TherOx Inc., an Irvine-based medical device maker, has re-emerged in the public eye with an eight-figure funding round and is preparing to work on eventual regulatory approval of its lead product.
The company provides what’s called SuperSaturated Oxygen Therapy, which consists of cartridges that deliver oxygenated blood to the heart in order to treat heart attack-damaged tissue.
It promotes SuperSaturated Oxygen Therapy as an alternative to traditional heart attack treatments, such as angioplasty and stents, saying it reduces diseased tissue more than those can.
“After a long time of sort of no visibility or very limited, we’re back up doing what we’re supposed to do, with the financial resourcing in place to get it done,” TherOx Chief Executive Kevin Larkin said in an interview last week.
$16.8M
The company recently said in a Securities and Exchange Commission filing that it has raised $16.8 million of a potential $23.2 million in financing. Of that amount, Larkin said $15 million is new money, $11.5 million of which has already closed.
The figure also includes a $6 million bridge loan from existing investors.
The rounds will bring TherOx’ total to about $150 million since its inception 21 years ago. Its backers include Silicon Valley venture capital pioneer Kleiner Perkins Caufield & Byers.
“It’s always important to have continuing investor support. When you go out to new investors, the first thing they ask is, ‘Who from your existing people expect to continue?’ ” Larkin said. “Now we’ve been around a long enough time that we’ve had some fallout—some funds no longer exist.”
TherOx plans to use some of its money to run a 100-patient final round of clinical trials with an eye toward Food and Drug Administration premarket approval sometime in 2017.
Larkin referred to regulators’ proposal of the study as “remarkable” and “very cooperative-based.”
Patient enrollment for the study is scheduled to start at the end of the year, and enrollment is projected to be completed next year.
The study’s purpose is to assess the size of a patient’s infarct, or dead heart tissue, 30 days after treatment to determine if it’s been reduced.
Profile
TherOx is raising its public profile again after several years of low-profile activity.
The company attempted to go public in 2008 but, like several other medical device and technology companies, ended up pulling the filing after the IPO markets and the overall economy started to deteriorate.
It also encountered a regulatory setback around that time.
An FDA advisory panel in 2009 nixed TherOx’ premarket approval application for SuperSaturated Oxygen Therapy, saying the device showed “only marginal benefit” and had potential for risks; the agency generally follows the recommendations of its panels.
“We’ve gotten the last several years behind us, [and] we’re on a good path now,” Larkin said.
TherOx was doing various projects in its quiet years, including conducting an animal study to prove SuperSaturated Oxygen Therapy’s safety, plus a small pilot study on 20 patients to show that the device, now in its second generation, “demonstrated a substantial improvement in reducing infarct size,” among other things, according to Larkin.
Regulators, upon looking at the data, told TherOx “… if you do 100 patients in what we call a confirmatory safety study successfully, we’ll give you [premarket] approval,” Larkin said.
TherOx is prerevenue. Larkin said the company has European regulatory approval for its devices but opted not to sell them there.
“We were in a cash conservation mode,” he said, adding that it “costs money” to set up overseas commercialization.
TherOx instead focused “on getting ourselves into a position of completing the last patients for U.S. PMA approval,” Larkin said.
TherOx has 12 workers and manufactures its devices at a facility on Cartwright Road in the Irvine Business Complex.
