The document discusses the ED1000 system, a breakthrough in treating erectile dysfunction (ED) using shockwave technology, which has achieved a 70% success rate, including among those who do not respond to traditional medications. It highlights the clinical backing, efficacy, and the treatment's non-invasive, drug-free nature, making it a significant advancement in urology. Additionally, the ED1000 can also serve as a multi-purpose treatment for related conditions such as chronic pelvic pain syndrome and Peyronie's disease.

1. Dr. Stanley Chan
MD (Canada), MPH (USA), DABFM (USA)
Men’s Health Specialist/ Lecturer
International Medical University (IMU)

2. The most significant medical revolution
in the treatment of erectile dysfunction
(ED) over the past 15 years
ED1000 – A Breakthrough in ED Treatments

3. Contents
• Statistics for ED
• Shockwave technology
• ED1000 highlights
• Clinical data
• Summary
Contents

4. Statistics for ED
Malaysia Cross-national Study of the Prevalence of ED in 1998

5. • How common is ED in specific group of people
 Heart disease 90%1
 High blood pressure 62%2
 Diabetes 51%3
1. Koh KC. Prevalence of erectile dysfunction in men with ischemic heart disease in a tertiary hospital in Malaysia. Med J
Malaysia. 2013 Aug;68(4):301-4
2. Fadzil MA. Socio-demographic and psychosocial correlates of erectile dysfunction among hypertensive patients.
Compr Psychiatry. 2014 Jan;55 Suppl 1:S23-8
3. Selvin E. Prevalence and risk factors for erectile dysfunction in the US. Am J Med. 2007 Feb;120(2):151-7

6. Estimated market size for ED in Malaysia
1.68 million men are suffering from ED1
1. Tambi I. Epidemiology of ED in Malaysia. Highlights of Symposium at 5th Asian Congress on Sexology. Nov 1998; Seoul Korea.

7. Shockwave Technology

8. • Impulse of acoustic energy propagating with supersonic speed in
the liquid or gas
• Natural phenomena
• Steep rise of positive peak
pressure
• Short duration
• V=1500m/sec in water
What are Shockwaves ?

9. ShockWavePressureLevel
(Bar)
100
500
1000
Cardiology ED
Lithotripsy Stone Fragmentation
Anti inflammatory
Angiogenesis
Orthopedics
1970’s 1980’s 2000’s 2010
Shockwave Applications

10. ED1000 Highlights

11. Evolution of ED Treatments

12. challenges with medications
• Lack of efficacy
 Lack of spontaneity
 30-50% non-responders
 Unsatisfactory hardness
• Drug dependency
 Side effects
 Certain patients can’t take
 Over 50% drop-out over time

13. K.A. Hanash. Comparative results of goal oriented therapy for erectile dysfunction. J. Urol. 157:2135 – 2138, 1997
• Simple
• Non-invasive
• Pain free
• High success rate
The Ideal Treatment Definition

14. • The most significant medical revolution in the treatment of ED
over the past 15 years
• Gold standard according to EAU guidelines
• Completely safe - no adverse events
Proven Success

15. • Over 200 ED-1000 installations*
• Thousands of patients treated
74
18
5
873
16
12
Successful installations in over 30 countries
* Data updated Q3/13

16. • The most important medical revolution for ED treatments – a
definite breakthrough in urology*
• A true solution to the ED problem - aiming at curing the
disease rather than just treating it*
• The first and only product in the market with proven and
extensive clinical supporting data
16
* Hatzimouratidis, K. (2010). "Can we cure erectile dysfunction?" Eur Urol 58(2): 249-250.
ED1000 – A Breakthrough in ED Treatments

17. • 70% Proven Success rate
• Generates new blood supply
• triggers the body’s natural repair mechanism
• High success rate (over 73%) with patients who are
non-responders to medications
• Successful & pain free results
• Completely free of side effects
Treatment Benefits

18. Patented Advantages
Medispec’s ED1000 is based on 2 registered patents:
• Large focal zone applicator
• Adjustable Voltage Stabilizer

19. Clinical Studies & Data

20. Worldwide Results
“The first morning erection in 10 years”
69 year-old male
ED for 10 years, no morning erection for 10 years
After 4 weeks, he experienced morning erection x3/w
Teikyo University Hospital
77 years old
ED for 7 years
ED Domain score: Baseline-7, Mid-11, End-20
La Zarzuela Hospital, Madrid
“Treatment was very well accepted “

22. Committed to Excellence
“The only treatment of the cause of ED, and not of the symptoms”

23. Terminology – EHS

24. Standard Protocol
300 shocks per site
5 sites
12 sessions
Total 18,000 shocks / patient
ED1000 - Treatment Methods

25. N=99
Mild (n=22), Mod (n=39) Severe (n=38)
* Internal Meta Analysis
Meta Analysis* – EHS Response by Sessions

26. Gruenwald, I., B. Appel, et al. . "Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in
severe ED patients who respond poorly to PDE5 inhibitor therapy." J Sex Med 2012); 9: 259-264
ED1000 – Poorly Responders to PDE5-I
N=29
Median age= 62
Etiology
• Severe vasculogenic ED
patients
• Poor responders to PDE5i
therapy

27. * Vardi, Y., B. Appel, et al. (2010). "Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-
up pilot study in patients with organic erectile dysfunction." Eur Urol 58(2): 243-248.
** Low Energy Shockwaves for the Treatment of Erectile Dysfunction , Vardi Y et al, ESSM Congress 2011, Milan, Italy
N 20 (100%)
subjects responding
to the treatment
15 (75%)
EF Domain
improvement >5
points
15 (75%)
EF Domain
improvement > 10
points
7 (35%)
Post treatment
patients off PDE5-I
Treatment
10 (50%)
24 months follow-up ***
ED1000 – How Long Does the Effect Last?

28. Graph source: Graham Jackson, Consultant Cardiologist , Guy’s & St Thomas’ Hospital, London, UK.
Multiple
sclerosis 3%Spinal Cord Injury 8% Diabetes Mellitus 40%
Vascular Disease 30%
Radical Surgery 13%
Endocrine disorders
6%
ED-1000 can treat 70% of ED etiologies
Who Is ED1000 Treatment For?

29. Country Name
Israel Prof. Y. Vardi
Greece Prof. D. Hatzichristou
England Dr. D. Ralph
Germany Prof. H. Porst
Argentina Prof. E. Becher
Brazil Dr. S. Glina
Mexico Dr. M. Sotomayor
Japan Prof. S. Horie
India Dr. S. Vasan
Turkey Prof. A. Kadioglu
Australia Prof. C. McMahon
Cooperation with International Key Opinion Leaders

30. Summary

31. Drug-Free, Pain Free, Long-lasting
treatment for erectile dysfunction
with over 70% success rate
Including non-responders
ED1000 – A Breakthrough in ED Treatments

33. Appendix

34. Other Indications

35. The ED1000 system can function as a multi-purpose
treatment system for Urologists, treating
Erectile Dysfunction as well as CPPS and
Peyronie’s Disease using one system only !
A Complete Shockwave Solution For Urologists

36. Inflammation of the prostate gland that may Result in pain during
urination and Sexual malfunction
CPPS (Choric Pelvic Pain Syndrome) Definition

37. Suggested Protocol
• 300 shocks per location (total of 2400
shocks per treatment)
• 8 locations (2 over the penile crura;
6 over the prostate)
• 6 sessions
• Total 14,400 shocks / patient
CPPS - Treatment Methods
Week 1 Week 2 Week 3

38. The suggested mechanism of effect is the analgesic effect; It can
significantly improve the patients' quality of life, due to
alleviation in pain
CPPS Suggested Treatment Effect

39. A connective tissue disorder involving the growth of fibrous
plaques in the soft tissue of the penis affecting up to 10% of men
Peyronie’s Disease Definition

40. Suggested Protocol - TBA
• XXX shocks per location (total of XXX
shocks per treatment)
• XXX locations
• XXX sessions
• Total XXX shocks / patient
Peyronie’s Disease - Treatment Methods

41. EDSWT can significantly improve quality of life for these patients
as pain is relieved
Peyronie’s Disease Suggested Treatment Effect

42. Clinical Results
Extended Data

43. EDSWT Clinical information
• Double Blind Study -
• Non-responders -
• Two Years follow up -

44. Double Blind Study

45. Non-Responders Study

46. 1. 72.4 % of patients converted from non responders to PDE5i
therapy - to responders
2. For 75.9% patients IIEF ED Domain scores change by 5 points and more
Non Responders Study Results
72%

47. 2 Years Follow-Up Study Results
24 month follow-up results show that ED patients can have sexual
intercourse – unachievable for them before EDSWT treatment
Low Energy Shockwaves for the Treatment of Erectile Dysfunction , Vardi Y et al, ESSM Congress 2011

48. Feasibly study – n=20
24 month follow-up results
• 5 subjects did not respond to the treatment protocol
• 15 patients improved ED domain >5 points
• 7 of them improved ED domain ≥ 10 points
• 5 use PDE5-I occasionally
• 10 patients stopped PDE5-I Treatment
Low Energy Shockwaves for the Treatment of Erectile Dysfunction , Vardi Y et al, ESSM Congress 2011
2 Years Follow-Up

49. System Operation

50. Control
Panel
Shockwave
Applicator
(SWA)
SWA
Holder
Shock Wave
Power Unit
Cabinet
Retractable
Wheels
Handles
Dimensions: height: 740 mm x width: 775 mm x depth: 410 mm;
Weight: ~ 50 kg
Device Description
Foot
Switch

51. SWA supporting
Arm Port
"Umbilical
Cord"
Mains Connection,
Footswitch Connection
& Master Switch
SWA
Holder
Device Description

52. ON/OFF
Switch
LCD
Touch-Screen
& Display
Touch Screen Control Panel

53. Patents

54. This technological advantage allows for 2 major benefits:
1. Less painful for the patient (in comparison to concentrating the
pressure in the center of the focal zone
2. Larger focal zone enables a larger treatment area
Patented Applicator

55. Adjustable Voltage Stabilizer:
The ED1000 automatically adjusts the voltage in order to
stabilize pressure during treatments
The Ideal Treatment Definition

56. Recently, the use of low-intensity extracorporeal shock wave therapy was proposed as a
novel treatment for ED (93). In the first randomised, double-blind, sham-controlled study,
it was demonstrated that low-intensity extracorporeal shock wave therapy had a positive
short-term clinical and physiological effect on the erectile function of men who respond
to oral PDE5Is (94). Moreover, there are preliminary data showing improvement in penile
hemodynamics and endothelial function, as well as IIEF-EF domain score in severe ED
patients who are poor responders to PDE5Is (95).The feasibility and tolerability of this
treatment, coupled with its potential rehabilitative characteristics, make it an attractive
new therapeutic option for men with ED. However, current data are limited and clear
recommendations cannot be given. Data regarding the mechanism of action of this
procedure are still lacking. In a diabetic rat model, low-intensity extracorporeal shock
wave therapy ameliorated diabetes mellitus associated ED by promoting regeneration of
nNOS-positive nerves, endothelium, and smooth muscle in the penis. These beneficial
effects appear to be mediated by recruitment of endogenous mesechymal stem cells
(MSCs) (96).
Chapter 3. TREATMENT OF ERECTILE DYSFUNCTION
Section 3.5.3. Shockwave therapy (page no. 555)

57. 93. Vardi Y, Appel B, Jacob G, et al.Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month
follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8.
http://www.ncbi.nlm.nih.gov/pubmed/20451317
94. Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological
effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012
May;187(5):1769-75.
http://www.ncbi.nlm.nih.gov/pubmed/22425129
95. Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile
dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64.
http://www.ncbi.nlm.nih.gov/pubmed/22008059
96. Qiu X, Lin G, Xin Z, et al. Effects of Low-Energy Shockwave Therapy on the Erectile Function and Tissue of a Diabetic Rat
Model. J Sex Med. 2012 Dec 17. doi: 10.1111/jsm.12024. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/23253086
References