NIA Small Business Showcase: Blue Iris Labs

Scientific and Clinical

• April 2024-July 2024: Planned a pilot clinical trial (N = 20) of the Speck and the Speck Connect app.
• Sept 2024-November 2024: Planned full clinical trial (N = 100) of the Speck and the Speck Connect app with 50 healthy older adults and 50 participants with mild cognitive impairment or early-stage AD/ADRD.

Business

• 2013: The first patent related to Blue Iris Labs’ light measurement work was issued.
• 2018: NIH Phase I SBIR award for a pilot study exploring how controlling light in AD/ADRD care facilities can improve health outcomes.
• 2019: NIH Phase II SBIR award for an expanded study exploring how controlling light in AD/ADRD care facilities can improve health outcomes.
• 2021: First commercial sales of Specks.
• 2022: NIH Phase IIB SBIR award that focuses on modifying the tools that Blue Iris Labs developed for light and health researchers into tools that could be used by AD/ADRD patients and their caregivers to directly modify their light exposure in ways that improve their health outcomes.

Financial Overview

In September 2022, Blue Iris Labs received a $2,478,222 NIA Phase IIB SBIR Award (2R44AG060857) called “A Light Exposure Tracker Designed to Improve the Circadian Entrainment for Alzheimer’s Disease Patients.” In September 2019, the company received a $2,472,857 NIA Phase II SBIR Award (2R43AG060857) called “Device to Control Circadian-Effective Light in Alzheimer’s Disease Environments.” In September 2018, the company received a $225,000 NIA Phase I SBIR Award (1R43AG060857) called “Device to Measure Circadian-Effective Light in Alzheimer’s Disease Environments.”

Blue Iris Labs is not currently seeking private capital. It may do so in the next one to five years, particularly if it pursues more consumer-oriented markets.

Intellectual Property

Blue Iris Labs and Erik Page hold three patents, with three more pending, in areas related to the measurement and control of light to support personal circadian entrainment. In addition, Blue Iris Labs holds registered trademarks for the Speck sensor, as well as the Blue Iris Labs name and logo design.

Product Development and Regulatory Strategy

Blue Iris Labs’ product development currently has two main focus areas. The first is to continue to refine and scale the Speck and associated data systems in order to support light and health researchers in accurately, affordably, and easily monitoring light exposure inputs as they study how these lighting patterns affect health outcomes in a growing number of applications. The second area is to tailor these measurements tools to let consumers or patients (rather than researchers) see what their own light exposure looks like and how it affects their own health. Blue Iris Labs does not anticipate a need for regulatory approval for the initial versions of this system, because the company will simply provide information on the environmental conditions (e.g., light exposure) that the consumer experiences rather than therapeutic interventions. But the company might later explore regulated solutions that include light therapy interventions that require or benefit from regulatory authorization.

Commercialization Strategy

Blue Iris Labs sees significant long-term potential in establishing itself as the industry leader in providing tools and insights related to quantifying the light exposure that people experience and the resulting impacts on their health. The company’s years of work developing personal light exposure systems that are accurate, robust, and scalable, along with its growing intellectual property portfolio, will be critical in addressing and defending these markets.