Biom’Up wins FDA PMA nod for Hemoblast Bellows surgical hemostatic

Biom’Up said today it won FDA premarket approval for its Hemoblast Bellows hemostatic product designed to control bleeding during surgeries including cardiac, general and orthopedic procedures.

The Paris-based company’s flagship Hemoblast Bellows product is a ready-to-use hemostatic solution that is usable several times during surgery to reduce bleeding.

Approval of the hemostatic came based on results from a prospective, controlled, randomized clinical trial of 412 patients who underwent cardiothoracic, abdominal or lower limb orthopedic surgeries.

Results from the trial indicated that the device met all primary and secondary endpoints with very high statistical significance.

The study produced interim results which indicated a 93% efficacy at six minutes with the Hemoblast product, versus 74% in the control arm. Biom’Up said that due to the interim results, members of an independent data monitoring committee unanimously recommended a stop to the study prior to its end date for faster application submission.

“This FDA approval to market Hemoblast Bellows represents the most significant milestone in Biom’Up’s development since its creation. We have done everything we could to obtain this approval, and we are delighted to have achieved it over half a year ahead of our initial schedule. This performance, which has set a new record in the surgical hemostasis sector for a first PMA, is the result of the extraordinary mobilization of all our teams. I would particularly like to congratulate and thank Professor William D. Spotnitz, our chief medical officer, and Dr. Valérie Centis, our chief scientific officer, without whom this success would not have been possible. I would also like to thank Mr. Thomas Maguire, our VP Clinical and Regulatory Affairs, and the entire NAMSA team, our CRO, headed by Mrs. Rachel W. Hoffman, the entire Hogan Lovells team headed by Ms. Janice M. Hogan, Professor Daniel L. Gillen, and all the surgeons who have helped us undertake the clinical study. Lastly, I would like to thank the FDA for its interactive contribution to the PMA process, as well as its input within the framework of the development of the SPOT GRADE surface bleeding severity scale. We will now be able to market our product over the summer in 2018. This approval, obtained in record time, allows us to calmly analyze access to other potential markets of very high strategic and commercial interest,” CEO Etienne Binant said in a press release.

Biom’Up began recruiting for its IDE-cleared trial of the Hemoblast Bellows last September.

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