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06 Dezember 2018

Saint-Priest, Frankreich, 06. Dezember 2018, 8:00 Uhr (Paris MEZ) - Biom'up (das "Unternehmen"), ein Spezialist für das Management von bei Operationen auftretenden Blutungen (chirurgische Hämostase), gibt den erfolgreichen Abschluss einer Privatplatzierung in Höhe von 7,67 Mio. € im Rahmen einer Kapitalerhöhung durch Ausgabe neuer Aktien ohne Bezugsrecht zu Gunsten bestimmter Anleger bekannt („Angebot"). Das Unternehmen gab insgesamt 1.597.332 neue Aktien zu einem Preis von 4,80 € je Aktie aus. Der Platzierungspreis entspricht einem Abschlag von etwa 2,1% auf den Schlusskurs vom 05. Dezember 2018 (4,90 € pro Aktie). Das Angebot entspricht 12,61% des bestehenden Grundkapitals der Gesellschaft.

» Biomup_PM_PIPE_Pricing.pdf


28 November 2018,

Saint-Priest, Frankreich, 28. November 2018, 8:00 Uhr (Paris MEZ) – Biom'up (das „Unternehmen“), ein Spezialist für das Management von bei Operationen auftretenden Blutungen (chirurgische Hämostase), kündigt heute ein Update über die ersten Monate der Kommerzialisierung von HEMOBLAST Bellows in den USA und Europa an und bestätigt die gute Resonanz in Krankenhäusern und bei Chirurgen.

» PM_BIOMUP_MarketMetrics_28.11.2018.pdf


8 NOVEMBER 2018

Biom’up verkündet Fertigstellung des 2018er Scale-ups seiner Produktion, um die kommerzielle Nachfrage nach HEMOBLASTTM Bellows zu decken

Fertigstellung des 2018 er Scale-ups in der Biom'up-Produktionsstätte bei Lyon, Frankreich, ermöglicht einen höheren Durchsatz und Lieferung größerer Chargen von HEMOBLASTTM Bellows in die US-amerikanischen und europäischen Märkte

Sechs zentrale Fertigungsprozesse wurden überarbeitet und von der FDA und der EMA eingehend geprüft und genehmigt; eine starke Validierung der Fähigkeit des Unternehmens, einen umfassenden und anspruchsvollen regulatorischen Prozess effizient umzusetzen

Biom’up hat einen weiteren wichtigen Meilenstein seiner Wachstumsstrategie erreicht und setzt seine im IPO gemachten Versprechen weiter konsequent um

Saint-Priest, Frankreich, 08. November 2018, 8:00 Uhr (MEZ) - Biom'up (das „Unternehmen“), ein Spezialist für das Management von bei Operationen auftretenden Blutungen (chirurgische Hämostase), gibt heute den Abschluss des 2018er Scale-ups seiner Produktion zur Deckung der kommerziellen Nachfrage nach HEMOBLASTTM Bellows in den USA sowie ausgewählten nationalen Märkten der EU bekannt. 

» 20180811 PM Biom'up US EU Launch DE.pdf


OCTOBER 16, 2018

Biom’up announces a first distribution agreement in Europe and the filing of a reimbursement dossier with Australian health authorities

The Company signed a first exclusive distribution agreement in Europe with Spain’s Palex Medical SA, a leading distributor of medical devices. A first shipment to Spain is expected at the end of 2018 with an official market launch scheduled in Q1 of 2019.


In Australia, the Company filed a reimbursement dossier for HEMOBLASTTM Bellows in the Prostheses list. Feedback from the Australian health regulators is expected in H1 2019.

» PR_Biomup_SpainAustralia_10162018.pdf


3 JULI 2018

Biom’up announces first sales of HEMOBLAST™ Bellows in the United States and the nomination to its board of directors of an independent director and an observer to support the company’s growth

- The first batch of HEMOBLAST™ Bellows was shipped to the United States in June, offering a test run for the entire supply chain and customs for its flagship product 

- A first supply agreement was signed with the UCLA Medical Center, a leading hospital in the Los Angeles area 

- Master agreements are in the process of being negotiated with more than 75 hospitals throughout the United States 

- The first deliveries to hospitals were made on July 2 

- On July 2 the company filed a supplement to obtain FDA approval for HEMOBLAST™ Bellows for use in laparoscopic surgery 

- An independent director and a non-voting observer are appointed at the company’s board of directors to support its development in North America 

 

Download the full press release below: 

» Biomup_PR.pdf


2 MAI 2018

Biom’up finalizes U.S. commercial organization to support U.S. launch of HEMOBLASTTM Bellows

 

- U.S. team of more than 100 specialist sales representatives & seasoned management in place

- On track with clinical, regulatory, financial, and commercial milestones

 

Download the full press release below: 

» Biomup_PR_US_orga .pdf


24 APRIL 2018

Biom’up has trained 200 surgeons in the US and in Europe ahead of HEMOBLAST™Bellows launch

 

- 200 KOLs and surgeons trained across the U.S. and Europe to date  

- Objective is to continue training a maximum of surgeons before the official launch of HEMOBLAST Bellows in mid-2018 

 

Download the full press release below: 

» Biomup_PR_surgeon_training_EN.pdf


16 APRIL 2018

Biom'up reports 2017 full-year results and provides corporate update

 

- 2017 results underscore focus on establishing a strong financial foundation as basis for commercial strategy going forward

- A total of c. €100 million raised through 2017 to date

- Marketing approval lead product HEMOBLASTTM Bellows obtained from the U.S.

FDA in December 2017, 7 months ahead of schedule

- 2018 focus on product launches, scale-up of manufacturing and hemostatic product portfolio expansion


Download the full press release below:  

» Biom'up reports 2017 EN .pdf


27 MÄRZ 2018

Biom’up Appoints Thierry Darnis as Global Vice President, Manufacturing & Engineering



Thierry Darnis, 54, brings extensive experience in the management of major manufacturing sites for medical devices, acquired at top-tier global companies. At Medtronic and CR Bard he managed plants pursuing a successful twofold objective of increasing volumes, while optimizing costs. Before joining Biom’up, Thierry Darnis was deputy chief executive officer of Sofradim Production, a subsidiary of Medtronic plc (Dublin, Ireland/Minnesota, USA), in charge of the Trevoux plant (340 employees) that he managed for more than 12 years. He has a Ph.D. in Life and Health Sciences, specialized in Biomaterials, from the University of Bordeaux II. (...) 

 

Download the full press release below:  

» PR Biom'up thierry Darnis EN.pdf


6 MÄRZ 2018

Biom’up is proud to receive the Lyon Metropolis president (David Kimelfeld) in our headquarters in St-Priest.

 

 


20 FEBRUAR 2018

Biom'up completes the first of its financing operations for a total amount of more than €40 million

 

“Biom’up wishes to thank all its investors those from France and those from further afield, those who have long supported us and those who have only recently come on board for making this fundraising transaction a success. The €16 million capital increase will enable us to accelerate the industrial development of Biom'up, and to prepare the expansion of our hemostatic range. As planned, these funds will be used to accelerate the ramp-up in our production in connection with the launch of HEMOBLAST™ Bellows and further clinical efforts on HEMOBLAST™ Bellows andHEMOSNOW™ ”. Etienne Binant, Biom’up’s Chief Executive Officer
 
Download the full press release bellow:  

» BiomUp_PR_EN Capital increase.pdf


18 DEZEMBER 2017

Biom’up receives FDA marketing approval  for HEMOBLASTTM Bellows, its flagship product 


 
-Approval granted several months ahead of the initial schedule

-Launch of HEMOBLAST™ Bellows in the United States expected over the summer in 2018 

 

Read more: 

» PR 18.12.17.PDF


13 DEZEMBER 2017

Biom’up to be included in the Euronext’s CAC® Small, CAC® Mid & Small and CAC® All-Tradable indexes 

 

Saint-Priest, France, December 13, 2017 – Biom’Up, specialist in surgical hemostasis, announces today that, as of Monday December 18, 2017, it will be included in three new CAC-family indexes: CAC® Small, CAC® Mid & Small and CAC® All-Tradable. 
The inclusion of Biom’Up shares in these indexes follows an analysis of the share by Euronext based on its free float market cap, and illustrates investor interest in Biom’Up, which recently reached a crucial milestone in its FDA approval process with the positive outcome of the inspection of the production facilities on Biom’up’s Saint Priest site by of the American Food & Drug Administration (FDA). 
The Euronext Paris Indexes’ Scientific Committee took this decision during its quarterly review of these indexes on December 7, 2017. 

Read more: 

» PR 13.12.17.PDF


07 DEZEMBER 2017

Biom’up appoints Cécile Ferracci as Global Vice President Marketing 

Etienne Binant, Chief Executive Officer of Biom’Up, says: “I am delighted to welcome Cécile Ferracci to Biom’up as our Global Vice-President, Marketing. Her solid and diverse experience within global medical technology companies represents a crucial asset for Biom’up’s success at a key time in its history. Her inclusion in the Company’s Executive Committee will enable her to have a maximum impact on HEMOBLASTTM Bellows’ launch strategy in Europe and the United States, in close cooperation with our regional sales and marketing managers.”

Read more: 

» PR 06.12.17.pdf


27 OKTOBER 2017

Biom’up provides regulatory update regarding HEMOBLAST™ Bellows 

 

Saint-Priest, France, October 27, 2017 – Biom’Up, specialist of surgical hemostasis, today provides a regulatory update regarding the United States Food and Drug Administration’s (FDA) review of the company’s Premarket Approval (PMA) application for its HEMOBLASTTM Bellows. 
 
The FDA conducted a PMA pre-approval inspection at the Biom’up Saint Priest, France, manufacturing facility. The four-day Premarket Approval inspection focused on the firm’s HEMOBLASTTM Bellows product line and did not result in any FDA-483, Inspectional Observations.  
This inspection was part of the medical device approval process to market HEMOBLASTTM Bellows within the United States of America. Following the inspection, the FDA will provide the company with an inspection report and continue its review of the PMA.  

Read more: 

» PR 27.10.17.pdf


11 OKTOBER 2017

Biom’up announces the success of its IPO,  raising close to €38.1 million on Euronext Paris 

 

-First initial public offering in the healthcare sector on the Euronext regulated market in Paris in the last 6 months 
 
-Strong institutional demand in France as well as abroad, especially in the United States and the United Kingdom: o balanced representation between general investors and healthcare specialists o Top 10 investors represented nearly 80% of institutional demand, a strong confidence in the company's fundamentals 
 
- Significant over subscription enabling an upsized transaction under favourable conditions: 

€38.1 million raisedfollowing the full exercise of the Extension Clause o Biom’Up could raise up to €43.9 million in the event the Overallotment Option is fully exercised 

-Offering Price set at €10.5 per share at the midpoint of the IPO range 
 
-Market capitalization of approximately €113 million   

-Trading will begin on Friday October 13, 2017

Read more: 

» PR 11.10.17.PDF


SEPTEMBER 26, 2017

Biom’Up launches its IPO on the Euronext regulated market in Paris

Saint-Priest, France, September 26, 2017 – Biom’Up, specialist of surgical hemostasis, today announces the launch of its IPO on the Euronext regulated market in Paris.

The Autorité des Marchés Financiers (AMF, the French financial markets authority) granted visa number 17- 508 dated September 25, 2017 for the prospectus relating to the IPO of Biom’Up shares.

» Biom'up PR - 26/09/2017


September 12, 2017

Biom’Up announces the filing of its Document de base within the framework of its planned IPO on the Euronext Paris regulated market

Saint-Priest, France, September 12, 2017 – Biom’Up, specialist of surgical hemostasis, announces that it filed its Document de base (source document) with the Autorité des Marchés Financiers (AMF, the French stock market authorities) on September 11, 2017 under the reference number I.17-064, within the framework of its planned IPO on the Euronext Paris regulated market.
The filing of the Document de base represents the first step in Biom’Up’s planned IPO on the Euronext Paris regulated market, contingent on market conditions and regulatory prerequisites, and notably the granting of a visa by the AMF for the prospectus that has to be drawn up relative to this operation.

» Biomup IPO PR DDB


December 20, 2016

Biom'up receives CE Mark Approval for HEMOBLAST™ Bellows, the first active hemostatic powder for management of mild to moderate intra-operative bleedings

Lyon (France), December 7th, 2016
Biom’up announces today that it has received CE Marking for HEMOBLAST™ Bellows active hemostatic powder and delivery system. HEMOBLAST™ Bellows is indicated in open surgical procedures as an adjunct to hemostasis when control of bleeding by conventional techniques is ineffective or impractical. HEMOBLAST™ Bellows is indicated in the following surgical specialties: cardiac, vascular, abdominal, urology, gynecology, orthopedic, spine, ear nose and throat (ENT), and head and neck.

[...]

» Pressemitteilung biom'up


Juli 15, 2016

Biom’up, Saint Priest, Lyon, July 15th 2016.  
Today biom’up announced the enrollment of the first patient in their prospective, randomized, controlled, multicenter, pivotal, clinical investigation evaluating the safety and efficacy of HEMOBLASTTM Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries.

 
HEMOBLASTTM Bellows is an investigational device, not currently for sale in the US that is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.   


Since its formation in 2005, biom'up has been developing medical devices based on patent protected biopolymers. Using this experience, biom'up has created innovative and clinically proven products that cover many different surgical specialties - orthopedics, spinal, cardiac, general, and maxillo-facial and dental. biom'up is committed to the design and development of novel high-performing solutions for a better patient outcome.  

» HEMOBLAST Bellows enrollment of the first patient PR.PDF


APRIL 2015

Biom'up continues its ascent with the promising research and development project progression: HEMOBLAST™ Bellows.

Lyon (France), April 1, 2015
Biom’Up announced today that it has received FDA IDE approval to begin studies in human patients on the HEMOBLAST™ Bellows hemostatic powder and delivery system. The initial phase of study will focus on Biom’Up’s system for evaluating bleeding severity as well as product safety followed by a multi-center, multi-national pivotal trial.

Find the full press release below,

» Biom'up press release


MARCH 20, 2015

Biom'up continues its ascent with the promising research and development project progression: COLOMATRIX.

Lyon (France), March 20, 2015
Biom’Up announced today that it has received public funding from the French State, the Rhone-Alpes Region, the Grand Lyon Metropole, the General Council of Isere and the FEDER European funds. These funds will be used to develop an innovative collagen-based medical device for the prevention of one of the major causes of morbidity and mortality in digestive surgery. The device will combine high tech polymers and textiles for unique biological and mechanical properties. This project is approved by Lyonbiopole and Techtera – two leading competitiveness clusters [...]

Find the full press release below,

» Biom'up press release


2. Oktober 2014

Biom'up auf dem Vormarsch

Rhône-Alpes in Kürze

Der Hersteller von resorbierbaren medizinischen Implantaten, Biom'up (GD: Sylvain Picot, wissenschaftliche Leiterin: Patricia Forest; Saint Priest; Umsatz 2013: 2,7 Mio. €; 45 Pers.), arbeitet an einem R&D-Programm, dessen erste Resultate in ein paar Wochen bekannt sein dürften. Das Unternehmen entwickelt ein hämostatisches Produkt, um Blutungen während der chirurgischen Eingriffe unter Kontrolle zu halten (...)


19. Juli 2014

Biom'up will sich international etablieren

“Tout Lyon Affiches” (Herausgeber von Zeitungen in Lyon)

Knapp zehn Jahre nach seiner Gründung in Saint-Priest beschleunigt das auf medizinische Implantate spezialisierte Lyoner Unternehmen seine Entwicklung und nimmt jetzt den deutschen und amerikanischen Markt in Angriff.

Biom'up, beispielhaft für die dynamische Entwicklung und die ehrgeizigen Ziele der Lyoner Industrie auf dem Gebiet der Medizintechnik, steht im Begriff, sich international zu etablieren (...)


15. Juli 2014

Biom'up in den USA und in Deutschland

Rhône-Alpes in Kürze

Der Lyoner Hersteller resorbierbarer medizinischer Implantate, Biom'up, hat vor kurzem zwei Filialen in den USA und in Deutschland eröffnet. Die amerikanische Filiale wird Rick Di Blasi leiten. Er ist seit dreißig Jahren auf dem Gebiet der chirurgischen Produkte tätig und wird für die Einführung der Biom’up-Sortimente zuständig sein (...)


2. April 2014

BIOM'UP – Körpernahe Innovation

THE ONLY

Die Handgriffe des Chirurgen erleichtern, den Patientenkomfort verbessern und die Risiken für die Gesundheit reduzieren – das alles ist möglich mit Kollagen. Hier, in Kürze, der Schlüssel zum Erfolg von Biom’up, einem jungen biotechnologischen Unternehmen, das jetzt den US-amerikanischen Markt erobern will. Am Beginn dieser Success Story standen zwei Ingenieure Sylvain Picot und Patricia Forest vom Lyoner INSAa-Institut, zusammen mit Doktor Christian Gagnieu. Das Spitzenprodukt von Biom’up ist eine strapazierfähige, perfekt tolerierte Membran namens COVATM, die sich nach 3 bis 4 Monaten natürlich auflöst. Dieses implantierbare System dient bei einer Operation dazu, die unterschiedlichen Gewebe voneinander zu trennen und so postoperative Adhäsionen zu vermeiden. Guillaume Laurent, Produkt-Manager, ist sich sicher: „Die Zukunft liegt in der regenerativen Medizin, die dem Körper hilft, sich selbst zu rekonstruieren (…)


13. Juni 2013

Biom’up kündigt die Markteinführung der Bauchwand-Verstärkung COVAMESH™ an

Diese zweiseitige Bauchwand-Verstärkung basiert auf der Technologie COVA™; ihre Verwendung stellt aufgrund der signifikanten Reduzierung der Adhäsionsrisiken einen entscheidenden Fortschritt in der laparoskopischen Chirurgie dar.

Lyon, am 13. Juni 2013 – Biom’up, Spezialist für die Herstellung medizinischer resorbierbarer Implantate, kündigt heute die Markteinführung seiner neuen Bauchwand-Verstärkung Covamesh an. Covamesh wurde speziell für die Anwender in der Abdominalchirurgie, insbesondere in der Laparoskopie entwickelt. Es besteht aus der von Biom’up entwickelten antiadhäsiven Kollagenmembran COVA und einem Polyestergewebe. Eine spezifische Markierung erleichtert das Einsetzen während der OP.

Lesen Sie hier die vollständige Pressemitteilung.


25. Oktober 2012

Biom’up beschafft Mittel in Höhe von 6,8 Millionen Euro

Die Mittel werden verwendet, um die kommerzielle Entwicklung des Unternehmens zu beschleunigen und um die klinischen Untersuchungen für zwei künftige Sortimente innovativer medizinischer Implantate zu finanzieren.

Lyon, den 25. Oktober 2012 – Biom’up, das auf resorbierbare medizinische Implantate spezialisiert ist, kündigt heute ein neues Fundraising in Höhe von 6,8 Millionen Euro an. Dazu beigetragen haben die traditionellen Aktionäre sowie drei neue Investoren: der von CDC Entreprises im Rahmen des Programms FSI France Investissement verwaltete Fonds InnoBio, Viveris Management und OTC Asset Management.
 

Lesen Sie hier die vollständige Pressemitteilung.