Biom’up Obtains CE Mark for Its HEMOBLASTTM Bellows Laparoscopic Applicator

Regulatory News:

Biom’up (Paris:BUP) (the "Company"), specialist of surgical hemostasis, today announces having obtained CE Mark for its Laparoscopic Applicator and thus extends its indications by enabling European surgeons to use HEMOBLAST Bellows hemostatic powder for both open and laparoscopic surgery, while continuing to benefit from the same advantages in terms of efficacy, simplicity and rapidity. This CE Mark attests to the conformity of the device with the essential health and safety requirements laid down by the applicable European regulations and attests that it has followed the appropriate conformity assessment procedures.

The HEMOBLAST Bellows Laparoscopic Applicator is designed to deliver the HEMOBLAST Bellows hemostatic powder in cases of surgical bleeding through a trocar with a diameter of at least 5 mm. The 35 cm polycarbonate accessory is compatible with the existing HEMOBLAST Bellows applicator, already with CE Mark.

HEMOBLAST Bellows is additionally indicated for hemostasis when the control of minimal, minor and moderate bleeding in classical procedures is ineffective or impossible during laparoscopic procedures for the following specialties: vascular, abdominal, urology, gynecology, head and neck surgery (excluding ophthalmic and neurosurgical procedures).

The laparoscopy market is significant in the United States and Europe, with nearly 443,000 and 500,000 surgeries per year respectively¹. Use of hemostatic products in this market remains however limited, notably due to the impact of traditional products on visibility in the surgical area and the difficulty of introducing them through trocars. HEMOBLAST Bellows, a hemostatic powder, is designed to overcome these obstacles by facilitating precision handling through its laparoscopic applicator.

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¹ Global Data, DNA Ink, Company.

As a reminder, HEMOBLAST Bellows, Biom’up's flagship product, obtained its CE Mark in December 2016 and its PMA (Pre-Market Approval) application was granted by the US FDA (Food & Drug Administration) in December 2017.

In addition, the Company filed a PMA (Pre-Market Approval) supplement on July 2, 2018, dedicated to obtaining approval for HEMOBLAST Bellows for all laparoscopic surgical procedures in the United States.

Etienne Binant, Chief Executive Officer, commented: "We are very pleased to be able to announce today this CE Mark for our HEMOBLAST^TM Bellows Laparoscopic Applicator, an important accessory which will further extend the use of our flagship product to laparoscopic surgery. This market potential for our product is significant as it is under-explored by existing technologies. It is thus with satisfaction that we are preparing to make this additional option available to surgeons and their patients in Europe. I would like to congratulate all our European regulatory teams for achieving this key milestone within a very short timeframe, illustrating our regulatory environment expertise".