Hyperfine Achieves Clinical Milestone Ahead of Plan With 100th Patient Enrolled in Neurology Office Study Using the Next-Generation Swoop® System

GUILFORD, Conn.--(BUSINESS WIRE)--Aug 4, 2025--

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system— today announced the successful enrollment of 100 patients in its NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study just 16 weeks after the study initiation, announced on April 15, 2025. This milestone reflects strong clinician enthusiasm for accessible, point-of-care brain imaging and supports Hyperfine's market expansion into outpatient neurology offices.

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The NEURO PMR study, being conducted at DENT Neurologic Institute and Texas Neurology, is the first multi-center, prospective observational study comparing portable ultra-low-field MRI with conventional high-field MRI in neurology office settings. All patients enrolled in the study have been scanned on the next-generation Swoop® system powered by OptiveAI™ software, with results expected to be announced in early 2026.

Dr. Laszlo Mechtler, Chief Medical Officer at DENT Neurologic Institute and the study's Principal Investigator, stated, “The next-generation Swoop® system delivers impressive image quality with a simplified clinic workflow and comfortable patient experience. The promise of this technology is that it puts brain imaging back into the hands of neurologists—by providing an affordable, easy-to-operate portable MRI system that fits seamlessly into a clinic setting without expensive siting costs."

This milestone supports Hyperfine’s commercial launch in the neurology office market, following the successful conclusion of its office pilot program. In the pilot, early neurology practices acquired and implemented Swoop® systems in their clinic, completed IAC accreditation, and obtained reimbursement from CMS and private insurers. To drive commercial adoption, Hyperfine has also entered into a strategic partnership with NeuroNet Pro, the largest U.S. association of independent neurology practices, to bring greater awareness and practice support for their portable MRI technology.

“Neurologists typically order between 500 and 600 brain MRIs each year, yet only 5% of private neurology offices have in-house imaging," said Maria Sainz, President and CEO of Hyperfine. "Our next-generation Swoop® system delivers an exciting opportunity for independent practices—expanding access to advanced imaging, boosting clinic efficiency, and elevating the level of patient care.”

For more information about the Swoop® system and Optive AI™ software, please visit HyperfineMRI.com.

About the Swoop® AI-Powered Portable MRI (V2) System
The Swoop® Portable MR Imaging® (V2) System is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com.

The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine, Inc.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company’s business; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Hyperfine Achieves Clinical Milestone Ahead of Plan With 100th Patient Enrolled in Neurology Office Study Using the Next-Generation Swoop® System

CARACAS, Venezuela (AP) — President Donald Trump is set to meet Thursday at the White House with Venezuelan opposition leader María Corina Machado, whose political party is widely considered to have won 2024 elections rejected by then-President Nicolás Maduro before the United States captured him in an audacious military raid this month.

Less than two weeks after U.S. forces seized Maduro and his wife at a heavily guarded compound in Caracas and brought them to New York to stand trial on drug trafficking charges, Trump will host the Nobel Peace Prize laureate Machado, having already dismissed her credibility to run Venezuela and raised doubts about his stated commitment to backing democratic rule in the country.

“She’s a very nice woman,” Trump told Reuters in an interview about Machado. “I’ve seen her on television. I think we’re just going to talk basics.”

The meeting comes as Trump and his top advisers have signaled their willingness to work with acting President Delcy Rodríguez, who was Maduro’s vice president and along with others in the deposed leader's inner circle remain in charge of day-to-day governmental operations.

Rodríguez herself has adopted a less strident position toward Trump and his “America First” policies toward the Western Hemisphere, saying she plans to continue releasing prisoners detained under Maduro — a move reportedly made at the behest of the Trump administration. Venezuela released several Americans this week.

Trump, a Republican, said Wednesday that he had a “great conversation” with Rodríguez, their first since Maduro was ousted.

“We had a call, a long call. We discussed a lot of things,” Trump told reporters. “And I think we’re getting along very well with Venezuela.”

In endorsing Rodríguez, Trump has sidelined Machado, who has long been a face of resistance in Venezuela. She had sought to cultivate relationships with Trump and key advisers like Secretary of State Marco Rubio among the American right wing in a political gamble to ally herself with the U.S. government. She also intends to have a meeting in the Senate on Thursday afternoon.

Despite her alliance with Republicans, Trump was quick to snub her following Maduro’s capture. Just hours afterward, Trump said of Machado that “it would be very tough for her to be the leader. She doesn’t have the support within or the respect within the country. She’s a very nice woman, but she doesn’t have the respect.”

Machado has steered a careful course to avoid offending Trump, notably after winning last year’s Nobel Peace Prize, which Trump coveted. She has since thanked Trump and offered to share the prize with him, a move that has been rejected by the Nobel Institute.

Machado’s whereabouts have been largely unknown since she went into hiding early last year after being briefly detained in Caracas. She briefly reappeared in Oslo, Norway, in December after her daughter received the Nobel Peace Prize on her behalf.

The industrial engineer and daughter of a steel magnate began challenging the ruling party in 2004, when the nongovernmental organization she co-founded, Súmate, promoted a referendum to recall then-President Hugo Chávez. The initiative failed, and Machado and other Súmate executives were charged with conspiracy.

A year later, she drew the anger of Chávez and his allies again for traveling to Washington to meet President George W. Bush. A photo showing her shaking hands with Bush in the Oval Office lives in the collective memory. Chávez considered Bush an adversary.

Almost two decades later, she marshaled millions of Venezuelans to reject Chávez’s successor, Maduro, for another term in the 2024 election. But ruling party-loyal electoral authorities declared him the winner despite ample credible evidence to the contrary. Ensuing anti-government protests ended in a brutal crackdown by state security forces.

Janetsky reported from Mexico City. AP Diplomatic Writer Matthew Lee in Washington contributed to this report.

FILE - Opposition leader Maria Corina Machado gestures to supporters during a protest against President Nicolas Maduro the day before his inauguration for a third term, in Caracas, Venezuela, Thursday, Jan. 9, 2025. (AP Photo/Ariana Cubillos, file)