Hyperfine, Inc.

Good afternoon, and welcome to HyperFund's first quarter 2022 earnings conference call. At this time, 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 Weiss from Gil Martin Group, Investor Relations, for introductory comments.

Thank you all for joining today's call. Joining me are Dave Scott, President and Chief Executive Officer, and Alok Gupta, Chief Financial Officer of Hyperfine. Earlier today, Hyperfine released financial results for the first quarter, ended March 31, 2022. A copy of the press release is available on the company's website, as well as sec.gov. Before we begin, I would 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, The impact of COVID-19 or geopolitical conflict, such as the war in Ukraine, on our business and prospects for recovery, expense management, expectations for hiring, physician training and adoption, growth in our organization, market opportunity, 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, Factors section of our Form 10-K filed with the Securities and Exchange Commission on March 25, 2022. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 11, 2022. HyperFind has claimed 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 Dave Scott, President and Chief Executive Officer.

Thank you, Marissa. Good afternoon and thank you all for joining us for our first quarter 2022 earnings call. I am honored to be here as Hyperfine's President and Chief Executive Officer and on the call with me is our Chief Financial Officer, Alok Gupta. Following our fourth quarter and 2021 results call in March, we are excited to be back to continue the conversation on Hyperfine's story with you and to share the meaningful progress we drove in the first quarter of the year including the placement of 11 commercial swoop systems, driving $1.5 million in total revenue. We will dive into our first quarter details shortly, but first I would like to introduce our newer listeners to Hyperfine and highlight some of our notable recent achievements. Hyperfine's vision is to transform healthcare by creating access to life-saving diagnostics and actionable data at the patient bedside. Today, brain diagnostics are a single point in time and delay the time from door to discharge. Our mission remains to transform that experience, first and foremost with our portable bedside MRI system. Our initial product, our portable MRI system called SWOOP, was FDA cleared in 2020. Today, we continue to launch that system into the hospital setting to solve significant unmet patient and provider needs. In addition, we are developing a brain sensing technology designed to use ultrasound to measure non-invasive blood flow pressure and flow in the brain. With these technologies, we aim to create an ecosystem of solutions over time, all based on a backbone of machine learning and artificial intelligence to drive diagnostic decision making. We have an immense market opportunity that we are continuing to capitalize on in 2022. The imaging segment alone offers a $23 billion market opportunity with potential for installations across numerous hospitals, clinics, and outpatient centers over time. The medical imaging market opportunity is our primary focus today. In addition, noninvasive brain sensing offers a $22 billion market across similar locations, including ICUs, emergency departments, ambulances, and outpatient settings. we see over a $40 billion addressable market opportunity. Today, just 10% of the world's population has access to MRI, and we are committed to improving that. As we have noted in the past, our near-term opportunities for improving patient care lie in the following areas. First, in the neuro-ICU. Next, in pediatric hospitals to address hydrocephalus. And third, in stroke. When patients are in the ICU for neurological conditions, patients are typically too unstable to transport to the MRI suite for imaging. The time it takes to get the imaging completed can be prohibitively long, and the process can consume valuable resources. As a result, there is simply not an effective way to perform MRI imaging for ICU patients today. We have been working with our clinical partners to build strong clinical validation to support the ICU use case. In 2021, a paper published by researchers at Yale in Nature addressed detection of brain hemorrhage in ICU patients and showed 90% accuracy in swoop imaging results compared to conventional MRI. This is great validation of our technology in exactly the market we're most focused on right now. And we continue to see a very positive response in this setting today. Secondly, hydrocephalus is an excellent use case for portable MRI. The problem of hydrocephalus is there a buildup of fluid in the brain, in the ventricles, and this is addressed by introducing a shunt and tubing to drain that fluid from the brain. MRI is the preferred approach for imaging these children instead of CT. However, MRI is infrequently available, and as a result, the next best option is to take these pediatric patients for CT scans. Our mission is to scan these children with bedside MRI as the better solution. It doesn't deliver any radiation, and our technology enables a quick, simple diagnosis by showing whether these shunts have failed or are operating normally. These are just two examples of use cases where we have received overwhelming early positive responses to the SWOOP system. Additionally, we have systems located at leading institutions across the country with ongoing studies to add even greater validation to the utility and the clinical efficacy of our technology. We also continue to focus on building our base of clinical data in stroke. As many of you know, 15 million people worldwide suffer from strokes annually. It's the second leading cause of death globally. 87% of these strokes are ischemic strokes. Data demonstrates that MRI scans can better detect ischemic stroke damage compared to CT scans. In fact, we were pleased to see a recent independent publication by our partners at Yale and Harvard Mass General in Science Advances, reviewing the value of SWOOP in the detection and evaluation of stroke, one of the core use cases we're building. The paper concluded that hyperfine SWOOP enabled highly accessible and dynamic bedside evaluation of ischemic stroke, obtaining actionable bedside neuroimaging for 50 confirmed patients. The study included patients in the neuro ICU and the emergency department, and uses of the SWOOP system included serial imaging to monitor the progression of stroke and assess the efficacy of treatment, as well as postoperative imaging in one patient who had already received mechanical thrombectomy. Overall, SWOOP detected infarcts in 45 out of 50 patients, or 90%, and captured lesions as small as 4 millimeters. The authors highlighted the safety and convenience of portable low-field MRI as a tool to expedite the treatment pathway and concluded that these results validated the use of low-field portable MRI to obtain clinically useful images of stroke setting the stage for broader use. We're continuing to engage multiple U.S. hospitals to collect data demonstrating the clinical value of swoop and stroke patients. As we gather greater clinical data, we will increase our focus on driving awareness and educating the field about swoop utilization for the stroke use case through our direct sales team. We look forward to sharing our progress on advancing our stroke use case as the year progresses. In addition to improving patient workflow and saving critical time for the aforementioned use cases, we are also hard at work to continue our progress on our next generation SWOOP platform to expand use cases beyond neuro ICU, beyond hydrocephalus and stroke, and into C-spine and extremities over time. We are also developing our non-invasive brain monitoring system which uses ultrasound technology to measure intracranial pressure and blood flow in the brain. Like a vital sign monitor for the heart, such as an EKG or pulse oximeter, this is intended to operate as a vital sign monitor for the brain. We intend to generate an ultrasound image through leads that are put on either side of the head, and from that image extract intracranial pressure and flow non-invasively. This will be a groundbreaking technology in the measurement of vital signs in the brain. Now that I've reacquainted you with our vision, our market opportunity, and the transformational potential of Swoop, I'd like to highlight the progress we made in the first quarter of the year. We installed 11 commercial Swoop systems in the first quarter of 2022, driving a revenue of $1.5 million. These included, among others, our first commercial contract with Tenet through Mission Trails Baptist Hospital in San Antonio, Texas, and a valuable new partnership with Memorial Hermann Hospital in Houston, Texas. We also broadened our global presence with important new customers in Toronto, Canada, and Karachi, Pakistan. We continued to develop and enhance our customer relationships through comprehensive programs to deliver value to the patient, clinician, and hospital side of care. We are seeing that SWOOP is truly a cross-functional solution with value spanning multiple stakeholders and more than one clinical discipline. We are working closely with neurosurgeons, interventional neuroradiologists, and critical care clinicians alongside radiology and hospital executives, all influential stakeholders, to roll out successful new programs and placements. We also continue to listen and integrate feedback from our ongoing partnerships into our commercial approach and future use case development, while reaching out to new hospitals and networks, including our ongoing Demo at Your Door program. For example, we recently completed our first Demo at Your Door Plus, which we worked directly with hospital leadership and patient consent for real-time ICU scans demonstrating Swoop's value in real patients. We continue to invest in our sales team and commercial toolbox through in-depth training modules and related activities. And as a reminder, we are currently focused most on training and development of our core sales team rather than sales team expansion. However, our broader organization continues to grow as we had valuable team members across the teams such as clinical science, research, manufacturing, and service. Today, our team remains hard at work stimulating awareness of our technology and placing swoop systems across U.S. hospitals and various global sites, and we are pleased to share that we are continuing to successfully engage with new hospitals into the second quarter. In addition, we are observing that overall access to hospitals is continuing to improve as we emerge from the COVID-19 pandemic with lifting restrictions on visitor and industry representative attendance. We are optimistic that the outlook for the healthcare industry will continue to improve gradually over the remainder of 2022 and that against that backdrop, we can meet our growth objectives and continue to ramp our commercial business given our strong value proposition. We are immensely proud of our progress and we continue to see a robust opportunity for growth and expansion into further hospitals and care settings going forward. Based on current trends in our business and our outlook for the remainder of the year, we are reaffirming our revenue guidance of 10 to 12 million for physical year 2022. We are also reaffirming expectations to install 50 to 60 commercial units for the year, roughly tripling our existing commercial installed base from 27 systems at year end to 21 to 77 to 87 systems at the end of this fiscal year. I will now turn the call over to Alok Gupta, our Chief Financial Officer, to review our first quarter performance and financial outlook in greater detail.