UNITED STATES
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CURRENT REPORT
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Item 2.02 | Results of Operations and Financial Condition. |
On January 10, 2022, Hyperfine, Inc. (“Hyperfine”) issued a press release reporting preliminary unaudited financial information, including preliminary unaudited total revenue, for the quarter ended December 31, 2021 and the year ended December 31, 2021, and other information about Hyperfine’s business.
In addition, from time to time, Hyperfine presents and/or distributes slides and presentations to the investment community to provide updates and summaries of its business. On January 10, 2022, Hyperfine updated its corporate presentation, which is available on the “Investors” section of Hyperfine’s website at https://hyperfine.io/. The corporate presentation includes preliminary unaudited financial information, including preliminary unaudited total revenue, for the quarter ended December 31, 2021 and the year ended December 31, 2021, and other information about Hyperfine’s business.
Item 7.01 | Regulation FD Disclosure. |
The press release issued on January 10, 2022 and the corporate presentation updated on January 10, 2022 also include information about Hyperfine’s business and operations. This press release and corporate presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 and Exhibit 99.2) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. | Description | |
99.1 | Press Release issued by Hyperfine, Inc. on January 10, 2022 | |
99.2 | Corporate Presentation of Hyperfine, Inc. dated January 10, 2022 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
HYPERFINE, INC. |
By: | /s/ Dave Scott | |
Name: | Dave Scott | |
Title: | Chief Executive Officer |
Date: January 10, 2022
3
Exhibit 99.1
Hyperfine Reports Preliminary Unaudited 2021 Revenue and Swoop® System Installations
GUILFORD, Connecticut, January 10, 2022 (GLOBE NEWSWIRE) – Hyperfine (Nasdaq: HYPR), the groundbreaking medical device company that created Swoop®, the world's first FDA-cleared portable MRI system™, today announced preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2021.
Preliminary unaudited total revenue for the fourth quarter 2021 is expected to be approximately $0.362 to $0.437 million. Preliminary unaudited total revenue for the full year 2021 is expected to be approximately $1.42 to $1.50 million. Additionally, the company realized a total of $0.81 million in grant funding for the fourth quarter of 2021 and a total of $1.45 million in grant funding for the full year 2021 as part of grant fulfillment for Swoop installations.
The Swoop total installed base consists of three components, discussed in further detail below: Commercial system installations (which make up total revenue), grant fulfillment installations, and research unit installations. The Swoop total installed base (or total installed units) is the number of Swoop devices deployed to hospitals, other healthcare providers, and research institutions. Hyperfine views the total installed base as a key metric of the growth of its business and is measured from period over period. Presented below is a breakout of total Swoop systems installed during 2020 and 2021:
TOTAL INSTALLED UNITS | ||||||||||||||||||||||||
2020 | 2021 | |||||||||||||||||||||||
Q1 | Q2 | Q3 | Q4 | TOTAL | ||||||||||||||||||||
Commercial Systems Installations | 4 | 5 | 7 | 4 | 7 | 27 | ||||||||||||||||||
Grant Fulfillment Installations | 0 | 2 | 2 | 4 | 10 | 18 | ||||||||||||||||||
4 | 7 | 9 | 8 | 17 | 45 | |||||||||||||||||||
Research Units | 15 | 2 | 2 | 3 | 3 | 25 | ||||||||||||||||||
Total Installed Units | 19 | 9 | 11 | 11 | 20 | 70 |
· | Commercial system installations reflect device sales and subscription services through commercial agreements (commercial sales) or through research transfer agreements (RTA sales). Commercial sales are made to hospitals and other healthcare providers as direct sales of devices and software subscription services or through subscriptions for the use of the device and software. RTA sales represent the sale of Swoop units for research use purposes. Hyperfine’s revenue for the years ended December 31, 2021, and 2020 is derived from commercial sales and RTA sales. |
· | Grant fulfillment installations consist of shipments of Swoop units to hospitals and other clinical facilities designated by the Bill & Melinda Gates Foundation (BMGF). The corresponding funding for these installations from BMGF is recorded as a reduction in the research and development expenses when realized during the period. |
· | Research units represent installed units, at no cost to the institutions, to expand clinical use cases. The installation of research units is recorded as a fixed asset with the related depreciation recorded as R&D expense over the life of the research unit. |
“2021 was a transformational year for Hyperfine and a year of significant achievements in driving our clinical and value proposition forward while establishing strong early commercial traction,” said Dave Scott, president and chief executive officer. “We are pleased to have installed over 50 Swoop devices in 2021, our first full year of commercialization, against the challenges posed by a global pandemic. We see a substantial opportunity and strong growth trajectory ahead as we expand our sales force, build relationships with new partners and medical centers, and invest substantially in further applications of low-field, portable MRI to increase our impact for patients in need of medical imaging around the world. This is just the first step in our journey to democratize imaging, sensing, and ultimately guided intervention, and I am incredibly optimistic about our future.”
About Hyperfine
Hyperfine, Inc. is the groundbreaking medical device company that created Swoop®, the world’s first FDA-cleared portable MRI system. Hyperfine designed Swoop to enable rapid diagnoses and treatment for every patient regardless of income, resources, or location, pushing the boundaries of conventional imaging technology and expanding patient access to life-saving care. The Swoop Portable MR Imaging System™ produces high-quality images at a lower magnetic field strength, allowing clinicians to quickly scan, diagnose, and treat patients in various clinical settings. Swoop can be wheeled directly to the patient’s bedside, plugged into a standard electrical wall outlet, and controlled by an iPad®. Designed as a complementary system to conventional MRIs at a fraction of the cost, Swoop captures images in minutes, providing critical decision-making capabilities in emergency departments, operating rooms outside the sterile field, and intensive care units, among others.
Preliminary Financial Information
The preliminary financial information included in this press release is unaudited and is subject to completion of Hyperfine’s quarter and year-end closing procedures and further financial review. In certain cases, Hyperfine has provided expected ranges, rather than specific amounts, because these results are preliminary and subject to change. Actual results may differ from these estimates as a result of the completion of our quarter and year-end closing procedures, review adjustments and other developments that may arise between now and the time such financial information for the period is finalized. As a result, these estimates are preliminary, may change and constitute forward-looking information and, as a result, are subject to risks and uncertainties. These preliminary estimates should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles (GAAP), and they should not be viewed as indicative of our results for any future period. Hyperfine’s independent registered public accountants have not audited, reviewed, compiled, or performed any procedures with respect to these estimated financial results and, accordingly, do not express an opinion or any other form of assurance with respect to these preliminary estimates.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Hyperfine’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about Hyperfine’s financial and operating results, the benefits of Hyperfine’s products and services, and Hyperfine’s future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of Hyperfine’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the completion and audit of Hyperfine’s financial statements for the year ended December 31, 2021; the success, cost and timing of Hyperfine product development and commercialization activities, including the degree that Swoop is accepted and used by healthcare professionals; the impact of COVID-19 on Hyperfine’s business; the inability to maintain the listing of Hyperfine’s Class A common stock on the Nasdaq following the recently completed business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and Hyperfine’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of Hyperfine to raise financing in the future; the inability of Hyperfine to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of Hyperfine to identify, in-license or acquire additional technology; the inability of Hyperfine to maintain its existing or future license, manufacturing, supply and distribution agreements; the inability of Hyperfine to compete with other companies currently marketing or engaged in the development of products and services that Hyperfine is currently marketing or developing; the size and growth potential of the markets for Hyperfine’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of Hyperfine’s products and services and reimbursement for medical procedures conducted using Hyperfine’s products and services; Hyperfine’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; Hyperfine’s financial performance; and other risks and uncertainties indicated from time to time in Hyperfine’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. Hyperfine cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Hyperfine does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
Hyperfine Contact
Emily Barnes
APCO Worldwide
ebarnes@apcoworldwide.com
Investor Contact
Marissa
Bych
Gilmartin Group LLC
investors@hyperfine.io
Exhibit 99.2
Defining the Future of Life-Saving Diagnostics at the Point of Care Corporate Presentation | January 2022 © 2022 Hyperfine, Inc. |
© 2022 Hyperfine, Inc. Forward Looking Statements This presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Hyperfine’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, Hyperfine’s expectations with respect to financial results, future performance, development and commercialization of products and services, the potential benefits and impact of Hyperfine’s products and services, potential regulatory approvals, and the size and potential growth of current or future markets for Hyperfine’s products and services. Most of these factors are outside of Hyperfine’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the completion and audit of Hyperfine’s financial statements for the year ended December 31, 2021; the success, cost and timing of Hyperfine product development and commercialization activities, including the degree that Swoop is accepted and used by healthcare professionals; the impact of COVID-19 on Hyperfine’s business; the inability to maintain the listing of Hyperfine’s Class A common stock on the Nasdaq following the recently completed business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and Hyperfine’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of Hyperfine to raise financing in the future; the inability of Hyperfine to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of Hyperfine to identify, in-license or acquire additional technology; the inability of Hyperfine to maintain its existing or future license, manufacturing, supply and distribution agreements; the inability of Hyperfine to compete with other companies currently marketing or engaged in the development of products and services that Hyperfine is currently marketing or developing; the size and growth potential of the markets for Hyperfine’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of Hyperfine’s products and services and reimbursement for medical procedures conducted using Hyperfine’s products and services; Hyperfine’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; Hyperfine’s financial performance; and other risks and uncertainties indicated from time to time in Hyperfine’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. Hyperfine cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Hyperfine does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. |
© 2022 Hyperfine, Inc. Preliminary Financial Information The preliminary financial information included in this presentation is unaudited and is subject to completion of Hyperfine’s quarter and year-end closing procedures and further financial review. In certain cases, Hyperfine has provided expected ranges, rather than specific amounts, because these results are preliminary and subject to change. Actual results may differ from these estimates as a result of the completion of our quarter and year-end closing procedures, review adjustments and other developments that may arise between now and the time such financial information for the period is finalized. As a result, these estimates are preliminary, may change and constitute forward-looking information and, as a result, are subject to risks and uncertainties. These preliminary estimates should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles (GAAP), and they should not be viewed as indicative of our results for any future period. Hyperfine’s independent registered public accountants have not audited, reviewed, compiled, or performed any procedures with respect to these estimated financial results and, accordingly, do not express an opinion or any other form of assurance with respect to these preliminary estimates. |
4 Today, brain diagnostics are single point-in-time and delay the time from door to discharge. Our mission is to transform patient care by creating access to life-saving diagnostics and actionable data at the point-of-care. |
The Hyperfine Ecosystem 13 A full ecosystem solution: Hardware, software, consumables and applications powered by artificial intelligence Democratizing Imaging, Sensing, and Guided Intervention to cover the care continuum Sensing (in development) Imaging (FDA cleared) Intervention (in development) |
Imaging, Sensing, and Guided Intervention are Large Markets Poised for Disruption 13 $23B $22B $28B Imaging Hospitals, Outpatient >100,000 Potential installation targets Sensing ICUs, Expanded Hospital, Surgical Centers, Outpatient, At-home ~4M Potential unit sales Guided Intervention Hospitals and Health Systems >50M Potential image guided procedures Estimated $70+ billion opportunity across the ecosystem |
We are Transforming Medical Imaging with Swoop® Swoop is the world's first FDA-cleared portable MRI system™ 11 MRI 1.0 1980 MRI 2.0 1990 MRI 3.0 FDA Cleared 2020 |
Swoop® is the Next Generation of MRI 12 Installed base of 70 units* as of year-end 2021 Current primary clinical uses: - Hydrocephalus and Pediatrics - Neuro ICU Follow-Up and Post-Operative - Stroke Portable low-field MRI Patent protected noise cancellation system enables clinical-grade images FDA Cleared in 2020 Reimbursed under existing imaging codes: MRI Brain without Contrast: 70551 *Installed base includes commercial system installations (which make up total revenue), grant fulfillment installations, and research unit installations |
Swoop® Brings MRI to the Patient 16 Acute Care Settings • Swoop is designed to enable rapid diagnoses and treatment for patients regardless of income, resources, or location • Produces high-quality images at low magnetic field strength, allowing clinicians to quickly scan, diagnose, and treat patients • Wheeled directly to a patient’s bedside, plugged into a standard electrical wall outlet, and controlled by an iPad® Intensive Care Units and Operating Rooms Global Health |
Clinical & Workflow Benefits |
Numerous challenges with conventional MRI : 14 Adverse events occur in 22-46% of cases during transport High-cost limits accessibility Complex site requirements and upgrades Scheduling delays lead to longer length of stay Consumption of valuable personnel resources Risk of adverse events during transportation Maintaining connection to life support equipment |
Hyperfine Workflow Benefits 15 MRI ordered Patient preparation Intra-hospital transfer to MRI MRI examination Intra-hospital transfer to unit Post MRI examination Traditional MRI workflow (25.8 hours) MRI ordered MRI examination Post MRI examination Hyperfine workflow (90mins, 94% reduction in total workflow time) |
© 2021 HYPERFINE Intensive Care Unit - Acute Mental Status Change - Ataxia - Cerebral Edema - Cerebrovascular Disease - Cranial Neuropathy - Extra Ventricular Drain Placement - Follow-up Intracranial Hemorrhage - Follow-up Ischemic Stroke - Follow-up Hematoma - Stroke - Tumor Pre- and Post-Op Emergency Department - Blurred Vision - Cranial Neuropathy - Dizziness - Headache - Numbness - Stroke - Tingling - Traumatic Brain Injury - Vertigo - Weakness Rehabilitation Clinic - Acute Mental Status Change - Brain Injury After Fall - Stroke Recovery Outpatient - Atrophy Monitoring - Hydrocephalus (Shunt Check) - Multiple Sclerosis Pediatric - Brain Volumetrics - Hypoxic Ischemic Encephalopathy - Hydrocephalus (Dx and Monitoring) - Sports Injury - Suspected Abuse Swoop Clinical Use Cases Today |
Clinical Validation of Hyperfine 20 Game changer is a good way to put it […] being able to do the level of sophisticated imaging in an ICU that MRI can provide.’’ Dr. Fady Charbel, MD, FAANS, FACS Hyperfine provides me with an opportunity to acquire the information, to interpret the information, and to make a decision based on the information that’s in front of me.’’ Dr. Shahid Nimjee, MD, PhD, FAANS, FAHA Portable MRI should be used to image any patients in ICUs in any [clinical] setting.’’ Dr. Michael Schulder, MD, FAANS Over 25 conference presentations and publications discussing clinical benefits for: Stroke | Hydrocephalus | Hematoma | Multiple sclerosis | Tumor resection |
Use Case: Stroke |
Hyperfine Provides Compelling Platform for Stroke Diagnosis 18 15 million people worldwide suffer a stroke annually Stroke is the 2nd leading cause of death globally 87% strokes are ischemic strokes MRI scans are better at detecting ischemic stroke damage compared to CT scans MRI use for stroke has been limited due to lack of access to this expensive equipment and experienced neuroradiologists to interpret the results. Hyperfine offers an affordable MRI platform that can perform diffusion imaging for stroke diagnosis at the patient’s bedside, images can be shared securely with neuroradiologists around the world |
Stroke Diagnosis Confirmed 19 62-year-old male Presented with new left sided weakness and tremor |
Use Case: Hydrocephalus |
Problem: Children can receive 1-12 CTs1 each year, increasing their risk for radiation-associated malignancy2 High field MRI is generally more resource intensive and expensive to perform than CT 50% of shunts fail in <2 years and 98% of shunts fail by year 10.3 Hydrocephalus: The buildup of fluid in ventricles, treated with shunt placement. Any symptoms cause trips to hospital for a shunt check. US Market: 36,000 shunt surgeries in the US each year4 2 scans/patient/year for shunt follow-up1 Radiation Exposure and Imaging Access for Hydrocephalus Shunt-Checks is an Overlooked Problem *1: https://link.springer.com/article/10.1007/s00381-019-04345-3 | *2: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6166961/ | *3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7053664/ | *4 https://www.hydroassoc.org/powerful-facts/ |
Hydrocephalus: Swoop’s Potential from Early Cases 5 y/o presents to Neurosurgery clinic with headache. Swoop scan performed in the clinic demonstrates ventricular catheter (without artifact from valve) along with enlarged ventricles – child admitted to hospital for shunt revision immediately, saving radiation and delay. |
Pipeline Opportunities |
Innovative R&D Engine Designed to Expand Product Roadmap 24 Stroke Hydrocephalus Extremities Intra and Post Operative Expanded Addressable Market Improved usability Automated Stroke Detection Lower cost of goods Existing applications V1 Potential future applications V2 C-spine Potential benefits: |
Developing a Non-Invasive Brain Vital Sensor 26 Breakthrough AEGTM Technology designed to unlock access to blood flow and pressure Non-Invasive Non-invasive use on every patient to enable broader access and earlier diagnosis Continuous Trend Analysis Designed for continuous sensing to build trends for data-backed treatment Easy to use Designed to be easy to use for immediate, precise care *The first AEGTM device is being developed, subject to regulatory authorization, to aid in the diagnosis and management of brain disorders through the development of novel acoustic sensing techniques and innovative algorithms for measuring key metrics of brain health. |
Brain-Sensing Clinical Opportunities 27 Intensive Care Unit Emergency Department Operating Room Outpatient & At Home - Hydrocephalus - Vasospasm - Stroke - Cerebral edema - Traumatic Brain Injury - Subarachnoid hemorrhage - Suspected seizures - Acute liver failure - Altered mental status - Brain tumors - Sepsis - Intraoperative monitoring/anesthesia - Post surgical monitoring - Thrombectomy - Shunts - Epilepsy - Tumor progression - Concussion long-term effects - Idiopathic intracranial hypertension - Asymptomatic carotid stenosis - Hypertension - Obstructive sleep apnea - Sickle cell anemia - Traumatic Brain Injury - Stroke - Seizures - Triage for lumbar punctures - Altered mental status - Headaches - Status epilepticus - Cardiac arrest - Hypertensive urgency and emergency - Hematoma - Stent thrombosis |
Financial Profile |
2021 Preliminary Financial Results* & Total Installed Units • Approximately $1.42 to $1.50 million preliminary unaudited 2021 total revenue • Realized approximately $1.45 million in grant funding for the full year 2021 as part of grant fulfillment for Swoop installations *See slide above titled “Preliminary Financial Information” for important information about our preliminary unaudited financial information. **The Swoop total installed base consists of three components: Commercial system installations (which make up total revenue), grant fulfillment installations, and research unit installations. The Swoop total installed base (or total installed units) is the number of Swoop devices deployed to hospitals, other healthcare providers, and research institutions. .. |
2021: A Milestone Year • July: Announced Definitive Agreement to be Listed on Nasdaq through a Business Combination with HealthCor Catalio Acquisition Corp. • August: Swoop® Demonstrates High Accuracy for Detection of Brain Hemorrhage in Study Published in Nature Communications • September: Announced Plans for Global Expansion Starting with Launches in the United Kingdom and Pakistan • September: Announced Receipt of Additional $3.3 Million Grant from Bill & Melinda Gates Foundation to Improve Access to Neonatal and Pediatric Brain Imaging in Low-Resource Settings Globally • November: Received FDA Clearance for Deep Learning Portable MRI, Defining the Future of Life- Saving Diagnostics • December: Announced Expansion into Canadian Market with Medical Device License Issued by Health Canada • December: Closed Business Combination with HealthCor Catalio Acquisition Corp. and Liminal Sciences, Began Trading under the Ticker "HYPR" on the Nasdaq Global Market |
Leadership Team |
Management Team with Proven Track Record of Success 35 Dave Scott Chief Executive Officer Alok Gupta Chief Financial Officer Dr. Khan Siddiqui Chief Strategy Officer & Chief Medical Officer Tom Teisseyre Chief Product Officer Mark Hughes Chief Operating Officer Scott White Chief Commercial Officer Kyla Pavlina Chief People Officer Neela Paykel General Counsel |
Thank You! |
Appendix |
Brain is the Largest MRI Market with Nearly 25% of MR Procedures N = 27.4 Million Procedures MR Procedure Mix, All Sites, by Percent, 2020 Distribution of MR Sites and Procedures, by Site Type, 2020 3,025 1,765 445 1,000 2,930 8.4 1.8 5.0 6.8 5.4 Spine Breast Chest Pelvis & Abdomen (including liver) Head & Neck (not including brain) Upper Extremities (muscular or skeletal) Lower Extremities (muscular or skeletal) Prostate Vascular & Cardiovascular MRAs Cardiac (excluding MRAs) Brain (non-vascular) Interventional & Misc. 1% 1% 1% *Source: 2020 IMV MR Benchmark Report .. |