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Edwards Maps 2017 Outlook at Investor Conference

Edwards Lifesciences Corp. highlighted growth plans for its core and newly acquired business lines next year. The Irvine-based heart device maker is seeking to get clearance to make its transcatheter aortic heart valve therapy available to a broader group of patients.

It also wants to make clinical progress on its mitral and tricuspid valves, which got a boost with a recent acquisition.

Executives outlined the plans at the company’s annual investor conference on Dec. 8 in New York.

The push for the transcatheter aortic heart valve—which involves a less invasive treatment—closely follows a fourth-quarter dip in sales of Edwards’ more invasive, surgical valve.

“We underperformed a little in the surgical valve [therapy sales] because of Sapien 3,” said Chairman and Chief Executive Michael Mussallem.

Sapien 3, which received FDA approval in August, is a catheter-based artificial aortic heart valve that can be implanted in patients with a severe obstructed aortic valve without open-heart surgery.

A strong adoption of the transcatheter heart valve, which is currently limited to patients with severe aortic stenosis, is expected to become available to patients with moderate aortic stenosis.

“A less invasive [and also] superior treatment option to surgery [with Sapien 3] opens the door to treating AS [aortic stenosis] early even in asymptomatic patients and moderate patients,” said Larry Wood, vice president of transcatheter heart valves at Edwards.

Wood said the company looks to initiate study of the treatment’s effectiveness in patients with less severe symptoms early next year.

The other side of Edwards’ outlook for next year covered efforts to build out its platform with mitral and tricuspid valve therapies.

Edwards is in agreement to buy Valtech Cardio Ltd. in Or Yehuda, Israel, for $340 million in cash and stock in a deal expected to close early next year. Valtech focuses on developments of transcatheter repair of mitral and tricuspid heart valves. The former received European CE Mark certification last September.

Shares of Edwards dropped from $117.03 per share on Oct. 24 to $94.25 after it reported its third quarter earnings on Oct. 25.

The briefing at the investor conference included a projection that next year’s sales would increase between 10% and 14%. That apparently helped buoy Edwards’ shares, despite a projection that fourth-quarter sales would trend toward the lower end of the previously stated $750 million to $790 million guidance, based largely on the soft surgical heart valve sales.

Shares of Edwards gained nearly 7% to around $90 per share following the announcement. The company entered last week with a market cap of about $19.1 billion, up about 10% over the past 12 months.

PEER

Mission Viejo-based Mynd Analytics Inc., a predictive analytics company, announced it secured additional financing of $1 million through private placement, issuing $160,000 shares of common stock at $6.25 per share. Proceeds will be used for the commercialization of the company’s technology platform, PEER Online.

PEER – Psychiatric EEG (electroencephalogram) Evaluation Registry, provides “objective, personalized data to assist physicians in the selection of appropriate medication” to treat mental illness. PEER allows medical professionals to exchange treatment outcome data obtained through EEG.

The EEG is a test that measures brain waves, providing evidence of how the brain functions over time. The test is used to evaluate brain disorders.

MYnd also announced that it entered a $10 million common stock purchase agreement and a registration rights agreement with Aspire Capital Fund LLC. The Chicago-based investment firm, with an emphasis on lifesciences, energy and technology sectors, also participated in the $1 million private placement.

MYnd is traded on OTC Market Group, and has a recent market cap of $15.5 million.

Bits & Pieces

Miller Children’s & Women’s Hospital Long Beach opened the Children’s Specialty Center, a new pediatric outpatient center in Irvine. Miller’s Children and the new center share the same pediatric specialists. Miller Children’s is part of Fountain Valley-based MemorialCare Health System. … The Leapfrog Group, a national hospital patient safety organization, named six hospitals in the Orange County area—out of the 2,633 hospitals evaluated nationally, in its recently released annual safety ratings for 2016. These hospitals are: Hoag Hospital Irvine; Hoag Memorial Hospital Presbyterian; Orange Coast Memorial Medical Center; Kaiser Foundation Hospital in Anaheim and Irvine; UC Irvine Medical Center in Orange.

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