COPD: A summary on devices and innovations in the area

A few developments in the COPD segment in April caught my attention:?

• An Australian smart inhaler by Adherium has been cleared by the FDA for use with AstraZeneca’s Airsupra and Breztri inhalers

The Hailie Smartinhaler device helps patients track their inhaler usage, and it is now approved for use with all triple-therapy inhalers in the US market (like GSK, Boehringer Ingelheim, and Teva). Adherium also sells the device directly to patients with asthma and COPD under a 510(k) over-the-counter clearance.

• In Ireland, The Midlands Regional Hospital Tullamore introduced the COPD virtual ward. Through this user-friendly application, patients can report daily symptoms, and are equipped with a pulse oximeter to monitor vital health metrics including oxygen levels and heart rate on a daily basis. This data is then transmitted directly to the healthcare professionals' platform. Any deviations from target levels or concerning trends, trigger instant alerts, prompting timely intervention and personalised care plans to address emerging issues before they escalate.
• A pilot remote monitoring & health coaching program, Living Well with COPD, was launched in Bristol, North Somerset and South Gloucestershire, to support people with COPD.
• Denmark extended their national remote monitoring scheme to everyone with severe COPD. The telemedicine solution was launched in November 2023 and is expected to be fully rolled out during 2024. GPs must refer patients to participate in telemedicine follow-up through a tablet continuous measurement device, reviewed later by a nurse. If there are signs of worsening COPD, the nurse contacts the patient to investigate further.?

Remote monitoring is crucial as the current treatment approaches to COPD are limited to symptoms management and prevention of exacerbations. See below for a quick summary of what else is going on in the COPD area.

A quick recap on COPD

Chronic obstructive pulmonary disease, or COPD, refers to a group of diseases that cause airflow blockage and breathing-related problems, such as emphysema and chronic bronchitis.?COPD is the 3d leading cause of death worldwide

It's primarily caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke. People with?COPD?are at increased risk of developing heart disease, lung cancer and a variety of other conditions. The disease burden on both patients and healthcare systems is high because of required regular hospital visits and emergency situations. In the UK, COPD exacerbations are the 2d most common cause of emergency admissions, accounting for 1 in 8 UK hospital admissions.

There is currently no cure for COPD and the treatments are focused on symptoms’ alleviation: inhaled medicines against breathing difficulties, steroids and antibiotics for inflammation and infections, an endobronchial valve implantation to improve lung function.

An immunology drug Dupixent by Regeneron and Sanofi?(FDA priority review expected by June 2024) could be the 1st biological treatment and a new approach in more than a decade.?

Similarly, ensifentrine by Verona Pharma is awaiting FDA review as a maintenance treatment?for COPD with the same due date, June 2024.

In addition, US Aer Therapeutics, Inc. raised $36M for their novel inhaled mucolytic in 2023, that addresses the airway obstruction caused by mucus plugs. The drug is undergoing phase 1 safety trials.

Devices and digital solutions

2024 has been rich in COPD-related device approvals so far. The first OTC fingertip pulse oximeter for home use was cleared by FDA in Jan 2024. The same month, NuvoAir Medical was granted 510(k) clearance for their spirometer: the device allows patients to conduct comprehensive lung function tests at home.

2023 saw several COPD-related startup rounds. The UK TidalSense raised $9.3 million for a spirometer that detects changes in lung function sensitively and enables quicker, more accurate and automated diagnosis of COPD. The Dutch RespiQ secured €4M development and miniaturisation of its breath diagnostics technology, enhancing non-invasive remote patient monitoring.?

As far as reimbursement, in Feb 2023, Germany started reimbursing the first and only so far COPD-related app, Kaia Health , through DIGA . Kaia Health offers a pulmonary rehabilitation program to improve physical performance and quality of life. Starting 2020 , Kaia Health has been collaborating with Chiesi Group to develop and roll out the COPD DTx.

A couple of relevant studies from 2023 as well:?

• admissions and hospital bed days during the 83-patient study at NHS Greater Glasgow and Clyde were both reduced by 50% for high-risk COPD patients using a digital support service by Lenus Health (the patients were able to input data about their symptoms and message clinicians through the app & access self-management advice).
• US-based Samay that measures multiple respiratory functions such as air trapping, combined with an AI algorithm in the app, reported 90% accuracy in COPD detection in the 110-patient trial. Air trapping is an important COPD biomarker: it occurs when air does not leave the lung creating resonance changes in the lung.

At the same time, in 2023 Israel-based?RespirAI Medical entered into a collaboration with Mayo Clinic to develop a wearable AI-based home platform for monitoring and rehabilitation process of COPD patients who have undergone the Zephyr Valve procedure.

In Italy through VITA Accelerator ator we have supported BPCOmedia - a class IIa medical device for remote monitoring and prevention of exacerbations in COPD patients.?

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It seems like by now we have a pool of clinically proven COPD innovations, both as devices to measure parameters as well as apps to monitor and predict exacerbation. Those countries that will roll out the innovations at the national level will be championing COPD care.