SlideShare uma empresa Scribd logo
1 de 12
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.
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
10
8
6
11
7
9 8 8.5
North
America
and
Caribbean
South and
Central
America
Africa Middle
East and
North
Africa
Europe South-East
Asia
Western
Pacific
World
Prevalence (%) of diabetes by region
© 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 Arizona
Following on from a briefing on pulseflow DF at the Diabetic Foot
Meeting
Malvern 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 Leigh
Head of Podiatry Services
Royal Free Hospital
London
pulseflow DF®
Support from Global Experts in Diabetic Limb Salvage
Dr Tudhope
Consultant Vascular Surgeon
Pretoria South Africa
Discussed
Armstrong
paper for
Oedema
Reduction in
Vascular Ulcers.
“this would be
my ultimate
device”
pulseflow DF® - Clinical Support Data
Proof 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
Woundclosurerate
after12weeksoftreatment
Compliant Non-compliant Overall
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
© THE DIABETIC BOOT COMPANY LTD.
Moving upmarket with a name change
7
Boot
• =Footwear
• = Low Reimbursement
Medical Technology
• Wider Audience
• High Tech = Higher
Reimbursement
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 / Urgo
Initial documents signed leading to regulatory clearance and
on to distribution
Singapore
Thailand
Malaysia
Germany/ Austria MSM Order received
Switzerland Guiela Medical Order received
South America Covaleo (Mexico) Signed distribution agreement
SAWC San Antonio May 2015
© THE DIABETIC BOOT COMPANY LTD. 9
Peak Pressure Profiles Average of Stances
© PULSEFLOW 10
RCW V PF DF OPM
RCW pulseflow DFShoe
Shoe v RCW
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
www.pulse-flow.comwww.pulse-flow.com
Thanks for listening

Mais conteúdo relacionado

Destaque

William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...
William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...
William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...Health-Tech Innovation LABS
 
Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...
Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...
Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...Health-Tech Innovation LABS
 
Chris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30th
Chris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30thChris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30th
Chris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30thHealth-Tech Innovation LABS
 
Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...
Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...
Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...Health-Tech Innovation LABS
 
Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...
Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...
Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...Health-Tech Innovation LABS
 
Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...
Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...
Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...Health-Tech Innovation LABS
 
Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...
Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...
Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...Health-Tech Innovation LABS
 
Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...
Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...
Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...Health-Tech Innovation LABS
 
Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015
Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015
Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015Health-Tech Innovation LABS
 
Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio...
 Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio... Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio...
Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio...Health-Tech Innovation LABS
 
Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...
Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...
Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...Health-Tech Innovation LABS
 
Orlando Agrippa, Draper & Dash at "Journeys of Health-Tech Innovation" Nov 3...
Orlando Agrippa, Draper & Dash  at "Journeys of Health-Tech Innovation" Nov 3...Orlando Agrippa, Draper & Dash  at "Journeys of Health-Tech Innovation" Nov 3...
Orlando Agrippa, Draper & Dash at "Journeys of Health-Tech Innovation" Nov 3...Health-Tech Innovation LABS
 
John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...
John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...
John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...Health-Tech Innovation LABS
 

Destaque (13)

William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...
William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...
William Beckett, Hip Impact Protection, at "Journeys of Health-Tech Innovatio...
 
Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...
Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...
Hari Ponniah, TheSelfCarePeople - at "Journeys of Health-Tech Innovation" Nov...
 
Chris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30th
Chris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30thChris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30th
Chris Thomas, Abbott - at "Journeys of Health-Tech Innovation" Nov 30th
 
Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...
Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...
Michael Wright, Guy's and St Thomas Charity at "Journeys of Health-Tech Innov...
 
Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...
Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...
Paul Rinne, Imperial College London. Presentation at Health-Tech Innovation L...
 
Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...
Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...
Ian Prangley, Michael Levens, Activehealthtech. Presentation at Health-Tech I...
 
Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...
Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...
Kevin Auton, Activ8rlives. Presentation at Health-Tech Innovation LABS Confer...
 
Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...
Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...
Karen Taylor, Deloitte. Presentation at Health-Tech Innovation LAB Connected ...
 
Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015
Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015
Daniel Jung, Doctify - at "Journeys of Health-Tech Innovation" Nov 30th 2015
 
Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio...
 Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio... Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio...
Jessica Warner, Tech Media Specialist, at "Journeys of Health-Tech Innovatio...
 
Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...
Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...
Barry Shrier, CEO, HTI LABS, at "Journeys of Health-Tech Innovation", March 2...
 
Orlando Agrippa, Draper & Dash at "Journeys of Health-Tech Innovation" Nov 3...
Orlando Agrippa, Draper & Dash  at "Journeys of Health-Tech Innovation" Nov 3...Orlando Agrippa, Draper & Dash  at "Journeys of Health-Tech Innovation" Nov 3...
Orlando Agrippa, Draper & Dash at "Journeys of Health-Tech Innovation" Nov 3...
 
John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...
John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...
John Finnemore, Partner, Nabarro at "Journeys of Health-Tech Innovation", Mar...
 

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

  • 1. 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.
  • 2. 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 10 8 6 11 7 9 8 8.5 North America and Caribbean South and Central America Africa Middle East and North Africa Europe South-East Asia Western Pacific World Prevalence (%) of diabetes by region
  • 3. © 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 Arizona Following on from a briefing on pulseflow DF at the Diabetic Foot Meeting Malvern 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 Leigh Head of Podiatry Services Royal Free Hospital London pulseflow DF® Support from Global Experts in Diabetic Limb Salvage
  • 4. Dr Tudhope Consultant Vascular Surgeon Pretoria South Africa Discussed Armstrong paper for Oedema Reduction in Vascular Ulcers. “this would be my ultimate device”
  • 5. pulseflow DF® - Clinical Support Data Proof 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 Woundclosurerate after12weeksoftreatment Compliant Non-compliant Overall
  • 6. 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
  • 7. © THE DIABETIC BOOT COMPANY LTD. Moving upmarket with a name change 7 Boot • =Footwear • = Low Reimbursement Medical Technology • Wider Audience • High Tech = Higher Reimbursement
  • 8. 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 / Urgo Initial documents signed leading to regulatory clearance and on to distribution Singapore Thailand Malaysia Germany/ Austria MSM Order received Switzerland Guiela Medical Order received South America Covaleo (Mexico) Signed distribution agreement
  • 9. SAWC San Antonio May 2015 © THE DIABETIC BOOT COMPANY LTD. 9
  • 10. Peak Pressure Profiles Average of Stances © PULSEFLOW 10 RCW V PF DF OPM RCW pulseflow DFShoe Shoe v RCW
  • 11. 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