Masimo Corp.’s longtime rivalry with another device maker is heating up again.
The Irvine-based manufacturer of patient monitors renewed a $1 million guarantee it introduced for hospital customers in 2008 that its Masimo SET pulse oximeters and rainbow Pulse co-oximetry devices will outperform Covidien Nellcor pulse oximeters in a test.
The devices improve the accuracy of a patient’s oxygen-level readings.
Masimo said in a news release that its guarantee covers all Nellcor pulse oximeters, including three that Covidien PLC received Food and Drug Administration clearance for. Covidien makes the devices through its Nellcor unit.
“Covidien’s recent announcements appear to be an attempt to create an impression that Nellcor products are clinically equivalent, or even superior to Masimo’s products,” Chief Executive Joe Kiani said.
“We hope this [$1 million] guarantee sends a clear message to clinicians, biomedical engineers, materials management and hospital administrators to look to the objective evidence when they are interested in improving pulse oximetry performance,” he said.
A Covidien spokesperson couldn’t be reached for comment.
Masimo and Nellcor’s battles stretch back more than a decade. Masimo sued Nellcor in 1999 for allegedly violating patents on its motion-tolerant pulse oximetry devices.
Nellcor filed patent lawsuits of its own against Masimo’s signal extraction processing technology, which is used in oximeters. A federal court eventually ruled that seven of Masimo’s patents didn’t infringe on Nellcor’s technology.
Kiani has said that Nellcor’s assertions of infringement were “merely a defensive response” to the original lawsuit.
The U.S. Court of Appeals in Washington, D.C., upheld a $164.5 million jury award to Masimo and against Nellcor in 2005 over patents. Nellcor was then part of Tyco International Ltd., which spun off its medical device as Covidien in 2007. Covidien is based in Dublin, Ireland, but operates from Massachusetts.
Masimo has also argued that hospital purchasing groups violated antitrust laws by awarding contracts primarily to larger suppliers, such as Nellcor. A U.S. Senate subcommittee blasted Premier Inc. of Charlotte, N.C., and Novation LLC, an Irving, Texas-based rival, for not signing supply deals with smaller companies such as Masimo.
Breathe Technologies Gets Clearance
Irvine-based medical device maker Breathe Technologies Inc. said that the FDA has granted it a 510(k) clearance to market its Sleep System continuous positive airway pressure device for treating obstructive sleep apnea.
More than 25 million Americans have some level of breathing obstructions when they sleep. It’s traditionally treated by larger CPAP devices, many of which are uncomfortable for patients.
Breathe is participating in lucrative markets.
Its noninvasive OPEN ventilation device already has FDA clearance for institutional and home healthcare settings. That device is a one-pound, wearable hospital-to-home miniaturized ventilator.
Chief Executive Larry Mastrovich has estimated that chronic obstructive pulmonary disease affects some 12 million Americans and is a $43 billion-a-year market.
The disease is usually treated by inhaled drugs, oxygen, lung-reduction surgery or full ventilation with life support in the most extreme cases.
Breathe moved to Irvine in 2011 from the Bay Area community of San Ramon because of the number of medical device workers in South Orange County and northern San Diego County, Mastrovich told the Business Journal that year.
“It is close to people. We have 10 competitors that are in the marketplace that we can recruit talent from,” said Mastrovich, who previously was president and chief operating officer of Lake Forest-based Apria Healthcare Group Inc.
Breathe’s competitors on the chronic obstructive pulmonary side include CareFusion Corp. and ResMed Corp., both of San Diego, and Philips Respironics, a suburban Pittsburgh unit of Netherlands-based Royal Philips Electronics NV. It competes on the sleep apnea side with New Zealand-based Fisher & Paykel Healthcare, which has operations in Irvine.
WaveTec Vision Raises $2M
Aliso Viejo-based startup WaveTec Vision Systems Inc. has raised $2 million in financing, according to a Securities and Exchange Commission filing.
WaveTec makes devices used to assist in surgeries that replace cataracts with intraocular lenses. They can be mounted directly on surgical microscopes.
The company’s filing didn’t disclose the investor, the transaction’s round or the proceeds.
WaveTec was established in 1997 and operated on angel funding until 2005, when Menlo Park-based Versant Venture Management LLC, which has a Newport Beach office, made its first investment in the company.
Bits and Pieces
La Palma Intercommunity Hospital and four other facilities owned by Ontario-based Prime Healthcare Services recently signed a deal with Los Angeles-based publicly operated insurer L.A. Care Health Plan. The deal means that L.A. Care members can receive care from La Palma Intercommunity and the other hospitals at in-network benefit levels. … Allegro Ophthalmics LLC in San Juan Capistrano said it’s working with Japan-based Senju Pharmaceuticals to develop and market its Integrin Peptide injection for treating retinal diseases. … Orange-based CalOptima said it is now providing materials about the Medi-Cal health insurance program in Korean. It noted that Koreans represent the second-largest Asian ethnic group in OC based on country of origin.
