UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 23, 2022, Hyperfine, Inc. (the “Company”) issued a press release announcing its results for the fourth quarter and year ended December 31, 2021 and providing a business update. A copy of the press release is furnished as Exhibit 99.1 hereto.
The information in this Current Report on Form 8-K (including Exhibit 99.1) 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 Number |
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Description |
99.1 |
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99.2 |
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Hyperfine Q4-21 and YTD 2021 Earnings Conference Call Presentation |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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HYPERFINE, INC. |
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Date: |
March 23, 2022 |
By: |
/s/ Dave Scott |
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Dave Scott |
Exhibit 99.1
Hyperfine Reports Fourth Quarter and Full Year 2021 Financial Results
GUILFORD, Connecticut, March 23, 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 fourth quarter and full year 2021 financial results and provided a business update.
“2021 was an incredible year at Hyperfine. We accelerated our Swoop launch by installing 23 commercial systems and over 50 total systems*, secured an experienced management team and Board of Directors, raised over $160 million in gross proceeds from our business combination, transitioned to a public company, and created several new opportunities for research at top clinical institutions while expanding our sales presence around the globe,” said Dave Scott, Chief Executive Officer and President of Hyperfine. “We look forward to continued success as we grow our impact in the field of medical imaging and diagnostics.”
Fourth Quarter 2021 Financial Results
Full Year 2021 Financial Results
* 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. We view the total installed base as a key metric of the growth of our business and is measured from period over period.
2022 Financial Guidance
Conference Call
Hyperfine will host a conference call at 4:30 p.m. ET on Wednesday, March 23, 2022, to discuss its fourth quarter and full year 2021 financial results and to provide a business update. The call may be accessed through an operator by dialing (888) 708-1168 for domestic callers or (630) 652-5889 for international callers, using conference ID 8268432. A live and archived webcast of the event will be available at https://investors.hyperfine.io/.
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.
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 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
HYPERFINE, INC. AND SUBSIDIARIES
COMBINED AND CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
(Unaudited)
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December 31, |
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2021 |
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2020 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
188,498 |
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$ |
62,676 |
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Restricted cash |
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2,662 |
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1,610 |
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Accounts receivable, net |
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553 |
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174 |
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Unbilled receivables |
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91 |
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— |
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Inventory |
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4,310 |
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1,718 |
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Prepaid expenses and other current assets |
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1,357 |
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|
691 |
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Due from related parties |
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14 |
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1,465 |
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Total current assets |
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$ |
197,485 |
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$ |
68,334 |
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Property and equipment, net |
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3,753 |
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1,904 |
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Other assets - related party |
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— |
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1,244 |
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Other long term assets |
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1,235 |
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44 |
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Total assets |
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$ |
202,473 |
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$ |
71,526 |
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LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
2,248 |
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$ |
948 |
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Deferred grant funding |
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2,662 |
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1,610 |
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Deferred revenue |
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730 |
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158 |
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Due to related parties |
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1,981 |
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136 |
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Accrued expenses and other current liabilities |
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8,115 |
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|
1,264 |
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Total current liabilities |
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$ |
15,736 |
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$ |
4,116 |
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Long term notes payable |
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— |
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178 |
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Long term deferred revenue |
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510 |
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— |
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Total liabilities |
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$ |
16,246 |
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$ |
4,294 |
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COMMITMENTS AND CONTINGENCIES |
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CONVERTIBLE PREFERRED STOCK |
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Hyperfine convertible preferred stock (Series A, B, C and D): $.0001 par value, aggregate liquidation preference of $0 and $147,651; 0 and 129,788,828 shares authorized; 0 and 95,010,858 shares issued and outstanding at December 31, 2021 and 2020, respectively |
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— |
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128,286 |
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STOCKHOLDERS' EQUITY (DEFICIT): |
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Class A Common stock, $.0001 par value; 600,000,000 and 130,000,000 shares authorized; 55,277,061 and 1,576,137 shares issued and outstanding at December 31, 2021 and 2020, respectively |
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5 |
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— |
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Class B Common stock, $.0001 par value; 27,000,000 and 0 shares authorized; 15,055,288 and 0 shares issued and outstanding at December 31, 2021 and 2020, respectively |
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2 |
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— |
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Additional paid-in capital |
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322,540 |
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10,415 |
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Accumulated deficit |
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(136,320 |
) |
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(71,469 |
) |
Total stockholders' equity (deficit) |
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$ |
186,227 |
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$ |
(61,054 |
) |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) |
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$ |
202,473 |
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$ |
71,526 |
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HYPERFINE, INC. AND SUBSIDIARIES
COMBINED AND CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
(Unaudited)
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Three months ended December 31, |
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Year ended December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Sales |
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Device |
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$ |
194 |
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$ |
123 |
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$ |
715 |
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$ |
200 |
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Service |
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|
242 |
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|
84 |
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|
781 |
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|
94 |
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Total sales |
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$ |
436 |
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$ |
207 |
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|
$ |
1,496 |
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$ |
294 |
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Cost of sales |
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Device |
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$ |
638 |
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|
$ |
395 |
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|
$ |
2,058 |
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|
$ |
763 |
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Service |
|
|
251 |
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|
|
8 |
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|
|
605 |
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|
|
8 |
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Total cost of sales |
|
$ |
889 |
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$ |
403 |
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$ |
2,663 |
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$ |
771 |
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Gross margin |
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(453 |
) |
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|
(196 |
) |
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(1,167 |
) |
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(477 |
) |
Operating Expenses: |
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|
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||||
Research and development |
|
$ |
8,893 |
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$ |
3,551 |
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$ |
25,842 |
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$ |
14,593 |
|
General and administrative |
|
|
12,149 |
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|
|
2,140 |
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|
|
27,497 |
|
|
|
5,921 |
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Sales and marketing |
|
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4,592 |
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|
|
973 |
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|
|
10,362 |
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|
|
2,500 |
|
Total operating expenses |
|
|
25,634 |
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|
|
6,664 |
|
|
|
63,701 |
|
|
|
23,014 |
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Loss from operations |
|
$ |
(26,087 |
) |
|
$ |
(6,860 |
) |
|
$ |
(64,868 |
) |
|
$ |
(23,491 |
) |
Interest income |
|
$ |
5 |
|
|
$ |
4 |
|
|
$ |
18 |
|
|
$ |
70 |
|
Other expense, net |
|
|
(3 |
) |
|
|
(6 |
) |
|
|
(1 |
) |
|
|
(6 |
) |
Loss before provision for income taxes |
|
$ |
(26,085 |
) |
|
$ |
(6,862 |
) |
|
$ |
(64,851 |
) |
|
$ |
(23,427 |
) |
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss and comprehensive loss |
|
$ |
(26,085 |
) |
|
$ |
(6,862 |
) |
|
$ |
(64,851 |
) |
|
$ |
(23,427 |
) |
Net loss per common share attributable to common stockholders, basic and diluted |
|
$ |
(2.73 |
) |
|
$ |
(4.45 |
) |
|
$ |
(17.57 |
) |
|
$ |
(15.38 |
) |
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted |
|
|
9,542,320 |
|
|
|
1,543,143 |
|
|
|
3,690,523 |
|
|
|
1,523,096 |
|
HYPERFINE, INC. AND SUBSIDIARIES
COMBINED AND CONSOLIDATED STATEMENT OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
Three months ended December 31, |
|
|
Year ended December 31, |
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|
2021 |
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2020 |
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|
2021 |
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2020 |
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Cash flows from operating activities: |
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|
|
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|
|
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|
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|
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Net loss |
|
$ |
(26,085 |
) |
|
$ |
(6,862 |
) |
|
$ |
(64,851 |
) |
|
$ |
(23,427 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
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|
||||
Depreciation and amortization |
|
|
337 |
|
|
|
85 |
|
|
|
726 |
|
|
|
289 |
|
Stock-based compensation expense |
|
|
3,770 |
|
|
|
260 |
|
|
|
6,901 |
|
|
|
1,117 |
|
Write-down of inventory |
|
|
56 |
|
|
|
50 |
|
|
|
75 |
|
|
|
213 |
|
Write-off of other assets - related party |
|
|
984 |
|
|
|
— |
|
|
|
984 |
|
|
|
— |
|
Sales under sales type leases |
|
|
— |
|
|
|
(46 |
) |
|
|
— |
|
|
|
(46 |
) |
Payments received on net investment in lease |
|
|
3 |
|
|
|
2 |
|
|
|
10 |
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|
|
2 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Accounts receivable |
|
|
387 |
|
|
|
(116 |
) |
|
|
(379 |
) |
|
|
(174 |
) |
Unbilled receivables |
|
|
(43 |
) |
|
|
— |
|
|
|
(91 |
) |
|
|
— |
|
Inventory |
|
|
(1,603 |
) |
|
|
(527 |
) |
|
|
(2,667 |
) |
|
|
(1,931 |
) |
Prepaid expenses and other current assets |
|
|
2,243 |
|
|
|
(115 |
) |
|
|
(666 |
) |
|
|
146 |
|
Due from related parties |
|
|
(1 |
) |
|
|
(1,160 |
) |
|
|
1,451 |
|
|
|
(782 |
) |
Other assets - related party |
|
|
102 |
|
|
|
52 |
|
|
|
260 |
|
|
|
226 |
|
Prepaid inventory |
|
|
— |
|
|
|
2 |
|
|
|
— |
|
|
|
651 |
|
Other long term assets |
|
|
(587 |
) |
|
|
— |
|
|
|
(1,201 |
) |
|
|
— |
|
Accounts payable |
|
|
(2,487 |
) |
|
|
(265 |
) |
|
|
1,436 |
|
|
|
(377 |
) |
Deferred grant funding |
|
|
(805 |
) |
|
|
— |
|
|
|
1,052 |
|
|
|
1,610 |
|
Deferred revenue |
|
|
126 |
|
|
|
103 |
|
|
|
1,082 |
|
|
|
158 |
|
Due to related parties |
|
|
647 |
|
|
|
25 |
|
|
|
1,845 |
|
|
|
27 |
|
Accrued expenses and other current liabilities |
|
|
4,821 |
|
|
|
698 |
|
|
|
6,851 |
|
|
|
773 |
|
Net cash used in operating activities |
|
$ |
(18,135 |
) |
|
$ |
(7,814 |
) |
|
$ |
(47,182 |
) |
|
$ |
(21,525 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Purchases of fixed assets |
|
|
(975 |
) |
|
|
(773 |
) |
|
|
(2,711 |
) |
|
|
(1,568 |
) |
Net cash used in investing activities |
|
$ |
(975 |
) |
|
$ |
(773 |
) |
|
$ |
(2,711 |
) |
|
$ |
(1,568 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Proceeds from exercise of stock options |
|
|
35 |
|
|
|
56 |
|
|
|
1,497 |
|
|
|
120 |
|
Proceeds from issuance of Series D convertible preferred stock |
|
|
— |
|
|
|
59,769 |
|
|
|
30,468 |
|
|
|
59,769 |
|
Stock issuance costs related to Series D convertible preferred stock |
|
|
— |
|
|
|
(129 |
) |
|
|
(7 |
) |
|
|
(129 |
) |
Proceeds from issuance of notes payable |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,067 |
|
Repayment of notes payable |
|
|
(178 |
) |
|
|
(889 |
) |
|
|
(178 |
) |
|
|
(889 |
) |
Investment from 4Bionics, LLC |
|
|
— |
|
|
|
500 |
|
|
|
3,516 |
|
|
|
1,000 |
|
Net proceeds from equity infusion from the Business Combination |
|
|
141,471 |
|
|
|
— |
|
|
|
141,471 |
|
|
|
— |
|
Net cash provided by financing activities |
|
$ |
141,328 |
|
|
$ |
59,307 |
|
|
$ |
176,767 |
|
|
$ |
60,938 |
|
Net increase in cash and cash equivalents and restricted cash |
|
|
122,218 |
|
|
|
50,720 |
|
|
|
126,874 |
|
|
|
37,845 |
|
Cash, cash equivalents and restricted cash, beginning of period |
|
|
68,942 |
|
|
|
13,566 |
|
|
|
64,286 |
|
|
|
26,441 |
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
191,160 |
|
|
$ |
64,286 |
|
|
$ |
191,160 |
|
|
$ |
64,286 |
|
Reconciliation of cash, cash equivalents, and restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
188,498 |
|
|
$ |
62,676 |
|
|
$ |
188,498 |
|
|
$ |
62,676 |
|
Restricted cash |
|
|
2,662 |
|
|
|
1,610 |
|
|
|
2,662 |
|
|
|
1,610 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
191,160 |
|
|
$ |
64,286 |
|
|
$ |
191,160 |
|
|
$ |
64,286 |
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash received from exchange of research and development tax credits |
|
$ |
50 |
|
|
$ |
- |
|
|
$ |
374 |
|
|
$ |
261 |
|
Supplemental disclosure of noncash information: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Noncash acquisition of fixed assets |
|
$ |
— |
|
|
$ |
136 |
|
|
$ |
— |
|
|
$ |
136 |
|
Defining the Future of Life-Saving Diagnostics at the Point of Care Corporate Presentation | March 23, 2022 © 2022 Hyperfine, Inc.
© 2022 Hyperfine, Inc. | Confidential and Proprietary Forward Looking Statements This presentation includes 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 geo-political 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 “Risk Factors” section of our S-1 filed with the Securities and Exchange Commission on January 24th, 2022.
Today, brain diagnostics are single point-in-time and delay the time from door to discharge. Our mission is to transform healthcare by creating access to life-saving diagnostics and actionable data at the patient bedside. © 2022 Hyperfine, Inc. | Confidential and Proprietary
The Hyperfine Ecosystem 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 (exploratory) © 2022 Hyperfine, Inc. | Confidential and Proprietary
Imaging, Sensing, and Guided Intervention are Large Markets Poised for Disruption $23B $22B $28B Imaging: Commercially Available Hospitals, Outpatient >100,000 Potential installation targets Sensing: In Development ICUs, Expanded Hospital, Surgical Centers, Outpatient, At-home ~4M Potential unit sales Guided Intervention: Longer-Term Opportunity Hospitals and Health Systems >50M Potential image guided procedures © 2022 Hyperfine, Inc. | Confidential and Proprietary 5
We are Transforming Medical Imaging with Swoop® MRI 1.0 1980 MRI 2.0 1990 MRI 3.0 FDA Cleared 2020 © 2022 Hyperfine, Inc. | Confidential and Proprietary 6
Swoop® is the Next Generation of MRI Installed base of 70 units* as of year-end 2021 Clinical Applications including: Neuro ICU Follow-Up and Post-Operative Hydrocephalus and Pediatrics 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 © 2022 Hyperfine, Inc. | Confidential and Proprietary >140 issued patents worldwide; >80 issued patents in the U.S. 7
Swoop® Brings MRI to the Patient 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 © 2022 Hyperfine, Inc. | Confidential and Proprietary
Clinical & Workflow Benefits
Numerous challenges with conventional MRI : 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 © 2022 Hyperfine, Inc. | Confidential and Proprietary
Hyperfine Workflow Benefits 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 (90 mins, 94% reduction in total workflow time) © 2022 Hyperfine, Inc. | Confidential and Proprietary 11
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 © 2022 Hyperfine, Inc. | Confidential and Proprietary
Clinical Validation of Hyperfine 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 40 conference presentations and publications discussing clinical benefits for: Stroke | Hydrocephalus | Hematoma | Multiple sclerosis | Tumor resection © 2022 Hyperfine, Inc. | Confidential and Proprietary 13
Use Case: Neuro-ICU
Patient Delays to Transfer in the ICU Creates Major Unnecessary Costs for Hospitals, is “Common and Costly” Estimated $300/hr for delays, >$22,000/week for hospital (>$1M/year) for large academic center Imaging capabilities of MRI, CT and Ultrasound should be available 24/7/365 at all facilities. In reality, patients can wait more than 24 hrs for MRI availability, resulting in cost for both the patient and the hospital, taking up an ICU bed. If only there was a way to improve access to imaging… © 2022 Hyperfine, Inc. | Confidential and Proprietary
Current ICU Imaging Workflow with Conventional MRI Patient preparation Intra-hospital transfer to MRI MRI examination Intra-hospital transfer to unit Post MRI examination Traditional MRI workflow can lead to prolonged delays in patient care and higher resources consumption MRI availability © 2022 Hyperfine, Inc. | Confidential and Proprietary DELAYED Transfer DELAYED Treatment Patient unstable NO imaging MRI ordered
MRI Ordered MRI Examination Post MRI Examination Portable MRI workflow enables timely care for earlier discharge by bringing brain imaging to the patient’s bedside Faster Transfer from ICU Faster Treatment Continue Monitoring with… Improved ICU Imaging Workflow with Swoop © 2022 Hyperfine, Inc. | Confidential and Proprietary
Using the scanner in the ICU is an important use case. What Swoop can offer versus a conventional MRI is the flexibility and the usefulness of having it right there. It favors time in a situation when you need something acute. Dr. Jennifer Moliterno-Gunel, Neurosurgeon Yale University School of Medicine Word from the Clinician © 2022 Hyperfine, Inc. | Confidential and Proprietary
Swoop’s Potential Benefits in the ICU Reduced adverse events associated with patient transport Adverse events occur in up to 46% of transported patients. Reduced costs associated with length of stay Shortening time to diagnosis, avoiding interruptions in care, and preventing adverse events Optimized staffing in the ICU Time consuming transport affects ICU staff: nurse, respiratory therapist, anesthesia, transport, and practitioner. Reduced exposure to ionizing radiation Ionizing radiation from CT used for serial follow-up scans = risk to patient and staff 1. Hyperfine, Care Area - Acute Mental Status Change, Page 1a © 2022 Hyperfine, Inc. | Confidential and Proprietary Reduced patient care interruption Transport time (2-3 hours) interrupts patient care and impacts staffing for entire ICU1 Reduced time to diagnosis Swoop workflow is significantly faster than conventional MRI
Use Case: Hydrocephalus
Pediatric Hydrocephalus Management is a Huge Problem ~400,000 hospital days, $2B in hospital charges in the US Children with hydrocephalus need life-long monitoring and use a disproportionate number of hospital days and resources.1, 2 Any symptoms cause trips to hospital for a shunt check to ensure pressure on the brain remains normal. 50% of shunts fail in <2 years and 98% of shunts fail by year 10.2,3,4 Children can receive 1-12 CTs5 each year, increasing their risk for radiation-associated malignancy6. Rapid MRI (T2 only) is preferred since it’s radiation free but may not be available. https://thejns.org/focus/view/journals/neurosurg-focus/37/5/article-pE5.xml https://www.gosh.nhs.uk/conditions-and-treatments/conditions-we-treat/ventriculomegaly/ https://www.hydroassoc.org/cerebral-shunt-malfunctions/ https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Hydrocephalus Swoop helps overcome existing workflow barriers to enable safe and timely imaging at the point of care for an improved patient experience. 5. https://link.springer.com/article/10.1007/s00381-019-04345-3 6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6166961/ 7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7053664/ 8. https://www.hydroassoc.org/powerful-facts/ © 2022 Hyperfine, Inc. | Confidential and Proprietary
Personal Story from the Hydrocephalus Association Received so many CT scans that we’re waiting on a cancer diagnosis. No radiation... Swoop is a parent’s dream. © 2022 Hyperfine, Inc. | Confidential and Proprietary
Hydrocephalus Workflow Improvement with Swoop® Traditional workflow results in delayed diagnosis and potential radiation exposure Hyperfine allows children to be imaged sooner, next to their loved ones, without radiation Patient preparation Transfer to imaging Fast MRI or CT Transfer to unit Diagnosis and treatment Scan ordered Scan Ordered Swoop Diagnosis and Treatment MRI or CT availability © 2022 Hyperfine, Inc. | Confidential and Proprietary
Hydrocephalus: Swoop’s Potential from Early Cases Hyperfine is an excellent addition to the neurosurgery clinic for screening of hydrocephalus patients. The convenience for the patient, reduced scan time, and cost of the machine make this a device that should be considered for any neurosurgery clinic. Jeff Leonard, MD Chief of Neurosurgery 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. © 2022 Hyperfine, Inc. | Confidential and Proprietary
Use Case: Stroke
Hyperfine Provides Compelling Platform for Stroke Diagnosis 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 © 2022 Hyperfine, Inc. | Confidential and Proprietary 26
Stroke Diagnosis Confirmed 62-year-old male Presented with new left sided weakness and tremor © 2022 Hyperfine, Inc. | Confidential and Proprietary 27
Clinical Settings Growth ~1000 Neonatal ICUs ~1250 Operating Rooms and Angio Suites ~115 Neuro ICU’s Today’s use cases provide a sizeable opportunity and platform for growth. © 2022 Hyperfine, Inc. | Confidential and Proprietary Near-Term Focus Over Time ~340 Pediatric Clinics 28 ~220 Childrens’ Hospitals ~5830 Emergency Departments ~2000 ICUs (Adult, Neuro)
Pipeline Opportunities
Innovative R&D Engine Designed to Expand Product Roadmap Neuro-ICU 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: © 2022 Hyperfine, Inc. | Confidential and Proprietary 30 Stroke
*The first medical device is being developed 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. Developing a Non-Invasive Brain Vital Sensor Breakthrough 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 © 2022 Hyperfine, Inc. | Confidential and Proprietary
Brain-Sensing Clinical Opportunities 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 © 2022 Hyperfine, Inc. | Confidential and Proprietary 32
Financial Profile
2021 Financial Results & Total Installed Units $1.496 million in 2021 total revenue Total sales increased by $1.2 million, or >400%, for the year ended December 31, 2021 compared to the year ended December 31, 2020. © 2022 Hyperfine, Inc. | Confidential and Proprietary TOTAL INSTALLED UNITS 2020 2021 Q1 Q2 Q3 Q4 TOTAL Commercial system installations* 4 5 7 4 7 27 Grant fulfillment installations — 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. 34
2022 Financial Guidance $10.0-$12.0 million in total revenue for full year 2022 50-60 commercial system installations in full year 2022 *2022 bar chart values reflect fiscal year financial guidance, not reported results
2021 & 2022: Major Accomplishments July 2021: Announced Definitive Agreement to be Listed on Nasdaq through a Business Combination with HealthCor Catalio Acquisition Corp. August 2021: Swoop® Demonstrates High Accuracy for Detection of Brain Hemorrhage in Study Published in Nature Communications September 2021: Announced Plans for Global Expansion Starting with Launches in the United Kingdom and Pakistan September 2021: 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 2021: Received FDA Clearance for Deep Learning Portable MRI, Defining the Future of Life-Saving Diagnostics December 2021: Announced Expansion into Canadian Market with Medical Device License Issued by Health Canada December 2021: Closed Business Combination with HealthCor Catalio Acquisition Corp. and Liminal Sciences, Began Trading under the Ticker "HYPR" on the Nasdaq Global Market January 2022: Placed Swoop system with Minnesota Medical Center to Grow its Advanced Imaging Systems Offering February 2022: Appointed Chip Truwit, M.D. as Senior Medical Director February 2022: Placed Swoop system with Queen’s University Radiology to Improve Access to Care for Canadian Patients in Remote Northern Communities © 2022 Hyperfine, Inc. | Confidential and Proprietary 36
© 2022 Hyperfine, Inc. | Confidential and Proprietary 37
Leadership Team
Management Team with Proven Track Record of Success 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 & Chief Compliance Officer © 2022 Hyperfine, Inc. | Confidential and Proprietary 39
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 . © 2022 Hyperfine, Inc. | Confidential and Proprietary 42