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MARCH 07TH 2018

NAMSA – Biom’up Achieves Record-Breaking Medical Device Development Timelines with NAMSA’s MRO® Approach

Interview of Etienne Binant, Biomu’up CEO and Rachid Zerouali, Sales director EMEA at Namsa

Watch the full video: http://NAMSA – Biom’up Achieves Record-Breaking Medical Device Development Timelines with NAMSA’s MRO® Approach Interview of Etienne Binant, Biomu’up CEO and Rachid Zerouali, Sales director EMEA at Namsa Watch the full video: https://www.youtube.com/watch?v=M4rbvoJ90_U


NOVEMBER 09, 2017

Biom’up confirms the success of its IPO

 

Reinforcement of shareholders' equity of €60 million through the initial public offering of witch: - around €42.5 million within the frame of the offer - €17.3 million in bonds capitalization  
Implementation of a liquidity contract with CM-CIC Market Solutions 

 

Read more: 

» PR 09.11.17.pdf


OCTOBER 27th, 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


OCTOBER 11th, 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 26TH, 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 12th, 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 20th, 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.

[...]

» biom'up press release


July 15th, 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


MAY 12, 2016

Today Biom'Up announced it has received FDA clearance for the HEMOBLASTTM Bellows IDE pivotal clinical trial design.

The prospective, randomized, controlled, multi-center clinical investigation evaluates the safety and efficacy of HEMOBLASTTM Bellows, the company’s novel hemostat, in cardiothoracic, abdominal, and orthopedic lower extremity surgeries.

The study meets the FDA requirement for reliability by establishing the eligibility of the target bleeding site and achievement of hemostasis based on the SPOT GRADETM, a validated Surface Bleeding Severity Scale (SBSS), that is a proprietary creation of Biom’Up. (...)

» Biom'up press release


SEPTEMBER 9TH, 2015

Biom’Up secures EUR 31,3 million in Series C financing from Bpifrance Large Venture, Gimv and Lundbeckfond Ventures.

St-Priest, 9 September 2015, 7:30 AM CET – Biom’Up today announced that the company has secured EUR 31,3 million in a Series C financing round from an investment syndicate consisting of Gimv, Bpifrance Large Venture and Lundbeckfond Ventures, alongside its existing shareholders (InnoBio, Sham Innovation Santé, ACG Management, Sofimac, Mérieux Développement, OTC AM, Euroainvest and l’Améliane) and the company’s management team. This third institutional financing round represents a milestone for the international growth and scaling of the business... 

Find the full press release below,

» Biom'up press release


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 20th,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


22 November 2013

Biom’Up: a first clinical study demonstrates the potential of COVATM+ CARD membrane in pediatric cardiology & heart surgery


• This collagen membrane forms a resorbable barrier to provide the guided healing of organs and tissues along distinct anatomical planes
• The clinical study that included 36 patients demonstrates the good tolerance of the membrane and its benefit for the patient: no severe adherence was observed, contrary to the usual practice
• These results have been reviewed and published in “Archives of Cardiovascular Diseases”, the official review of the French Society of Cardiology


Lyon, France, December 02, 2013 - Biom'Up, a specialist manufacturer of absorbable medical implants, today announces the results of a first clinical study in pediatric cardiac surgery.

» BiomUp press release 22 11 2013 EN.pdf


June 13th, 2013

Biom'Up launches the COVAMESH™ abdominal wall reinforcement implant

Featuring Cova(TM) technology, the double-sided wall reinforcement implant represents real practical progress for
laparoscopic procedures, significantly reducing the risk of adhesions

Lyon, France, June 14, 2013 – Biom'Up, a specialist manufacturer of absorbable medical implants, today announces the launch of its new wall reinforcement implant, Covamesh. Made from Biom'Up's anti-adhesion collagen membrane, Cova, and a polyester textile layer with special markings for ease of placement during surgery, Covamesh is designed to fulfil surgeons' needs in abdominal surgery, particularly in laparoscopic procedures.

» Biom'Up Press