Eko Devices Inc. said Tuesday that it is collaborating with British pharma giant Astrazeneca plc to speed the development of digital health tools to improve early detection of cardiovascular diseases, including heart failure. The partnership could lead to more personalized care for heart failure patients, improving long-term outcomes.

Through the partnership, the companies will explore ways to accelerate the development of Eko algorithms, enhance clinical trials of investigational drug products using Eko technology and expand the portfolio of heart failure detection solutions.

“Eko was founded to provide a better way to understand our heart and lung health and to improve cardiopulmonary care for patients through digital technology and novel algorithms,” said Connor Landgraf, Eko’s CEO and co-founder. The new collaboration “will allow us to expand the capability of our technology, generate real-world data and explore disease management solutions while leveraging Astazeneca’s global expertise and existing relationships across the treatment continuum for heart failure.”

Breakthrough status

The Oakland, Calif.-based startup won a breakthrough device designation from the U.S. FDA in December 2019 for its artificial intelligence-powered electrocardiogram (ECG) algorithm that doctors could use to screen patients for heart failure during routine physical exams.

Eko’s algorithm analyzes 15 seconds of ECG data collected from the company’s Duo digital stethoscope during an exam in a doctor’s office and, within seconds, displays a binary prediction of the patient’s likelihood of left ventricular ejection factor (LVEF) less than or equal to 40% on a smartphone or other device. LVEF is an indicator that the heart’s pumping mechanism is underperforming and not enough blood is leaving the heart each time it contracts.

In May, the FDA granted Eko emergency use authorization to use the ECG algorithm for purposes of assessing LVEF as an aid in screening for potential cardiac complications related to COVID-19 or underlying heart issues that could affect patient management. Chief Medical Officer Adam Saltman said the company is still in the early stages of identifying clinical partners to use the low LVEF detection algorithm for emergency use care.

Enthusiasm for digital health

Working with stakeholders across the health care ecosystem is key to Eko’s goal to meaningfully move the needle on cardiovascular disease, he told BioWorld. “What drew us to a collaboration around heart failure with Astrazeneca was its global expertise, existing relationships across the treatment continuum, enthusiasm for digital technology and commitment to improve the way heart failure is screened, diagnosed and managed.”

Financial terms of the partnership were not disclosed.

Heart failure affects about 6.5 million adults in the U.S. and was a factor in one in every eight deaths in 2017, according to the CDC. In 2012, the combined costs of health services, medication and lost workdays associated with heart failure exceeded $30 billion. Worldwide, roughly 64 million people suffer from heart failure.

“There are millions of people living with or at risk for heart failure,” said Joris Silon, senior vice president of cardiovascular renal and metabolism at the Cambridge, U.K.-based drug company. “Astrazeneca’s collaboration with Eko will tap into cutting-edge digital health technologies that could allow us to harness the potential to improve access to individualized care and generate better patient outcomes.”

Saltman said the collaboration is initially focused on heart failure due to the huge cost burden combined with often vague symptoms and limited access to echocardiography and other diagnostics. “New technologies are greatly needed to bring higher speed and accuracy to diagnosis, slow disease progression and reduce hospital readmission rates.”

Progress on other fronts

This has been a busy year for seven-year-old Eko. In January, the company got the FDA’s nod for two algorithms to detect atrial fibrillation and heart murmur using the Duo stethoscope. Then in May, in addition to the EUA for the ECG algorithm, the company launched Eko Telehealth – billed as the first AI-driven telehealth platform for virtual cardiac and pulmonary monitoring.

And last month, the company announced a $2.7 million Small Business Innovation Research grant from the National Institutes of Health. The award will support ongoing collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute to validate algorithms that assist providers in screening for pathologic heart murmurs and valvular heart disease during doctor office visits.

The privately held company has raised a total of about $30.5 million, including the NIH grant. Its financial backers include Artis Ventures, Ntt Venture Capital, Digitx Ventures, Mayo Clinic and Sutter Health.

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