Aptatek Biosciences Announces Initial Close of Financing to Advance PheCheck™ Clinical Program

FDA Breakthrough-designated PheCheck is the first application of Aptatek’s connected HomeCheck™ platform for decentralized metabolic monitoring.

PRINCETON, N.J.--(BUSINESS WIRE)--Aptatek Biosciences, Inc., a clinical-stage diagnostics company developing connected, aptamer-enabled technologies for decentralized metabolic monitoring, today announced the initial close of its financing round, led by Canterbury Scientific Ltd. and Longview Innovation. Terms were not disclosed.

Proceeds will support the clinical evaluation and continued development of PheCheck™, the first application of Aptatek’s HomeCheck™ platform for rapid, quantitative home monitoring of phenylalanine (Phe) in blood.

PheCheck is being developed for routine at-home self-testing for people living with phenylketonuria (PKU), an inherited metabolic disorder in which uncontrolled Phe levels can have serious health consequences throughout life. PheCheck has received Breakthrough Device Designation from the U.S. Food and Drug Administration. Aptatek expects to complete its ongoing clinical study before year-end and use the resulting data to support a planned FDA regulatory submission. Additional information is available at ClinicalTrials.gov (NCT07551921).

PheCheck combines DNA aptamer-based sensing with a reusable handheld reader, single-use test cartridge and smartphone-connected application. The system is designed to capture Phe measurements over time and enable data to be securely shared with authorized care teams, supporting timelier and more informed PKU management. Aptatek has completed preclinical testing of the investigational system, including analytical evaluation against LC-MS reference testing.

“People living with PKU manage phenylalanine levels throughout their lives, yet today’s testing process can involve lengthy delays in receiving results,” said Michael Boyce-Jacino, PhD, Chief Executive Officer of Aptatek Biosciences. “This financing supports the clinical evaluation of PheCheck and our goal of generating the evidence needed for an FDA regulatory submission, while continuing to advance a connected diagnostic platform with potential applications beyond PKU.”

“Aptatek is working to move sophisticated biomarker testing closer to the patient, addressing an important need in conditions where frequent, timely measurement can improve disease management,” said Clive Seymour, Chief Executive Officer of Canterbury Scientific, a global OEM supplier of in vitro diagnostic controls. “PheCheck represents an important first application for a platform with the potential to expand home-based testing to other chronic diseases.”

“We invested in Aptatek because of the team’s technical foundation, clear patient need and the opportunity to build a broader platform for decentralized biomarker monitoring,” said Jason Smith, Managing Partner of Longview Innovation. “PheCheck provides a focused first application in PKU while establishing the device, assay and connected-data infrastructure to support additional applications over time.”

PheCheck is investigational, has not been cleared or approved by the FDA and is not commercially available.

About Aptatek Biosciences

Aptatek Biosciences, Inc. is a Columbia University spinout developing connected, aptamer-enabled diagnostic technologies for decentralized metabolic monitoring. Its lead investigational program, PheCheck, is designed for quantitative phenylalanine measurement at home for people living with PKU.

For more information, visit aptatek.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding Aptatek’s financing, clinical evaluation and development of PheCheck, anticipated study timing, future regulatory activities, potential applications of the HomeCheck platform and commercialization plans. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Aptatek undertakes no obligation to update forward-looking statements except as required by applicable law.