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Investor Presentation
August 2020
1
NYSE: MLSS
Safe Harbor Statement
This presentation contains forward-looking statements regarding the timing
and financial impact of Milestone's ability to implement its business plan,
expected revenues, timing of regulatory approvals and future success. These
statements involve a number of risks and uncertainties and are based on
assumptions involving judgments with respect to future economic, competitive
and market conditions, future business decisions and regulatory developments,
all of which are difficult or impossible to predict accurately and many of which
are beyond Milestone's control. Some of the important factors that could cause
actual results to differ materially from those indicated by the forward-looking
statements are general economic conditions, failure to achieve expected
revenue growth, changes in our operating expenses, adverse patent rulings,
FDA or legal developments, competitive pressures, changes in customer and
market requirements and standards, and the risk factors detailed from time to
time in Milestone's periodic filings with the Securities and Exchange
Commission, including without limitation, Milestone's Annual Report for the
year ended December 31, 2019. The forward-looking statements in this
presentation are based upon management's reasonable belief as of the date
hereof. Milestone undertakes no obligation to revise or update publicly any
forward-looking statements for any reason.
2
Company History
With 133 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology
Milestone Scientific Inc. (MLSS) is a leading
medical research and development
company that designs and patents
innovative injection technology. Milestone's
computer-controlled systems make
injections precise, efficient, and virtually
painless.
3
Why Enter the Epidural Market?
Market Size
Epidural procedures are one of the fastest growing procedures in the US and worldwide. It is
estimated that over 11 million epidural procedures are performed each year in the US and over
30 million worldwide.
Over $5 billion is spent annually on epidural injections in the US alone. The approximate break
down of epidural procedures in the US is:
▪ 2.4 million labor procedures out of almost 4 million births
▪ 9 million pain intervention steroid injections
▪ ~900,000 total and growing Neuroaxial Regional Blocks for hip and knee surgeries
4
Current Technology Being Used Today!
The technique of "single-shot" lumbar
epidural anesthesia was first developed
in 1921 by Spanish military surgeon
Fidel Pagés, and hasn’t changed
significantly since.
Glass Loss of Resistance
(LOR) 1946
“Modern” LOR
Syringes
5
Innovating a New Standard of Care
in Anesthesia
• Now with our patented
CompuWave™ and CathCheck™
features, anesthesiologists should
be able to save significant time and
institutions should save significant
costs
• Correlates subjective feel with
objective visual and audible
verification of pressure changes
• Offers real-time needle location
with consistent distinction of true
loss of resistance
• Builds physician confidence
resulting in fewer attempts; less
Dural punctures reducing
complications and costs
• Accelerates procedure learning
curve for residents and trainees
Welcome to the 21st
Century
6
Listening to Providers, Addressing
Unmet Needs
▪ Placement of an epidural needle is difficult;
Requiring 60-90 placements before reaching an
adequate skill level
▪ 17% of failure rates are due to false loss of
resistance (False Loss of resistance is when the
needle enters soft tissue or fatty tissue and the
provider believes it is in the epidural space when it
is not) resulting in a failure to provide pain relief.
This requires another attempt while the patient
remains in labor and pain.
▪ Epidural Dural punctures are as high as 5+%. An
Epidural puncture is when the Dura is breached
and the needle enters into the spinal canal, causing
cerebral spinal fluid to leak resulting in headaches,
pain, infection, and other morbidities costing
insurance companies and hospitals additional time
and money.
▪ 20% of epidural blood patches also fail and require
additional care (A blood patch is a procedure to try
and repair the Dural punctures)
7
CompuFlo Epidural Instrument
Commercial Momentum
▪ The CompuWave™ patented feature is allowing precise
location identification of the epidural space
▪ Nine peer-reviewed published studies validate
instrument effectiveness in identifying the epidural space
▪ Additional ongoing studies
▪ More than 2,000 epidural procedures performed
worldwide including key opinion leaders
▪ Hospital in Italy adopts CompuFlo for all epidurals in
labor and delivery
▪ Moving to a direct sales model in the USA
▪ Study on Economic Benefit
8
New Clinical Trial Finds CompuFlo® Instrument a Safe
Alternative to Current Standards of Care
▪ 160 labor and delivery (L&D) patients –
400 total
▪ 99 % effective in identifying epidural
space on first attempt
▪ 14 % more successful in patients with
high BMI
▪ L&D epidurals resulted in 0 dural
punctures, loss of resistance 4 (old
technique being used today)
▪ Procedure time reduced by 1 minute with
CompuFlo
ANESTHESIA & ANALGESIA
NOV 2019
9
Anesthesiology Research & Practice
Jan 2019
▪ 120 patient clinical study
▪ CompuFlo blocks performed successfully with
no complications
▪ Consistent differentiation of true loss of
resistance
“The pressure sensing innovation
in CompuFlo offers a more
objective, reliable and simpler way
to identify the epidural space. This
confidence in recognizing a true
loss of resistance can help
improve the efficacy of anesthesia,
reduce complications, and speed
the procedure learning curve for
trainees.”
Dr. Giorgio Capogna
Director of the European School of
Obstetric Anesthesia and Maternal
Neonatal Simulation Center
10
International Journal of Obstetric Anesthesia
Nov 2018
▪ Objective identification of ligamentum flavum
and epidural space
▪ Difficult blocks rescued in a single attempt
▪ Differentiation of true loss of resistance for
accurate epidural placement
“We [have] validated the CompuFlo
device as a means of adequately
identifying the ligamentum flavum
and the epidural space. “
“Our preliminary findings suggest
that it could assist the physician in
training when performing epidural
insertion.”
Study investigators from the Citta di
Roma Hospital and Careggi Hospital:
Dr. Giorgio Capogna,
Dr. Michela Camorcia
Dr. Alessandra Coccoluto
Dr. Massimo Micaglio
Dr. Matteo Velardo
11
Cost Savings Studies Underway
 Large academic institution completed a definitive economic study
aimed to prove:
 Significant reduction of accidental Dural punctures
 Associated cost reduction
 One anesthesiologist completed over 500 CompuFlo epidurals,
reporting no Dural punctures
 KOL relationship development in progress in France, Spain,
Germany, UK, Belgium, Italy and USA
12
Cost Savings of More Than $500 Per
Hospital Stay on Average
 Department of Anesthesiology,
University of Texas Medical Branch at
Galveston
 Objective: Cost effectiveness analysis
of CompuFlo with real-time pressure
sensing technology and traditional LOR
technique in parturients requesting
labor epidural anesthesia
 4483 deliveries from 4353 parturients
were included in the study
 Conclusion: CompuFlo costs about
$504 less per hospital stay on average
 For a hospital with 6000 epidural
procedures per year, potential cost
savings could be 3 Million dollars
13
▪ Establish CompuFlo as the preferred
procedure using the cost saving
analysis
▪ Moving to a direct sales force with
clinical support personnel
US Sales
 Over 200 physician demo’s
completed in over 16 hospitals
 Given the significant reduction of
time that CathCheck™ affords
anesthesiologists, we believe that
this will be our first point of entry
into the US hospital market.
14
Sales Strategy
International Sales
 Addition of MOVI Group in Italy
 10 instruments purchased
 28 sales agents in the field
 1 dedicated product manager,
3 regional managers
 First sale by MOVI to Ospedale
“Pugliese Ciaccio” di
Cantanzaro, hospital in Italy
 Agreement with new Croatian
distributor, EMA d.o.o.
 3 instruments purchased
 Trials in 4 hospitals
 Sales to Algeria, Diagal
 6 instruments
 Lebanon distributor, Sterimed
 Presented CompuFlo at 3
congresses
 Trials in 2 University Hospitals in
progress
 MOU with Russian distributor, REAN
 1 demo instrument sold to
investigate market size and
potential
 Presented at 4 congresses
15
Marketing
▪ Refined market messaging to
providers
▪ Invested in US live birth data by
hospital for sales targeting
▪ Developed Cost Calculator App
for sales team
▪ Launched a Commercial
Procedure Tracker & Reporting
Tool for loaner trials
▪ Updated marketing and sales
brochures
▪ Initiated Digital Marketing
Strategy
▪ New packaging concept including
preassembled disposables
▪ Developed CompuFlo Trainer
product to target simulation Labs
& Medical Training Centers
▪ Launched CompuWave™ and
CathCheck™ features
16
Product Brochure
Marketing Collateral
Quick Start Guide
Video Animation
17
Beyond Epidural:
The Medical Opportunity
Peripheral
Nerve Block
Thoracic
Catheter
Check
Intra-articular
✓ Now with our patented CompuWave™ technology the
CompuFlo Epidural Instrument can now check catheters in
1-2 minutes not 20-40 minutes.
✓ High-risk nature of procedure; 3 – 5 % of all epidurals,
Study currently underway.
✓ Received peripheral nerve block patent
✓ Large worldwide market for injections into the joints
✓ Received Botox Patent in Jan 2020Botox
18
Business Plan Summary/Strategy
▪ With the market and individual hospital systems all having different criteria
and purchasing models, we will have 3 different sales strategies.
1. Sell the CompuFlo instrument and disposables.
2. Consign the CompuFlo instrument and upcharge the disposables.
3. Lease the CompuFlo instrument and disposables, we include the
instrument and a minimum number of disposables into a monthly
payment. More disposables can be purchased if they exceed the
minimum.
▪ The strategy is to accommodate the different hospital systems purchasing
procedures. If consigned or leased it is a different process and often easier
and less time consuming and falls into a different budget. Often a less time
consuming process is available if the product is consigned or leased to a
hospital.
19
Milestone Scientific- Market Re-Cap
Epidural is one of the fastest growing segments in Medicine-
▪ 11 million performed in the US and 30 million worldwide
▪ 2.4 million Labor and Delivery- US
▪ 9 million nerve blocks for pain intervention- US
▪ 900,000+ for pain blocks in Hips and Knees- US
▪ Over a $5+ Billion Dollar Market in the US and growing
Peripheral Nerve Blocks
▪ Globally there are 41 million Peripheral Nerve blocks performed, US market is
expected to reach $430 Million by 2027. ( Milestone Scientific currently has a study
being conducted by Dr. Oliver Choquet at the Lapeyronie University Hospital -
Montpellier, France )
▪ With the passing of the Substance Abuse Disorder Prevention That Promotes Opioid
Recovery and Treatment for Patients and Communities (SUPPORT) act, physicians are
using more pain blocks to reduce the opioid use post surgery.
Insurance companies now require at least 3 pain injections for prognostic and diagnostic
workup prior to approving surgery in orthopedics and spine.
20
Two New Features added to the
CompuFlo Epidural Instrument
With the addition of the patented CompuWave™ technology we can
now not only verify epidural placement but also confirm catheter
placement in real time with the patients’ pulse
21
What Do These New Features Mean?
When performing an epidural
the CompuFlo™ instrument
objectively identifies the False
Loss of Resistance and True
Loss of Resistance.
CompuWave™ allows the
practitioner to also verify that
the needle is in the epidural
space when the pulsatile
waveform is displayed
False Loss of
Resistance
True Loss of
Resistance
22
What Do These New Features Mean?
Until now clinicians check
catheters by administering a bolus
of anesthetic to a patient and are
then required to wait 20-40
minutes to see if patient’s pain has
subsided, if it doesn’t the catheter
has to be removed and another
epidural must be performed.
With CathCheck™ they can, in 1-
2 minutes identify if the catheter
is in place or has become
dislodged from the epidural
space.
This saves considerable time and
money and provides better
patient care.
If the Catheter is in the epidural
space the waveform indicates it.
If it’s not that will be indicated
as well.
23
The Importance of CathCheck™
The CathCheck™ feature is unique to Milestone Scientific…the ability
to check catheters is reduced to 1-2 minutes from 20 - 40 minutes.
CathCheck™ will allow much faster verification time of the catheter
placement. Patients are often moved multiple times daily which can
lead to the catheter being dislodged from the epidural space. The
dislodgement of the catheter prevents the patients from receiving pain
relief. CathCheck™ is significantly reducing catheter placement
verification time.
CathCheck™’s ability for fast verification will considerably reduce
anesthesiologists’ time which will translate into considerable savings
to the institution and better patient care.
24
Thank You!
25
NYSE: MLSS

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Milestone Scientific Inc. Investor Presentation

  • 2. Safe Harbor Statement This presentation contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2019. The forward-looking statements in this presentation are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason. 2
  • 3. Company History With 133 foreign patents and 19 US patents issued Milestone Scientific is the leader in modern injection technology Milestone Scientific Inc. (MLSS) is a leading medical research and development company that designs and patents innovative injection technology. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. 3
  • 4. Why Enter the Epidural Market? Market Size Epidural procedures are one of the fastest growing procedures in the US and worldwide. It is estimated that over 11 million epidural procedures are performed each year in the US and over 30 million worldwide. Over $5 billion is spent annually on epidural injections in the US alone. The approximate break down of epidural procedures in the US is: ▪ 2.4 million labor procedures out of almost 4 million births ▪ 9 million pain intervention steroid injections ▪ ~900,000 total and growing Neuroaxial Regional Blocks for hip and knee surgeries 4
  • 5. Current Technology Being Used Today! The technique of "single-shot" lumbar epidural anesthesia was first developed in 1921 by Spanish military surgeon Fidel Pagés, and hasn’t changed significantly since. Glass Loss of Resistance (LOR) 1946 “Modern” LOR Syringes 5
  • 6. Innovating a New Standard of Care in Anesthesia • Now with our patented CompuWave™ and CathCheck™ features, anesthesiologists should be able to save significant time and institutions should save significant costs • Correlates subjective feel with objective visual and audible verification of pressure changes • Offers real-time needle location with consistent distinction of true loss of resistance • Builds physician confidence resulting in fewer attempts; less Dural punctures reducing complications and costs • Accelerates procedure learning curve for residents and trainees Welcome to the 21st Century 6
  • 7. Listening to Providers, Addressing Unmet Needs ▪ Placement of an epidural needle is difficult; Requiring 60-90 placements before reaching an adequate skill level ▪ 17% of failure rates are due to false loss of resistance (False Loss of resistance is when the needle enters soft tissue or fatty tissue and the provider believes it is in the epidural space when it is not) resulting in a failure to provide pain relief. This requires another attempt while the patient remains in labor and pain. ▪ Epidural Dural punctures are as high as 5+%. An Epidural puncture is when the Dura is breached and the needle enters into the spinal canal, causing cerebral spinal fluid to leak resulting in headaches, pain, infection, and other morbidities costing insurance companies and hospitals additional time and money. ▪ 20% of epidural blood patches also fail and require additional care (A blood patch is a procedure to try and repair the Dural punctures) 7
  • 8. CompuFlo Epidural Instrument Commercial Momentum ▪ The CompuWave™ patented feature is allowing precise location identification of the epidural space ▪ Nine peer-reviewed published studies validate instrument effectiveness in identifying the epidural space ▪ Additional ongoing studies ▪ More than 2,000 epidural procedures performed worldwide including key opinion leaders ▪ Hospital in Italy adopts CompuFlo for all epidurals in labor and delivery ▪ Moving to a direct sales model in the USA ▪ Study on Economic Benefit 8
  • 9. New Clinical Trial Finds CompuFlo® Instrument a Safe Alternative to Current Standards of Care ▪ 160 labor and delivery (L&D) patients – 400 total ▪ 99 % effective in identifying epidural space on first attempt ▪ 14 % more successful in patients with high BMI ▪ L&D epidurals resulted in 0 dural punctures, loss of resistance 4 (old technique being used today) ▪ Procedure time reduced by 1 minute with CompuFlo ANESTHESIA & ANALGESIA NOV 2019 9
  • 10. Anesthesiology Research & Practice Jan 2019 ▪ 120 patient clinical study ▪ CompuFlo blocks performed successfully with no complications ▪ Consistent differentiation of true loss of resistance “The pressure sensing innovation in CompuFlo offers a more objective, reliable and simpler way to identify the epidural space. This confidence in recognizing a true loss of resistance can help improve the efficacy of anesthesia, reduce complications, and speed the procedure learning curve for trainees.” Dr. Giorgio Capogna Director of the European School of Obstetric Anesthesia and Maternal Neonatal Simulation Center 10
  • 11. International Journal of Obstetric Anesthesia Nov 2018 ▪ Objective identification of ligamentum flavum and epidural space ▪ Difficult blocks rescued in a single attempt ▪ Differentiation of true loss of resistance for accurate epidural placement “We [have] validated the CompuFlo device as a means of adequately identifying the ligamentum flavum and the epidural space. “ “Our preliminary findings suggest that it could assist the physician in training when performing epidural insertion.” Study investigators from the Citta di Roma Hospital and Careggi Hospital: Dr. Giorgio Capogna, Dr. Michela Camorcia Dr. Alessandra Coccoluto Dr. Massimo Micaglio Dr. Matteo Velardo 11
  • 12. Cost Savings Studies Underway  Large academic institution completed a definitive economic study aimed to prove:  Significant reduction of accidental Dural punctures  Associated cost reduction  One anesthesiologist completed over 500 CompuFlo epidurals, reporting no Dural punctures  KOL relationship development in progress in France, Spain, Germany, UK, Belgium, Italy and USA 12
  • 13. Cost Savings of More Than $500 Per Hospital Stay on Average  Department of Anesthesiology, University of Texas Medical Branch at Galveston  Objective: Cost effectiveness analysis of CompuFlo with real-time pressure sensing technology and traditional LOR technique in parturients requesting labor epidural anesthesia  4483 deliveries from 4353 parturients were included in the study  Conclusion: CompuFlo costs about $504 less per hospital stay on average  For a hospital with 6000 epidural procedures per year, potential cost savings could be 3 Million dollars 13
  • 14. ▪ Establish CompuFlo as the preferred procedure using the cost saving analysis ▪ Moving to a direct sales force with clinical support personnel US Sales  Over 200 physician demo’s completed in over 16 hospitals  Given the significant reduction of time that CathCheck™ affords anesthesiologists, we believe that this will be our first point of entry into the US hospital market. 14 Sales Strategy
  • 15. International Sales  Addition of MOVI Group in Italy  10 instruments purchased  28 sales agents in the field  1 dedicated product manager, 3 regional managers  First sale by MOVI to Ospedale “Pugliese Ciaccio” di Cantanzaro, hospital in Italy  Agreement with new Croatian distributor, EMA d.o.o.  3 instruments purchased  Trials in 4 hospitals  Sales to Algeria, Diagal  6 instruments  Lebanon distributor, Sterimed  Presented CompuFlo at 3 congresses  Trials in 2 University Hospitals in progress  MOU with Russian distributor, REAN  1 demo instrument sold to investigate market size and potential  Presented at 4 congresses 15
  • 16. Marketing ▪ Refined market messaging to providers ▪ Invested in US live birth data by hospital for sales targeting ▪ Developed Cost Calculator App for sales team ▪ Launched a Commercial Procedure Tracker & Reporting Tool for loaner trials ▪ Updated marketing and sales brochures ▪ Initiated Digital Marketing Strategy ▪ New packaging concept including preassembled disposables ▪ Developed CompuFlo Trainer product to target simulation Labs & Medical Training Centers ▪ Launched CompuWave™ and CathCheck™ features 16
  • 17. Product Brochure Marketing Collateral Quick Start Guide Video Animation 17
  • 18. Beyond Epidural: The Medical Opportunity Peripheral Nerve Block Thoracic Catheter Check Intra-articular ✓ Now with our patented CompuWave™ technology the CompuFlo Epidural Instrument can now check catheters in 1-2 minutes not 20-40 minutes. ✓ High-risk nature of procedure; 3 – 5 % of all epidurals, Study currently underway. ✓ Received peripheral nerve block patent ✓ Large worldwide market for injections into the joints ✓ Received Botox Patent in Jan 2020Botox 18
  • 19. Business Plan Summary/Strategy ▪ With the market and individual hospital systems all having different criteria and purchasing models, we will have 3 different sales strategies. 1. Sell the CompuFlo instrument and disposables. 2. Consign the CompuFlo instrument and upcharge the disposables. 3. Lease the CompuFlo instrument and disposables, we include the instrument and a minimum number of disposables into a monthly payment. More disposables can be purchased if they exceed the minimum. ▪ The strategy is to accommodate the different hospital systems purchasing procedures. If consigned or leased it is a different process and often easier and less time consuming and falls into a different budget. Often a less time consuming process is available if the product is consigned or leased to a hospital. 19
  • 20. Milestone Scientific- Market Re-Cap Epidural is one of the fastest growing segments in Medicine- ▪ 11 million performed in the US and 30 million worldwide ▪ 2.4 million Labor and Delivery- US ▪ 9 million nerve blocks for pain intervention- US ▪ 900,000+ for pain blocks in Hips and Knees- US ▪ Over a $5+ Billion Dollar Market in the US and growing Peripheral Nerve Blocks ▪ Globally there are 41 million Peripheral Nerve blocks performed, US market is expected to reach $430 Million by 2027. ( Milestone Scientific currently has a study being conducted by Dr. Oliver Choquet at the Lapeyronie University Hospital - Montpellier, France ) ▪ With the passing of the Substance Abuse Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) act, physicians are using more pain blocks to reduce the opioid use post surgery. Insurance companies now require at least 3 pain injections for prognostic and diagnostic workup prior to approving surgery in orthopedics and spine. 20
  • 21. Two New Features added to the CompuFlo Epidural Instrument With the addition of the patented CompuWave™ technology we can now not only verify epidural placement but also confirm catheter placement in real time with the patients’ pulse 21
  • 22. What Do These New Features Mean? When performing an epidural the CompuFlo™ instrument objectively identifies the False Loss of Resistance and True Loss of Resistance. CompuWave™ allows the practitioner to also verify that the needle is in the epidural space when the pulsatile waveform is displayed False Loss of Resistance True Loss of Resistance 22
  • 23. What Do These New Features Mean? Until now clinicians check catheters by administering a bolus of anesthetic to a patient and are then required to wait 20-40 minutes to see if patient’s pain has subsided, if it doesn’t the catheter has to be removed and another epidural must be performed. With CathCheck™ they can, in 1- 2 minutes identify if the catheter is in place or has become dislodged from the epidural space. This saves considerable time and money and provides better patient care. If the Catheter is in the epidural space the waveform indicates it. If it’s not that will be indicated as well. 23
  • 24. The Importance of CathCheck™ The CathCheck™ feature is unique to Milestone Scientific…the ability to check catheters is reduced to 1-2 minutes from 20 - 40 minutes. CathCheck™ will allow much faster verification time of the catheter placement. Patients are often moved multiple times daily which can lead to the catheter being dislodged from the epidural space. The dislodgement of the catheter prevents the patients from receiving pain relief. CathCheck™ is significantly reducing catheter placement verification time. CathCheck™’s ability for fast verification will considerably reduce anesthesiologists’ time which will translate into considerable savings to the institution and better patient care. 24