GLUCOSENZ SDN BHD

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Transcript of GLUCOSENZ SDN BHD

AXUDA BERHADProduct Development &
Traditional Invasive
Glucosenz is the future of blood glucose screening.
It will replace the conventional method of blood glucose testing via pricking
of finger to draw blood. It requires no intrusive mechanism for blood
drawing and will have no reagent for blood analysis.
Conventionally, blood glucose level are measured via drawing out a small
amount of blood by pricking a finger with a lancet and using a strip to
measure the blood sugar with the blood glucose monitor.
GLUCOSENZ
• self-screening
• portable and digital
The product works simply by placing the thumb on the photonic reader for
30 seconds and the result is calculated and reported on the screen
attached to the device. Results can also be downloaded to medical records
or sent to the patient or physician via Bluetooth / Wi-Fi. Wireless data
collection and dissemination capabilities are core components and will
facilitate remote monitoring by caregivers.
It is the first device of its kind to report blood glucose levels digitally,
without any invasive blood draw or finger stick.
This method requires:
blood
daily for 5 years
Comparatively, there is a great potential for cost benefit by replacing the
conventional method with Glucosenz as it requires:
Apply lease facility from 3rd party
financier for up to 5 years (lifespan
of 5 years)
one-time investment of
RM120,000* or
Therefore, there is a potential cost savings (5-year period) of RM701,250.
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The eventual Glucosenz platform consists of four pillar technologies that
enables the device to be at the forefront of screening device for diabetes.
Advanced Photonics
Glucosenz is able to gauge human glucose content through no-intrusive
method utilizing the non-intrusive near spectroscopic field infrared and
Intelligent Deap-Learning algorithm to measure the glucose level.
Internet of Things (IoT)
Glucosenz will create a real-time remote IoT-based continuous glucose
monitoring system. The implemented IoT-based architecture is a complete
system starting from biosensor to a back-end server. Through the system,
doctors and caregivers can easily monitor their patient anytime, anywhere
via a browser or a smart-phone application. Sensor nodes of the system
are able to obtain several types of data (i.e. glucose, body temperature,
and environmental data) and transmit the data wirelessly to the gateway
efficiently.
The patient’s smart-phone becomes a gateway for receiving data from
biosensor. In addition, the gateway with its application provides advanced
services to users, such as a notification service. The results show that it is
feasible to remote monitor glucose level in real-time. Data can be collected
and stored on the device or in the cloud for inclusion into the patient
medical record and/or inclusion into large data sets for clinical registries or
epidemiological studies.
Artificial Intelligence (AI)
AI deep learning capabilities of Glucosenz would enable faster evolution of
from benchtop model to portable and wearable devices. As more data is
collected and the accuracy of the algorithm is increased, the product
design can be further miniaturized to meet the demands of the market for
smaller and wearable devices.
BACKGROUND OF OSA TECHNOLOGY
OSA Technology Sdn Bhd (OSA) was incorporated in 2004 and built on
its foundation of modern hi-tech and cutting-edge CNC Orthopedic
Medical Devices precision machining technologies in stainless steel for
private and public hospitals, for domestic and global markets.
The founder of OSA is Dr Hyzan Mohd Yusof, an orthopaedic surgeon
by profession. Dr Hyzan has been involved in humanitarian work in
Malaysia, Afghanistan, Aceh, North Pakistan, Lebanon and others.
Given his concerns for medical devices for surgical operations and
treatment, Dr Hyzan established OSA to provide medical products
which are safe, affordable and accessible to patients.
OSA has been identified by the Ministry of Trade and Industry (MITI) as
a major player in the medical device industry and was chosen as one of
the High Impact Program 5 (HIP5) company by Malaysia’s SME Corp.
OSA has also been a major supplier to the Ministry of Health (MOH)
hospitals nationwide where OSA’s Orthopedic Implant products have
been listed in the Approved Product Purchase List (APPL) since 2008.
For the last 5 years, OSA has conducted research and development
(R&D) of new innovative medical device products in collaboration with
MIMOS Berhad, Malaysia's national applied research and development
centre under the purview of the MITI. Two revolutionary products have
been developed and are ready for commercialisation:
Non-Invasive Blood Glucose Monitoring Device
Vital Sign Blood Analysis Device
Certification and Registrations
European CE Marking Certification
Medical Device Authority (MDA)
MOF Bumiputera Company Registration
Registered Office Arris Management Services Sdn Bhd
Suite 39.1.6, First Floor, Jalan Kenari 17C
Bandar Puchong Jaya
47100 Puchong, Selangor
Universiti Kebangsaan Malaysia 43600 Bangi,
Selangor
Research and development
Vice Chairman of Medical Technology Industry Group – Federation of
Malaysian Manufacturers (FMM)
Industry
Reviewer – Malaysian Orthopaedic Journal 2008 till present
Past Appointments
Kebangsaan Malaysia (HUKM)
Head of Sport Injury Unit – HUKM
Lecturer – Universiti Kebangsaan Malaysia (UKM)
Honorary Secretary of Malaysian Orthopaedic Association
Exco member of Malaysia Relief Agency
Academic Qualifications
Medical Doctor – UKM
United States
Malaysia
Award 2005
AAOS nominee for Humanitarian Award 2007
Quality Award for the Best Innovation for the External Fixator System
The Outstanding Young Malaysian Award
Humanitarian and relief works in various countries such as Pakistan,
Afghanistan, Cambodia, Lebanon, Acheh, Indonesia, Syria and more
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Technology Sdn Bhd
Areas of Responsibilities
Technical and Manufacturing Expertise
- Manufacturing plant to manufacture orthopaedic implants at Bangi
- Managing over all documentation required for various certifications
from planning, preparation and maintenance of technical files,
preparation, adoption and adherence to Standard Operating
Procedure (SOPs), etc. Current and active certifications at OSA
Technology Sdn Bhd including Medical Device Authority (MDA),
ISO 13485, Good Distribution Practice for Medical Devices
(GDPMD), CE marking (product certification mark within European
Economic Area).
- Liaison person for internal and external audit with the various CBs
- Liaison person with Ministry of Health (MOH) and Pharmaniaga for
Approved Product Purchase List (APPL) contract with MOH
- QMR – Quality Management Representative for OSA – required for
ISO certifications and maintenance
Areas of Responsibilities
Overall Financial Management
Planning and Budgeting
- Oversee (macro level) the financial and operational
- Develop products from zero to being market and export ready
- Approach and secure hypermarket outlet accounts
- Maintain customer and supplier relationships
Finance Director | Async Technology Resources Sdn Bhd | April 2002
to Current
- Oversee the managing of resources for technical consulting and
project management
tender submissions for projects such as Kuala Lumpur International
Airport 2 (KLIA2), Universiti Teknologi Petronas (UTP), Malaysia
Airlines, Kuala Lumpur Central (KL Sentral) and Petaling Jaya
Central (PJ Sentral)
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PRODUCT DEVELOPMENT & EVOLUTION
Glucosenz was developed in Malaysia by OSA in collaboration between MIMOS Berhad, a Government Linked-Company under the Malaysian Ministry of
International Trade (MITI). Glucosenz successfully developed working prototypes that underwent and completed clinical trial at Hospital Universiti Kebangsaan
Malaysia (HUKM) in 2019.
first quarter of 2021
Consolidate Glucosenz
Considering the market direction of medical devices towards wearable personal devices, Glucosenz will also evolve from the current benchtop model to a
portable model and ultimately towards a wearable model. The timeline of evolution is dependant on fundraise. OSA has the technology and expertise.
Target market Hospital / Healthcare
Purchase
centre / personal
purchase
use, in-app purchase
Target sales per
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Develop Financial Requirement
USD 727 Billion in 2017.
The burden of diabetes management has become a
major concern, with high socio-economic costs and
implications across Asia Pacific. With diabetes on the
rise, self-monitoring with blood glucose meters and
strips have become an increasingly important aspect of
diabetes management in Asia Pacific, specifically, and
the world, generally.
number of people with diabetes has risen from 108
million in 1980 to 422 million in 2014. In 2017, there
were 425 million diabetics in the world. By 2045,
projections show this number rising to some 629 million
diabetics globally.
Currently, there are almost 138 million diabetics in the
Western Pacific Region and by 2035, this will rise to 202
million (16% of Malaysians are diabetic).
Due to the trends of rapid economic development and
urbanization across Asia, the next several generations
of Asians are especially at risk of developing diabetes.
Recent studies show that Malaysia, India, Indonesia,
China, Vietnam, and the Philippines will have the
highest levels of new diabetes diagnoses over the next
20 years.
Together, the countries of Southeast Asia have some of the highest rates of diabetes prevalence
in the world. However, many of these cases remain undiagnosed.
DIABETES - GLOBAL
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Annual spending on diabetes treatment (US$ billion)
Singapore Malaysia Thailand Indonesia
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Almost 200 million of the world’s 370 million people diagnosed
with diabetes live in Asia. Indonesia is among the top 10 nations
with the most diabetics. In addition, Vietnam, Malaysia and the
Philippines are forecast to have increasingly high levels of new
diabetes diagnoses over the next two decades. Recent research
suggests Southeast Asians are more genetically predisposed to
type II diabetes.
Half of the global elderly population lives in Asia and that share
will rise to more than 60% by 2050. In Southeast Asia, the
percentage of people over age 65 will more than quadruple by
2050.
The ASEAN countries have a combined population of more than
620 million, nearly double that of the United States and more
than 100 million higher than that of the EU. Topping $2.3 trillion,
their combined GDP is equal to around one-quarter that of China.
The region saw GDP growth of about 6% IN 2019, compared with
negative growth in the EU and approximately 2% growth in the
United States.
Growing prosperity means more healthcare spending, leading to
growth in the region’s medical device market. Valued at more
than $4.5 billion in 2013, the region’s medical device market was
projected to reach $8 billion by 2017, led by Thailand, Indonesia,
and Malaysia.
DIABETES - ASEAN
- Population
DIABETES - MALAYSIA
In 2019, 3.6 million Malaysians were suffering from diabetes, the highest rate on
incidence in Asia and one of the highest in the world. By 2025, 7 million Malaysians
will likely have diabetes i.e. 31.3% of adults aged 18 years old and above. It is
becoming a major economic burden on the healthcare system and national economy.
Diabetes is a major public health concern as it is closely related to increase in:
macro and micro-vascular complications
premature and preventable mortality
screenings and for medical professional sponsors conferences
addressing diabetes prevention, detection and treatment.
The support of the Ministry of Health (MOH) is critical to ensure the
success of market penetration of Glucosenz. National public
funding and policy are required and these can be justified by the
long-term cost savings in reduced consumables and reduced
complications arising from late diagnosis of diabetes.
It is the stated goal of Malaysia to focus on prevention wherever
possible. Glucosenz can fit well into this strategy by providing
devices for screening at government hospitals, clinics and even
schools. In collaboration with MOH, Glucosenz can play a major
role in promoting self-care and preventive diabetes measures.
As the number of private hospitals in Malaysia increases, private
healthcare spending should increase with the heavy promotion of
medical tourism by the Government and the healthcare industry.
Malaysia is also a leading retirement destination of expatriates due
to quality healthcare facilities.
Diagnosed Undiagnosed
DIABETES is increasing rapidly in Malaysia, and most cases are UNDIAGNOSED
3% Dental equipment & supplies
Includes dental hand instruments,
drills, sterilizers, dental chairs,
appliances, surgical dressings, disposable surgical
drapes, hydrotherapy appliances, surgical kits,
rubber medical and surgical gloves, wheelchairs
6% Ophthalmic goods
optical and magnification products
equipment, computed tomography equipment
based on North American Industry Classification System (NAICS)
THE U.S. LEADS
MEDICAL DEVICES - GLOBAL
The global medical devices market should expand at a CAGR of 4.5% over the
next four years, reaching a total of $409.5 billion by the year 2023.
Forecasted CAGR in the medical device sector of 5% globally over the period
from 2018 through 2022.
The US market currently dominates healthcare spending with a market share of
nearly 45%; followed by Europe, the Middle East, and Africa (EMEA); and the
Asia-Pacific region (APAC).
Growth in the Asia-Pacific region will be highest over the over the forecast
period, followed by EMEA, making them good targets for medical device
innovators
By the end of the forecast period, healthcare spending in emerging markets will
account for 30% of overall spending.
The market is expected to witness a CAGR of 6.2%, during the forecast period,
owing to the well-developed healthcare infrastructure, the significant presence of
multinational medical device companies, and well-planned reimbursement
policies, among others.
device multinationals, and well-organized reimbursement policies. The analysts
expect APAC to lead growth, driven by rising R&D expenditures by governments
and private-sector healthcare companies.
Surgical and Infection Control
FORECAST BY APPLICATION FROM 2018 TO 2023
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In its recent report, Frost & Sullivan stated that the testing and monitoring of blood
glucose level in diabetic patients is a multi-billion dollar industry led by North America
which holds the largest market share in 2016.
The global blood glucose monitoring (BGM) market was valued at
approximately USD 12.23 billion in 2017 and is expected to
generate around USD 18.87 billion in revenue by the end of 2024,
growing at a CAGR of approximately 5.6% between 2018 and
2024.
In 2017, Asia Pacific held the largest share in the BGM market due
to the large patient pool and wide acceptance of advanced
technologies
BGM Market Size and Annual Growth Rate (2011-2016)
Market siza (USD billion) Annual Growth Rate (%)
Sources: Frost & Sullivan: BMI Espicom; IEK Industrial Technology Research Institute (2014)
COMPETITOR’S COMPANY VALUATION
Market Price per Share $0.02 $6.25 $0.69
Market Capitalisation $4,400,000 $41,194,300 $52,128,369
Valuation - During IPO
Market Price per Share $3.74 $0.42 $394.01
Market Capitalisation $85.622 million $84.22 million $37.72 billion
Valuation – Current as of 15 October 2020
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Market Price per Share $3.74 $0.42 $394.01
Market Capitalisation $85.622 million $84.22 million $37.72 billion
Latest Financials (AR)
Revenue - $208,762 $1,476 million
Profit / (Loss) After Tax (4,160,196) - $101.1 million
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Manufacturer OSA/AXUDA Abbott Dexcom Dexcom Senseonics Nemaura Medical
Technology Non-invasive
Reliability Clinical trial based on
ISO 15197:2013
Reliability (overall MARD) <20.0% 11.4% 9.8% 9.0% 11.4% <12.0%*
Reliability (Clarke Error
Patients Studied 1050 72 324 97 44 >75
Patient Days Studied 1 14 10 9 90 1 - 4
Warm-up Time 15-45 mins 1 hour 2 hours 2 hours NA 30 – 60 mins
Daily Calibration 1x none none 2x 2x 1x
Glucose Display
Manual activation
of sensor
Every 5 mins Every 5 mins Every 5 mins Every 5 mins
Patch/Sensor Life 1625 days 14 days 10 days 7 days 90 days 1 day
Regulatory Approvals EU US Worldwide EU EU
Basis for reimbursement NA Finger stick NA CGM CGM Finger stick
Daily Average
Reimbursement Cost
Daily Retail Cost UK
PROJECT COSTING REVENUE MODEL
The pricing of Glucosenz is highly dependent on the cost of raw material
especially the highly specialised and imported spectrometer. Other material
costs are relatively reasonable and can be easily sourced locally.
Direct Costs of Manufacturing
1 Quality Assurance Officer RM 4,000 per month
Logistic 2% of Sales
Gross Profit Margin ~56%
- Benchtop Version - Outright Purchase
financier (RM120,000)
- Premium User Subscription (RM4/month)
Average Net Assets Value 315,142,700
Market Approach (Y10 but discounted) 533,113,436
Average Valuation 485,897,157
Glucosenz Benchtop Version 2021
Glucosenz Miniature Version 2023
Glucosenz Wearable Version 2025
OFFER SUMMARY
Offer Size The Offer is to raise up to USD 10,000,000
Instrument Ordinary Shares
Minimum Investment USD 1,000,000
Target Investors Targets participation from institutional and sophisticated investors
Potential Exit An Exit may be carried out in various ways, including but not limited to:
an Initial Public Offering of the Company's shares (“IPO”)
a trade sale of all or substantially all of the Company’s shares (for cash or share consideration)
BENEFITS AND RETURNS ON INVESTMENT
Malaysia Business opportunity to be part of Malaysia’s nation building through the production of essential
medical device equipment
Equity Equity in Glucosenz technologies and medical devices with the following status:
completed working prototype for Glucosenz benchtop model
proven and working technology
Joint-Venture with OSA Technology Sdn Bhd to secure:
experience in manufacturing of medical devices with ISO 13485 and GDPMD certification
access to medical technologies and research team
connection to the business network in the medical industry