Irvine-based Edwards Lifesciences Corp. is known for its replacement aortic heart valves but has been busy on the mitral front.
The cardiovascular device maker has completed its $400 million purchase of CardiAQ Valve Technologies Inc., a startup based in Irvine.
Chicago-based Zacks Investment Service called CardiAQ “a promising mitral valve technology” that has already received Food and Drug Administration investigational device exemption approval to conduct an early feasibility trial of up to 20 patients.
CardiAQ also is in line for a study to receive European regulatory approval.
“We believe the combined knowledge and efforts of the talented CardiAQ and Fortis transcatheter mitral valve system teams will help us advance a therapy that offers a meaningful solution to patients,” Chief Executive Michael Mussallem said after the CardiAQ completion.
Zacks also briefly mentioned Fortis in its article about CardiAQ.
Edwards temporarily paused work on Fortis in May.
The stoppage included halting enrollment in a clinical trial after it observed evidence of valve thrombosis, or blood clotting, that it believed warranted additional investigation.
The company recently said it completed a review of Fortis and revised protocols, including selecting patients, post-procedure drug regimens, and enhanced imaging surveillance.
The FDA has OK’d an early feasibility study of Fortis.
Edwards and Ireland-based rival Medtronic PLC are poised to face a more crowded less-invasive heart valve market soon. Medtronic got into the market in 2009 through its $700 million purchase of Irvine-based CoreValve Inc.
Chicago-based Abbott Laboratories, owner of Santa Ana eye device maker Abbott Medical Optics, recently said it’s paying $250 million to acquire the remaining part of Minnesota startup device maker Tendyne. Abbott already owned a piece of Tendyne, which is developing minimally invasive mitral valves.
Abbott also invested an undisclosed amount of money in San Jose-based Cephea Valve Technologies, which is developing a catheter-based replacement mitral valve based on nonstent anchoring technology, along with getting an option to purchase the company.
CHOC in Cancer
Demonstration Project
Children’s Hospital of Orange County’s Hyundai Cancer Institute is participating in the California Kids Cancer Comparison Initiative.
It’s one of two demonstration projects selected by the California Initiative to Advance Precision Medicine.
CHOC will be joined by several other institutions in the project, including investigators from the University of California-Irvine.
The initiative is designed to give cancer clinicians a much broader pool of genetic data for their work, including tumor sequencing information from children and adults.
CHOC said its key contribution to the initiative centers on a clinical trial:
“Patients, whose cancer is either recurrent (returned after treatment) or refractory (not responding to treatment), have tumor and non-tumor specimens collected and sequenced to identify their molecular profiles,” it said in a news release.Â
Such information helps doctors and the care teams personalize a patient’s treatment plans and provide insight on why some cancers respond to therapy or recur in spite of treatment.
Peregrine Gives Clinical Update
Tustin-based Peregrine Pharmaceuticals Inc. recently presented data at a medical summit that supports the ability of its lead drug candidate, bavituximab, to promote antitumor activity.
Peregrine develops cancer drugs.
Jeff Hutchins, its vice president of preclinical research, presented study data late last month at the 10th annual Immunotherapy and Vaccine Summit in Boston.
The data showed, among other things, that bavituximab can potentially shift the microenvironment in which tumors grow from one where tumors evade a patient’s immune system detection to one in which the immune system recognizes and fights the tumor.
HCP Names New Executive
Irvine-based HCP Inc. has a new chief investment officer.
The owner and investor of healthcare real estate named J. Justin Hutchens its executive vice president and chief investment officer of senior housing and care, effective Sept. 8.
Hutchens comes to HCP from Murfreesboro, Tenn.-based National Health Investors Inc., where he’d been its chief executive since 2011. He has more than 20 years of investing and operating experience in senior care, encompassing skilled nursing and assisted living.
