Signant Health and Lothar Medical Sign Letter of Intent to Commercialize ALDS PRO for Clinical Trials

Collaboration creates a path to combine Signant's market-leading eCOA and digital endpoint capabilities with Lothar Medical's three-in-one ALDS PRO respiratory assessment system

PHILADELPHIA, and WÜRZBURG, Germany, Sept. 5, 2026 /PRNewswire/ -- Signant Health, a leading provider of evidence generation solutions for clinical trials, and Lothar Medical today announced that they have signed a letter of intent outlining a planned strategic collaboration to bring Lothar Medical's next-generation pulmonary function technology to the global clinical trial market.

The companies are discussing plans to develop an integrated clinical trial offering that combines Signant's electronic clinical outcome assessment (eCOA) solutions, including TrialMax®, with Lothar Medical's ALDS PRO, an all-in-one respiratory assessment system. The planned offering would help sponsors connect patient-reported symptoms and daily functioning with objective measures of pulmonary function and airway inflammation, providing a more complete view of treatment effects in respiratory studies.

ALDS PRO combines three essential respiratory assessments -- spirometry, airway oscillometry, and fractional exhaled nitric oxide (FeNO) --in one portable, guided system. By replacing multiple devices and disconnected assessment workflows with a single solution, the combined technologies will simplify equipment management and training for sites, promote more consistent data collection across study locations, and create a more straightforward assessment experience for patients.

Oscillometry is increasingly used alongside spirometry and FeNO in clinical trials to capture airway mechanics during normal tidal breathing. FeNO provides an objective measure associated with airway inflammation. Bringing these complementary assessments together will help sites collect broader respiratory evidence with less workflow fragmentation and operational challenges.

As part of the planned commercialization framework, the companies intend Signant to serve as the exclusive provider of ALDS PRO for drug trial applications. Signant and Lothar Medical will work together on the scientific, technical, operational, and commercial activities required to prepare the solution for use by study sponsors and clinical research sites.

The collaboration supports Signant's Sensor-Enhanced eCOA (SEE) strategy, which brings together patient-reported outcomes and sensor-generated evidence through a unified scientific, operational, and technology approach. Signant's acquisition of Ametris, formerly ActiGraph, combined its eCOA capabilities with validated wearable-derived digital outcome measures, creating a platform designed to connect what patients report with continuous, objective measures of how they move, sleep, and function.

"Respiratory development programs increasingly need evidence that reflects both the patient's real life experience and the underlying physiology of disease," said Roger Smith, chief executive officer of Signant Health. "Our planned collaboration with Lothar Medical creates a compelling path to bring its innovative pulmonary function technology to clinical research. By combining ALDS PRO with TrialMax and Ametris, we intend to give sponsors an integrated and more accurate way to capture patient-reported, respiratory, and movement-based evidence while designing an experience that is more manageable for sites and patients."

"ALDS PRO was created to make comprehensive pulmonary assessment more accessible and less fragmented," said David Markus Thomas, managing director of Lothar Medical. "Signant brings the eCOA leadership, digital endpoint expertise, scientific depth, and global clinical trial infrastructure needed to translate that vision into a purpose-built solution for research. This planned collaboration represents an important step toward making ALDS PRO available to sponsors and sites conducting respiratory trials around the world."

Experience ALDS PRO at ERS 2026

The companies are announcing the planned collaboration ahead of the European Respiratory Society International Congress 2026, taking place September 5–9 in Barcelona, Spain. The two companies will staff a booth at the Congress to promote the planned partnership and gain feedback from sponsors.

Congress attendees are invited to visit Lothar Medical at booth U.02B to see demonstrations of:

• Lothar Medical ALDS PRO, which combines forced spirometry, airway oscillometry, and FeNO in one portable system.
• Ametris ActiGraph LEAP®, a medical-grade multisensor watch that supports the collection of movement-based digital endpoints and continuous measures of activity, sleep, and mobility.

The demonstrations will illustrate the companies' shared vision for connecting pulmonary assessments, patient-reported outcomes, and movement-based digital measures to build a more comprehensive picture of patient health in respiratory clinical trials. Demonstrations are for showcasing device functionality and do not indicate current commercial availability of an integrated Signant–Lothar solution.

To learn more about Signant's Sensor-Enhanced eCOA strategy, visit discover.signanthealth.com/sensor-enhanced-ecoa.

About Signant Health

Signant Health is the evidence generation company, leveraging software, deep therapeutic and scientific knowledge, and operational expertise to deliver quality evidence across traditional, virtual, and hybrid trial models. For over 25 years, 600+ sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant's comprehensive eClinical solutions. Our clinical outcome assessments (eCOA, clinician ratings, cognitive testing) and wearable digital health technologies powered by Ametris provide the industry's most comprehensive evidence generation capabilities, alongside EDC, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.

About Lothar Medical

Lothar Medical develops respiratory diagnostic technologies designed to make lung assessment faster, more comprehensive, and easier to perform. Its portable ALDS platform combines respiratory measurements with cloud-based analysis to support efficient, multidimensional lung-function assessment. ALDS PRO integrates airway oscillometry, forced spirometry, and FeNO measurement in a single system. Learn more at lothar-medical.com.

SOURCE Signant Health