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Biozen to Present Prospective Clinical Validation Data at ACC 2026

Press Release

Issued March 24, 2026, before the BP1000 received FDA 510(k) clearance on May 11, 2026.

Oklahoma City, OK — March 24, 2026

OKLAHOMA CITY, March 24, 2026 /PRNewswire/ --

Biozen, LLC, today announced it will present prospective clinical validation data for its cuffless blood pressure technology at the American College of Cardiology (ACC) Scientific Sessions, taking place March 28–30, 2026 at the Ernest N. Morial Convention Center in New Orleans. Biozen’s moderated poster presentation is scheduled for March 30.

The presentation will feature results from a prospective study evaluating Biozen’s measurement device against the clinical gold standard, conducted in accordance with the ISO 81060-2:2018 validation protocol, the internationally recognized standard for noninvasive blood pressure device evaluation.

The study evaluated 264 participants and tested the Biozen device under prospective conditions, meaning the device and algorithms were finalized prior to the study and remained unchanged during testing.

Using proprietary pressure sensing and optical sensing in conjunction with physiologically-informed algorithms, Biozen’s ultra-compact BP1000 device, coupled with a companion app, directly measures blood pressure by occluding the artery at the fingertip.

“Blood pressure measurement hasn’t fundamentally changed in decades. We’ve built a new way to do it—one that’s grounded in physiology without the need for a cuff or calibration,” said Dikran Tourian, Chief Executive Officer of Biozen. “Presenting these results at ACC reflects the progress of our platform and the work behind it.”

“The study was designed to evaluate the device as it would be used in practice,” said Omer Inan, PhD, Chief Scientific Officer of Biozen. “Prospective evaluation under the ISO validation framework is an important milestone for demonstrating the performance of our cuffless blood pressure technology.”

The study included over-representation of participants with Fitzpatrick V & VI skin tone, and Obesity Class I & II, populations that have historically presented challenges for cuffless blood pressure monitoring systems.

Biozen’s presentation at ACC reflects continued progress toward scalable, physiology-based blood pressure measurement and monitoring technologies.

About Biozen

Biozen, LLC is a privately held digital health company headquartered in Oklahoma City, Oklahoma, with research and development in Atlanta, Georgia. The company’s cuffless blood pressure platform, protected by more than 65 granted U.S. and international patents, integrates advanced biosensors with proprietary algorithms to deliver absolute, cuffless blood pressure readings from the fingertip.

Note: The Biozen BP Sensor and BP1000 are investigational devices and are not yet cleared by the U.S. Food and Drug Administration (FDA) for commercial distribution.

For more information, visit biozen.com.

Media Contact

Ashley Wilson

press@biozen.com

+1 405-413-5201

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FDA Cleared1

  1. Biozen BP1000 has received FDA 510(k) clearance, the first cuffless blood pressure device cleared to deliver calibration-free, clinically validated spot measurement from the fingertip.

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