BRINGING ADVANCED ENERGY TO ENDOSCOPY Investor Open Event 17 - - PowerPoint PPT Presentation

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BRINGING ADVANCED ENERGY TO ENDOSCOPY Investor Open Event 17 - - PowerPoint PPT Presentation

CREO MEDICAL BRINGING ADVANCED ENERGY TO ENDOSCOPY Investor Open Event 17 October 2018 2 DISCLAIMER IMPORTANT NOTICE This presentation comprises the written materials/slides for a presentation concerning Creo Medical Group PLC (the


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CREO MEDICAL

BRINGING ADVANCED ENERGY TO ENDOSCOPY Investor Open Event 17 October 2018

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DISCLAIMER

IMPORTANT NOTICE

This presentation comprises the written materials/slides for a presentation concerning Creo Medical Group PLC (the “Company”) and its Investor Open Event at Chepstow. By reviewing this presentation you agree to be bound by the conditions set out below. No reliance may be placed for any purposes whatsoever on the information in this presentation or on its completeness. The presentation is intended to provide a general overview of the Company’s business and does not purport to deal with all aspects and details regarding the Company. Accordingly, neither the Company nor any of its respective directors, officers, employees or advisers nor any other person makes any representation or warranty, express or implied, as to, and accordingly no reliance may be placed on, the fairness, accuracy or completeness of the information contained in the presentation or of the views given or implied. Neither the Company nor any of its respective directors, officers, employees or advisers nor any other person shall have any liability whatsoever for any errors or omissions or any loss howsoever arising, directly or indirectly, from any use of this information or its contents or otherwise arising in connection therewith. Certain statements in this presentation regarding the Company are or may be forward-looking statements. These forward-looking statements are neither historical facts or guarantees of future performance. Such statements are based on current expectations and belief and, by their nature, are subject to a number of known and unknown risks and uncertainties which may cause the actual results, prospects and developments of the Company to differ materially from those expressed or implied by these forward-looking statements. The information contained in this presentation is for background purposes only. The subject matter of the presentation may be subject to change and the Company does not take any responsibility for updating or amending the contents to reflect such changes. The material contained in this presentation reflects current legislation and the business and financial affairs of the Company which are subject to change without notice and audit, and is subject to the provisions contained within legislation. This presentation summarises information presented at the Company's Investor Open Event at Chepstow. Without prejudice to the generality of these conditions, this summary information, including any views given or implied, or any statement made, in relation to such information should not be relied upon, nor should it be treated as accurate or complete. This presentation and all such information contained herein should be read subject to the Company's latest interim results. The information contained in this presentation has been obtained from Company sources and from sources which the Company believes to be reliable but it has not independently verified such information and does not guarantee that it is accurate or complete. No statement in this presentation is intended to be a profit forecast and no statement in this presentation should be interpreted to mean that earnings per Company share for current or future financial years would necessarily match or exceed the historical published earnings per Company share.

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Agenda

  • 14:30 – 14:45

– Registration

  • 14:45 – 15:30

– Welcome, Introduction to senior management by Craig Gulliford & Investor Presentation (45 mins)

  • 15:30 – 15:45

– Q&A (15 mins)

  • 15:45 – 16:00

– Group A tour of facility / Group B product demonstration / conversations with senior team members (15 mins)

  • 16:00 – 16:15

– Group B tour of facility / Group A product demonstration / conversations with senior team members (15 mins)

  • 16:15 – 17:00

– Final words & thanks followed by drinks and canapés

  • 17:00

– Close

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Focused on the Emerging Field of Surgical Endoscopy to perform

clinical procedures minimally and non-invasively

Creo Medical utilises patented technology combining microwave and bi-polar

radio frequency energy via its advanced energy platform

Enabling a wide range of miniature endoscopic devices with precise

cut, coagulation and ablation capability to treat as many conditions as possible Aiming to exploit a Paradigm Shift in endoscopic surgery

Saves time and cost as both procedure time and hospital stay are reduced Potential to Change the Treatment Pathway due to less risk of infection,

ability to treat conditions what are currently untreatable and move operating room treatment to outpatient treatment

The overall aim:

Significantly Improved Patient Outcomes!

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OVERVIEW

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SLIDE 5

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FACTS AND FIGURES

~50 People Employed in a Creative, Innovative, Fun and Driven Environment with

the aim to change lives!

Listed on London Stock Exchange in December 2016 raising £20M to

further develop IP, with a further raise of £48.5M in August 2018 to fully commercialise our products so that we can treat patients

FDA clearance and CE mark gained for Creo’s CROMA platform generator and

first device (Speedboat RS2 device) in 2017

45 physicians trained1 to use the first device and beginning to use – we

now have a Global footprint

~50 human procedures performed using first device (Speedboat) – life changing

for these patients

118 Worldwide patents granted, 79 patent families and 385 patents pending1 Growing Global Market with addressable size of $3-4bn2,3, minimal competition Commercialisation via multiple distributors including strategic investor HOYA

Pentax Group (Asia), Diagmed (UK), South Africa, Spain and Benelux

1 As at 30 September 2018 2 Boston Scientific investor presentation, 2015 3 Conmed investor presentation, August 2016

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OUR BOARD

Craig Gulliford, CEO

  • Experience of delivering large exits to small

start-up technology companies

  • Previously NED Chairman of Cloud Amber

and COO of ACIS

Professor Chris Hancock, CTO & founder

  • Senior engineer at Gyrus
  • Named inventor and lead author on over 300

patents, patent applications & publications, including original Gyrus patents

Charles Spicer, Chairman

  • Specialist medtech director,
  • Aircraft Medical, Stanmore Implants,

Medivance, Vision RT, 11 Health, PuriCore, IXICO, Gyrus

Senior management team with experience from companies including:

Richard Rees, CFO

  • 19 years as senior financial executive
  • Previously CFO of SPTS
  • 7 years tenure at KPMG

John Bradshaw, Audit committee chair, NED

  • Chartered Accountant
  • 15 years experience as CFO with venture-

backed and listed companies

  • FD at Gyrus; CFO Syncona

David G. Woods, NED

  • President, CEO of Pentax Americas
  • Proven track record in General and Orthopedic

Surgery, Gastroenterology, Pulmonology and ENT

  • ASGE member

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SLIDE 7

THE RAPID RISE OF ENDOSCOPY

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PARADIGM SHIFT

Advances in single-port laparoscopy, robotic surgery, natural orifice translumenal endoscopic surgery & flexible endoluminal endoscopy herald a new era of healthcare.

GOLDEN ERA

Open surgery remains as standard of care but availability of fibre optic and CCD endoscopes leads to development of early endoscopic devices.

SURGICAL MILESTONE

Keyhole/laparoscopic surgery

  • vertakes open surgery, accounting for

75% of all procedures.

1990-2010 1970-1990 2010-2025 OPEN SURGERY 1800-1970

“A leap in the advancement of colonic submucosal dissection…”

  • Dr. Zacharias P. Tsiamoulos MBBS, PHD

Endoscopy Clinical Lead, Consultant in Gastroenterology and Specialist in GI Endoscopy East Kent University Hospitals Trust, Honorary Consultant in Endoscopy St Mark’s Hospital /Academic Institute

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ADVANCED ENERGY PLATFORM

15 years ago microwave was used in Telecoms but was not sufficiently advanced & too expensive for use in

endoscopy

Microwave for controlled coagulation & Bi-polar RF for precise cutting

Laparoscopic surgeons have Bi-polar RF and harmonic devices, however will not use mono-polar devices for complicated surgery due to the risk associated. Why would a gastroenterologist be any different?

118 (76 Dec-16) granted patents and 385 (184 Dec-16) patents pending *

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Advantages

Bi-polar RF for precise localised cutting Microwave coagulation provides control Single interface port, no need to swap instruments Small integrated unit

Physician Benefits

Safe, peace of mind, fast set-up Predictable tissue effect Saves considerable time during procedures Can be used in surgery & endoscopy

Patient Benefits

Lower risk of remote burns Lower risk of thermal damage to adjacent tissues Less time in hospital

* Correct on 30 Sept 2018

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Growth of GI indications

  • Poor diet, obesity, sedentary lifestyles and

an aging population is driving growth in the Endoscopy device market.

  • Continued expansion in endoscopic

screening programs driving an increase in the detection rates for a range of conditions requiring the resection/biopsy of tissue and the control of bleeding.

  • Western practice continues to refer lesions >

2.5cm for surgical resection on a significant scale.

  • Surgical removal, whilst delivering excellent

curative results, is also a major operation requiring long hospital stay (4-5 days) with a significant mortality rate.

“Speedboat RS2 would transform my repertoire”

Mr Mike Williamson

Endoscopist, RUH Bath

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GI DEVICES

“….a great start point for the new user and a fundamental tool for the experienced operators”

  • Dr. Zacharias P. Tsiamoulos MBBS, PHD

Endoscopy Clinical Lead, Consultant in Gastroenterology and Specialist in GI Endoscopy East Kent University Hospitals Trust, Honorary Consultant in Endoscopy St Mark’s Hospital /Academic Institute

Suite of GI Devices:

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SLIDE 10
  • 1. US surgical procedure volumes 2010, Millennium Research, RPUS43SV10, February 2010
  • 2. Gastrointest Endosc 2014;80-133-43
  • 3. Ann R Coll Surg Engl 2011; 93: 445–450

SPEEDBOAT RS2

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16m screening colonoscopies are

performed per annum in the US1

1.1m will find a lesion which should be

treated2 Approximately 50% of those lesions are surgically removed1

But traditional colorectal surgery is

associated with a 6% mortality rate at 30 days3

COLORECTAL CANCER WORLDWIDE:

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INTEGRATED INJECTION NEEDLE

no instrument exchange required

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BIPOLAR ELECTRODES

precise lateral and forward dissection

MICROWAVE COAGULATION

controlled haemostasis

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PROTECTIVE HULL

reduces risk of muscle damage

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ROTATION

  • rientation in any plane

“You don’t have to be an expert to use Speedboat”

Dr Francisco Jose García Fernández,

Spain

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EXAMPLE CLINICAL CASES PERFORMED USING SPEEDBOAT

  • 25 mm lesion
  • 64 year old male
  • Removed under

conscious sedation in under 40 minutes

  • 90 mm lesion
  • 89 year old

female

  • Removed under

general anesthesia in under 1h 40 minutes

  • 20 mm lesion
  • 63 year old male
  • Removed

without sedation in under 30 minutes

Source - http://www.acgaec.com/colon-polyps?lightbox=imageyip Source - http://retroflexions.com/endoscopy/ Patient information is restricted due to patient confidentiality and GDPR

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THE ALTERNATIVE

  • Up to 30cm of bowel removed and the two sections re-joined
  • Change to the anatomy of the patient – never the same

again in terms of function

  • Colostomy bag for at least 6 months or life
  • Other associated effects such as depression
  • One of these patients could not have tolerated surgery
  • Between 3-4 hours of treatment under general anesthetic with

associated risks

  • Up to 5 days hospital stay
  • In one day, 3 patients treated under sedation saved ~12

hours of operating theatre time and up to 15 inpatient days

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PHYSICIANS TRAINED

Goal: 50> by end of 2018

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PHYSICIANS TRAINED: 45*

“This is the most professional training I have ever attended”

Dr Tan Attila, Turkey

ACCUMULATED

“I can’t thank you enough for a fantastic experience. As you know I’m sure there is a tremendous future for Speedboat and I’d love to be involved in the evolution it will allow.”

Dr John Hancock, UK

* By 30 September 2018

UK Europe US AsiaPac Africa Endoscopist Colorectal Surgeon Nurse in training Nurse not trained Nurse trained later

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SLIDE 14

“Can you imagine the utility of this? If we can navigate to lesions, sample them, but also ablate them all in one go? I think that will be completely revolutionary for lung cancer management”

Dr Pallav Shah

Consultant Pulmonologist Royal Brompton Hospital, UK

Screening not performed 1.8m Global cases of lung cancer each

year1

17% Five-year

survival rate2

85% Nodules are

considered to be inoperable3

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LUNG CANCER:

15% 36% 49%

Radiotherapy Untreated or chemotherapy Surgery

ABLATION DEVICES

In 2018 ~55,440 Americans will be diagnosed with pancreatic cancer in the U.S., and over 44,330 will die.4 One of the few cancers for which survival has not improved substantially over nearly 40 years. Highest mortality rate of all major cancers. 91% of pancreatic cancer patients will die within five years of diagnosis – only 8% will survive more than five years. 74% of patients die within the first year of diagnosis.

PANCREATIC CANCER:

1. Chin J Cancer (2016) 35:71 2. American Cancer Society. Cancer Facts & Figures 2016. Atlanta: American Cancer Society; 2016. 3. Data for England & Wales – National Lung Cancer Audit annual report 2015 (for the audit period 2014), Royal College of Physicians, 2015 4. www.pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/

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PARADIGM SHIFT

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CROMA & Speedboat

CE Mark & FDA Cleared

Commercial Launch GI Suite

Planed for DDW 2019

2017 2021 2018 2019 2020 2022 Suite of GI Products

CE / FDA Filed

Ablation Products

CE / FDA Cleared

Commercial Launch Flexible Ablation Products

Planed for DDW 2020

Establish Distribution Framework Growth

CROMA Estate - x00 Continued investment in product portfolio

Clinical Education Program Key

Well trained users become users for life

“The Speedboat is a very nifty and elegant device and I am sure it will do well, and I hope it finds even more uses than just colorectal. I also very much look forward to your future products which all look so promising”

Dr Galya Chinnery, South Africa

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GROWTH OF DISTRIBUTORS 2018 & 2019

16 Framework distribution agreements Pentax Europe Pentax APAC Direct / Distribution TBD

Draft framework agreements for distributors:

  • APAC – Pentax – existing agreement, commencement of distribution underway
  • Central and Eastern Europe – Initial discussions with Pentax
  • UK, Western Europe and South Africa – Creo managed distributors – agreements signed for

UK, S Africa, Spain and Benelux, the rest are under discussion

  • USA and beyond:
  • Various distribution potentials in addition to direct sales
  • Other regions will follow through 2019 and beyond
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ISO:13485 AUDITED R&D AND MANUFACTURING CAPABILITY

  • We have dedicated spaces for:
  • Innovation (Bath)
  • Design & development (Bath/Chepstow)
  • Cleanroom manufacturing & assembly (Chepstow)
  • Capacity for growth:
  • Upstream & downstream manufacturing currently at scale
  • Growth requires a need to scale-up assembly capability or out-source
  • Current low capacity line able to manufacture ~2,400 devices per annum

and ~120 generators, with the ability to double output with minimal investment (additional facilities and operatives)

  • Additional funding allows addition of moderate scale to allow for pilot lines

for pipeline products

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KEY MILESTONES

2017 2018 2019

Generator & instruments with EU KOL’s FDA clearance of the Speedboat RS2 Develop a distributor network for regions outside the core markets CE Mark for the Generator & Speedboat RS2 KOL advocacy phase for Speedboat RS2 in US market Continued roll-out of instruments Generation of clinical data and medical industry recognition Expand the portfolio of consumable instruments available Initiate general sales roll-out Pentax Medical to initiate the regulatory procedures for entry into the Asia-Pacific region during 2017 Identify new broader GI customer base in EU Identify early-adopters for ablation device CE/FDA submission for ablation products Lung ablation device pre- submission meeting with FDA Continued placements in EU and Asia- Pacific CE /FDA Clearance for suite of devices

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    

2017 Milestones completed Ahead of plan for FDA clearance

 

Ahead of plan for distributor network

  

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CONCLUSION

  • Creo’s advanced energy platform – utilises Creo’s patented technology to combine

microwave and bi-polar radio frequency energy and enables a wide range of miniature endoscopic devices with precise cut, coagulation and ablation capability saving time and cost

  • 2018 Fundraise has strengthened the balance sheet and provides the funding to accelerate roll
  • ut of products, increased training and market seeding via multiple distribution partners
  • Health economic benefits and improved patient outcome validated as

both procedure time and hospital stay are reduced

  • Oversubscribed Placing strengthened institutional shareholder presence in view of current

M&A landscape in sector

  • Creo’s Clinical Education Programme well established – pathway to 50 trained in

2018

  • Multiple in-human procedures performed using Speedboat with no reported

complications

  • Manufacturing capability ready to scale with minimal investment
  • Investment takes advantage of market momentum
  • Razorblade model with multiple devices over multiple markets and multiple indications

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CREO MEDICAL

ANYTHING IS POSSIBLE WITH THE RIGHT APPROACH

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