SAINT-PRIEST, France--(BUSINESS WIRE)--Regulatory News:
Biom'up (Paris:BUP) (EPA: BUP), a specialist in surgical hemostasis, today announced it has finalized the commercial infrastructure to support the imminent launch of its lead product HEMOBLAST Bellows. The Company has recruited senior management and a large number of independent specialist sales representatives to drive the nationwide marketing and sales campaign of HEMOBLAST Bellows, which is expected to start in mid-2018.
Etienne Binant, Chief Executive Officer, said: “Under the leadership of Dave Clark, U.S. Vice President of Sales, and Steven Ford, U.S. Vice President of Marketing, we have swiftly built a dedicated national hybrid sales organization. With a large team of specialists now in place, and given its clinically demonstrated high value, we are confident that HEMOBLAST Bellows will make substantial inroads and become a fixture of hemostasis in operating rooms across the USA. Biom’up is now perfectly positioned to pursue its growth ambitions and transition towards a fully-fledged commercial organization.”
The Company will use a hybrid sales model in the USA, relying on a team of veteran executives at Biom’up, as well as a strong nationwide network of independent specialist sales representatives. This commercial organization has already attracted in excess of 100 members, providing sufficient geographic coverage to successfully launch HEMOBLAST Bellows later this year.
Biom’up’s own sales and marketing team, which will oversee the efforts of those in-direct sales professionals, has recently been reinforced with the appointments of Clay Beaty as Area Vice President Sales, Western U.S., Paul Uricchio as U.S. Director of Marketing, and Ken Mingus as Regional Business Director, West Coast. Clay has over two decades of surgical device experience, including time focused in sales and sales management within the hemostasis market (St Jude Medical, Baxter). Paul Uricchio has extensive experience with launching hemostasis products (Mallinckrodt, The Medicines Company and ZymoGenetics). Ken Mingus has a highly successful track record within the surgical device industry, including key experience in the hemostasis market (Mallinckrodt, Baxter and Genzyme).
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.
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.