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April 14, 2022

Versantis to develop blood ammonia monitoring device

The TS-01 assay is being developed using transmembrane pH-gradient polymersomes that encapsulate a ratiometric fluorophore.

Versantis is set to receive nearly $508,753 (Sfr475,000) from Swiss national innovation agency Innosuisse for the development of a point-of-care (POC) device to monitor blood ammonia in liver disease patients.

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The company plans to enlist the Zurich University of Applied Sciences School of Engineering and develop a prototype POC device, TS-01, using a polymersome-based ammonia quantification method.

TS-01 is designed for the measurement of ammonia in blood at home, mainly for hepatic encephalopathy (HE).

Exclusively licensed by Versantis, the assay is being developed using transmembrane pH-gradient polymersomes that encapsulate a pH-sensitive ratiometric fluorophore.

The ammonia concentration in the blood sample can be determined by measuring the fluorescence signal.

Versantis chief sales officer and co-founder Dr Vincent Forster said: “There is a great unmet medical need for an accurate and user-friendly device to monitor the levels of ammonia in patients with liver disease.

“Hyperammonemia and its associated neurological manifestations, such as hepatic encephalopathy, affects 30%-45% of cirrhotic patients and can lead to coma and death.

“We believe using a novel portable point-of-care device will allow daily monitoring of ammonia, thereby significantly reducing hospitalizations and fatal outcomes for patients, while also saving time, effort, and expense of health care professionals, supporting caregivers, and family members.”

The ZHAW School of Engineering plans to utilise the funding from Innosuisse for the development of the optoelectronic component of the device and engineer its biomedical instrumentation.

Versantis noted that the TS-01 assay has been demonstrated to be accurate in a wider physiological and pathological ammonia concentration range compared to the existing instruments.

Versantis CEO Mark Fitzpatrick said: “This Innosuisse grant will allow us to advance our TS-01 technology to a fully functional in-vitro diagnostic (IVD) POC device and partner with leading IVD manufacturers for planned marketing authorisation and commercialisation.

“This unique technology provides us with a significant market opportunity both as a standalone product and as a companion diagnostic to our lead therapeutic product candidates VS-01 and VS-02, potentially alleviating the growing healthcare burden associated with ACLF and HE.”

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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