DEVICES LIMITED - Q3 Medical · 2020-06-11 · DEVICES LIMITED Q3 MEDICAL | 03 Q3 Medical Devices Limited is a Dublin, Ireland based holding company formed April 17, 2013 by an international

DEVICES LIMITED

A Q3 Medical Company



CREATING VALUE BY HELPING PEOPLE

Q3 Medical Devices LimitedQ3 Medical Devices Limited is a Dublin, Ireland based holding company formed by an international group of entrepreneurs, manufacturers, distributors, industry doctors, and investors focused on the development and acquisition of medical device businesses with annual revenues between 1-10 Million Euros.

DEVICES LIMITED

Q3 MEDICAL | 03

Q3 Medical Devices Limited is a Dublin, Ireland based holding company formed April 17, 2013 by an international group of entrepreneurs, manufacturers, distributors, industry doctors, and investors focused on the development and acquisition of medical device businesses with annual revenues between 1 -10 Million Euros.

TA B L E O F CO N T E N T S

04 Overview05 Value Proposition06 Growth07 Competitive Opportunity08 Biodegradable 1st Mover Advantage

08 Micro Invasive Technology 1st Mover Advantage

09 Drug Delivery Technology Platforms 1st Mover Advantage

09 Global Distribution: Multi-National Partnerships, Regional Partnerships, Country Partnerships, & Direct Sales

10 Progress of “3V’s” Products Focus11 New Pathway for Biodegradable Implants11 ARCHIMEDES Biodegradable Biliary and Pancreatic Stent

12 UNITY-B Biodegradable Balloon Expandable Stent System

13 QualiMed Innovative Medizinprodukte GmbH

14 Localized Intraluminal Drug Delivery (LIDD)

15 Breakdown of Global Medical Device Market23 History (Wholly Owned Subsidiaries)

23 QualiMed Innovative Medizinprodukte GmbH

24 Sales & Marketing Approach: Modified Generic Strategy

25 amg International GmbH

26 Greenfield Activity26 QualiMed USA, LLC

27 Qsan China

27 Exit28 China Growth Strategy29 China Needs Q3 Medical31 China Channel Marketing Strategy31 Overview

31 Trade Sales

31 IPO

32 Global Sales Network and Distribution Agreement with Medtronic 34 The Future34 Capital Raise36 Appendix: “HKEX” Time Line and Capital Raise38 Clinical Stages of Core and Growth Products39 Disclaimers & Legal Statements

DEVICES LIMITED

Q3 MEDICAL | 02

DEVICES LIMITED DEVICES LIMITED

Q3 MEDICAL | 04 Q3 MEDICAL | 05

Q3 Medical Devices Limited is focused on organic growth through the development of its novel breakthrough technologies in the interventional cardiology, peripheral vascular and non-vascular specialities, with an emphasis on Three Verticals [3V’s] product using its patented Biodegradable, Micro Invasive Technology [MIT] and Localized Intraluminal Drug Delivery [LIDD] platforms. In addition, it is targeting acquisitions that will help facilitate the collective vertical independence of its member groups through the addition of key manufacturing, distribution, or technology-based business that improve margin, reduce cost, and help minimize reliance on external channel participants. The Company is currently implementing SAP globally to allow for improved reporting, tracking, processing, and efficiency management while providing a scalable platform for future optimizations and integrations.

Holding Company Focus: Q3 Medical is focused on maximizing its value through the continued improvement and execution on product development, channel expansion, and operating efficiencies that will enhance financial synergies between its member companies. The wholly owned subsidiaries are primarily focused on the development, manufacturing, and sales of interventional Cardiology, Peripheral Vascular, and Non-Vascular technologies with an emphasis on “3V’s” where it believes it can achieve a 1st or 2nd market position. The “3V’s” consist of novel Biodegradable implants, Micro Invasive Technology “MIT”, and Localized Intraluminal Drug Delivery “LIDD” devices, to treat patients with various cardiac, peripheral vascular, or oncology related issues.

Acquisition Targets: The acquisitions are targeted in areas to expand the group’s manufacturing capabilities, grow its distribution channels, and accelerate its product offering focused on

cardiology, peripheral vascular, and non-vascular diseases. Q3 Medical will focus on strategic acquisitions that accelerate the growth of its Biodegradable, Micro Invasive and Drug Delivery technology Verticals.

In a market where there has been a concerted effort to increase the size and scope of the offerings across multiple specialties through consolidation at the Large Cap and Mid Cap level, Q3 Medical believes there is a significant opportunity to expand its competitiveness through the accelerated organic growth of its “3V’s” in Biodegradable, Micro Invasive Technology “MIT”, and Localized Intraluminal Drug Delivery “LIDD” technology platforms. Currently Q3 Medical is focused on the continued development of its first two acquisitions, QualiMed and AMG, as it expects to realize significant revenue and margin improvements from the launch of its first Biodegradable product ARCHIMEDES™, the Biodegradable replacement for plastic biliary stents. Traditional plastic stents are used approximately 2 Million times annually and require a second invasive procedure to remove them as they become problematic if left in place for longer than 90 days. ARCHIMEDES, one of a number of the Company’s strategic developments in its Biodegradable Vertical received CE approval in the 2nd half of 2018. The company expects to take a minimum of 20% of the global market share of the 2 Million plastic stents (400,000 units) at a blended selling price of approximately 300 euros per unit over the next 5 years with an estimated annual revenue volume exceeding 120 Million in 7 years at 85% plus margin.

The Company expects to launch its second Biodegradable product as well as several of its Micro Invasive Technology “MIT”, and Localized Intraluminal Drug Delivery “LIDD” technologies in the 2020 period.

O V E R V I E W VA LU E P R O P O S I T I O N

Q3 Medical is focused on the development of Innovative and Disruptive Technologies that reduce clinical complication and procedure costs while improving quality of life for patents.

Q3 Medical has developed and continues to focus on its novel technology verticals in: Biodegradable, Micro Invasive Technology “MIT”, and Localized Intraluminal Drug Delivery “LIDD” platforms. Q3 Medical and its wholly owned subsidiaries remain focused on development efforts in technology that is “Creating Value by Helping People”.

Q3 Medical's investment in its “3V’s” emphasizes the product displacement opportunity in large mature markets, with slow moving competitors that have heavily invested in capital expenses to drive their outdated platforms. Q3 Medical’s technology is focused on areas where it can reduce overall complications and expense, while drive down total procedural related healthcare cost.

Through strategic investment and internal development, Q3 Medical has positioned itself and its technology to achieve and maintain the 1st or 2nd market position in the “3V’s” it will compete.

Through its existing global network of distribution partners, Q3 Medical's businesses have started registering and commercializing products globally.

Additionally, Q3 Medical recently signed a strategic partnership agreement with Medtronic, to be the exclusive global distribution partner for the ARCHIMEDES biodegradable replacement for the 2 million plastic stents placed annually. This agreement is the first major global distribution deal signed between a leading multinational and an innovative technology company, which further validates Q3 Medical as one of the elite innovators in the interventional space. Through its partnership with Medtronic, the world’s largest medical device company, Q3 Medical is able to take advantage of its 1st mover advantage and accelerate the global registration for ARCHIMEDES. As part of the agreement, Q3 Medical can leverage the support of Medtronic’s global regulatory and clinical trial teams to support its needs.

The Q3 Medical Group of companies has over 20 years of experience in the design, development, and manufacturing of various medical devices and technology in the interventional cardiology, peripheral vascular, and non-vascular spaces.

The Group plans to more than triple its manufacturing capacity in Winsen, Germany with its new high-tech manufacturing facility in Shanghai, China. Q3 Medical, through its wholly owned subsidiary in China (“Qsan”), will embark on a 3 Phase China strategy that will see it register its novel technology and complete the buildout of its manufacturing facilities in China. The 3 Phase China Strategy will see Q3 Medical leverage existing relationships and continue expansion with the completion of its manufacturing facility in the North of China in Phase 1 during the 2020 time period. This new state of the art facility will have the exact same capabilities as the facilities in Germany, to ensure continuity of production and risk mitigation. Should any complications arise at either site, the other can fill demand. The completion of Phase 1 will be followed by expansion to the middle of China, following the old silk road to the west in Phase 2, before embarking on its final expansion into the South of China in Phase 3. Q3 Medical, through its 12-step product development pathway, will train its China team in the same development methodology that has allowed it to successfully bring to market the products identified in its “3V’s”.

Innovative Technology & Solutions

Market Value & Opportunity

Strategic Partnerships

Manufacturing Infrastructure & Experience

Strategic Partnerships

Market Value & Opportunity

InnovativeTechnology& Solutions

ManufacturingInfrastructure & Experience

• Medtronic Global Partnership• Agreement for Endoscopic

Products• Global Network of Distributors

(EU, EMEA, LATM, ASIA/PAC)

• 20 years of design, development, and manufacturing in Medtech

• High-tech manufacturing sites (Germany & China)

• Over $12.7 billion in total market value (excluding cardiology)

• Novel Products targeting large market with slow moving competitors



CORE &ENGINEERING A Q3 Medical Company


In 2020 the company expects to launch its second Biodegradable product, a Biodegradable Balloon Expandable Biliary Stent Implant (UNITY-B). The UNITY-B, which is a combination biodegradable implant made of a magnesium centre and a polymer outer, gives the implant the same characteristics as a metal implant with the added advantage of being biodegradables. The UNITY-B device will come in both an endoscopic version and a percutaneous version, to allow both sets of doctors (Endoscopist and Interventional Radiologist) to use the implants. The UNITY-B device will be followed closely with the launch of the UNITY-P (Biodegradable Balloon Expandable Peripheral implant). In addition, Q3 Medical has initiated the controlled launch of its Micro Invasive Technology platform, and will continue expanding it globally throughout Europe, USA, and China. This, coupled with the completion of its Phase 1 China Strategy, will insure Q3 Medical is positioned to take advantage of its growth opportunities in the coming years.

As the global commercial launch of its first CE approved biodegradable ARCHIMEDES, (the replacement for plastic biliary stents) starts to accelerate, Q3 Medical and its companies expect to see more organic growth, through the ongoing development and commercialization of its “3V’s” in the Biodegradable, Micro Invasive Technology, and Localized Intraluminal Drug Delivery platforms. Future growth is expected to continue to accelerate with the global registration and launch of its novel technology.

G R O W T H

“Q3 Medical and its companies expect to see more organic growth, through the ongoing development and commercialization of its “3V’s” in the Biodegradable, Micro Invasive Technology, and Localized Intraluminal Drug Delivery platforms.”

CO M P E T I T I V E O P P O R T U N I T Y

“Q3 Medical’s wholly owned subsidiaries are focused on the development, registration, manufacturing, and commercialization of its three new verticals. Through the introduction of its novel Biodegradable, Micro Invasive Technology, and Localized Intraluminal Drug Delivery platforms, Q3 Medical believes it will have the ability to compete in the 25 Billion Euro global market for Interventional Cardiology, Radiology/Peripheral Vascular, and Non-Vascular products.”

In a global market where large multinationals struggle with the speed of change required to maintain technology competitiveness, Q3 Medical believes it can gain a competitive 1st or 2nd mover advantage in its “3V’s”. They are designed to reduce complications associated with traditional long-term implants, eliminate costly procedures associated with removals or redo’s due to complications, and obviate the use of expensive technology that has known complications. Through the use of the advanced technology, Q3 Medical will not only improve patient care, but will help reduce the cost of care for the global medical device market by potentially billions of euros.

G R O W T H P R O D U C T S : P L AT F O R M T E C H N O LO G YT H E 3 K E Y S TAG E S

Each vertical represents an annual multibillion-euro global market opportunity.

BIODEGRADABLE IMPLANT TECHNOLOGYBiodegradable products have the potential to provide solutions designed to reduce clinical complications, procedures, and to reduce overall healthcare costs to patients, clinicians, and hospitals.

MICRO INVASIVE TECHNOLOGY “MIT”It is widely documented in the literature, that the vascular puncture size (hole) used to introduce devices to treat various coronary and peripheral vascular diseases, has a direct impact on Vascular Access Complications [VASC]. Through the reduction of device diameters and increasing the lengths, you can reduce the size of the hole you put in the artery, reduce the complication rates, improve the patients’ recovery time (ambulation), and give the interventionalist additional options for access, for example through the arm, to treat diseases in the leg. In order to gain wider acceptance for this downsizing, the Interventionalists need a full “Kit” of instruments they can use, that allow for such procedures to be successful. Q3 Medical, through its wholly owned subsidiaries, is in the final phases of completing the full “Kit” and has started to launch its “Micro Invasive Technology “MIT”, Vertical. The “MIT” system provides the added benefit of working more effectively in-patient populations or ethnicities that have smaller vessel sizes, such as Asian based patients that traditionally have a vessel size 1mm smaller than that of westerners.

LOCALIZED INTRALUMINAL DRUG DELIVERY “LIDD” TECHNOLOGYLocalized Intraluminal Drug Delivery technology is designed to provide localized delivery therapies, involving venous and oncology applications. The LIDD technology allows the doctor to ensure localized delivery of the therapy, with the added benefit of applied pressure, to increase the potential for the uptake of the therapy into the cell structure. The regulatory strategy has a low clinical risk, since approval will not require a device/drug combination. That is because the drug administered is separate from the device. In addition, the device may have the added benefit of limiting systemic toxicity associated with traditional and evolving oncology therapies, through localized delivery.



ARCHIMEDES

UNITY-B(Endoscopic and Interventional Radiology)

UNITY-PC

UNITY-BC

UNITY-P

UNITY-AD

UNITY-C

UNITY-PCC

PTA Balloon Catheters

GSQ Guiding Catheter

GWQ 18 Guidewire

SCQ Support Catheter

QBX 18 Balloon Expandable Stent System

400 CM Guide Wire for Radial Approach

Peripheral Vascular Self Expanding Stent System (4F)

Peripheral Vascular Self Expanding Stent System (5F)

Drug Delivery for Venous insufficiency

Immuno-Oncology

Anti-Angiogenesis(beads)

Chemotherapeutics for oncology

Non Viral Based Gene Therapy

Multi-National Partnerships

Global Distribution

Regional Partnerships

Country Partnerships, & Direct Sales

1. BIODEGRADABLE 1ST MOVER ADVANTAGE:

The launch of the 1st Biodegradable Implant, ARCHIMEDES (with 3 different absorption profiles depending on clinical need), the Biodegradable replacement for plastic hepatobiliary stents that are used approximately 2 Million times annually, marks the 1st in a number of new technology advancements from Q3 Medical. Unlike ARCHIMEDES Biodegradable, the plastic stents require a 2nd procedure to be removed, as well as additional procedural cost and risk to the patients. The controlled launch of ARCHIMEDES and subsequent strategic partner relationship with Medtronic, followed by other Biodegradable Vertical product launches, which include the UNITY-B (Biliary Balloon Expandable Biodegradable Implant) followed closely by UNITY-P (Peripheral Balloon Expandable Biodegradable Implant), and UNITY-C (Cardiology Balloon Expandable Biodegradable Implant), along with a variety of other Biodegradable implants, position Q3 Medical and its wholly owned subsidiaries as the market leader.

2. MICRO INVASIVE TECHNOLOGY 1ST MOVER ADVANTAGE:

It is widely documented in the literature, that the vascular puncture size (hole) used to introduce devices to treat various coronary and peripheral vascular diseases, has a direct impact on Vascular Access Complications [VASC]. Through the reduction of device diameters and increasing the lengths, you can reduce the size of the hole you put in the artery, reduce the complication rates, improve the patients’ recovery time (ambulation), and give the interventionalist additional options for access, for example through the arm, to treat diseases in the leg. In order to gain wider acceptance for this downsizing, the Interventionalists need a full “Kit” of instruments they can use, that allow for such procedures to be successful. Q3, through its wholly owned subsidiaries is in the final phases of completing the full “Kit” and has already started to launch a number of devices to be utilized in its “Micro Invasive Technology “MIT”, Vertical. In addition, it will be difficult for those multinationals, who have invested in traditional technologies, to migrate quickly to the Micro Invasive Approach, as they will have switching cost issues associated with manufacturing, regulatory, and clinical barriers.

CO M P E T I T I V E O P P O R T U N I T Y

3. LOCALIZED INTRALUMINAL DRUG DELIVERY “LIDD” TECHNOLOGY PLATFORMS 1ST MOVER ADVANTAGE:

As the evolution of biotechnology and both new and old drug treatments continue to evolve, there becomes a greater need for devices that allow for controlled Localized Intraluminal Drug Delivery “LIDD” in order to permit localized vs systemic treatment of the diseases, to help minimize or avoid systemic toxicity. The utilization of pressure to improve the uptake or effectiveness of drugs or the expression of genes in the cell structure, is well documented. The novel drug delivery technology will initially be used to treat patients suffering from Venous Insufficiency. There are over 1,200,000 documented cases per year. With the added benefit to treat Pelvic Congestion Syndrome and other associated diseases through the use of Anti-Angiogenesis (Beads), Oncology (Chemotherapeutics), Immuno-Oncology, and Gene delivery. The company believes that it can penetrate the delivery market by offering a device for controlled delivery, with the added benefit of pressure mediation, to allow physicians the options to treat the disease with their drug or modality of choice, without subjecting their patients to the harmful effects of systemic toxicity.

4. GLOBAL DISTRIBUTION: MULTI-NATIONAL PARTNERSHIPS, REGIONAL PARTNERSHIPS, COUNTRY PARTNERSHIPS, & DIRECT SALES

The company has contracted or developed a global channel through its relationship with Multi-Nationals and Regional Partnerships to take advantage of its 1st mover advantage and accelerate global sales growth through leveraging their existing reach and infrastructure especially in the sales, regulatory, and clinical trials area. In addition the company has established over 50 Country Partnerships to allow for the commercialization of its core and innovative vertical technologies. These world class distributors have been searching for new partners after the mass consolidation in the midcap market due to the large cap acquisitions to replace there lost distribution opportunities. These distributors are well trained, have strong existing doctor and hospital relationships, and need replacement products for the ones lost due to the consolidation. The Multi-National, Regional, and Country Partnerships coupled with a direct sales strategy in some key markets will allow the company to see continued accelerated growth in the coming years as it looks to accelerate top line and bottom line growth.



Source: EMA, FDA, Frost & Sullivan analysis

DEVICES ARE 5 F OR SMALLER

DIAMETER (mm)

SURFACE AREA (mm2)

8 F PSSA is 255% > 5 F

7 F PSSA is 195% > 5 F

6 F PSSA is 145% > 5 F

5.599

4.264

3.142

2.190

2.672.332.001.670

Puncture Site Surface Area (PSSA)

MICRO INVASIVE TECHNOLOGIES

5 F

P R O G R E S S O F “3 V ’S” P R O D U C T S F O C U S

FOCUS VERTICAL

PRODUCT

RELATED SURGERY

LATEST PROGRESS

BIODEGRADABLE STENT

• Biodegradable biliary and pancreatic stent

• Biodegradable Balloon Expandable Stent

Therapeutic ERCP

ARCHIMEDES – CE Approval

UNITY-B – US clinical trial

for biliary disease

MICRO INVASIVE ENDOVASCULAR

DEVICE

• Aspiration Catheter• PTA Balloon Catheter• Balloon Expandable

Stent• Guide Cath• Support Cath• 400 CM Guide Wire for

Radial Approach• Self Expanding Stent

(Pre-Clinical)

Endovascular Surgery

CE Approval and 5 Country

Limited Launch

DRUG DELIVERY BALLOON

• Localized Intraluminal Drug Delivery

Interventional Therapy

Pre-Clinical

N E W PAT H WAY F O R B I O D E G R A DA B L E I M P L A N T S F O R B I L I A R Y A N D PA N C R E AT I C D I S E A S E S

Plastic Hepato-Pancreato-Biliary Stents that always require a 2nd procedure for removal and can be replaced by biodegradable Hepato-Pancreato-Biliary Stents, (ARCHIMEDES), reducing cost and complications associated with removal.

• Q3 Medical has launched its biodegradable replacement for plastic stents with a global distribution relationship with the world’s largest medical device company, Medtronic.

• There are approximately 2 million plastic stents used worldwide each year, with an estimated complication rate of close to 30%, based on the existing literature.

• The biodegradable eliminates the need for the 2nd removal procedure currently needed for the traditional plastic stents. It thus reduces the cost associated with the removals, which are in the range of 5k to 10k euros or more, depending on the market.

• CE APPROVED

Plastic Biliary And Pancreatic Stent > Biodegradable Biliary And Pancreatic Stent

Biodegradable Biliary and Pancreatic Stent

1434

We have established long-term cooperation with over 50 distributors worldwide and most recently partnered with the world’s largest medical device company, Medtronic, to be the sole distributor of the ARCHIMEDES fully biodegradable biliary and pancreatic stent, in several key markets such as Western Europe, the US, and Japan.

> Three degradation profiles address all biliary and pancreatic drainage indications

> Reduces cost, morbidity and complication rates by eliminating subsequent stent removal procedure

> Proximal and distal flaps help minimize migration> Anatomical shape for enhanced positioning> Tapered tip facilitates smooth cannulation



FEMORAL

PEDAL

BRACHIAL

RADIAL

5 F

DEVICES WITH 5 F SHEATH COMPATIBILITY OR SMALLER

Access through the Radial, Brachial, Femoral or Pedal artery: Our Micro-Invasive Technology is focused on reducing Puncture Site Diameter (PSD) and Puncture Site Surface Area (PSSA) by minimizing the device entry and crossing profiles to 5 F or less while maintaining device functionality. By reducing profile and maintaining functionality, Vascular Access Site Complications (VASC) can be significantly reduced with the added potential to eliminate the need and cost associated with Vascular Closure Devices (VCD).

GWQ 180.018” Guidewire

GSQ / SCQGuiding Sheath / Support Catheter

PVQ 18 DF0.018” PTA Balloon Catheter (Dialysis Fistulae)

PVQ 18 0.018” PTA Balloon Catheter

PVQ 140.014” PTA Balloon Catheter

QBX 185 F Balloon Expandable Stent System

UNITY-B Hybrid BRS is a biodegradable stent that:> Functions like a metallic stent> Can be used in non conforming lesions> Can be over-dilated without fracturing> Has minimal recoil and foreshortening> Does not require in advance preparation of the lesion > Can be placed with the same traditional approach

used for a normal metallic or DES stent> Can be easily produced in a wide range of sizes

Biodegradable Balloon Expandable Stent SystemUNITY-B

DESIGNED TO> Reduce Puncture Site Diameter (PSD)> Reduce Puncture Site Surface Area (PSSA)> Minimize Device Profile> Maintain Device Functionality> Reduce Procedure Time> Reduce Port Site Thrombogenicity> Improve Patient Morbidity> Reduce Utilization of Vascular Closure Devices (VCD’s)> Allow to reach more distal lesions thanks to lower profiles> Offer operator more access sites options

Metal Hepato-Pancreato-Biliary Stents can be replaced by Biodegradable Balloon Expandable Stent System.

• It is anticipated that Q3 Medical will launch its next generation hybrid (UNITY = Polymer and Alloy) biodegradable stent for use in following areas:

• UNITY Biliary Biodegradable Balloon Expandable Stent • UNITY Biliary Biodegradable Balloon Expandable Stent Covered Stent • UNITY Peripheral Vascular Biodegradable Balloon Expandable Stent • UNITY Coronary Biodegradable Balloon Expandable Stent

• These UNITY stents function like a metallic stent with minimal recoil, foreshortening and able to dilate without fracturing, and can be used in non-conforming lesions. [Non-Conforming are vessels with different diameters on each end (Conical)]

• Active clinical trial in EU/Asia

• CE Approval Pending

Metal Biliary And Pancreatic Stent > Biodegradable Balloon Expandable Stent System



31.8%

3.4%

4.6%

4.6%5.5%

Billion USDAt ex-factory priceroughly estimated

52.6

46.9

39.5

36.5

27.7

22.1

18.5

18.5

13.9

128.8

Breakdown of Global Medical Device Market

IVD

Cardiovascular Implants

Medical Imaging

Orthopedic

Ophthalmic

Low-value Medical Consumables

Endoscopic equipment

Drug delivery system

Dental

Others

13.0%

11.6%

9.8%

9.0%

6.8%

Source: Frost & Sullivan analysis

B R E A K D O W N O F G LO B A L M E D I C A L D E V I C E M A R K E TF R O S T A N D S U L L I VA N R E P O R T 2017

In Vitro Diagnostic [IVD], Cardiovascular implants and medical imaging are the top 3 segments of global medical device market by revenue, with a total share of 34.3% globally medical device market. Due to the technology evolvement and growing number of gastrointestinal endoscopy treatments, the market share of endoscopic equipment will continue to grow in future.

In addition, 70% of the people with cardiovascular disease will have peripheral vascular, which includes arterial and venous problems. That being the case, the Micro Invasive Technology “MIT” and other endovascular devices and Localized Intraluminal Drug Delivery “LIDD” along with the Biodegradable implants will play a significant role in treating these patients and reducing healthcare cost associated with these disease segments.

LOCALIZED INTRALUMINAL DRUG DELIVERY (LIDD)

Unique delivery for various treatments for vascular and oncology indications including

• Immune Oncology Therapy

• Chemotherapy Localized delivery for Liver, Pancreatic, Kidney, Colonic, and Pulmonary Treatments

• Non-Viral based Gene Therapy

• Sphere delivery for Antiangiogenic applications

• Venous Insufficiency

Micro-drilled localized intraluminal drug delivery (LIDD) balloon catheters only release medication when they are dilated – in the exact locations where the active drugs are required to do their job. Conversely, drug coated balloons (DCB), lose some of their medication before they reach the lesion or target site.

LIDD balloons can release medication multiple times by repeated dilation of the balloon. This means a single LIDD device can be used to treat multiple lesions consecutively.

• The delivered dose of medication depends on the duration of dilation, the pressure, and the number of holes in the balloon.

• The drugs are blended into the contrast medium which is filled into the balloon catheter just before the moment of intervention.

• The drilled balloon catheter itself does not face drug expiry limitations.

• Drilled balloon catheters can also be used as “standard” balloon catheters without the addition of medication.



TOTAL0% 100%

Plastic Stent Biodegrable Stent1

47%54%2030E

20%80%2025E

100%2017

3,004

2,399

1,357

TOTAL0% 100%

Metal Stent1 Biodegrable Stent2

31%69%2030E

22%78%2025E

100%2017

486

388

219

Frost and Sullivan estimate that Hepato-Pancreato-Biliary Stent usage will grow to over 3 million implants by 2030, with biodegradable stents replacing over 50% of the plastic stents, representing a market opportunity for biodegradable stents of over 1.2 billion euros based on an average price to the hospital of 800 Euros.

G LO B A L R E P L AC E M E N T O F P L A S T I C H E PATO -PA N C R E ATO - B I L I A R Y A N D PA N C R E AT I C S T E N T SA R C H I M E D E S

B I O D E G R A D A B L E S T E N T W I L L R E P L AC E A R O U N D 50% P L A S T I C S T E N T S U N I T: T H O U S A N D S E T S

Challenges• Professional sales team, established sales channel by distributors and clear strategic plan from

management level are needed when the biodegradable biliary and pancreatic stent hits the market.

Opportunities• Plastic stents are frequently used in Europe and America, so there is a huge potential for biodegradable

biliary and pancreatic stent market growth, especially with the gaining population.

• Biodegradable stents do not require the second removal procedure, avoiding increased costs for the healthcare systems as well as increased costs and risk of post-operative complications to patients.


1. Mainly includes ARCHIMEDES from Q3 Medical

G LO B A L R E P L AC E M E N T O F M E TA L B I L I A R Y A N D PA N C R E AT I C S T E N T SU N I T Y - B A N D OT H E R U N I T Y B A S E D S T E N T S

Opportunities• UNITY-B and other UNITY based stents can reduce complication rates, procedural costs, and removal

procedures.

• Metal biliary and pancreatic stent market in China is growing fast with great potential in the future.

• Metal stent is used for 2nd-line treatment of patients with malignant biliary and pancreatic tumours.

• UNITY-B can avoid the secondary removal process and alleviate patients’ procedure related complications and associated pain.

Challenges• Patients from commercially less developed countries may not be able to pay if UNITY-B and other UNITY

based stents are priced according to European and American standards.

• Doctors are used to using biliary and pancreatic stents, and may not be able to change their minds without professional education and excellent clinical results published.

B I O D E G R A D A B L E S T E N T W I L L R E P L AC E A R O U N D 30% M E TA L S T E N T SU N I T: T H O U S A N D S E T S


1. Metal stents includes covered metal stents and bare metal stents2. Source: Mainly includes UNIT Y – B and other UNIT Y based stents from Q3 Medical



2013 2014 2015 2016 2017 2018 2019E 2020E 2021E 2022E

11.0% 11.2% 11.3% 11.5% 11.6% 11.6% 11.7% 11.7% 11.8% 11.9%

Global Cardiovascular Devices Market Size % in Global Medical Devices Market

39.9 41.9 42.1 44.6 46.9 49.5 52.5 55.8 59.1 62.6

Period

2013 – 20172017 – 2022E*Compound Annual Growth Rate

Billion USD at ex-factory price

CAGR*

4.1%5.9%

2019E 2020E 2021E 2022E 2023E20142013 2015 2016 20217 2018 2024E 2025E 2026E 2027E 2028E 2029E 2030E

10.3 10.9 11.5 12.1 12.6

7.36.77.9 8.5 9.1 9.7

13.2 13.7 14.2 14.7 15.2 15.7 16.1

Period

2013 – 20172017 – 2022E2022E – 2030E*Compound Annual Growth Rate

Billion USD at ex-factory price

CAGR*

7.7%5.9%3.7%

10.7 22.7 46.5 80.2 122.0182.8

260.5

366.8493.3

607.2

743.6

867.2

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period

2019E – 2025E2025E – 2030E*Compound Annual Growth Rate

Million USD at ex-factory price

CAGR*

70.2%27.2%

5.59.7

16.521.9

25.729.6

32.435.1 36.3

38.8 41.3 42.9

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

34.5%5.7%

10.7 22.7 46.5 80.2 122.0182.8

260.5

366.8493.3

607.2

743.6

867.2

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

70.2%27.2%

G LO B A L C A R D I O VA S C U L A R D E V I C E S M A R K E T S I Z E2013 - 2022 E

G LO B A L M A R K E T S I Z E O F M I C R O I N VA S I V E T E C H N O LO G Y “ M I T ” E N D O VA S C U L A R D E V I C E O P P O R T U N I T Y 2013 - 2030 E

• Increasing intervention of cardiovascular diseases all across the globe has resulted in the upsurge demand for minimally invasive hence, the global cardiovascular devices market grew at a CAGR of 4.1% from US$39.9 billion in terms of sales revenue in 2013 to US$46.9 billion in 2017.

• The market is expected to further grow at a CAGR of 5.9% from 2017 to 2022, driven by ongoing research and development and huge investment in the cardiovascular devices.

• MIT device is equivalent to peripheral vascular device, including angioplasty stents, catheters and other devices. The global MIT endovascular device market was USD 9.1 billion in 2017 with a CAGR of 7.7% during 2013 to 2017, and it is estimated to reach USD 16.1 billion in 2030. Factors driving the growth of this market are the clinical benefits of drug-eluting stents and the widespread accessibility of these devices globally.


G LO B A L M A R K E T S I Z E O F LO C A L I Z E D I N T R A LU M I N A L D R U G D E L I V E R Y “ L I D D ” B A L LO O N 1 2019 E - 2030 E

• Unmet medical needs, clinical benefits of drug delivery balloon and developed health care infrastructure are expected to fuel the growth of the global drug eluting balloon market during the forecast period. The global drug delivery balloon market will reach USD 867.2 million in 2030, with a CAGR of 70.2% and 27.2% from 2019 to 2025 and 2025 to 2030 respectively. Market players including Q3 Medical and other pioneer medical device companies will benefit from this growth.

• Complications with tumour micro environment and delivery of various treatment options are associated with elevated interstitial fluid pressures, aberrant vasculature, and the migration of dense stoma. It is estimated this market will grow rapidly with the increased rates of various hollow organ disease, both benign and malignant, in areas such as the lungs, oesophagus, liver, kidneys, pancreases, and colon.


1. Only indicates for drug delivery vertical, including balloon in balloon products.

G LO B A L M A R K E T S I Z E O F LO C A L I Z E D I N T R A LU M I N A L D R U G D E L I V E R Y “ L I D D ” B A L LO O N F O R V E N O U S I N S U F F I C I E N C Y 2019 E - 2030 E• Severe venous insufficiency is mainly treated by operation. Thrombosis and anticoagulation are the difficulties after

operation. Thrombosis seriously affects the effect of operation, while the use of a large number of anticoagulants will face the risk of bleeding. Drug delivery balloon can reduce the risk of coagulation and bleeding after operation.

• It is estimated that there will be USD 5.5 million global addressable market of drug delivery balloon for venous insufficiency in 2019, and this number will be USD 42.9 million in 2030 with a CAGR of 34.5% from 2019 to 2025 and 5.7% from 2025 to 2030.



1.8 3.9 8.3 15.0 24.0 37.856.5

83.6

118.0152.5

196.1

240.1

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

77.3%33.6%

2.5 4.17.3

10.914.4

18.823.3

28.533.4

35.738.0 38.6

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

45.0%10.6%

2.5 4.17.3

10.914.4

18.823.3

28.533.4

35.738.0 38.6

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

45.0%10.6%

2.5 3.0 4.59.4

13.818.2

24.131.3

40.0

51.2

64.0

76.8

89.1

102.5

112.8121.8

131.5 139.4

0.6 0.7 0.7 0.8 0.9 1.0 2.2 5.717.1

37.7

52.8

66.079.2

88.797.6

105.4113.8

120.6

200

180

160

140

120

100

80

60

40

20

0

140

120

100

80

60

40

20

02013 2014 2015 2016 2017 2018E 2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

GLOBAL CHINA

United States:Billion USD

China: Billion RMB

Period


Billion

GLOBAL*

52.7%52.7%

CHINA*

9.6%46.1%

0.8 5.7 15.7 33.858.4

94.0138.3

195.3

257.0298.0

336.3 350.4

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

136.0%20.4%

0.8 5.7 15.7 33.858.4

94.0138.3

195.3

257.0298.0

336.3 350.4

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

136.0%20.4%

G LO B A L M A R K E T S I Z E O F LO C A L I Z E D I N T R A LU M I N A L D R U G D E L I V E R Y “ L I D D ” B A L LO O N F O R C H E M OT H E R A P Y 2019 E - 2030 E

• Chemotherapy is an effective therapy for cancer before and after operation. Currently, it is mainly administered orally, subcutaneously or intravenously, and the short half-life, long-term use of small molecule antineoplastic drugs will lead to drug resistance and reduce the therapeutic effect. However, LIDD will effectively mitigate such risks.

• It is estimated that there will be USD 1.8 million global addressable market of LIDD for chemotherapy in 2019, and this number will be USD 240.1 million with a CAGR of 77.3% from 2019 to 2025 and 33.6% from 2025 to 2030.


G LO B A L M A R K E T S I Z E O F LO C A L I Z E D I N T R A LU M I N A L D R U G D E L I V E R Y “ L I D D ” B A L LO O N F O R A N T I - A N G I O G E N I C T H E R A P Y 2019 E - 2030 E

• Anti-Angiogenesis is a critical step in the progression of almost all human malignancies and some other life-threatening diseases. Anti-angiogenic therapy is a novel and effective approach for treatment of angiogenesis-dependent diseases such as cancer, diabetic retinopathy, and age-related mascular degeneration.

• It is estimated that there will be USD 2.5 million global addressable market of LIDD for anti-angiogenic therapy in 2019, and this number will be USD 38.6 million in 2030 with a CAGR of 45.0% from 2019 to 2025 and 10.6% from 2025 to 2030. There may be a significant increase in efficacy and reduced complications through the use of Anti-angiogenic beads through LIDD, using its patented ability to deliver therapies utilizing intraluminal pressure to ensure the deepest penetration.

GLOBAL MARKE T S IZE OF LOCALIZED INTRALUMINAL DRUG DELIVERY “L IDD” BALLOON FOR ANTI-ANGIOGENIC THERAPY 2013-2030E

• The market size of the global immuno-oncology therapy market (including the market for PD-1/PD-L1 inhibitors) in terms of sales revenue, grew at a CAGR of 52.7% from 2013 to 2017, reaching US$13.8 billion in 2017, and is expected to further grow at a CAGR of 19.5% from 2017 to 2030, reaching US$139.4 billion in 2030. In comparison, the immuno-oncology therapy market in China grew relatively slowly at a CAGR of 9.6% from 2013 to 2017, reaching RMB0.9 billion in 2017, but is expected to rapidly expand at a CAGR of 46.1% from 2017 to 2030 reaching RMB120.6 billion in terms of sales revenue in 2030.

G LO B A L M A R K E T S I Z E O F D R U G D E L I V E R Y B A L LO O N F O R I M M U N O - O N CO LO G Y T H E R A P Y 2019 E - 2030 E

• Immuno-oncology with monoclonal antibodies (mAbs) targeting cytotoxic T lymphocyte-associated antigen 4 (CTLA4) and the PD-1 and its ligand PD-L1 has become standard of care for an increasing number of indications. The drug delivery balloon will surely address the great market dynamic of immuno-oncology therapy.

• It is estimated that there will be USD 0.8 million global addressable market of drug delivery balloon for immuno-oncology therapy in 2019, and this number will be USD 350.4 million with a CAGR of 136.0% from 2019 to 2025 and 20.4% from 2025 to 2030.


Historical and forecasted market size of global and China immuno-oncology therapies market 2013-2030E



0.1 0.2 0.6 1.1 1.8 2.94.6

7.110.6

14.3

19.3

24.7

2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E

Period



CAGR*

89.4%39.9%

QualiMed employees in Winsen, Germany.

Q3 MEDICAL | 23

G LO B A L M A R K E T S I Z E O F D R U G D E L I V E R Y B A L LO O N F O R N O N - V I R A L B A S E D G E N E T H E R A P Y 2019 E - 2030 E

• Benefits of gene therapy, as opposed to other protein-based treatments, include less immunogenicity and more effective penetration into solid tumours. However, due to the physiological barrier of the human body and the characteristics of non-viral vector, its low transfection efficiency and short duration of target gene expression limit its clinical use. Meanwhile, LIDD will solve these pain points by precise drug delivery and sustained medication delivery, through the pressure medium provided by the LIDD technology.

• It is estimated that there will be USD 0.1 million global addressable market of LIDD for non-viral based gene therapy in 2019, and this number will be USD 24.7 million with a CAGR of 89.4% from 2019 to 2025 and 39.9% from 2025 to 2030.


QualiMed Innovative Medizinprodukte GmbH (QualiMed), a Q3 Medical Limited Holding, is a German based manufacturer and developer of high end, implantable medical devices for the Interventional Cardiology, Peripheral Vascular, and Non-Vascular specialties. QualiMed was founded in 1997 as an OEM manufacturer for implantable medical devices with a focus on the development and regulatory approval of coronary stents and their respective delivery devices. As an OEM they designed and manufactured implantable stent devices for some of the most well-known global medical device companies. Later, the business was expanded to peripheral vascular and non-vascular implants, that included the world’s first removable pulmonary, oesophageal, and biliary stents. In the last years QualiMed has focused on the development of various Micro Invasive Technology, Biodegradable and Drug Delivery platforms, as part of its global commercialization strategy for its novel products. The company has CE approvals to sell its core technology products including mechanical implants, catheter-based technologies, including delivery devices, balloons, aspiration devices, drug device combination technology (Drug Eluting Stents and Balloons), and biodegradable technologies.

Manufacturing is organized in an owned facility outside of Hamburg Germany, in the town of Winsen, where QualiMed runs two Class 10,000 Clean rooms according to EEC GMP standards. The Company has production capabilities for stents, catheters, drug device combination products, and biodegradable technologies for a variety of interventional and surgical applications and holds more than 70 patents and utility models worldwide.

H I S TO R Y ( W H O L LY O W N E D S U B S I D I A R I E S )

Q UA L I M E D I N N O VAT I V E M E D I Z I N P R O D U K T E G M B HQ UA L I M E D I N N O VAT I V E M E D I Z I N P R O D U K T E G M B H


DEVICES LIMITED

Q3 MEDICAL | 24

IK (Intelligent K

inetics)Stron Medical

Tsunamed

Own Brand

OEM

Private Label

Non VascularCardiologyPeripheral Vascular

Cardiology

Non Vascular

Peripheral Vascular

Card

iolo

gy

Non Vascular

Perip

hera

l Vas

cular

DevelopmentMechanical, Catheter,

Drug Device, andBiodegradables

The Company current sells its products through a combination of direct sales and distribution model

for its OEM, Private Label, Own Brand, and Development offerings. This expanding channel or “Network”

approach allows QualiMed to leverage its core expertise and skills in design, development, and

manufacturing, while taking advantage of market consolidation conditions that have left many channel

participants with a reduced portfolio of interventional products seeking new innovative technology.

Because these channel partners are well trained, have strong historical relationships with the key user

base, and are working with physicians that are skilled in the clinical use of the technology, there is a

significant opportunity to accelerate the Company’s growth through this multi-channel approach.

S A L E S & M A R K E T I N G A P P R OAC H : M O D I F I E D G E N E R I C S T R AT E G Y

AMG International GmbH (AMG), is a Q3 Medical Limited Holding, a German based developer, manufacturer, and seller of high-end Cardiology and Peripheral Vascular devices in Europe, South America, Middle East, and Asia. AMG was founded in 1997 as a manufacturer and distributor for implantable medical devices, with a focus on the development and regulatory approval of coronary and peripheral vascular devices. AMG is currently commercializing its technology in over 30 countries and has recently completed its clinical studies for an advanced coronary stent with a fast absorbing biodegradable polymer, that may limit the time required for post implant dual anti-platelet therapy with 5-year follow up.

AMG GI: In 2017 the interventional coronary and peripheral vascular core customers were transferred to QualiMed’s own branded products and AMG will serve as the channel and brand for the company’s new Non-Vascular product lines, including ARCHIMEDES Biodegradable replacement for the 2 Million plastic stents that are used annually. Plastic stents have the distinct disadvantage of requiring a removal procedure and a high complication. In addition, its UNITY-B Biodegradable Balloon Expandable Biliary technology, (a hybrid platform of magnesium and polymer) is currently undergoing clinical studies and is expected to be launched in 2020.

Numerous other Biodegradable developments are ongoing from the Biodegradable covered version of the UNITY-B platform, to a Biodegradable oesophageal, and pseudocyst drainage system. All products built for the AMG GI product line will be Biodegradable. The distribution channel has already begun to form in Europe, Asia, South America, and the Middle East through its exclusive distribution partnership with the world’s largest medical device company Medtronic.

A M G I N T E R N AT I O N A L G M B H

amg site in, Germany.

DEVICES LIMITED

Q3 MEDICAL | 25

Q3 Medical Devices (Shanghai) Co. Ltd. (Qsan) a Q3 Medical Limited Holding, is a Baoshan, China (Shanghai Region) based wholly owned foreign subsidiary focused on the development, manufacturing, registration, and commercialization of products for the Chinese market, as well as to support the manufacturing needs of Q3 Medical Holdings combined companies, to further enhance competitiveness and optimize supply, distribution channels, and margin improvements. The Baoshan facility will have the same capabilities as the German manufacturing (QualiMed) facility with the added benefit of 3x the capacity and an optimized production flow.

The combined manufacturing entities give the Company the capacities and the redundancies it needs as it continues to execute on its global growth initiatives, while providing risk reduction through the multiple production facility locations. The 45,000 sq/ft (4500 sq/m) facility is expected to be operational in late 2020 with the ability to provide products to the Q3 Medical companies at that time. Q3 Medical is working very closely with the local Baoshan and regional Shanghai governments to ensure that the project meets all local registration requirements. Qsan China has recently received its Manufacturing License from the local government. The facility is an owned facility.

Q S A N C H I N A

Shanghai, China.


DEVICES LIMITED

Q3 MEDICAL | 26

G R E E N F I E L D AC T I V I T Y

Charlotte, North Carolina.

QualiMed USA, LLC (QualiMed USA), a Q3 Medical Limited Holding, is a Charlotte North Carolina based wholly owned subsidiary focused on the development, manufacturing, registration, and commercialization of products for the North American market. It is currently in the process of registering an IDE with the USA FDA to gain approval to trial its ARCHIMEDES Biodegradable replacement for plastic biliary stents. The US market alone represents an annual usage of approximately 500,000 stents. As mentioned previously, the ability of ARCHIMEDES to eliminate the cost and complications associated with the traditional removal procedures required for plastic stents at a maximum of 90 days post implant, represents a significant opportunity for the Company, patients, doctors, and insurance providers to deliver a better quality of care at a substantially lower cost. With US facility fees alone for removals ranging from $5,000-$10,000, the Company believes there is a significant opportunity to supplant the traditional plastic stents with ARCHIMEDES and save billions in healthcare cost for the US providers.

Q UA L I M E D U S A , L LC A Q3 Medical Company

DEVICES LIMITED

Q3 MEDICAL | 27

BAOSHANSHANGHAI

SHENZHEN

CHONGQING

3 Point Strategy to directly touch 80% of the 1.425 Billion people in China.

Phase 1 Northern: Baoshan / Shanghai Facility • Develop the primary manufacturing site in China to support local product registration as well as to

export goods to the rest of the world. • Facility will be state of the art facility producing the same high technology products as are produced

in Germany for the Coronary, Peripheral Vascular, and Non-vascular space.• The facility site in China will mirror the capabilities in Germany but will be 4x larger. • 4,500 sqm. Factory is built, inner decoration is planned to be completed 9-12 months after the closing

of the Pre-IPO financing.

Phase 2 Western: Chongqing Facility• Develop discussions have started with local western government to develop a 30,000 sqm facility to

support the western population.• Currently no known high-tech medical device implant manufacturing company exist in the west.• Leveraging the local government for support to drive introductions and adoptions to locally owned

hospitals will be part of the penetration strategy. • The factory would ensure global redundancies needed to support the Baoshan facility and

German facility.• Supporting technologies to further advance the vertical integration of the business. (Extrusions,

Coiling, Braiding, Molding, etc…) would be implemented to further improve margins and accelerated developments.

Phase 3 Southern: Shenzhen / Gounzhou Facility • Develop a specialty state of the Art R&D/Biodegradable Center to perpetuate the companies desire to

establish a development center of excellence for innovation in China.

A growing share of China’s population will soon be over the age of 60, making China an aging society. Rising living standards have given rise to rapid growth in the demand for medical products and services.

Chinese government invests big in healthcareThe Chinese government has made a priority of developing the health care sector as well, especially investing in the central and western parts of the country, where the quality of health care is lagging behind the rest of China.

China relies heavily on foreign imports for its medical supplies and devicesThis is especially true for high-tech, high-price items, for which the U.S., Germany and Japan serve as major exporters.

Chinese government loosens policy on the healthcare market and opens more opportunities for a big profitChina's state medical insurance administration has lowered the procurement prices of 14 cancer drugs, asking provincial-level drug procurement platforms to follow the new standard.




C H I N A G R O W T H S T R AT E G Y C H I N A N E E D S Q 3 M E D I C A L

DEVICES LIMITED


E X I T

O V E R V I E WThe Company expects that it will see an exit opportunity for its shareholders in the next 24 months, as it continues to commercialize its novel Core, Biodegradable, Micro Invasive, and Drug Delivery technologies in the Cardiology, Peripheral Vascular, and Non-Vascular areas.

T R A D E S A L E SThe Company believes various trade sale opportunities exist to maximize its return to shareholders, as large multi-nationals look for new technologies to maintain or expand their competitive advantage, or new entrants desiring to enter the interventional coronary, peripheral, and non-vascular space. The Company has positioned itself to allow for the divestiture of business units based on Cardiology, Peripheral Vascular, Non-Vascular, and Manufacturing to accommodate opportunities as they arise.

I P OThe IPO market for MedTech continues to remain open globally and offers an opportunity for emerging companies with sustainable disruptive technology platforms, to tap the public markets for funding various growth strategies, liquidity events and acquisitions, to deliver long term shareholder value. The Company is in current discussions with bankers to further evaluate the options on the Hong Kong and NASDAQ exchanges. The company has had initial discussions with the “HKEX” and has established a preliminary date for listing in late 2020/2021.

C H I N A C H A N N E L M A R K E T I N G S T R AT E G Y

Stage 1 (Years 1 – 3)• Target estimated 1,400 Tier 3 hospitals in major urban areas generating upwards of 50 million Euros

in 3 – 5 year period post product introduction.• Promotion, Distribution, and Sales of our Multi-Disciplinary Product Portfolio through Strategic

partners, National / Regional Distributors, Direct Sales, and End Users of the technology based on our three (3) verticals: Biodegradables, Micro Invasive Technology, and Intraluminal Drug Delivery.

Stage 2 (Years 3 – 5)• Target estimated 10,000 Tier 2 hospitals at the provincial levels generating upwards of 100 million

Euros in revenue in a 3 – 5 year period post product introduction.• Promotion, Distribution, and Sales of our Multi-Disciplinary Product Portfolio through Strategic

partners, National / Regional Distributors, Direct Sales, and End Users of the technology based on our three (3) verticals: Biodegradables, Micro Invasive Technology, and Intraluminal Drug Delivery.

A Q3 Medical CompanyA Q3 Medical Company

BAOSHANSHANGHAI

SHENZHEN

CHONGQING

Product PromotionProduction Logistics Provider Distribution Customers

• Downstream Product Marketing & Training Support

• Primary product promotion via experienced in-house team

• Focus on covering Tier 3 hospitals and linking experts with sales team from channel partners

• National and regional logistics provider for all products

• Clinicians/Doctors, Hospital Administrative Staff, Key Hospital Stake Holders

GI / Endoscopic

IR / PVGI / Endoscopic

Q-San Q-San Pioneer Biopharma Medtronic

Pan China Dist.

Regional Dist.

End Users

Global Strategic Partner Chosen Over Country Wide or Regional Distributor: Why Medtronic?• Medtronic is the world’s largest medical device company and a globally trusted leader in medical

technology, services, and solutions.• 1st Known multinational distribution contract involving a biodegradable implant in the

interventional non-vascular/peripheral vascular/ or cardiovascular areas.• Collaborating Partner: “Take Healthcare Further, Together“ + “Creating Value by Helping People”

leads to innovative change to improve outcomes and reduce cost in a global healthcare market.


Product CustomersPromotion Logistics Provider

Glob. StrategicPartner

• Downstream Product Marketing & Training Support

• Primary product promotion via experienced in-house team

• Focus on covering Tier 3 hospitals and linking experts with sales team from channel partners

• National and regional logistics provider for all products

• Clinicians/Doctors, Hospital Administrative Staff, Key Hospital Stake Holders

Pioneer Biopharma MedtronicQ-San End UsersGI / Endoscopic

• Global Strategic Partner with global reach and resources (sales & marketing, clinical, and regulatory)

• Cross divisional support and access to additional sales channels

DEVICES LIMITED



DEVICES LIMITED

LATIN AMERICABRAZIL, VENEZUELA, ECUADOR, ARGENTINA, COLUMBIA, ETC.

EUROPEAN UNIONFRANCE, GERMANY, SWITZERLAND, IRELAND, ITALY, SPAIN, AUSTRIA, BELGIUM, ETC.

MIDDLE EAST AND AFRICASAUDI ARABIA, ISRAEL, IRAN, EGYPT, ETC.

ASIAJAPAN, KOREA, SINGAPORE, THAILAND, MALAYSIA, VIETNAM, ETC.

CHARLOTTE, USASALES, MARKETING

WINSEN, GERMANYR&D, PRODUCTION, SALES

DUBLIN, IRELANDQ3 MEDICAL - HQ

SHANGHAI, CHINAPRODUCTION

DEVICES LIMITED

Q3 Medical Devices Limited enters into a distribution agreement with Medtronic for its Biodegradable Biliary and Pancreatic Stent ARCHIMEDES.

Dublin, Ireland – Q3 Medical Devices Limited (Q3 Medical) based in Dublin, Ireland, announced today that it has entered into a distribution agreement with Medtronic plc for ARCHIMEDES, the first to market fully biodegradable biliary and pancreatic stents, designed as an alternative to traditional plastic stents.

Medtronic’s Gastrointestinal and Hepatology business, which is part of the Minimally Invasive Therapies Group and Q3 Medical, agreed to a six-year exclusive global distribution agreement to distribute ARCHIMEDES biodegradable stent.

G LO B A L S A L E S N E T W O R K

Typically, biliary and pancreatic duct stents are made of plastic or metal. The ARCHIMEDES stent however, is made of a combination of dissolving materials permitting, different rates of degradation depending on the patient’s need. Use of degrading materials in a stent, decreases reinterventions that are common with current stents and allows the potential for eliminating a stent removal procedure, which is almost always done for plastic and metal stents currently. ARCHIMEDES has CE Mark.

Eric Mangiardi, President & CEO of Q3 Medical stated, “We are excited and fortunate to have partnered with the world’s largest medical device organization like Medtronic. Entering into this agreement is a major step towards our goal of becoming the world’s leading developer of biodegradable implants.” Mangiardi further stated, “The promise of ARCHIMEDES is based in its potential to eliminate the second removal procedure required for traditional plastic stents, which could reduce billions of expenses from the global healthcare system, while improving patient care.”

WIDESPREAD SALES NE T WORK ACROSS THE EU, LATIN AMERICA, MIDDLE EAST AND AFRICA, AND HAS ESTABLISHED LONG-TERM COOPERATION WITH 50+ DISTRIBUTORS WORLDWIDE.

DEVICES LIMITED




In the coming years, the company will continue to focus on the continued development and commercialization of its 3 Verticals, with the goal of creating

over 1 billion Euros of shareholder value. Through the continued development and commercialization of product Verticals in the Biodegradable,

Micro Invasive Technology, Localized Intraluminal Drug Delivery, and Core Product areas, the company plans to create a sustaining leading position

in the Verticals, where it will compete. The Company is in active discussions with several investors, to finalize its last institutional investor for its

Pre-IPO round of funding and is refining its plan for a listing. The company has term sheets signed for investments totalling over 50 million Euros.

C A P I TA L R A I S E

T H E F U T U R E

PRE-IPO IN 1ST HALF 2020ISSUING NEW SHARE; POST-MONEY VALUATION OF €200MM

USE OF PROCEEDS AMOUNT (€) DESCRIPTION

Proceeds 50,000,000

Manufacturing Capabilities & Capacity 12,000,000

Germany & China Facility Capacity Expansion & Process Capabilities in Laser Cutting, Biodegradable Testing, Coating, & Extrusions of Various Materials

Product Registration and Clinical Studies 20,000,000

US, China & Japan registration of Biodegradable, Micro Invasive Technology “MIT” & Local Intraluminal Drug Delivery “LIDD” Technology

Research & Development 4,000,000

Continued development of the Biodegradable, Micro Invasive Technology “MIT” & Local Intraluminal Drug Delivery “LIDD” Technology Technology Platforms

Sales Channel Development 4,000,000 Sales & Marketing Expansion

Working Capital 10,000,000 General business & cashflow needs

IPO IN 1ST HALF 2021EXPEC TED IPO VALUATION OF €600MM-800MM

USE OF PROCEEDS AMOUNT (€) DESCRIPTION

Proceeds 150,000,000 – 200,000,000

Manufacturing Capabilities & Capacity 20,000,000 – 35,000,000

Germany & China Facility Capacity Expansion & Process Capabilities in Laser Cutting, Biodegradable Testing, Coating, & Extrusions of Various Materials

Product Registration and Clinical Studies 50,000,000 – 65,000,000

US, China & Japan registration of Biodegradable, Micro Invasive Technology “MIT” & Local Intraluminal Drug Delivery “LIDD” Technology

Research & Development 30,000,000 – 45,000,000

Continued development of the Biodegradable, Micro Invasive Technology “MIT” & Local Intraluminal Drug Delivery “LIDD” Technology Technology Platforms

Sales Channel Development 15,000,000 – 20,000,000 Sales & Marketing Expansion

Working Capital 35,000,000 General business & cashflow needs



Note: Graphic based on ideal timeline guidance given by Listing Department’s Marketing Department, the IPO Process may be completed after 4 months but in most situations, IPO is likely to take 7 months on average.

REGISTER PROSPECTUS & LAUNCH INVESTORROADSHOW (3 WEEKS)• Computershare to print Prospectus• Finalize all share registrar & banking arrangements• Management conducts Roadshows in HK, China & USA (Europe?)

LIST ON THE SEHK(7 months from submission of Listing Application)• Prepare IPO Events on Listing Day with PR �rm• Prepare Press Release & conduct Press Conference with PR �rm & Sponsors• Attend IPO Events

LIST ON THE SEHK(most optimistic 4 months fromsubmission of Listing Application)

PUBLISHES POST HEARING INFORMATIONPACK (PHIP) & FINALIZE PROSPECTUSPublish PHIP Pack & Finalize Prospectuswith Lawyers & Sponsors

HEARING BY LISTING COMMITTEE(10 WEEKS - 5 MONTHS)Attend Hearing with Sponsors & Lawyers,and obtain formal approval to List

FOLLOWS UP COMMENTS(5 WEEKS - 3 MONTHS)Q3 Management, Lawyers,Accountants & Sponsors to prepareAnswers to LD's Questions

LD PUBLISHES FIRST COMMENTS(expect at least 3 rounds of comments)

LD REVIEWS A1 FORM

LD CONFIRM RECEIPTOF AP & PUBLISHESAP ONLINE

SUBMIT LISTING APPLICATION,INCLUDING AP (A1)

AUDIT OF MID-YEAR FINANCIALSDepending on the �nal timing of the listing an audit of mid-year group audited �nancials may be necessary

COMPLETE ANNUAL AUDITED GROUP FINANCIALS• Grant Thornton• Q3 Group Finance Team

A P P E N D I X : “ H K E X ” T I M E L I N E A N D C A P I TA L R A I S E

COUNTDOWN TO LAUNCH HONG KONG IPO TIMELINE & MILESTONES

*Q3 Medical is committed to looking at the public markets and exchange that will best represent the value of this business be it the HKEX, NASDAQ, LSE, or other major exchange that will appropriately value the business and allow for future funding (secondaries) for growth and acquisitions.



C L I N I C A L S TAG E S O F CO R E A N D G R O W T H P R O D U C T S

STAGE

Product

CLINICAL, REGULATORY, AND COMMERCIAL MILESTONES

ARCHIMEDES(Biodegradable)

UNITY Biliary (Biodegradable)

*Micro Invasive Technology

Localized Intraluminal

Drug Delivery/Venous

UNITY Peripheral

(Biodegradable)

UNITY Coronary

(Biodegradable)

US Commercial Traction

FDA Approval

FDA Submission

FDA IDE Approval

Compelling OUS Clinical Data

FDA IDE Submission

OEU Launch

Clinical Data

Technology Validation

CE Approval

Pre-Clinical Data

Technology Development

In process

Complete

Complete

Complete

Complete

Complete

2nd half 2020

In process

Complete

1st half 2020

Complete

Complete

2017 – 2021

In process

Complete

2017 – 2021

Complete

Complete

2022

2021

Complete

2021

In process

Complete

2024

2021

In process

2023

In process

Complete

2026

2023

In process

2024

In process

Complete

CE Submission

In Vitro Data

Complete

Complete

Submission Complete Pending Additional

Clinical Data

Complete

2017 – 2021

Complete

2021

In process

2022

In process

2024

In process

* Micro Invasive Technology is a system made of a number of individual devices. The initial controlled launch of the technology in 5 countries commenced at the start of 2020. Single devices were sold when approved for clinical testing prior to 2020. Additional product development is ongoing.

D I S C L A I M E R S & L E G A L S TAT E M E N T S

About Q3 Medical Devices Ltd.

Q3 Medical Devices Ltd. is an Ireland based holding company with multiple global operations in Germany, China & the United States, along with strong global partnerships and an ever-growing strategic investor base, including China Pioneer Pharma Holdings Limited listed on the Hong Kong Exchange (1345) and Boill Holding Group, Shanghai China. The holding and its companies are focused on the development, manufacturing and distribution of its novel Biodegradable, Micro Invasive Technology “MIT” and Localized Intraluminal Drug Delivery “LIDD”, and core products platforms for interventional cardiology, peripheral vascular and non-vascular diseases.

Q3 Medical Devices Ltd. was formed by a global group of entrepreneurs, manufacturers, distributors, industry doctors and investors, focused on the development and acquisition of medical device businesses with annual revenues between 1-10 Million. The acquisitions are targeted in areas that expand the group’s manufacturing base and capabilities, grow its distribution channel and accelerate its products offering, focusing on the minimally invasive treatment of patients with cardiology, peripheral vascular and non-vascular diseases.

For further information, visit http://www.q3medical.com

About Boill Holding Group

Boill Holding Group is an international diversified investment group with a global presence, focused on real estate development and transformational investments in the emerging industries of comprehensive healthcare and intelligent manufacturing sectors. With over 12 Billion RMB in Assets, Boill will continue to focus on expanding its global presence in the Asset Management and Financial Investment areas, with focus on the comprehensive healthcare and intelligent manufacturing sectors.

Founded in 1996 and headquartered in Shanghai, China Boill Holding Group, through the visionary leadership of Chairman Qiu Dong Fang, has led the transformation from a traditional real estate development enterprise to a diversified conglomerate with a global presence in Hong Kong, Japan, Australia, France, Ireland, and the USA.

For more information, visit http://www.boill.com

Forward Looking Statements

This announcement includes “forward-looking statements”, which incorporate all statements other than statements of historical facts, including, without limitation, those regarding the Group’s financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group’s products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words “targets”, “believes”, “estimates”, “expects”, “aims”, “intends”, “will”, “can”, “may”, “anticipates”, “would”, “should”, “could” or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group’s control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group’s actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Q3 Medical’s & QualiMed’s funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements are valid at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.

Q3 MEDICAL DEVICES LIMITED88 HARCOURT STREET | DUBLIN 2 | IRELAND

PHONE +49 172 243 9649 | WWW.Q3MEDICAL.COM

CREATING VALUE BY HELPING PEOPLE

Documents

DEVICES LIMITED - Q3 Medical · 2020-06-11 · DEVICES LIMITED Q3 MEDICAL | 03 Q3 Medical Devices Limited is a Dublin, Ireland based holding company formed April 17, 2013 by an international