Please log in
to access more information

loading...

User name and Password not recognised

Home Page > News

FOCUS: Valve 2019

We are happy to be part of FOCUS: Valve 2019 in Innsbruck from September 15th to 18th 2019. 

The congress, which should be attended by nearly 200 international doctors, is part of a four module educational program in minimally invasive valve surgery offered by the Department of Cardiac Surgery of the Medical University of Innsbruck (Course directors: Ludwig Müller, Michael Grimm, Nikos Bonaros) and will feature presentations and live surgeries retransmissions.

The following retransmissions will feature our lead product HEMOBLAST™ Bellows

  • Endoscopic repair of complex MV disease (Surgeon: Patrick Perrier, Germany)
  • Totally endoscopic repair of degenerative MR (Surgeon: Ludwig Mülller, Austria)
  • Totally endoscopic MV repair with percutaneous cannulation (Surgeon: Nikos Bonaros / Ludwig Müller, Austria)

These live surgery will be retransmitted in 3D from FOCUS: Valve's Operating Room

Find out more about HEMOBLAST™ Bellows >


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

 

» Continue reading (PDF) >


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

 

» Continue reading (PDF) >


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.

» Continue reading (PDF) >


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.

 

» Read more (PDF) >


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

 

» Read more (PDF) >


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

 

» Read more (PDF) >


Schilddrüsen Kongress 2019

We will be in Munich during the 2019 Schilddrüsen Congress during which we are expecting more than 300 participants to attend our lunch symposium. 

 

A new type of bleeding control in thyroid surgery

Thursday, June 6th, 2019
Hörsaal Frauenklinik Maistrasse
Maistrasse 11
80337 München
Germany

PROGRAM

  • 12:30 – 12:45:

Moderation / Introduction
Professor Dr. med. M. Spannagl
LMU Klinikum der Universität München, Campus Großhadern und Innenstadt

  • 12:45 – 13:00:

Postoperative bleeding in thyroid surgery and treatment / prevention
Prof. Dr. med. P. Goretzki
Charite Universitätsmedizin Berlin

  • 13:00 – 13:15:

Hemostyptics for thyroid surgery in patients at risk of re-bleeding - Use or waste?
PD Dr. med. S. Schopf
Krankenhaus Agatharied

  • 13:15 – 13:30:

The perioperative risk of bleeding complication (best practice)
Prof. Dr. med. U.  Mittelkötter
Katharinen Hospital Unna

» Download the program (in German)


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.

» Read more


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

 

» Read more


36th UNAIBODE National Days of Studies and Improvement

We welcome you from May 15th to 17th at the Pierre Baudis Congress Center in Toulouse (stand E11) to the 36th UNAIBODE National Days of Studies and Improvement.

"AN IBODE ODYSSEY" - The latest scientific advances in surgical procedures will be presented during these themed days giving Biom'up a great opportunity to showcase Hemoblast™ Bellows its new bleeding management solution.

More information (french website)


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.

» Read the full press release


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.

» Read more


NB

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


EUROPEAN EDUCATIONAL SYMPOSIUM AND HANDS-ON SESSION IN VIENNA

On April 10th and 11th we gathered 30 people including 15 surgeons as well as distributors and prospects at the Medical University of Vienna, for 3 hands-on sessions covering the use of HEMOBLAST™ Bellows in the following specialties:

 

  • Cardiac surgery
  • General surgery
  • Laparoscopic surgery

 

This European event was led by our Chief Medical Officer, William SPOTNITZ, M.D., M.B.A while the hands-on sessions were conducted by Roberto Manson, M.D., VP of Surgical Education.

Among participants, we had the chance to include two International Key Opinion Leaders :

 

 

Discover HEMOBLAST™ Bellows


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

» Read more


136th German Society of Surgery Congress - DCK 2019

We'll be in Munich at the 136th Gesellschaft für Chirurgie, the German Society of Surgery Congress, from March 26 to 29, 2019. 


19th Journées du Club Cœlio, Orléans (France)

We'll be in Orléans, France at the 19th Journées du Club Cœlio. Join us on Friday March 15 and Saturday March 16 at the Centre hospitalier régional d'Orléans.

The program will include the following talk by Dr Alain Valverde, Chief of Visceral Surgery at Groupe Hospitalier Diaconesses Croix Saint-Simon : Risk and bleeding management in liver surgery


Le Choix des Armes convention

Join us at the 30th Le Choix des Armes convention from Thursday March 14 to Saturday March 16 in Marseille's (France) Fort Ganteaume. 

Find out more on (french only) lechoixdesarmes.org


[WEB SESSION] Bleeding and Hemostasis Management in Cardiac Surgery

Many visitors have joined us on Tuesday March, 5th 2019 for the latest PCI (Pitié cardiac institute) international web session, an event proposed by Pr Pascal Leprince, Chief of Cardiac Surgery at La Pitié-Salpêtrière and sponsored by Biom'up. 

 

►  Watch the full replay of the web session (registration required).

 

PROGRAM

6:30 - Introduction
Pascal LEPRINCE - M.D., PhD - Sorbonne University, Chief of Cardiac surgery Pitié-Salpêtrière

6:35 - Risk assessment and management before surgery
Adrien BOUGLÉ - M.D., PhD - Sorbonne University, Anesthesiologist and Surgical Intensive Care Unit, Pitié-Salpêtrière

6:50 - Per and Post operative Bleeding issues during surgery and Presentation of case study with HEMOBLAST™ Bellows (movie)
Guillaume LEBRETON - M.D., PhD - Sorbonne University, Cardiovascular and Thoracic Surgery, Pitié-Salpêtrière

7:05 - SPOT GRADE™ and Presentation of HEMOBLAST™ Bellows PMA results
William SPOTNITZ - M.D., M.B.A - Chief Medical Officer, Biom’up Professor of Surgery, Univ. of Virginia

7:25 - Conclusion
Bertrand ROZEC - M.D., PhD - Anesthesiology and Intensive Care, Centre Hospitalier Universitaire de Nantes

» Download the program


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.

» Read and download the press release


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

» Read and download the press release


OFFICIAL LAUNCH OF HEMOBLAST™ BELLOWS IN SPAIN

Today, Thursday January 24th, Biom’up and Palex have launched Hemoblast Bellows into the Spanish market at a kick-off meeting in Barcelona (Spain). All surgical sales and marketing  staff  of Palex Medical were educated on HEMOBLAST Bellows, a hemostatic powder to control bleeding in a broad range of both traditional and laparoscopic surgical procedures, such as cardiac, general and orthopedic surgeries, and give patients a better quality of life.

The session included hands-on application of Hemoblast Bellows by every participant, an expert round table on its benefits in Cardio-thoracic, spine and laparoscopic surgeries, as well as clinical data and commercial discussions.   

Carlos Chordá, General Manager of Palex Medical, a leading medical device distributor in the Iberian Peninsula, based in Barcelona and Madrid, opened the session with his team emphasizing the broad range of indications that Hemoblast Bellows will be used in. The program was led by Prof. William Spotnitz, Biom’up Chief Medical Officer in collaboration with key  surgeons who are using HEMOBLAST Bellows successfully in their surgical routine  and clinical trials, Dr. Thierry Barthes (Abdominal and Laparoscopic Surgeon, Polyclinic of Poitiers, France), Dr. Pierre-Marie Longis (Spine Surgeon, Private Hospital of Confluent, Nantes, France) and Dr. Alexandros Paraforos (Chief Consultant and Deputy Medical Director, Department of Cardio-Thoracic Surgery, Trier, Germany).

Prof. William Spotnitz comments on the session: « Wonderfully informative, innovative, and cooperative meeting, with a lot of interaction and helpful discussion ».

Through its comprehensive sales network covering Spain’s main hospitals, Palex will contribute to an important commercial breakthrough for Biom’up. The Spanish market for topical hemostats is one of the largest in the European Union, estimated to have reached €75m and growing at 5% annually (source: Grand View Research)


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.

» Read and download the press release


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