International Edition
`
`-1-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`RegulatoRy Notice
`
`this annual Report (“annual Report, international and investor edition”) presents Masimo features and/or products that are marketed outside of the united States
`
`and for the global investor audience.
`
`See the “annual Report, u.S.” for Masimo features and/or products that are FDa-cleared for the united States market.
`
`at the time of printing, not all Masimo features and/or products profiled in the “annual Report, international and investor edition” have worldwide regulatory
`
`clearances and/or approvals.
`
`For example, the following profiled features and/or products are pending clearances as of February 12, 2015:
`
`• europe ce Marking: animal Health products, iSpo2, and iSpo2 Rx for infant & neonatal use and MightySat Rx
`
`• canada MDl: iSa aX+, iSa oR+, iSpo2 Rx for infant & neonatal use, Radius-7 and oRi.
`
`To the many who have helped shape, guide, inspire, and innovate the first 25 years of Masimo,
`
`thank you.
`
`-2-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`table oF
`coNteNtS
`
`Timeline
`
`6
`
`ceo leTTer
`
`18
`
`THankS
`
`28
`
`SeT®
`
`62
`
`Hemoglobin
`
`76
`
`rooT
`
`92
`
`rainbow®
`
`expanSion
`
`FuTure
`
`leaderSHip
`
`appendix
`
`FinancialS
`
`110
`
`120
`
`134
`
`142
`
`144
`
`152
`
`4
`
`5
`
`-3-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`tHe FiRSt
`25 yeaRS
`
`1989
`
`Founding of masimo
`
`company founded by
`
`Massi Joe e. Kiani and
`
`soon after Mohamed Diab
`
`and Mary Kiani joined
`
`1995
`
`High-Fidelity
`pleth waveform
`
`First true diagnostic-
`
`quality pleth waveform
`
`1995
`
`mS-1™ board
`
`First commercially available
`
`Set® oeM board
`
`1995
`
`masimo SeT®
`pulse oximetry
`
`First Measure-through
`
`Motion and low Perfusion™
`
`pulse oximetry – debuts at
`
`the Society for technology
`
`in anesthesia™ and wins
`
`excellence in technology
`
`innovation award
`
`PI
`
`1995
`
`perfusion index
`
`First accurate quantification
`
`of amplitude of the pleth
`
`waveform to 0.02%
`
`First
`Implementation
`with Masimo SET®
`
`1996
`
`kontron
`multi-parameter
`
`First Masimo Set® mulit-
`
`parameter implementation
`
`1996
`
`lnop® Sensors
`
`High signal-to-noise ratio
`
`sensor with non-absorbent
`
`material, rejuvenating
`
`adhesive, and replaceable
`
`tapes – minimizing waste
`
`1998
`
`iVY biomedical 2000
`
`First Masimo Set®
`
`standalone device
`
`implementation in the u.S.
`
`First Standalone
`with Masimo SET®
`
`1997
`
`nec
`
`First Masimo Set®
`
`standalone device
`
`implementation
`
`Breakthrough
`Study
`
`1998
`
`breakthrough study shows
`
`masimo lnop® sensors
`
`last nearly twice as long
`
`as the market-leading
`
`adhesive disposable
`
`sensors
`
`thomas a et al. Respir Care.
`1998;43(10):860.
`
`6
`
`7
`
`-4-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`tHe FiRSt 25 yeaRS
`
`Measure-through
`Motion
`
`510(k)
`
`1998
`
`First FDa 510(k) clearance
`
`for Measure-through
`
`Motion pulse oximetry
`
`SmarTone
`
`1998
`
`SmarTone™
`
`ability to maintain
`
`saturation tones with
`
`variable pitch during low
`
`signal-to-noise conditions
`
`1998
`
`SofTouch™
`
`First Masimo sensor
`
`designed for sensitive
`
`skin of neonates
`
`Max
`
`1998
`
`max Sensitivity Setting
`
`allowing reliable
`
`measurement in the most
`
`challenging conditions of
`
`low perfusion
`
`1998
`
`datascope
`
`Datascope, along with
`
`other oeMs, brings
`
`commercialization of
`
`Masimo Set® in to their
`
`patient monitors
`
`Measure-through
`Low Perfusion
`
`510(k)
`
`1999
`
`First FDa 510(k) clearance
`
`for Measure-through low
`
`Perfusion pulse oximetry
`
`2000
`
`radical® pulse oximeter
`
`First 3-in-1 pulse oximeter
`
`standalone device for
`
`bedside monitoring with
`
`detachable handheld unit
`
`for portable monitoring,
`
`SatShare ® interface to
`
`upgrade conventional pulse
`
`oximetry in multi-parameter
`
`patient monitors to Masimo
`
`Set®, and first monitor
`
`to have an automated
`
`rotational screen
`
`2000
`
`Signal iQ®
`
`First to quantify
`
`measurement quality
`
`and give clinicians a way
`
`to know when to have
`
`confidence in the Spo2
`
`values during motion
`
`and low perfusion
`
`FastStart
`
`2000
`
`FastStart™
`
`Spo2 value in less than 10
`
`seconds from the time the
`
`instrument is turned on
`
`2000
`
`FastSat ®
`
`enabling accurate tracking
`
`of rapid saturation changes
`
`Award-winning
`Breakthrough
`Study
`
`2000
`
`Study shows masimo SeT®
`
`helps increase caregiver
`
`efficiency
`
`Durbin c.g. et al. Anesthesiology.
`2000; 93(3a): a-556.
`
`Breakthrough
`Study
`
`2002
`
`Study shows masimo
`
`SeT® helps wean patients
`
`from the ventilator faster,
`
`reduce Fio2 levels, and
`
`reduce arterial blood gas
`
`measurements
`
`Durbin c.g. et al. Crit Care Med.
`2002 aug;30(8):1735-40.
`
`8
`
`9
`
`-5-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`Alarm triggered
`
`PI Baseline determined by the Radical-7
`
`PI Delta % Change = 25
`(within a 1 hour period)
`
`Time
`
`1.0
`
`0.9
`
`0.8
`
`0.7
`
`0.6
`
`0.5
`
`0.4
`
`Perfusion Index
`
`2005
`
`3d perfusion index
`delta alarm™
`
`First alarm to alert
`
`clinicians of changing
`
`peripheral perfusion
`
`status that may indicate
`
`worsening condition
`
`2005
`
`rad-57®
`
`First handheld capable of
`
`noninvasively measuring
`
`carbon monoxide levels in
`
`the blood
`
`SpCO
`
`2005
`
`Spco®
`
`First noninvasive
`
`carboxyhemoglobin
`
`measurement
`
`Time (in minutes)
`
`20
`
`40
`
`60
`
`80
`
`100%
`
`Desat Index
`Alarm Limit 93%
`
`Low SpO2
`Alarm Limit 90%
`
`SpO2
`
`2005
`
`3d desat index alarm™
`
`First alarm to alert
`
`clinicians to patterns of
`
`transient desaturation
`
`that may predict
`
`respiratory depression
`
`2004
`
`lncS ® Sensors
`
`low noise cable
`
`sensor design
`
`2005
`
`blue ® Sensor
`
`First sensor for accurate
`
`measurements in cyanotic
`
`infants and children
`
`2004
`
`rad-5 ® Handheld
`pulse oximeter
`
`First handheld incorporating
`
`Masimo Set®
`
`2004
`
`newborn Sensor
`
`First sensor designed
`
`for newborn monitoring
`
`during resuscitation
`
`2005
`
`rainbow® SeT® in
`mx-1® board
`
`First noninvasive blood
`
`constituent platform
`
`tHe FiRSt 25 yeaRS
`
`Breakthrough
`Study
`
`2002
`
`breakthrough study shows
`
`masimo SeT® linked to
`
`reduced medical errors in
`
`critical care medicine
`
`Hay W.W.et al. J Perinatol. 2002
`Jul-aug;22(5):360-6.
`
`APOD
`
`2003
`
`adaptive probe off
`detection ® (apod®)
`
`Reducing false display of
`
`values by 83% when the
`
`probe is not on the patient,
`
`compared to competing
`
`pulse oximeters
`
`Breakthrough
`Study
`
`2003
`
`breakthrough study shows
`
`masimo SeT® linked to
`
`reduced retinopathy of
`
`prematurity in neonatal
`
`patients
`
`chow l.c. et al. Pediatrics. 2003
`Feb;111(2):339-45.
`
`10
`
`11
`
`-6-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`tHe FiRSt 25 yeaRS
`
`SpMet
`
`2006
`
`Spmet ®
`
`First noninvasive
`
`methemoglobin
`
`measurement
`
`2005
`
`radical-7®
`
`First bedside rainbow Set®
`
`Pulse co-oximeter®
`
`Breakthrough
`Study
`
`2005
`
`breakthrough study shows
`
`assessment with masimo
`
`SeT® improves screening
`
`for congenital heart
`
`disease in newborns
`
`de-Wahl granelli a. et al. Acta
`Paediatr. 2005 Nov;94(11):1590-
`1596.
`
`2007
`
`patient Safetynet™
`
`First remote notification
`
`system capable of rainbow®
`
`measurements – with
`
`optional central monitoring
`
`based on 802.11 abg
`
`PVI
`
`2007
`
`pleth Variability
`index (pVi)
`
`First noninvasive
`
`and continuous fluid
`
`responsiveness
`
`measurement
`
`2008
`
`national Fire protection
`association Standard
`
`NFPa 1584 releases
`
`fire rehab standards
`
`and includes carbon
`
`monoxide assessment
`
`during fire rehab
`
`Breakthrough
`Study
`
`2008
`
`breakthrough study
`
`shows pVi® predicts
`
`fluid responsiveness
`
`during surgery
`
`cannesson M. et al. Br J Anaesth.
`2008 aug;101(2):200-6.
`
`2008
`
`neopt-500
`
`First sensor for extremely
`
`low birth weight babies
`
`2008
`
`rad-87®
`
`First Pulse co-oximeter
`
`with integrated 802.11
`
`abg wireless radio
`
`SpHb
`
`2008
`
`SpHb ®
`
`First noninvasive
`
`and continuous
`
`total hemoglobin
`
`measurement
`
`Breakthrough
`Study
`
`2008
`
`breakthrough study
`
`shows Spco ® identifies
`
`unsuspected co poisoning
`
`in the eR
`
`Suner S. et al. J Emerg Med. 2008
`May;34(4):441-50.
`
`2009
`
`rainbow reSposable ®
`Sensor System
`
`featuring performance
`
`of adhesive sensors with
`
`green Designed in™, which
`
`reduces both landfill and
`
`carbon footprint
`
`12
`
`13
`
`-7-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`tHe FiRSt 25 yeaRS
`
`RRa
`
`2009
`
`rainbow® acoustic
`monitoring (ram™)
`
`First noninvasive and
`
`continuous respiration
`
`rate (RRa®) monitor with
`
`acoustic sensor
`
`Breakthrough
`Study
`
`2010
`
`Study shows masimo
`
`SeT® and masimo patient
`
`Safetynet improve
`
`outcomes in adults on the
`
`med-surg unit – fewer rapid
`
`response activations, icu
`
`transfers, and icu days
`
`taenzer a.H. et al. Anesthesiology.
`2010 Feb;112(2):282-7.
`
`Fluid
`Management
`Study
`
`2010
`
`Study shows pVi helps
`
`clinicians improve
`
`fluid management and
`
`decrease lactate levels
`
`in surgical patients
`
`Forget P. et al. Anesth Analg. 2010
`oct;111(4):910-4.
`
`Breakthrough
`Study
`
`2010
`
`Study shows pVi helps
`
`assess which patients will
`
`become hemodynamically
`
`unstable with the addition
`
`of PeeP
`
`Desebbe o et al. Anesth Analg.
`2010;110:792-798.
`
`Foundation for Ethics,
`Innovation, and Competition
`in Healthcare
`
`2010
`
`masimo Foundation for
`
`ethics, innovation, and
`
`competition in Healthcare
`
`created with a
`
`$10 million gift
`
`2010
`
`radical-7
`
`Featuring touch screen
`
`display, wireless capability,
`
`and external display
`
`functionality
`
`Halo
`Index
`
`2011
`
`Halo index™
`
`cumulative trending
`
`assessment of the global
`
`patient status. increases
`
`in Halo index suggest
`
`physiologic deterioration
`
`and may indicate a need for
`
`clinicians to more closely
`
`assess the patient
`
`Breakthrough
`Study
`
`2010
`
`SpHb
`
`breakthrough study shows
`
`SpHb monitoring helps
`
`clinicians optimize blood
`
`management
`
`ehrenfeld J.M. et al. American
`Society of Anesthesiologists.
`2010;lb05.
`
`RRp
`
`2011
`
`respiration rate from
`the pleth (rrp™)
`
`First noninvasive and
`
`continuous respiration
`
`rate measurment from
`
`the pulse oximeter signal
`
`2010
`
`pronto ® and pronto-7®
`
`First noninvasive spot
`
`checking of hemoglobin,
`
`Spo2, pulse rate, and
`
`perfusion index
`
`Adaptive
`Threshold
`Alarm
`
`2010
`
`adaptive
`Threshold alarm
`
`First dynamic physiologic
`
`alarm threshold based
`
`on changes from each
`
`patient’s baseline value
`
`2012
`
`capnography and
`gas monitoring
`
`Masimo begins offering
`
`innovative, multispectral
`
`technologies for measuring
`
`respiratory gases and
`
`anesthetic agents
`
`14
`
`15
`
`-8-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`tHe FiRSt 25 yeaRS
`
`SpfO2
`
`2012
`
`Spfo2™
`
`the first noninvasive
`
`fractional oxygen
`
`saturation monitor
`
`measurement
`
`2013
`
`root ® patient
`monitoring and
`connectivity platform
`
`First device to integrate:
`
`> rainbow® measurements
`
`> iris™ connectivity for
`third party devices
`
`> Masimo open
`connect™ (Moc-9™) for
`measurement expansion
`
`2013
`
`iSa™ capnography
`
`the iSa capnography
`
`Moc-9 module for Root
`
`features high sidestream
`
`performance and offers
`
`cost-effective disposables
`
`through the innovative
`
`Nomoline™ adapter with
`
`extended monitoring time
`
`and use of generic cannulas
`
`2014
`
`radius-7™
`
`Radius-7 for Root is the
`
`first and only wearable,
`
`wireless monitor with
`
`Masimo’s breakthrough
`
`rainbow Set® technology
`
`2014
`
`eve™ newborn
`Screening application
`
`animated tutorial for
`
`the Radical-7 specifically
`
`designed to help clinicians
`
`more effectively and
`
`efficiently screen
`
`newborns for critical
`
`congenital heart
`
`disease (ccHD)
`
`ORI
`
`2014
`
`ori™
`
`the first noninvasive and
`
`continuous parameter
`
`to provide insight
`
`into oxygen reserve
`
`in patient’s receiving
`
`supplemental oxygen
`
`2013
`
`iSpo2 ® pulse oximeter
`
`the first pulse oximetry
`
`for both ioS (apple) and
`
`android™ mobile devices
`
`2013
`
`Sedline ® brain
`Function monitoring
`
`the Sedline Moc-9
`
`module for Root features
`
`4 simultaneous channels
`
`of high-quality eeg
`
`data; Sedline provides
`
`continuous information
`
`about both sides of the brain
`
`and provides information
`
`about a patient’s response
`
`to anesthesia
`
`2014
`
`o3™ regional oximetry
`
`the o3 Regional oximetry
`
`Moc-9 module for Root
`
`features near-infrared
`
`spectroscopy (NiRS) and
`
`reflectance pulse oximetry
`
`to enable simultaneous
`
`monitoring of tissue
`
`oxygen saturation (rSo2)
`
`in the brain and arterial
`
`blood oxygenation (Spo2)
`
`2014
`
`rainbow® dci®-mini
`
`the first and only reusable
`
`spot check hemoglobin
`
`sensor for infant and
`
`pediatric patients from
`
`3 to 30 kg
`
`2014
`
`TFa-1™
`
`Single-patient-use
`
`forehead sensor for
`
`Masimo Set®
`
`2015
`
`mightySat™
`
`First fingertip pulse oximeter
`
`with Masimo Set® Measure-
`
`through Motion and low
`
`Perfusion™ technology
`
`For sports and aviation use only
`in the u.S.
`
`16
`
`17
`
`-9-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`letteR FRoM tHe
`cHaiRMaN & ceo
`
`2014 marked the 25th anniversary of Masimo. i would like to thank everyone, from our employees and customers to our investors
`
`and advisors, who has helped Masimo achieve its mission of improving patient outcomes and reducing cost of care by taking
`
`noninvasive monitoring to new sites and applications.
`
`We believe that Masimo Set® pulse oximetry now
`
`helps clinicians monitor more than 100 million
`
`patients a year and is the primary pulse oximetry technology
`
`for eight of the top 10 hospitals on the u.S. News & World
`
`Report best Hospitals Honor Roll for 2014-2015. that’s a long
`
`way from 1989, when we started with a $40,000 loan on my
`
`condominium and the dream that one day we could fulfill our
`
`Mission stateMent
`
`Improve patient outcomes and reduce the cost of care by taking noninvasive monitoring
`to new sites and applications.®
`
`mission, make a contribution to society, reward the investors
`
`So even as i take humble pride in Masimo’s achievements,
`
`current market needs and, more importantly, anticipating
`
`who believed in us, and achieve financial stability.
`
`i can tell you we are all committed to achieving even greater
`
`future market expectations. a few of the highlights include:
`
`accomplishments in the years to come. this is one reason why
`
`Since its introduction, Masimo Set® Measure-through Motion
`
`we worked so hard to put in place a plan several years ago to
`
`and low Perfusion™ pulse oximetry has helped prevent at least
`
`produce a product a month during 2014, our 25th anniversary.
`
`25,000 potential cases of retinopathy of prematurity (RoP) in
`
`this was more than just flexing our innovation might. by
`
`1 ce Marking of o3 regional oximetry* for Root. o3 regional
`
`oximetry uses near-infrared spectroscopy (NiRS) through
`
`Moc-9 with up to two sensors per Moc-9 module. each sensor
`
`newborns worldwide, and has impacted the quality of care for
`
`producing clinically significant products at a pace unmatched
`
`contains four light-emitting diodes (leDs) and two detectors to
`
`millions of patients of all ages, including babies born with critical
`
`by anyone else in the medical technology industry, we
`
`continuously and simultaneously measure both organ oxygen
`
`congenital heart disease, and adults in post surgical wards.
`
`demonstrated that Masimo is more than capable of addressing
`
`saturation (rSo2) and arterial blood oxygenation (Spo2). Root
`
`*o3 regional oximetry is pending FDa 510(k). Not available in the u.S.
`
`Joe kiani
`Chairman & CEO, Masimo
`
`1818
`
`19
`
`-10-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`reVenueS // 2 0 0 5 - 2 0 1 4
`
`I n m I l l I o n s o f d o l l a r s
`
` P r o d u c t r e v e n u e s //
`
` r o ya lt y r e v e n u e s
`
`allows either one or two o3 Moc-9 modules
`
`to be connected, enabling monitoring with as
`
`3 FDa 510(k) clearance of the Root
`
`patient monitoring and connectivity
`
`few as one and as many as four sensors. organ
`
`platform. Root can be a hub at the bedside,
`
`innovative and cost-effective Nomoline
`
`offering patients continuous monitoring
`
`sampling line
`
`with freedom of movement. Radius-7, which
`
`received FDa 510(k) clearance in 2014, can alert
`
`oximetry, also known as regional oximetry
`
`enable Masimo’s breakthrough noninvasive
`
` > Wireless functionality – capable of
`
`clinicians – at the bedside or remotely, through
`
`and cerebral oximetry, enables the continuous
`
`measurements to be used by experts
`
`transmitting information through
`
`our Patient SafetyNet* remote monitoring
`
`assessment of the oxygenation of the organ
`
`and novices with trend and analog views,
`
`bluetooth and Wi-Fi.
`
`system – of critical changes in a patient’s
`
`beneath the sensor. o3 helps clinicians detect
`
`take advantage of a rich set of additional
`
`cerebral hypoxemia that pulse oximetry alone
`
`measurements, and provide other companies
`
`can miss. in addition, the Root monitor can
`
`a robust platform on which to develop other
`
`automate the differential analysis of regional
`
`innovative measurements via Moc-9. High-
`
`4 later, Masimo also announced iSa oR+
`
`multigas monitoring, a Masimo open
`
`connect (Moc-9) Module for Root. During
`
`to central oxygen saturation. o3 monitoring
`
`impact innovations in Root that are now
`
`general anesthesia, the iSa oR+ monitors
`
`is as simple as applying o3 regional oximetry
`
`available in the u.S. include:
`
`the inhaled and exhaled concentration of five
`
`sensors to the forehead and connecting the o3
`
`anesthetic gas agents (Sevoflurane, isoflurane,
`
`Moc-9 module to any Root through one of its
`
` > iris – built-in connectivity gateway through
`
`Halothane, Desflurane, enflurane), carbon
`
`three Moc-9 ports.
`
`iris for verified standalone devices such as
`
`dioxide (co2), nitrous oxide (N2o), and oxygen
`
`2 iSpo2 Pulse oximeter for android. With
`
`the release of iSpo2 in the popular
`
`android operating system, more consumers
`
`iV pumps, ventilators, hospital beds, and
`
`(o2), in addition to respiration rate. When
`
`other patient monitors to eMR
`
`technology modules are connected with Root,
`
`multiple additional parameters are available
`
` > Moc-9 – Flexible measurement expansion
`
`including Masimo Set® pulse oximetry,
`
`through Masimo open connect (Moc-9)
`
`noninvasive and continuous hemoglobin
`
`oxygen saturation and pulse rate – even during
`
`states of motion and low perfusion – as well as
`
`GuidinG
`PrinciPles
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`than ever have access to Masimo Set®
`
`Measure-through Motion and low Perfusion™
`
`with Moc-9 modules from Masimo or third-
`
`(SpHb), PVi, Sedline brain function monitoring,
`
`pulse oximetry – the same technology used in
`
`party measurements from other companies
`
`and o3 regional oximetry.
`
`leading hospitals worldwide. iSpo2 provides
`
`to expand the platform’s measurements
`
`accurate, real-time oxygen saturation
`
`and capabilities. New Moc-9 modules may
`
`(Spo2), pulse rate (PR), and perfusion index
`
`require new 510(k) clearances
`
`(Pi) readings – ideal for anyone who desires
`
`5 another amazing technology for Root
`
`that we’re very proud of is Radius-7, the
`
`first and only wearable, wireless monitor with
`
`access to accurate health data through their
`
` > capnography – iSa co2 sidestream module
`
`Masimo’s breakthrough Masimo Set® and
`
`mobile devices.
`
`featuring fast warm-up time and the
`
`rainbow acoustic Monitoring™ technology,
`
`total revenues
`Product revenues
`royalty revenues
`
`2005
`
`107.9
`---
`---
`
`2006
`
`224.3
`155.5
`68.8
`
`2007
`
`256.3
`200.2
`56.1
`
`2008
`
`307.1
`259.6
`47.5
`
`2009
`
`349.1
`300.1
`49.0
`
`2010
`
`405.4
`356.4
`49.0
`
`2011
`
`439.0
`406.5
`32.5
`
`2012
`
`493.2
`464.9
`28.3
`
`2013
`
`547.2
`517.4
`29.8
`
`2014
`
`586.6
`556.8
`29.8
`
`*the use of the trademarks Patient SafetyNet and PSN is under license from university Health System consortium.
`
`> Remain faithful to your promises
`
`and responsibilities
`
`> thrive on fascination and
`
`accomplishment and not on
`
`greed and power
`
`> Strive to make each year better
`
`than the year before, both
`
`personally and for the team
`
`> Make each day as fun as possible
`
`> Do what is best for patient care
`
`20
`
`2121
`
`-11-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`inSTalled baSe // 2 0 0 5 - 2 0 1 4
`
`e s t I m at e d u n I t s
`
`e x c l u d e s h a n d h e l d s
`
`1,313,000
`
`1,205,000
`
`1,088,000
`
`979,000
`
`855,000
`
`back to Root or with upgradeable WiFi‡ for
`
`MightySat is the only fingertip pulse oximeter
`
`long-range communication – ensures the
`
`available with the optional Pleth Variability
`
`patient can be continuously monitored and
`
`index (PVi), a measure of the dynamic changes
`
`connected to caregivers wherever they are
`
`in Pi that occur during one or more complete
`
`in the hospital. Radius-7 allows clinicians to
`
`8 oxygen Reserve index (oRi™†). With ce
`
`Mark and limited market release, oRi
`
`became the first noninvasive and continuous
`
`hemoglobin (SpHb) spot-check sensor for
`
`infants and small children (weight 3 to 30
`
`kg). Paired with Masimo’s handheld Pronto
`
`parameter of its kind to provide insight into
`
`device, the rainbow® Dci-mini sensors are
`
`640,000
`
`567,000
`
`respiration through acoustic respiration rate
`
`color screen that can be rotated for real-time
`
`its name to the daughter of annamarie
`
`prolonged intubation.4 the study was among
`
`(RRa). lightweight at only 0.34 lbs. (155g), the
`
`display of the pleth waveform as well as
`
`Saarinen, co-founder and ceo of the Newborn
`
`12 selected from more than 1,000 as one of
`
`Radius-7 attaches to the patient’s arm, allowing
`
`measurements. optional bluetooth wireless
`
`Foundation. eve was diagnosed at 48 hours
`
`the best abstracts at the american Society
`
`untethered monitoring while they are in bed or
`
`functionality enables measurement display via
`
`old with ccHD, and annamarie has made it
`
`of anesthesiologists (aSa) annual Meeting
`
`out. With no need to disconnect and reconnect
`
`a free, downloadable app on ioS and android
`
`her life’s mission to make sure all newborns
`
`in New orleans, the largest gathering of
`
`the cable to get out of bed, the Radius-7
`
`mobile devices as well as the ability to trend
`
`are screened. We hope our eve software
`
`anesthesiologists in the world.
`
`reduces the need for nursing assistance.
`
`and communicate measurements. and for
`
`feature will help professionals accomplish
`
`and the Radius-7’s wireless communication
`
`those who want to use their pulse oximeter
`
`their mission to help save the lives of babies
`
`functionality – either short-range via bluetooth
`
`to evaluate another physiologic dimension,
`
`and spare families from heartbreaking loss.
`
`9 ce Mark, clearance in Japan, and
`
`limited market release of the rainbow®
`
`Dci-mini™¥. Dci-mini is the first noninvasive
`
`respiratory cycles.2
`
`continuously monitor their patients when
`
`they are mobile, and studies have shown that
`
`patient mobility is a key factor in more rapid
`
`patient recovery.1
`
`a patient’s oxygen reserve when they are
`
`designed to help clinicians quickly and easily
`
`7 ce Mark of eve™*, a newborn screening
`
`application for the Radical-7. Masimo
`
`gained its first commercial foothold in the
`
`receiving supplemental oxygen. With oRi,
`
`spot-check hemoglobin levels. Dci-mini allows
`
`Masimo’s rainbow Set® Pulse co-oximeters
`
`clinicians and public health programs around
`
`with the latest MX-5 circuit board can now
`
`the world to expand hemoglobin assessment
`
`Nicu, so this new technology holds a special
`
`measure an unprecedented 11 parameters3
`
`to vulnerable populations who need a
`
`6 MightySat, the first fingertip pulse
`
`oximeter with Masimo Set®. MightySat,
`
`for sports and aviation use, is available in
`
`place for us. eve is an intuitive software
`
`through noninvasive optical rainbow® sensor
`
`noninvasive and convenient method. We hope
`
`feature to help clinicians more effectively
`
`technology. a clinical study at the university
`
`that the new rainbow® Dci-mini will help more
`
`screen for critical congenital heart disease
`
`of texas Southwestern and children’s Medical
`
`infants and small children, along with their
`
`three versions – each of which provides
`
`(ccHD). eve automates the screening steps
`
`center in Dallas evaluating oRi showed
`
`moms, around the globe to receive timely
`
`oxygen saturation (Spo2), pulse rate (PR),
`
`with animated instruction, including sensor
`
`that oRi can provide advanced warning of
`
`assessment and treatment, which will benefit
`
`and perfusion index (Pi) measurements in a
`
`application, measurement selection, and
`
`potential hypoxia and may help clinicians
`
`their long-term health, as well as the health of
`
`compact, battery-powered design with a large
`
`screening result determination. eve owes
`
`optimize oxygenation before and during
`
`our society.
`
`470,000
`
`449,000
`
`342,000
`
`‡ the configuration for long-range communication is not yet released. * eve ce Marked. currently not available in the u.S. † oRi is ce Marked. currently not available in the u.S. ¥ rainbow® Dci-mini is ce Marked. currently not available in the u.S.
`1 Needham D, Korupolu R, Zanni J, Pradhan P, colantuoni e, Palmer J, brower R, Fan e. “early Physical Medicine and Rehabilitation for Patients With acute Respiratory Failure: a Quality improvement Project.” Archives of Physical Medicine and Rehabilitation Vol 91, issue 4, PP 536–542, april 2010.
`2 the utility of PVi is unknown at this time and requires further clinical studies. technical factors that may affect PVi include probe position and patient motion. 3 eleven parameters include: 1) oxygen saturation (Spo2); 2) Pulse rate; 3) Perfusion index (Pi); 4) Pleth Variability index (PVi);
`5) Respiration Rate from the pleth (RRp); 6) total hemoglobin (SpHb); 7) oxygen content (Spoc); 8) carboxyhemoglobin (Spco); 9) Methemoglobin (SpMet); 10) Fractional oxygen saturation (Spfo2); 11) oxygen Reserve index (oRi). 4 Szmuk P, Steiner J, olomu P, Dela curuz J, Sessler D. oxygen
`Reserve index - a New, Noninvasive Method of oxygen Reserve Measurement” Proceedings of the american Society of anesthesiologists, oct.14, 2014, New orleans, boc12, Room 275-277.
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2222
`
`23
`
`-12-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`10 ce Mark of the tFa-1*
`
`transflectance forehead adhesive
`
`While we are happy that we fulfilled the
`
`expectations of everyone who invested
`
`before. that included product revenue of
`
`lifesaving breakthrough products become
`
`$556.8, million – up 8% from $517.4 million.
`
`ubiquitous in healthcare settings and beyond.
`
`sensor. tFa-1, a single-use sensor for adult
`
`in Masimo up until we went public, we are
`
`Since 2007, we have focused on building
`
`our technology will expand and evolve to
`
`and pediatric patients, offers clinicians
`
`restless in fulfilling the expectations of our
`
`a strong and knowledgeable worldwide
`
`meet the future needs of healthcare, by
`
`the power of Masimo Set® pulse oximetry
`
`investors, post our iPo. i am grateful for the
`
`sales and marketing organization, capable
`
`helping improve surgical and post-surgical
`
`on an alternative monitoring site for rapid
`
`patience that our investors have exhibited
`
`of expanding both our Masimo Set® and
`
`outcomes with shorter lengths of stay. by
`
`detection of oxygen saturation changes
`
`while we work through the 10-year plan we
`
`rainbow® businesses. While we continue to
`
`better assessing patients we can help reduce
`
`during low perfusion. tFa-1 also offers
`
`established in 2007. the good news for those
`
`make strategic investments in our worldwide
`
`the cost of care.
`
`pulse rate, perfusion index, and PVi
`
`who remained patient over the past 7 years
`
`organization, we believe that we have now
`
`measurements. tFa-1 gives clinicians yet
`
`is that we expect all of the planning and
`
`reached the level of staffing needed for our
`
`We’ve set in motion the “consumerization” of
`
`another way to leverage the breakthrough
`
`execution of the past 7 years will begin to pay
`
`sales, marketing, engineering, and other
`
`our core technologies with the iSpo2 pulse
`
`measurement capability in Masimo Set®
`
`off in not only the lives we improve and save,
`
`organizations to support higher product
`
`oximeter for smartphones, and more recently
`
`pulse oximetry. by continuing to take
`
`but the increase we expect in our earnings
`
`revenue growth.
`
`Masimo’s breakthrough technologies to
`
`and hopefully our stock price.
`
`MightySat, the world’s first fingertip pulse
`
`oximeter with Masimo Set® pulse oximetry.
`
`new sites and applications, we are helping
`
`it is not hubris to envision that within the
`
`elite athletes such as an olympic silver
`
`improve patient outcomes and safety while
`
`For fiscal year 2014, total revenue rose 7% to
`
`next 3 years, Masimo will reach new heights
`
`medal cyclist and a four-time free diving
`
`reducing cost of care.
`
`$586.6 million from $547.2 million the year
`
`with our customers and shareholders, as our
`
`champion and guinness World Record holder
`
`earningS per SHare daTa For annual reporT // 2 0 0 8 - 2 0 1 4
`
`FY2008
`year ended
`January 3, 2009
`
`FY2009
`year ended
`January 2, 2010
`
`FY2010
`year ended
`January 1, 2011
`
`FY2011
`year ended
`december 31, 2011
`
`FY2012
`year ended
`december 29, 2012
`
`FY2013
`year ended
`december 28, 2013
`
`FY2014
`year ended
`January 3, 2015
`
`$1.30
`
`$1.21
`
`$0.88
`
`$1.05
`
`$1.07
`
`$1.02
`
`$0.53
`
`diluted earnings per Share
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`*tFa-1 is ce Marked. currently not available in the u.S.
`
`first masimo set® technology board
`
`dr. Peter cox testing masimo pulse
`
`oximeter while breathing nitrogen
`
`first test patient using masimo set® technology
`
`one year anniversary of
`
`masimo listing on nasdaQ
`
`one millionth oximeter shipped
`
`executive team helps millionth oximeter on its way
`
`24
`
`
`
`2525
`
`-13-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`it is humbling and profoundly motivating to
`
`are using our technologies to help improve their training
`
`stop us from getting our breakthrough technologies in the
`
`think that the technology we have created
`
`– and continue to create – is saving and
`
`improving lives around the world.
`
`and recovery regimens. throughout most of Masimo’s
`
`hands of clinicians for the safety and care of patients.
`
`history, our medical devices have been designed to help
`
`patients recuperate. Now, we’re also helping healthy
`
`it is humbling and profoundly motivating to think that the
`
`people improve their lives.
`
`technology we have created – and continue to create – is
`
`saving and improving lives around the world. this is a
`
`Since its beginning, Masimo has confronted and overcome
`
`great honor, and a great responsibility. on behalf of all of
`
`obstacles – a real-world David versus goliath story, only
`
`us at Masimo, we look forward to rising to the challenges
`
`with sequels. it has been a wonderful journey, with many
`
`of this millennium, driven by the mission to improve
`
`successes and challenges, and undoubtedly many more yet to
`
`patient outcomes, while reducing the cost of care by taking
`
`come. but we stand alert and ready and will not let anything
`
`noninvasive monitoring to new sites and applications.
`
`Joe kiani
`Chairman & CEO
`
`
`
`2626
`
`27
`
`Joe Kiani and mohamed diab solved the “unsolvable”
`
`– inventing pulse oximetry that was accurate when
`
`patients moved or had low perfusion.
`
`-14-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`ouR StoRy,
`FRoM tHoSe
`WHo liVeD it
`
`
`
`2828
`
`29
`
`-15-
`
`MASIMO 2066
`Apple v. Masimo
`IPR2022-01292
`
`

`

`The Early Years
`
`as told by Mohamed diab, Mary Kiani,
`Walt Weber, Bob smith, and ammar al-ali
`
`Mohamed diab
`
`“it’s mixed in-between. if you’re not shaking your hand, then you
`
`on physiology that helped us better understand the problems we
`
`get a good reading. as the late Dr. Swan characterized it, “Pulse
`
`were facing.
`
`oximetry has been, at best, a fair weather friend.” What DSt gives
`
`> At Masimo, we learned from the beginning that if it could be imagined, Mohamed could make
`
`you is a map; it says this is the good number and here are some of
`
`“wHen maSimo STarTed, i wanted to help my brother, because
`
`it become reality. That’s how good he is. From figuring out how to make adaptive filters work in
`
`the bad numbers. it just breaks things up and shows a total map.
`
`he was working full time and doing Masimo at the same time with
`
`noninvasive monitoring, to figuring out the discrete saturation transform, he has always been
`
`that enabled us to extract the correct arterial saturation even
`
`no help from anyone. i was a licensed dentist, and working full time
`
`from the 1975 debut of the nihon Kohden olv-5100, the world’s first pulse oximeter,
`
`a core of technical ability and integrity that allowed our company to attract many other amazing
`
`under motion conditions, and that’s the power of it. that changed
`
`at an office in brea, but my work was at night and Saturdays which
`
`the science of pulse oximetry was plagued by unreliability when it was needed most
`
`engineers because they love working around Mohamed.
`
`everything for us because we knew that there was at least one
`
`gave me all day to help him. i did secretarial duties, answered
`
`Joe Kiani
`
`– during patient motion and low perfusio