biosurfit press / news

Find out more about the latest news and updates of biosurfit.

biosurfit achieves IFCC and NGSP certifications for its spinit® HbA1c point-of-care test

 

Lisbon, Portugal, 31st October 2017 biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, announces that its spinit® HbA1c point-of-care test has successfully achieved both IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) certification and NGSP (National Glycohemoglobin Standardization Program) certification.

The IFCC maintains the JCTLM (Joint Committee for Traceability in Laboratory Medicine) endorsed reference measurement procedure for HbA1c, accepted worldwide as the analytical control for traceability of HbA1c measurement.

 

The NGSP certification is awarded to systems that yield results sufficiently accurate and precise to be comparable to those reported in the Diabetes Control and Complications Trial (DCCT).

The recent awarding of both IFCC and NGSP certifications, clearly demonstrate that the spinit® HbA1c test meets all the extremely demanding requirements set by two independent certifying bodies.

Glycated hemoglobin (HbA1c) testing is globally recognised as the gold standard in monitoring of diabetic patients, enabling more complete control of their disease management. The spinit® HbA1c test offers precise and accurate results in less than 6 minutes from just 5μL of blood, using a simple system capable of performing further blood tests.

João Garcia da Fonseca, CEO of biosurfit, commented:“It is with immense pride and honour that biosurfit receives these certifications. We believe this is the recognition of our hard and intense work along the years to make spinit® a new reference in the way of performing blood analysis.”

 

For enquiries please contact:

biosurfit SA
João Garcia da Fonseca, Chief Executive Officer
Daniel Neves, Chief Marketing Officer
Tel: +351 218 860 169

 
Notes to editors
About biosurfit and spinit®

biosurfit is a fast-growing and highly innovative commercial stage European medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market. Its lead product spinit®, which was commercially launched in 2014, addresses an unmet need for fast, precise, reliable, easy-to-use blood analysis for medical testing in the point-of-care setting.

biosurfit and Axonlab Sign Distribution Agreement for Switzerland

 
Axonlab is now a distributor for spinit® in six European countries. biosurfit continues to build a strong commercial presence in more than twenty countries

 

Lisbon, Portugal, 27th June 2017 – biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, announces that it has signed a distribution agreement with Axon Lab AG (“Axonlab”) for the commercialisation of its spinit® point-of-care instrument in Switzerland. spinit® offers a comprehensive menu of fast, easy to perform laboratory quality tests in a point-of-care instrument, including HbA1c (Haemoglobin A1c), CRP (c-reactive protein) and BC (blood count).
 

This is the sixth national distribution agreement biosurfit has signed with Axonlab, an independent European distribution, services and production company focusing on medical diagnostics, life science and software solutions for the healthcare sector. Under the terms of these agreements, biosurfit has granted Axonlab the rights to promote, market, and sell the spinit® instrument and associated discs to hospitals, doctors, clinics, private laboratories and research institutions in Austria, Croatia, Slovakia, the Czech Republic, Slovenia and now Switzerland.

 

Axonlab has dedicated diagnostics franchises and direct offices in each of the countries covered under the agreements and is well positioned to accelerate the commercial launch of spinit® in Switzerland and the Central and Eastern European markets. biosurfit will continue its direct sales programs in its home market of Portugal.

 

“We are excited to partner with biosurfit for the commercial distribution of the spinit® instrument and test discs in several of our core markets in Europe,”, said Roland Steger, CEO of Axonlab. “spinit® unique technology and attractive menu of tests, on a rapid and simple to use instrument, will allow these key tests to be performed in doctors’ offices, clinics, and other testing sites at the point-of-care. Our collaboration with biosurfit is expected to be another driver for our future growth at Axonlab in the years ahead.”

 

João Garcia da Fonseca, CEO of biosurfit, commented: “We are pleased to expand our partnership with Axonlab, whose track record has shown that they are the right partner for us in these markets. Now with the addition of Switzerland, the Axonlab collaboration adds several important markets to our distribution portfolio and will allow us to accelerate the commercial roll-out of spinit®”.

 

“biosurfit has already has a strong commercial presence, either directly or through our distribution partners, and we plan to continue expanding this worldwide network through the addition of new commercial partnerships.”

 
Enquiries
biosurfit SA
João Garcia da Fonseca, Chief Executive Officer
Daniel Neves, Chief Marketing Officer
+351 218 860 169
 
FTI Consulting (media relations)
Simon Conway / Natalie Garland-Collins
Tel: +44 (0)203 727 1000

 
Notes to editors
 

About biosurfit and spinit®

biosurfit is a fast-growing and highly innovative commercial stage European medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market. Its lead product spinit®, which was commercially launched in 2014, addresses an unmet need for fast, precise, reliable, easy-to-use blood analysis for medical testing in the point-of-care setting.

 

About Axonlab

Axonlab is a cutting-edge, customer-oriented service company operating in the fields of medical diagnostics, life science and software solutions for the health-care sector. Since 1990 Axonlab has collaborated with reputable international supply partners in selling innovative systems to clinics, doctors and the research sector. Axonlab focuses on providing a comprehensive, future-oriented service, to provide a foundation for long-term business relations.

 

biosurfit wins award of distinction “BORN FROM KNOWLEDGE” at the 14th National Meeting of Innovation COTEC-ANI

 

Lisbon, Portugal, 17th May 2017 – biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, is pleased to announce the awarded distinction “BORN FROM KNOWLEDGE” at the 14th National Meeting of Innovation COTEC-ANI for the development of the spinit® HbA1c, the POC test to monitor and diagnose diabetes

 

The distinction, first time established, recognizes the award to innovative products that are targeted to global markets and developed by companies with their activity in Portugal. It’s a distinction award to products that are “born from knowledge” and with activities based on Research & Development (R&D).

 

spinit® is the first and only point-of-care diagnostic system capable of performing all three of the major blood tests (haematology, immunoassays and clinical chemistry) on the same instrument. This combination of different detection methods on a CD/DVD format of the spinit® disposable disc, along with powerful microfluidics, is facilitating the development of a pipeline of tests. A lipids panel, an inflammation panel and a D-dimer test are all currently in the advanced stages of development to be added to the existing available tests in the market: C-reactive Protein (CRP), Blood Count (BC) and HbA1c (glycated haemoglobin).

 

João Garcia da Fonseca, CEO of biosurfit, commented: “It is with great pride and honour that biosurfit receives this award. We believe this is the recognition of our hard and intense work along the years to make spinit® a new reference in the way of performing blood analysis.

 

Enquiries
biosurfit SA
João Garcia da Fonseca, Chief Executive Officer
Daniel Neves, Chief Marketing Officer
+351 218 860 169

 
Notes to editors
 

About biosurfit and spinit®

biosurfit is a fast-growing and highly innovative commercial stage European medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market. Its lead product spinit®, which was commercially launched in 2014, addresses an unmet need for fast, precise, reliable, easy-to-use blood analysis for medical testing in the point-of-care setting.

 

biosurfit announces drawdown of €6 million tranche of funding from the EIB to increase manufacturing capability and support commercialisation of spinit®

Manufacturing scale-up to support rapid commercial roll-out in key markets

 

Lisbon, Portugal, 5th May 2017 – biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, announces that it has drawn down the second €6 million tranche from the €12 million loan signed with the European Investment Bank (“EIB”) in November 2015 to fund biosurfit’s transition to industrial-scale manufacturing, and support the rapid commercial roll-out of the Company’s spinit® PoC device in key EMEA markets. The first €6 million was drawn down in April 2016.

 

Due to the high levels of customer interest and rapid commercial roll-out of its spinit® PoC diagnostic system, in addition to the expected launch of further new tests during 2017, biosurfit will use the funds to support the ongoing commercialisation of spinit® in key EMEA markets and to progress the regulatory approval processes in other new markets.

 

In addition, the EIB funds, together with additional Portuguese grants, will accelerate biosurfit’s transition to industrial-scale manufacturing through the construction and commission of a new manufacturing facility in Azambuja, approximately 50km from Lisbon, creating new job opportunities in the region. The 4,500m2 facility, which will be modular in design, will allow for rapid construction and flexibility for future expansion. Initially, it will include 2,500m2 of space for automated manufacturing of spinit® instruments and disposable discs and 1,000m2 of R&D lab space. Construction is expected to commence in Q2’17 with commissioning expected in H1’18.

 

biosurfit’s investment programme is supported by “InnovFin – EU Finance for Innovators” MidCap Growth Finance, with the financial backing of the European Union under Horizon 2020 Financial Instruments. InnovFin is a range of EIB Group products designed to facilitate access to finance for innovative businesses. InnovFin MidCap Growth Finance offers long-term senior, subordinated or mezzanine loans ranging from €7.5 to 25 million for innovative larger midcaps (up to 3,000 employees) but also SMEs and small midcaps.

 

João Garcia da Fonseca, CEO of biosurfit, commented: “We are very pleased with the high level of customer interest in, and take-up, of the spinit® device. This, and the expected launch of our new lipids and inflammation panels during 2017, necessitates us upgrading our manufacturing capacity. The EIB funds will support the construction and commissioning of this facility and our continued commercial roll-out in both existing and new markets, including the USA and Asia, following the necessary regulatory approval.

 

For enquiries please contact:

FTI Consulting (media relations)
Simon Conway / Natalie Garland-Collins
+44 (0)203 727 1000

 

Biosurfit SA
João Garcia da Fonseca, Chief Executive Officer
Daniel Neves, Chief Marketing Officer
+351 218 860 169

 

Northridge Advisory Ltd. (advisor to biosurfit)
Jamie Adams / Robin Stürken
Tel: +44 (0)20 8906 6738

 

Notes to editors

 

About biosurfit and spinit®

biosurfit is a fast-growing and highly innovative commercial stage European medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market. Its lead product spinit®, which was commercially launched in 2014, addresses an unmet need for fast, precise, reliable, easy-to-use blood analysis for medical testing in the point-of-care setting.

 

About The European Investment Bank (EIB)
EIB is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.

 

About InnovFin financial products
Under Horizon 2020, the EU research programme for 2014-20, the European Commission and the European Investment Bank Group (EIB and EIF) launched a generation of financial instruments and advisory services in 2014 to help innovative firms access finance more easily. Until 2020, “InnovFin – EU Finance for Innovators” will offer a range of tailored products which will make available over €24 billion of financing support for research and innovation (R&I) by small, medium-sized and large companies and the promoters of research infrastructure. This finance is expected to support up to €48 billion of final R&I investments.

InnovFin is building on the success of the Risk-Sharing Finance Facility developed under the seventh EU framework programme for research and technological development (FP7), which financed 114 R&I projects to the tune of €1.3 billion and in addition provided loan guarantees worth over €1.4 billion.

Backed by funds set aside under Horizon 2020 and by the EIB Group, InnovFin financial products support R&I activities, which by their nature are riskier and harder to assess than traditional investments and therefore often face difficulties in accessing finance. All are demand-driven instruments, with no prior allocations between sectors, countries or regions. Firms and other entities located in EU Member States and Horizon 2020 Associated Countries will be eligible as final beneficiaries.

biosurfit Achieves Significant Commercial Milestone – 500 spinit® Instruments Placed with European Customers

On track to deliver over 1,000 devices by end of 2017, biosurfit now has a commercial presence in more than twenty countries

Lisbon, Portugal, 3rd April 2017 – biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, is pleased to announce that it has reached a significant commercial milestone, and also provides an update on recent progress.

 

At the end of February 2017, biosurfit achieved a key commercial milestone by delivering the 500th spinit® point-of-care instrument to a European customer. With a commercial presence in over 20 countries, a growing distributor network and a current order backlog of approximately 150 instruments, biosurfit is on track to have over 1,000 spinit® instruments in daily use by customers by the end of 2017.

 

biosurfit is building a suite of tests on its proprietary spinit® device. With the CE-Marking of the new HbA1c (Haemoglobin A1c) test in November 2016, along with CRP (c-reactive protein) and BC (blood count), spinit® offers a comprehensive menu of fast, easy to perform laboratory quality tests in a point-of-care instrument.

 

spinit® is the first and only point-of-care diagnostic system capable of performing all three of the major blood tests (haematology, immunoassays and clinical chemistry) on the same instrument. This combination of different detection methods on the CD/DVD format of the spinit® disposable disc, along with powerful microfluidics, is facilitating the development of a pipeline of tests. A lipids panel, an inflammation panel and a D-dimer test are all currently in the advanced stages of development are expected to launch over the next few months.

 

João Garcia da Fonseca, CEO of biosurfit, commented: “The delivery of 500 spinit® devices marks a significant commercial milestone for biosurfit. We are very encouraged by the growing customer interest in our spinit® system and our recent commercial progress. We are targeting over 1,000 instruments in daily use by the end of 2017 and are looking forward to continuing the roll-out and commercialisation of the expanded spinit® test menu during the course of the year.

 

For enquiries please contact:

FTI Consulting (media relations)
Simon Conway / Natalie Garland-Collins
+44 (0)203 727 1000

 

Biosurfit SA
João Garcia da Fonseca, Chief Executive Officer
Daniel Neves, Chief Marketing Officer
+351 218 860 169

 

 

Notes to editors

 

About biosurfit and spinit®

biosurfit is a fast-growing and highly innovative commercial stage European medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market. Its lead product spinit®, which was commercially launched in 2014, addresses an unmet need for fast, precise, reliable, easy-to-use blood analysis for medical testing in the point-of-care setting.