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March 10, 2023

Hyperfine upgrades software as it looks ahead to next-gen hardware

PHOTO | CONTRIBUTED Hyperfine's Swoop portable MRI device can be wheeled to a patient's bedside.

With a series of recent software upgrades, Guilford-based Hyperfine is sharpening the images on its Swoop portable MRI scanner and moving toward better detection of strokes as it pursues wider commercial adoption, President and CEO Maria Sainz said in a recent interview with New Haven Biz.

“We are on a journey of continuous innovation on both the hardware and the software,” said Sainz, who has led the publicly traded company since October of last year.

Hyperfine, founded by local entrepreneur Jonathan Rothberg in 2014, has announced several software updates to Swoop in recent months, in addition to a key patent that boosted its share price by 34% in January.

Both of the recent upgrades have focused on improving one of four elements of Swoop’s bedside MRI scans – diffusion weighted imaging, Sainz said. 

“We’ve been really strong on the first three… and we wanted to take the diffusion weighted imaging – which is the critical one in stroke – up a notch in terms of quality, consistency and reliability,” Sainz said.  “I believe with this latest software we're getting there on that special sequence that is so important for stroke detection.”

The specific improvements focus on compensating for the small movements patients make during the Swoop scanning process, which takes about 20 minutes, Sainz said. 

“What is special about this software is that one of the trickier things for our technology is to correct the images for any kind of movement of the patient,” Sainz said. The newest version of the software removes distortion from small movements like breaths and improves image accuracy, she said. 

Behind the software upgrades is the technology that Hyperfine secured a patent for in January – artificial intelligence-powered software that generates better images from MRI data. The FDA approved the company’s newest AI-powered software in February. 

Now Sainz and Hyperfine’s leadership are seeking to expand adoption of Swoop by hospitals and refine the device’s ability to detect strokes and other brain injuries. (Swoop is currently in use only for brain imaging but the device’s next version will be adaptable to the entire body, Sainz said.)

“[Swoop] is currently being used in neurocritical care, we probably want to wait one or two more software upgrades to get squarely into stroke,” Sainz said.  “We have plans also to do a multicenter study to show how our device will detect stroke compared to what is the standard of care, which is CT [scans].” 

Hyperfine is also marketing its device as a lower-radiation option for uses like brain scans of children, Sainz said. Young patients with conditions like hydrocephalus often need dozens of brain scans a year, which can expose them to extensive radiation with devices like CT scanners.

“We offer a modality that doesn't expose the patients to radiation compared to CT,” Sainz said.  “Although it is not a huge market, it is very impactful. Clearly it is a modality that offers a very high level of diagnostic quality, but also with a significantly more patient-friendly and patient-safe platform.”

According to a recent article in Science, Hyperfine has sold 100 Swoop scanners since its approval by the FDA in 2020, at about $250,000 per device. The company is marketing Swoop as a quick and convenient way to diagnose patients in settings like neuro ICUs, and it is studying its use and potential in-depth at Yale New Haven Hospital. 

Hyperfine's Swoop was the first device approved in the growing category of "low-field scanners," or MRI machines that use smaller permanent magnets which generate lower-power fields for use in imaging, according to Science. The smaller magnets allow for smaller and less expensive machines that can be wheeled to a patient’s bedside.

Hyperfine went public in July 2021 in a $580 million SPAC deal – the most recent of Rothberg’s locally founded companies to debut on the stock market. 

Butterfly Network, which makes a portable ultrasound machine, went public in November 2020 in a deal worth $1.5 billion, and protein-sequencing device maker Quantum-Si debuted in February 2021 in a $1.46 billion deal.

Sainz was elevated to the CEO role in October after a career in the medical device industry and serving on Hyperfine's board. Company leaders said at the time that Sainz would lead the commercial expansion of Swoop.

Hyperfine’s previous CEO, Dave Scott, stepped down in July after serving just over a year in the role, citing personal reasons.

Sainz said a dedicated team at Hyperfine’s Guilford headquarters is currently developing a second version of Swoop’s hardware, set to be introduced next year or so.  

“In order to sort of have a jump up in terms of the opportunity for further quality and speed, we need to move to the next level of hardware,” Sainz said.  “Version 2 will allow us to focus on the brain, like our focus right now, but we will have a main body of the device that over time with different coil fixtures could help us image other parts of the body.”

Contact Liese Klein at lklein@newhavenbiz.com.

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