Hyperfine, Inc.

Good afternoon, and welcome to Hyperfine's first quarter 2024 earnings conference call. Currently, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Marissa Beitsch from Gil Martin Group for introductory disclosures.

Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ended March 31, 2024. A copy of the press release is available on the company's website as well as sec.gov. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation, those relating to our operating trends and future financial performance, expense management, expectations for hiring, training, and adoption, growth in our organization, market opportunities, commercial and international expansion, regulatory approvals, and product development, are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risks factor section of our latest periodic filing with the Securities and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 13, 2024. Hyperfine, Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I will turn the call over to Maria Sainz, President and Chief Executive Officer.

Good afternoon and thank you all for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. We're off to a solid start in 2024 with healthy top line growth and a 3.3 million revenue quarter. We continue to ask flagship institutions in the US and build strong programs, giving us a solid foundation to drive the development of these new markets of affordable brain MR. We also recognize significant international contributions in Q1 driven by the addition of select outside of the U.S. markets to our commercial focus. And I'm also very excited about the progress we've made in the quarter on our Alzheimer's program and our stroke study. As a team, We delivered a strong success across all fronts while maintaining spending discipline and preserving capital. I am very proud of the lean execution of the Hyperfine team in Q1. Innovation, clinical evidence, and commercialization drive our success near and long term. In 2024, we remain an early commercial stage company while investing healthily in development and clinical activities that will drive commercial growth through expansion into new clinical applications and new sites of care in 2025 and beyond. We continue to have a significant focus on innovation. We launched our latest AI power software in January and have received very positive feedback from users on the image quality of our DWI sequence, which is clinically important for stroke detection. The latest software includes proprietary AI and deep learning algorithms and expands denoising to all sequences available on the subsystem. Looking forward, we continue to invest in all areas of innovation, including hardware, software, and AI. We remain committed to launching a steady cadence of AI-powered software and sequence development improvement. And we expect to release our next AI power software by late summer. We plan to continue to improve image quality and shorten acquisition time, which is important for the use of the soup system in acute settings. Technology improvements on image quality and usability make the portable soup brain MR scanner more relevant across more clinical applications and sites of care. I want to now focus on clinical evidence. As I have mentioned before, we are developing a new market of portable brain MR. The value of our platform technology is that it enables timely and early clinical decisions at multiple sites of care. Our clinical work is intended to yield the data to drive awareness and adoption of our differentiated technology across different clinical applications, as we already benefit from a very broad, clear indication by FDA for brain imaging of patients of any age. The subsystem scans are also covered by the same reimbursement codes used for conventional MRIs. First, our clinical development aims to position the subsystem as a clinical tool in the hands of clinicians that perform neurointervention. In this area, our immediate focus is our study to assess the detection and workflow value of soup in acute stroke triage. Our second focus is on soup position as a tool for clinicians managing and caring for patients suffering from chronic neurodegenerative diseases. Here, our greatest opportunity is our active Alzheimer's program. These two near-term areas of clinical use expansion stroke, and Alzheimer's are massive, multi-billion dollar markets for the soup system in the U.S. alone. These are also markets with unmet needs that align with the strengths of soup technology, namely soup's portability, small footprint, easy access, and high ease of use. As a reminder, our technology aims to broaden the reach of brain MRIs in the new clinical uses and sites of care, complementing conventional MRI. Turning to a more detailed update on our Alzheimer's efforts, MRI is becoming a key component of Alzheimer's care, and there is a strong potential for the subsystem to become a very valuable tool to enable more scalable patient-centric care models. Over 50 million people globally suffer from Alzheimer's. Even the vast and compelling opportunity this presents, we have mobilized to be the comprehensive Alzheimer's program, beginning with our Alzheimer's utility study, CARE-PMR. CARE-PMR is led by Dr. Benzinger at Washington University School of Medicine. In the study, clinicians have placed subsystems at local Lekembe infusion centers. The studies comparing high-field MRIs and portable ultra-low-field MRIs to assess the ability of SOOP to detect ARIA complications in patients who are taking this amyloid targeting therapy. By bringing imaging closer to the patient than a conventional MRI, we expect to significantly optimize workflow and ultimately open up the opportunity for more patients to be treated safely and efficiently. We expect preliminary data from this study to be shared by the end of 2024. In stroke, we continue to enroll patients in our ACTION-PMR study, which has now surpassed 100 patients. ACTION-PMR is a multicenter evaluation assessing the use of SUP systems in detecting acute ischemic stroke. We remain bullish about this opportunity, which will open up the placement of SUP units in emergency departments and hub-unspoke stroke networks and look forward to sharing updates in the coming quarters. Additionally, our technology was highlighted in four abstracts at the International Stroke Conference, which was held in February. These abstracts highlighted the clinical utility and applications of portable ultra-low-field brain MR imaging. I also want to provide additional detail on our commercial progress in Q1. In the US, we continue to add flagship institutions to our user base, most recently through the addition of MedStar Washington Hospital Center in Washington, DC. We remain very focused on building stroke programs. We have newly established a SUP user community to share best practices for the clinical use of SUP to propel further adoption of this transformative technology. In international markets, we have established a distribution infrastructure to support additional commercial efforts. As we announced late last week, we have now appointed distributors in three key European markets and have hired an experienced market development resource to coordinate our international efforts. The distributor model allows us to focus on driving international revenue growth without significant OPEX use. I am very pleased with the progress we're making on the three areas of focus and investment for our company and doing so while maintaining spending discipline. Our efforts in innovation, clinical evidence, and commercialization support a comprehensive strategy which will yield an acceleration of our business and growth in 2025 and beyond. The opportunities ahead are incredibly large and compelling, and our execution is very strong. I will now turn the call over to Brett to review our performance in the quarter.