Sunflower

Alzheimer's affects millions of people, currently averaging around 6 million diagnoses every year and that number is growing. Pharmaceuticals that aim to treat the disease fail to demonstrate safety and efficacy often having detrimental side effects including the risk of death. Alzheimers patients largely have no treatment options as there are currently zero safe & effective Alzheimer’s treatments with FDA Approval in the marketplace. Photobiomodulation has been clinically shown to effectively treat Alzheimer’s but remains unavailable to consumers due to its complexity and lack of commercial availability.

JustLight’s medical device, Sunflower Rx™, makes photobiomodulation understood, accessible, and enjoyable. Through intelligent software, Sunflower Rx™ automatically replicates clinical parameters, delivering precise and effective photobiomodulation treatment in the comfort of home. Sunflower Rx™’s simple phone controls eliminate the need for a trained medical professional to administer the therapy. The experience of using Sunflower is engaging and enjoyable; in a recent study, several dementia patients described Sunflower treatments as “the happiest part of their day.” To date, Sunflower Rx™ has completed a formal pilot study demonstrating cognitive decline reversal as measured by ADAS scores and has received positive feedback from a completed FDA Presubmission. The next step to FDA Approval is to begin the Phase Two Clinical Trial. Starting Q4 2022, Sunflower will also be an FDA Approved device for Chronic Pain Relief.

Sunflower Rx™ provides treatment options to Alzheimer's patients living independently or within assistive care facilities. Currently there exist no FDA-Cleared therapeutic options for Alzheimer’s Disease treatment. Our team at JustLight was inspired to invent Sunflower by the incredible systematic clinical review by Dr. Hambin titled Photobiomodulation for Alzheimer’s Disease: Has the Light Dawned?. This clinical review describes the mechanisms of photobiomodulation reversing neurodegenerative decline. The review goes on to discuss the completed clinical studies on Alzheimer’s Disease with photobiomodulation - detailed safe & effective reversal of the symptoms.

The target population of Alzheimer’s patients we are serving do not have access to the incredible technology of photobiomodulation. We have developed Sunflower to make photobiomodulation for Alzheimer’s Disease simple to perform accurately at home

Ethnography remains at the heart of JustLight’s design process, striving to understand the needs and preferences of our users and deliver a device fit to their needs. Beginning in May 2021 JustLight has made a conscious effort to engage users in sharing their experiences, participating in usability tests, and providing input on Sunflower’s design. JustLight’s sole focus is to design devices fit to the lives of these individuals to maximize compliance and facilitate a seamless user experience. Our design team works closely with teams overseeing clinical research to ensure the highest level of efficacy. Additionally, JustLight has formed relationships with non-profit organizations and experts in the fields of photobiomodulation and Alzheimer’s treatment providing the team beneficial access to expert consulting.

Photobiomodulation is a budding field of science and technology that until recently was unviable for the consumer market due to cost barriers, however, recent advancements in LED technology have transformed it into a viable treatment option for many ailments. Cultural barriers do exist, however, and widespread adoption is hindered by the lack of public understanding and scientific research. The MIT Solve challenge will aid in this effort by providing public awareness of this technology both directly, through visibility and public education, and indirectly through funding of clinical research. FDA clearance of Sunflower Rx™ is JustLight’s focus to gain public trust and maximize adoption and compliance.

Photobiomodulation has yet to show widespread consumer adoption because of its complexity. The application of the therapy requires precise control of multiple variables to ensure its efficacy. These variables, including light intensity, time, distance, wavelength, and others, are difficult to control in a consumer setting with existing technology. JustLight’s device, Sunflower, aims to mitigate this difficulty by using software and smart devices to control these variables, taking the guesswork out. This improved user experience maximizes the effectiveness and allows a direct connection for consumers to take advantage of new clinical findings. Sunflower’s ability to be controlled by software and smart devices also allows for data analysis, further improving the efficacy and providing personalized treatment for every individual.

FDA clearance for Alzheimer’s treatment is JustLight’s ultimate goal. This recognition from our country’s regulatory body will foster trust in the technology by the public and prove its effectiveness. Additionally, FDA clearance will provide the necessary credentials to the device for health insurance coverage, eliminating financial barriers for those who may otherwise be unable to afford the treatment. Long-term, JustLight hopes to have widespread adoption of PBM with hundreds of thousands of devices distributed and being used daily, improving the health of every user.

FDA clearance for Sunflower™ is dependent on the completion of a multi-step clinical trial proving its safety and effectiveness. Efforts to support this process have already been undertaken and the completion of each step proves a major milestone on this track to FDA clearance. Additionally, because Sunflower™ is controlled via a smart device, JustLight is able to track usage data, informing efforts to further the spread of our device’s use.

The distribution of Sunflower devices provides the most direct outputs and outcomes. Sunflowers in the hands of consumers provides immediate benefit to those users, proven in both pilot studies and clinical trials to reduce or eliminate ailments that are affecting these consumers' daily lives. In addition, with mass distribution efforts, each Sunflower device becomes a data gathering portal, feeding the control algorithm with the information necessary to constantly improve the therapy. With efficacy proven amongst consumers on such a large scale, users become salespeople, recommending the technology to their network and furthering the effects of Sunflower’s mass adoption. Furthermore, actions taken by the company to educate consumers about the benefits of PBM leads to immediate benefits in the hope consumers have for diseases they have previously been told have no treatment options. With a greater public understanding of PBM science, JustLight stands poised to provide resources and hardware options to fit consumers' newfound needs. With a growing ecosystem of products and educational content JustLight is able to serve as a one-stop shop for healthcare education and service unlike any other scheme available today.

Sunflower™ uses a range of technologies to deliver PBM to the homes of consumers. PBM itself is an old technology, discovered in the late 1800’s, and used to treat a range of diseases in clinical settings. It uses light in the red and infrared wavelengths, directed at the skin to achieve its beneficial effects. This technology has historically been very expensive to achieve, limited in its light source to expensive vapor lamps that are capable of producing select wavelengths of light. Recent advancements in LED technology however have made it possible to achieve the necessary light output for a fraction of the cost and in a much smaller footprint. Sunflower™ uses 4 different types of LEDs, all controlled individually by a custom-designed app to deliver a range of PBM routines depending on the application. Further, Sunflower’s™ app control allows it to collect data from users to better their experience. This data, with the help of algorithms and AI, can be analyzed to tune the parameters of each individual Sunflower™ routine to maximize efficacy.

JustLight is committed to fostering diversity equity and inclusivity in all of its operations. JustLight has layed out policies and implemented programs to ensure all employees are treated with respect and offered opportunities in an equitable manner. The current team features both men and women in management positions and hiring efforts in the near future will focus on bringing new perspectives to the table.