Credit: AusMed Global

For diabetic ketoacidosis (DKA) and ketosis (fat metabolism), ketones are crucial biomarkers. If untreated, diabetic ketoacidosis (DKA), a major consequence of diabetes, can swiftly become life-threatening. When your body doesn’t produce enough insulin, blood sugar can’t enter your cells to be used as energy, which leads to DKA. The body manufactures ketones from stored fat during the natural metabolic process of ketosis, which is used as a backup energy source when glucose is not easily accessible. According to studies, the possible advantages of ketosis may include weight loss, brain function protection, epilepsy reduction, the killing of some cancer cells, the reduction of inflammation, the management of non-alcoholic fatty liver disease, and improved athletic performance.

Currently, a finger-prick blood test that measures the blood ketone concentration is the most intrusive and expensive way to measure ketone levels (for both point-of-care and home use). AusMed and its collaborators have been developing novel non-invasive technologies, such as high-precision sensors and sophisticated materials, to identify the concentration of breath ketone (acetone).

AusMed Global Limited (AusMed), a rapidly expanding life science firm with a focus on photonic sensing technologies for the non-invasive assessment of biomarkers from breath, was founded in Hong Kong in 2017. The first version of AusMed’s hand-held breath acetone (BrAce) analyzer, which allows more effective management of DKA and ketosis (fat metabolism), is soon to be released after six years of collaborative work. The founder and CEO of AusMed, Christine Yip, discusses with HKTDC Research the process of turning its research into a user-friendly medical equipment on the Hong Kong market.

Pinprick Tests: A Non-Invasive Alternative

A finger prick test may seem like an easy way for people with diabetes to check their blood ketone levels on a regular basis, but doing so hurts and raises the possibility of wound infection. Instead of using pinpricks, AusMed offers a method to measure ketone levels through breath analysis. A truly non-invasive, simple-to-use breath ketone testing equipment is on the horizon for people who are wary of using traditional finger-prick blood ketone metres (invasive) and urine ketone testing strips (messy and delayed) for managing their diabetes and ketosis.

Yip said: “AusMed is headquartered in Hong Kong, with an R&D Centre & Laboratory and Software & Production Centre set up in the Hong Kong Science and Technology Park (HKSTP). Our team has taken charge of the deployment of the core novel sensing technologies for measuring BrAce with wide medical and healthcare applications. Our first‑generation BrAce analyser, the KetoMetrics breath ketone analyser, aims to provide a quick and accurate non‑invasive measurement method for DKA and ketosis (fat metabolism) management. In some cases, DKA can occur when the blood glucose level remains at a normal or relatively low level (i.e., euglycemic diabetic ketoacidosis (EDKA)), this could conceal the underlying DKA under conventional screening protocol and pose a diagnostic challenge. AusMed’s handheld breath acetone (BrAce) analyser offers a timely non‑invasive method to detect breath ketone regardless of blood glucose levels aiming to mitigate the risk of both patients and healthcare providers due to a delay in realization of the EDKA condition.”

International Patents

With patents issued in the USA, China, and Australia, this invention won the silver medal at the 2022 Geneva International Exhibition of Inventions for its fat reduction management solution. The portable BrAce analyzer made by AusMed is a game-changer and differs significantly from other models now on the market. In contrast to traditional metal-oxide based metres, Yip explained, “Our analyser uses a proprietary disruptive photonic sensing technology that is extremely selective to BrAce but not other volatile organic compounds (VOCs) including ethanol and methanol. Alcohol consumption or the presence of evaporated alcohol gas in the hospital environment, therefore, have no impact on the measurement’s accuracy. Another irreversible byproduct of fat breakdown is breath acetone. A person can determine the most suitable ketosis and weight-management plan for their daily needs by measuring ketone for monitoring ketosis purposes. This reveals how rapidly the body burns fat. Our company has been certified by ISO 9001 (GB/T 19001), ISO 13485 (YY/T 0287), and FDA as a medical device establishment. With patents issued in the USA, China, and Australia, Our KetoMetrics is currently an FDA-listed medical device that won the silver medal at the 2022 Geneva International Exhibition of Inventions for its fat reduction management system.

Other distinguishing features of AusMed’s BrAce analyzer make it stand out from the competition. “First, KetoMetrics supports a broad range of BrAce measurements, including DKA screening, nutritional ketosis (4–20 ppm), exercise effective ketosis (20–40 ppm), and therapeutic ketosis (40–75 ppm), according to Yip. Simply insert the disposable testing kit and exhale once into the handheld gadget, and the result will appear on the device within a minute. Secondly, it is simple to use with excellent accuracy. Disposable testing kits are designed to minimise carryover contamination, which is essential for any medical device. Third, the device will include either a disposable breath sample collector for point-of-care use or a washable breath bottle for home use.

This makes it possible for every breath measurement to be accurate, whether it is used by one person in the privacy of their own home or by several people in a clinic or public setting. Additionally, users can connect their breath ketone, daily food intake, and personal health data from health wearable devices to the KetoMetrics breath ketone analyser via Bluetooth connection with AusMed’s KetoMetrics novel AI diet management system and app in order to produce personal health reports for diet management and aid in their wellness initiatives. Users can also choose to give their personal reports to their personal trainers and healthcare providers for individual consultations.

The cutting-edge AI diet management system and app from KetoMetrics encourage wellbeing and a healthy lifestyle, which is in line with the growing worldwide trend of primary care and remote medicine.

Leveraging the GBA

Yip decided to start AusMed in Hong Kong because of a number of important considerations, including a straightforward tax system, a solid legal system, a thriving capital market, independent R&D facilities, a strong supply chain network, and accessibility to the mainland Chinese market. Yip said: “The bio‑cluster at the HKSTP offers state‑of‑the‑art R&D facilities and support. We’ve also partnered with Hong Kong Productivity Council (HKPC) for prototype development. There are more than 100 electronic parts and components in our device, so we need to conduct repeated tests and verifications to ensure, for example, the strength of the user’s exhaled gas flow is enough for the sensor to collect data and ensure measurement accuracy, whether the direction of the gas flow will affect the results, and whether water vapour in the gas flow will affect the measurement.”

During AusMed’s business journey in Hong Kong, Yip has identified some of the strengths and weaknesses in the city’s start‑up ecosystem. “In the past few years, HKSAR Government has put more emphasis on innovation policy and funding support for R&D. We’ve also received funding from the Innovation Technology Fund. However, we would love to see further streamlining of the application procedures, particularly when it comes to proposal content, budget, and quotation, considering the practicalities of R&D operation and expediting reimbursement as cash flow is always a major concern for start‑ups.” She continued: “Since Hong Kong has strong intellectual property (IP) rights protection, we develop the most sensitive technology of our device in the city. Although Hong Kong does not have a strong local manufacturing base, as long as we can source any necessary electronics parts and components rapidly and outsource production to the mainland Greater Bay Area (GBA) cities, we believe it is best for us to keep our core R&D function in the SAR.”

There are downsides, however, Yip explained: “It is still very expensive to rent an office or lab space in Hong Kong. The high cost of living makes it difficult to attract talent from overseas. As we are going to launch our device in the near future, we need to hire more competent R&D talents, engineers, and project management experts to secure the long‑term growth of our venture.” 

The Way Forward

In response to the first input from the industry, AusMed intends to launch KetoMetrics concurrently in the business-to-business (B2B) and business-to-consumer (B2C) markets. The initial model of KetoMetrics will have a soft launch later in 2023 after the alpha prototype [2] was finished in 2022. The target audiences for ketone will include the diabetic community, the weight management and sports groups, and the general public seeking wellness and a healthy lifestyle because ketone is a flexible biomarker for both DKA and ketosis maintenance. Over the next two years, AusMed will concentrate on Hong Kong, Southeast Asia, mainland China, and the US as regional markets. While there are difficulties entering various markets since regulatory approval procedures vary by market. Yip said: “The most effective way is to find a local partner to sort out the regulatory approval requirements and purchase systems of medical institutions in different markets.”

Yip said: “The pandemic has delayed the clinical side timeline of KetoMetrics, but we are now resuming our clinical studies at Queen Mary Hospital and HKSTP. We expect that clinical collaborations with other health sciences clinicians and researchers and with local private health care practitioners will be kicking off later this year.”

Capital is an important factor for every start‑up’s long‑term development. Currently, AusMed is funded primarily by angel investors and research funding from the governmentYip said: “Headquartered in Hong Kong, an international financial hub, we have connected with or been approached by numerous family offices, private equity funds, and venture capitalists in Hong Kong and the region. More recently we have been approached by distributors and insurance companies for collaboration opportunities. While keeping our options open, we are looking forward to meeting with strategic partners to oil the wheels of the company’s long‑term growth.”

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