Saint-Priest, France, January 30, 2019, 8:00 am (CET) – Biom’up (the “Company”), a specialist in surgical hemostasis, today announced the publication of scientific and clinical data with the Company’s lead product HEMOBLAST Bellows, a hemostatic product to control bleeding in a broad range of both traditional and laparoscopic surgical procedures in the January edition of the Journal of Cardiac Surgery.
- Article provides full data set of pivotal clinical trial showing that HEMOBLAST Bellows is clinically and statistically superior to control at achieving hemostasis
The Journal of Cardiac Surgery is a peer-reviewed, international publication devoted to contemporary surgical treatment of cardiac diseases.
The clinical data, published in open access in the article entitled “Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale”, clearly demonstrates the outstanding superiority of HEMOBLAST Bellows in terms of effectiveness for patients and surgeons under the usage prerequisites versus a control agent. In comparison to absorbable gelatin sponge and thrombin, HEMOBLAST Bellows achieved hemostasis in 71.1% of patients within three minutes (45.8% in the control arm) and in 93.1% of patients within six minutes (73.5% in the control arm). No signs or symptoms of postoperative bleedings were observed with HEMOBLAST Bellows.
HEMOBLAST Bellows met all primary and secondary endpoints with high statistical significance prior to completion of the clinical trial at the scheduled interim analysis. This allowed the product to receive pre-marketing approval (PMA) by the FDA seven months ahead of the trial’s scheduled end which in turn allowed the Class III medical device to be marketed in the United States in December 2017.
The results were assessed using the only quantitative bleeding severity scale (SPOT GRADE™ Surface Bleeding Severity Scale, SBSS) clinically validated by the FDA and another major Biom’up innovation. SBSS constitutes a method for reproducibly quantifying surgical wound bleeding developed under the coordination of Prof. William Spotnitz, itself published in Spine Journal on June 1, 2018.
“We are delighted to be able to share the data of this very important study with the scientific community by publishing it in such a distinguished scientific journal,” said Prof. William Spotnitz, Chief Medical Officer at Biom’up. “The acceptance of an article to be published in Journal of Cardiac Surgery testifies not just to the prominence and the high quality of the study results but also to the scientific excellence and ambitions of the Biom’up research team.”
The publication can be viewed here: onlinelibrary.wiley.com/doi/10.1111/jocs.13982
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