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Med Device Firm Starts Clinical Studies After FDA Nod

Irvine-based Modulated Imaging Inc. has received FDA clearance for its first medical device. The Ox-Imager CS System uses near-infrared light to see a few millimeters below the surface of the skin and measure how much oxygen is being delivered to tissue.

It’s intended to help doctors monitor healing of chronic wounds and can be used in real time during lower-limb vascular surgery to determine if good circulation has been re-established.

Modulated Imaging can now conduct clinical studies throughout the U.S. and has begun long-term clinical studies at university medical centers in California and Arizona, Chief Operating Officer Richard Oberreiter said. Orange County Wound and Hyperbaric in Santa Ana also is participating in chronic wound clinical studies.

“This FDA clearance is a major milestone for our company and for the patients and physicians within the vascular treatment communities,” said Chief Executive and Chief Technology Officer David Cuccia. “Ox-Imager can lead to significant preventive care actions, as well as an estimated potential of $6.2 billion in savings per year.”

Modulated Imaging was founded in 2008 to develop light-based imaging technology to prevent, diagnose and cure medical conditions.

The company closed its first round of financing last August, obtaining $500,000. It’s also secured $9.3 million in grants over the past six years from the Department of Defense and National Institutes of Health, Oberreiter said.

Marijuana in Can

The creators of a cannabis-infused citrus soda are gearing up for retail sales of recreational marijuana in California, which will begin by early next year following state voter approval of Proposition 64 last fall.

Newport Beach-based Posy LLC’s original product is Sprig, a 12-oz can that sells for $7 and contains 45 milligrams of THC, the main active ingredient in marijuana. Co-founders Ethan Feffer and Michael Lewis claim it’s the only THC beverage in a can.

The company is working on creating sugar-free and lower-THC versions of Sprig that it hopes to bring to market by the end of the year.

Feffer and Lewis launched Sprig in 2015 and started selling the soda in medical dispensaries around the state last June.

They’ve been manufacturing the product at a brewery while they build their own plant at a California location they declined to disclose. That plant is scheduled to start production this month, Feffer said. Sprig is lab-tested, which is not always the case with “edibles,” he added.

Marijuana is gaining more credibility as some states have legalized it recreationally. And Orange County Congressman Dana Rohrabacher is the lone Republican of the 18-member pro-cannabis caucus, which in 2014 sent a letter to then President Barack Obama requesting he “instruct Attorney General Holder to delist or classify marijuana in a more appropriate way.” It’s unclear yet how the Trump administration will treat the use of recreational marijuana in states that have legalized it.

Posy said it’s selling 15,000 cans per month in 200-plus shops. Late last year it had revenue of $42,000 per month.

The founders said they want to grow the business to a regional brand by 2020 and that they’ve raised about $1 million from friends and family.

An Orange County investor who didn’t want to be identified because of the perceived stigma of recreational marijuana said he invested in Sprig because of the market opportunity.

“The growing market is evidenced by market growth in other states where marijuana was legalized for recreational use and the national trend that indicates well over a majority of people now favor legalization,” he said via email. “I invested prior to legalization in California, but at the time I was confident that recreational legislation would pass in California … a larger market than many other legalized states combined. Even without recreational legalization, the market for medical products is significant.”

Grants Energy

An innovation program that supports California’s most promising energy entrepreneurs is accepting applications for its $24 million California Sustainable Energy Entrepreneur Development grant program.

The CalSEED program is seeking early-stage clean-energy companies, which can apply for a $150,000 grant.

Visit www.calseed.fund for more information.

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