24.2.2023 11:34:53 CET | ViroGates | Company Announcement

COMPANY ANNOUNCEMENT - No. 3-2023 – Inside information - 24 February 2023  

BIRKERØD, DENMARK - ViroGates A/S, a medical technology company developing blood tests for better triaging in hospitals to improve patient care and reduce healthcare costs, today announces the commercial launch of its newly developed suPARnostic® POC+ product for complete quantitative analysis of suPAR in finger prick blood.

suPARnostic® POC+ was approved according to CE-IVD in 2022. Before commencing the commercial roll-out, ViroGates wanted to collect additional clinical and handling data from users with limited or no experience handling finger prick blood analysis.

Topline data from a Greek study comprising two hospitals have today been released, showing a robust and highly statistically significant correlation between finger prick blood samples and a reference blood sample processed using existing EDTA plasma samples on the suPARnostic® ELISA platform. Clinical data from the study have also been analyzed, showing a strong and highly statistically significant ability to predict patient outcome (based on 30 days mortality data).

The data support the ability of the target customer segment, doctors, nurses and other healthcare personnel not trained as professional lab users, to run suPAR analysis near patients with results that can be obtained in approx. 20 minutes.

The suPARnostic® POC+ development is a collaboration between ViroGates, and GENSPEED Biotech GmbH. It is based on the GENSPEED Technology that allows for quick and fully automated processing of finger-prick blood to help the hospital sector to triage patients better and faster.

The product may incorporate more biomarkers into the same panel in the future. ViroGates and GENSPEED are collaborating in a program supported by an EU grant to exploit the ability to add to the POC+ additional relevant, complementary biomarkers.

The commercial rollout will now be initiated by ViroGates’ salesforce and its distribution partners across Europe.

Data analysis of the Greek study is ongoing, and final results will be made available via publication in a scientific journal.

The results from this announcement are not expected to impact ViroGates’ full-year 2023 revenue or EBIT guidance.

ViroGates’ strategic objective of becoming cash flow positive during 2024 is maintained. 

CEO Jakob Knudsen comments: “Before placing the suPARnostic® POC+ product in the market we wanted to ensure that results are reliable. This goes for both technology and user handling. The results obtained in Greece confirm that the target audience for suPAR can be increased to include healthcare personnel that are not lab trained. We know from our hospital customers in several markets that they value obtaining triage results as early as possible. suPARnostic® POC+ allows us to move out into the much earlier triage stages, such as rural hospital settings, ambulances and potentially also with general practitioners. We are very grateful to our Greek clinical collaboration partners and our partners at GENSPEED and look forward to commercialising this product now.”

CSO Jesper Eugen-Olsen, PhD says: “It is truly great to see that suPAR measured on POC+ gives strong prognostic results in a large clinical trial comprising more than 300 patients. Combining finger prick blood and quick point-of-care analysis opens new avenues for measuring chronic inflammation in individuals and patients.”

GENSPEED Biotech GmbH, CEO, Max Sonnleitner says: “We are excited to see the commercial launch of suPARnostic® POC+ and the positive clinical data from the Greek study, which demonstrates the ability to run suPAR analysis on GENSPEED devices near patients with reliable results that can be obtained in just 20 minutes out of a drop of blood. This is an important milestone in our collaboration with ViroGates, and we look forward to continuing our work together to incorporate additional relevant biomarkers in multiplex tests in the future”

The announcement can be found at https://www.virogates.com/investor/announcements 

For further information, please contact:

ViroGates A/S:

CEO, Jakob Knudsen

Tel. (+45) 2226 1355, email: jk@virogates.com

Certified Advisor:

Västra Hamnen Corporate Finance

Per Lönn

Tel. (+46) 40 200 250, email: per.lonn@vhcorp.se

About ViroGates

ViroGates A/S is an international medical technology company developing and marketing blood test products under the suPARnostic® brand for better triaging in hospitals to improve patient care, reduce healthcare costs and empower clinical staff.

The company was founded in 2000. Headquartered in Denmark, ViroGates' sales force covers the Nordics, Spain, France and Benelux, while distributors serve other markets.

ViroGates' shares (VIRO) are listed on Nasdaq First North Growth Market Denmark. For more information, visit www.virogates.com.

About suPAR and suPARnostic®

suPAR is a biomarker detected by ViroGates' suPARnostic® products. It is a protein found in the plasma. suPAR is considered a general risk status biomarker measuring inflammation and can indicate disease presence, severity, and progression across disease areas such as cardiovascular diseases, kidney diseases, type 2 diabetes, cancer, etc. Strong scientific evidence from more than 900 clinical trials and studies shows that the higher the level of suPAR, the worse the prognosis for the patient.

The suPARnostic® products can support healthcare professionals in making clinical decisions on hospitalisation or discharge of acute care patients. The increasing global demands on health systems and tightening healthcare budgets necessitate efficiency improvements and innovative hospital solutions. The use of suPAR in clinical routine in emergency departments can improve patient care and reduce healthcare costs by increasing the number of discharges by up to 34% and reducing the average hospital length of stay by up to 6% without affecting mortality. suPARnostic® TurbiLatex is currently available on Roche Diagnostics' cobas® instruments, Siemens Healthineers ADVIA® XPT and Atellica® instruments and the Abbott Labs Architect™ and Alinity™ instruments. ViroGates works with partners to develop solutions for other platforms.

About GENSPEED Biotech GmbH and the GENSPEED® Technology

GENSPEED Biotech offers a unique technology platform on which rapid tests can be developed for medical diagnostics and various industrial applications. The technology combines microfluidics, miniaturized opto‐electronics and automation as the proprietary basis of a small, simple, reliable and IVD CE certified test system. The system enables the detection of up to 8 different biomarkers as a multiplex assay on‐site within only a few minutes and with high sensitivity. For more information on GENSPEED Biotech please visit www.genspeed‐biotech.com.

Disclosure regulation

Prospects about the future reflect ViroGates' current expectations for future events and results. The statements are by nature inherent in risks, uncertainties and other matters that are difficult to predict or out of control. The actual results may therefore differ from the expectations expressed.

Contacts

• Jakob Knudsen, CEO, +45 2226 1355, jk@virogates.com

Attachments

• 20230224 - ViroGates Company ann. 3.pdf