UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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MASIMO CORPORATION
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On June 17, 2024, Masimo Corporation (“Masimo”
or the “Company”) launched its website, www.ProtectMasimosFuture.com, in connection with Masimo’s 2024 Annual Meeting
of Stockholders. A copy of the website content (other than content previously filed) can be found below.
# # #
Videos - 35th anniversary
Video Transcript
Music: And the men who hold high places must be the ones who start.
Mold a new reality, closer to the heart.
Joe Kiani: To truly make a difference, you have to commit yourself.
You have to be obsessed with what you do. The obsession is doing things that no one thought was possible.
Voiceover: Since 1989 we’ve been on a mission to solve
the unsolvable. That’s 35 years of setting the standard in medical biosensing. For the millions monitored by Masimo SET technology
each year, and the world class healthcare professionals that rely on our innovations every day, we’re here to do what others say
can’t be done.
To continuously improve patient outcomes and save lives. From the most
vulnerable NICU babies, to everyday people everywhere. One person. One story. One life at a time.
We’re taking the lead to combat the U.S. opioid crisis that claims
over 80,000 lives each year. We’re making it easier for anyone to take charge of their health. We’re giving people the power
to hear music the way their favorite artists always intended and helping new parents stay connected to their babies like never before.
It’s all part of our vision for the future. One where we will
all see how smartwatches can become health watches and where Masimo technology keeps you connected to your well-being and that of your
family. What else would you expect from one of the most innovative companies in North America?
So, here’s to 35 years of defying the odds. 35 years of improving
lives. 35 years of solving the unsolvable.
Patient: This right here has saved my life, and that’s
why I’m here today.
Music: Closer to the heart. Yes. Closer to the heart.
# # #
FDA clears over-the-counter Stork baby monitor from Masimo (Mass
Device)
Mass Device
By Sean Whooley
06 May 2024
Link: FDA clears over-the-counter Stork baby monitor from Masimo (massdevice.com)
Masimo (Nasdaq: MASI) announced today that the FDA cleared its Stork
baby monitoring system for over-the-counter use.
Stork offers a continuous and accurate view of a baby’s health
data. It leverages Masimo’s noninvasive neonate monitoring technologies.
Masimo’s smart home baby monitoring system received its initial
FDA clearance in December 2023. The company already began its U.S. rollout to major retailers in August, having kicked off its initial
launch in May. Now, the company can provide its technology for use with healthy babies between 0-18 months of age without the need for
a prescription.
The FDA-cleared over-the-counter version of Masimo Stork monitors a
baby’s key vitals data including oxygen saturation level (SpO2), pulse rate (PR) and skin temperature. Stork notifies caregivers
with visual and audible alarms if a baby’s SpO2 or PR readings fall outside of preset ranges.
Masimo designed Stork to utilize its Signal Extraction Technology (SET)
for pulse oximetry. The technology helps reduce the incidence of neonatal blindness from retinopathy of prematurity. Masimo says it led
to significant improvements in screening newborns for critical congenital heart disease.
“I believe that by empowering parents and caregivers with the
same Masimo pulse oximetry technology that hospitals have been using on babies for decades, we can help them feel more informed and confident
when caring for their baby,” said Joe Kiani, founder and CEO of Masimo. “I am so proud of our team for Stork – it is
a culmination of science and design at its best.”
More about the Masimo Stork system
The company’s SET sensor nests within the Stork boot, made from
an ultra-soft, medical-grade silicone. This boot conforms gently to the baby’s skin and comes in three sizes to ensure a perfect
fit as the child grows.
Masimo designed Stork as a sleek, minimalist option to fit seamlessly
into any nursery and onto the baby’s foot. Its camera hardware and software architecture can work with future edge AI-based features
currently under development.
The system’s clearance covers the monitoring of multiple physiological
parameters. Masimo Stork is indicated for spot-checking and continuous monitoring of SpO2 and PR during no motion, motion, and low perfusion
conditions in infants and neonates who are 0 to 18 months of age and between 6 and 30 lbs. It is also indicated for continuous skin temperature
measurements of infants and neonates in the same age and weight range. Stork’s indication covers use in home environments.
Masimo currently sells Stork bundles at major and specialty retailers
in the U.S. It sells the system as a non-medical device for general health and wellness purposes. The company plans to make new alarm
features available to all existing and new users through its Stork App. It expects to release that update this summer.
# # #
This health tech company is working to stop opioid overdoses
(Fast Company)
Masimo is one of Fast Company’s Most Innovative Companies
in North America for 2024.
Fast Company
By Grace Snelling
19 March 2024
Link: Masimo is one of Fast Company's Most Innovative Companies
Masimo, the $5 billion market-cap health tech company, achieved several
notable breakthroughs in 2023. In April, it received FDA clearance for Opioid Halo, the first and only opioid overdose-and-prevention-alert
system. Opioid overdose is the leading cause of accidental death in the United States, responsible for more than 80,000 of the approximately
105,000 drug-related deaths in 2022. Masimo’s device monitors the wearer’s risk of accidental overdose, providing alerts to
the wearer, a caretaker, or emergency services if an issue arises.
In May, the company introduced the Stork, an extension of its line
of pulse oximetry technology for babies. The soft silicone boot uses sensors to measure pulse rate, oxygen saturation, and skin temperature,
helping parents get a clearer sense of their baby’s health. Finally, in November, Masimo earned FDA approval to sell its W1 smartwatch
as a remote patient-monitoring device that, like the Stork, tracks oxygen saturation levels and pulse rates. The nod came after Masimo
won a ruling by the U.S. International Trade Commission that the Apple Watch’s built-in pulse oximeter violated Masimo’s intellectual
property rights. For the first nine months of 2023, Masimo garnered $1.5 billion in revenue, a 5.7% increase from a year earlier.
With reporting from Leila Frankina
# # #
The Entrepreneur Who Bet His Company on a Fight With Apple (The
Wall Street Journal)
Joe Kiani has taken on Apple in a patent dispute that has cost his
company millions of dollars to pursue. So far he is winning, but the fight isn’t over.
The Wall Street Journal
By Aaron Tilley
30 December 2023
Link: The Entrepreneur Who Bet His Company on a Fight With Apple
- WSJ
Masimo Chief Executive Joe Kiani bet the future of the company he spent
three decades building in an expensive legal battle with the world’s most valuable company. So far, he is winning, but it isn’t
over.
His company, which pioneered a better method for measuring blood-oxygen
levels, has spent around $100 million fighting Apple in a dispute that temporarily halted Apple Watch sales.
Sales have resumed while a court weighs the company’s request
to stay the ban during an appeal. Kiani has vowed to fight on and said he won’t settle with Apple unless the tech giant pays for
his technology and agrees to change how it interacts with smaller companies.
Apple has denied allegations that it stole Masimo’s technology
and has accused the company of copying its technology.
Joe Kiani, in a striped shirt,
with family members in Alabama in the 1970s after their move from Iran. PHOTO: JOE
KIANI
Kiani has prevailed in previous battles over his company’s intellectual
property and believes he will win this one as well. An Iranian immigrant, Kiani has a combination of pugnaciousness and idealism that
friends and associates said leads him to fixate on what he thinks is fair.
“Justice isn’t just blind but very slow,” Kiani,
58 years old, said in an interview. “It’s painful. It’s an ugly thing to go through. It’s like war.”
Some have seen his aggressive use of the U.S. patent system as exploitation
that stymies the innovation of others. In 2006, he prevailed in a seven-year patent spat with Nellcor, a company that was then a dominant
provider of a rival pulse oximeter device. In 2016, he beat Royal Philips in another patent-infringement case.
Apple might be Kiani’s biggest war yet, one that likely won’t
be settled for years.
The U.S. International Trade Commission in October ruled that Apple
violated Masimo’s patents and ordered a ban on some Apple Watches shipped to the U.S., which went into effect Dec. 26. Apple on
Wednesday won a reprieve to resume sales. In addition to Apple’s appeal, there are several related lawsuits working their way through
the court system.
Joe Kiani in Southern California
after graduating with a master’s degree from San Diego State University. PHOTO: JOE
KIANI
Before taking on Apple, Masimo employees and friends of Kiani warned
him on the risks of going forward. “People were telling me I’m crazy and I can’t go against Apple,” said Kiani.
“They have unlimited resources.”
A number of smaller companies have over the years made similar allegations
against Apple over taking their ideas and violating their patents, The Wall Street Journal reported in April. When these companies attempt
to claim patent infringements against Apple, the tech giant responds with an aggressive legal strategy through the U.S. patent system.
“No one is standing up to them,” Kiani said. “If
I can do it, it might change Apple for the better.”
An Apple spokeswoman said previously about Masimo’s claims: “We
deeply respect intellectual property and innovation and do not take or use confidential information from other companies. We will continue
to protect the innovations we advance on behalf of our customers against false claims.”
Born in Iran, Kiani moved with his family to Alabama when he was 9
in order for his father to study engineering. The family brought $10,000 and lived for a time in public housing.
A Masimo pulse oximeter was displayed at a Las Vegas consumer technology
trade show in 2013. PHOTO: DAVID BECKER/GETTY IMAGES
Kiani, who now has three children and counts himself as a lover of
Persian poetry and Pink Floyd, excelled in math and was placed several grades ahead of his age. As a result, he was smaller than the rest
of his classmates, making him a target. “I learned that you can’t walk away from bullies,” he said. “You have
to punch back.”
When Kiani was 14, his parents had to move back to Iran, leaving him
and his sister alone. He graduated early from high school and by 1987 had earned a master’s degree in electrical engineering from
San Diego State University, he said. He founded Masimo in 1989, when he was 24, after the startup he had joined opted not to pursue his
design for an improved pulse oximeter that didn’t produce erroneous false alarms when patients moved.
He next took on Nellcor, the leading pulse oximeter provider. In 1994,
Nellcor offered to license Masimo’s technology. The money would have been enough for Kiani to retire at a young age, said Steve
Jensen, Masimo’s longtime lawyer. Kiani walked away from the deal when Nellcor wouldn’t promise to quickly introduce his technology
to patients, Kiani and Jensen said.
Later, Nellcor announced it had technology that allowed blood oxygen
to be measured while the user was in motion. In 1999, Masimo sued over patent infringement. In 2006, Nellcor settled and began paying
out for damages and royalties that eventually amounted to nearly $800 million. A spokeswoman for the company that now owns Nellcor said
the company disagrees with Masimo’s characterizations of the early licensing discussions as well as the later patent battle, but
declined to share more, citing confidential discussions.
In 2009, Masimo sued Royal Philips over a patent-infringement issue
and eventually settled in 2016, with Philips paying out $300 million and agreeing to incorporate Masimo’s technology into its product
that Kiani said ended up generating more than $1 billion for Masimo.
At a 2013 consumer-technology show, Masimo revealed a portable pulse
oximeter reader that hooked up to Apple devices. A few months later, Apple reached out.
Representatives of the two companies met in 2013. An Apple official
said the company didn’t dig deep into Masimo’s technology, the meeting didn’t last long and the two never met in-person
again. At the time of the Apple Watch development, Apple met with many other smaller players, not just Masimo, the company said. Apple
also said that the two never got close to working together because Masimo was more focused on the clinical side, too far outside Apple’s
consumer-focused plans.
A few months after that initial 2013 meeting, Apple hired Masimo’s
chief medical officer. Later it added a top engineer who was working at a Masimo spinoff, as well as dozens of other Masimo employees.
In a later trial, the former Masimo chief medical officer and another former employee testified that Apple hadn’t asked them to
bring confidential Masimo information to the company and had, in fact, told them explicitly not to do so.
Apple announced the Apple Watch Series 6 with a pulse oximeter in 2020. PHOTO: APPLE
In 2019, Apple published a number of patents related to sensing blood-oxygen
levels, listing the former engineer of the Masimo spinoff as the inventor.
“It really felt like a knife in my stomach,” said Mohamed
Diab, a founding co-inventor of Masimo’s technology. “It was truly painful.”
Masimo sued Apple in January 2020 over allegations that Apple stole
its trade secrets. Apple announced the Apple Watch Series 6 with a pulse oximeter later that year. The case, along with other legal efforts
against Apple, has cost Masimo about $100 million so far. The publicly traded company posted about $144 million in profit in 2022.
Masimo’s federal trade-secret case, which is separate from its
complaint with the trade commission, went to trial, but it ended with a hung jury in spring 2023. The trade-secret case is scheduled to
go back to court in 2024.
Apple has yet to engage in what Kiani sees as serious discussions about
a settlement, Kiani said. He remains determined to take his war with Apple to the very end, he said, even if it means losing his company.
The mounting legal bills have eaten into his company’s profits.
“I feel like I have to do this,” said Kiani. “If
I can change the most powerful company in the world from continuing to act badly, that’ll have more impact on the world than anything
else I’m doing.”
# # #
Forward-Looking Statements
This communication includes forward-looking statements as defined
in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, in
connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others,
statements regarding the 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”) of Masimo Corporation
(“Masimo” or the “Company”) and the potential stockholder approval of the Board’s nominees, the
proposed separation of Masimo’s consumer business, including the potential timing and structure thereof and the expectation
that the proposed separation will maximize shareholder value or be the best path for success. These forward-looking statements are
based on current expectations about future events affecting Masimo and are subject to risks and uncertainties, all of which are
difficult to predict and many of which are beyond Masimo’s control and could cause its actual results to differ materially and
adversely from those expressed in its forward-looking statements as a result of various risk factors, including, but not limited to
(i) uncertainties regarding a potential separation of Masimo’s consumer business, (ii) uncertainties regarding future actions
that may be taken by Politan in furtherance of its nomination of director candidates for election at the 2024 Annual Meeting, (iii)
the potential cost and management distraction attendant to Politan’s nomination of director nominees at the 2024 Annual
Meeting and (iv) factors discussed in the “Risk Factors” section of Masimo’s most recent periodic reports filed
with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov.
Although Masimo believes that the expectations reflected in its forward-looking statements are reasonable, the Company does not know
whether its expectations will prove correct. All forward-looking statements included in this communication are expressly qualified
in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of today’s date. Masimo does not undertake any obligation to update, amend or clarify these
statements or the “Risk Factors” contained in the Company’s most recent reports filed with the SEC, whether as a
result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Additional Information Regarding the 2024 Annual Meeting of Stockholders
and Where to Find It
The Company has filed a definitive
proxy statement containing a form of GOLD proxy card with the SEC in connection with its solicitation of proxies for its 2024 Annual
Meeting. THE COMPANY’S STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE DEFINITIVE PROXY STATEMENT (AND ANY AMENDMENTS AND SUPPLEMENTS
THERETO) AND ACCOMPANYING GOLD PROXY CARD AS THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders may obtain the proxy statement, any
amendments or supplements to the proxy statement and other documents as and when filed by the Company with the SEC without charge from
the SEC’s website at www.sec.gov.
Certain Information Regarding Participants
The Company, its directors and
certain of its executive officers and employees may be deemed to be participants in connection with the solicitation of proxies from the
Company’s stockholders in connection with the matters to be considered at the 2024 Annual Meeting. Information regarding the direct
and indirect interests, by security holdings or otherwise, of the Company’s directors and executive officers in the Company is included
in the Company’s definitive proxy statement for the 2024 Annual Meeting, which can be found through the SEC’s website at https://www.sec.gov/ix?doc=/Archives/edgar/data/937556/000121390024053125/ea0206756-05.htm,
and any changes thereto may be found in any amendments or supplements to the proxy statement and other documents as and when filed by
the Company with the SEC, which can be found through the SEC’s website at www.sec.gov.
29
Masimo (NASDAQ:MASI)
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Masimo (NASDAQ:MASI)
過去 株価チャート
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