More than “windows to the soul,” the eyes are the only external part of the body that can give doctors a glimpse into patients’ cardiovascular health. The same blood vessels that feed the heart are visible through the eyes.
With that in mind, Toku, Inc.—a healthcare artificial intelligence (AI) developer—recognized a revolutionary opportunity for monitoring a patient’s risk of cardiovascular disease, stroke and diabetes. The company created Cardiovascular Risk AI (CLAiR), an AI-based retinal imaging technology platform that detects subtle changes in an individual’s blood vessels, pigmentation and other markers to help optometrists and ophthalmologists assess broader health risks during routine eye exams.
In November 2023, CLAiR received Breakthrough Device status from the US Food and Drug Administration (FDA), which will accelerate the development and review process.
After building the patented AI technology in New Zealand, Toku set its sights on entering the United States, a market with greater potential for securing partners, customers, investors and other opportunities.
Toku was selected for McDermott’s Life Sciences Entrepreneurs Acceleration Program (LEAP) and connected with a US-based team led by Brian Gordon, Byron Kalogerou, Jacob Kuipers and Sarah Sarb, with assistance from Joan-Elisse Carpentier.
McDermott worked closely with the company in achieving its goals: 1) relocating its headquarters from New Zealand to the US and 2) raising capital to fast-track technology development and make vital health screenings more accessible to patients worldwide.
In April 2023, Toku secured $8 million in Series A preferred financing from two lead investors, both prominent US-based suppliers in the eye care industry.
While negotiating with the investors and structuring the financing, the McDermott team simultaneously helped Toku navigate a pre-closing “Delaware flip,” which involved aligning the interests of Toku’s New Zealand shareholders with the new investors. The Delaware flip allowed Toku to establish a US corporate governance presence, making it more appealing to US investors. The company is now headquartered in California with a subsidiary in New Zealand.
In close communication with Toku, the McDermott team collaborated across its tax and transactions practices to manage complexities and achieve objectives. For example, negotiations with investors impacted the team’s approach to the Delaware flip and corporate structuring. At the same time, both factors were affected by Toku’s discussions with its legacy shareholders and New Zealand law. Toku and its McDermott team triangulated all three work streams to align and finalize the necessary legal pieces concurrently.
McDermott also helped Toku executives navigate the US immigration and visa process as part of the move overseas.
Through deferred fees and other benefits, LEAP provides promising early-stage life sciences companies with high-quality legal services prior to a substantial fundraising round. Toku was selected as a LEAP participant in 2022.
Toku’s lead investors operate a combined 60,000 clinics around the world. Having obtained FDA Breakthrough Device status, Toku plans to roll out CLAiR in US clinics by mid-2025, with locations in Australia, New Zealand and the United Kingdom to follow. At-risk patients will benefit from CLAiR’s affordable, noninvasive technology and ability to deliver results immediately, which could lead to early prevention and better health outcomes.
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