IoT-based medical adherence is likely to become a major field, and there are already signs it is taking off in some areas, one being around inhalers for respiratory conditions. especially asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). This has attracted a cluster of start-ups, with London-based Amiko emerging as one of the most successful outside the US.
Medical non-compliance is a major cause of health problems and below par treatment outcomes. The biggest study so far has been conducted in the US by the National Institutes of Health (NIH), finding that between $100bn and $300bn of avoidable health care costs result from nonadherence in the US annually, equating to between 3% and 10% of the country’s total health care costs.
The wide span of these figures itself illustrates the scale of the problem, highlighting how until now doctors and health care agencies have had to rely almost entirely on self-reporting to determine whether patients are taking their medications correctly at the right times and doses. Respiratory diseases treated by inhalers were identified as a major area of poor compliance alongside the many conditions treated by medications taken orally.
The main issue with respiratory inhalers is not so much over acute outbreaks, particularly asthma attacks, where inhalers have to be used quickly and hopefully successfully. It is more over ongoing treatment to alleviate symptoms and manage the condition on a long-term basis. Amiko decided to focus on these three respiratory conditions which have distinct pathologies and treatment requirements, while also sharing common features given that in all cases, they cause airway obstruction.
Asthma and COPD diseases such as emphysema are both associated with inflammation, but the underlying molecular pathways are different which alters the optimum composition of the inhaled compounds. For asthma the best first-line maintenance therapy for most patients is an inhaled corticosteroid, a steroid, to reduce inflammation of the airways, while short-acting bronchodilators such as salbutamol are inhaled to treat acute symptoms as required. Then if the steroid does not control the condition, long-acting bronchodilators called beta2-agonists may be inhaled instead in the hope of reducing prevailing inflammation levels gradually.
For COPD, the opposite approach is taken with bronchodilators being the first-line maintenance treatment with inhaled corticosteroids reserved in combination with long-acting beta2-agonist for severe cases.
CF is totally different in that the condition results in excessive mucus production rather than casing inflammation directly and this attracts bacterial infections. Inhalers therefore contain antibiotic powder to treat the infections locally in the airways without causing the complications associated with long lasting systemic consumption of such drugs, such as impaired absorption of nutrients and skin conditions. Even local long-term use can give rise to infection by resistant strains of bacteria and to counter this CF sufferers are often prescribed at least two types of antibiotic to be inhaled during alternate weeks. This then requires careful compliance and is one reason firms like Amiko have been targeting CF, even though asthma and COPD are more common.
Start-ups in respiratory compliance do not manufacture the inhalers themselves and so must partner with established players, in Amiko’s case including Sanner of Germany, Teva Pharmaceuticals based in Israel and GlaxoSmithKline. Amiko provides three components, firstly the connected unit for integration with the inhaler called Respiro, which measures compliance, lung function, and disease progression. Then a patient smartphone app communicates with the inhaler via Bluetooth, offering coaching and support based on data analysis. Finally, a provider-facing app can be used for remote monitoring or tracking, connecting with the patient’s mobile via cellular.
However, the latter is not always used, which reflects the huge logistics and cost issue associated with connected medical appliance. For health agencies stretched to the limit by ever growing demands from ageing populations, it is hard to invest in the resources needed to accommodate new procedures within their first and second-line healthcare. This is however presenting an opportunity for firms like Amiko, to make compliance enforcement as transparent and straightforward as possible.
The connected inhaler space has emerged over the last decade with the US almost inevitably forging ahead. So far Amiko has declined to enter the US market preferring to establish a firm base in Europe first, where competition is less intense. The big names among respiratory inhaler compliance start-ups are in the US, led by Propeller Health, which has raised $69.9mn so far. There has also been some consolidation with pediatric inhaler company Gecko Health Innovations acquired by Teva Pharmaceuticals in 2015 and smart inhaler company Inspiro Medical bought by Opko in 2014.
Amiko was only founded in 2014 and has raised undisclosed sums in two rounds, currently turning over around $3.5mn a year. It received a boost in December 2017 by winning first prize in the IBM Watson AI XPRIZE’s annual Milestone Awards, for its algorithms determining the optimal treatment regime for patients on the basis of feedback, as well as predicting likelihood of acute symptoms arising.