Hyperfine Completes Enrollment in Contrast PMR Study, Plans FDA Submission by Year-End
HYPR is trading near its 52-week low of $0.775 (5.8% above the low).
Summary
Hyperfine has completed enrollment in its Contrast PMR study, a prospective multi-center trial evaluating contrast-enhanced imaging with the Swoop portable MRI system. The study is designed to support the first expansion of the Swoop system's indications for use since its original FDA clearance, targeting visualization of brain lesions with gadolinium-based contrast agents. The company plans to submit a 510(k) application to the FDA by the end of 2026. This milestone follows recent FDA clearance of the Optive AI software update and publication of the NEURO PMR study, reinforcing the company's regulatory and clinical momentum. If cleared, contrast-enhanced imaging could broaden the Swoop system's clinical utility and tap into established reimbursement pathways, potentially accelerating adoption in outpatient and surgical settings. The next key event is the planned FDA submission by year-end, with clearance decision expected in 2027.
At the time of this announcement, HYPR was trading at $0.82 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $85.3M. The 52-week trading range was $0.78 to $2.22. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.