Periodic Reporting for period 1 - iScan (Automated retinal scans for early detection of diabetic eye diseases through use of artificial intelligence)
Reporting period: 2023-01-01 to 2023-12-31
Oivi’s mission is to provide affordable eye care for all. Our vision is to eliminate unnecessary blindness by providing a high-quality camera for retinal (fundus) photography, with fully automated image capture and diagnostics. Our goal is for Oivi to become the point-of-care device for preventative eye screening, with diabetic retinopathy (DR) as our first area of focus. DR currently affects >100 million people worldwide and is projected to surpass 160 million by 2045. It is the most common cause of blindness among working-age adults. However, through early detection and proactive treatment, it is possible to considerably decrease the risk of severe vision impairment, potentially reducing such cases by over 50%. The major financial and social burden caused by DR will be vastly reduced through a solution like Oivi's.
Current solutions for DR screening are often expensive and require extensive operator training, limiting accessibility for patients, especially in developing countries. Oivi’s device is a unique combination of automated, easy-to-use, low-cost and AI-integrated AI solutions in a highly portable design. These features will allow healthcare professionals and pharmacists to carry out screening anywhere with no prior training and address the unmet need for early screening in primary care.
Oivi’s solution will be equally relevant for low- and middle-income countries like India, as for the European and US markets. Oivi envisions moving the standard of care of screening DR from the ophthalmologist's clinic to the primary care level. This leads to a smooth patient flow between primary care and specialists and reduces patient fallout. Also, pharmacies provide excellent coverage and can make DR screening as common as blood glucose tests.
The iScan project constitutes a vital step to prepare the company’s business strategy, mature the device for its diagnostic functionalities and align it with end-user needs, regulatory standards and IP strategy. The project is expected to untap a large unmet need with the first application – DR screening and diagnosis.
The project represents a pioneering effort in healthcare innovation, with its mission to provide accessible and affordable retinal screening for diabetes patients for early retinopathy diagnosis. The significance of this project goes beyond its technological advancements; it lies in its potential to transform lives, prevent blindness, and enhance healthcare delivery.
Current solutions for DR screening are often expensive and require extensive operator training, limiting accessibility for patients, especially in developing countries. Oivi’s device is a unique combination of automated, easy-to-use, low-cost and AI-integrated AI solutions in a highly portable design. These features will allow healthcare professionals and pharmacists to carry out screening anywhere with no prior training and address the unmet need for early screening in primary care.
Oivi’s solution will be equally relevant for low- and middle-income countries like India, as for the European and US markets. Oivi envisions moving the standard of care of screening DR from the ophthalmologist's clinic to the primary care level. This leads to a smooth patient flow between primary care and specialists and reduces patient fallout. Also, pharmacies provide excellent coverage and can make DR screening as common as blood glucose tests.
The iScan project constitutes a vital step to prepare the company’s business strategy, mature the device for its diagnostic functionalities and align it with end-user needs, regulatory standards and IP strategy. The project is expected to untap a large unmet need with the first application – DR screening and diagnosis.
The project represents a pioneering effort in healthcare innovation, with its mission to provide accessible and affordable retinal screening for diabetes patients for early retinopathy diagnosis. The significance of this project goes beyond its technological advancements; it lies in its potential to transform lives, prevent blindness, and enhance healthcare delivery.
Oivi was founded in 2017 and by 2019, 2 early prototypes were developed. We accomplished developing the full cycle of the optics system and the auto-alignment allowing us to take automatic images of the back of the eye in <1 min. Regarding the deep learning-based annotations for the AI diagnosis, proof-of-concept of the annotations ID of the prototype photos was achieved. A comparative study between our camera and a top high-end camera model revealed similar image quality, allowing for diagnostics in < 10 seconds alignment speed. These achievements are already patent-applied.
In 2021, we started a preliminary clinical validation, collaborating with hospitals in India, where product reliability and stability are being tested. Now, we need to mature the HW design and validate it in clinical studies to reach certification and launch our MVP in 2024 in India and the US, and improve the diagnostic AI tool to integrate it and launch a second iteration of the product in 2026.
In 2021, we started a preliminary clinical validation, collaborating with hospitals in India, where product reliability and stability are being tested. Now, we need to mature the HW design and validate it in clinical studies to reach certification and launch our MVP in 2024 in India and the US, and improve the diagnostic AI tool to integrate it and launch a second iteration of the product in 2026.
Available solutions are too expensive, bulky, and manual, to integrate an eye screening service outside of the eye hospitals. PCPs, like diabetes clinics, do not have access to specialised retinal cameras to complement their diabetes consult with an eye exam, nor do they have enough ophthalmologists to perform and interpret the exam. Thus, the burden of diabetes-induced blindness is still beyond the control of the professionals who provide disease management in primary healthcare centres, as DR is a silent progression disease, and there is a lack of screening services. Only 10-15% of the world's diabetes population has access to the existing screening programs. Overall, PCPs earned the loyalty of diabetes patients (particularly in rural areas) due to their regular interaction and close presence, but are not able to provide any form of diabetes-associated blindness prevention due to a lack of affordable, user-friendly, and accurate solutions to screen and diagnose DR.
Our camera was developed to be a turning point for DR screening, especially in LMICs, by relieving the major pains Oivi’s active end-users face, as it is the first solution that offers:
1)a feasible business model. Oivi’s production price can allow for low scan prices, this is particularly important in India where 80-90% of people pay out of pocket, encouraging the diabetes population to get annually screened.
2)portability and easy-to-use allow the DR screening to be spread to sites where this is not possible today, also addressing the eye specialist shortage – most primary care centres, which are located close to the patients incl. in remote areas, do not have an ophthalmologist. Oivi’s autonomous alignment, capture and diagnostics allow for DR screening to be performed by non-trained staff, allowing for the referral of only DR patients for treatment, relieving eye specialists from screening.
Our camera was developed to be a turning point for DR screening, especially in LMICs, by relieving the major pains Oivi’s active end-users face, as it is the first solution that offers:
1)a feasible business model. Oivi’s production price can allow for low scan prices, this is particularly important in India where 80-90% of people pay out of pocket, encouraging the diabetes population to get annually screened.
2)portability and easy-to-use allow the DR screening to be spread to sites where this is not possible today, also addressing the eye specialist shortage – most primary care centres, which are located close to the patients incl. in remote areas, do not have an ophthalmologist. Oivi’s autonomous alignment, capture and diagnostics allow for DR screening to be performed by non-trained staff, allowing for the referral of only DR patients for treatment, relieving eye specialists from screening.