Edwards Lifesciences Corp. (NYSE: EW) scored a win with its Pascal transcatheter valve repair system that received European CE Mark for the treatment of patients with mitral regurgitation, or abnormal blood flow.
CE Mark is the European equivalence of Food and Drug Administration approval in the U.S.
The Irvine-based company, OC’s largest publicly traded device maker with a $35 billion market cap, makes artificial heart valves and other products. It is best known for pioneering less-invasive, transcatheter procedure that does not require open heart surgery.
“Mitral valve disease is complex, varied and prevalent, and patients are in significant need of multiple safe and effective therapies to treat debilitating symptoms that can lead to a high rate of mortality,” said Bernard Zovighian, corporate vice president of transcatheter mitral and tricuspid therapies. He said Pascal provides “a differentiated, minimally-invasive therapy to address the needs of patients with mitral regurgitation.”
In the U.S., approximately 7 million people—nearly 2% of the nation—have mitral regurgitation, according to market research firm Reportlinker.com. Europe has about 4.1 million people with moderate to severe mitral regurgitation. The transcatheter mitral regurgitation market is projected to reach about $3 billion by 2022.
Masimo FDA Approved
Another Irvine-based device maker also got regulatory OK.
Noninvasive patient monitoring device maker Masimo Corp. (Nasdaq: MASI) recently received FDA clearance for a new measurement on its MightySat Rx spot-check fingertip pulse oximeter, as well as for use in the home environment.
Respiration rate is the number of breaths taken per minute. The measurement typically requires manually counting breaths with a timer and then converting that to a rate per minute, or being fitted with chest leads or straps.
Masimo said the inclusion of the measurement in its portable device “offers clinicians more way to accurately measure breathing rate than ever, helping to ensure they have the right tools for each patient scenario.”
MightySat weighs less than 100 grams, including batteries, and can provide approximately 1,800 spot checks with each set of two AAA batteries. It first received FDA clearance in 2015.
Mynd Reverse Merger
Mission Viejo-based Mynd Analytics Inc. (Nasdaq: MYND), a provider of analytics to improve mental health, is being bought as a reverse merger vehicle by Torrance-based biopharmaceutical company Emmaus Life Sciences Inc.
Emmaus shareholders will own 94.1% of Mynd’s common stock and the resulting company will change its name to Emmaus and receive a new ticker symbol EMMA.
Existing Mynd shareholders will own the rest. Based on a Mynd market cap of $10.6 million, the stock value of the new Emmaus could be around $169.1 million.
Emmaus is involved in treatments and therapies in the rare and orphan disease categories. Its lead drug Endari treats sickle cell disease, which is estimated to be a $3 billion annual industry. Endari received Food and Drug Administration approval in 2017.
Mynd’s goal is to improve mental health through data analytics and reduce the cost of services through video conferencing and telephones.
Mynd reported 2018 revenue of $387,100 and a net loss of $2.7 million.
Mynd Chief Executive Patrick Herguth in December replaced George Carpenter, who took on a new role as chief innovation officer. Mynd will retain its management and spin off its assets and liabilities into a separate company called Mynd Analytics California.
Shares have doubled to about $1.50 and a $12.7 million market cap since the Jan. 7 announcement. In the past year, Mynd shares have risen as high as $3.60 and fallen as low as 70 cents.
Gala Raises $3M
CHOC Children’s raised more than $3 million at its annual gala last month. The sold-out event at the Disneyland Hotel featured a 60-minute concert from Grammy Award-winning singer-songwriter Kelly Clarkson.
The William and Nancy Thompson Family Foundation received the hospital’s Champion Award in recognition of their $10 million founding gift to build the Thompson Autism Center. It will offer services to children with autism spectrum disorder, a development disorder that affects communication and behavior, and their families.
The evening also showcased CHOC’s commitment to integrative health. The provider is the only hospital in the region to offer pediatric-focused integrative health services, ranging from acupuncture and hypnotherapy to guided imagery and massage therapy.
Separately, CHOC named Mary Zimmer as vice president of operations. She oversees laboratories, radiology and imaging services, pharmacy, clinical nutrition and lactation, among others, at the hospital’s main campus in Orange.
Zimmer came from Citrus Valley Health Partners, where she was most recently chief patient and clinical services officer.
