iRhythm Technologies Enters License Agreement with BioIntelliSense for Multiparameter Sensor Technology to be Used in Ambulatory Cardiac Monitoring
iRhythm Technologies (NASDAQ:IRTC) has entered an exclusive license agreement with BioIntelliSense for multiparameter sensor technology in ambulatory cardiac monitoring (ACM). The deal grants iRhythm access to BioIntelliSense's patented pulse oximetry, accelerometry, and trending non-invasive blood pressure technologies for use in ACM products and services.
This collaboration aims to expand iRhythm's product capabilities, potentially entering adjacent indications like obstructive sleep apnea. The agreement includes an upfront payment to BioIntelliSense, with additional considerations based on future milestones and royalties on annual net sales in the home sleep testing field.
iRhythm reaffirms its 2024 financial guidance for revenue, gross margin, and adjusted EBITDA, excluding this transaction. The company expects no material incremental development expenses in 2024 beyond the acquired in-process research and development (IPR&D) expense.
iRhythm Technologies (NASDAQ:IRTC) ha stipulato un accordo di licenza esclusiva con BioIntelliSense per la tecnologia dei sensori multiparametrici nel monitoraggio cardiaco ambulatoriale (ACM). L'accordo consente a iRhythm di accedere alle tecnologie brevettate di ossimetria da impulso, accelerometria e monitoraggio non invasivo della pressione sanguigna di BioIntelliSense, da utilizzare nei prodotti e servizi di ACM.
Questa collaborazione mira ad ampliare le capacità del prodotto di iRhythm, potenzialmente entrando in indicazioni adiacenti come l'apnea ostruttiva del sonno. L'accordo include un pagamento iniziale a BioIntelliSense, con considerazioni aggiuntive basate su futuri traguardi e royalty sulle vendite nette annuali nel campo del test del sonno a domicilio.
iRhythm ribadisce le sue previsioni finanziarie per il 2024 riguardanti il fatturato, il margine lordo e l'EBITDA rettificato, escludendo questa transazione. L'azienda non prevede spese di sviluppo incrementali significative nel 2024 oltre quelle per la ricerca e sviluppo in corso (IPR&D) acquisita.
iRhythm Technologies (NASDAQ:IRTC) ha firmado un acuerdo de licencia exclusiva con BioIntelliSense para la tecnología de sensores multiparamétricos en el monitoreo cardíaco ambulatorio (ACM). Este acuerdo otorga a iRhythm acceso a las tecnologías patentadas de oximetría de pulso, acelerometría y monitoreo no invasivo de la presión arterial de BioIntelliSense, para su uso en productos y servicios de ACM.
Esta colaboración tiene como objetivo expandir las capacidades del producto de iRhythm, potencialmente incursionando en indicaciones adyacentes como la apnea obstructiva del sueño. El acuerdo incluye un pago inicial a BioIntelliSense, con consideraciones adicionales basadas en futuros hitos y regalías sobre las ventas netas anuales en el campo de las pruebas de sueño en el hogar.
iRhythm reafirma su guía financiera para 2024 en ingresos, margen bruto y EBITDA ajustado, excluyendo esta transacción. La empresa no espera gastos de desarrollo incrementales materiales en 2024 más allá de los gastos de investigación y desarrollo en curso (IPR&D) adquiridos.
iRhythm Technologies (NASDAQ:IRTC)는 BioIntelliSense와 외래 심장 모니터링(ACM)을 위한 다기능 센서 기술에 대한 독점 라이선스 계약을 체결했습니다. 이 계약은 iRhythm이 BioIntelliSense의 펄스 산소 측정, 가속도 측정 및 비침습적인 혈압 모니터링 기술에 접근할 수 있는 권한을 부여합니다. 이 기술은 ACM 제품 및 서비스에 사용됩니다.
이 협력은 iRhythm의 제품 역량을 확장하고, 잠재적으로 폐쇄성 수면 무호흡증과 같은 인접 진단 영역에 진입하는 것을 목표로 하고 있습니다. 이 계약에는 BioIntelliSense에 대한 선불 지급이 포함되며, 향후 이정표 및 연간 순매출에 대한 로열티에 따라 추가적인 고려 사항이 포함됩니다.
iRhythm은 이 거래를 제외한 2024년 수익, 총 마진 및 조정 EBITDA에 대한 재무 지침을 재확인합니다. 이 회사는 인수한 진행 중 연구 및 개발(IPR&D) 비용을 제외하고 2024년에 추가적인 중요한 개발 비용이 없을 것으로 예상하고 있습니다.
iRhythm Technologies (NASDAQ:IRTC) a conclu un accord de licence exclusif avec BioIntelliSense pour la technologie de capteurs multiparamétriques dans la surveillance cardiaque ambulatoire (ACM). Cet accord donne à iRhythm accès aux technologies de mesure de pouls, d'accélérométrie et de pression artérielle non invasive brevetées de BioIntelliSense à utiliser dans les produits et services ACM.
Cette collaboration vise à élargir les capacités de produit d'iRhythm, avec la possibilité d'aborder des indications adjacentes telles que l'apnée obstructive du sommeil. L'accord comprend un paiement initial à BioIntelliSense, ainsi que des considérations supplémentaires basées sur de futures étapes et des redevances sur les ventes nettes annuelles dans le domaine des tests du sommeil à domicile.
iRhythm réaffirme ses prévisions financières pour 2024 concernant le chiffre d'affaires, la marge brute et l'EBITDA ajusté, en excluant cette transaction. La société ne prévoit aucune dépense de développement incrémentielle significative en 2024 au-delà des dépenses de recherche et développement en cours (IPR&D) acquises.
iRhythm Technologies (NASDAQ:IRTC) hat eine exklusive Lizenzvereinbarung mit BioIntelliSense für multiparametrische Sensortechnologie im ambulanten kardiologischen Monitoring (ACM) getroffen. Das Abkommen ermöglicht es iRhythm, auf die patentierte Puls-Oximetrie, Akzelerometrie und nicht-invasive Blutdrucktechnologien von BioIntelliSense zuzugreifen, um diese in ACM-Produkten und -Dienstleistungen zu verwenden.
Diese Zusammenarbeit hat zum Ziel, die Produktfähigkeiten von iRhythm zu erweitern und potenziell benachbarte Indikationen wie obstruktive Schlafapnoe zu erschließen. Die Vereinbarung umfasst eine Vorauszahlung an BioIntelliSense sowie weitere Überlegungen, die auf zukünftigen Meilensteinen und Lizenzgebühren für den jährlichen Nettoumsatz im Bereich Home-Sleep-Testing basieren.
iRhythm bekräftigt seine Finanzprognose für 2024 in Bezug auf Umsatz, Bruttomarge und bereinigtes EBITDA, ohne diese Transaktion zu berücksichtigen. Das Unternehmen erwartet im Jahr 2024 keine wesentlichen zusätzlichen Entwicklungskosten über die bereits aufgenommenen laufenden Forschungs- und Entwicklungskosten (IPR&D) hinaus.
- Exclusive license for advanced sensor technologies in ACM
- Potential expansion into adjacent markets like sleep apnea
- No material impact on 2024 financial guidance
- Opportunity to enhance clinical insights and improve patient outcomes
- Upfront payment and potential future payments to BioIntelliSense
- Acquired IPR&D expenses may impact non-GAAP financial measures
This licensing agreement marks a significant step for iRhythm in expanding its ambulatory cardiac monitoring (ACM) capabilities. The exclusive access to BioIntelliSense's advanced biosensor technologies, including pulse oximetry, accelerometry and non-invasive blood pressure monitoring, positions iRhythm to enhance its product offerings substantially.
The integration of these multi-parameter sensors could lead to more comprehensive patient data collection, potentially improving the accuracy of cardiac monitoring and expanding into new areas like obstructive sleep apnea detection. This move aligns with the industry trend towards more holistic, continuous patient monitoring, which could lead to earlier interventions and improved patient outcomes.
However, the financial impact remains to be seen, as the deal involves upfront payments and potential milestone-based considerations. Investors should monitor how quickly iRhythm can integrate these technologies and bring new products to market to justify the investment.
From a financial perspective, this deal presents both opportunities and challenges for iRhythm. The company is making a strategic investment in expanding its technological capabilities, which could drive future revenue growth and market share in the ACM space. However, the immediate financial impact includes:
- An upfront payment to BioIntelliSense (amount undisclosed)
- Potential milestone payments through 2026
- Future royalties on net sales in the home sleep testing field
These expenses will be recognized as acquired in-process R&D, impacting the company's GAAP and non-GAAP results. Notably, iRhythm has reaffirmed its 2024 financial guidance, suggesting minimal short-term financial disruption. Investors should focus on the long-term potential for revenue growth and market expansion, balanced against the R&D investments required to commercialize these new technologies.
The technology licensed from BioIntelliSense represents a significant advancement in wearable health monitoring. The white-light enhanced pulse oximetry is particularly noteworthy, as it addresses a important gap in current SpO2 monitoring technology by accurately measuring blood oxygen levels across all skin pigmentations. This could be a game-changer in ensuring equitable health monitoring.
Moreover, the integration of multiple vital sign indicators into a single platform aligns with the trend towards more comprehensive, AI-driven health monitoring. The potential to combine ECG data with other vital signs could lead to more nuanced and predictive health insights. However, the challenge lies in effectively integrating these technologies into iRhythm's existing platforms and ensuring seamless data interpretation. The success of this venture will depend on iRhythm's ability to create user-friendly, clinically valuable products that leverage these advanced sensing capabilities.
iRhythm granted exclusive license to BioIntelliSense’s patented pulse oximetry, accelerometry and trending non-invasive blood pressure technologies for use within ambulatory cardiac monitoring (ACM) market
SAN FRANCISCO, Sept. 04, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the company has signed an exclusive license agreement with BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, to develop and commercialize certain patented technology assets within ambulatory cardiac monitoring (ACM).
“As a natural complement to iRhythm’s leading ambulatory cardiac monitoring platform, BioIntelliSense’s multiparameter sensing technologies position us to significantly expand the capabilities of our product platform over the next several years,” said Quentin Blackford, iRhythm’s President and CEO. “We believe that the licensed technology from BioIntelliSense can advance our premium positioning within ACM and further enables us to enter other adjacent indications such as obstructive sleep apnea over time. By incorporating medical grade, connected, multi-sensor capabilities, we believe iRhythm will be well positioned to deliver broad clinical insights that improve patient outcomes, enhance clinical and operational efficiency, and reduce costs to the healthcare system. We look forward to collaborating with the BioIntelliSense team to accelerate the next chapter of connected patient care.”
BioIntelliSense offers a comprehensive set of vital sign indicators that enables early identification and detection of adverse trends to improve patient monitoring safety and effectiveness from in the hospital to the home via a portfolio of medical grade wearable devices and data services. Their comprehensive set of patient trending and algorithmic-based personalized notifications includes resting heart rate, respiratory rate, and skin temperature via their FDA-cleared BioButton® wearable device. BioIntelliSense also has patented capabilities that represent a significant advancement in the field of oximetry with its white-light enhanced pulse oximetry (SpO2) sensor chipset and integrated processing technology that facilitates measurement of blood oxygen levels across the full range of light to very dark skin pigmentations with unique motion-tolerance capabilities.
“We couldn’t be more excited about this collaboration with iRhythm, whose deep experience in ECG ambulatory cardiac monitoring is a perfect complement to the continuous vitals sign and medical grade wearable expertise of BioIntelliSense,” said James Mault, MD, founder and CEO of BioIntelliSense. “Through the integration of advanced biosensors and algorithmic-based analytics, we can collectively address a critical gap in the current healthcare system, by providing clinicians with more timely and actionable information to facilitate earlier clinical intervention and better, safer patient care.”
As multiple vital signs and digital data assets are increasingly combined to generate clinical insights, iRhythm and BioIntelliSense are excited to be market leaders in defining how continuous monitoring could look over the next decade and beyond. iRhythm is building a data-driven health care portfolio for the future and is uniquely positioned to address the quintuple aim of healthcare in the years to come.
License Overview
Under the terms of the agreement, BioIntelliSense has granted iRhythm an exclusive license to develop and commercialize pulse oximetry, accelerometry, and trending non-invasive blood pressure technologies for use within iRhythm’s ACM products and services. In connection with the license agreement, BioIntelliSense will receive an upfront payment, and they will be eligible to earn additional consideration based on future technology validation and regulatory milestones. BioIntelliSense will also be eligible to receive royalties on annual net sales of products and services that include licensed rights in the home sleep testing field of use.
The license consideration payable to BioIntelliSense will be recognized on iRhythm’s consolidated statements of operations as acquired in-process research and development (“IPR&D”) expense. Additional consideration may be earned by BioIntelliSense through December 31, 2026, relating to the achievement of certain development milestones and may be recognized as acquired IPR&D expense. In alignment with SEC guidance around non-GAAP financial measures relating to acquired IPR&D expense, iRhythm will not exclude expenses related to IPR&D from its non-GAAP results, which include adjusted operating expenses, adjusted net loss, adjusted net loss per share, and adjusted EBITDA.
iRhythm provided 2024 annual financial guidance on August 1, 2024, related to revenue, gross margin, and adjusted EBITDA. Based on currently available information, iRhythm reaffirms its current 2024 annual financial guidance for revenue, gross margin, and adjusted EBITDA excluding this transaction. iRhythm does not expect to incur any material incremental development expenses in 2024, other than the acquired IPR&D expense, associated with this transaction. iRhythm will provide an update for its 2024 annual financial guidance when iRhythm reports its third quarter 2024 results.
About iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.
About BioIntelliSense, Inc.
BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for virtual care and remote patient monitoring (RPM) from in-hospital to home. Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multiparameter vital signs and physiological biometrics through an effortless user experience. The FDA-cleared BioButton® multiparameter wearable, BioHub™ gateways, BioMobile™ downloadable applications, BioCloud™ data services and the BioDashboard™ clinical intelligence system creates a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. Through the platform’s AI-driven analytics, clinicians have access to high-resolution patient trending and data-driven insights to deliver better, safer care from in-hospital to home.
Use of Non-GAAP Financial Measures
We refer to certain financial measures that are not recognized under U.S. generally accepted accounting principles (GAAP) in this press release, including adjusted EBITDA. We use these non-GAAP financial measures for financial and operational decision-making and to evaluate period-to-period comparisons. See the schedules in our most recent filings made with the Securities and Exchange Commission, including those on the Form 10-Q filed on August 1, 2024, for additional information and reconciliations of such non-GAAP financial measures. We have not reconciled our adjusted operating expenses and adjusted EBITDA estimates for full year 2024 because certain items that impact these figures are uncertain or out of our control and cannot be reasonably predicted. Accordingly, a reconciliation of adjusted operating expenses and adjusted EBITDA estimates is not available without unreasonable effort.
Adjusted EBITDA excludes non-cash operating charges for stock-based compensation expense, impairment and restructuring charges, business transformation costs, and loss on extinguishment of debt. Business transformation costs include costs associated with professional services, employee termination and relocation, third-party merger and acquisition, integration, and other costs to augment and restructure the organization, inclusive of both outsourced and offshore resources.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding the anticipated benefits and accounting treatment of our licensing agreement and partnership with BioIntelliSense, anticipated technology improvements and expectations for growth. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled “Risk Factors” and elsewhere in our filings made with the Securities and Exchange Commission, including those on the Form 10-Q filed on August 1, 2024. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. iRhythm disclaims any obligation to update these forward-looking statements.
iRhythm Contact Information
Investor Contact
Stephanie Zhadkevich
investors@irhythmtech.com
Media Contact
Kassandra Perry
irhythm@highwirepr.com
FAQ
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