The U.S. Food and Drug Administration recently approved clinical trials of a Korean company’s artificial liver transplant on humans.

The approval is expected to help H2 Holdings raise capital to finance research and development.

U.S.-based bio-tech firm HepaHope, which will run the trials, is an affiliate of H2 Holdings, a Korea-based company founded by Dr. Park Sung-soo. Park is the majority shareholder of H2 Holdings, which holds a 10 percent stake in HepaHope.

H2 Holdings held more than 17 billion won ($15.5 million) in capital at of the end of last year. Park owns the proprietary technology of its artificial liver transplant procedure.

A company official said H2 Holdings could possibly move to re-list on the tech-heavy KOSDAQ next year for R&D, but also to commercialize its artificial liver technology.

In the short-term, the Korean company could seek fundraising of between 100 million and 200 million won via convertible bonds, bond warrants or rights offerings to finance research operations, the official added.

H2 Holdings chose to de-list in June last year due to “differences of opinion” with stock regulators of the Korea Exchange. It has been temporarily sanctioned to raise large funds on the Korean capital market. But the FDA approval is expected to pave the way for H2 Holdings to go public again in Korea, the official explained.

The company’s IPO in 2006 was around 10 billion won. It had issued rights offering in 2010 using Golden Bridge Investment & Securities as its underwriter.

When asked whether H2 Holdings’ affiliate HepaHope could seek an IPO on the U.S. NASDAQ, the official declined comment.

The U.S. FDA’s green light will allow HepaHope to conduct tests in three phases, and the official said it expects to complete the trials within one to two years.

This timeline corresponds with H2 Holdings’ hope of re-listing on the KOSDAQ for the commercialization of its artificial liver technology both in the U.S. and Korea.

“The approval, its technology commercialization and potential fundraising would certainly benefit both the Korean and the U.S. bio-medical industry,” the official said.

It took about seven years for HepaHope to gain approval from the FDA, with total R&D investment of about 50 billion won.

The company rechristened itself H2 Holdings early this year, a change from HepaHope Korea.

By Park Hyong-ki (hkp@heraldcorp.com)