Saint-Priest, France, January 22, 2019, 8:00 am (CET) – Biom’up (the “Company”), specializing in surgical hemostasis, has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its HEMOBLAST Bellows Laparoscopic Applicator for all minimally-invasive procedures. Biom’up submitted the premarket approval (PMA) supplement to the FDA in July, 2018. The FDA completed its response within the standard 180 days, for this type of supplement, applicable when no challenge is raised, demonstrating the quality of the Company’s regulatory work.
- HEMOBLAST Bellows can be used with a specially designed 35 cm cannula in the United States in minimally-invasive surgeries
- FDA approval creates options for patients and surgeons across a broad spectrum of multiple surgical specialties
- The market opportunity for HEMOBLAST will increase by more than 400,000 surgical procedures annually in the U.S. alone
The HEMOBLAST Bellows Laparoscopic Applicator offers a quick and simple delivery of the HEMOBLAST powder to bleeding sites in minimally invasive surgeries. The 35cm long polycarbonate applicator fits easily into the existing applicator and delivers HEMOBLAST powder to minimally invasive bleeding sites in under one minute. HEMOBLAST Bellows is the only surgical hemostatic agent approved by the FDA based on the validated Spot Grade™ Surface Bleeding Severity Scale (SBSS), which demonstrates the ability to control a range of bleeding from minimal (oozing), mild (pooling) and moderate (flowing) bleeding. HEMOBLAST Bellows is proven to control bleeding with flow rates up to 117 mL per minute.
Uncontrolled bleeding is a major surgical complication associated with increased mortality, longer hospitalization, higher rates of transfusions, and reoperations. Controlling bleeding in minimally invasive surgery is especially challenging because surgeons have to utilize instruments and cameras through small port sites of 5mm to 10mm instead of a much larger field of operation in traditional surgery.
The FDA approval allows Biom’up to expand its use of HEMOBLAST Bellows in a growing laparoscopy market that is estimated at nearly 443,000 surgeries per year¹. Biom’up obtained a CE Mark for its HEMOBLAST Bellows Laparoscopic Applicator in July 2018 for use in the European market, valued at 500,000 laparoscopic procedures annually ¹.
«Today we have reached a new, significant regulatory milestone with the approval of HEMOBLAST Bellows for laparoscopic surgery in the U.S. Minimally invasive surgeries are challenging procedures for traditional hemostats. HEMOBLAST Bellows stands out amongst the competition because it combines strength, ease of use, and a swift time to hemostasis while preserving a surgeon’s field of vision.» said Etienne Binant, Chief Executive Officer of Biom’up, «This approval provides a significant expansion of the addressable market which encompasses several surgical specialties. I want to again thank our U.S.-based regulatory affairs team, led by our Chief Medical Officer, Pr. William Spotnitz, who have consistently demonstrated their ability to execute flawlessly on our regulatory roadmap.»
¹ Global Data, DNA Ink, Company
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