VoluMetrix's NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA

June 15, 2021 — VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced that its NIVAHF device has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA).

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients, and represents the company's flagship application for its Non-Invasive Venous waveform Analysis (NIVA) technology. Development of NIVAHF, which is being prepared for submission for De Novo regulatory clearance, is supported by a Fast-Track grant provided by the National Institutes of Health (NIH) and LaunchTN SBIR/STTR Matching Fund Program. As part of the Breakthrough Device program, FDA will work closely with VoluMetrix to advance pre-commercial development of NIVAHF and prioritize the review of subsequent regulatory submissions.

The intended purpose of the NIVAHF device is to provide a proprietary NIVA Score that corresponds to a pulmonary capillary wedge pressure, or PCWP. Currently, this clinically important value can only be obtained through invasive catheterization of the heart and vasculature. NIVAHF provides a non-invasive solution in heart failure care — taking this from hospital to home.

"We are thrilled that FDA has recognized NIVAHF as a Breakthrough Device with important prospective clinical applications," said Kyle Hocking, Ph.D., President & CEO of VoluMetrix. "NIVAHF is the culmination of our organization's talent, intellect, passion, and hard work. It represents the first of many potential vehicles for our NIVA vital monitoring technology, and we look forward to working closely with regulators to expedite its development and regulatory review. Ultimately, our mission is to improve the care experience for as many heart failure patients as possible, as quickly as possible. This designation is a powerful milestone in that journey, and we are grateful for it."

The NIVA technology represents a major innovation in vital monitoring technology. NIVA was developed to optimize hemodynamic assessment in three key ways: signal capture (using a non-invasive wrist sensor), signal deconstruction (mapping individual amplitudes within a patient's waveform), and signal decoding.

What is the Venous Waveform?
The venous waveform is an energy-based signal generated by the heart and respiratory activity that reflects numerous physiologic conditions, including pulse rate and respiration, as well as intravascular and extravascular dynamics.

About Breakthrough Device Designation
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request ("De Novo request").

This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

For more information about this designation: https://www.fda.gov/media/108135/download

For more information: www.volumetrix.com