Biom’up SA, a specialist 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 €4.0 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.