Vital Therapies (San Diego) might be closer to bringing the Extracorporeal Liver Assist Device (ELAD) to market with its recent report of starting a third clinical phase trial for the device in September, but funding is still a concern for the small med-tech company, which has run out of cash twice in the past.

"Is funding an issue, it's always an issue with any small med-tech company," Terry Winters Vital Therapies CEO told Medical Device Daily. "We're not a Medtronic or a Pfizer. But I think we'll overcome any funding issues because we've got some of the best investors in the medical device industry."

Since Winters joined the company back in 2003, nearly $40 million of funding has been raised.

The latest round of funding occurred in 2007, when the company raised $28 million.

ELAD, which has garnered the support of investors such as Versant Ventures (Menlo Park, California), is more of a biological machine than a device, according to Winters. It peforms the liver's functions outside of the body, creating essential proteins and cleaning toxins from the body – a key difference from other devices in the past.

"In no sense of the word is this a filtration device," he told MDD.

The device is about the size of a refrigerator, but there are plans in the future to scale the machine down and get something more convenient for the clinical setting.

If ELAD gains FDA clearance, then it could provide an alternative to liver transplants. It could also buy patients time until a donated organ could become available.

Previous trials of the company have seen more than 120 patients treated in the U.S., UK, China and Singapore. The company said that the study in China has shown improvement in survival without transplant in some patients. The company applied for marketing approval in China in 2007.

Winters said if everything goes according to plan then the device could be on the market in the U.S. by the end of 2011.

"The best we could do to get this to market in the U.S. is in two years, and that's if nothing goes wrong," Winters said.

But there have been difficulties in the past. The company is on its third iteration and previous iterations of the company have gone bankrupt twice. The first bankruptcy came during the first ELAD clinical trial and then the second came during the second phase of clinical trials.

Vital Therapies isn't the only company that has had difficulty in trying to bring a liver assisted device to market. In August of last year Arbios Systems (Waltham, Massachusetts) suspended its operations in a move that it said was a way to conserve cash while seeking financing to fund clinical trials for its Sepet Liver assist device (Medical Device Daily, August 7, 2008).

The device was intended as a bridge-to-transplant for patients waiting for a new liver – a list that is more than 17,000 names long. Sepet is a sterile, disposable cartridge containing microporous hollow fibers with permeability characteristics. When a patient's blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration).

Sepet was designed for use with standard blood dialysis systems available in hospital intensive-care units.

There are still some med-tech companies who haven't quite run into the funding roadblocks that Vital Therapies and Arbios have. Both Hepalife (Boston) and HepaHope (Irvine, California) are also developing devices to assist in the liver's functions.

But despite problems and competition, Winters is still hopeful for the device which had its beginnings at Baylor College of Medicine in Houston back in 1991.

Winters said it was a difficult plight that small med-tech companies found themselves in, when it came down to funding.

"I don't think any small company should be afraid to say that (funding is an issue)," he said. "But we've got the clinical data and results to back up [ELAD's] effectiveness."

Omar Ford, 404-262-5546; omar.ford@ahcmeida.com