Melbourne-based ESN Cleer is set to deliver a major medical breakthrough in the next 12 months as it releases the world’s first early risk detection screening for heart disease.
The medtech startup has developed a simple saliva test that can be used by GPs to detect early risk for developing heart failure, which kills 10 million people annually.
ESN Cleer has raised $2.5 million and is in the final stages of commercialising the product ahead of a global roll-out of the low-cost, non-invasive saliva test that has a 95% accuracy rate.
The company has opened a new $2.4 million raise to launch its first product, with expressions of interest currently open via the equity crowdfunding platform Birchal.
CEO Leo de Bruin said the company is also in talks with leading global pharmaceutical companies to bring the test to market.
Around one-in-eight deaths are attributed to the disease. The economic cost is estimated at more than US$100 billion annually.
Pharma giant AstraZeneca is among those following ESN Cleer’s progress. The company’s senior director of global commercial digital and innovation, Olivier Delannoy, said heart failure affects 64 million people globally.
“Digital solutions such as the one being developed by ESN Cleer have the potential to help healthcare systems fighting heart failure and its associated burden by providing affordable and scalable early diagnostic tools,” Delannoy says.
Leo de Bruin says heart disease is a silent killer that people don’t know they have it until it’s too late.
“So many people around the world, myself included, have had a loved one yanked from their family from undetected heart disease,” he said.
“ESN Cleer’s technology can detect such early risk of heart failure simply and allow lifestyle and drug treatments that can likely slow and even reverse the progression of heart disease failure and improve survival rates substantially.”
He said the company’s goal is to lower hospital admissions and the incidence of fatal heart failure by identifying high-risk patients early.
“We’ve built this technology to save lives, and it’s a true innovation with enormous global impact,” de Bruin said.
“Tragically, most cases of heart failure aren’t detected until symptoms appear, and it’s often too late, because the damage done can’t be reversed. Current testing for heart disease occurs in hospital at a late stage when symptoms are prevalent at a high cost with many barriers to conduct the test.”
The ESN Cleer test also has the potential to help deal with the ongoing consequences of Covid-19, which include heart disease. Heart disease patients who contract Covid-19 are at an increased risk of dying from the disease.
Heart disease researcher and cardiologist Prof. Andrew Coats AO is a medical advisor to ESN Cleer and chairs the company’s board.
“There remains a huge need for a reliable test that picks up the risk of heart failure even before it starts. That is what so attracted me to the potential of ESN Cleer. The more I saw, the more I liked,” Coats said.
“The tragedy remains, however, that we can only offer these treatments when someone is diagnosed with heart failure that is usually only after a life threatening emergency hospitalisation which sadly means many patients do not survive.”
ESN Cleer is aiming to start a clinical study in the next few months for the test-kit and is seeking FDA, CE, and TGA approval by mid-2021.