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The company

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 surgical procedures in numerous specialties such as cardiac, general and orthopedic and in laparoscopic surgeries, and give patients a better quality of life.

The Company’s lead product, HEMOBLASTTM Bellows and its laparoscopic applicator are marketed in Europe and the United States.*



Christian Gagnieu Dr. Christian Gagnieu
Founder

A Key Opinion Leader in the field of biopolymers for medical applications, Dr. Christian Gagnieu was a researcher at the INSA Lyon Engineering School and Research Manager at the Lyon Pharmacy Faculty. Dr. Gagnieu has collaborated with many companies in the medical field as an expert in biomaterials in general and in resorbable polymers in particular. Biom'up was founded on the basis of the development of his research.

Biom'up: Timeline

Q2

Exclusive distribution agreement in Australia

Q1

FDA approval for HEMOBLAST™  Bellows Laparoscopic Applicator

Submission IDE application to FDA for HEMOSNOW

Renewal of the supply agreement for human-derived thrombin for 7 years

2019

 

Q4

Filing of a reimbursement dossier for HEMOBLAST™ Bellows in Australia

Completion of the scale-up of manufacturing facility

6 key manufacturing processes upgraded and approved by FDA and EMA

Exclusive distribution agreement in Spain

€7,67 million capital increase

€3 million raised bringing bond financing with Athyrium up to €28 million

Q3

CE Mark for HEMOBLAST™ Bellows Laparoscopic Applicator

First sales of HEMOBLAST™ Bellows in the US

Q2

200 surgeons and KOL trained in the US

Bond financing for €25 million with Athyrium

Finalization of commercial organization in the US

Q1

Announcement of the construction of a new production plant

€16 million capital increase

2018

 

2017

Biom’up receives FDA marketing approval for
HEMOBLAST™ Bellows

Completion of the pivotal clinical study assessing HEMOBLAST™ Bellows in the U.S.A.

European launch

Biom’up launches its IPO on the Euronext regulated market in Paris and raise 38,1 M€

2016

marking of HEMOBLAST Bellows

Conducting pilot study
(27 patients)

The IDE authorizes the launch of a pivotal clinical study of HEMOBLAST Bellows in humans

Inclusion of the first patient in the pivotal clinical study, prospective, randomized, multicentric clinical trial assessing the efficacy and safety of HEMOBLAST Bellows in most types of surgery

Over 150 000 medical devices implanted in Europe

2015

IDE approval to initiate studies in human patients for HEMOBLAST Bellows

Raised 31,3 M€

Public funding COLOMATRIX

2014

Biom’up opens two subsidiaries in the USA and in Germany

2013

marking and launch of the COVAMESH range

Second FDA 510(k) clearance, for the COVAMESH range

Certified to ISO 13485 and ISO 9001 by the SNCH and by the BSI

logo bsi logo snch

2012

marking and launch of the HEMOSNOW range

Second FDA 510(k) clearance, for the COVA ORTHO NERVE

Over 100 000 medical devices implanted in Europe

Raised 6,8 M€

2011

First FDA 510(k) clearance, for the COVA MAX range

2010

Raised 3 M€

2009

marking and launch of the COVA and MATRI ranges

2008

Raised 1,5 M€

2007

Approval and development of the first OEM products

2006

ISO 9001 and ISO 13485 certifications

logo snch

2005

Creation of

Biom'up's Awards

Winner of the Fondation Rhône-Alpes Futur and the Innovact competition awards.
Winner of the Rhône-Alpes Entreprendre Association award and the French National Competition for Creation award in the emerging project category. Biom'up received the French high-tech mutual fund label (FCPI) and became a successful 'Start-Up'.
Winner of the National Competition for Creation award in the creation category; Novacité Labelling.