NEW YORK & SAINT-PRIEST, France--(BUSINESS WIRE)--Regulatory News:
Biom'up (Paris:BUP) (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 in the US and in Europe.
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 412 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 the company to accelerate the submission of its filing for premarket approval (PMA) to regulatory authorities in June 2017.
For Class III medical devices such as HEMOBLAST Bellows, the FDA imposes the strictest criteria for granting the PMA. Prior to granting this authorization, the FDA conducted a thorough review of the Biom'up plant, HEMOBLAST Bellows production lines, and the Company's quality systems. At the conclusion of the inspection, the FDA didn't make comments within the meaning of FDA 483, Inspectional Observations, the form listing any observations (deficiencies).
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 and has bonded 25 million euros with Athyrium, a US fund specializing in innovative companies in the healthcare sector.
For more information, please visit www.biomup.com.