BioTelemetry, Inc. operates as a remote medical technology company.
The company provides remote cardiac monitoring, centralized core laboratory services for clinical trials, remote blood glucose monitoring, and original equipment manufacturing that serves both healthcare and clinical research customers.
Segments
The company operates through two segments, Healthcare and Research.
Healthcare segment
The Healthcare segment, or BioTel Heart, focuses on remote cardiac monitoring to identify card...
BioTelemetry, Inc. operates as a remote medical technology company.
The company provides remote cardiac monitoring, centralized core laboratory services for clinical trials, remote blood glucose monitoring, and original equipment manufacturing that serves both healthcare and clinical research customers.
Segments
The company operates through two segments, Healthcare and Research.
Healthcare segment
The Healthcare segment, or BioTel Heart, focuses on remote cardiac monitoring to identify cardiac arrhythmias or heart rhythm disorders and to monitor the functionality of implantable cardiac devices. The company offers cardiologists, electrophysiologists, neurologists and primary care physicians a spectrum of solutions, which provides them with a single source of remote cardiac monitoring services. These services include mobile cardiac telemetry (MCT), event, traditional Holter, extended Holter, Pacemaker, international normalized ratio, implantable loop recorder (ILR), and other implantable cardiac device monitoring. The majority of the company’s Healthcare revenue is derived from the monitoring of devices that the company has developed, manufactured and marketed.
MCT
The company’s MCT services incorporate a patient-worn sensor attached to electrodes that capture two-channel electrocardiogram (ECG) data, measuring electrical activity of the heart, on a compact wireless handheld monitor. The monitor analyzes incoming heartbeat-by-heartbeat information from the sensor on a real-time basis by applying proprietary algorithms designed to detect arrhythmias. The monitor could detect an arrhythmic event even in the absence of symptoms noticed by the patient. When the monitor detects an arrhythmic event, it automatically transmits the ECG to the company’s monitoring centers.
At the company’s 24/7 monitoring centers, trained cardiac technicians analyze the data, respond to urgent events and report results in the manner prescribed by the physician. The MCT devices employ two-way wireless communications, enabling continuous transmission of patient data to the monitoring centers and permitting physicians to remotely adjust monitoring parameters and request previous ECG data from the memory stored in the monitor. The MCT devices have the capability of storing 30 days of continuous ECG data, in contrast to a maximum of 10 minutes for a typical event monitor and a maximum of 24 hours for a typical Holter monitor.
In 2016, the company obtained the U.S. Food and Drug Administration (FDA) approval of its next generation MCT device, in a patch form factor. The MCT patch is a four-lead, two-channel system that provides the same technology as the company’s traditional MCT devices. The MCT patch was commercially launched in limited accounts during 2017, with a full launch in 2018.
Event
The company’s event monitoring services provide physicians with the flexibility to prescribe wireless event monitors, digital loop event monitors, memory loop event monitors and non-loop event monitors. Event data is transmitted, either through automatic transmission of event data with wireless event monitors or through telephonic transmission of stored event data with the company’s traditional event monitors, to one of the company’s 24/7 monitoring centers where the company’s trained cardiac technicians analyze the data.
Holter
Traditional Holter and extended Holter monitors locally store, on a memory card, ECG data of every heartbeat or irregularity. At the end of service, the device is returned. The company’s trained cardiac technicians then analyze the data. The company’s next generation Holter monitors, the CardioKey and ePatch are cardiac monitors, which could continuously store approximately 14 days of ECG data.
Geneva
The company’s Geneva platform is a cloud-based solution for point of care and remote monitoring data that consolidates and manages information from ILRs and other implantable cardiac devices of various manufacturers into a single workflow. When combined with Geneva’s cardiac monitoring services, the company’s trained cardiac technicians analyze and report the data.
The company markets its services throughout the United States and receives reimbursement for the monitoring provided to patients from government and commercial payors.
Research segment
The Research segment, or BioTel Research, engages in centralized core laboratory services providing cardiac monitoring, imaging services, scientific consulting and data management services for drug and medical device trials. The centralized services include ECG, Holter monitoring, ambulatory blood pressure monitoring, echocardiography, multigated acquisition scan, a range of imaging services, protocol development, expert reporting and statistical analysis.
The company’s imaging service offerings were bolstered by its 2016 acquisition of VirtualScopics, Inc., a major provider of clinical trial imaging solutions and services in the cardiac, oncology, metabolic, musculoskeletal and neurologic therapeutic areas. The company provides a range of support services in Phase I-IV trials and Thorough QT Trials, which include project coordination, setup and management, equipment rental, data transfer, processing, analysis and 24/7 customer support and site training.
The company’s data management systems enable complete customization for sponsors’ preferred data specifications, and the company’s web service, CardioPortal, provides access to data from any web browser. The company’s primary customers in this segment are pharmaceutical companies and contract research organizations (CROs).
In 2017, the company collaborated with Apple, Stanford Medicine and American Well in the Apple Heart Study, to improve the technology used to identify irregular heart rhythms and advance heart science.
Other Businesses
The Corporate and Other category contains the company’s other operating business brands, such as BioTel Alliance, which focuses on manufacturing, testing and marketing of cardiac devices to medical companies, clinics and hospitals; and BioTel Care, which manufactures blood glucose monitoring devices and is working to expand its position in the digital population health management space. The company offers contract manufacturing services, developing and producing devices to the specific requirements set by customers.
The company manufactures various devices, including MCT, event and Holter monitors utilized by its Healthcare and Research segments.
Sales and Marketing
The company markets its cardiac monitoring solutions in its Healthcare segment through its direct sales force primarily to cardiologists, electrophysiologists, neurologists and primary care physicians who diagnose and treat patients with arrhythmias.
The company is the primary member of the Remote Cardiac Service Provider Group (RCSPG). The RCSPG collaborates with physician specialty societies, as well as the American Telemedicine Association to advocate to the Centers for Medicare and Medicaid Services and Congress for appropriate valuation of remote diagnostic services that the RCSPG members provide.
The company markets its Research segment services to pharmaceutical companies, medical device companies, CROs and academic research organizations. The company is a founding member and the cardiac core laboratory to join the Cardiac Safety Research Consortium (CSRC). Through the CSRC, the company is able to network with key thought leaders and decision makers of major pharmaceutical companies, as well as discuss key cardiac safety issues during the drug development process.
The company’s BioTel Alliance brand, included in the Corporate and Other category, markets its manufactured products to physicians, hospitals and other cardiac monitoring providers. BioTel Care is working to expand its position in the digital population health space, and continues to evaluate various connected health technologies and solutions to understand where the company could leverage its capabilities. Primarily, the company engages in increasing awareness and utilization of its wireless BGM and its diabetes management platform.
The company’s commercial team primarily focuses on securing contracted relationships for its diabetes management services with commercial managed care plans; accountable care organizations; integrated delivery networks; physicians groups; durable medical equipment distributors; and employer groups.
Business Strategy
The key elements of the company’s business strategy are to increase overall demand for its cardiac monitoring services; expand its presence in the clinical research market; and leverage its core competencies to new market opportunities.
Seasonality
The company’s Healthcare segment experiences some seasonality during the third quarter (year ended December 2019), as well as during the year-end holiday season. This is the result of patients electing to delay the company’s monitoring services during the summer months or holidays.
Intellectual Property
The company’s trademarks, certain of which are material to its business, are registered or otherwise legally protected in the United States and in certain international jurisdictions and include, among others, the registered trademarks BioTelemetry, BioTel Heart, Geneva Healthcare, BioTel Care, and BioTel Europe; and the unregistered trademarks Mobile Cardiac Outpatient Telemetry, MCOT, ePatch, CardioPortal, BioTel Research, and BioTel Alliance.
Government Regulation
The medical devices that the company uses to provide patient monitoring services are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act.
The algorithms that the company uses in the MCT service maintain FDA 510(k) clearance as a Class II device. The algorithms that the company uses in the BGM service also maintain FDA 510(k) clearance as a Class II device.
History
BioTelemetry, Inc. was founded in 1994.
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