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Butterfly Network Advances Medical Imaging in Canada with Butterfly iQ+

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Butterfly Network (NYSE: BFLY) announced that its second-generation iQ+ received a Class III Medical Device License in Canada. The iQ+ features innovative Ultrasound-on-Chip technology and enhancements for improved usability. The device is designed to support advanced medical imaging with features like real-time Biplane Imaging and enhanced battery life. The company anticipates strong demand in Canada, following the success of its first-generation device launched in 2020. With this approval, Butterfly iQ+ will be available in 20 countries, aiming to enhance medical imaging accessibility.

Positive
  • Approval of Butterfly iQ+ for a Class III Medical Device License in Canada.
  • Innovative Ultrasound-on-Chip technology enhances usability and medical care delivery.
  • Significant demand anticipated based on previous device success, with over 86,000 physicians in Canada.
  • Availability in 20 countries, expanding market reach.
Negative
  • None.

Butterfly Network, Inc. (NYSE: BFLY) (“Butterfly”) announced today that its second-generation iQ+ has been approved for a Class III Medical Device License in Canada. The iQ+ features the world’s only Ultrasound-on-Chip™ technology, with several hardware and software advances designed to improve usability and care delivery.

Butterfly iQ+ (Photo: Business Wire)

Butterfly iQ+ (Photo: Business Wire)

“We are excited that the Butterfly iQ+ will now be available for purchase by Canadian medical professionals,” said Todd Fruchterman, MD, Ph.D., President and Chief Executive Officer of Butterfly Network. “Thousands of new practitioners and millions of patients will now have access to a transformative advanced assessment tool that can deliver valuable insights that enable more informed clinical decisions at the point of care.”

Innovative technology

Butterfly iQ+ will help unlock the power of medical imaging earlier in the treatment journey with an entire suite of advanced imaging features, such as real-time Biplane Imaging™ (the first such feature for a handheld ultrasound device), automatic bladder volume calculation with 3D rendering, Needle Viz™ onscreen needle highlighting, and Pulsed Wave Doppler. It includes Educational View Guidance, which helps clinicians improve their scanning technique by providing a visual indication of the quality of the image being collected. Relative to the first-generation device, the iQ+ is built to perform even more reliably throughout demanding shifts with 20% extended battery life and 15% faster frame rates, and has a smaller form factor that allows for tighter control.

Enterprise imaging software that transforms care

Butterfly iQ+ can be coupled with its integrated enterprise software solution that allows clinicians to scan, document, upload, and review images seamlessly. More integrated workflows and educational resources, including tutorial videos and remote scanning assistance via TeleGuidance™, will allow Canadian healthcare providers to quickly implement Butterfly iQ+ into their practices.

Significant opportunity for impact

The Butterfly iQ+ is well suited for the needs of the Canadian healthcare system, consisting of over 86,000 physicians1 across 830 hospitals2. Demand for Butterfly’s first-generation iQ device, launched in Canada in March 2020, has been very strong. Butterfly iQ+’s advanced features, improved usability, and functionality are expected to further accelerate demand and deliver more value.

With Canada’s approval, Butterfly iQ+ is now available in 20 countries across the world. To purchase Butterfly iQ+, visit https://store.butterflynetwork.com/product/butterfly-iq.

About Butterfly Network

Founded by Dr. Jonathan Rothberg in 2011 and recently listed on the New York Stock Exchange through a business combination with Longview Acquisition Corp., Butterfly Network created the world's only handheld, single-probe whole-body ultrasound system using semiconductor technology, the Butterfly iQ. Its mission is to democratize medical imaging and contribute to the aspiration of global health equity by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected—including for the 4.7 billion people around the world lacking access to ultrasound. Through its proprietary Ultrasound-on-Chip™ technology, Butterfly is paving the way for earlier detection and remote management of health conditions around the world. The Butterfly iQ+ can be purchased online 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 medical device intended for trained and qualified healthcare professionals only.

For more information, visit www.butterflynetwork.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 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 Company’s expectations with respect to commercial sales, financial results, future performance, development of products and services, maintenance of regulatory approvals, anticipated financial impacts and other effects of the Company’s business combination on its business, and the size and potential growth of current or future markets for its 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 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 Company’s business; the ability to recognize the anticipated benefits of the business combination; the Company’s ability to grow and manage growth profitably; the success, cost and timing of the Company’s product and service development activities; the potential attributes and benefits of the Company’s products and services; the Company’s ability to obtain and maintain regulatory approval for its products, and any related restrictions and limitations of any approved product; the Company’s ability to identify, in-license or acquire additional technology; the Company’s ability to maintain its existing license, manufacture, supply and distribution agreements; the Company’s ability to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; changes in applicable laws or regulations; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using its products and services; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; the Company’s ability to raise financing in the future; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission. The Company cautions that the foregoing list of factors is not exclusive. The Company cautions you not to place undue reliance upon any forward-looking statements, which speak only as of the date of this press release. The 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 the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based.

1 Canadian Medical Association

2 Definitive Healthcare

 

FAQ

What is the significance of Butterfly Network's iQ+ approval in Canada?

The approval allows Canadian medical professionals to purchase the iQ+, enhancing access to advanced medical imaging technology.

What innovative features does the Butterfly iQ+ offer?

The iQ+ features real-time Biplane Imaging™, Needle Viz™, and extended battery life, aimed at improving usability.

How does the iQ+ impact healthcare in Canada?

The iQ+ is expected to unlock advanced imaging capabilities, aiding clinical decisions for over 86,000 physicians across Canada.

In how many countries is the Butterfly iQ+ available?

The iQ+ is now available in 20 countries, including Canada.

Butterfly Network, Inc.

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