Saint-Priest (France), November 08, 2018, 8:00 am (Paris time) – Biom’up (the “Company”), a specialist in surgical hemostasis, announces today the completion of the 2018 scale-up of its manufacturing facility to meet commercial demand for HEMOBLAST™ Bellows, in the US and selected national markets in the EU.
- 2018 scale-up of Biom’up’s manufacturing facility near Lyon (France) completed, allowing for a larger throughput and increased shipments of devices to the US and EU markets
- Six key manufacturing processes upgraded, thoroughly reviewed and approved by the FDA and EMA; a strong validation of the Company capability to efficiently execute a comprehensive and demanding regulatory plan
- Biom’up reaches a new important milestone in its growth strategy and continues to execute in line with commitments made at IPO
Approved in Europe in December of 2016, HEMOBLAST Bellows received US Food and Drug Administration (FDA) approval in December 2017, 7 months prior to the anticipated approval date. It was made available to a limited number of hospitals in France and Germany in 2018 and launched onto the US market in July of the same year with a list price of $270.
To meet the encouraging market demand, the Company efficiently executed a rigorous scale-up of its manufacturing facility in France, including upgrading and fully validating 6 key internal and outsourced processes allowing for a much larger throughput and increased shipments of devices to the US and EU markets.
As a consequence, the Company’s product output grew to more than 4,000 units of HEMOBLAST Bellows in October 2018. This number is expected to grow to 7,000 units per month by H1 2019, fulfilling the Company’s production commitment to investors made at the time of their IPO in October 2017.
All updated processes were thoroughly reviewed and ultimately approved by the FDA and the European Medicines Agency (EMA), allowing for the release of the products manufactured under said upgraded processes to the US and EU markets.
Philip Corcoran, M.D., surgeon at Johns Hopkins Community Physicians and one of the area’s “Top Doctors” in cardiovascular and thoracic surgery according to Washingtonian magazine, said: “As one of the surgeons involved in the pivotal clinical trial that led to HEMOBLAST Bellows approval in the US market in December 2017, I am excited that Biom’up has now fully launched this hemostat onto the US market. Requiring almost no preparation time, effective in just minutes, and the sole hemostat approved for up to and including moderate bleeding, HEMOBLAST Bellows is a dramatic change in how surgeons will manage bleeding in the operating room.”
Etienne Binant, Chief Executive Officer, commented : “This is a watershed moment in the history of Biom’up. The increased availability of HEMOBLAST Bellows, in line with the business plan communicated at time of the IPO, demonstrates the Company’s ability to execute a comprehensive and demanding plan, including meeting manufacturing, human resources, regulatory and financial challenges quickly and successfully. For this, my gratitude and congratulations go to the entire Biom’up staff and, in particular, to our Manufacturing, Industrialization and Quality teams who invested so much time and energy to ensure as many devices as possible could be provided quickly to patients and surgeons in the US and EU.”
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