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biosurfit receives CE Mark for its spinit® HbA1c point-of-care blood test to assist doctors diagnose and monitor diabetes

 

biosurfit receives CE Mark for its spinit® HbA1c point-of-care blood test to assist doctors diagnose and monitor diabetes

  • spinit® is the only point-of-care instrument able to perform all three of the major blood tests (haematology, immunoassays and clinical chemistry) on the same instrument
  • spinit® could enable cost-savings due to its three-in-one capabilities
  • spinit® can assist physicians in diagnosing and monitoring diabetes without having to collect and send blood samples to a central laboratory

Lisbon, Portugal, 30th November 2016 – Today, biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, announces CE Marking (Conformité Européenne) for its HbA1c (Haemoglobin A1c) test, the third in a series of tests available on its spinit® point-of-care instrument.

 

The CE Mark approval of the HbA1c clinical chemistry test signifies the latest advancement of biosurfit’s spinit®, the first and only, PoC diagnostic system capable of performing all three of the major blood tests (haematology, immunoassays and clinical chemistry) on the same instrument. The spinit® test could also signal cost-efficiencies for physicians who can now use just one instrument, instead of several ones. Existing, commercially launched tests for the spinit® instrument include CRP (c-reactive protein) and BC (blood count).

 

The HbA1c test is one of the key diagnostic tests used by physicians to diagnose and monitor diabetes as well as to identify patients at risk of developing diabetes. With a requirement for a tiny finger stick blood sample of only 5µl, the new spinit® clinical chemistry HbA1c test allows physicians to manage the progression of this very serious disease in a few minutes. HbA1c is one of the most commonly used PoC tests performed in physicians’ offices. With the CE marking of biosurfit’s spinit® HbA1c test, biosurfit is now able to offer this valuable tool to help physicians efficiently diagnose and monitor diabetes without having to collect and send blood samples off to a central laboratory.

 

With the new HbA1c test, along with CRP and Blood cell counting, biosurfit now offers a comprehensive menu of fast, easy to perform laboratory quality tests on the spinit® instrument. The combination of different detection methods on the CD/DVD format of the spinit® disc along with powerful microfluidics will facilitate the development of the pipeline of products in the near future, including a lipid panel, an inflammation panel and a d-dimer test. This attractive menu of tests, on a rapid and simple to use instrument will allow the performance of these key tests in GP offices, clinics, pharmacies and other PoC testing sites.

 

João Garcia da Fonseca, Chief Executive Officer of biosurfit, commented: “We are delighted to have secured this new and important milestone in the continuous development of spinit®. It is a clear testament to its disruptive, technical viability and rising commercial acceptance in setting the future gold standard in IVD PoC diagnostics. We are looking forward to continuing the roll out and commercialisation of the expanded spinit® test menu in the near future.

 

Ian Gilham, Chairman of biosurfit, commented: “CE-Marking of the HbA1c test is a major milestone in the development of the spinit instrument and test menu providing an indispensable aid to patients and physicians in their fight against diabetes. We are excited by the ever expanding menu of spinit tests and the increased installed base of instruments which will be further driven by the launch of new tests and the opening of new global markets in the near future.”

 

For enquiries please contact:

FTI Consulting (media relations)
Con Franklin
con.franklin@fticonsulting.com
+44 (0)203 727 1000

 

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

 

 

Notes to editors

 

About the HbA1C test

In 2016, it is estimated that more than 415 million people worldwide were living with diabetes and nearly half of the people with diabetes remain undiagnosed. If left undiagnosed, or not properly managed, diabetes can cause serious health complications[1]. The HbA1c test is a blood test that reflects a person’s average blood glucose levels over the past three months. In 2009, an international expert committee recommended that physicians may use an HbA1c test for the diagnosis of type 2 diabetes and identification of patients at risk of developing diabetes if the assay meets specific performance criteria, such as certification and standardisation processes outlined by the National Glycohemoglobin Standardization Program (NGSP) and the International Federation of Clinical Chemistry (IFCC). Diabetes can be managed by using diabetes medicines, making important lifestyle changes related to diet and exercise, and monitoring blood glucose and HbA1c levels. The American Diabetes Association recommends that people with diabetes who are meeting treatment goals and have stable blood glucose levels have the test twice a year. Health care providers may repeat the test as often as four times a year until blood glucose levels reach recommended levels.[2] When diabetes is not managed properly, it can lead to damage of important systems in the body, including the heart, kidneys, and eyes, and even cause life-threatening complications.

 

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 PoC setting.

 

[1] International Diabetes Federation. IDF Diabetes Atlas, 7th edition, Brussels, Belgium: International Diabetes Federation; http://www.diabetesatlas.org. Accessed 6 November 2016.

[2] NIH – National Institute of Diabetes and Digestive and Kidney Diseases: The A1C Test and Diabetes; www.niddk.nih.gov. September 2014.

biosurfit secures €12 million loan from the European Investment Bank

Biosurfit secures €12 million loan from the European Investment Bank

Supporting the development and commercialization of innovative point-of-care diagnostic tests.

biosurfit SA (“biosurfit” or ”the Company”), the in vitro point-of-care diagnostics company, today announces that it has secured a €12 million loan from The European Investment Bank (“EIB”) to support the funding of the Company’s research, development and innovation (RDI) activities in point-of-care (PoC) diagnostics. Román Escolano, EIB Vice-President and João Garcia da Fonseca, CEO, biosurfit, have signed the financing contract in Lisbon today.

 

biosurfit is a fast-growing and highly innovative early commercial stage medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market and financed by Portugal Ventures, Beta Capital, Caixa Capital and PME Investimentos. The Company’s lead platform technology, spinit®, addresses an unmet need for fast, precise, reliable and affordable blood analysis for PoC medical testing.

 

The financing will support the development of novel diagnostic tests to expand biosurfit’s existing spinit® technology platform and its ongoing commercialization in key markets. The main focus will be to establish a wide range of diagnostic tests in one simple to use instrument across a broad spectrum of applications, including diabetes, cardiology inflammation, haematology, renal and metabolic diseases. The loan will also fund investments to expand the Company´s manufacturing capacity in line with the wider product portfolio and expected market demand for tests.

 

The investments will be carried out in Portugal and will be implemented over the next three years. The loan will support biosurfit in its transition to industrial-scale operations and in the expansion of the Company´s intellectual property portfolio. This funding will, therefore, contribute to the creation of highly skilled jobs in Portugal and to the implementation of R&D activities that will help to improve patients’ health and quality of life.

 

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, Chief Executive Officer of biosurfit, commented: “We are delighted to have secured this financing from the European Investment Bank which provides us with access to long-term, committed capital on favourable terms. It is a clear endorsement from the EIB of the strength, quality and potential of Biosurfit’s innovative diagnostics technology.”

 

Román Escolano, EIB Vice-President, said: “The €12 million loan provided by the European Investment Bank to support biosurfit’s activities in innovative diagnostics illustrates European Union’s commitment to innovation and to its citizens, who will benefit most from this important project. We are happy to contribute to biosurfit’s RDI and commercialization activities, which aim to improve patients’ health and quality of life as well as creating highly skilled employment opportunities in Portugal.

 
Enquiries
biosurfit SA: +35 1 21 886 01 69
Ian Gilham, Chairman
João Garcia da Fonseca, Chief Executive Officer
Daniel Neves, Chief Financial Officer
 
FTI Consulting: +44 (0)20 3727 1000
Ben Atwell
Simon Conway
Natalie Garland-Collins
 
Northridge Advisory Ltd. (Advisor to Biosurfit): +44 (0)20 8906 6738
Jamie Adams
Robin Stürken
 
Notes to Editors

About biosurfit SA

biosurfit is a Portuguese, commercial stage, point-of-care (PoC) diagnostics company with highly innovative proprietary technology. biosurfit’s spinit® platform is the first, and only, diagnostic system capable of performing the major PoC blood test modalities (haematology, immunoassays and clinical chemistry) on the same instrument. biosurfit’s first two tests, C-Reactive Protein (CRP) and Blood Count, were CE-marked and launched in the EU in 2014 and an extensive test menu is expected to be rolled-out in the EU and USA over the next 3 years. biosurfit´s investors are the founders, Portugal Ventures, Caixa Capital, Beta Capital and PME Investimentos.

 
For further information about Biosurfit, please visit www.biosurfit.com.
 
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 featured on national news: ” The future today”

Find out the whole story in this link.

(If you don’t understand portuguese, enable english subtitles on the video)

RevDiagnostics

 

“We are proud to represent spinit ® in the Benelux market and to work with the very driven team of biosurfit. spinit® is a great innovative product with a lot of possibilities in the field of POCT.
The feedback that we have been receiving from customers is tremendously positive. spinit® is already recognized for its quality, stability and ease of connecting. It is the only true Multi Parameter POCT system. “

 

Ernst De Jong – Founder and Director at RevDiagnostics

DVU

 

“At DVU we want to be on the top of innovation while providing quality, decentralized and efficient care to our customers. With the implementation of spinit® we are taking one more step forward as a company in that direction.” 

 

Antoon Van Elderen – Chief Business Development at DVU