Sintact Medical IHIF Momenutm Intro Deck

Preventing Surgical
Complications with
Contact Barriers
Erik Robinson, PhD, CEO
“In September of 2004 former President Bill Clinton underwent open heart surgery.
6 months later part of his left lung collapsed due to excessive scarring and fluid build-up.
A second invasive surgery was needed to remove the scar tissue to restore normal organ function.
Surgical complications such as the one former President Clinton experienced are unfortunately a
common occurrence after surgery.
At Sintact Medical Systems we prevent surgical complications through the use of contact barriers.
These contact barriers prevent internal scarring and related scarring defects from occurring.
1
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
SURGICAL SCARRING
Healing on the skin differs from
healing of the internal organs
and this difference is magnified
when a patient undergoes
surgery.
Because of the
compartmentalized nature of
the internal organs it is
exceedingly difficult for these
surfaces to heal properly after
they are damaged. This injury
leads to internal scar formation
or scar related defects.
2
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
http://www.cea1.com/
SURGICAL SCARRING
Jin, J., et al., J of Surgical Research, 2009,
156(2), 297-304.
Matthews, B.B., et al., J of Surgical Research
2005, 123(2), 227-234.
These are images of
surgical related
scarring taken from
patients during a
repeat procedure to
remove the scar tissue
"Consensus in adhesion reduction management." The
Obstetrician & Gynaecologist 6(S2): 1-16. (2004).
3
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
The patient suffers from a
great deal of pain and
discomfort but the surgeon
also has a difficulty in
removing these structures
without causing more
damage resulting in scar
re-formation
SURGICAL SCARRING RISK
60-90%
70-90%
4
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
30-60%
50-90%
The likelihood of someone
developing a scarring event or
scar related defect depend on
what type of surgery you are
having and what body cavity is
involved.
Whether in the chest cavity
(cardiac), abdominal cavity,
pelvic cavity, and various
neurological procedures; the
patient is at a seemingly
constant risk of developing a
scarring event or defect
MARKET OPPORTUNITY CLINICAL IMPACT
$300M
$3-4B
%
5.6
Revenue
Expenditures
CAGR
Current
products
sales of antiadhesion
products in
the U.S.
15%
Market
Penetration
Projected
growth over
the next few
years within
this market
Market penetration of current products, this
underpenetrated market is due to the poor efficacy
(~50%) of available products which rely on resorbable
or biodegradable formulations
5
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
500K
Estimated cost
of repeat
procedures,
hospital
readmissions,
extended stays
Repeat Surgeries
Number of
repeat surgeries
to remove scar
tissue annually
SINTACT FILM™
At Sintact Medical we’ve developed a nondegradable surgical film to prevent the incidence
of surgical scar formation.
The non-degradable nature of the film lends to
assuring scar formation cannot occur or re-form
over extended periods of time.
What we’ve been able to do is re-purpose an
existing biocompatible material, one which is
already used in current medical devices.
There are tens of thousands of patients who
currently have this same polymer somewhere in
their body.
This aspect lends to the safety and utilizing this
material in this fashion due to its inclusion in
other FDA approved devices.
6
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
PROJECTED MILESTONES
A non-provisional patent was submitted to the USPTO office in
2014, through Northwestern University.
Q2
2013
Prov. Patent
Q3
2015
Q4
2018
Regulatory
Approval
Q4
2019
Abdominal
Application
Q2
2019
Terms of a license
agreement have
been reached and
are awaiting further
administrative and
legal approval.
7
Non-Prov.
Q2 Patent
2014
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
Post Market
Surveillance
Abdominal Patients
Exit
Post Approval
Q2
2020
Exit
Post
Market
Surveillance
Our current path leads us to gaining regulatory approval and
further develop the Sintact Film. Do to the simplicity of the
product and large unmet need we do envision several exit
opportunities upon completion of several value creating
milestones.
TEAM IN PLACE – FUNDING
Funding Raised To Date
• $325,000 in dilutive & non-dilutive funding
• NSF SBIR $150,000 grant awarded June 2015
Gali Baler, PhD
Erik Robinson, PhD
COO
Co-Founder
CEO
Co-Founder
Co-Inventor
Advisors
David Wiseman, PhD
Jim Kelly, MD, MBA, FACS
Owner, Synechion, Inc.
Leading Surgical Adhesion Expert
Former Cardio Thoracic Surgeon
Founded Medical Investment & Strategy Firm
Dean Ho, PhD, BME
Principal Investigator and Professor
UCLA School of Dentistry
8
Jim Whittle, MBA
General Business Counsel
Medical Device Market Experience
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
Expected Financing Required
• $750,000 for 24 months of operation to finalize,
submit, and gain regulatory approval of a 510(k)
clearance
• Further financing to perform pilot clinical trials
and gain initial traction/sales $4.2M
FUNDING REQUIRED TO ACQUISITION
$750k
9
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.
$4M
Preventing Surgical
Complications with Contact
Barriers
There is an obvious gap in the field of preventing scar formation following surgery. Sintact Medical
bridges this gap in providing surgeons a means of reducing scar related complications keeping the
patients out of the hospital
We are Sintact Medical Systems and we are preventing surgical complications.
Erik Robinson, PhD, CEO
Sintactmed.com | erik@sintactmed.com | 312.493.3140
10
Presentation
to Joe
Smith
© Sintact
Medical
Systems,
Inc. All Rights Reserved.