Shares in Echo IQ Ltd (ASX: EIQ) have surged more than 13% in early trade after the company announced a revised deal with the Mayo Clinic to sell and distribute its heart failure detection software in the US.
Echo IQ said in a statement to the ASX on Tuesday that its EchoSolv HF technology would be deployed via the Mayo Clinic Platform â Solutions Studio Program, enabling Mayo Hospitals and 80 external partner hospitals to participate.
Regulatory hurdles remain
The EchoSolv software is currently going through the Food & Drug Administration (FDA) clearance process, after the company lodged a market clearance application for the technology in December.
Echo IQ said further re the agreement.
The expanded agreement follows a validation study conducted through the Mayo Clinic Platform validation program. The study met its primary endpoint, with EchoSolv HF demonstrating a sensitivity of 99.5% in identifying patients with heart failure and a specificity of 91.1% in correctly identifying patients without heart failure. These results have not been reviewed or cleared by the FDA and are subject to the FDA’s regulatory review process.
The company said it would keep shareholders advised as to the progress through the FDA clearance process.
The company said:
Clearance has the potential to unlock a significant market opportunity for Echo IQ. Heart failure represents a substantial and growing burden on the US healthcare system, with about 6.7 million Americans currently living with the condition and an estimated 2 million more patients remaining undiagnosed. Upwards of 16 million echocardiograms are performed in the US per annum, with around 8 million studies containing heart failure-relevant findings, representing approximately 50% of all echocardiographic exams.
Confident for the future
Echo IQ Chief Executive Officer Dustin Haines said the Mayo agreement was “one of the more strategically important milestones in the company’s History”.
He added:
A more equitable arrangement with one of the most respected hospital systems in the US, as we move closer to FDA clearance and commercial deployment, leaves us well positioned for the months ahead. This milestone reflects the strength of the EchoSolv HF clinical utility and the growing commercial value of the solution, while the revised agreement provides a scalable pathway to market through the Mayo Clinic Platform. This may give us access to Mayo’s hospital network and a broader ecosystem of healthcare providers seeking validated AI solutions.
Mr Haines said while the FDA application was still under review, the company remains confident in its submission.
The ASX biotech’s shares were 13.8% higher in early trade at 70 cents. The shares have more than doubled in value over the past three months.
The company was valued at $405 million at the close of trade on Monday.
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