Butterfly Network Expands its Next-Generation Butterfly iQ3™ to Europe

Rhea-AI Summary

Butterfly Network Inc. (NYSE: BFLY) has launched its third-generation handheld point-of-care ultrasound system, Butterfly iQ3™, in Europe. The device, built on advanced Ultrasound-on-Chip™ technology, offers improved image quality, new 3D imaging capabilities, and a smaller, lighter design. Key features include:

1. Unparalleled image quality with twice the processing power of its predecessor
2. Novel tools: iQ Slice™ and iQ Fan™ for advanced 3D imaging
3. Ergonomic design: 17% smaller probe face, 7% shorter probe, and 2.5x faster charging
4. CE marked and EU MDR certified

The Butterfly iQ3 is now available in 16 European countries, expanding the company's mission to democratize ultrasound technology.

Positive

• Launch of advanced Butterfly iQ3 in 16 European countries, expanding market reach
• Improved image quality with twice the processing power of previous model
• Introduction of new 3D imaging capabilities: iQ Slice and iQ Fan
• Enhanced ergonomic design with smaller, lighter probe and faster charging
• CE marked and EU MDR certified, compliant with RoHS Directive without lead exemption

Negative

• None.

Insights

Medical Technology Expert

Butterfly Network's launch of iQ3 in Europe marks a significant leap in portable ultrasound technology. The new Ultrasound-on-Chip™ technology offers unparalleled image quality and 3D imaging capabilities, potentially revolutionizing point-of-care diagnostics. The iQ Slice™ and iQ Fan™ features demonstrate innovative approaches to image capture, particularly beneficial for less experienced users. The device's compliance with EU MDR and RoHS without lead exemption is a notable environmental and safety advantage. The ergonomic redesign addresses user comfort, important for widespread adoption. However, the true impact on patient outcomes and healthcare efficiency remains to be seen in real-world applications across various European healthcare systems.

Market Research Analyst

The expansion into 16 European countries represents a significant market opportunity for Butterfly Network. The $3.5 billion global POCUS market is projected to grow at a 5.2% CAGR through 2027, with Europe as a key region. Butterfly's strategy to offer advanced features at an accessible price point could disrupt traditional ultrasound markets. However, challenges include:

• Competition from established medical device giants
• Potential resistance from traditional imaging departments
• Variability in healthcare reimbursement policies across Europe

The company's success will depend on its ability to demonstrate clear clinical and economic benefits to diverse healthcare systems.

Financial Analyst

While the European expansion is promising, investors should note that Butterfly Network has yet to achieve profitability. In Q2 2023, the company reported:

• Revenue of $18.5 million, up 7.5% YoY
• Net loss of $36.8 million
• Cash and marketable securities of $252.4 million

The iQ3 launch could potentially accelerate revenue growth, but it's important to monitor:adoption rates, average selling prices and operating expenses in the coming quarters. The company's ability to scale operations efficiently across multiple European markets will be critical for achieving profitability. Investors should also watch for potential partnerships or distribution agreements that could enhance market penetration.

• Butterfly iQ3 is built on the next-generation Ultrasound-on-Chip™ technology featuring unparalleled image quality, new 3D imaging capabilities, and a smaller, lighter, probe design.
• Effective today, September 4, 2024, Butterfly iQ3 is available for purchase in Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK.

BURLINGTON, Mass. & NEW YORK--(BUSINESS WIRE)-- Butterfly Network Inc. (“Butterfly,” “the Company”) (NYSE: BFLY), a digital health company transforming care with portable semiconductor-based ultrasound technology and intuitive software, announced the commercial launch of its third-generation handheld point-of-care ultrasound (POCUS) system, Butterfly iQ3™ in Europe. Butterfly iQ3 is powered by the Company’s most advanced semiconductor chip, enabling unparalleled image quality and new advanced 3D capabilities: iQ Slice™ and iQ Fan™.

Butterfly iQ3 handheld point-of-care ultrasound device. (Photo: Business Wire)

Butterfly iQ3 is CE marked, certified under European Union Medical Device Regulation (EU MDR), and it is fully compliant with the Restriction of Hazardous Substances (RoHS) Directive without relying on the lead exemption that traditional piezoelectric crystal-based ultrasound devices require due to hazardous levels of lead in their transducers.

Joseph DeVivo, Butterfly Network’s President, Chief Executive Officer, and Board Chairman, commented, "After witnessing the enthusiastic uptake of Butterfly iQ3 in the United States and Canada over the past few months, we’ve been eager to receive the regulatory approval to introduce this high-performance device in Europe. We’re confident that the enhanced image quality and advanced features of Butterfly iQ3 will bring significant value to healthcare providers across Europe, supporting them in delivering quality patient care. Our mission to democratize ultrasound continues, and we are excited to continue seeing the promise of Butterfly iQ3 benefit new regions."

Unparalleled image quality.

Butterfly iQ3 brings best-in-class high-resolution image quality with twice the processing power compared to Butterfly iQ+ and a novel “no focus” rubber lens, enabling providers to intuitively identify anatomy, observe small structures, and ultimately make more confident diagnostic decisions. In a blind survey distributed by third-party vendor Intellisurvey, 475 clinicians across more than eight specialties compared Butterfly iQ3 images to GE Vscan Air™ CL, with the majority across all categories ranking iQ3’s overall image quality better than that of GE Vscan Air™ CL.*

"I was privileged to have a preview of the Butterfly iQ3 and am thoroughly impressed with the improvements so far and the positive impact they will have on patient care in my practice," said Dr. Zack Ferguson, Specialty Registrar in Acute Internal Medicine at West Middlesex Hospital. "Notably, the enhancement in echo image quality on the new Butterfly iQ3 represents a significant advancement from the prior iQ models, and the biplane mode for cannulation has already proven beneficial in managing patients with challenging IV access."

Novel tools: iQ Slice and iQ Fan.

Launching on Butterfly iQ3 are two new advanced 3D imaging capabilities designed to make image capturing easier: iQ Slice and iQ Fan. These tools join Butterfly’s existing robust feature list of over 20 anatomical presets, six imaging modes (B-Mode, M-Mode, Color Doppler, Power Doppler, Pulsed-Wave Doppler, and Biplane Imaging™), and a collection of artificial intelligence (AI) and advanced imaging tools (e.g., Auto Bladder Volume Capture, Auto B-Line Counter, NeedleViz™, and a rich set of Calculation tools).

• Butterfly iQ Slice: The world’s first automated sequential ultrasound capture mode on a handheld device, made uniquely possible by Butterfly’s proprietary Ultrasound-on-Chip™ technology. iQ Slice automatically steers the beam to scan an organ and capture up to 46 ultrasound slices at a time across a wide angle. The imaging mode is designed to make it easier and faster to acquire excellent images without skilled maneuvering. These files can either be immediately read and measured at the bedside by skilled scanners or, for those less experienced, can be sent to a specialist for further review—similar to the workflow of a CT or MRI.
• Butterfly iQ Fan: A dedicated lung tool that further builds on the core iQ Slice technology to allow providers to benefit from real-time back-and-forth virtual fanning, making it easier to visualize A-lines and other lung pathology. With iQ Fan, the user leverages Butterfly’s beam steering capabilities to reduce the movements necessary to capture information and make informed clinical decisions.

The new shape of ultrasound: enhanced comfort and efficiency.

Butterfly iQ3 features a new user-centric ergonomic design that is smaller, lighter, and better distributed, and with even stronger battery:

• 17% smaller probe face allows for better intercostal access for cardiac and lung imaging as well as vascular access.
• 7% shorter probe with ergonomic weight distribution designed to reduce the physical strain on scanners and ensure better control and maneuverability, allowing for more precise and comfortable scans.
• 3 configurable control buttons can be tailored for functionality, allowing for user-friendly seamless navigation, quick scans, and interpretations, saving critical time during diagnoses.
• 2.5x faster charge time than Butterfly iQ+ and up to 2 hours of thermal run time for outstanding continuous scanning.

Butterfly Network’s Chief Medical Officer, John Martin, MD, concludes, “'We are pleased that our customer response to Butterfly iQ3 matches our enthusiasm for this remarkable advance. Our customers asked for better resolution, and we delivered with exceptional image quality, as well as a smaller more ergonomic design, and improved performance. iQ3’s immediate boot-up, long run time, and fit-in-hand comfort ensure it is always ready for use. We are proud to bring Europe our newest solution that meets the standards of advanced users while remaining accessible for those new to ultrasound, all at an unmatched value.”

As of today, September 4, 2024, Butterfly iQ3 is now commercially available to healthcare providers in Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK. To learn more about Butterfly iQ3, pricing, trade-in offers for existing customers, or to purchase, visit your local website: https://www.butterflynetwork.com/choose-your-country

About Butterfly Network

Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission to democratize medical imaging 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. Butterfly created the world's first handheld single-probe whole-body ultrasound system using semiconductor technology, Butterfly iQ. The company has continued to innovate, leveraging the benefits of Moore’s Law to launch its second-generation Butterfly iQ+ in 2020 and third-generation iQ3 in 2024—each with increased processing power and performance enhancements. The disruptive technology has been recognized by TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50, and MedTech Breakthrough Awards, among other accolades. With its proprietary Ultrasound-on-Chip™ technology, intelligent software, and educational offerings, Butterfly is paving the way to mass adoption of ultrasound for earlier detection and remote management of health conditions around the world. Butterfly devices are commercially available to trained healthcare practitioners in areas including but not limited to parts of Africa, Asia, Australia, Europe, the Middle East, North America, and South America; to learn more about available countries, visit: butterflynetwork.com/choose-your-country.

*Internal data available upon request.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240904845777/en/

Butterfly Media:

Liz Learned

Head of Corporate Communications

media@butterflynetwork.com

Butterfly Investors:

Heather Getz

Chief Financial and Operations Officer

investors@butterflynetwork.com

Source: Butterfly Network Inc.

FAQ

What new features does the Butterfly iQ3 offer compared to its predecessor?

The Butterfly iQ3 offers improved image quality with twice the processing power, new 3D imaging capabilities (iQ Slice and iQ Fan), a smaller and lighter design, and faster charging compared to the Butterfly iQ+.

In which European countries is the Butterfly iQ3 (BFLY) now available?

As of September 4, 2024, the Butterfly iQ3 is available in Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK.

How does the Butterfly iQ3's image quality compare to competitors?

In a blind survey, the majority of 475 clinicians across eight specialties ranked Butterfly iQ3's overall image quality better than that of GE Vscan Air™ CL in all categories.

What are the key ergonomic improvements in the Butterfly iQ3 (BFLY)?

The Butterfly iQ3 features a 17% smaller probe face, 7% shorter probe with better weight distribution, 3 configurable control buttons, and 2.5x faster charging time compared to the Butterfly iQ+.