophthalmology and urology) as an adjuvant hemostatic gadget when controlling minor, delicate, and reasonable bleeding by standard procedures is ineffective or impractical. On account of its non-swelling properties, LifeGel can be utilized in surgical procedures the place swelling can’t be tolerated.
The FDA’s Breakthrough System Program is offered for therapeutic units that show they’ve the potential to offer simpler remedy for life-threatening or irreversibly debilitating ailments or situations. The tremendous designation gives a number of vital advantages, together with quicker and extra collaborative overview of future regulatory submissions with larger alternative to work together with FDA specialists all through the overview course of.
“We’re very happy with the chance to proceed working carefully with the FDA to enhance the surgeon’s capability to manage and cease the wide range of bleeding situations for which now we have been awarded the Breakthrough Designation Award,” stated Medcura President and CEO. Jim Buck. “This designation gives a extra collaborative partnership with the FDA that ought to speed up affected person entry to LifeGel as a brand new, game-changing resolution for the administration of surgical bleeding.”
Different hemostatic brokers swell after software. When utilized in confined areas such because the spinal canal, the place as much as 60% of those merchandise are utilized, hemostatic brokers have been documented to trigger nerve compression that may result in extreme hostile occasions together with paralysis. Medcura’s proprietary and patented components is designed to not swell upon use, eliminating the prospect of spinal twine compression attributable to hemostatic swelling brokers. In contrast to many different thinning brokers, LifeGel doesn’t comprise human or animal proteins, together with thrombin, and doesn’t require pre-mixing, preparation, or cold-chain storage. Being ready-to-use, LifeGel may also help keep away from pricey delays, dangers and issues related to uncontrolled bleeding and scale back wastage of high-priced supplies for hemostasis within the working room. These distinct options, mixed with the platform’s disruptive price benefit, place Medcura’s LifeGel to turn into the long run customary of take care of the administration of surgical bleeding.
Medcura’s chief medical officer, neurosurgeon Dr. Ken Renkins. “With expertise gained by way of in depth pre-clinical testing, LifeGel has confirmed to be simple and intuitive to make use of whereas demonstrating a powerful capability to reliably management a variety of difficult bleeding situations that the surgeon usually encounters.”
Medicura, Inc. is a phase-to-market medical gadget firm that develops versatile hemostatic merchandise that serve vital alternatives within the surgical, medical and client market. The corporate’s proprietary expertise platform combines the usage of protected, inert substances with patented chemical compounds, all geared toward delivering devastatingly low-cost merchandise able to safely and successfully controlling bleeding throughout a broad vary of scientific functions. Be taught extra about Medcura’s rising product line at www.medcurainc.com.
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Supply: Medcura, Inc.