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Supported by an $86 million round, first bio-artificial liver moves toward pivotal trials

12:10 pm by | 0 Comments

The liver is an incredibly complex organ, critical for processing toxins and synthesizing 3,000 proteins and other molecules. It’s also one that’s in great demand by thousands of people needing a liver transplant each year.

But it’s also unique in its ability to regenerate damaged cells, so some people with acute damage may be able to survive if an artificial liver could do the job until their own healed.

Vital Therapies says it has the world’s first cell-based, bio-artificial liver designed to stabilize liver function in patients with life-threatening acute liver failure, and it’s headed for pivotal trials.

Called Elad, the device has survived two companies that went bankrupt after spending $65 million developing it, according to Forbes.

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In September, Vital announced closing the first tranche of a $76 million round of financing led by existing private investors. Now it appears that round got a boost from additional investors, as the company disclosed in a recent SEC filing that it’s raised $86.1 million since September. Through six rounds of capital, the company has raised about $150 million in total.

Company executives couldn’t be reached at the time of publishing, but in a September announcement they said that the funds would be used to carry Elad through three pivotal phase 3 studies in a total of 375 patients with acute alcoholic hepatitis and fulminant hepatic failure. Those studies will take place in the U.S., Europe and Australia/New Zealand, with one scheduled to enroll this quarter and two others in early 2013.

The device uses human liver cells derived from a liver tumor that are grown in cartridges and immortalized, then mounted on a bedside unit. Patients’ plasma is run through the cartridges, and the cells filter toxins and synthesize proteins before the plasma is returned to the patient’s bloodstream. According to Vital, the current treatment protocol involves three to five days of therapy.

Phase 3 trials are expected to wrap up by the end of 2015, the company said. If they’re successful, and if Vital’s marketing application is given priority review, the device could launch before the end of 2016. An artificial liver has been the focus of other research at institutions including Massachusetts General Hospital and Mayo Clinic, but this device is the first of its kind to reach phase 3.

Formed in 2003, the San Diego-based company has already run seven clinical trials of the artificial liver. It has a subsidiary in Beijing, China, and sees the Chinese market, where liver disease is pandemic, as a key target market in addition to the U.S., EU and Australia.

[Elad artificial liver cartridge photo from Vital Therapies]

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Deanna Pogorelc

By Deanna Pogorelc MedCity News

Deanna Pogorelc is a Cleveland-based reporter who writes obsessively about life science startups across the country, looking to technology transfer offices, startup incubators and investment funds to see what’s next in healthcare. She has a bachelor’s degree in journalism from Ball State University and previously covered business and education for a northeast Indiana newspaper.
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