HYPERFINE Stock Price, News & Analysis

Hyperfine, Inc. (HYPR) reported record quarterly revenue of $3.63 million in Q2 2024, up 7.4% year-over-year. The company achieved a 50% gross margin and sold 13 commercial Swoop® systems. Hyperfine raised its FY 2024 revenue guidance to $13-16 million, reflecting 31% growth at the midpoint. Key achievements include FDA clearance of 9th generation AI-powered brain imaging software and initiation of the CARE PMR study for Alzheimer's patients. The company expanded internationally, appointing distributors in 12 EU markets and India. Despite progress, Hyperfine reported a net loss of $10.16 million for Q2 2024, slightly improved from $10.64 million in Q2 2023.

Hyperfine (Nasdaq: HYPR) presented initial data from observational clinical studies evaluating the use of its Swoop® Portable MR Imaging® system for Alzheimer's patients at the 2024 Alzheimer's Association International Conference (AAIC). The CARE PMR study, involving multiple sites, assesses the clinical utility of Swoop® images in detecting amyloid-related imaging abnormalities (ARIA) in patients receiving amyloid-targeting therapy.

Key findings include:

• Evidence of ARIA-E detection in one patient using low-field strength imaging
• Strong agreement between low-field and high-field MR images in brain morphometry evaluation
• Potential for portable MRI to transform Alzheimer's disease management across various care settings

Hyperfine (Nasdaq: HYPR) has received FDA clearance for its ninth-generation AI-powered Swoop® system software, significantly reducing scan times for brain imaging without compromising image quality. This advancement positions Hyperfine as a leader in AI-powered health technology, potentially speeding up diagnoses in acute care settings, particularly for time-sensitive conditions like stroke. The software update may also help mitigate the impact of patient motion on image quality.

Professor Adnan Siddiqui from the University of Buffalo highlighted the importance of this development for stroke diagnosis workflows. Hyperfine's commitment to AI innovation is evident in its leading position on the FDA's AI/ML-Enabled Medical Devices list. Tom Teisseyre, Chief Operating Officer at Hyperfine, emphasized the company's focus on balancing speed and image quality to inform better patient care decisions in acute settings.

Hyperfine (Nasdaq: HYPR) highlights results from a multi-site study demonstrating the value of its Swoop® Portable MR Imaging® System in acute stroke diagnosis. The study, to be published in the August 2024 issue of Annals of Neurology, shows promising results for using Swoop® system images to assess stroke patients and guide critical treatment decisions. The study included 71 patients and was conducted by teams from Massachusetts General Hospital and the University at Buffalo.

This publication marks the first to include a subset of data from the ACTION PMR stroke study, which has already enrolled over 100 patients at four institutions. The study aims to compare stroke detection capabilities between ultra-low-field MRI, conventional high-field MRI, and CT. A workflow phase evaluating the Swoop® system's ease of access and versatility in emergency departments and stroke centers is set to begin later this year.

Hyperfine is set to announce its second-quarter 2024 financial results on August 8, 2024. The company, known for its FDA-cleared portable MR brain imaging system, the Swoop system, will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET. The call will be accessible via a live audio webcast on the Investors page of Hyperfine's corporate website. Participants are encouraged to register at least 15 minutes early.

Hyperfine (Nasdaq: HYPR), a leading health technology company, announced new distribution partnerships in Germany, Austria, Switzerland, and Nordic markets for its FDA-cleared portable MR brain imaging system, the Swoop®. This strategic move expands Hyperfine's reach to twelve European countries, complementing previous agreements in France, the UK, and Italy. The Swoop® system, known for its affordability, accessibility, and high performance, aims to enhance brain imaging services globally. Hyperfine's strong track record in securing international approvals supports its commercial growth, with plans for further expansion into Asian markets, including India.

Hyperfine (Nasdaq: HYPR) has announced the acceptance of two presentations on the clinical utility of their portable ultra-low-field MRI system, Swoop®, for Alzheimer's disease monitoring at the 2024 Alzheimer’s Association International Conference, from July 28 to August 1 in Philadelphia. These presentations, prepared by clinicians from Washington University, Massachusetts General Hospital, and Yale University, will focus on the use of the Swoop® system for detecting and monitoring treatment efficacy in Alzheimer's patients. Hyperfine aims to make brain imaging more accessible and affordable, enhancing care in diverse settings. The company is also conducting the CARE PMR study to evaluate the system's utility in detecting amyloid-related imaging abnormalities (ARIA) in patients undergoing amyloid-targeting therapy.

Hyperfine (Nasdaq: HYPR) will host an analyst and investor education webcast on June 25, 2024, at 2:00 PM ET, focusing on advancements in ultra-low-field (ULF) MR imaging.

Led by Dr. Edmond Knopp, VP of Medical Affairs, the event features key opinion leaders (KOLs) discussing the Swoop® portable MR imaging system's application in critical care, stroke, and dementia, including Alzheimer's workflows.

Guest speakers include Dr. Jamal Derakhshan from Jefferson Abington Hospital, Dr. W. Taylor Kimberly from Mass General Hospital, and Dr. Cyrus A. Raji from Barnes Jewish Hospital. The webcast will end with an interactive Q&A session. The live audio and an archive of the webcast will be accessible on Hyperfine's investor relations page.

Hyperfine (Nasdaq: HYPR) is expanding its global reach by partnering with Radiosurgery Global to distribute its portable MR imaging system, Swoop®, in India. This strategic move addresses India's significant shortage of MRI scanners, with fewer than 5,000 units for over 1.4 billion people. The Swoop® system is designed to enhance diagnostic capabilities, particularly in underserved critical care and emergency settings. Hyperfine also plans future expansions into Malaysia, Indonesia, and Singapore. The company’s expansion is bolstered by recent certifications in the EU and UK and aims for regulatory approval in India through CDSCO. This collaboration signifies a major step toward improving healthcare accessibility and patient outcomes across Asia.