Irvine-based heart valve maker Edwards Lifesciences Corp.’s pipeline and positive second-quarter news recently landed it an upgrade from Chicago-based Zacks Investment Research to a “buy” ranking.
Its shares are up 60% since the start of the year, with a recent market value of $11.2 billion after a tough 2013.
“As expected, through the entire second quarter, Edwards remained in the headlines,” Zacks said in a news release announcing its decision.
Zacks said those headlines included:
• positive clinical trial results for the Edwards Sapien 3 transcatheter heart valve;
• launching the Edwards Sapien XT valve in the U.S.;
• and receiving Food and Drug Administration approval for its ClearSight noninvasive critical care monitoring device.
Zacks also mentioned Edwards’ disclosure of positive five-year data from its Partner trial “reflecting benefits of using Sapien valves in patients unable to undergo an open-heart surgery.”
The research firm added that it was “encouraged” by Edwards’ focus on building its pipeline.
Edwards’ enrollment of 1,000 intermediate-risk patients in the domestic clinical trial for Sapien 3 “is on track and is expected to be completed by the end of 2014,” Zacks said, adding that Edwards has also reported completed enrollment in the trial’s high-risk and inoperable patient arm. FDA approval for Sapien 3 is expected to take place in 2016.
Zacks said Edwards was also gaining experience with Centera, another transcatheter heart valve that’s expected to be introduced in Europe this year.
“Successful commercialization of these products should drive the company’s top line in the long term,” Zacks said.
Edwards is due to report its third-quarter results on Oct. 23. Analysts expect the device maker to post a $76.3 million profit on sales of $543.9 million.
Surgical Management Firm News
Mission Viejo-based Sovereign Healthcare said this month that the Institute for Sports Sciences, a strategic and management services company it’s part of, finalized an agreement with Los Angeles-based Cedars-Sinai Health System for the Kerlan-Jobe Orthopedic Clinic and Santa Monica Orthopaedic and Spine Group to be formally affiliated with Cedars-Sinai.
Sovereign, a management services company for doctors, is a partner with Kerlan-Jobe and Santa Monica Orthopaedic in the Institute for Sports Sciences. The institute serves as a governance and strategic planning entity for the three parties and also provides clinic and surgery center management services; oversees research and fellowship programs; and coordinates development of new opportunities in orthopedics, sports medicine and related specialties.
Separately, Sovereign and partners Scottsdale Healthcare and a group of surgeons opened the North Valley Surgery Center in Scottsdale, Ariz., at the start of October. Sovereign manages the 34,000-square-foot center.
In other surgical news, Disc Sports & Spine Center, a Marina del Rey-based medical practice with a Newport Beach facility, said it formed a joint venture with Deerfield, Ill.-based Surgical Care Affiliates Inc.
Surgical Care, which is publicly traded, said in a news release that it would become a majority equity partner in Disc and “will help evolve the business by providing daily management” while Disc continues day-to-day clinical operations.
Disc’s founder, Dr. Robert Bray, said his practice would collaborate with Surgical Care to design national benchmarking programs for outpatient care.
Workers’ Comp Data Presented
Officials of Irvine-based Harbor Health Systems and San Jose-based EK Health Services Inc. recently presented a study showing that early care by “high-performing” doctors for workers injured on the job produces superior outcomes at lower costs.
“The purpose of our study was to determine whether claims outcomes were impacted by delays in care and whether accelerating care created unintended consequences,” Chief Executive Gregory Moore said.
“The message here is that claims operations leaders need to look at practices or inefficiencies that are delaying care delivery and consider the financial impact of these delays. We feel strongly this opens further conversation around the evidence that identifying high-performing doctors and letting them practice assertive medicine produces the best outcomes, lowers costs and shortens claims duration,” he said.
