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October 15, 2019 Bioscience Notebook

Rothberg’s Hyperfine pioneers portable MRI

PHOTO | Courtesy 4Catalyzer New Haven genomics pioneer Jonathan Rothberg hopes to revolutionize medical imaging.

Around this time a year ago, serial entrepreneur Jonathan Rothberg’s Butterfly Network launched a pocket-sized medical imaging device with a goal of revolutionizing ultrasound.

Now, another company founded by the Elm City-born genomics pioneer is trying to do the same with MRI.

Hyperfine Research Inc., housed in Rothberg’s Guilford-based 4Catalyzer health technology incubator, announced Monday it has developed “the world’s first portable, low-cost magnetic resonance imaging (MRI) system.” 

The five-year-old startup said it will begin piloting its Hyperfine Portable POC (point of care) MRI device, which plugs into a wall outlet and works right at a patient's bedside, in the neuro intensive care unit at Yale New Haven Hospital. 

The pilot is part of a Yale School of Medicine and American Heart Association study examining the device’s use on patients who are too unstable to be transported out of the ICU. 

“As Hyperfine’s first clinical partner, Yale is helping us to change how medicine is practiced with point-of-care MRI,” Rothberg said in a statement. “Yale’s early experience with the system will guide us as we seek to revolutionize medical imaging by making MRI more accessible.”

So far, YNHH has used the technology to do brain scans on 123 patients, who were suffering from brain conditions such as hemorrhages, ischemic stroke, tumors, hematomas and swelling. 

The hospital is helping test the clinical workflow, user interface and image quality of the system and will compare those scans to standard MRI and CT scans of the same patients, Hyperfine said. Preliminary findings are expected to be announced in 2020.

Yale School of Medicine neurology and neurosurgery professor Kevin N. Sheth, MD, said existing MRI technology requires a “strict, limited-access environment because of their high-field magnet design.”

“The result is that we’ve taken a very safe technology and made it very difficult for patients and clinicians to access it,” he said. “I'm excited to be part of a project that is finding a way to bring MRI to patients in a feasible, safe and efficient way.” 

The device is awaiting federal regulatory approval. The company is hoping for a 2020 commercial launch, according to a spokesman. 

Rothberg, a Yale alumnus who lives in Guilford, is best known for inventing high-speed and inexpensive DNA sequencing with his CuraGen Corp. and later 454 Life Sciences. He won the National Medal of Technology and Innovation for his work in 2015. 

Last fall, his Guilford-based Butterfly Network became a health technology “unicorn” (a private company with a valuation of more than $1 billion) following a $250 million series D financing round from investors that included Fidelity and the Bill & Melinda Gates Foundation.

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Alexion Pharmaceuticals Inc. has signed an agreement with a Massachusetts biotech for an option to co-develop and commercialize a drug for mitochondrial diseases.

Alexion will pay Newton, Mass.-based Stealth BioTherapeutics Corp. $30 million upfront, with the potential for additional payments, including those based on milestones, the companies announced last week. 

Under the deal, Alexion will have the opportunity to exercise its option to develop the drug, elamipretide, after the release of results from a Phase 3 study currently underway for a condition known as primary mitochondrial myopathy (PMM). 

There are currently no approved therapies for the disease, which is marked by progressive skeletal muscle weakness, chronic fatigue and exercise intolerance, Alexion said. 

“[We] believe this is an exciting potential opportunity to further expand our rare neurology portfolio,” John Orloff, MD, Alexion’s head of research and development, said in a statement. 

If Alexion chooses the option, the companies will co-develop a subcutaneous (injectable just under the skin) formulation of the drug to treat PMM and two other mitochondrial diseases, Barth syndrome and Leber’s hereditary optic neuropathy (LHON).

The agreement calls for the two companies to co-promote the drug equally in the domestic market and gives Alexion exclusive rights to develop and commercialize it outside the U.S.

Contact Natalie Missakian at news@newhavenbiz.com

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