- Source : Press Release
- Date : 2018-11-28
- Event type : Marketed
- Companies : Biom'Up SA
Biom'Up Sees a Strong Commercial Uptake in HEMOBLAST Bellows in the US and Europe
Saint-Priest (France), November 28, 2018, 8:00 am (Paris time) – Biom’up (the “Company”), a specialist in surgical hemostasis, announces today an update on its first months of commercialization of HEMOBLAST Bellows in the US and Europe and confirms a strong uptake among hospitals and surgeons.
Since its introduction to the US market in July 2018, 26 hospitals have purchased HEMOBLAST Bellows, indicating that the product has already successfully passed hospital evaluations. In total, more than 240 US hospitals are now also currently evaluating HEMOBLAST Bellows, up from 140 in mid-September.
In Europe, Biom’up focused the delivery of HEMOBLAST Bellows to key customers in France and the DACH region. 21 hospitals in France, 9 of them university hospitals, already use HEMOBLAST Bellows in their clinical routines which is an encouraging sign of market adoption. In addition, 15 hospitals among some of the most renowned in Germany, Austria and Switzerland have placed several orders. At present, more than 70 hospitals across Europe are now evaluating HEMOBLAST Bellows.
In Europe, French, German, Swiss and Austrian markets are directly addressed through the Company’s own sales force. In other European markets, Biom’up is actively identifying distribution partners and has recently signed its first distribution deal in Spain.
As recently communicated, the company efficiently executed a scale-up of its French manufacturing facility in October 2018 to meet encouraging market demand, increasing output of HEMOBLAST Bellows to more than 4,000 units. The Company expects this number to grow to 7,000 units per month by H1 2019. HEMOBLAST Bellows is sold in the US at a base price of $270 and in Europe at €250 per unit.
Etienne Binant, Chief Executive Officer, commented: “Our product is gaining traction in all of our target markets. Surgeons increasingly see the benefits associated with using HEMOBLASTTM Bellows including no preparation time and an efficacy that can be measured in just minutes, a dramatic shift in how bleeding is managed in the operating room. On the supply side, we are fully on track with the rigorous scale-up of our production capacity and can thus continue to execute our strategy to establish HEMOBLAST Bellows as the leading product in the global hemostatic market.”
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HEMOBLASTTM Bellows is an innovative hemostatic product to control bleeding in a broad range of surgical procedures, such as cardiac surgery, general surgery, and orthopedic surgery. The product is available in select European markets and was approved in the United States in December 2017, seven months prior to the anticipated approval date. The early FDA approval was based on Biom’up’s successful clinical trial in the United States with 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 before the initially planned date after an interim analysis of the data. This allowed the Company to accelerate the submission of its filing for premarket approval (PMA) to regulatory authorities in June 2017.
After obtaining FDA approval Biom’up’s efforts have been focused on industrial and commercial activities including the recruitment of sales and marketing teams in the US to prepare the commercial roll-out of the Company’s lead product in the United States.
On July 12, 2018, Biom’up also obtained CE Marking for its HEMOBLAST Bellows Laparoscopic Applicator designed to deliver the HEMOBLAST Bellows powder in minimally-invasive procedures. This has opened the way for the Company in a new market segment representing approximately 500,000 surgeries annually in Europe. In addition, on July 2, 2018 the Company filed a PMA supplement to obtain approval for HEMOBLAST Bellows for all laparoscopic surgical procedures also in the United States.
Founded in 2005 and based in the Lyon suburb of Saint-Priest (France), Biom’up designs innovative 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.
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. This was followed by a €16 million capital increase in February 2018 and a €25 million bond financing agreement with Athyrium, a US fund specializing in innovative companies in the healthcare sector in March 2018.
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 forwardlooking
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.