SAINT-PRIEST, France--(BUSINESS WIRE)--Regulatory News:
Biom’up (Paris:BUP) (the "Company"), specialist of surgical hemostasis, today announces having been selected by France’s Prime Minister to be one of the eleven young innovative companies, showcase of the French know-how, gathered at the Hôtel de Matignon (France’s Prime Minister’s residence) on July 10, 2018 for the 8th Strategic Council of Health Industries (CSIS) to concretely illustrate the dynamism of the French ecosystem for innovation.
Etienne Binant, Chief Executive Officer, commented: “While it is an honor that Biom’up was selected to attend the Strategic Council of Health Industries, it also is the recognition of the worth and talent of our teams that made it possible for our flagship product, HEMOBLASTTM Bellows, to be ranked as the world’s leader in hemostatic products. I warmly thank our teams for their involvement. This Strategic Council of Health Industries is an opportunity to praise Biom’up’s international journey, particularly our implantation in the US market, where the first deliveries of HEMOBLASTTM Bellows were made at the beginning of July.”
Biom’up also announces that HEMOBLAST Bellows is now undergoing a medico-economic evaluation (via Value Analysis Committees) at more than 95 hospitals throughout North America, versus 75 at the beginning of the month. This growth occurs while the very first commercial delivery of HEMOBLAST Bellows to a first-class hospital in the southern United States was just completed.
Finally, Biom’up announces that its sales network in charge of selling HEMOBLAST Bellows in the United States continues to grow, allowing the Company to further extend its geographical coverage in North America. This is now a strong network of 135 members, bringing together seasoned senior executives and a strong national network of independent, specialized sales representatives.
These promising elements demonstrate the interest of North American surgeons for our first-class innovative product resulting from French research and whose commercial launch in the United States is planned in the near future. With a cash position of €44.1 million as of June 30, 2018, the Company believes to be able to meet the short and medium term investments required for this successful commercial launch.
Biom’up obtained FDA approval for HEMOBLAST Bellows in December 2017. The expedited approval arrived 7 months ahead of original plan, and led to a focus on 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 US regulatory authorities in June 2017. On July 12, 2018 Biom’up received the CE Mark for its Laparoscopic Applicator HEMOBLAST Bellows designed to deliver the HEMOBLAST Bellows powder in minimally-invasive procedures. The Company can thus be positioned on a new market segment of approximately 500,000 surgeries per year in Europe. On July 2, 2018, the Company also submitted an additional application to the FDA for approval of HEMOBLAST Bellows for all laparoscopic surgical procedures in the United States.
Founded in 2005 and based in the Lyon suburb of Saint-Priest (France), Biom’up designs hemostatic products based on patented biopolymers that aim to simplify surgical procedures in numerous 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), usable once or several times during the surgery and offering unique efficacy features. Developed by a world-renowned scientific team, HEMOBLAST Bellows has obtained positive results for all the primary and secondary endpoints of Phase III of its 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 FDA (Food & Drug Administration) in December 2017 with a view to the commercial launch in the United States in the summer of 2018. Since its creation, Biom’up has benefited from the support of 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 in April 2018, concluded a €25 million bond with Athyrium Opportunities III Acquisition LP, a US fund specializing in innovative companies in the healthcare sector.