We are a commercial-stage, wearable medical device and digital healthcare
company focused on transforming patient outcomes in cardiovascular disease using
monitoring and therapeutic intervention technologies that are intuitive,
intelligent, and connected. We have developed and are commercializing our
Cardiac Recovery System platform, a comprehensive and advanced system that
integrates monitoring, therapeutic treatment, digital health, and patient
support services into a single, unified solution. The cornerstone of our Cardiac
Recovery System platform is the ASSURE WCD, a next generation wearable
cardioverter defibrillator (“WCD”) used to protect patients at an elevated risk
of sudden cardiac arrest (“SCA”), a major public health problem that accounts
for approximately 50% of all cardiovascular deaths in the U.S. The ASSURE WCD
automatically monitors elevated risk patients and, if needed, delivers a
defibrillation shock to return the patient’s heart to normal rhythm. The ASSURE
WCD was purpose-built to enhance patient comfort and compliance and directly
address the key barriers to adoption associated with the only other commercially
available WCD. We believe the ASSURE WCD offers significant clinical and
functional advantages, including greater patient compliance as a result of a
major reduction in false alarms and enhanced comfort and wearability. In
addition to the ASSURE WCD, our Cardiac Recovery System platform includes a
comprehensive suite of fully integrated digital solutions and services that
enable enhanced patient and provider engagement and oversight, with the
objective of improving patient outcomes. We believe our Cardiac Recovery System
platform addresses serious unmet needs in the cardiac patient population and has
the potential to disrupt and grow the market which has been limited to a single
solution for more than 20 years. As of January 31, 2025, our system is actively
being prescribed by more than 550 hospitals across the U.S., representing
approximately 20% of WCD prescribing hospitals in the U.S., and has been worn by
over 17,000 patients since it was fully commercially launched. In our top 50
hospitals, we believe we have successfully captured approximately 45% of the
currently available prescriptions based on company-sourced data on all hospitals
that we serve in the U.S. and the percentage of WCD filled prescriptions at
those hospitals that are for our ASSURE WCD.
SCA is a life-threatening emergency characterized by the abrupt cessation of the
heartbeat caused by an electrical malfunction in the heart. This is typically
triggered by ventricular arrhythmias, such as ventricular fibrillation (“VF”),
and leads to a loss of consciousness and potentially death within minutes if not
promptly treated. The American Heart Association (“AHA”) estimates that SCA
causes approximately 436,000 deaths per year, making it the third leading cause
of death in the U.S. Defibrillation, or an electrical shock, is the only way to
restore a fibrillating heart to a normal rhythm. Each minute of delay in
restoring the heart to a normal rhythm reduces a patient’s chance of survival by
7% to 10%. The average time for Emergency Medical Services (“EMS”) arrival is 7
minutes from the time of a 911 call, and often longer in rural communities. The
most common location of a SCA in adults is at a home or residence, representing
approximately 73% of SCAs. In addition, approximately 50% of all SCAs are
unwitnessed.
A WCD is a wearable, non-invasiveminiaturized automated external defibrillator
and is worn underneath regular clothing. The device continuously monitors a
patient’s heart rhythm and is capable of delivering a defibrillation shock.
Wires connect electrodes inside the garment to the monitor, which is carried in
a small pack or shoulder bag. The electrodes continuously acquire a patient’s
heart rate and rhythm for evaluation by the automated external defibrillator. If
the monitor detects a potentially life-threatening arrhythmia, the WCD first
alerts the patient via an audible alarm and then administers a shock, if needed.
For over 20 years, WCDs have been used to protect patients at elevated risk of
SCA. However, until the ASSURE WCD received Food and Drug Administration (“FDA”)
approval in July of 2021, the market was limited to a single solution. Since the
approval of the first WCD in 2001, global WCD revenues have grown to
$1.3 billion in 2023, with approximately 85% of the revenues generated in the
U.S based on our analysis of third-party claims data and estimated average WCD
wear prescription lengths and average reimbursement rates in the U.S. and in
select international markets derived from industry data and internal estimates.
The volume of patients prescribed a WCD in the U.S. grew at roughly 6% annually
between 2021 and 2023, and we expect WCD revenues to continue growing.
Despite being proven as safe and effective in treating dangerous cardiac rhythms
when worn, WCD therapy remains underutilized, reaching just 14% of the eligible
U.S. patient population in 2023 based on data on patients indicated for a WCD
and WCD prescription data from industry sources. We believe that the low
penetration of WCD therapy is largely due to the limitations of the incumbent
commercially available device. In feedback we have collected through directly
engaging with patients and providers and customer feedback on public platforms,
commonly cited reasons for patients or providers failing to use the competitor
device include high false alarm frequency, poor wearability and patient
discomfort, a unisex-only garment, low utility data and limited connectivity
with patients. In the U.S., we estimate that there are approximately 800,000
cardiac patients each year who have experienced a myocardial infarction (“MI”)
or are diagnosed with heart failure and have low Left Ventricular Ejection
Fraction (“LVEF”), therefore making them eligible for WCD therapy. Additionally,
approximately 50,000 patients each year either have documented ventricular
tachycardia (“VT”) or VF, an inherited genetic condition, or have had their
implantable cardioverter defibrillators (“ICD”) temporarily explanted, and are
also indicated for WCDs. Based on an average WCD wear prescription length of 3.4
months per patient and an average Medicare reimbursement rate of $3,436 per
patient per month, we believe this represents an approximately $10 billion
annual addressable market. In select international markets, we estimate based on
patient population data collected by various third-party industry sources that
there are approximately 3.7 million people each year who experience an MI, are
diagnosed with heart failure, have documented VT or VF, have an inherited
genetic condition, or have had their ICD temporarily explanted. Among these
patients, based on the same third-party industry sources, we estimate that
approximately 1.8 million patients meet the indications for WCD therapy. Based
on estimated average WCD wear prescription length in these international markets
of 2.5 months per patient and estimated average reimbursement rate of $3,000 per
patient per month derived from industry data and internal estimates, we believe
this represents an approximately $14 billion total annual market opportunity
outside the U.S.
The ASSURE WCD is the next generation of WCD therapy, delivering a safe and
effective solution for patients with a design that enhances patient comfort and
compliance. In addition to the ASSURE WCD, the various digital solutions and
services of our Cardiac Recovery System platform include the ASSURE patient
application, Kestra CareStation remote patient data platform, Heart Alert
Services, and ASSURE Assist services. The ASSURE patient application engages
patients with real-time mobile updates to promote compliance, while the Kestra
CareStation remote patient data platform equips healthcare providers with
actionable insights to support timely and informed care decisions. Heart Alert
Services and ASSURE Assist services work together to enhance safety and are
designed to provide critical alerts to healthcare providers for significant
arrhythmias and notify emergency services when therapy is administered. This
post-therapy EMS support is critical as a range of injuries, such as head
injuries, soft tissue damage and bone fractures, can result from falling down
after a SCA. In addition, the ASSURE wearable ECG as part of our Cardiac
Recovery System platform provides monitoring and connectivity for patients no
longer indicated for a WCD but who still require ongoing support while their
heart continues to remodel. We believe we offer the most comprehensive and
cohesive platform, with digital solutions and services that are seamlessly
integrated with our ASSURE WCD, meaningfully differentiating our Cardiac
Recovery System platform from the only other commercially available WCD.
We are building a body of clinical evidence supporting the safety, efficacy, and
benefits of the ASSURE WCD, with six publications completed to date. This
growing portfolio includes our pivotal trials—the ASSURE WCD Clinical
Evaluation—Detection and Safety Study (“ACE-DETECT”) and the ASSURE WCD Clinical
Evaluation—Conversion Efficacy Study (“ACE-CONVERT”)—which served as the basis
for our premarket approval (“PMA”). In addition, we are conducting the ASSURE
WCD Clinical Evaluation—Post Approval Study (“ACE-PAS”) as part of a broader
ongoing ASSURE Patient Registry. All patients prescribed the ASSURE WCD in the
United States after August 5, 2022 are included in the Registry. As of
January 31, 2025, our ongoing registry has enrolled over 17,000 patients, and
its findings further validate the results of ACE-DETECT and ACE-CONVERT. Our
most recent FDA submission from ACE-PAS from July 2024, which includes data from
5,929 patients, reported first shock conversion efficacy of approximately 96%, a
low false alarm rate with only 6% of our patients experiencing a false alarm,
compared to 46% for the competitor’s device, and a median daily use of
23.2 hours. These results underscore the ASSURE WCD’s competitive advantages in
wearability, usability, and patient compliance, providing strong support for
continued adoption. We believe this collection of real-world evidence will
generate additional publications, continue to increase awareness of WCDs as a
proven therapy for elevated risk cardiac patients and further demonstrate the
clinical differentiation of our ASSURE WCD.
We have made material investments in infrastructure to support rapid growth and
scalability, specifically in our commercial organization, distribution and
supply chain capabilities, as well as revenue cycle management capabilities. In
the U.S., we have built a commercial sales team of approximately 70 direct sales
representatives and more than 40 sales and clinical support professionals with
deep expertise in cardiac rhythm management and established relationships in the
cardiology and electrophysiology fields. This team is responsible for developing
sales territory business plans, targeting and opening new accounts, and
processing prescriptions of our ASSURE WCD. Our direct sales team is supported
by a contracted team of over 250 ASSURE Patient Specialists (“APSs”) who assist
patients with fitting and training. At fitting, we deliver our ASSURE WCD from
our distribution network to the patient. We utilize a lease business model, and
when a patient’s wear time has concluded, the device is returned for
reprocessing and reintroduction into the distribution network. To support our
growth, we have developed a highly scalable supply chain in collaboration with
experienced, top-tier medical technology suppliers. Our substantial investment
in a fleet of devices, each with a capacity for approximately three patient
wears per year, are reprocessed through efficient reconditioning, which enables
the business to scale with an attractive unit economic profile. Finally, our
revenue cycle management capabilities streamline reimbursement processes by
ensuring claims are accurately prepared and submitted according to individual
payor requirements, facilitating timely collections. These capabilities are a
critical asset in driving operational efficiency and supporting both patient and
prescriber satisfaction. We believe our significant investments in
infrastructure create a high barrier to entry that will help us protect and grow
our market share.
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Kestra Medical Technologies, Ltd. was incorporated as a Bermuda exempted company
on May 20, 2021 in anticipation of this offering and has not engaged in any
business or other activities to date other than those incidental to its
formation, the Organizational Transactions and the preparation of the prospectus
and the registration statement of which this prospectus forms a part. Our
principal office is located at 3933 Lake Washington Blvd NE, Suite 200,
Kirkland, Washington 98033, and our registered office is located in Bermuda at
Cumberland House, 7th Floor, 1 Victoria Street, Hamilton HM 11, Bermuda. Our
telephone number is (425) 279-8002. Our website address is
https://www.kestramedical.com.