Meracle Health is a leading innovator in the digital health industry, dedicated to transforming medicine delivery for individuals with chronic diseases. Our mission is to provide relief and assurance to patients suffering from respiratory and chronic ailments by optimizing therapy delivery safely and efficiently.

At Meracle Health, we have developed a unique and user-friendly smart spacer and related digital platform that fosters the effective delivery of patient medications and seamless collaboration between patients and doctors. Our innovative solution empowers patients to take control of their health by streamlining medication management, enhancing treatment adherence, and facilitating effective communication with healthcare professionals. Our platform aims to eliminate the barriers and inefficiencies associated with suboptimal medicine delivery in chronic diseases.

The Whizz is a simple, intuitive, and convenient solution to achieving good clinical outcomes by addressing the issues of incorrect technique and low compliance. It is the first product in the market to utilize a dual-pronged approach, providing a comprehensive solution to patients, caregivers, and doctors. The system incorporates real-time feedback on the correct technique, ensuring medication is delivered directly to the lungs and not to the back of the throat.

The Whizz is paired with a mobile application, which tracks patient behavior and encourages good compliance. This simplifies the medication routine and, through gamification, incentivizes patients to take ownership of managing their chronic condition by automatically tracking progress against goals. Doctors will also have access to accurate and objective data to track progress and identify suboptimal techniques and compliance, thus optimizing treatment dosage and improving the quality of care. These are actionable and valuable data that can potentially be used to detect patients' treatment patterns, customize therapy and quantify potential risks.

By setting new industry benchmarks and standards, we strive to enhance the well-being of patients while revolutionizing the healthcare landscape.

Our team of experienced professionals combines healthcare, technology, and patient care expertise. Meracle is founded by a group with over 50 years of experience in medical device development and commercialization. This multifaceted team consists of:

Victor Loh (CEO) Founding partner, former MD of Vicplas International Ltd & Forefront Medical Technology Pte Ltd. Successfully listed three companies on the Singapore stock exchange.

Melvin Loh (COO) Director, MERCI, NUS. Led & managed innovation of novel medical devices within NUS with 11 successfully commercialized products.

Rachel Hong (CTO) Co-director, MERCI, NUS. Led product engineering teams by designing and developing a portfolio of 21 projects.

The team brings many capabilities and vast experience in manufacturing, finance, product development, regulatory, quality, operations, and commercialization. Driven by our first-hand knowledge of loved ones diagnosed with asthma, the team understands the frustration of frequent exacerbation and emergency room visits despite regular follow-ups and increasing medication dosage. Thus, the inspiration emerged to bring this innovation to patients suffering from respiratory diseases.

With a deep understanding of the challenges patients and healthcare providers face, we have designed our digital health technologies to address their specific needs and deliver measurable improvements in patient outcomes. We continuously strive to stay at the forefront of digital health innovation, leveraging the latest advancements in technology and medical research to enhance our solutions further.

While we focus on optimizing therapy delivery, we recognize the importance of collaborating with industry partners, healthcare organizations, and regulatory bodies. By fostering strategic alliances and adhering to the highest standards of quality and compliance, we ensure that our solutions are aligned with the evolving needs of the healthcare ecosystem.

Total Addressable Market (TAM): USD40B. The market's annual growth rate is 45% (Demand validated by competitors.) There are 25 million people with asthma in the US. Nearly 9 million of these are children. Proper inhalation techniques, particularly in children, and compliance are hurdles to successfully managing asthma.

This is equal to 26.6M units of spacers a year. We assume a 20% conversion to smart spacers. SAM - 5.32M units per year. SOM - 1.06M units per year.

The estimated revenue on this volume is 117M per year.

Pulmonary disease is a wide field with rather low innovations in drugs and delivery devices. The device could potentially work for other types of medications and applications (e.g., inhaled insulin and pain medications). The usability and clinical trials demonstrated that the Whizz improved asthma control and reduced symptoms on one side. The intended use of the proceeds to perform regulatory testing lacks details of what is already proven and expected to meet FDA requirements.

We anticipate Meracle to be revenue-generating in 2023. With regulatory approvals from the HSA (Singapore), they will first enter the Singaporean market, followed by major ASEAN nations, including Malaysia, Indonesia, and Thailand. Meracle anticipates PMDA (Japan) approvals by the end of 2023 and has distributors in place. In 2024, they plan to enter Australia, New Zealand, Korea, and Taiwan and be ready for the European and US market in 2025. They expect to turn profitable by 2025.

Reimbursement development in Europe and the US is promising, whereas the solution can be made available via the DiGA (Digital Health Applications) reimbursement platform in Germany. In the US, the newly introduced CPT codes for Remote Therapeutic Monitoring (RTM) code exclusively for monitoring compliance for respiratory conditions allows recurring charges of as much as USD55.00 a month.

Market Players and Competition:

There are currently two segments of solutions in the market that address delivery of inhaled treatment, which we consider potential competitors to the Whizz.

These are 1) regular spacers (e.g.: Aerochamber, Optichamber, Space Chamber)

2) connected inhalers (e.g., Adherium, Propeller Health, Cohero Health, Proair Digihaler). Propeller Health is the frontrunner in this space and was acquired by ResMed for USD225M.

However, none of the currently available solutions can address the problem of inhalation technique. Good asthma control requires managing both design and compliance. As the first product in the market that addresses technique improvement, compliance, and quality of care, we believe that the Whizz spacer device is a unique product that provides a comprehensive solution to patients, caregivers, and physicians and reduces the economic burden on the healthcare system. Key opinion leaders in asthma therapy, such as Prof Adnan Custovic, Clinical Chair in Pediatric Allergy, Imperial College, London, agree that this dual-pronged approach by the Whizz will help deliver inhalation medication more effectively to patients.

Meracle Health has achieved significant traction in the market, with a growing clinical trial database and strong clinical acceptance of its smart spacer. The company further develops its digital platform to capitalize on personalized medicine. Our deep knowledge and experience in commercializing medtech devices to meet market demands, our dedication to continuous improvement, and our commitment to delivering exceptional value to patients and healthcare professionals set us apart from the competition. We envision a future where our digital health technologies are pivotal in transforming chronic disease management and improving millions worldwide's lives.

With regulatory approval now in Singapore, pending in Japan (August) and Luxembourg (2024), 510K in the US (2024), and a strong network of distribution ready to meet market demand, Meracle Health will make a profound impact on the lives of its patients, redefine industry standards, and empower individuals to live healthier, happier lives.

Meracle's Planned ESG impact is focused on improving patient outcomes and saving lives from the world's respiratory diseases:

a) Reduction in mortality rates associated with targeted respiratory diseases.

b) Decrease in hospitalization rates for patients using Meracle Health's solutions.

c) Improve respiratory health indicators (e.g., lung function tests and symptom severity scores) for patients receiving Meracle health interventions.

d) Increase in the percentage of patients achieving disease management goals (e.g., improved lung capacity, reduced symptom frequency) through Meracle Health's treatments.

e) Decrease in the burden of respiratory diseases, measured in terms of disability-adjusted life years (DALYs) or years of healthy life gained.

Providing clinicians with objective data to give the right treatment and information at the right time to the right patient:

a) Increase the accuracy of treatment decisions made by clinicians using Meracle Health's objective data.

c) Improve patient outcomes based on treatment decisions guided by Meracle Health's data-driven insights.

d) Increase adherence to evidence-based treatment guidelines among clinicians utilizing Meracle Health's solutions.

e) Improvement in patient satisfaction and trust in healthcare providers due to personalized and timely interventions facilitated by Meracle Health

The 4 Key indicators selected are as follows:

Reducing the reliance on rescue medication by 20%,

Improve asthma control via the asthma control test by 1.5 points.

Improve compliance with drugs by 50%

Improve inhalation technique scores by 70%

FINANCIAL TERMS

Meracle is raising its seed round for USD500K to fund regulatory activities leading to regulatory approval in Europe (CE Mark) and Singapore (HSA).

Structure: Priced round USD6.88M post money - USD6M pre

Pricing: Pre-Seed of USD500K followed by Seed of USD2M.

Syndicate partners: Enterprise Singapore, Plug and Play Asia, R3i Ventures, TRIUM Angels.

Board Seat: A single board observer seat is to be assigned to the lead LP. The Board of Directors shall be formalized in Series A prior to the conversion round. The initial seed funding will be delivered based on a standard SAFE note. A Board of Advisors will be formalized on finalization of the MVP and Anchor Lead User.

Meracle received the following grants to support regulatory and clinical activities.

Enterprise Singapore (ESG), Startup SGTech Proof of Value grant (Quantum: SGD500,000. Status: Awarded: March 2021)

Luxinnovation Fit4Start edition 10 graduated (Quantum: 50,000 Euro. Status Awarded July 2021)

National University Health System (NUHS), Singapore, Practice Changing Innovation (Quantum: SGD200,000. Status: Awarded July 2022)

Luxembourg Ministry of Economy, Digital Health PPP grant. (Quantum: 1.35mil Euro, Status: Awarded: April 2022, in partnership with Luxembourg Institute of Health)

Exit Options

With their competition being acquired by ResMed for 225M, R3i anticipates offers for exit within three years of investment from big pharma as a companion device to their inhalers.

About Meracle Health‎