Biom’up announces first US sales in laparoscopy for HEMOBLAST™ Bellows and the signing of an exclusive distribution agreement for HEMOBLAST™ Bellows in Australia

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Saint-Priest, France, April 15th, 2019 – 8h00 (CET) – Biom’up SA (the “Company »), specializing in surgical hemostasis, announces today first sales on the US market of its HEMOBLAST Bellows Laparoscopic Applicator.

  • Successful launch of the HEMOBLAST Bellows Laparoscopic Applicator in the US, first sales booked in March 2019
  • Major framework agreement signed with Life Healthcare Distribution (“LHC”) for the exclusive distribution of HEMOBLAST Bellows in the sizeable and growing Australian market

The first kits have been shipped overseas from Saint-Priest (France) production unit and delivered to hospitals earlier in March. The U.S. surgeons are now able to use the hemostatic powder for both open and laparoscopic surgeries with the same patient and surgeon benefits of efficacy, simplicity and rapid availability. The U.S. laparoscopy market, in a growing phase, is estimated at nearly 443,000 surgeries per year¹.

The HEMOBLAST Bellows Laparoscopic Applicator offers a quick and simple delivery of the HEMOBLAST powder to bleeding sites in minimally invasive surgeries. The 35 cm long polycarbonate applicator fits easily into the existing applicator and delivers HEMOBLAST powder in seconds. HEMOBLAST Bellows is the only surgical hemostatic agent approved by the FDA based on the validated SPOT GRADE™ Surface Bleeding Severity Scale (SBSS), which demonstrates its 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.

Uncontrolled bleeding is a major surgical complication associated with increased mortality, longer hospitalization, higher rates of transfusions, and reoperations. Controlling bleeding in minimally invasive surgery is especially challenging because surgeons have to utilize instruments and cameras through small port sites of 5 mm to 10 mm instead of a much larger field of operation in open surgery.

Biom’up also announces today the signature of an important exclusive agreement with LHC, a leading independent distributor of medical devices and healthcare solutions in Australia, for future distribution of its medical device pending approval for sale in Australian market. LHC wide footprint in and network creates a broad platform for launching HEMOBLAST Bellows with its indications in many surgical specialties. LHC and Biom’up have defined clear milestones for the market development with an initial focus on spine and cardiac surgeries.

The regulatory submission for approval of the product, was initially filed on March 15th, 2018. The final decision of the Australian authorities is now expected in the second half of 2019. Australia has a well-established use of hemostatic devices, with a market for hemostats forecasted to reach US$ 50 million in 2020, with an annual growth of 7% ².

Biom’up continues to execute its commercial plan and to establish the foundation for robust growth in the coming years. Minimally invasive surgeries are challenging procedures for traditional hemostats, and a space where HEMOBLAST Bellows stands out amongst the competition with its combination of efficacy, versatility and ease of use while preserving a surgeon’s field of vision.” declared Etienne Binant, Chief Executive Officer of Biom’up.These first sales of our Laparoscopic Applicator in the U.S. alongside the conclusion of a major, strategic agreement with LHC in Australia demonstrate our total focus on commercial expansion in 2019 forward.

¹ Global Data, DNA Ink, Company
² Source: Grand View Research

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Caution: Federal law restricts this device to sale on or by the order of a physician. The trademark of HEMOBLAST™ Bellows and SPOT GRADE™ are the property of Biom’up. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information. The presentation contains pictures owned by third party and remains their property.
E-MR-318-V1
HEMOBLAST™ Bellows Hemostatic Agent [instructions for use: E-MR-217-V6]