Deep-tech product development company, Hydrix (ASX: HYD), has signed a contract with Picard Medical subsidiary SynCardia Systems to commence development on SynCardia’s next-generation Emperor fully-implantable total artificial heart technology.
The $2.5 million deal was secured through Hydrix's wholly-owned subsidiary, Hydrix Services, and represents an initial project phase within a multi-stage and multi-year development program comprising defined engineering, verification, and regulatory milestones.
Advancement between stages is subject to technical progress and performance, safety validation, regulatory considerations and alignment, as well as SynCardia’s funding availability.
Global selection process
Hydrix was subject to a competitive global selection process with SynCardia which highlighted its experience in mechanical circulatory support systems and highly-regulated medical device development and a demonstrated track record in advancing complex, cardiovascular technologies.
The collaboration will encompass a ground-up system architecture, incorporating the company’s skills in electromechanical actuation, embedded software, energy management and safety-critical redundancy.
Hydrix will be tasked with developing Emperor’s controller, alongside various sub-system technologies using highly-specialised electronics, software, mechanical, usability and safety-critical design engineering disciplines.
Critical development
Hydrix executive chairman Gavin Coote said the contract strengthened the company’s position as a global partner of choice for complex, safety-critical cardiovascular technologies.
“We are excited to commence this critical development with SynCardia, a highly-regarded global leader in advanced heart replacement technology,” he said.
“It endorses our capacity to deliver complex, safety-critical medical device development programs for leading international medical technology companies.”
He said the companies would collaborate on a shared objective of developing transformative solutions for patients with advanced heart failure.
Mirroring human heart function
Emperor has been designed to perform in a way that closely mirrors how a natural human heart works, with studies showing it can deliver stable haemodynamics (in other words, steady and controlled blood flow), physiologic pre-load sensitivity (where the pump output increases naturally as more blood enters the device) and afterload independence (consistent pumping performance even as systemic vascular resistance changes).
It is the first artificial heart approved by the U.S. Food and Drug Administration and Health Canada and remains the only commercially-available device of its kind in both regions.
With more than 2,100 implants performed to date across 27 countries, studies show that Emperor is the world’s most widely used and extensively studied artificial heart.
