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TherOx Raises Debt In Hopes of Launch

Irvine-based TherOx Inc. secured debt financing this month from existing investor Zoll Medical Corp. to support a limited launch of its SuperSaturated Oxygen therapy system upon receipt of Food and Drug Administration approval. It filed for regulatory OK in September.

TherOx declined to disclose the amount. It’s raised $145 million in equity financing, including the last equity raise, in 2015, totaling $16.8 million, according to a company spokesperson.

Zoll, which develops and markets medical devices and software solutions used in emergency care, is an Asahi Kasei Group company. The group is a division of a global Japanese chemical company with operations in the materials, homebuilding and diversified healthcare businesses.

TherOx Chief Executive Kevin Larkin said proceeds will also support additional headcount, but that it’s too early to provide detail. He said it hopes to receive FDA approval this year.

The company, founded in 1995, according to Larkin, is focused on developing products that improve the standard of care for treatment of heart attack patients. Its device is designed to prevent heart tissue damage by delivering a one-time, 60-minute infusion of superoxygenated blood—1,000 mmHg, or seven times normal levels—directly to the area impacted by the heart attack.

A heart attack is caused when an artery in the heart becomes blocked. The current standard of care is to re-establish blood flow in the blocked artery, typically through a combination of medication and percutaneous- or needle-puncture coronary intervention. The latter procedure, while successfully restoring blood flow, could still result in damage to the patient’s heart due to oxygen deprivation brought on by the blockage.

On the long road to FDA approval, TherOx pulled a September 2008 $100 million initial public offering filing that it withdrew in 2009 amid the Great Recession. It also sustained an FDA no vote the same year, the panel ruling the SS02 device showed “only marginal benefit” and could be risky.

TherOx’ Irvine operations include research and development, clinical and regulatory, administration, finance, quality assurance and limited manufacturing. It has 12 employees.

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