FDA-cleared Caption AI^TM will be exclusively combined with Butterfly’s hardware and software solution to pave the way for a new generation of ultrasound diagnostic support.

Butterfly Network, Inc. (NYSE: BFLY), manufacturer of Butterfly iQ+, the world’s first handheld whole-body ultrasound system with patented Ultrasound-on-Chip™ technology and comprehensive software platform, and Caption Health, creator of Caption AI, the world’s first and only FDA-cleared AI-guided ultrasound software, today announced that they have entered into an exclusive strategic partnership. For a broad set of healthcare professionals, Butterfly and Caption’s integrated solution should enhance cardiac assessment by improving the ease of image capture and image interpretation in a variety of care settings including the hospital, clinic, and home.

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Butterfly iQ+ Ultrasound Solution (Photo: Business Wire)

Recently, Caption Guidance™ received CMS (Centers for Medicare and Medicaid Services) new technology add-on payments (NTAP) authorization, which will go into effect on October 1, 2021. The NTAP designation is awarded to new medical technologies and services which are expected to substantially improve the diagnosis or treatment of Medicare beneficiaries.

“Seeing is knowing, and our mission to democratize medical imaging and transform healthcare is enabled by Butterfly’s unique ability to deliver powerful clinical information at the point of care,” said Dr. Todd Fruchterman, President and CEO of Butterfly Network. “By combining Butterfly’s differentiated solution with Caption’s AI capabilities, we are accelerating on our promise to provide practitioners with an easy-to-use advanced assessment tool that allows them to make more informed clinical decisions earlier in the patient care journey. With this partnership, we are enabling better care that can lead to improved patient outcomes.”

“Our partnership with Butterfly unlocks a new frontier in patient care. This is a pivotal time when imaging can reinvent diagnostic speed and accuracy. Butterfly’s comprehensive and versatile whole-body ultrasound solution will now have FDA-cleared AI guidance and interpretation, allowing every healthcare provider the ability to capture and understand cardiac function, and this is only the beginning,” said Steve Cashman, CEO and President of Caption Health. “The timing of our recent NTAP approval also means a transparent reimbursement pathway for the millions of Medicare patients receiving in-patient care.”

Butterfly and Caption Health are expected to introduce the combined platform on Butterfly iQ+ in the United States later this year.

About Butterfly Network

Founded by Dr. Jonathan Rothberg in 2011, Butterfly has created the world’s first handheld, single-probe whole-body ultrasound system using its patented Ultrasound-on-Chip™ semiconductor technology. Butterfly’s mission is to democratize medical imaging and contribute to the aspiration of global health equity, including for the 4.7 billion people around the world lacking access to ultrasound. Butterfly is paving the way for earlier detection and remote management of health conditions around the world. The Butterfly iQ+ can be purchased today by healthcare practitioners in the United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. Butterfly iQ+ is a prescription device intended for trained and qualified healthcare professionals only.

About Caption Health

Caption Health was founded on a simple but powerful concept: use technology to emulate the expertise of highly trained medical experts and put that ability into the hands of every care provider. The world’s first and only FDA cleared AI-guided ultrasound software, Caption AI, empowers healthcare providers with new capabilities to acquire and interpret ultrasound exams. For more information, visit captionhealth.com.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. The combined company’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, the combined company’s expectations with respect to financial results, future performance, development of products and services, potential regulatory approvals, anticipated financial impacts and other effects of the business combination on the combined company’s business, and the size and potential growth of current or future markets for the combined company’s products and services. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside the combined company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the impact of COVID-19 on the combined company’s business; the ability to maintain the listing of the combined company’s Class A common stock on the NYSE following the business combination; the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and the ability of the combined company to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the ability of the combined company to raise financing in the future; the success, cost and timing of the combined company’s product and service development activities; the potential attributes and benefits of the combined company’s products and services; the combined company’s ability to obtain and maintain regulatory approval for its products, and any related restrictions and limitations of any approved product; the combined company’s ability to identify, in-license or acquire additional technology; the combined company’s ability to maintain its existing license, manufacture, supply and distribution agreements; the combined company’s ability to compete with other companies currently marketing or engaged in the development of products and services that the combined company is currently marketing or developing; the size and growth potential of the markets for the combined company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the combined company’s products and services and reimbursement for medical procedures conducted using its products and services; the combined company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the combined company’s financial performance; and other risks and uncertainties indicated from time to time in the proxy statement/prospectus relating to the business combination, including those under "Risk Factors" therein, and the combined company’s other filings with the SEC. The combined company cautions that the foregoing list of factors is not exclusive. The combined company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The combined company does not undertake or accept any obligation or undertake 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.

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