Valo Health has published the initial findings of a joint study with the US Food and Drug Administration (FDA), which demonstrated the potential of the company’s Biowire platform in predicting clinical efficacy of cardiac contractility modulation (CCM) devices for the treatment of heart failure.
The study is part of a five-year research collaboration between the parties and its initial results were published in the recent edition of Frontiers in Physiology.
The health regulator is evaluating how the Biowire platform can be used to assess current and future CCM medical devices for heart failure patients’ treatment.
Valo Health said that the platform is an alternative, especially to animal testing by recreating functional adult human heart muscle in vitro. For this, the platform is said to utilise advances made in stem cell technology and tissue engineering.
According to the Boston-based technology company, Biowire delivers an in vitro model that recapitulates clinical CCM response. It could offer mechanistic insights that enable the prediction of which patient populations and parameters will respond to CCM therapy, said the company.
The technology firm currently uses these in vitro human tissues to expedite drug discovery efforts.
Valo Health discovery and translational biology head Michael Graziano said: “Through advances in stem cell technology and human tissue engineering Valo’s Biowire platform is currently used as a translational tool to accelerate drug discovery efforts.
“We are thrilled to extend the use of Valo’s Biowire platform through our collaboration to potentially help the FDA assess the safety and efficacy of medical devices; with the ultimate goal of helping to save lives.”
The data from the study demonstrated that delivering CCM pulses to 3D Biowire tissues causes a significant increase in cardiac contractility. The US-based technology firm said the change simulated the impact observed clinically in patients with heart failure.
Valo Health added that no change in contractility was observed when the same cardiac cells that were cultivated in 2D on conventional hard substrates were exposed to the same pulses.
The study provides data to evaluate in vitro technologies that might be used to introduce new, safe, and effective medical devices to patients. This could be applied to help define standards and FDA guidance as well, said the company.
