Hyperfine Completes Patient Enrollment in Contrast-Enhanced MRI (Contrast PMR) Study of Swoop MRI System

Hyperfine announced that it has completed patient enrollment in its contrast-enhanced PMR study, which is designed to evaluate the potential of the company's portable Swoop MRI system to use gadolinium-based contrast agents. The study will investigate the contrast-enhancement capability of ultra-low-field magnetic resonance imaging to improve visualization of brain lesions. Hyperfine plans to use the study data to support the first expanded indication application for the Swoop system since it initially received FDA clearance.

The focus of this study is on how the Swoop system can use gadolinium-based contrast agents to visualize lesions associated with blood-brain barrier disruption, such as those observed in brain tumors and inflammatory diseases. The study's specific objectives include evaluating three different measures of lesion appearance. Maria Sainz, the company's President and Chief Executive Officer, said that contrast-enhanced imaging can be a key catalyst for expanding the adoption of the Swoop system and extending its value.

Hyperfine believes that contrast-enhanced imaging can create a solid foundation for supporting critical diagnostic and treatment decisions across a wide range of clinical settings, while also delivering long-term value to providers through established dedicated reimbursement pathways. This is expected to expand use in outpatient settings and open new applications for postoperative imaging in surgical settings. The Swoop portable MRI system has received FDA clearance for brain imaging in patients of various ages and provides internal structural head images in settings where standard diagnostic examinations are not feasible.

In addition to supporting an expanded indication application, the results of this study are of great significance to Hyperfine. Contrast-enhanced images have enormous potential in various clinical settings and can provide physicians with more valuable diagnostic information. By leveraging the portability of the Swoop system and the advantages of contrast-enhanced imaging, Hyperfine aims to improve the accessibility and efficiency of healthcare delivery.

While focusing on its contrast-enhanced research, Hyperfine is also actively advancing the commercialization of the Swoop MRI system. The company recently launched its next-generation Swoop MRI system (Model 2) in selected European markets, marking its continued commitment to providing innovative imaging solutions to the healthcare industry. As this study progresses, Hyperfine expects to gain valuable insights in further validating the value and clinical potential of the Swoop system, thereby further consolidating its position as a leader in the field of healthcare imaging technology.

Hyperfine is committed to addressing unmet needs in healthcare through its Swoop MRI system and to supporting improvements in patient care. By focusing on contrast-enhanced imaging and continuous innovation, the company is positioned to transform the diagnostic process through accessible and cost-effective solutions and to provide medical professionals with tools to improve patient outcomes. The completion of this study and the subsequent submission of an FDA application confirm Hyperfine's firm belief in the impact of its technology and its development in the healthcare field.