/ Key word(s): Regulatory Approval
07.10.2019 / 08:00
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Biom’up announces the approval of HEMOBLASTTM Bellows and its laparoscopic applicator in Australia
Saint-Priest, France, October 7th, 2019 – 8h00 (CET) – Biom’up SA (the “Company”), specializing in surgical hemostasis, announces its flagship product, HEMOBLAST Bellows, has been approved for open as well as laparoscopic surgery by the Australian TGA regulatory authority for commercialization in the sizeable and growing Australian market. Simultaneously, HEMOBLAST Bellows and its laparoscopic applicator have secured reimbursement through the PLAC (Prostheses List Advisory Committee), an independent committee which makes recommendations on the most clinically efficient and effective devices.
The regulatory submission for approval of the product was initially filed on March 15th, 2018. Australia has a well-established market for the use of hemostatic devices, with the hemostats market forecasted to reach US$30 million in 2020, with an annual growth rate of 7%.
As previously announced in April 2019, Biom’up signed an exclusive agreement with LHC, a leading independent distributor of medical devices and healthcare solutions in Australia, for the distribution of HEMOBLAST Bellows. LHC’s wide commercial footprint in the market provides a broad platform for launching the Company’s novel hemostatic agent with an initial focus on spine and cardiac surgeries.
While its Board of Directors continues to explore options to ensure continuity of operations, Biom’up expects first shipments of HEMOBLAST Bellows to Australia in the fourth quarter of 2019, under its agreement with LHC. The prospect of those shipments allows the Company to remain confident in its ability to reach its 2019 revenue guidance of EUR4.0 to 4.5 million, as announced on May 20th, 2019.
“We are delighted by this positive outcome, which opens up a new sizeable market for HEMOBLAST Bellows, and provides access to a broad population of patients that will now benefit from the safety and efficacy of this novel hemostatic agent. Our Regulatory Affairs and Quality teams worked efficiently in close collaboration with the Australian regulatory authorities to achieve swift approval and reimbursement,” said Patrice Ferrand, Chief Executive Officer of Biom’up. “We now look forward to working with LHC to achieve broad adoption of HEMOBLAST Bellows in Australia. This agreement reflects the incredible opportunities visible to the entire team at Biom’up and underscores my own excitement in having officially joined as CEO earlier last month. Together we are a step further towards our goal to ensure more patients and surgeons worldwide have access to the only surgical hemostatic agent approved by the FDA based on the validated SPOT GRADETM Surface Bleeding Severity Scale (SBSS), which demonstrates its ability to control a range of bleeding from minimal (oozing), mild (pooling) and moderate (flowing) bleeding“.
Founded in 2005 and based in the Lyon suburb of Saint-Priest (France), Biom’up develops and commercializes hemostatic products based on patented biopolymers designed to simplify the surgeons practices for open and minimally invasive surgical procedures, including laparoscopic, in multiple specialties such as cardiac, general, and orthopedic surgery. The Company’s lead product, HEMOBLASTTM Bellows and its laparoscopic applicator are marketed in Europe and the United States.
HEMOBLAST Bellows is a hemostatic product to control bleeding in a broad range of open and minimally invasive surgical procedures including laparoscopy for multiple specialties such as cardiac, general, and orthopedic surgery.
Uncontrolled bleeding is a major surgical complication associated with higher mortality, longer hospitalization and higher rates of transfusions and reoperations. Beyond its impact on patient’s health, this major complication causes excess costs in all surgical specialties and is a burden for hospital budgets across the globe. HEMOBLAST Bellows is the only surgical hemostatic agent approved by the FDA based on the validated SPOT GRADE(TM) Surface Bleeding Severity Scale (SBSS), which demonstrates the ability to control a range of bleeding from minimal (oozing), mild (pooling) and moderate (flowing) bleeding. HEMOBLAST Bellows is proven to control bleeding with flow rates up to 117 mL per minute. Due to its efficacy, versatility and ease of use, HEMOBLAST Bellows is quickly becoming a popular choice amongst U.S. surgeons looking for new options to control surgical bleeding challenges.
Biom’up obtained CE Marking for HEMOBLAST Bellows in December 2016. On the basis of compelling preliminary results (93% effectiveness at 6 minutes, compared with 74% for the control arm) in a major clinical trial, FDA approval for HEMOBLAST Bellows in December 2017, seven months ahead of the original plan. This allowed for the commercial roll-out of its lead product in the U.S. in the summer of 2018.
In July 2018, Biom’up additionally obtained CE Marking for its HEMOBLAST Bellows Laparoscopic Applicator designed to deliver the HEMOBLAST Bellows powder in all minimally-invasive procedures. In January 2019, the Company obtained the respective approval for HEMOBLAST Bellows Laparoscopic Applicator in the U.S. This has opened up new market segments, representing approximately 500,000 and 443,000 surgeries per year in Europe and the US respectively.
Currently the Company is working to expand the range of applications for HEMOBLAST Bellows.
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