CardieX Ltd (ASX:CDX) subsidiary ATCOR Medical Pty Ltd has entered a co-development and commercial partnership agreement with Andon Health Co Ltd (SHE:002432), one of China’s largest manufacturers of home-use medical electronic devices.
A three-year co-development and commercialisation agreement with Andon provides for the development and commercialisation of new medical and consumer health devices for home-use based on ATCOR’s patented and global standard SphygmoCor® technology for measuring central blood pressure and arterial stiffness.
The first device under the agreement will be named ATCOR 'Pulse' and will be targeted for commercial launch in the US, Europe, Australia and China in the fourth quarter of 2021.
"Major value milestone"
CardieX CEO and managing director Craig Cooper said: “This is the most significant announcement of the company's evolution since I became CEO and represents a major value milestone for all shareholders.
“We now have the foundations of a fully developed ecosystem of home-health devices, digital health and telehealth solutions, wearable partnerships, and a remote patient monitoring platform - each of which target significant health-tech market opportunities - and each based on our patented SphygmoCor technology.
“Going forward we will continue to expand our product portfolio with new devices including new partnerships in medical and clinician based vital signs monitoring, wearables, and other health technologies."
Shares have been as much as 15% higher intra-day to 6.5 cents.
ATCOR ‘Pulse’ will be the first new medical device for ATCOR since 2012 and represents a game-changing medical technology collaboration for home-use vital signs monitoring.
This unique device will be the world’s first cloud-connected home-use BP monitor to include ATCOR’s SphygmoCor technology and Arty, ATCOR’s new cardiovascular vital signs and telehealth platform.
Commercial market opportunity
The agreement and ATCOR ‘Pulse’ device significantly expands the commercial market opportunity for CardieX into the home consumer health device market, which is estimated to be worth US$2.5 billion annually.
When paired with ATCOR’s Arty app, the device will provide full remote patient monitoring of a patient’s vital signs at home.
The remote patient monitoring market is estimated to reach US$43 billion by 2027.
At launch, the device will also be fully telehealth-enabled with video, chat, messaging, customisable screens and full vital signs sharing features between clinician and patient when paired with the company’s Arty app.
The key terms of the agreement are:
- Intellectual property ownership is explicitly retained by ATCOR as the sole and exclusive owner of all intellectual property rights related to ATCOR technology and ATCOR BPM;
- ATCOR has the sole exclusive right to distribute the product in ANY territory;
- The agreement has a term of three years and can be extended or renewed upon the written agreement of both parties;
- Terms of payment by ATCOR to Andon are generally based around milestones of the product development and FDA clearance and this will revert on completion of the FDA clearance to a per-unit payment to Andon to produce product for ATCOR’s inventory and sales distribution; and
- ATCOR will sell and supply to Andon its CBP Chip that will be used as part of the production process of the new ATCOR Pulse device.
Under the agreement, Andon will be responsible for obtaining regulatory approvals in all target markets.
Regulatory approvals will initially be required for the USA, Australia, China and Europe.
ATCOR’s SphygmoCor technology is already approved in all of those markets as is Andon’s blood pressure module which will be incorporated into ATCOR ‘Pulse’.
Upon receiving US regulatory approvals, ATCOR ‘Pulse’ will also provide access to a CPT reimbursement code through Medicare and Medicaid allowing physicians to receive reimbursement for remote patient monitoring of central blood pressure and other parameters via the new device.