September 2019

THERMASPEC
MICROWAVE THERMOTHERAPY (TUMT)
TREATMENT FOR BPH AND CPPS
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Contents

• About Medispec
• The Thermaspec
• Thermaspec Applications
• CPPS
• BPH
• Thermaspec Advantages
• Marketing
• Summary
• Appendix
• Operations
• Clinical data
• Current Technology in the Market
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About Medispec

• Founded in 1992

• Innovators in the SWT for Erectile Dysfunction

• Specializes in shockwave-based systems for the fields of Urology,

Cardiovascular, Orthopedics as well as Veterinary

• Global leaders in low intensity SW treatments

• A leader in installations of ESWL systems in the U.S.A. since 2001

• Thousands of medical systems installed worldwide

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Our Vision:
To improve quality of people’s lives everywhere, through meaningful
profitable innovations

Our Mission:
To continuously explore new medical
applications where Shockwave Therapy
can be used to heal and better people’s
lives, wherever it's needed
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Products Line

UROLOGY SEXUAL MEDICINE CARDIOLOGY

E3000 & EM1000 ED1000 Cardiospec
Extracorporeal Shock Wave revolutionary treatment for ED SWT for Cardiac Ischemic
Lithotripter Erectile Dysfunction Shock Wave Therapy Diseases

AESTHETICS ORTHOPEDIC THERMOTHERAPY LITHOTRIPSY

Slimspec Orthospec Thermaspec Lithospec
RWT for Cellulite Orthopedic ESWT Thermotherapy for Intracorporeal
Treatments Prostate Problems Lithotripsy System
The Thermaspec
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The Thermaspec

Proven treatment alternative to CPPS as

well as safe and efficient treatment to Flat screen
BPH, when other treatment alternatives
are not favorable

Main Unit

Applicator
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CE Approved
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The Mechanism

• Microwave energy is used as a source of heat

dedicated to reduce prostatic mass and
alleviate urinary obstruction symptoms
• Tissue necrosis resulting from application of
heat (high temperatures)
• Induction of apoptosis (low temperatures)
• Sympathetic nerve degeneration (disruption of
alpha-1 adrenergic receptors)
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The Mechanism – Continuation

• Microwaves produce electromagnetic radiation with oscillating

electrical and magnetic fields.
• Heat is produced while the microwaves are absorbed by the tissue.
• It rises mainly by electrical dipoles (water molecules) oscillating in
the microwave field and electrical charge carriers (ions) moving back
and forth in the field. These movements transfer energy to the tissue
in form of heat.
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Local Effect of TUMT

• Heating in excess of 45°C is followed by coagulation necrosis

• Histopathological effect of thermotherapy appears to be related to
the induction of cell death
• Induced necrosis was shown to disrupt periurethral α-adrenergic
receptors reflecting denervation of smooth muscle cells consisting
with increased urinary flow rate after TUMT.
• Recently, it was demonstrated that TUMT increased the sensory
threshold (evoked by electrical stimulation) in the posterior urethra
by 30%, resulting in the reduction of irritative symptoms
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Thermaspec Highlights

• Ideal for:
• Sexually active men
• When anesthesia or an invasive procedure are not advisable
• For moderate BPH patients who do not wish to undergo an invasive procedure
• Extremely safe system and treatment – low energy and
temperatures using thermocouples
• The only non-surgical proven specific medical treatment alternative
as well as safe and efficient treatment to BPH
• Can be used in addition to TURP
• No need of rectal probe
• Outpatient solution
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Advantages

• Safe and efficient:

 Rapid, precise & controlled heating* - no need for rectal probe or cooling
system
 No need for anesthesia (topical anesthetics & PO analgesics are sufficient)
 Low degree of (non ionizing) radiation exposure

• Offers complete solution for treatment and diagnosis of BPH, CPPS

and urinary tract obstructions together with the Urospec
uroflowmetry system

* Controlled heating by the software – 2 thermocouples with 2 heating points – if one is not
functioning properly the systems shuts down automatically
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Thermaspec Applications

• Prostatitis
• Chronic prostatitis/Chronic pelvic pain syndrome (CP/CPPS),

• Bacterial Prostatitis

• Benign Prostatic Hyperplasia (BPH)

Enlargement of prostate gland that occurs as men age (non-malignant)
 CP/CPPS
Chronic Prostatitis &
Chronic Pelvic Pain Syndrome
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CP/CPPS*

Inflammation of the prostate gland that may result in pain during

urination and Sexual malfunction

* Thermaspec treats CP/CPPS & bacterial Prostatitis

in which antimicrobial medications are not effective
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CP/CPPS Manifestations
Severe impact
• History of Recurrent UTI on quality of life
• Pain and burning sensation during urination
• Decreased Urinary Stream
• Urinary Hesitancy
• Frequent Urination
• Incontinence

• Lower Back Pain

• Perineal or Pelvic Floor Pain
• Pain with bowel movement

• Pain With Ejaculation

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CP/CPPS Prevalence

• ~ 50% of all men develop CP/CPPS symptoms

• 25% of men evaluated for a urologic problem
• 8% of all visits to urologists
• The most common urologic problem in men younger than 50
• Third most common urologic problem in older men
• Prevalence: ~ 10% in a population of men ages 20-74
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CP/CPPS Treatment Alternatives

Saw palmetto
Anti-Inflammatory
Medications Muscle Relaxants Drinking Extra
Fluids

Hot Baths Ejaculating Frequently Changed Diet Relax When Urinating

* According to Dr. Leroy Nyberg, Jr., director of Urology Programs, US National Institutes of Health,
January 2008
 BPH
Benign Prostatic Hyperplasia
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BPH

Benign Prostatic Hyperplasia (BPH) - Enlargement of prostate gland

that occurs as men age (non-malignant)
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BPH Prevalence

• 50% of men over the age of 50 will develop BPH, a non-cancerous

enlargement of the prostate that might restrict urine flow

• 80% of men will experience urinary symptoms by the time men

reach their 70s or 80s
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Target Population of BPH

• For sexually active men over 50

• Elderly Patients

• When anesthesia is not an option

• When treatment is needed, but TURP is not advisable

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Treatment Protocol

Insertion of catheter
(containing the Applicator)

Inflation of catheter balloon

& repositioning of catheter

CP/CPPS- Temperature is raised BPH- Temperature is gradually raised

to 39°c (for at least 3 min) than gradually to 45-48°c (over 5 min) then
raised to 46-47°c for additional 57 min. raised to 60°c for additional 55 min.

Following treatment - immediate removal

of catheter (post-treatment Foley catheter
insertion is optional)

CP/CPPSA- Additional treatment if required.

Interval between treatments: 1 month
BPH- Post treatment follow-up: 1-3 months
Marketing
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World Market Information

• Reimbursement in several European countries

• European health authorities are looking for outpatient solutions due

to cost factors
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Potential Users

• Hospitals

• Private clinics

• Mobile service
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Marketing Channels (1) – Hospitals

• System cost

• Consumables cost (catheter – one use)

• Applicator – 30 patients

• Income :Treatment fee

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Marketing Channels (2) – Private Clinics

• System cost

• Consumables cost (catheter – one use)

• Applicator – min. 30 patients

• Personnel cost

• Clinic cost (rental and other expenses)

• Payment per visit pre and post treatment, follow up visit - out of
pocket money? Reimbursed?
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Marketing Channels (3) – Mobile Services

• Vehicle costs & maintenance

• Consumables cost (catheter – one use)

• Applicator – 30 patients

• No. of treatments per day

• Technician fee

• Physician fee
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Medispec Treatment & Diagnosis Center

• Medispec offers a complete solution for treatment and diagnosis of

BPH, CPPS and urinary tract obstructions

• Medispec Urospec is the most accurate uroflowmeter assisting the

physician in the diagnosis of various
diseases causing urinary tract obstructions

• The Urospec software can be incorporated as part

of the Thermaspec system
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Summary

• The only non-surgical proven specific medical treatment alternative

to CPPS, safe & efficient for BPH

• Ideal for sexually active & high risk, as well as no-option patients

• Extremely safe system and treatment

• Highly Efficient - reduces urination frequency, urgency

and intermittent flow

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Summary- Continuation

• Can be used in addition to TURP

• Cost effective – the only consumable is the catheter

• One fast treatment protocol

• Anesthesia-free outpatient treatment

• Minimal ambulatory admittance required
• Fast withdrawal of Foley Catheter

• Simple operation & maintenance

marketing@medispec.com
Appendix
Operations
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Flexible Multi-use Applicator

Innovative applicator assembly consists of:

• Flexible multi-use applicator containing 2 thermal sensors
• 3-way single use Foley catheter
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Catheter

• Catheter Size: 18Fr

• Three Channels: Applicator, Balloon and Urine Bag Balloon
20cc
Applicator Channel

Indicators for Applicator

Positioning Urine bag
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Applicator Assembly

Balloon Balloon
inflation port

Maximal heating point marker Maximal heating point- Urine bag Thermocouple
mirrored marker port connector
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Applicator Placement

Medispec unique applicator enables optimal positioning in accordance with

the prostate size:
Medium Prostate => 4 cm Small Prostate <= 4 cm

MHP on middle line MHP on first line

Medium prostate – Most of the energy Small prostate - The surplus energy
is transmitted to the prostate is transmitted to the bladder

Simple procedure - One protocol for all prostate sizes

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Heating Point

Balloon

Heating
point center
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Heat Distribution

60
Heating point center

cm

For BPH: 55 to 60° C

For Prostatitis: 47° C
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Large Prostate > 6cm

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Medium Prostate 4-6 cm

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Small Prostate < 4cm

Thermaspec Software
User Friendly
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Treatment Screen - Temperature Monitoring

The system will

automatically
shut down if the
temperature
reaches above
the set
temperature
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Statistics
Clinical Data
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Clinical Results - CPPS

Prof. Lucan, Romania

• N=78
• Treatment Protocol: Temp. 45° - 60 ° C
• Duration: 30 Min.
• Post Treatment Catheter: 10 Days
• Results:
• NIH CPSI (Chronic Prostatitis Symptoms) total score: 57.6%
• Pain Score: 66.6%
• QOL (Quality of Life) Impact Score: 53.6%
• Urinary Score: 40.8%
• Complete Symptom Disappearance: 28%
• Partial response: 81%
• 1 Year Follow Up: 70% with at least 50% reduction of pain
• Side Effects: Minimal and Temporary
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Clinical Results (1) - BPH

• N=209 (Various Centers)

• Treatment Protocol: Temp. 42° - 60 ° C
• Duration: 30-90 Min.
• Post Treatment Catheter: 10 Days
• Results:
• IPSS total score: 62.2%
• PVR (Post Voiding Residual Volume): 50% Improvement
• 26 Patients with Chronic Catheter: 54% Catheter Free
• Additional testing by Prof. Lucan, Romania (N=155):
• 79.3% Able to Urinate
• 74.2% Able to reduce or Stop Medication
• Mean time of Catheterization: 3.2 Weeks (Initial Prostate
Size: 59.3 ml)
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Clinical Results (2) - BPH

Dr. Foux, Russia

• N=13
• Treatments between 2008 to 2010
• Each of the patients underwent 2 Theramspec sessions
• 4 out of 13 BPH patients had Cystostomy (external drainage system)
• Results:
• Treatment enabled removal of Cystostomy for 3 out of 4 patients!
• After 2 TUMT sessions the residual volume in average decreased from 120 to
45 ml (62% decrease), IPSS index in average has decreased by 32% from 24 to
16.8 points
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Chronic Non-Bacterial CPPS

Signs & Symptoms: Diagnosis Modes:

• Urinary frequency and urgency • DRE - Digital Rectal Exam
• Nocturia
• 3-Glass Urine Collection
• Difficulty urinating – decreased
force of urinary stream • Video urodynamics
• Incontinence (analysis of bladder
• Burning or painful urination
• Perineal Pain (referring to the function and physiology)
perineum, the anus)
• Low-back, joint or muscle pain
• Tender or swollen prostate
• Blood in the urine
• Painful ejaculation
• Decreased libido
• Impotence
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NIH Classification - Prostatitis

• Cat I: Acute Bacterial CPPS

• Cat II: Chronic Bacterial CPPS
• Cat III: Chronic Pelvic Pain Syndrome (CPPS)
• Cat IIIA: Inflammatory CPPS
• Cat IIIB: Non-inflammatory CPPS
• Cat IV: Asymptomatic Inflammatory CPPS

BPH Symptoms & Diagnosis Modes
Signs & Symptoms:
• A hesitant, interrupted & weak
stream
• Nocturia
• More frequent urination
• Urgency and leaking or dribbling
• Painful urination
• Hematuria (blood in urine)
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Diagnosis Modes:
• DRE - Digital Rectal Exam
• PSA - Prostate Specific Antigen
Blood Test
• Rectal Ultrasound
• Uroflowmetry
• IVP - Intravenous Pyelogram (an
X-Ray of the urinary tract)
• Cystoscopy
• Kidney function blood tests
Current Technology
in the Market
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Treatment Methods

• Comparison
• TURP
• TUNA
• RF
• Laser
• TUMT (Thermaspec) technology
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Treatment Methods Comparison

TUMT TURP
Laser TUNA RF
(Thermaspec) (gold standard)
Minimal Minimal Minimal Minimal
Treatment invasive
invasive invasive invasive invasive
Topical
Anesthesia No need yes yes n/a
anesthesia
Hospitalization No need yes yes n/a n/a
Minor – see Yes – see Minor –
Side Effects Yes – see list Yes – see list
table list see table
Requires Additional
possible Less cases n/a n/a n/a
Treatment
Only beginning Throughout
Supervision During Throughout
and end of treatment n/a n/a
Treatment treatment time
treatment time
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TURP* - The Gold Standard Treatment

* TURP = Transurethral Resection of Prostate

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TURP Summary

Advantages Disadvantages/Complications
• The most spread modality of BPH’s • Requires anesthesia
treatment • Requires hospitalization
• The “Gold Standard” • Potential complications:
• Transfusion rate (7.1%)
• Clot retention (5%)
• Urinary tract infection (8.2%)
• Urinary retention (9%)
• Bleeding (2%)
• Incontinence (30-40%)
• ED (30%)
• Bladder neck contracture (9.2%)
• Urethral strictures (9.8%)
• Infection (4%)
• TURP syndrome (1.1%)
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TUMT vs. TURP – Less Side Effects

* Source: High-energy transurethral microwave thermotherapy for benign Prostatic hyperplasia,

November 2005
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Thermotherapy Advantages over TURP

• Less invasive therapy

• No need for hospitalization
• No need for anesthesia
• Lower ED rate and other adverse events following treatment
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Laser

• Permanent effects are vaporization and coagulation

• The procedure is usually performed in a hospital or surgical center
• Anesthesia may be used
• Contraindicated in patients with acute
prostatitis, acute urinary tract infection,
or confirmed or suspected prostate
cancer, as well patients with prostates
larger than 120 g.
• Not FDA approved

Laser Summary
Advantages
• Minimal invasive therapy
• Fewer side effects than TURP
• Quicker recovery
• Shorter hospital stays
• Short treatment time
* Source: J Endourol. 2009
64
Complications
• Retrograde ejaculation and in rare instances,
erectile dysfunction (impotence, about 1%)
• Intraoperative bleeding (1.4%)
• Postoperative clinically non-significant
hematuria (78.5%)
• Hematuria requiring clot evacuation (1.4%)
• Urinary retention requiring recatheterization
(2.8%)
• Urinary tract infection (4.3%)
• Prostatitis (1.4%)
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Thermotherapy Advantages over Laser

• No need of anesthesia
• Less complications rate
• Treatment is more tolerable by the patient
• Less catheterization time post treatment
• Thermaspec treatment can be done under physician supervision
only in the beginning and end of each treatment session
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TUNA*

• A therapy which induces prostate

tissue necrosis using thermal energy
• Energy is delivered via
low-level radio-frequency through
needles placed into the prostate

* Trans Urethral Needle Ablation

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TUNA Summary

Advantages Complications
• Minimal invasive treatment • Post-operative urinary retention (13-41%)
• Treatment can be performed under topical • Irritative voiding symptoms (40%)
anesthesia • Bleeding (32%)
• Urinary tract infection (8%)
• Urethral stricture (1.5%)
• Re-operation rate within 2 years (14%)
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RF*

• A therapy which induces prostate tissue necrosis using Radio

Frequency energy
• Energy is delivered via low-level bipolar radio-frequency through
electrodes to the prostate
• Used by one company only

* Bipolar Radio Frequency


RF
Advantages
• Generate in-depth precise tissue necrosis
using an external applicator, with no effect
on the surrounding structures
• Ideal for Prostate Cancer treatments
* Source: J Endourol. 2009
69
Complications
• Acute urinary retention (5.71%)
• Urinary infection (5.71%)
• Rest of complication similar to other non-
invasive treatments
• Not advisable for patients with pacemaker
marketing@medispec.com