Biom’up Has Trained 200 Surgeons in its International KOL-Led Program Ahead of HEMOBLAST Bellows™ Launch


  • 200 KOLs and surgeons trained across the U.S. and Europe to date
     
  • Objective is to continue training a maximum of surgeons before the official launch of HEMOBLAST Bellows in mid-2018

NEW YORK and SAINT-PRIEST, France, April 24, 2018 (GLOBE NEWSWIRE) -- Biom'up (EPA:BUP), a specialist in surgical hemostasis, today announced that its intensive training program to train surgeons in the use of its lead product HEMOBLAST Bellows is on track and has reached the Company’s objective of 200 trained surgeons ahead of the launch of HEMOBLAST Bellows in mid-2018.

To prepare the surgical community for the imminent launch of HEMOBLAST Bellows, Biom’up ran 6 highly attended training sessions for surgeons in the U.S. and Europe, which were led by the Company’s experts in collaboration with key opinion leaders in surgical hemostasis. The HEMOBLAST Bellows boot camps will continue in the months ahead with more surgeons to be fully trained on HEMOBLAST Bellows.

Etienne Binant, Chief Executive Officer, said: “We are extremely encouraged by the positive feedback collected after our boot camps regarding the efficacy and ease of use of HEMOBLAST Bellows. It confirms the findings of market research conducted in early 2017, which concluded that 93% of surgeons who tried HEMOBLAST Bellows were satisfied and would recommend its use. We will continue to run these boot camps across the U.S. and Europe to help drive adoption, and sustained use of the product, and forge strong relationships with the surgical community.”

Biom'up obtained FDA approval for HEMOBLAST Bellows in December 2017. The expedited approval arrived 7 months ahead of original plan, and led to an acceleration of the process of refocusing industrial activities, as well as the recruitment of sales and marketing teams in the U.S. to prepare the mid-2018 commercial roll-out of our lead product in Europe and the U.S.

HEMOBLAST Bellows is an advanced hemostatic product to control bleeding in a broad range of surgical procedures, such as cardiac surgery, general surgery, and orthopedic surgery. Biom'up conducted a successful clinical trial in 258 patients admitted to cardio-thoracic, abdominal or orthopedic (lower limb) surgeries, which met all of its primary and secondary endpoints. Given the compelling preliminary results (93% effectiveness at 6 minutes, compared with 74% for the control arm), the Independent Data Monitoring Committee (IDMC) unanimously recommended to stop the study after an interim analysis of the data, which allowed us to accelerate the submission of our filing for premarket approval (PMA) to regulatory authorities.

Contacts

Biom'up
Chief Financial Officer
Jean-Yves Quentel
investisseurs@biomup.com
+33 4 86 57 36 10
NewCap
Investor relations
Tristan Roquet Montégon
biomup@newcap.eu
+33 1 44 71 00 16
LifeSci Advisors
Investors
Hans Herklots
hherklots@lifesciadvisors.com
+41 79 598 7149

About Biom'up
Founded in 2005 and based in Saint-Priest, close to Lyon (France), Biom'up develops hemostatic products based on patented biopolymers that aim to simplify surgical procedures in numerous surgical specialties (spine, cardiothoracic, general, orthopedic, plastic), and give patients a better quality of life. Its flagship product, HEMOBLAST Bellows, is a unique hemostatic solution, ready to use (no preparation time needed, no need to mix, no heat required), and usable once or several times during surgery. Developed by a world-renowned scientific team, HEMOBLAST Bellows has successfully met all primary and secondary endpoints of a Phase III pivotal study involving 412 patients in the United States. HEMOBLAST Bellows obtained its CE Mark in December 2016, and its PMA (Pre-Market Approval) application was granted by the U.S. Food & Drug Administration in December 2017 with a view to commercializing in the United States in mid-2018. Since inception, Biom'up has been supported by prominent European investors such as Bpifrance, Innobio, GIMV, Lundbeckfond, Mérieux Participation, SHAM and ACG, as well as all the Company’s managers, who have invested €2 million in equity. Biom'up successfully completed its IPO on Euronext Paris, raising €42.5 million in October 2017. In addition, the Company concluded a €16 million capital increase by means of a public offering without preferential subscription rights in February 2018.

For more information, please visit www.biomup.com.

Forward looking statement
This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.