les lindsay, pulseflow. presentation at health-tech innovation labs conference 18.09.2015

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Our Vision 1 © THE DIABETIC BOOT COMPANY LTD. We will transition from a single product company that specialises in healing DFUs, to a multi product medical technology provider, working through excellent distribution partners dedicated to helping the avalanche of patients with lower limb circulatory problems, such as venous leg ulcers and lymphedema. With our innovative, first of its kind product, pulseflow DF®, we will addresses several issues in the treatment of DFUs, and which we believe will have a major impact on reducing the amputation rate, and DFU treatment costs across the globe. This focus on premium price, feature rich products, will see us transition from a small start-up company into a mid-cap ( $100-500m) medical device company with a range of novel and attractive products.

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Page 1: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

Our Vision

1© THE DIABETIC BOOT COMPANY LTD.

We will transition from a single product company that specialises in healing DFUs, to a multi product medical technology provider, working through excellent distribution partners dedicated to helping the avalanche of patients with lower limb circulatory problems, such as venous leg ulcers and lymphedema.

With our innovative, first of its kind product, pulseflow DF®, we will addresses several issues in the treatment of DFUs, and which we believe will have a major impact on reducing the amputation rate, and DFU treatment costs across the globe.

This focus on premium price, feature rich products, will see us transition from a small start-up company into a mid-cap ( $100-500m) medical device company with a range of novel and attractive products.

Page 2: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

More than Half a Billion people will suffer from Diabetes by 2035

© THE DIABETIC BOOT COMPANY LTD. 2

Healthcare Expenditure due to Diabetes and Prevalence; USD, 2013, age group 20-79 years

Estimated increase in diabetic patients; 2013 -2035

108

6

11

79 8 8.5

NorthAmerica

andCaribbean

South andCentralAmerica

Africa MiddleEast and

NorthAfrica

Europe South-EastAsia

WesternPacific

World

Prevalence (%) of diabetes by region

Page 3: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

© THE DIABETIC BOOT COMPANY LTD. 3

“Les:It was a pleasure visiting with you today.I can't tell you how enthusiastic I am about the near medium and long-term potential of this project. I can tell you absolutely positively without reservation that this is the most important thing going on in this area of massive unmet need right now. I know that if taken to fruition it's going to make a very big difference in the lives of a lot of people with diabetes.Cheers”Prof David Armstrong Global Opinion Leader in Diabetic Limb Salvage, Tuscon ArizonaFollowing on from a briefing on pulseflow DF at the Diabetic Foot MeetingMalvern May 16th 2014

“pulseflow DF® is potentially the most exciting new product in Podiatry for many years. I am delighted to have been asked to Chair the Clinical Advisory panel”Richard LeighHead of Podiatry ServicesRoyal Free HospitalLondon

pulseflow DF®

Support from Global Experts in Diabetic Limb Salvage

Page 4: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

Dr TudhopeConsultant Vascular SurgeonPretoria South Africa

Discussed Armstrong paper for Oedema Reduction in Vascular Ulcers.

“this would be my ultimate device”

Page 5: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

pulseflow DF® - Clinical Support DataProof of Concept Study

Armstrong (2000) study showed that standard therapy healed 51% of DFU patients in a 12 week period.

When intermittent plantar compression (IPC) was added to standard therapy, healing rates improved to 75%

Patients that were compliant, (i.e. used the device more than 50 hours of use per week) showed a 100% wound closure rate.

Clinical trial design was 12 week, two arm, double-blind, randomised, placebo controlled trial with n = 97

© THE DIABETIC BOOT COMPANY LTD. 5

100%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Active Placebo

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12

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Compliant Non-compliant Overall

Page 6: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

6

1.3 million boots sold p.a.Value circa £146m

Offloading is now recommended by all major consensus documents for the treatment of DFUs

Page 7: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

© THE DIABETIC BOOT COMPANY LTD.

Moving upmarket with a name change

7

Boot

• =Footwear

• = Low ReimbursementMedical Technology

• Wider Audience

• High Tech = Higher Reimbursement

Page 8: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

pulseflow DF® Business Model – Dealer Model is the preferred Modus Operandi

© THE DIABETIC BOOT COMPANY LTD. 8

TDBC currently owns all IP outright and retains 100% of the economics of all commercial rights

Based on patented IP, pulseflow DF® will be sold B2B, into targeted markets across the globe, through networks of specialist stocking distributors, in 40 target countries

Exclusive distributor contracts by country, but will flex this dependent upon certain circumstances (5 years term)

TDBC will have Export manager and some small Marketing function in the UK; In the US there will be 3 sales representatives and 3 clinical advisors to establish inroads in key initial target accounts and in support of initial regional distributors sales efforts

Territory Distributor Status of agreement

USA 1 national coverage In detailed negotiations for a $400m 5 yr exclusive deal

Canada Steven’s of Toronto Signed

UK Patterson Healthcare NHS Supply Chain agreement in place

Australia / NZ Intermed Signed distribution agreement + first order confirmed!

Philippines

All via HCP / UrgoInitial documents signed leading to regulatory clearance andon to distribution

Singapore

Thailand

Malaysia

Germany/ Austria MSM Order received

Switzerland Guiela Medical Order received

South America Covaleo (Mexico) Signed distribution agreement

Page 9: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

SAWC San Antonio May 2015

© THE DIABETIC BOOT COMPANY LTD. 9

Page 10: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

Peak Pressure Profiles Average of Stances

© PULSEFLOW 10

RCW V PF DF OPM

RCW pulseflow DFShoe

Shoe v RCW

Page 11: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

pulseflow DF® - A novel, multifunctional therapeutic footwear pulseflow DF® is therapeutic footwear for DFUs that combines

the benefits of:

Offloading (the current standard of care)

Intermittent plantar compression (IPC) boosts blood back up the veins allowing fresh oxygenated blood into the foot

Aesthetic design to address social stigma

IPC is the key differentiating feature of pulseflow DF® from the current standard of care and competitive devices and primary basis for patent protection of the device:

IPC is achieved through the activation of a battery powered inflatable bladder positioned under the arch of the foot to “squeeze” veins for 1 second.

This action mimics the plantar foot pump and leads to improved venous blood flow away from the foot allowing oxygenated blood to enter the capillaries and hence nourishing the tissue

pulseflow DF® is designed to be worn around 10-15 hours per day and for up to 12 weeks of therapy, after which, the offloading component is removed, and the boot with new insole, gives protection from new ulcer formation

© THE DIABETIC BOOT COMPANY LTD. 11

pulseflow DF® offers more than the existing offloading therapies/devices:

It looks like normal footwear, causing less social stigma

It offloads as well as the market leader

It pumps blood back up the venous return system

It reduces oedema to help the wound heal

It is supplied as a pair of boots to improve gait stability

pulseflow DF®is taken off at night to give the patient (and partners) a better night’s sleep

pulseflow DF® goes on the protect your patient from future DFU formation once therapy is over

pulseflow DF® therapy costs only about $8.50 per day

pulseflow DF®lets you track patient compliance with prescribed therapy

pulseflow DF® works with all known wound healing therapies

Page 12: Les Lindsay, PulseFlow. Presentation at Health-Tech Innovation LABS Conference 18.09.2015

www.pulse-flow.comwww.pulse-flow.com

Thanks for listening