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Problem Tech Solves
Tech Brief
Butterfly is not solving the problem of low awareness, low utilization or cost of ultrasound. Butterfly is solving the dilemma that too many clinical decisions are made with incomplete information. The reality is that in the majority of clinical scenarios, across a variety of care settings and geographies, clinicians go by how the patient describes symptoms and by history, vitals, and by a physical examination. But this limited information, for most, can only narrow assumptions of the diagnosis. Also, for 2/3 of the world, medical imaging is absent altogether - it is either unaffordable, too far away, or both. This is true in low-mid income nations and in parts of higher income countries in rural settings. Butterfly introduces more, better and in some cases new information to the settings of clinical assessment and clinical decision making. With Butterfly, in all care settings, the dilemma around what is happening inside the body disappears. When armed with Butterfly, practitioners gain more complete ultrasound information to enable more informed clinical decisions. Overall Butterfly believes its solution addresses an unmet need across an addressable market of approximately 45 million healthcare practitioners, including approximately 2 million veterinarians and vet technicians, approximately 13 million medical doctors and approximately 30 million nurses and midwives worldwide. Butterfly's solution empowers practitioners with imaging information at point-of-care that is practical, mobile, interoperable, and easy-to-use. The company’s aspiration is to be as ubiquitous as the stethoscope and a tool used by caregivers everywhere and anywhere care is delivered, including the home.
Tech Differentiators
Butterfly reinvented ultrasound from the ground up, replacing piezoelectric crystal sensors with its postage stamp-sized Ultrasound-On-Chip™ technology—making medical imaging more accessible and affordable than ever before. As the world’s first FDA-approved semiconductor chip-based, handheld, whole body ultrasound device, the ButterflyiQ+ solution far transcends what's possible with traditional ultrasound and has evolved well-beyond other point-of-care imaging products. Specifically, Butterfly iQ+ is built with both custom-made and off-the-shelf components. The patents owned and in-licensed by Butterfly relate to the architecture of the company’s ultrasonic imaging devices, micro-fabricated ultrasonic transducers and machine learning for ultrasound applications. The key custom-made component in the Butterfly probe is the ultrasound transducer module consisting of a custom chip and lens. Creating the functional chip itself was the first major development breakthrough. Butterfly’s silicon chip offers 10,000 independent channels and 3D imaging, all while being small enough to fit on the 3x2 cm area at the end of the probe, and using low enough power to run on a battery. The second milestone was developing the transducer sensor design, process and integration. The R&D team built the transducer directly on the electronics, then combined it with a custom lens and package, creating an entire ultrasound system on a single chip. Functionally, what makes Butterfly unique is its ability to close an information gap and facilitate better, more informed care at a time when caregivers need more connectedness to patients, better tools to know-more sooner, and interaction with technology that makes them better vs. distracts from what they love.
Validation
From September 2018 - June 2021, 4,695 pregnant volunteers were recruited in North Carolina and Zambia and obtained blind ultrasound sweeps (cineloop videos) of the gravid abdomen alongside standard fetal biometry. A UNC landmark study published in NEJM Evidence, found that, using Butterfly iQ and AI assistance, nurse midwives in Zambia with no prior sonography training can perform at the level of trained sonographers. A study done by South Metro Fire rescue in Colorado evaluated paramedics who were using Butterfly iQ+ devices to capture ultrasound video of patients in need of assistance to help with diagnosis. The paramedics recorded impressions of the ultrasound video for 49 patients and those videos were reviewed by a single POCUS expert investigator to determine adequacy of image quality and accuracy of interpretation. The study found that POCUS video images were considered adequate in 42/49 of patients, and they accurately interpreted the POCUS images in 43/49 of patients. That had a substantial impact on paramedic decision making and patient management in about 30% of patients. A pilot study of 44 subjects was conducted at a public hospital involving subjects with a history of heart failure. After a 15 min training session involving a tutorial video, subjects performed four-zone lung ultrasounds on themselves using a Butterfly device. This study found that Butterfly was effective when used by patients to assess the health of their lungs. This supports further investigation into a telemedicine model using lung ultrasounds to reduce emergency department visits and hospitalizations associated with heart failure.
