This company aims to measure glucose painlessly with photoacoustics

It is a known fact that people with diabetes have to monitor their blood sugar levels regularly by pricking their skin. That has prompted many glucose-monitoring device makers to pursue needle-free approaches to make this process easier to manage. Among them is a South Korean company called HME Square, which uses photoacoustics to test glucose levels non-invasively.

Founded in 2020 by former Samsung employee Yoonho Khang and medical doctor Sooah Im, HME Square was created to address this common health issue, which affects more than half a billion people worldwide — and is expected to increase to 1.3 billion by 2050.

The company claims its initial study shows accuracy better than continuous glucose monitoring (CGM) devices on the market. A preliminary study shared with investors, based on the mean absolute relative difference (MARD) and the Clarke Error Grid (CEG) — a tool used to assess the accuracy of glucose monitors — shows its current MARD is 7%. The lower the MARD, the higher the accuracy. In comparison, CGM devices made by the likes of Abbott, Dexcom, and Medtronic show MARD between 8.7% and 9.2%.

HME Square's device uses a MEMS sensor and photoacoustics with deep learning to measure blood sugar. Photoacoustics is a noninvasive sensing technique that involves shining light on a substance (such as blood) and reading the ultrasonic waves it emits.

The technology also can be used for broader applications in various biological substances in the body. For instance, it can monitor ketones, glycated hemoglobin (HbA1c), cholesterol in phase 2, and bilirubin and creatinine in phase 3.

The company is in the R&D stage now, and it will take a couple more years to bring the device to market in South Korea and the U.S., aiming for 2025. The startup plans to apply good manufacturing practices (GMP), which is a set of standards that ensures pharma products are consistently produced. After getting GMP approval, it will start clinical trials in the country, which will take around a year.

Unlike invasive measures such as blood sampling or CGM, which can easily set a reference point because samples are collected directly, with noninvasive glucose monitoring techniques - it is not easy to get accurate outcomes or data.

"For example, the optical method technology used by Apple obtains a lot of data, but because it cannot directly compare signals from different wavelengths, it is challenging to improve measurement accuracy. We are focused on solving this problem, and we are currently making significant progress," Khang explained.

He went on to claim their photoacoustic method is superior because photoacoustic ultrasonic signals are made from glucose-absorbed energy from lasers and contain more information.

HME Square will use a direct-to-consumer business model, selling products to people with diabetes and people who use invasive measures like CGM. It is also considering adding subscription models once it commercializes, adding that its device will likely cost around $1,000 for two years of use.

So far, the company has raised more than $3 million from investors, including Postech Holdings. It is currently in the process of raising $2 million for R&D and hiring additional staff.

source

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