As we are working on our 510K trial in the US, IVDR registration in the EU, TFDR registration in Taiwan, and MFDS registration in Korea, we see a much larger global clinical use of our products to help more liver disease patients worldwide.

M30 Apoptosense® could assist many more patients globally to detect NASH at an early stages before late stage fibrosis is developed, hence allowing for a early reversal of the disease.

To date, there are no FDA or EMA cleared NAFLD drugs but several candidates are in the late stages of the pipeline. With an entry of a new pharmacological treatment to help these patients in the near future, we believe the M30® will serve as benefit to identify patients that would be in need of the treatment

2022 – VLVbio currently consists of 6 employees, based in Stockholm, with a product line used globally by hospitals, academia and industry!

• 2020 – The VLVbio products are accepted for clinical use by ANVISA in Brazil.

• 2019 – Patient enrollment starts for the 510K de novo trial for FDA approval in diagnosing NASH.

• 2018 – The M30 Apoptosense® is included in the large EU funded LITMUS project, to evaluate and find the best performing NAFLD biomarkers.

• 2017 – The M30 Apoptosense® is included as a screening tool for obese pediatric patients in Sweden’s second largest region.

• 2014 – VLVbio moves its headquarters to Nacka, close to the Stockholm City Centre.

• 2013 – The M30 Apoptosense® ELISA is further optimized and improved in a newer more sensitive version.

• 2013 – VLVbio is formed in a Stockholm suburb called Sundbyberg, taking over the PEVIVA product line.

• 2010 – The M30® is CE marked for IVD use in Europe to be used on liver disease patients in all sectors of healthcare.

• 2005 – Interest and awareness of NAFLD starts to grow and the interest in M30® as a biomarker for NASH is established, as apoptosis is found to be a key driving factor of NASH.

• 2000 – The PEVIVA product line launches with ELISA kits measuring M30® and M65® for the quantification of apoptosis and necrosis in epithelial cells.

• 1996 – Oncology research on the effect of substances on cancer cells leads to the discovery of an antibody detecting caspase-cleaved keratin 18 antigen fragments. The antibody gets the name M30®.