The first part: "Whizz", an innovation in bronchial asthma inhalation therapy

To improve the technique and compliance of inhalation therapy

It is estimated that there are about 262 million asthma patients in the world*¹, and the number of patients is increasing in countries all over the world. The situation is similar in Japan, where it is estimated that there are more than 4.5 million asthma patients*² in Japan. In daily asthma treatment, inhaled steroids are the mainstay of treatment, and two or three fixed-dose combinations with a Long-acting Beta2-agonist (LABA) and a Long-acting Muscarinic Antagonist (LAMA) are used. Besides, Biological Preparations such as anti-IgE antibodies (Omalizumab), anti-IL-5 antibodies (Mepolizumab), anti-IL5 receptor alpha-chain antibodies (Benralizumab), and anti-IL4 receptor alpha-chain antibodies (Dupilumab)*³ are used. The number of new treatment options is increasing, and we are facing a great change. 

However, regarding the use of inhaled medication, which is the core of the treatment, there are still compliance issues such as inability to inhale well or incorrect use of inhaled medication. At first glance, this may seem like a very rudimentary problem, but instability of the inhalation technique is often a problem, especially in children and the elderly. Another major challenge is that some patients with severe asthma, such as those with poor response to treatment, exacerbations, and repeated emergency visits, also have problems with medication inhalation technique.

Meracle Pte Ltd, a Singapore-based start-up, has developed a digital device called “Whizz” that addresses this unmet need in respiratory diseases. This is the world's first digital spacer device that can be used to assess and improve compliance with inhalation procedures.

What led to the development of “Whizz”?
Meracle is a MedTech*⁴ start-up established in 2018 as a spin-off*³ from the National University of Singapore (NUS). The company was established with the aim of providing technology that is useful to all those involved in disease and treatment, including patients, families, and medical professionals, by integrating clinical research and data with digital technology.
Meracle has also been selected as one of the participating start-ups in the “500 Kobe Accelerator 2020” which is organized by Kobe City in collaboration with 500 Startups, a venture capital firm in Silicon Valley, USA.

The inspiration for the development of “Whizz” came from one of the founders of Meracle, Mr. Melvin’s experience. His grandmother repeatedly visited the emergency room with severe asthma. He found that the cause of the asthma was that she was not able to inhale medicine accurately, and it led to the start of development.　In addition, the development was initiated by pediatric respiratory and allergic physicians at the National University Hospital of Singapore, who were concerned about the large number of bronchial asthma patients whose treatment was ineffective or worsened due to the rudimentary problems of inability to learn accurate techniques and poor compliance.

Key features of Whizz
“Whizz” is a simple and intuitive solution to improve inhalation technique and compliance.
Each function is explained below.

(1) Evaluate whether the inhalation technique is being performed correctly
The sensor in the device measures the inhalation rate, and the LED panel lights up green when the inhalation rate is sufficient and lights up red when the rate is out of range, thereby assisting in proper inhalation technique.
Since this function can be used for practice, it is also useful for learning proper inhalation technique.

(2) Remind by App
The system can be used in conjunction with a dedicated app, and has functions to improve compliance, such as inhalation schedule management and alert functions with reminders.

(3) Report on usage status
By interfacing with the dedicated app, the system has a function to display a report on the monthly usage status and the usage rate at the appropriate inhalation rate.
This allows patients to check their own usage status and take action to improve it.

(4) Reward system for children
To make it easier for children to use the app, a game-like reward system that motivates them to use the drug and makes it easier to track their progress can be used in the app. The level of difficulty can be set freely, so parents and children can have fun while improving drug compliance.

As a digital spacer, the “Whizz” device is powered by a rechargeable battery, making it portable and easy to maintain. The electronic unit can be removed and washed with water just like a regular spacer. Since it is a spacer, the inhaler that can be used is limited to pMDI*³, and the current application to the FDA is for bronchial asthma. 

“Whizz” is expected to help improve the accuracy and compliance of inhalation therapy, including asthma treatment and other respiratory diseases such as COPD. It is expected to be particularly effective in inhalation therapy for children and the elderly, where treatment is more difficult, and is awaiting approval as a medical device in Singapore and overseas.

(To be continued next part)

【Footnote】
*1　“Asthma”,　WHO,　2019, https://www.who.int/news-room/fact-sheets/detail/asthma
*2　「喘息診療実践ガイドライン2021」 Japan Asthma Society, Kyowa Kikaku Limited, 2021/7/15
*3　Beta-2 stimulants: Dilate bronchioles and relieve dyspnea.
　　Anticholinergic: Prevents constriction of the airways and eases breathing.
　　「セルフマネジメント③　薬物療法」, Environmental Restoration and Conservation Agency, 
　　https://www.erca.go.jp/yobou/zensoku/copd/about/09.html
*4　「成人気管支喘息における生物学的製剤の適正使用ステートメント」　The Japanese Respiratory Society, Japanese Society of Allergology, 2020/５/11、　https://www.jrs.or.jp/uploads/uploads/files/assemblies/20200624_AII.pdf
*5　spin-off： Employees of major companies commercialize their own business ideas and become independent as a company.
*6　MedTech： An IT coined word combining Medical & Technology, referring to efforts to introduce technologies such as IoT into healthcare.
*7　pMDI：　pressurized Metered Dose Inhaler. The pressure of the gas injects the medicine. When inhaling, the timing of the drug injection and the drug inhalation must be matched. If it is difficult to do so, a spacer, which is an auxiliary device, can be used to ensure reliable inhalation. 
「成人ぜん息の基礎知識」, Environmental Restoration and Conservation Agency, https://www.erca.go.jp/yobou/zensoku/basic/adult/control/inhalers/feature01.html

【References】

• MERACLE Pte Ltd Website, https://www.meraclehealth.com 
• 500 Kobe Accelerator 2020　website,　http://500kobe.com/
• Ministry of Health, Labour and Welfare, 大臣官房統計情報部　「平成15年保健福祉動向調査の概況　アレルギー様症状」　2003、　http://www.mhlw.go.jp/toukei/saikin/hw/hftyosa/hftyosa03/.

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