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December 6TH, 2018

Saint-Priest, France, December 6, 2018, 8:00 (Paris time) – Biom’up (the "Company"), a specialist in surgical hemostasis, announces the success of its private placement financing of €7.67 million through a capital increase by the issuance of new shares without preferential subscription rights for the benefit of a category of beneficiaries (the "Offering"). The Company sold 1,597,332 new shares at a price of €4.80 per share, representing a discount of approx. 2% to the closing share price on December 5, 2018 (€4.90 per share). The Offering represents 12.61% of the Company’s existing share capital.

» Biomup - CP Pricing PIPE Décembre 2018 VO


December 5TH, 2018

Saint-Priest, France, December 5, 2018, 6:00 p.m. (C.E.T.) – Biom’up (the "Company"), a specialist in surgical hemostasis, announces the launch of a capital increase by the issuance of new shares without preferential subscription rights for the benefit of a category of beneficiaries (the "Offer"). Biom’up wishes to raise a minimum of €7 million.

» Biomup CP Pricing PIPE Décembre 2018 VO


November 28TH, 2018

Saint-Priest (France), November 28, 2018, 8:00 am (Paris time) – Biom’up (the “Company”), a specialist in surgical hemostasis, announces today an update on its first months of commercialization of HEMOBLAST Bellows in the US and Europe and confirms a strong uptake among hospitals and surgeons.

» BIOMUP_MarketMetrics_28.11.2018.pdf


November 8TH, 2018

Biom’up announces completion of the 2018 scale-up of its manufacturing facility to meet commercial demand for HEMOBLASTTM Bellows

2018 scale-up of Biom’up’s manufacturing facility near Lyon (France) completed, allowing for a larger throughput and increased shipments of devices to the US and EU markets

Six key manufacturing processes upgraded, thoroughly reviewed and approved by the FDA and EMA; a strong validation of the Company capability to efficiently execute a comprehensive and demanding regulatory plan

Biom’up reaches a new important milestone in its growth strategy and continues to execute in line with commitments made at IPO

Saint-Priest (France), November 08, 2018, 8:00 am (Paris time) – Biom’up (the “Company”), a specialist in surgical hemostasis, announces today the completion of the 2018 scale-up of its manufacturing facility to meet commercial demand for HEMOBLASTTM Bellows, in the US and selected national markets in the EU. 

Download the full press release below: 

» 2018 0611 PR Biom'up US EU Launch EN.pdf


OCTOBER 16TH, 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


SEPTEMBER 13TH, 2018

H1 2018 RESULTS
ON TRACK WITH THE COMPANY’S BUSINESS PLAN 

▪ €41 million raised through a capital increase and an OBSA bond issue

▪ Successful implementation of commercial infrastructures in the United States

▪ Reinforced management team

Saint-Priest, France, September 13, 2018 – 8:00 CEST – Pursuant to the adoption of the interim consolidated financial statements for the period ended June 30, 2018 by the Board of Directors on September 12, 2018, Biom’up (the "Company"), specialist of surgical hemostasis, today announces its first-half results.

The statutory auditors have performed a limited review of the consolidated financial statements adopted by the Board of Directors on September 12, 2018.

Etienne Binant, Chief Executive Officer of Biom’up, commented: "Biom’up has made significant progress since its successful IPO in October 2017. The two financing deals completed at the start of the year, i.e. the capital increase through a public offering and the bond issue with stock warrants attached, have allowed the Company to raise €41 million since the IPO, thus ensuring we have the resources to match our ambitions over the medium-term. The first half results published today reflect our efforts of the last six months, focused on financing, increased production capacity and the successful implementation of our commercial infrastructure in the United States. The remainder of the year will be focused on launching the construction of the second manufacturing facility near Saint-Priest, the expansion of the hemostatic line with continuing studies required for HEMOBLASTTM Bellows and HemosnowTM and, of course, the commercial launch of our lead product in the United States". 

» Biomup_-_PR_RFS_2018_VO_4134-9267-7399_2_c79b7.pdf


SEPTEMBER 4TH, 2018

Biom’up completes its Board of Directors with the nomination of Dr. Peter Byloos to support its international growth

 

Saint-Priest (France), September 4, 2018, 8:00 a.m. (CET) – Biom’up (the "Company"), a specialist in surgical hemostasis, today announces Dr. Peter Byloos’ co-optation to its Board of Directors as an independent director. Dr. Byloos’ international experience in the healthcare and medical equipment sectors, combined with his knowledge of the US market will contribute additional support to Biom’up’s management team as the commercial roll-out of its lead product, HEMOBLASTTM Bellows, hits North America.

 

Download the full press release below: 

» Biom up CP ENG.pdf


JULY 25th, 2018

Biom’up present at the 8th Strategic Council of Health Industries hosted by France’s Prime Minister

 

-An illustration of Biom’up’s first achievements and growing position in international markets

-Significant growth of the number of U.S. hospitals undergoing a medical-economic evaluation of HEMOBLASTTM Bellows

-A strengthened sales force in the United States 

 

Download the full press release below: 

» Biomup_PR_EN.pdf


JULY 12th, 2018

Biom’up obtains CE Mark for its HEMOBLASTTM Bellows Laparoscopic Applicator

-An additional device designed to deliver the HEMOBLAST Bellows powder in minimally-invasive procedures

-Biom'up ready to address a new European market segment where traditional hemostatic products are generally difficult to use or unusable

-Yet another important milestone enabling Biom’up to address a new market of approximately 500,000 surgeries per year in Europe 

Download the full press release below: 

» Biomup_PR_applicator _12072018_a79f0.pdf


JULY 3TH, 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


MAY 2TH, 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


APRIL 24TH, 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


APRIL 16TH, 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


MARCH 27TH, 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


MARCH 6TH, 2018

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

 

 


FEBRUARY 20TH, 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


DECEMBER 18TH, 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


DECEMBER 13TH, 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


DECEMBER 07tH, 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


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


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


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


October 25th, 2012

Biom’Up raises EUR 6.8 million

 

These funds will be used to accelerate the company’s commercial development and finance clinical studies into two future innovative ranges of medical implants.

Lyon, October 25, 2012 - Biom’Up, a young company specialised in the manufacture of re-absorbable medical devices, announces today that it has raised EUR 6.8 million in new funds from existing shareholders and acquired three new investors: the InnoBio fund, managed by CDC Entreprises under the ‘FSI France Investissement’ program, Viveris Management and OTC Asset Management.

» BiomUp press release 25 10 2012 EN.pdf