1. MEDTECHSTRATEGIST.COM
See page 7
MARCH 16, 2016
Vol.3, No.4
MARKET TRACK
Fastest Growing Categories in Connected Health
Published twice monthly by Innovation In Medtech,llc
EXECUTIVE INTERVIEW
Dealmaker Anthony Viscogliosi Discusses
Orthopedics’ Changing
Business Models
Wendy Diller, 26
TECHNOLOGY TRENDS
HIMSS Survey Data Reveals
Growing Provider Reliance on
Connected Health Tools
Mary Thompson, 21
START-UPS TO WATCH
CARTIHEAL:
Regenerating True Hyaline Cartilage
Tracy Neilssien, 38
LABSTYLE
INNOVATIONS:
A Simple, Smart (Phone) Solution
for Mobile Diabetes Management
Mary Thompson, 40
PERSPECTIVE
Medtech: What’s in a Name?
David Cassak, 4
Who Will Pay for Wearables?
Drug Compliance: A Wearable
Device Improves Drug Efficacy with
Patient-Specific Timing and Support
A Digital Biomarker Helps Hospitals
Treat Post-Op Patients
Cardiovascular Monitoring: The
Power of Continuous Data
Epilepsy: Predictive Capabilities
Save Lives, Empower Patients
CONNECTED HEALTH
WEARABLE
TECHNOLOGIES:
What’s in it for Medical
Device Companies?
Mary Stuart, 6
Fastest Growing Categories in Connected Health
2014-2015 Overall Funding and YoY Growth
Figure 1
$250M
$500M
Personal Health Tools
and Tracking
Care Coordination Life Sciences
Technologies
223%
152%
49%
2014 funding 2015 funding 2014-2015 YoY growth
3. MARCH 16, 2016
7CONNECTED HEALTH
issue). Intel, Qualcomm, Apple, Google, Ford Motor Compa-
ny, and Ralph Lauren are but a few of the strange new bedfel-
lows in the healthcare industry, which these days is defined
more broadly to encompass both products that address sick-
ness and promote/maintain health. Healthcare promises to
be one of the largest consumer markets ever and there are
business opportunities for strategic investors.
The digital health accelerator Rock Health estimates that
in 2015 a total of $4.5 billion in venture funding poured into
connected health, with a preponderance of seed- and Se-
ries A-stage deals. Some 267 digital health companies each
raised more than $2 million last year. Digital health turned
in a strong performance in terms of exits as well. M&A activ-
ity in the space nearly doubled over the previous year, with
187 deals worth $6 billion, and five IPOs raised $1.4 billion
in 2015 to create $8 billion worth of market capitalization.
Wearable devices and biosensors attracted $499 million
of the total amount invested. Indeed, Rock Health identified
Personal Health Tools and Tracking (including wearables)
as the fastest-growing category in connected health. This
highlights the important role consumers/patients can play
in achieving the “Triple Aim” goals of healthcare, which in-
clude improving the patient experience of care, improving
the health of populations, and lowering the per-capita cost
of healthcare (see Figure 1).
The individual has been an untapped resource in health-
care, and there has been much discussion on the part of
providers, innovators, and payors, including the US govern-
ment, about how to change
this dynamic. The US govern-
ment is supporting research in
the nascent field of precision
medicine, which aims to give
clinicians tools to customize
medicine (and disease preven-
tion) to the individuals under
their care based on the pa-
tient’s unique genetics, envi-
ronment, and lifestyle factors.
President Obama recently
launched the Precision Medi-
cine Initiative with a $215 mil-
lion investment earmarked in
the 2016 budget. Intel Corp.
and Verily (formerly Google
Life Sciences; now part of
Alphabet Inc.) have already
signed up to develop capabili-
ties to support the initiative.
Wearable technologies, which use patient-worn sensors
to provide objective measurements of vital signs, activity
levels, and other measures of physiology, will be key tools
in this new framework. And automating certain kinds of
tracking with devices, sensors, and continuous monitoring
technologies now makes it possible to get more and better
data from patients, who are notoriously non-compliant with
anything medical, especially when it comes to self-reporting
data. The information gleaned by wearable sensors could
result in the creation of digital biomarkers (a term coined by
Rock Health)—signatures of disease that can be gleaned by
noninvasive monitoring, shared, combined with other data,
and mined digitally to provide medical insights never before
possible. That’s the promise of wearables and the reason for
much of the hope and optimism in the scientific and invest-
ment communities.
But the medical device industry is less sanguine, de-
spite the fact that it possesses perhaps the best skillsets
for developing these new technologies. Medical device
companies excel at engineering and have sensor expertise,
experience in the clinical validation of products, relation-
ships with physicians and providers, and an understanding
of regulatory processes. However, the ultimate product
of wearable (and other connected health) technologies is
data, and while medical device companies want to operate
in this space, for many, it is outside the normal bounds of
their core product businesses. And, perhaps most impor-
tantly, the business models for how they’ll get paid for their
investment are still unclear.
Figure 1
Fastest Growing Categories in Connected Health
2014-2015 Venture Funding* and YoY Growth
*Only includes US deals>$2M, data through Dec. 8, 2015
Source: Rock Health
Fastest Growing Categories in Connected Health
2014-2015 Overall Funding and YoY Growth
Figure 1
$250M
$500M
Personal Health Tools
and Tracking
Care Coordination Life Sciences
Technologies
223%
152%
49%
2014 funding 2015 funding 2014-2015 YoY growth
5. MARCH 16, 2016
9CONNECTED HEALTH
One initiative towards that goal is the
aggregation of information from wear-
able devices and apps patients can use
to empower both themselves and the
hospital system. Richardville’s group
has developed CarolinasTracker, a free
app that that accepts information from
activity trackers like Fitbit and other
consumer tracking devices for anyone
out in the community who wants it,
and MyCarolinasTracker, a free app
that aggregates data from wearable
devices used by patients the hospital
system serves.
“Taking care of our patients is part
of our business, but the other part is
keeping them healthy and well,” says
Richardville. His statement is some-
what surprising, because we haven’t
traditionally thought of hospitals as in-
stitutions that sell health and wellness;
they take care of sick people, right?
But the healthcare landscape is
changing. After two years of planning,
in February 2016, Carolinas HealthCare
System launched its clinically integrated
network (CIN). A CIN strategically com-
bines (i.e., does not require the pur-
chase of practices) multiple healthcare
providers and systems into one larger
network in which healthcare provid-
ers can streamline the delivery of care
across primary care and specialty phy-
sicians to improve the quality of care
and lower costs. CINs can negotiate col-
lectively with payors to get better re-
imbursement arrangements (collective
bargaining is prohibited under other
kinds of hospital or physician affilia-
tions). The model is not unlike the Ac-
countable Care Organization, a type of
network that gets to share in whatever
savings it can achieve in the delivery of
care, except ACOs currently only serve
Medicare patients (Partners Health-
care, mentioned above, participates
in such an organization, called Pioneer
Accountable Care Organization). Since
the passage of the Affordable Care Act,
the number of CINs has grown from a
handful to more than 500 in the US, ac-
cording to the Advisory Board.
In the press release announcing the
launch of its CIN, Carolinas HealthCare
System describes its initiative: “The
CIN will have several patient popula-
tions and initiatives as part of its fo-
cus areas. Some of those initiatives
will include management of chronic
diseases and preventative screenings,
reducing the cost of care, improving
efficiency, avoiding unplanned read-
missions, preventable care, and overall
quality improvement.” Those are the
oft-expressed goals of healthcare to-
day, but now, the Carolinas CIN will be
paid a per-member per-month fee to
achieve them. “Part of the opportunity
to lower my costs and achieve better
outcomes is to keep [patients] healthy
and well, manage chronic disease, and
to optimize new channels such as vir-
tual care and retail.” says Richardville.
For employees of the Carolinas
HealthCare System, that model is al-
Who Will Pay for Wearables?
“The patient is the most under-utilized resource in healthcare,” says Craig Rich-
ardville, senior VP and chief information Officer for Carolinas HealthCare System,
a network of 900 care locations throughout North and South Carolina. “As we
have learned from other industries like retail and financial services, a lot of work
that used to be done by clerks is now being done by the consumer. We shop
online and our financial services come to us online. And most importantly that
type of interaction is what consumers prefer.” Healthcare has lagged in tapping its
consumers, and Carolinas HealthCare System aims to lead that effort.
Figure 2
Business Models for Wearable Medical Technologies
Source: The MedTech Strategist
CONSUMER PAYS
out of pocket
(NeuroMetrix Quell
pain device; Empatica
epilepsy monitor)
REIMBURSEMENT
under existing fee-for-
service framework:
bundled DRG code
(AbStats in the surgery
market) alternative to
other reimbursed
technology (iRhythm)
PRIVATE PAY
Insurance company or
Employer reimburses
members/employees
for using health
technology (Chrono
Therapeutics)
PAY-FOR-VALUE:
Accountable Care Organization,
Clinically Integrated Network,
Population Health Manager, or
other “at-risk” provider pays for
technologies that help them
achieve goals of lowering the
per-patient cost of care in
exchange for a share in the savings
7. MARCH 16, 2016
11CONNECTED HEALTH
The proven efficacy of drugs is based
on rigorously controlled clinical trials
but in the real-world, the patient is a
wild card capable of single-handedly
throwing off the results. With all
drugs, compliance is a major issue.
Patients are compliant about taking
pills as directed less than 50% of the
time; for transdermal patches, com-
pliance is believed to be even lower.
Obviously, drugs can’t help if patients
don’t take them.
Chrono Therapeutics Inc. has de-
veloped a wearable device and smart
phone-enabled support platform that
offers several strategies (compliance
among them) to mount a multi-pronged
attack that will help patients succeed on
their drug therapies.
The company was initially founded in
2003 by Guy DiPierro, an attorney spe-
cializing in corporate M&A and technol-
ogy licensing, who licensed some pat-
ents concerning biologically timed drug
delivery from the University of Basel in
Switzerland. In 2013, Alan Levy, PhD, a
seasoned veteran of both the pharma-
ceutical and medical device industries,
joined as chairman and CEO. Previously,
Levy served as the founding CEO of the
pharmaceutical firm Incline Therapeu-
tics, which was acquired by The Medi-
cines Company; the president and CEO
of Northstar Neurosciences, which was
developing an innovative neurostimu-
lation therapy for stroke survivors; and
also as the CEO of Heartstream Inc. and
the president of Heart Technology Inc.
With Levy at the helm, Chrono Thera-
peutics began crafting a broader strat-
egy, including compliance monitoring
and behavioral support. “Our focus is
on improving patient outcomes by put-
ting together four distinct technolo-
gies: biologically timed drug delivery,
compliance monitoring, behavioral
support, and data analytics,” says Levy.
A Large Market and
a Clear Business Model
For its initial commercial product, the
company is developing a smoking ces-
sation device, which provides a good
entry point for its platform for a cou-
ple of reasons. First, smoking is a ma-
jor public health problem. According
to the US Centers for Disease Control
and Prevention (CDC), cigarette smok-
ing kills more than 480,000 people in
the US each year, 41,000 of them from
exposure to secondhand smoke. In ad-
dition, smoking-related illness in the
US costs more than $300 billion a year,
including nearly $170 billion in direct
medical care for adults and $156 bil-
lion in lost productivity. The CDC esti-
mates that in 2014, 40 million adults
were cigarette smokers.
Second, nicotine, the established
smoking cessation drug, has been
safely used for 20 years, which lowers
Drug Compliance:
A Wearable Device Improves Drug Efficacy with Patient-Specific
Timing and Support
CHRONO THERAPEUTICS
Hayward, CA
Sector: Improved Outcomes for
Pharmaceuticals with Wearable-
Enabled Support
Founded: 2003 initially, but
expanded its vision in 2013
Contact: Alan Levy,
ALevy@chronothera.com
Founder: Guy DiPierro, who
licensed the patents for
biologically-timed drug delivery
from the University of Basel in
Switzerland.
Funding to date: $34 million
from a Series A round. Investors
include Canaan Ventures, 5Am
Ventures, Fountain Healthcare
Partners, Mayo Clinic, GE
Ventures and Rock Health.
The company has also received
two grants from the National
Institutes of Health.
How the company gets paid:
Under the Affordable Care
Act, FDA-approved smoking
cessation products are
reimbursed and many companies
reimburse their employees for
smoking cessation products
and programs.
9. MARCH 16, 2016
13CONNECTED HEALTH
that you are using it and that you are
getting the drug at the appropriate
time.” This feature, which provides the
sense that the patient is being watched
over, has proven to be important for
patient engagement with wearables
generally speaking, but it’s particularly
helpful in the smoking cessation appli-
cation. Levy notes that smokers have a
chemical dependency, which the nico-
tine replacement therapy addresses,
but smoking is also a habit, which is
why it’s so difficult to quit. “The more
support and reinforcement you can
give smokers, the better they do.” Levy
points to studies that show that just
having nurses or other professionals
call smokers every two weeks helps im-
prove quit rates. “But that is not a very
scalable approach. We want to be able
to reach 20 million people who are try-
ing to quit each year in the US.”
Thus, if the patient doesn’t comply
with changing the cartridge, he or she
will get a reminder message via the
program’s mobile app. Through the
app, patients will also get periodic en-
couragement, and they can become
part of networks that are similar to the
communities that Fitbit users set up, to
compare themselves, anonymously, to
others who share the same goals.
To deal with social cues that tempt
the smoker, there is a “crave” button
on the wearable pod. “They can press
the button to record the craving and
trigger an immediate response from
the app: ‘Take a deep breath. Walk
around for a few minutes’ and the
craving will pass.” With the patient’s
permission, family members can also
receive alerts so they can provide en-
couragement and support. “All of the
things that have been demonstrated
to work when clinicians and other care
givers call patients, we are able to do
via smart phone and just in time, as op-
posed to every two weeks,” says Levy.
The smoking cessation product
doesn’t yet have FDA clearance;
the company will be meeting with
the FDA to discuss the next studies,
which will likely
revolve around
demonstrating
that the quan-
tity of nicotine
delivered over
a 24-hour pe-
riod is compa-
rable to previ-
ously approved
products.
In the near
term, the com-
pany is scaling
up a pilot pro-
duction line of
its smoking ces-
sation product
to support pivotal trials, with the goal
of filing in the US and Europe at the
end of 2017 or early 2018.
A Platform for Many Diseases
Chrono Therapeutics has future
products in its pipeline: indications
where patients will benefit from bio-
logically timed drug delivery, compli-
ance monitoring, and behavioral sup-
port. Parkinson’s disease (PD) is one
such application. Many PD patients
suffer from levodopa-induced dys-
kinesia, or LID, and experience mo-
tor fluctuations as a result of chronic
treatment with the drug. “When they
wake up, they are often very stiff and
have difficulty getting out of bed un-
til they take their medication. We can
deliver that drug about an hour before
they get up so they can get right up
and function.”
While the smoking cessation product
will be sold over-the-counter (OTC) at
a price comparable to other smoking
cessation products, the Parkinson’s
product would contain drug and be
prescribed by a physician. The compa-
ny hasn’t arrived at a pricing model for
this product, but it will take value into
consideration. Value will be assessed in
part by the degree to which, in reduc-
ing symptoms of the disease, the Chro-
no Therapeutics product is able to cut
down on office visits or take other costs
out of the equation.
Levy says he’s not aware of any other
drug-delivery company that’s wrapped
its arms as broadly around the patient,
but Proteus Digital Health comes
closest. Proteus has developed a tiny
ingestible sensor that can be manufac-
tured into pills to record patient drug
dosage compliance and other infor-
mation. The pill communicates with
a patient-worn patch that can send
information to a smart phone. Proteus
and Otsuka Pharmaceutical Co. Ltd.
worked together to turn Abilify (ar-
ipiprazole, a treatment for schizophre-
nia and other severe mental illnesses)
into the first “digital drug” to file an
NDA with the FDA.
Levy notes that Proteus is exploring
applications that provide great value,
for example, for patients with neu-
ropsychiatric problems who aren’t
compliant, or to improve compliance
for very expensive medications. He
points to Sovaldi (sofosbuvir, from
Gilead Sciences Inc.) as another such
an example. “It can cure Hepatitis C,
but you have to stay on it for two to
three months and if you stop taking
it, you have to start all over again.”
Sovaldi costs $80,000 for a course of
treatment. “If you can improve com-
pliance, there are enormous savings
to the healthcare system.”
Figure 4
Chrono Wearable Drug-Delivery Pod and App
Source: Chrono Therapeutics Inc.
11. MARCH 16, 2016
15CONNECTED HEALTH
sors who is the co-director of the UCLA
Wireless Health Institute in Los Ange-
les. In the course of that work, the two
became acquainted with another proj-
ect Kaiser was working on with gas-
troenterologist Brennan Spiegel, MD,
then associate professor of medicine
in the division of digestive diseases at
the UCLA School of Medicine. Spiegel
had asked “Why are gastroenterolo-
gists the only clinicians that can’t get
a relevant vital sign on which to base
treatment for their patients?” Other
specialties can rely on ECGs, blood
pressure cuffs, or pulse oximeters, but
gastroenterologists only have the 200-
year old stethoscope and their subjec-
tive judgments on what they can hear
and feel from the surface of the belly.
Kaiser devised precise vibratory sen-
sors and algorithms to categorize in-
testinal movements, and Beeton and
Sterling gained an exclusive worldwide
license to the technology from UCLA.
They founded GI Logic in 2013 with
$1.8 million in funding from individual
investors to further develop and com-
mercialize AbStats, the first noninva-
sive monitor for diagnosing functional
disorders of the alimentary tract.
AbStats gained FDA 510(k) clearance
in December 2015. Its predicate device
was the electronic stethoscope, but
AbStats is much more capable. “While
a clinician using a stethoscope listens
for 10-15 seconds and moves the
stethoscope around, we put vibratory
sensors on the patient’s belly where
they take in a broad range of vibrations
created by both muscular and food
movements—and not just the sounds
that you can hear—on a continuous
basis.” The system also gives back to
clinicians a value by which to guide
therapeutic intervention. The company
is conducting studies on known disease
states within the gut such as gastropa-
resis and pancreatitis, and says Bee-
ton, “We are able to absolutely classify
what these vibrations mean and to give
back useful information.”
To Feed or Not to Feed
In the post-op setting, that informa-
tion will guide clinicians as to when to
safely feed patients to set them on a
course of healing and get them out of
the hospital. As a result of surgery and
anesthesia, in most patients, the diges-
tive tract is stunned for a period follow-
ing surgery and is unable to move food
along. Patients are not released from
the hospital until it’s clear that their
gastrointestinal motility has returned
and they can tolerate food.
Doctors don’t have objective nonin-
vasive tools to determine whether or
not a patient has postoperative ileus
(the term for prolonged paralysis of
the gastrointestinal tract causing in-
tolerance of oral intake). They often
rely on the stethoscope, patient’s re-
ports of pain levels and whether or not
they’ve had a bowel movement, and
clinical examination. The gold standard
for measuring intestinal motility, antro-
duodenal manometry, requires the in-
sertion of a nasogastric tube (it goes in
through the patient’s nose and down
the throat), to measure the GI tract’s
muscle movement by measuring pres-
sure waves. That procedure is not well
tolerated by patients; not feasible in
many cases, since patients need to
discontinue certain drugs; and is time
consuming and expensive, as are other
invasive assessment tools.
Since the 1990s, many hospitals have
implemented a protocol called ERAS
(Enhanced Recovery After Surgery) a
postoperative care plan designed to
decrease complications, hasten re-
covery, and shorten hospital stay, one
directive of which is to feed patients
as early as possible. However, says
Beeton, in 25% of cases, patients are
fed before they’re ready, food festers
in the stomach, and several negative
consequences can happen. Patients
may feel discomfort or vomit. What’s
worse, aspirated food can lead to
pneumonia, additional surgeries, early
readmission, and even death.
According to some studies, postop-
erative ileus (POI) prolongs hospital
length of stay by 30% and, in the US,
is responsible for excess costs of more
than $1.46 billion annually. There is no
definitive set of codified risk factors to
guide surgeons or bedside caregivers
as to which patients may or may not
develop POI. AbStats will give physi-
cians objective information about in-
testinal motility so they can determine
what and when to feed patients.
AbStats consists of a pair of dispos-
able biosensors that detect intestinal
vibration signals. It is placed on a pa-
tient’s abdomen and connects to a
small bedside computer with a moni-
tor that measures intestinal event
rates and displays a graph, which is a
trend analysis over time, as well as a
numeric value per hour of these in-
testinal events. “In studies conducted
using the system, these rates corre-
lated to physiologic digestive status.
These event rates thus can now allow
clinicians to make informed decisions
on when and how to advance patient
feeding,” says Beeton.
For the postoperative ileus indica-
tion, the company first validated its
new measurement (in a study led by
Brennan Spiegel, MD) in eight healthy
controls, seven postoperative patients
tolerating the fast-track feed protocol,
and 25 patients with evidence of post-
operative ileus. AbStats measurements
showed high motility rates in patients
tolerating fast-track feeding versus
those with postoperative ileus.
In a second peer-reviewed study (by
Kaneshiro et al and published Septem-
ber 25, 2015 in the Journal of Gastro-
intestinal Surgery) the investigators
developed an automated prediction
rule about the probability of a patient
developing postoperative ileus, but cli-
nicians were blinded to the values. The
study recruited 28 patients undergoing
colorectal surgery, and nurses and sur-
geons delivered care as they normally
would, without the benefit of AbStats
13. MARCH 16, 2016
17CONNECTED HEALTH
iRhythm Technologies Inc. got into
the wearables game very early. Electro-
physiologist Uday Kumar, MD, founded
the company in 2006 to develop a more
patient-friendly alternative to the Holt-
er electrocardiographic (ECG) monitor,
and one that by virtue of continuous
monitoring would have a higher di-
agnostic yield. Data published by the
company in February 2016 has borne
out its thesis. (See “Incidence and Tim-
ing of Potentially High-Risk Arrhythmias
Detected Through Long-Term Continu-
ous Ambulatory Electrocardiographic
Monitoring,” Biomed Central Cardio-
vascular Disorders, February 17, 2016.)
The conventional Holter monitor is
the original wearable. It looks, heart-
beat-by-heartbeat, for heart rhythm
abnormalities (indicative of disorders
like atrial fibrillation) in patients over a
24-48 hour period. IRhythm designed
its wearable patch ZIO to capture the
same type of ECG data over 14 days.
The recent study, led by researchers
from Kaiser Permanente Northern Cali-
fornia, found that a significant amount
of arrhythmias were detected well after
the 48-hour limit of Holter monitoring.
Between 2012 and 2013, the study
gathered 128,401 episodes of moni-
toring with the ZIO service. The aver-
age monitoring wear time was approx-
imately ten days and more than 25%
of the monitors were worn for almost
14 days. One-third of the episodes of
sustained ventricular tachycardia, a
serious condition that can be fatal, and
more than half of potentially serious
bradyarrhythmias were detected af-
ter more than 48 hours. Overall, there
was an incrementally higher detection
of potentially high-risk arrhythmias
during the 14-day maximum monitor-
ing period.
The Benefits of a Patient
Friendly Device
The advantages of the ZIO monitor
go beyond its ability to provide a longer
monitoring period. The design helps
improve both patient compliance and
the diagnostic quality of the ECG data.
The old-fashioned Holter monitor is at-
tached to three or four electrodes on
a patient's chest by a tangle of wires.
The ZIO monitor is wireless and not
much bigger than a big BandAid. It also
helps patients correlate symptoms
and activities with rhythm abnormali-
ties through a smart phone app called
MyZIO.
Judy Lenane, executive VP and chief
clinical officer for iRhythm, says that
Holter monitors can’t be exposed to
water, so patients have to disconnect
and reconnect three or four electrodes
every time they shower. By contrast,
patients can leave the ZIO patch on
while they shower (although it can’t
be submerged), so there is no need
to change it during the monitoring
period. Moreover, says Lenane, the
Holter monitor’s wires and electrodes
introduce noise and artifacts. The sig-
nals the ZIO patch captures are much
cleaner because the ZIO device stays
Cardiovascular Monitoring:
The Power of Continuous Data
IRHYTHM TECHNOLOGIES INC.
San Francisco, CA
Sector: Cardiovascular
Monitoring
Founded: 2006
Contact: Judy Lenane, Executive
VP and Chief Clinical Officer
JLenane@iRhythmtech.com
Founder: Uday Kumar, MD, an
electrophysiologist, when he was
a fellow in the Stanford Design
Medical Device Innovation
Fellowship
Funding to date: $68 million in
five venture rounds. Investors
include: Mohr Davidow Ventures,
Synergy Life Science Partners,
St. Jude Medical Inc., New
Leaf Venture Partners, Kaiser
Permanente Ventures, Norwest
Venture Partners, Novo/AS
How the company gets paid:
reimbursed under existing
reimbursement codes, the
family of CPT codes covering
continuous rhythm monitoring
of duration longer than 48
hours
15. MARCH 16, 2016
19CONNECTED HEALTH
Epilepsy is a frightening disease for
the 2.2 million people in the US who
suffer from its seizures, as it is for
their loved ones. The unpredictabil-
ity of seizures lingers in their aware-
ness at all times. Will I have a seizure
during the high school musical? Is
it safe to ski? Will my child wake up
tomorrow?
Each year, one out of 1,000 people
with epilepsy die of SUDEP—the sud-
den unexpected death of someone
with epilepsy. In the US more people
die of SUDEP, says Rosalind Picard,
chief scientist of start-up Empatica
Inc., than of SIDS (sudden infant death
syndrome) or a house fire. “Everyone
knows to place a baby on his back
during sleep to prevent SIDS, or to in-
stall a smoke detector in their house,
but most people have never heard of
SUDEP, and there is no warning sys-
tem.” CEO Matteo Lai says that at a
meeting of Partners Against Mortal-
ity in Epilepsy he met the parents of
children who had died unexpectedly.
When he left, he thought, “We can’t
send people with this type of epilepsy
home without a monitor.”
Developing a wearable technol-
ogy that predicts and sends alerts for
SUDEP is the ultimate (and ambitious)
goal of Empatica, but the company is
taking a phased approach to that end.
For the first phase, it is selling a wrist
watch called Embrace, which tracks a
number of physiological signals to help
patients and their caregivers under-
stand their own patterns of seizures.
It is also selling a clinical-grade device,
the E4 sensor, for the collection of rel-
evant data from epilepsy patients for
the purpose of research. These new de-
vices are important because of the het-
erogeneity of epilepsy patients. Picard
hopes that data gathered in this phase
will inform the development of future
epilepsy monitors and therapies.
Empatica brings together two in-
dependent research efforts. In 2012,
Picard licensed technology from the
Massachusetts Institute of Technol-
ogy’s Media Lab for monitoring the
response of the autonomic nervous
system. She was initially developing
a monitoring system for people with
autism, who might be nonverbal or
otherwise unable to speak about what
they were feeling. Along the way, she
discovered that seizures could also be
detected with the platform. Empatica
SRL in Milan, Italy, was doing similar
work, but in the consumer space, and
the two entities combined to form Em-
patica Inc. in 2013.
Many companies are developing
wearable epilepsy monitors to alert
caregivers by measuring the repeti-
tive shaking motions of patients during
seizures (for example Emfit Ltd. and
Smart Monitor). Empatica’s Embrace
watch also has a motion-detection
algorithm, but it additionally offers a
sensor capable of identifying the au-
tonomic signature of a seizure, which
leads to greater accuracy in detecting
convulsive seizures, according to stud-
ies conducted with research partners
at Children’s Hospital Boston, Brigham
and Women’s Hospital, and other insti-
tutes. (See “Convulsive Seizure Detec-
Epilepsy:
Predictive Capabilities Save Lives, Empower Patients
EMPATICA INC.
Cambridge, MA
Founded: 2013
Sector: Neurological: Epilepsy
Contact: Rosalind Picard, ScD,
Chief Scientist, rp@empatica.com
Founders: Rosalind Picard, ScD,
Director of Affective Computing
Research and faculty Chair
of MIT's Mind+Hand+Heart
initiative, MIT Media Lab, Matteo
Lai, CEO, who trained as an
architect and has worked in
Design and IT; Simone Tognetti, a
software engineer with expertise
in artificial intelligence, affective
computing and human-computer
interaction; and Maurizio
Garbarino, a software engineer
with expertise in affective
computing
Funding to date: $2 million
How the company gets paid:
Initially, selling a consumer
device for vital signs and activity
tracking for $199 and a monthly
fee for an alert system; ultimate
goal is FDA approval for epilepsy
claims and reimbursement
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