HYPERFINE Stock Price, News & Analysis

Hyperfine (Nasdaq: HYPR) has announced its first commercial sales of the next-generation Swoop® Portable MR Imaging system, powered by Optive AI™ software. Two leading hospitals in the northeastern United States have purchased the units following recent FDA clearance, planning to deploy them in intensive care units and emergency departments.

The new Swoop® system features enhanced signal-to-noise ratio and, combined with Optive AI™ software, delivers improved image resolution, uniformity, and faster acquisition times. The system's patient-centric design makes it particularly suitable for pediatric, elderly, and anxious patients, advancing Hyperfine's mission to transform MRI accessibility.

Hyperfine (HYPR) has announced two key executive appointments to strengthen its leadership in AI-powered portable MRI technology. Rob Fasciano, PhD, joins as Chief Regulatory and Quality Officer, bringing 25 years of experience in regulatory affairs and R&D from companies like Abiomed and Johnson & Johnson. Rafael O'Halloran, PhD, becomes Vice President of Technology, with over 20 years of MRI physics expertise and recent leadership in developing Hyperfine's AI-driven image pipeline. These appointments support the commercialization of their next-generation Swoop system with Optive AI software, which recently received FDA clearance. CEO Maria Sainz emphasized that these strategic hires will help accelerate global adoption of the Swoop system and advance the company's mission in transforming brain health.

Hyperfine (HYPR) has received FDA clearance for its next-generation Swoop® portable MRI system, powered by Optive AI™ software. This breakthrough advancement represents the company's most significant technological innovation, featuring improved signal-to-noise ratio, enhanced image quality, better resolution, uniformity, and faster acquisition times. The redesigned system offers a more user and patient-friendly design, accommodating diverse patient populations including pediatric, elderly, and anxious patients. The development was accelerated through collaboration with leading portable MRI programs, including Jefferson Abington. The new system is currently being evaluated in the NEURO PMR study, with positive feedback from users and patients. This advancement aims to transform access to MRI globally and expand adoption across various care settings including critical care, emergency departments, clinics, neurology offices, and remote healthcare environments.

Hyperfine (NASDAQ: HYPR) has received FDA clearance for its Optive AI™ software, a significant upgrade for its Swoop® system - the world's first FDA-cleared AI-powered portable MRI system for brain imaging. The tenth-generation software release delivers substantial improvements in image quality through enhanced AI algorithms that optimize noise cancellation, image acquisition, reconstruction, and post-processing.

Early clinical users reported image quality approaching that of conventional 1.5 tesla MRI scanners. The company plans to roll out the software to accounts in Q3 2025. This release represents one of two major technology milestones for 2025, supporting Hyperfine's growth strategy for expansion into new hospital sites and entry into the neurology office market.

Hyperfine (NASDAQ: HYPR), known for developing the Swoop® system - the first FDA-cleared AI-powered portable magnetic resonance brain imaging system, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's management will deliver a presentation on Thursday, June 5th at 4:20pm ET and will be available for in-person meetings on Wednesday, June 4th. Interested parties can schedule one-on-one meetings through their Jefferies representative.

Hyperfine (NASDAQ: HYPR) reported its Q1 2025 financial results, showing revenues of $2.1 million, down from $3.3 million in Q1 2024. The company sold six Swoop® systems during the quarter. The net loss was $9.4 million ($0.12 per share), compared to $9.8 million ($0.14 per share) in Q1 2024. Gross margin remained stable at 41.3%. The company strengthened its financial position by raising $6 million through a registered direct offering and implementing cost-reduction measures. Management updated guidance, expecting H1 2025 revenue of $5-6 million and full-year growth of 10-20% over 2024. Notable developments include FDA submission of next-gen Swoop® technology and progress in the NEURO PMR study for neurology office applications.

Hyperfine (Nasdaq: HYPR), creator of the pioneering Swoop® system - the first FDA-cleared portable magnetic resonance brain imaging system - has scheduled its Q1 2025 financial results announcement for May 13, 2025.

Key Details:

• Event Date: Tuesday, May 13, 2025
• Conference Call Time: 1:30 PM Pacific / 4:30 PM Eastern
• Access: Live audio webcast available through Hyperfine's investor relations website
• Registration: Participants should register at least 15 minutes before the call

The webcast recording will be archived and accessible through the company's investor portal at https://investors.hyperfine.io/

Hyperfine (NASDAQ: HYPR) has initiated the NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study, enrolling initial patients to evaluate their AI-powered portable MRI system in neurology offices. This multi-center study compares their Swoop® system, first FDA-cleared in 2021, with conventional high-field MRI systems.

The study, conducted at the DENT Neurologic Institute and Texas Neurology, targets 100 patients and aims to conclude by year-end. It will assess pathology findings, clinical utility, and patient experience. The portable system offers significant advantages, requiring no costly siting, helium, or specialized MRI technologists.

Notably, starting November 2024, IAC Accredited medical offices using portable MRI systems will qualify for Centers for Medicare and Medicaid Services (CMS) reimbursement, potentially expanding accessibility in underserved, rural, and community centers.

Hyperfine (HYPR) reported Q4 2024 financial results, with revenues of $2.32 million, down from $2.69 million in Q4 2023. The company sold 9 Swoop® systems in Q4 2024 versus 7 in Q4 2023.

Full year 2024 revenues increased 17% to $12.89 million, with 48 Swoop® systems sold compared to 37 in 2023. Gross margin improved to 46% from 43%. Net loss for 2024 was $40.72 million ($0.56 per share), improved from $44.24 million ($0.62 per share) in 2023.

The company strengthened its financial position through a $6.0 million registered direct offering, extending cash runway through 2026. For 2025, management projects revenue growth of 20-30% and reduced cash burn of $25-27 million, a 32% decline from 2024.