Tesseract Health Inc. has closed an oversubscribed series B financing, reeling in $80 million with support from Foresite Capital, Glenview Capital and Opaleye. The proceeds will be used to advance the company’s Tesseract Ic eye-imaging diagnostic technology platform, including U.S. and overseas regulatory clearances.

This is the first independent financing round for the Guilford, Conn.-based startup, which is developing a platform capable of diagnosing a range of diseases without a single blood draw. The company received prior seed funding as part of the 4Catalyzer med-tech incubator.

The Tesseract Ic system utilizes a chemical sensor and combined, multiple dimensions of imaging technology and artificial intelligence (AI) to image the retina – the only part of the body where arteries, veins, capillaries and nerves are readily visible. The hand-held, binocular eye-imaging device is portable, affordable and easy to operate, features aligned with a post-COVID world with a focus on accessibility and telemedicine.

Tesseract envisions a new branch of diagnostics that leverages the best in imaging and laboratory medicine to support screening, diagnostics, monitoring and treatment across a range of clinical sites and disease states.

“We anticipate retinal imaging to become a new 21st century diagnostic platform with new and unanticipated applications unlocked by the capabilities of new sensor technology, lower-cost semiconductor and computing technology and new applications from machine learning,” David Rosenthal, Tesseract’s chief medical officer, told BioWorld. “The Tesseract device will cost a fraction of current technologies, due to our ability to vertically integrate and [the] introduction of proprietary semiconductor technology.”

Use of proceeds

The new funds will support a variety of activities, including further research and development and clinical trials and human factor validation studies to satisfy regulatory requirements in the U.S. and globally, Rosenthal said. “We are working closely with FDA and anticipate a series of different approvals, including 510(k) clearance.”

Funding is also earmarked for company growth and to scale up manufacturing and prepare for commercialization. Rosenthal said the company will be working with regulators to best define regulatory submissions, and with clinicians and data scientists to develop a broad menu of AI capabilities for the Tesseract Ic platform.

“Our mission is to democratize health care on a global scale,” said Jonathan Rothberg, Tesseract’s founder. “Tesseract aims to disrupt health care by leveraging the wealth of information that exists in the human eye to promote health equity.”

Founded in 2018, Tesseract started as a vision of Rothberg to create portable, affordable devices for disease monitoring and prevention using information gleaned through the eye. The technology was developed completely in-house. Rosenthal is a scientist and serial entrepreneur, known for inventing next-generation DNA sequencing and for founding several companies including Raindance Technologies Inc., later acquired by Bio-Rad Laboratories Inc., Ion Torrent Systems Inc. and Butterfly Network Inc. He founded 4Catalyzer in 2014.

“The name Tesseract refers to the multimodality of the device and the fact that we are looking at the retina in four dimensions, three optical dimensions plus the chemical dimension,” Rosenthal said. He noted that tesseract is also the name of a 4D cube, also known as a hypercube. The Ic in the platform’s name stands for “I see” or “Eye see.”

“We are excited about the potential of the Tesseract Ic to combine a portable, noninvasive view of the eye with advances in AI,” said Jim Tananbaum, CEO and managing director of Foresite Capital. “We believe this combination will unlock the potential of the human eye to transform diagnostics.”

In conjunction with the financing, Vik Bajaj, managing director at Foresite Capital, and Lee Hathaway, partner and co-head of health care investing at Glenview Capital, will be joining Tesseract’s board of directors.

Unlocking secrets in the eye

Other medical technology companies are also looking to the eye and AI to reveal changes in the body. In 2018, Idx LLC patented an AI-based diagnostic system to detect cardiovascular risk by measuring blood vessels in retinal images. That same year, the company garnered a de novo approval for Idx-dr as the first FDA-approved autonomous AI screening system for diabetic retinopathy.

The following year, Optina Diagnostics Inc. obtained FDA breakthrough status for its Retinal Deep Phenotyping platform, which combined hyperspectral retinal imaging and AI to better characterize brain health. The first application under development is in early diagnosis of Alzheimer’s disease.

And last year, Eyenuk Inc. won the FDA’s nod for its Eyeart autonomous AI system for diabetic retinopathy screening in the U.S. The 510(k) clearance was based on Eyenuk’s substantial equivalence to Idx-dr.