Findings Part of Five-Year Research Collaboration Between Valo and FDA Developed on Valo’s Biowire Platform
Valo Health, Inc (“Valo”) shared the initial results of a collaborative study with the U.S. Food and Drug Administration (FDA), demonstrating the potential of Valo’s Biowire platform to predict clinical efficacy of Cardiac Contractility Modulation devices to treat heart failure. The study, which is part of a five-year research collaboration between Valo and the FDA was published by the research team in a recent issue of Frontiers in Physiology.
The FDA is working to understand how Valo’s Biowire platform could be leveraged to evaluate current and future Cardiac Contractility Modulation (CCM) medical devices for the treatment of heart failure patients. The Biowire platform offers an attractive alternative particularly to animal testing by recreating functional adult human heart muscle in vitro, leveraging advances in stem cell technology and tissue engineering. At Valo, these in vitro human tissues are currently being used to accelerate drug discovery efforts.
“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,” said Michael P. Graziano, Head of Discovery and Translational Biology at Valo. “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,” added Graziano.
While previous studies have provided important insights into the understanding of CCM, a major hindrance to the detailed study has been the lack of appropriate in vitro human cardiac models. Lack of human nonclinical models to evaluate cardiac medical device safety and effectiveness currently hinders the regulatory review process and produces a significant burden on animal models. Valo’s Biowire platform offers an in vitro model that recapitulates clinical CCM response and may provide mechanistic insights that make it possible to predict which parameters and patient populations will respond to CCM therapy.
In the research paper, which was featured in Frontiers in Physiology, the data show that applying CCM pulses to 3D Biowire tissues results in a robust increase in cardiac contractility, mirroring the effect seen clinically in heart failure patients. Conversely, applying the same pulses to the same cardiac cells cultured in 2D on traditional hard substrates, no change in contractility was observed. Valo’s functionally mature cardiac tissues provide a physiologically relevant response to the CCM stimulation ranges being used in clinical protocols. The data confirm that 3D models are ideal surrogates when human testing is not possible and animal models are insufficient. This novel in vitro human model opens the door to investigating the mechanism and provides the ability to validate the safety parameters of CCM therapy pre-clinically.
This project provides additional data to support the evaluation of in vitro tools that can potentially be used to bring safe and effective new medical devices to patients faster. and may be used to inform the development of standards and FDA guidance.
About Valo Health
Valo Health, Inc (“Valo”) is a technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence driven computation. As a digitally native company, Valo aims to fully integrate human-centric data across the entire drug development life cycle into a single unified architecture, thereby accelerating the discovery and development of life-changing drugs while simultaneously reducing costs, time, and failure rates. The company’s Opal Computational Platform™ is an integrated set of capabilities designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs across cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, New York, NY, and San Francisco, CA. To learn more, visit www.valohealth.com.
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