Hyperfine, Inc. to Expand Global Market Reach with Appointment of International Distributors in Key European Markets

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop system—today announced it has entered into agreements with three experienced and accomplished distributors to support commercial expansion plans of the Swoop system into European markets with an initial focus on France, the United Kingdom, and Italy.

In 2023, Hyperfine, Inc. obtained CE certification under the EU MDR and UKCA certification in the United Kingdom for its latest hardware and eighth-generation AI-powered software. The system the company is introducing to the European markets is commercialized in the U.S. and is the highest performing Swoop system to date in terms of image quality and usability. Introducing the Swoop system into international markets is a significant step in supporting the commercial growth of Hyperfine, Inc. The Swoop system can expand the existing imaging market with its transformative, affordable, and accessible platform to serve more clinicians and patients needing brain imaging.

“There is a growing global demand for accessible MR brain imaging, which the versatile Swoop system can meet. These strategic distributor partnerships enable a broader market footprint for our business beyond our direct commercial team in the U.S. The clinical applications of our Swoop system in international markets will also expand from critical care inside hospitals to other professional healthcare facilities such as outpatient clinics and offices. The use of the Swoop system in Alzheimer’s disease and acute stroke represent significant additional opportunities for our business globally,” said Maria Sainz, President and CEO of Hyperfine, Inc. “We are very encouraged by the high interest level and positive feedback from international clinicians thus far.”

Hyperfine, Inc. also announced the expansion of its management team with Enrico Barini joining as International Business Development Director. In this role, Mr. Barini will build the framework for the company’s business in Europe and drive the international introduction of the Swoop system by building awareness and adoption. Mr. Barini joins the company with deep expertise in commercial operations and extensive imaging and capital experience, most recently from ViewRay, Inc. and Boston Scientific Corporation.