- WKN: A2H5VA
- ISIN: FR0013284080
- Land: Frankreich
Nachricht vom 14.08.2019 | 08:00
Biom'up: New Publication Highlights Application of HEMOBLAST(TM) Bellows in Cardiovascular Surgery
DGAP-News: Biom'up / Key word(s): Study
New Publication Highlights Application of HEMOBLASTTM Bellows in Cardiovascular Surgery
Saint-Priest, France, August 14, 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.
The Journal of Cardiac Surgery is a peer-reviewed, international publication devoted to contemporary surgical treatment of cardiac diseases.
Two clinical case studies taken from the pivotal trial for HEMOBLAST Bellows that was originally published in the January 2019 edition of the Journal of Cardiac Surgery are described in the article entitled "Application techniques of a novel hemostat in cardiac operations: HEMOBLAST" involving the insertion of a left ventricular assist device in a 53 year old female with end-stage heart failure and a reoperation coronary artery bypass procedure on a 73 year old male who had been on chronic therapy with commonly prescribed platelet inhibitors. Both are described as high-risk patients prone to bleeding and therefore also at risk of postoperative complications related to surgical blood loss, blood transfusion, and the associated morbidity and mortality risks. Bleeding was indeed noted in both cases and HEMOBLAST Bellows was used successfully to resolve the bleeding in both instances. Importantly, the authors note that the multiple components unique to HEMOBLAST Bellows appeared to have more adherence properties while also providing strong blood clotting activity versus other powder-based agents while also delivering the advantages of ease of use in both small and large area bleeding. The authors also noted a clear glaze over the wound after application of HEMOBLAST Bellows facilitating visualization of the operative field.
Prof. William Spotnitz, Chief Medical Officer at Biom'up, said: "We are always gratified to see the successful application of HEMOBLAST Bellows especially in cases that present higher risk for patients and greater challenges for surgeons, which is why Biom'up developed the technology. We believe the cases described in the Journal of Cardiac Surgery are instructive in a variety of ways. Most importantly in describing the proper application of HEMOBLAST Bellows to resolve bleeding, but also in describing how the unique properties associated with HEMOBLAST Bellows contribute to its success as an effective and convenient hemostatic agent."
The publication can be viewed here: onlinelibrary.wiley.com/doi/10.1111/jocs.14171
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, HEMOBLAST Bellows and its laparoscopic applicator are marketed in Europe and the United States.
Since its creation, Biom'up has benefited from the support of prominent European and U.S. investors. The Company's shareholders include Bpifrance (including its Innobio fund), Gimv, Lundbeckfond, Athyrium Capital, Financière Arbevel and Invesco, as well as all the Company's management team. Biom'up successfully completed its IPO on Euronext Paris, raising EUR42.5 million in October 2017.
Since then, the Company carried out a EUR16 million capital increase in February 2018 and a EUR7.7 million capital increase by means of a private placement in December 2018. It also entered into a EUR25 million bond financing agreement with Athyrium, a U.S. fund specializing in innovative companies in the healthcare sector, in March 2018, that was successively brought to EUR28 million in December 2018 and EUR33 in August 2019.
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 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 was obtained 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. In addition, the approval from the Australian health authorities for the Company's lead product is expected during the second half of 2019.
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