Edwards Lifesciences Corp. (NYSE: EW), known for pioneering less-invasive transcatheter heart repair procedures, will work with San Francisco-based Bay Labs Inc. to apply artificial intelligence to cardiovascular imaging, to improve the detection of heart disease.
“It is unfortunate that patients suffering from severe aortic stenosis frequently do not receive a proper diagnosis for a variety of reasons,” said Don Bobo, Edwards’ corporate vice president, strategy and corporate development. “The value of Bay Labs’ technology is in providing help for these patients to be appropriately diagnosed and successfully find their way to proper treatments.”
The partnership plans to develop new AI-powered algorithms in Bay Lab’s EchoMD, a suite of measurement and interpretation software tools, and incorporate them into Edwards’ CardioCare quality care navigation platform.
Bay Labs, founded in 2013, is trying to improve medical imaging “by combining deep learning and ultrasound,” according to a company press release. It received Food and Drug Administration clearance for its first release of EchoMD software suite last June.
“Working with Edwards to deploy Bay Labs’ AI software with deep learning technology into clinical settings has the potential to derive quality improvements and increase the accuracy of timely heart disease detection,” said Bay Labs co-founder and Chief Executive Charles Cadieu.
Aortic valve stenosis is one of the most common vascular diseases and is the third most common cardiovascular disease in developed countries. Earlier detection, such as using tools like echocardiography—a sonogram of the heart—may lead to more appropriate treatment for patients.
“Improving detection of [heart] disease starts with better quality echoes,” according to Dr. Madalina Petrescu, director of echocardiographic laboratory at Swedish Hospital in Seattle. She said the combination of CardioCare, which helps to reduce variability in echoes, and Bay Lab’s AI technology, “has the potential to impact patient lives, namely by improving the accuracy of disease detection and diagnosis.”
Separately, Edwards also announced its next-generation heart valve Sapien 3 Ultra has received FDA approval for transcatheter aortic valve replacement in patients who are at intermediate or greater risk of open-heart surgery. The valve is already approved for use in Europe.
The valve “provides meaningful technology improvements that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care,” said Dr. John Webb in a statement. Webb, who is a consultant to Edwards, is the director of interventional cardiology and cardiac catheterization laboratories at St. Paul’s Hospital in Vancouver, Canada, and professor of cardiology at the University of British Columbia.
Japanese Study
Aerie Pharmaceuticals Inc. (Nasdaq: AERI) announced positive topline results of its pilot second-phase study of netarsudil ophthalmic solution—marketed in the U.S. as Rhopressa, a glaucoma eye drop that lowers intraocular eye pressure.
The study, designed in accordance with Japan’s Pharmaceuticals and Medical Device Agency to support the potential regulatory submission of the drug in Japan, evaluated 40 Japanese and Japanese-American patients.
“These pilot study results, while representing a relatively low number of subjects, may hold great promise for the Japanese glaucoma market,” Chief Executive Vicente Anido Jr. said. He pointed out that the once-daily eye drop “compares favorably to that of a twice-daily Rho kinase inhibitor currently marketed in Japan.”
Aerie said it plans to initiate a Phase 2 clinical trial in Japan in the first quarter this year. The company also announced the opening of a branch office in Tokyo and two key hires—Yasuhide Fukushima as head of strategy and professional affairs, and Kenji Aso as head of clinical.
Fukushima previously held a related position at Alcon Japan Inc. and Aso at Japan Bayer Yakuhin Ltd. Both are reporting to Teresa Heah, Aerie’s vice president of clinical research, and medical and professional affairs.
The Japanese glaucoma market is one of the largest in the world at approximately $1 billion annually, according to Anido.
Aerie, which began in OC, moved its headquarters to Durham, N.C. last year. It maintains significant operations, including sales and marketing, at its former headquarters in Irvine. It received the FDA’s nod for Rhopressa about a year ago.
Bits & Pieces
Torrance-based Honda Motor Co. donated $50,000 to Children’s Hospital of Orange County and the Pediatric Brain Tumor Foundation, a nonprofit solely dedicated to children and teens with brain tumors. … Persimmony International Inc., a software developer, marketer and distributor for government health and human services program, relocated its headquarters from Aliso Viejo to 18022 Cowan, Irvine. The software developer’s cloud-based products, including Electronic Case Management and Targeted Case Management, are designed to create a central repository for audit-ready data for reimbursement.
