HYPERFINE Stock Price, News & Analysis

Hyperfine, Inc. (Nasdaq: HYPR) reported fourth quarter and full year 2022 financial results, achieving revenue of $6.8 million for the year, up from $1.5 million in 2021. In Q4 2022, revenue was $1.424 million, compared to $0.436 million in Q4 2021. The net loss for the year was $73.164 million, or $1.04 per share, an increase from $64.851 million or $17.57 per share in the previous year. The company ended the year with $117.472 million in cash. 2023 guidance estimates revenue between $10 to $14 million with a cash burn of $40 to $45 million. Significant achievements included FDA clearances and the installation of 35 commercial systems.

Hyperfine, Inc. (Nasdaq: HYPR), creator of the first FDA-cleared portable MRI system, Swoop®, announced it will report financial results for Q4 and full year 2022 on March 21, 2023. The management will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET, accessible through their investor page. The Swoop® system, approved for brain imaging in multiple countries, aims to enhance patient care through accessible diagnostic imaging. Since its FDA clearance in 2020, it has revolutionized neuroimaging by bringing bedside MRI capabilities to clinicians, improving diagnosis where conventional MRI is not feasible.

Hyperfine, Inc. (Nasdaq: HYPR) announced FDA 510(k) clearance for an updated version of its Swoop® Portable MR Imaging® system software, enhancing clinical utility in neurocritical care. The new software improves diffusion-weighted imaging (DWI) with a 42% increase in signal-to-noise ratio, essential for diagnosing neurological conditions. This update aims to provide clearer images and better patient care in diagnosing and monitoring stroke progression. The improved software is expected to roll out to customers in March 2023.

Hyperfine, Inc. (Nasdaq: HYPR) has achieved CE Marking for its portable MRI system with AI-powered imaging software, confirming compliance with EU safety standards. This milestone allows the company to explore future commercial opportunities within the European Economic Area (EEA) while maintaining its focus on the U.S. market in 2023. Compliance with the EU's Medical Device Regulation (MDR) was essential for legal marketing in Europe, reflecting an increase in regulatory rigor. CEO Maria Sainz emphasized the achievement's significance in enhancing the company's market potential.

Hyperfine, Inc. announced FDA 510(k) clearance for the upgraded Swoop^® software, enhancing diffusion-weighted imaging (DWI) quality with improved signal-to-noise ratios.

This release also expands the system's field of view by 10% for key MRI sequences, aiding in pathology visualization. The enhancements aim to boost diagnostic confidence and support clinical decision-making.

With a total installed base of 100 Swoop^® systems globally, Hyperfine demonstrates commitment to software advancement and AI integration, focusing on accessible neuroimaging. The ongoing software updates are positioned as pivotal for commercial adoption.

Hyperfine, Inc. (Nasdaq: HYPR) announced groundbreaking data on its Swoop® portable MRI system at the 2023 International Stroke Conference. The study, conducted at Yale-New Haven Hospital, focused on stroke patient follow-ups using bedside portable magnetic resonance imaging following mechanical thrombectomy procedures. The findings suggest that low-field pMRI can assess ongoing brain injury that is typically unmonitored due to the unavailability of conventional imaging post-procedure. Hyperfine's CEO highlighted the significance of these advancements in improving patient care and diagnostics.

Hyperfine, Inc. (Nasdaq: HYPR) announced the appointment of Brett Hale as Chief Administrative Officer and Chief Financial Officer, effective February 13, 2023. Hale brings over 25 years of experience in finance, predominantly in the medical technology sector, having held CFO positions at various companies, including Bigfoot Biomedical. He succeeds Alok Gupta, who will transition out by March 31, 2023. The transition is expected to enhance Hyperfine's operational efficiencies and expand the adoption of its portable MRI system, Swoop. In connection with his hiring, Hale was granted inducement stock options to purchase 1 million shares, vesting over four years.

Hyperfine, creator of the Swoop® Point-of-Care MRI System™, recently announced the acceptance of twelve abstracts for presentation at the ISMRM and ISMRT annual meeting in Toronto from June 3–8, 2023. The research, conducted by teams from prestigious institutions like UPenn and NYU, includes advanced topics in MRI technology. The Swoop® system aims to enhance patient outcomes by providing portable, ultra-low-field brain imaging at the bedside. The ongoing research supports Hyperfine's mission to revolutionize patient care through accessible MRI technology.

Hyperfine (Nasdaq: HYPR), a leader in medical technology, announced its participation in the 5th Annual Evercore ISI HealthCONx Conference scheduled for November 30, 2022, at 9:15 AM Eastern Time. The company will present their groundbreaking Swoop®, the world’s first FDA-cleared portable MRI system, which enhances patient access to MRI diagnostics.

Interested individuals can view the live and archived webcast via the Investors section of their website.