les lindsay, pulseflow. presentation at health-tech innovation labs conference 18.09.2015
TRANSCRIPT
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
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
© 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
Dr TudhopeConsultant Vascular SurgeonPretoria South Africa
Discussed Armstrong paper for Oedema Reduction in Vascular Ulcers.
“this would be my ultimate device”
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
Wo
un
d c
losu
re r
ate
af
ter
12
we
eks
of
tre
atm
en
t
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 ReimbursementMedical 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 / 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
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