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TherOx to File for FDA Approval for Oxygen Product

Irvine-based device maker TherOx Inc. plans to file for U.S. Food and Drug Administration approval early next year on a product that delivers “super-saturated oxygen”—a saline solution with the patient’s blood that contains seven times normal oxygen levels—for treatment of heart attack patients.

The Irvine-based device maker this month completed enrollment of its 100-patient study for “SSO2” for clinical trial purposes.

Heart attacks happen when an artery in the heart gets blocked. Treatment includes medication and a percutaneous, minimally invasive procedure that uses a catheter to place a small stent to open blood vessels in the heart.

The move aims to re-establish blood flow as quickly as possible, but there can still be damage to the heart due to oxygen deprivation.

TherOx’ device works with the procedure to introduce the super-oxygenated blood and reverse ischemia—the inadequate blood supply to heart muscles—as well as resuscitate tissue that may otherwise die.

TherOx has raised $145 million to date; investors include DAG Ventures in Palo Alto; Integral Capital Partners and Kleiner, Perkins, Caufield and Byers in Menlo Park; and New Science Ventures in New York.

Heart Health

Bodymatter Inc. in Irvine tapped Eugene Spiritus as chief executive. Spiritus previously served as chief medical officer for the University of California-Irvine Medical Center for nearly 14 years.

The digital health technology startup develops apps for smartphones and wearables and was founded last year with K5 Ventures in Newport Beach.

Apps involve cardiovascular data analytics for consumers. A sleep monitoring app called Sleep Watch detects and monitors estimated sleep time, awake time, sleeping heart rate and overall sleep quality, while an in-the-works app called NextHeart is meant as a mobile-based, blood pressure management platform.

“It’s about giving patients more data,” said Spiritus. “Data that’s meaningful and approachable.”

He noted the connection between sleep deprivation and hypertension and said the apps can help people take better care of themselves.

Bodymatter is among 156 companies globally participating in the IBM Watson AI XPrize, a $5 million artificial intelligence and cognitive computing competition.

Gut Health

The Susan Samueli Center for Integrative Medicine at UC Irvine Health promoted digestive system health at its 15th annual women’s wellness day at the Irvine Marriott. About 500 attended the event. Proceeds will go toward financing a portion of a new culinary medicine program.

The morning started with a talk on the “emotional gut,” connecting the gastrointestinal track to the brain. Feelings like anger, anxiety, sadness and elation can trigger symptoms in the gut, such as feeling “butterflies” in the stomach or having a “gut-wrenching” experience. Speakers shared aspects of prevention and treatment, including nutrition, exercise and lifestyle solutions, as well as medication, acupuncture and intravenous therapy for autoimmune diseases.

Alice Waters, chef and proprietor of Chez Panisse and vice president of nonprofit Slow Food International, was the luncheon keynote speaker. Slow Food is a global movement that works to support food choices that prevent the disappearance of local food cultures and traditions.

“I like to use the word wellness … to me health is the outcome of living well, and it’s a much richer conversation than just about how much vitamins I need to take or how much exercise I need to do,” Waters said.

CE Mark

Staar Surgical Co. is set for commercialization in Europe after getting CE Mark for its new lens, EVO+ Visian ICL with aspheric optic. The lens is designed to correct farsightedness and nearsightedness.

The medical device company makes implantable lenses for the eye. It’s based in Monrovia in Los Angeles County but maintains a manufacturing facility in Aliso Viejo.

The company recently traded at about a $380 million market cap.

Alzheimer’s Prevention

ATP Clinical Research Center in Costa Mesa is one of 90 global sites—and one of two in California—in the five-year generation study that’s part of the Alzheimer’s prevention initiative led by Banner Alzheimer’s Institute in Phoenix. The study plans to identify presymptomatic treatments or interventions that will postpone, slow or prevent the disease’s progression, enrolling more than 1,300 cognitively healthy adults, ages 60 to 75, who are at high risk of developing symptoms of Alzheimer’s because of their genetic profiles—two copies of the e4 type of the apolipoprotein gene. Partners include Novartis Pharmaceuticals Corp., Amgen Inc. and National Institutes of Health.

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