This document discusses HECOLCAP, a new product being developed by B2S to treat bone infections. HECOLCAP aims to enable sustained local delivery of antibiotics while also actively promoting bone regeneration in a single surgery, improving on current treatment which requires multiple surgeries and weeks of intravenous antibiotics. It has the potential to more effectively eradicate infections, reduce treatment time, and lower healthcare costs. An estimated 800,000 cases of bone infection in the US and Europe each year could benefit from HECOLCAP. The company is seeking €2.7 million in funding to complete product development and clinical studies.

1. HECOLCAP
by
B2S
-­‐
Biomime&c
Bone
Solu&ons

2. Team
Susana
Sousa
João
Cortez
Fernando
Monteiro

3. Bone
infec6on,
associated
to:
• diabe6c
foot
ulcers;
• prostheses;
• open
fractures…
8.5
million
in
USA
&
EU
150
million
worldwide
SOURCE:
Bonesupport;
McNally,
Lead
Surgeon
of
the
Bone
Infec6on
Unit
at
the
Nuffield
Orthopaedic
Centre
in
Oxford,
UK
Osteomyeli3s

4. STANDARD
TREATMENT
Surgery
-­‐
6ssue
debridement
Intravenous
an6bio6c
administra6on
Final
surgery
for
bone
replacement
Treatment
6me
N
x
4-­‐6
weeks

5. -­‐ Difficult
to
eradicate
infec6on
-­‐ Up
to
40%
recurrence
and
high
risk
of
amputaJon
-­‐ Impaired
long-­‐term
bone
regeneraJon
(at
least
6
months
to
regenerate)
-­‐ Prolonged
hospital
stay
-­‐ Pa6ent
pain
and
impaired
mobility
MAJOR
ISSUES
raised
by
specialists

6. NO
EFFICIENT
SOLUTION
TO
ERADICATE
BONE
INFECTION
AND
ACTIVELY
PROMOTE
BONE
REGENERATION
Eradica6on
of
infec6on
Bone
growth
An6bio6c
effec6veness
Ac6ve
bone
regenera6on

7. HECOLCAP:
the
single
intervenJon
soluJon

8. Enables
sustained,
local
delivery
of
an
anJbioJc
AcJvely
promotes
bone
regeneraJon
HECOLCAP:
the
single
intervenJon
soluJon

9. STANDARD
TREATMENT
Surgery
-­‐
6ssue
debridement
Intravenous
an6bio6c
administra6on
Final
surgery
for
bone
replacement

10. STANDARD
TREATMENT
Surgery
-­‐
6ssue
debridement
Intravenous
an6bio6c
administra6on
Final
surgery
for
bone
replacement

11. HECOLCAP
Surgery
-­‐
6ssue
debridement
HECOLCAP
applica6on
SINGLE
SURGERY

12. Bone
growth
Bone
infec6on

13. Bone
growth
Bone
infec6on

14. Bone
growth
Bone
infec6on

15. Bone
growth
Bone
infec6on

16. Bone
growth
Bone
infec6on

17. Bone
growth
Bone
infec6on

18. Bone
growth
Bone
infec6on

19. Bone
growth
Bone
infec6on
HECOLCAP
-­‐
local
an6bio6c
delivery,
increasing
its
efficacy,
and
ac6vely
promotes
bone
regenera6on.
All
in
a
single
interven6on.

20. PCT
ApplicaJon
WO2015162561
(A1)
Priority
Date:
21.04.2014
COMPOSITION
FOR
LOCAL
AND
CONTROLLED
RELEASE
OF
DRUGS
AND
METHODS
THEREOF
83%
17%

21. STANDARD
TREATMENT
COMPETITORS
CERAMENT™
&
EluJBone
HECOLCAP
4
-­‐
6
weeks
2
-­‐
3
weeks
2
-­‐
3
weeks
Parenteral
an6bio6c
administra6on
Sustained
local
an6bio6c
delivery
Sustained
local
an6bio6c
delivery
High
an6bio6c
dose
High
local
an6bio6c
dose
OpJmized
anJbioJc
dose
-­‐
-­‐
AcJvely
promotes
bone
regeneraJon

22. Market
Total
cases
of
OsteomyeliJs
in
the
USA
and
Europe
8.5
million
65%
5.5
million
USA
3
million
Europe
CAGR
3.8%
SOURCES:
Bonesupport;
McNally,
Lead
Surgeon
of
the
Bone
Infec6on
Unit
at
the
Nuffield
Orthopaedic
Centre
in
Oxford
(UK)

23. Market
Total
cases
of
OsteomyeliJs
in
the
USA
and
Europe
Acute
OsteomyeliJts
represent
10%
of
total
cases
850
000
USA
&
Europe
Reten6on
rate
95%
ca.
800
000
USA
&
Europe
8.5
million
65%
5.5
million
USA
3
million
Europe
CAGR
3.8%
SOURCES:
Bonesupport;
McNally,
Lead
Surgeon
of
the
Bone
Infec6on
Unit
at
the
Nuffield
Orthopaedic
Centre
in
Oxford
(UK)

24. Investment needs
1
2
3
4
Proof
of
concept
Years
€
100
k
Clinical
studies
€
2.6M
TOTAL
INVESTMENT
€
2.7
M

25. 1 2 3
PRODUCT
DEVELOPMENT
PRE
MARKET
APPROVAL
TRADE
SELL
Exit Strategy
Johnson
&
Johnson
Striker
Baxter
Healthcare
Velcura
Therapeu6cs

26. Orthopedic
surgeons
now
have
a
product
that:
ü Op6mises
an6bio6c
delivery/dosage
ü Maximizes
bone
forma6on
ü Reduces
overall
treatment
6me
and
cost
HECOLCAP
–
Single
intervenJon
soluJon
for
osteomyeliJs

27. HECOLCAP
–
Single
intervenJon
soluJon
for
osteomyeliJs
G.B.,
Orthopedic
Surgeon,
Cleaveland
Clinic,
USA
“...
I
believe
this
is
the
way
forward.
A
soluAon
such
as
this
would
be
really
valuable
for
us.”