VoluMetrix NIVA HF Receives FDA Breakthrough Designation for Heart Failure Patients

MedTech Outlook | Tuesday, June 29, 2021

NIVA|HF is a research device designed to monitor venous waveform, a novel physiological signal in heart failure patients. NIVA|HF is VoluMetrix's first proprietary venous waveform technology. As a breakthrough device, NIVA|HF receives FDA premarket development assistance and prioritized regulatory review.

FREMONT, CA:VoluMetrix, a Nashville-based biotech company dedicated to developing a new wave of vital monitoring solutions to improve well-being, declares that its NIVAHF device has been designated a Breakthrough Device by the United States Food and Drug Administration (FDA).

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

The NIVAHF device intends to provide a proprietary NIVA Score that matches a capillary pulmonary wedge pressure, or PCWP. This clinically significant value can only be obtained by invasive heart and vasculature catheterization. NIVAHF provides a non-invasive heart failure care solution—taking it home from the hospital.

"We are thrilled that FDA has recognized NIVAHF as a Breakthrough Device with important prospective clinical applications," says 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."

NIVA technology is a significant innovation in vital monitoring technology. NIVA optimizes hemodynamic assessment in three key ways: signal capture (using a non-invasive wrist sensor), signal deconstruction (mapping individual waveform amplitudes), and signal decoding.

The venous waveform is an energy-based signal generated by the heart and respiratory activity that reflects numerous physiological conditions, including intravascular and extravascular dynamics, including pulse rate and respiration.

The Breakthrough Devices Program is a voluntary program for specific medical devices and combination products that provide more effective treatment or diagnosis of life-threatening or irreversible diseases or conditions. It is available for pairing devices and device-led products that are subject to premarket approval (PMA), premarket notification (510(k)), or De Novo classification request ("De Novo request").

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