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Biom’up announces opening of a court-supervised reorganization procedure (redressement judiciaire)

Saint-Priest, France, October 31, 2019 – Biom’up SA (the “Company”), specializing insurgical hemostasis, announces that following a hearing held on October 30, 2019, the
Lyon Commercial Court decided the opening of a reorganization procedure (redressement
judiciaire) for the Company.

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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.

  • Successful review of HEMOBLAST Bellows’ performance and safety profile as well as Biom’up’s Quality Management System by the Australian Therapeutic Goods Administration (TGA)
  • In parallel, HEMOBLAST Bellows has been submitted for inclusion in the Prostheses List of reimbursed products
  • First major shipment to Life Healthcare Distribution (“LHC”), HEMOBLAST Bellows’ exclusive distributor for the sizeable and growing Australian market for hemostats, planned for the fourth quarter
  • The Company reiterates its revenue guidance in the range of €4.0 to 4.5 million for 2019 as announced on May 20th, 2019

 

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Approval of 2019 H1 interim results postponed: Board of Directors pursues review of options available to the Company

Saint-Priest, France, September 30, 2019 – 19h00 (CET) - Biom’up SA (the “Company”), specializing in surgical hemostasis, today announced that its Board of Directors resolved on September 27, 2019 to postpone the approval of the H1 interim results as it pursues the review of options available to the Company.

  • Estimated total sales of HEMOBLAST™ Bellows for the first nine months of 2019 are expected to show strong growth at €2.5 million (compared to €1.5 million for the first half of 2019 and €0.6 million for the full year 2018) and are expected to be on track to achieve the 2019 revenue guidance range of €4.0-€4.5 million
  • Consolidated cash at end of September 2019 estimated at €4.5 million (compared to €8.5 million at June 30, 2019): cash shortfall still anticipated in early November 2019
  • Board of Directors’ review of available options is on-going, resulting in the postponement of the approval of the H1 interim results on the basis of the going concern principle

 

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Biom’up strengthens management team

Saint-Priest, France, September 18, 2019 - 8h00 (CET) - Biom’up SA (the “Company”), specializing in surgical hemostasis, today announced that Patrice Ferrand was appointed CEO, replacing Dr. Jan Ohrstrom. Dr. Ohrstrom, who was appointed CEO in May of this year, remains Chairman of the Board, a role in which he has served for the Company since 2015. Mr. Ferrand will also be appointed Chairman of the Company’s U.S. subsidiary, Biom’up USA, Inc.

  • Veteran MedTech executive Patrice Ferrand is appointed CEO
  • Experienced pharmaceutical and biotech industry executive Evelyne Nguyen is appointed Group CFO
  • Dr. Jan Ohrstrom continues his tenure as Chairman of the Board
  • Current CCO for the United States George Makhoul is appointed CEO of Biom’up USA, Inc.

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New Publication Highlights Application of HEMOBLAST™ Bellows in Cardiovascular Surgery

Saint-Priest, France, August 14th, 2019 – 8:00am (CET) - Biom’up (the « Company »), specializing in surgical hemostasis, today announced the publication of clinical case studies highlighting the use of the Company’s lead novel hemostatic product, HEMOBLAST Bellows in cardiovascular procedures and describing methods to optimize the use of HEMOBLAST in procedures where bleeding rates are typically higher and more challenging for conventional hemostatic agents. In these cases, published first online in the Journal of Cardiac Surgery, HEMOBLAST Bellows was observed to facilitate excellent hemostasis at both focal and over larger bleeding surfaces.

 

  • Article describes successful use and advantages of HEMOBLAST Bellows in high risk patients prone to bleeding undergoing cardiovascular surgical procedures.

 

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Biom’up issues a new tranche of €5 million from the credit line granted by Athyrium

Saint-Priest, France, August 7, 2019, 6:00 PM (CET) – Biom’up (the “Company”), a specialist in surgical hemostasis, today announces the issuance of a third tranche of its bond financing for €5 million.

 

 

  • Issue of bonds with warrants attached, fully subscribed by Athyrium within the framework of the €35 million facility announced on April 3, 2018
  • A cash shortfall now estimated as of early November 2019
  • €2 million remain available to the Company until December 31, 2019, subject to Athyrium’ s approval

 

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Biom’up Provides Business Update for the First Half of 2019 and confirms its Revenue Guidance for the year

Saint-Priest, France, July 10, 2019 - 8h00 (CET) - Biom’up SA (the « Company »), specializing in surgical hemostasis, announced unaudited sales of HEMOBLAST Bellows for the first half of 2019 ended June 30th totaled €1.4 million, a sequential month-over-month growth rate of 23% since global launch in July 2018. HEMOBLAST Bellows sales for 1H 2019 were more than twice as much as the €627 K recorded for the previous six months. The revenue recorded for HEMOBLAST Bellows during 1H 2019 is also in line with the full-year 2019 guidance for global sales in the range of €4.0-4.5 million. US orders already represent close to 2/3 of total orders, demonstrating HEMOBLAST Bellows’ potential in the strategic US market.

  • Global, unaudited sales of HEMOBLAST™ Bellows for the first half of 2019 were €1.4 million – on track to achieve 2019 revenue guidance range of €4.0-4.5 million; projection for 15% market share in the US and main European countries remains a long-term goal
  • Operating expenditures for 2019 expected to reach circa €30 million, a significant decrease versus 2018
  • Upgrades at manufacturing facility in Saint-Priest will now provide sufficient capacity to meet HEMOBLAST Bellows demand through 2021, pushing out the need for a new facility at least 24 months
  • Consolidated, unaudited cash position as of June 30, 2019 at €8.5 million

 

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Industry Veteran Dr. Jan Ohrstrom takes on Executive Leadership of Biom’up

Saint-Priest, France, May 31, 2019 - 8h00 (CET) - Biom’up SA (the « Company »), specializing in surgical hemostasis, today announced a change in the Company’s leadership position.

Etienne Binant steps down from his positions as Chief Executive Officer and board member of Biom’up to pursue new business opportunities. Dr. Jan Ohrstrom has been elected Executive Chairman. In this function, he will assume full executive responsibility for the Company. Dr. Jan Ohrstrom has been Chairman of the Board of Directors of Biom’up since 2015.

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Biom’up provides 2019 guidance for HEMOBLAST™ Bellows global sales

Saint-Priest, France, May 20, 2019 - 8h00 (CET) - Biom’up (the « Company »), specializing in surgical hemostasis, is providing for the first time, full-year 2019 guidance for global sales of HEMOBLAST Bellows (including its laparoscopic applicator) in the range of €4.0-4.5 million.

 

  • Biom’up provides full-year 2019 guidance for global sales of HEMOBLAST Bellows in the range of €4.0-4.5 million
  • 2019 operational expenditures forecasted to decrease significantly versus 2018
  • Operational break-even on a quarterly basis expected during 2H 2021

 

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Biom’up reports 2018 full-year results and confirms strong commercial uptake in 1st quarter of 2019

Saint-Priest, France, April 30, 2019, 8:00 am (CET) – Biom’up (the "Company"), a specialist in surgical hemostasis, today announced its full-year results for the year ending

December 31, 2018, as approved by the Company’s Board of Directors on April 29, 2019, and provided an update on its operations.

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Biom’up granted FDA IDE approval for HEMOSNOW™

Saint-Priest, France, April 24, 2019 - 8h00 (CET) - Biom’up (the « Company »), specializing in surgical hemostasis, announced today that the U.S. Food and Drug Administration (FDA) approved the IDE (Investigational Device Exemption) application for HEMOSNOW, a hemostatic dry powder made from porcine collagen and bovine-derived chondroitin sulfate developed by the Company for managing minimal and mild levels of bleeding during surgical procedures. The Company initially submitted the IDE application to FDA for HEMOSNOW in January 2019.

This approval demonstrates once again Biom’up’s ability to meet all IDE requirements set by the U.S. regulatory process.

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NB

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement. 


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

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

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Biom’up appoints George Makhoul as Chief Commercial Officer (USA)

Saint-Priest, France, January 31, 2019 - 8h00 (CET) - Biom’up (the « Company »), specializing in surgical hemostasis, today announced the appointment of George Makhoul as Chief Commercial Officer with responsibility for the United States, effective today.

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Biom’up HEMOBLAST™ Bellows full pivotal trial results published in Journal of Cardiac Surgery

Saint-Priest, France, January 30, 2019, 8:00 am (CET) – Biom’up (the "Company"), a specialist in surgical hemostasis, today announced the publication of scientific and clinical data with the Company’s lead product HEMOBLAST Bellows, a hemostatic product to control bleeding in a broad range of both traditional and laparoscopic surgical procedures in the January edition of the Journal of Cardiac Surgery

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BIOM’UP GRANTED FDA APPROVAL FOR ITS HEMOBLAST™ BELLOWS LAPAROSCOPIC APPLICATOR

Saint-Priest, France, January 22, 2019, 8:00 am (CET) – Biom’up (the “Company”), specializing in surgical hemostasis, has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its HEMOBLAST Bellows Laparoscopic Applicator for all minimally-invasive procedures. Biom’up submitted the premarket approval (PMA) supplement to the FDA in July, 2018. The FDA completed its response within the standard 180 days, for this type of supplement, applicable when no challenge is raised, demonstrating the quality of the Company’s regulatory work.

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ACHIEVEMENT OF TWO MAJOR DEVELOPMENT MILESTONES

Saint-Priest, France, January 7, 2019, 8:00 am (CET) – Biom’up (the "Company"), a specialist in surgical hemostasis, today announces an IDE (Investigational Device Exemption) application submitted to the FDA for HEMOSNOW, a hemostatic dry powder made from porcine collagen and bovine-derived chondroitin sulfate for managing minimal and mild levels of bleeding during surgical procedures. The Company now plans to prepare the launch of the clinical studies required to obtain approval in the United States in 2020. 

» Download the press release