Edwards Lifesciences Corp. (NYSE: EW) recently won European CE Mark for its next-generation transcatheter valve Sapien 3 Ultra for transcatheter aortic valve replacement.
The advance “incorporates enhancements to the valve, as well as a new delivery system,” said Corporate Vice President of Transcatheter Heart Valves Larry Wood.
Sapien 3 Ultra has an “on balloon” design, eliminating the need for valve alignment during replacement, helping “simplify and improve the efficiency of the procedure,” said Dr. John Webb, director of interventional cardiology and cardiac catheterization laboratories at St. Paul’s Hospital in Vancouver, and a consultant to the Irvine-based medical device maker. He’s a professor of cardiology at the University of British Columbia.
Webb said “this design innovation represents a meaningful advancement over previous generations of this technology.”
Edwards, which specializes in critical-care monitoring and heart valves, will introduce the valve in Europe as part of a controlled rollout to include training. It won’t be launched in Germany as a result of an October preliminary injunction that Boston Scientific Corp. (NYSE: BSX) implemented there.
The German court will hold a full hearing on the merits of the dispute next year. Edwards expressed confidence it will ultimately prevail in the matter.
Sapien 3 Ultra hasn’t been approved in the U.S. Edwards anticipates FDA approval by year-end.
Analytics Offering
Irvine-based NextGen Healthcare Inc. (Nasdaq: NXGN) added Quality/Cost Fusion to its population health management platform, a new analytics capability that enables healthcare providers to measure the true value of care.
The software, services and analytics provider to medical and dental group practices offers health records and practice management, financial management and billing services, mobile health and population health.
The new tool “allows our physicians to objectively answer the question, ‘Am I creating more value for my patient?’” said Dr. Verlin Janzen, chief medical officer, medical informatics and population health, at customer Hutchinson Clinic in Kansas. “These analytics will be transformational.”
The company changed its corporate name in September from Quality Systems. Its market cap is about $1 billion.
Staff Moves
• ChromaDex Corp. (Nasdaq: CDXC) recently named Matthew Roberts chief scientific officer and senior vice president of innovation. He joined the company from Pharmavite LLC, where he served as chief technology and quality officer.
The subsidiary of Japanese-based drugmaker Otsuka Pharmaceutical Co. is a consumer packaged goods maker of the Nature Made line of vitamins, minerals and other supplements.
Chromadex is best known for flagship ingredient nicotinamide riboside, a form of vitamin B3 sold directly to consumers as Tru Niagen and promoted as having antiaging benefits. It got an international boost when it received a $25 million investment from Hong Kong billionaire Li Kai-shing.
Clinically, the company also made headway. It announced last month that it received two New Dietary Ingredient notifications, as well as the Generally Recognized as Safe notification from the Food and Drug Administration.
• Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI) added Dr. Jeffrey Vacirca to its board of directors. He’s a practicing oncologist and president of the Community Oncology Alliance, an advocacy group supporting community oncology clinics. He’s also medical director of the largest U.S. community oncology purchasing organization, International Oncology Network; chief executive and managing partner of North Shore Hematology Oncology Associates; and vice chairman of breast cancer drug developer Odonate Therapeutics Inc. (Nasdaq: ODT).
Spectrum Pharmaceuticals develops commercial and clinical-stage drugs, primarily in hematology and oncology.
Chief Executive Joe Turgeon said Vacirca’s reputation “is invaluable and precisely what is needed as Spectrum advances its two late-stage pipeline products, [cancer drugs] poziotinib and Rolontis.”
The former is in a second-phase trial for nonsmall-cell lung cancer, the latter being investigated for use in chemotherapy-induced low white blood cell count.
The Henderson, Nev.-based biotechnology company’s administrative and research and development facility is in Irvine.
Bits & Pieces
Newport Beach-based CureDuchenne Ventures recently funded TRiNDS—short for Therapeutic Research in Neuromuscular Disorders Solutions—a new contract research organization formed from the Cooperative International Neuromuscular Research Group academic consortium. The funding amount wasn’t announced. CureDuchenne funds startups working on Duchenne muscular dystrophy, an incurable inherited disorder that causes progressive muscle weakness. … Anaheim-based CleanCut Technologies LLC announced the release of packaging product Quick Tray with Pop ‘N Lock Technology. The pouch card product is designed with reinforced side rails to improve strength and stability, thereby better protecting shipments and saving money in the long run.
