A San Diego-based biotech has been gathering tens of millions of dollars to put an artificial liver into a trio of pivotal studies designed to pave the way to a potential approval for a groundbreaking new technology.
Vital Therapies has disclosed to the SEC that it's raised $86 million from investors, part of a $150 million fundraising effort that has been devoted to creating the world's first cell-based artificial liver, which uses cartridges packed with cancerous cells to filter toxins and synthesize proteins in plasma that is then pumped back into critically ill patients, according to a report in MedCityNews.
Profiled by Forbes back in early 2009, Elad has proven to be wickedly expensive to develop, taking down two predecessor developers after they invested $65 million in development work. It's also been a time-consuming endeavor. At the time, Vital Therapies--which was formed in 2003--told Forbes it could get an approval in two years, a timeline that it has not adhered to. Now the biotech says the Phase III program could wrap up by the end of 2015, putting it on track to a 2016 approval. And the biotech says that if it can gain approval, it expects to see the market in China, where a pandemic of liver disease afflicts the population, emerge as one of its biggest markets.
"We are delighted to have secured funding to begin the largest pivotal program involving artificial liver support ever implemented. Acute liver failure represents a clear, unmet need and, if this program is successful and regulatory approvals can be obtained, ELAD will hopefully provide a life-saving alternative to these patients for whom so few options exist," said Dr. Michael Millis, the transplant chief at the University of Chicago and a member of Vital Therapies' board, in a statement on the first tranche of the financing released in late September.
- see the SEC document
- here's the report from MedCityNews