Astellas brings its first digital health product to US

Astellas is ready to launch its first digital health offering in the US, a toolkit dedicated to providing at-home monitoring for people living with heart failure.

Called Digitiva, it combines Eko Health's CORE 500 digital stethoscope, backed up by artificial intelligence algorithms to interpret readings, with a smartphone app built on Welldoc's disease management platform.

In addition, the tech platform is backed up by a clinical review team that triages patient data, looks for biomarkers specific to heart failure, and notifies the patient's treating physician when the patient may benefit from intervention. Ultimately, the aim is to prevent acute decompensation events and re-hospitalisations.

Digitiva (formerly known as Z1608) has been listed by the FDA as a Class I (minimal or low risk) Software as a Medical Device (SaMD), which means it is exempt from the usual 510(k) premarket submission review. The companies are now hoping to sell the platform to commercial health programmes in the US.

The patient monitoring platform puts heart failure patients "at the centre of their care, allowing them to take a more active role in managing their health while working in partnership with their care team," according to Astellas.

It's a good example of the trend among pharma companies to look beyond simply providing medicines and developing innovative new products that can benefit patients in other ways, which is particularly important as outcome-based contracts are on the increase. It is well documented that getting patients to engage with their disease management leads to better outcomes.

Heart failure is a prime disease to tackle in this way, not least because in the US, it contributes to more than $135 billion in total medical costs annually, primarily attributable to inpatient costs, according to Astellas figures, which estimate annual per-patient medical costs are around $87,000. Keeping patients in their own homes for as long as possible is one way to reduce those costs.

Digitiva's development started with an alliance between Astellas, Eko and Welldoc just over a year ago aimed at developing a platform for remote monitoring of physiological biomarkers associated with heart failure in patients, coupled with coaching on diet, activity, and medication adherence.

Earlier this year, Eko claimed FDA approval for an AI algorithm that can detect low ejection fraction (EF), a reduction in outflow of blood from the heart to the aorta that is a feature of around half of all heart failure cases. A decline in LVEF can be symptomless but is a sign that an intervention may be needed.

"We believe Digitiva has the potential to help patients and their physicians better manage heart failure by providing patients with a new option that facilitates disease monitoring from home, enabling physician intervention, as needed," said Richard Cassidy, head of Astellas' Rx+ Business Accelerator unit, which developed the platform along with the partner companies.

"This achievement marks a significant milestone for Astellas as we integrate innovative technology with tailored patient support," he added.