Bay Labs Achieves Significant Clinical Milestone and Receives Breakthrough Device Designation; Changes Name to Caption Health

Caption Guidance, the company’s transformational ultrasound software, successfully meets primary endpoints in pivotal clinical study

Bay Labs, a growing medical technology company applying deep learning technology to emulate the expertise of highly-trained medical experts, announced today that it has achieved a number of significant milestones, including renaming the company to Caption Health, effective immediately. The company has also renamed their flagship technology, EchoGPS, to Caption Guidance. Caption Guidance technology will be incorporated onto compatible ultrasound devices and the packaged product will be offered to the market as Caption AI.

Caption AI is a transformational new product that is designed to enable healthcare practitioners at various skill levels to perform ultrasound exams quickly and accurately, by providing clinicians with real-time guidance, automated interpretation, and quality assessment capabilities. The product is undergoing FDA review and is not yet available for sale.

“Caption Health’s AI technology occupies a unique space in healthcare, because it is designed to enable a broader set of healthcare providers to use ultrasound, a powerful and safe diagnostic tool,” said Andy Page, chief executive officer of Caption Health. “We are rapidly moving towards commercialization of Caption AI and our vision of moving specialty diagnostics to the point of care.”

Page, past president and board member of 23andMe, joined Caption Health as CEO in February 2019, bringing 25 years of experience from industry-defining healthcare technology and eCommerce companies.  He joined Caption Health to guide the company through its next phase of growth as it transitions from development to commercialization.

“The recent milestones we have achieved are inspiring, and I’m excited about our future as Caption Health,” said Charles Cadieu, president and co-founder of Caption Health. “Since our founding, we’ve focused on developing and refining our products and have refrained from offering details about our market readiness. We strongly believe that actions speak louder than words and are proud to share these promising developments.”

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The FDA granted Breakthrough Device Designation to the Caption Guidance software based on a reasonable expectation that it could provide more effective diagnosis for life-threatening or irreversibly debilitating diseases relative to the current standard of care in the U.S. As a breakthrough device, Caption Guidance will receive priority review during the marketing authorization submission process, with the goal of providing more timely access to this breakthrough technology. The company will also receive interactive and timely communications with the Agency to align on novel regulatory considerations.

As part of its participation in the Breakthrough Devices Program, Caption Health and the FDA worked together to develop a prospective, multicenter, pivotal clinical study conducted at Northwestern Medicine and Minneapolis Heart Institute, part of Allina Health. The study evaluated the use of Caption Guidance by medical professionals without specialized echocardiography training.

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In this study, eight registered nurses (RNs) with no prior cardiac ultrasound experience used Caption Guidance to acquire a total of 240 limited exams, following a short training course. Patients were stratified to include a wide range of body-mass index and cardiac pathologies. The RNs acquired limited echo exams of 10 views each. Each exam was assessed by a panel of 5 expert cardiologists to determine if the exam was of sufficient quality to make a set of specific qualitative visual assessments.

Caption Guidance successfully met all four primary endpoints, meeting the pre-specified criteria for study success. The criteria for study success was that greater than 80% of exams provided sufficient quality for specific clinical assessments. Namely, the RNs successfully acquired limited echo exams for qualitative visual assessments of left ventricular size: 98.8%, 95% CI [96.7, 100]; left ventricular function: 98.8% [96.7, 100]; right ventricular size: 92.5% [88.1, 96.9]; and pericardial effusion: 98.8% [96.7, 100].

“This is a landmark study of a breakthrough application of artificial intelligence in healthcare, and the top-line results are very promising,” said principal investigator Akhil Narang, Cardiologist at Northwestern Medicine. “Caption AI’s unique technology offers the potential to empower more healthcare providers to perform ultrasound, including nurses, who are often the first point of care for patients.”

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