NuvoAir-Clinical Trials Business

What NuvoAir-Clinical Trials Business does

NuvoAir's clinical trials business operates as the decentralized clinical trials (DCT) segment within NuvoAir Medical, a virtual-first cardiopulmonary care company. It offers a location-agnostic, end-to-end digital platform for sponsors and CROs running cardiopulmonary clinical research, providing remote patient monitoring, spirometry data collection (FVC, FEV1, PEF), clinical trial endpoints, and remote assessments. The segment is accessed via a dedicated support channel ([email protected]) and is sold through partnerships with biopharmaceutical companies and contract research organizations. Sponsors gain a single integrated stack rather than cobbling together point solutions for home spirometry, patient engagement, and endpoint capture.

The underlying technology is built on three FDA- and EU-cleared components: the Air Next Spirometer (Class IIa, FDA 510(k) cleared, EU MDR certified, ISO 13485, validated against ATS/ISO standard curves), the NuvoAir Home mobile app (iOS/Android, Bluetooth-paired, ATS2019-compliant, CE-certified Class Im medical device, integrated with Apple HealthKit and Hailie asthma sensors), and a HIPAA-compliant, SOC 2 Type II certified cloud platform with AES-256 encryption at rest and TLS 1.2+ in transit. The platform also includes add-on devices such as the NuvoAir Aos pMDI inhaler sensor for adherence capture. AI is applied to voicemail triage (NLP) and predictive cardiopulmonary analytics for early exacerbation detection.

Commercially, the clinical trials business generates revenue through professional services partnerships with biopharma sponsors and CROs, and benefits from the parent company's distribution into 100+ US health plans and physician practice partnerships (Privia Medical Group - Georgia, Cary Medical Management, Dresden Pulmonology, Prescott Pulmonology, Incredible Heart) for patient recruitment. The broader NuvoAir Medical entity operates from Boston, MA (US) and Stockholm, Sweden (EU), with in-person pulmonary clinics in Tucson and Prescott, AZ, and a registered footprint in South Africa. The company was founded in Sweden in 2016, pivoted to the US market around 2020, and was named to the 2025 Inc. 5000 list of America's fastest-growing private companies.

Name

NuvoAir-Clinical Trials Business

Legal name

NUVOAIR U.S., INC.

Website

https://nuvoair.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

51–100 employees

Short description

NuvoAir's clinical trials business is the decentralized clinical trials segment of NuvoAir Medical, offering biopharmaceutical sponsors and CROs an end-to-end digital platform for remote cardiopulmonary monitoring, home spirometry, and clinical trial endpoint capture, built on its FDA-cleared Air Next device and connected mobile app stack.

Ownership category

akta.pro rank

Product category

Decentralized Clinical Trial Technology

NAICS

Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), Services-Home Health Care Services (8082)

akta.pro primary industry

Decentralized/Hybrid Trial Enablement (DCT) Platforms (HLACAOAL)

akta.pro secondary industries

Pulmonology & Sleep Medicine Telemedicine Platforms (HLALAGAF), Cardiometabolic RPM & Chronic Disease Management (diabetes, hypertension, CHF, obesity) (HLALAFAA), Decentralized & Hybrid Trial Site Services (Home Health/Nursing) (HLAGACAH), Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK), Medication Adherence & Smart Drug Delivery (Connected Inhalers, Pens, Pill Dispensers) (HLACAPAH)

Keywords

• Decentralized clinical trials
• Cardiopulmonary clinical research
• Remote spirometry monitoring
• Clinical trial endpoint data
• Home-based respiratory diagnostics

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Virtual Care Services: Subscription-based virtual-first cardiopulmonary care services delivered to patients with chronic lung and heart conditions. Includes remote monitoring, virtual consultations, and care coordination.
2. Remote Patient Monitoring (RPM) and Chronic Care Management (CCM): Billable care management services for providers including Remote Physiological Monitoring and Chronic Care Management codes, creating new revenue streams for physician practices.
3. Air Next Spirometer Device Sales: Hardware sales of Air Next spirometer devices. Device is sold directly to patients and healthcare providers with 1-year warranty.
4. Value-Based Care Contracts: Risk-sharing arrangements with health plans where reimbursement is tied to clinical outcomes and cost reduction metrics.
5. Clinical Trial Services: Partnership with biopharmaceutical companies and CROs to provide cardiopulmonary monitoring services for clinical research trials.

Pricing tiers

Go-to-market motion2 records

Distribution channels7 records

Marketing channels7 records

Core offering

NuvoAir's clinical trials business offered a location-agnostic, end-to-end digital platform for decentralized clinical trials (DCTs) in cardiopulmonary indications. The platform combines FDA 510(k)-cleared home spirometry hardware (Air Next), patient- and clinician-facing mobile applications (NuvoAir Home App, Air MD Professional Spirometry App), a HIPAA-compliant, SOC 2 Type II certified cloud backend, and an API exchange system for sponsor/CRO data integration, enabling remote spirometry endpoints, remote patient monitoring, and longitudinal respiratory data capture for biopharma and CRO trial sponsors.

Product overview

NuvoAir Clinical Trials Business operates as a virtual-first cardiopulmonary care company with a portfolio of connected medical devices, mobile applications, and clinical service offerings. The core hardware product is the Air Next Spirometer (also sold as Air Smart Spirometer), an FDA 510k-cleared and CE-certified home spirometer that pairs via Bluetooth with the NuvoAir Home App (patient-facing) and Air MD Professional App (clinician-facing). The company also offers the NuvoAir Cough App for extended respiratory monitoring, and add-on sensors including the NuvoAir Aos pMDI inhaler sensor and Hailie® asthma sensor integration. On the services side, NuvoAir provides Remote Patient Monitoring (RPM), Chronic Care Management (CCM), and a full practice management platform for cardiologists and pulmonologists. The ecosystem is unified through NuvoAir's API exchange system and Apple HealthKit integration, enabling spirometry data (FVC, FEV1, PEF) to flow between the patient app, clinical dashboard, and Apple Health.

Differentiator

Problem solved

Functional benefit

Products and services

• Air Next Spirometer FDA 510(k)-cleared and CE-certified Class IIa medical device that measures FEV1, FVC, and PEF via Bluetooth-connected spirometry testing for home use by patients and trial participants; uses disposable single-use turbines, requires no sterilization or calibration, and is validated against ATS/ISO standard curves. Registered/cleared for sale in the United States, European Union, and South Africa, and may be legally distributed for use in clinical research trials outside these jurisdictions.
• NuvoAir Home App Patient-facing mobile app (iOS/Android) that pairs with the Air Next Spirometer via Bluetooth to perform at-home lung function tests; provides personal insights on lung health trends, medication and symptom tracking, activity monitoring, air quality data, and automatic data sharing with the care team and trial sponsors. Supports the ATS2019 Spirometry Standard and Apple HealthKit integration.
• Air MD Professional Spirometry App Professional-grade spirometry application for healthcare providers and clinical trial staff that conducts spirometry sessions with trial participants using the Air Next Spirometer, supports multiple patient profiles under a single account, and provides session grading.
• NuvoAir Cough App Mobile application that captures cough-related health data for respiratory monitoring beyond spirometry, usable as an additional endpoint or symptom channel in clinical research.
• NuvoAir Clinical Trials Platform (API Exchange System) Location-agnostic, end-to-end digital platform for decentralized clinical trials that combines remote patient monitoring, a cloud-native HIPAA/SOC 2 Type II infrastructure, an integrated clinician dashboard, and a data exchange API for sharing spirometry and clinical data with biopharmaceutical sponsors, CROs, physicians, hospitals, and insurers. With prior consent, the platform can receive data from partner systems or share trial data with them.

Quantifiable outcome

• 31% reduction in all-cause hospitalizations
• +6 more outcomes

Named customers12 records

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability5 records

Feature4 records

Partnerships

Six partnerships are on record, tiered core.

• NuvoAir Medical TucsoncoreStrategic or Co-development Partner · 1 February 2025In-person pulmonary clinic opened in Tucson, AZ to continue care established by Dignity Health Yavapai Regional Medical Group.
• Incredible HeartcoreStrategic or Co-development PartnerPartnership to provide comprehensive cardiopulmonary care services, combining cardiovascular and respiratory care coordination.
• Prescott PulmonologycoreStrategic or Co-development PartnerContinued care partnership to maintain patient access to pulmonary specialists in Prescott area, transitioning patients from Dignity Health Yavapai Regional Medical Group.
• Dresden PulmonologycoreStrategic or Co-development PartnerPartnership to elevate respiratory care in rural Tennessee, bringing virtual-first pulmonary care to underserved areas.
• Privia Medical Group - GeorgiacoreStrategic or Co-development PartnerPartnership to transform cardiopulmonary care delivery across Georgia using NuvoAir's virtual-first care model.
• Cary Medical ManagementcoreStrategic or Co-development PartnerPartnership to bring high-quality cardiopulmonary care to rural North Carolina communities.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Signant Health: Clinical trial technology provider offering eCOA, ePRO, sensors, and patient engagement for decentralized and hybrid trials. Comparable to NuvoAir's combination of validated at-home spirometry and remote data capture for respiratory/cardiac trials.
• ObvioHealth: DCT-focused CRO running fully virtual and hybrid trials across multiple therapeutic areas including respiratory. Similar operating model and biopharma customer base to NuvoAir's clinical trials business.
• Propeller Health (ResMed): Digital respiratory health platform, now part of ResMed, offering connected inhaler sensors and analytics for asthma/COPD patients. Directly comparable to NuvoAir's inhaler adherence (Aos, Hailie integration) and pulmonary focus.
• Castor: Cloud-based EDC and DCT platform used by pharma, CROs, and academic researchers to run hybrid and decentralized trials. Overlaps with NuvoAir's DCT platform and clinical trial data exchange capabilities.
• Medable: Decentralized clinical trial (DCT) enablement platform serving biopharma and CROs with eCOA, ePRO, telehealth, and remote monitoring. Directly comparable to the NuvoAir clinical trials business in DCT technology stack and customer base.
• Science 37: DCT platform operator with a virtual site model and integrated home-based assessments for clinical research. Comparable to NuvoAir's location-agnostic, end-to-end DCT offering for biopharma.
• Wellinks: Virtual cardiopulmonary care company providing connected devices, RPM, and coaching for COPD and other chronic lung conditions. Closest competitor to NuvoAir's core virtual-first specialty care offering.

Broad incumbents

• Vivify Health: Established RPM and connected care platform used by health plans and providers across multiple conditions. Broader incumbent with overlapping RPM capabilities to NuvoAir's RPM service line.
• Hinge Health: Large virtual specialty care platform focused on musculoskeletal conditions, sold to employers and health plans. Comparable in go-to-market model (virtual-first specialty care with outcomes-based contracts) but in a different therapeutic area.

Emerging players

• Eko Health: Maker of FDA-cleared connected stethoscopes and cardiopulmonary digital diagnostic devices with AI analytics. Comparable to NuvoAir's combination of FDA-cleared hardware, AI-driven cardiopulmonary analytics, and clinical workflow integration.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/nuvoair

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NuvoAir-Clinical Trials Business