EX-99.1 3 exhibit991.htm

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HealthTronics Logo

A Leading Provider of
Orthopaedic and Urologic
Non-Invasive Medical Devices
and Medical Services



Safe Harbor Statement

This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties or other factors which may cause actual results, performance or achievements of HealthTronics Surgical Services, Inc. to be materially different from any future results, performance or achievements express or implied by such forward-looking statements. As always, these expectations and projections are based on currently available competitive, financial, and economic data, along with operating plans, and are subject to future events and uncertainties. Among the events and uncertainties which could adversely affect future periods are: inability to establish or maintain relationships with physicians and hospitals; health care regulatory developments that prevent certain transactions with health care professionals or facilities; inability of the Company or health care providers to obtain reimbursement for use of the Company’s current or future products; competition or technological change that impacts the market for the Company’s products; and difficulty in managing the Company’s growth. Additional factors that might cause such a difference, include, but are not limited to those discussed in the Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002, and in subsequent documents filed by HealthTronics Surgical Services with the Securities and Exchange Commission.

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2



Company Profile

Worldwide technology leader in Electrohydraulic Shock Wave medical devices

 

 

A leading provider of non-invasive urologic services

 

Lithotripsy – Leading treatment for kidney stones

 

TUMT – Treatment of benign prostate enlargement

 

Cryotherapy – Treatment for prostate cancer

 

Beginning FDA Clinical trials for New Prostate Treatment - HIFU

 

 

The U.S. pioneer of orthopaedic Extracorporeal Shock Wave Surgery

 

OssaTron® is the first FDA approved device for treating orthopaedic conditions with orthopaedic shock wave surgery

 

OssaTron® is the only FDA approved device for multiple indications

 

First mover in estimated $2 billion market

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Company Profile (Cont.)

Leading manufacturer and distributor of lithotripsy and orthopaedic shock wave surgery devices worldwide

 

Distribution in over 35 countries

 

Research and Manufacturing Facilities in Switzerland

 

In the U.S., approximately 177 devices providing services in 47 states

 

 

Relationship with approximately 15% of all U.S. urologists

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Corporate Strategy

Build infrastructure to support growth of Orthopaedic Extracorporeal Shock Wave Surgery in the U.S. and worldwide

 

 

Continue generating cash flow and earnings from urology operations

 

 

Establish new urology businesses and introduce new urology products by leveraging existing base of U.S. urology network

 

 

Produce world-class products and increase penetration of worldwide medical devices

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Market Drivers

Growing demand for non-invasive and minimally invasive surgical procedures

 

 

Trend from health care facilities to outsource specialized services

 

 

Aging of U.S. population and promotion of healthy, active lifestyle

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Multiple Revenue Sources

Turnkey Clinical and Technical Services provided to doctors, hospitals and patients

 

 

Sale of Equipment – LithoTron®, LithoDiamond®, OssaTron®, EvoTron®* and VersaTron®

 

 

Sale of Consumables

 

 

Equipment Maintenance and Support

 

 

Management Fees from Partnerships

*Not approved by the FDA in the U.S. Market

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ESWS Manufacturer Market
Share Worldwide

Dornier

 

 

22%

 

Siemens

 

 

12%

 

Direx

 

 

10%

 

Storz

 

 

9%

 

HealthTronics/HMT

 

 

8%

 

EDAP

 

 

6%

 

Wolf

 

 

6%

 

Medstone

 

 

5%

 

Rest

 

 

22%

 

*Company Estimates and publicly available information

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Technology

Electrohydraulic shock wave generation

Electrohydraulic shock wave generation

High Medical Technologies Logo

 

 

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Technology

The core of the technology of electrohydraulic shock wave surgery is the electrodes (the consumables) which generate the shock wave.

Electrodes        Electrodes

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Technology

Characteristics of shock waves

Characteristics of Shock Wave

 

 

 

 

Short rise time in ns range

Small pulse width at -6 dB

High positive pressure amplitude

Low tensile wave

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

High Medical Technologies Logo

 

 

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Current Scientific and Clinical Studies

FDA study on non-union indication OssaTron®

 

 

Pressure measurement (Boston University)

 

 

Lateral epicondylitis study (Baylor University Hospital)

 

 

Chip model study (Colorado State University)

 

 

Multicenter study with LithoDiamond®

 

 

Shoulder study with EvoTron®

 

 

Clinical study and Scintigraphy (Zürich University)

 

 

Clinical study on Osteoarthritis for small animal (dogs, cats) with VersaTron®

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Lithotripsy

 

LithoTron

 

LithoTron®

 

 

 

 

 

 

 

 

 

 

 

 

 

LithoDiamond®

 

LithoDiamond

 
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Total Lithotripters Sold per Region
(HealthTronics and HMT)

GRAPHIC

Americas = 138
Europe = 96
Asia = 42

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Lithotripsy Economics in USA

Accepted treatment protocol by physicians and insurers for treating kidney stones

 

 

Approximately 250,000 cases per year

 

 

Reimbursement averages $2,000 per procedure for HealthTronics

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Lithotripsy Entities

Active with 44 lithotripsy entities (of which we consolidate 30) in 35 states

 

 

Average entity now treating 800 cases per year

 

 

HealthTronics Surgical Services’ average partnership stake is approximately 30%

 

 

HealthTronics Surgical Services’ average equity stake in unconsolidated partnerships is approximately 15%

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Urology Services

Transurethral Microwave Therapy

 

Treatment of benign prostate enlargement

 

Outpatient procedure

 

One of the largest providers in the U.S., projected to treat approximately 3,300 patients in 2004

 

Partnership model does not generally apply

 

 

Cryosurgery (controlled freezing)

 

Minimally invasive treatment of prostate cancer

 

Outpatient or limited stay procedure

 

185,000 new cases in the U.S. each year

 

Better long-term outcomes compared to radiation; faster and less expensive

 

Partnership model applies

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BPH – Benign Prostatic Hypertrophy

Non-cancerous enlargement of the prostate

 

 

Affects 50% of men over age 60

 

 

Symptoms associated with restricted flow of urine

 

 

Multiple treatments available

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HealthTronics BPH Treatment Options

Trans Urethral Microwave Therapy (TUMT)

 

In office

 

Single treatment – 30 minutes

 

Good Medicare reimbursement

 

 

Laser Excision

 

In surgery center

 

Single treatment – 1 hour

 

Doctors like it (more like surgery)

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Prostate Cancer

Second most common cancer in males

 

 

230,000 new cases per year in the U.S.

 

 

PSA has changed the management of prostate cancer

 

 

Five treatment options

 

Surgery

 

Radiation

 

Cryosurgery

 

Medication

 

HIFU

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Concerns

 

Patient Concerns

 

Payor Concerns

 


 


 

  Efficacy

 

  Cost

 

  Potency

 

  Cost

 

  Incontinence

 

  Cost

 

  Time

 

  Cost

 

  Complications

 

  Cost

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Efficacy Comparison of Treatment Options
for Stage T1-T2 Prostate Cancer

 

 

 

MONTHS

 

 

 

 


 

bRFS

 

 

0

 

 

12

 

 

24

 

 

36

 

 

48

 

 

60

 

 

72

 

 

84

 


 

 


 

 


 

 


 

 


 

 


 

 


 

 


 

 


 

EB>72

 

 

100

 

 

99

 

 

92

 

 

88

 

 

82

 

 

82

 

 

82

 

 

82

 

EB<72

 

 

100

 

 

99

 

 

92

 

 

62

 

 

55

 

 

50

 

 

47

 

 

45

 

COMB

 

 

100

 

 

98

 

 

95

 

 

88

 

 

83

 

 

78

 

 

78

 

 

76

 

PI

 

 

100

 

 

98

 

 

97

 

 

98

 

 

88

 

 

85

 

 

78

 

 

76

 

RP

 

 

100

 

 

92

 

 

90

 

 

88

 

 

82

 

 

82

 

 

78

 

 

76

 

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Non-Efficacy Comparisons*

 

 

 

Surgery

 

 

Radiation

 

 

Cryo

 

 

Medications

 

 

HIFU

 

 

 

 


 

 


 

 


 

 


 

 


 

Potency

 

 

1

 

 

2

 

 

1

 

 

1

 

 

2

 

Incontinence

 

 

1

 

 

3

 

 

2

 

 

3

 

 

3

 

Time

 

 

2

 

 

0

 

 

3

 

 

0

 

 

3

 

Complications

 

 

1

 

 

2

 

 

2

 

 

2

 

 

2

 

 

 

 


 

 


 

 


 

 


 

 


 

 

 

 

5

 

 

7

 

 

8

 

 

6

 

 

10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Estimated
Treatment Cost

 

 

$ 12,000

 

 

$ 25,000

 

 

$ 12,000

 

 

$ 50,000

 

 

$ 12,000

 

*Company’s evaluation. Rating system: 0-awful; 1-poor; 2-acceptable; 3-good

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Orthopaedic Extracorporeal
Shock Wave Surgery

 

 

 

 

OssaTron®

 

 

 

 

 

 

 

OssaTron



OssaTron

EvoTron®

 

 

EvoTron

 

 

 

 

 

 

 

 

 

 

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Total OssaTrons® Sold per Region

GRAPHIC

Americas = 71
Europe = 35
Asia = 11

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Total EvoTrons® Sold per Region

GRAPHIC

Americas = 0*
Europe = 77
Asia = 6

*EvoTron® is not FDA approved for use in the U.S.

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Orthopaedic Partnerships

Active with 51 Partnerships in 47 States

 

 

Average location now treating 150 cases per year

 

 

Orthopaedic Division is losing money overall but pre-tax net income loss decreased from$1.5 million in 2002 to $700,000 in 2003

 

 

HealthTronics Surgical Services’ average partnership stake is approximately 50-60%

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OssaTron® Treatment for
Chronic Plantar Fasciitis

American Podiatric Medical Association estimates over 17 million cases of heel pain in U.S. per year

 

 

Over 17,000 patients treated to date in U.S. by HealthTronics

 

 

HealthTronics patient history (2000 to present) demonstrates are-treatment rate of <10%

 

 

Based on current data, outcomes appear to be better than surgery

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OssaTron® Treatment for
Chronic Lateral Epicondylitis

More than “tennis” elbow

 

 

Opens orthopaedic market for OssaTron®

 

 

Procedure easily learned by doctor

 

 

Minimal complications

 

 

In double-blind, placebo-controlled clinical trial, the FDA concluded treatment is safe and effective

 

 

Training of physicians now underway

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Veterinary Extracorporeal Shock
Wave Surgery VersaTron®

 

VersaTron

 

 

 

 

VersaTron®

 

 

Introduced in 2001 in USA for equine specialists

 

 

5.5 Million Horses in the U.S.

 

 

145 Units sold by year-end 2003

 

 

Excellent results in several indications

 

 

FDA accepted study with CSU in Denver

 

 

Provides excellent data that can be used by Orthopaedics

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Total VersaTrons® Sold per Region

GRAPHIC

Americas = 145
Europe = 25
Asia = 9

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Orthopaedic US Market
Opportunity

Condition

 

Estimated # of
Cases per Year

 

Estimated
Market Size

 


 


 


 

*Heel Spurs

 

 

250,000

 

 

$

500 Million

 

*Tennis Elbow

 

 

250,000

 

 

$

500 Million

 

Non-Union Fractures

 

 

75,000

 

 

$

300 Million

 

Achilles Tendonitis

 

 

100,000

 

 

$

250 Million

 

Patellar Tendonitis

 

 

100,000

 

 

$

250 Million

 

Shoulder Tendonitis

 

 

100,000

 

 

$

250 Million

 

AVN of the Femoral Head

 

 

25,000

 

 

$

100 Million

 

 

 

 

 

 

 



 

 

 

 

Total

 

$

2.15 BILLION

 

*FDA approved indications

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32



Shock Wave vs. Traditional
Surgery for Plantar Fasciitis

 

 

Orthotripsy®

 

Traditional Surgery

 

 

 


 


 

 

 

Orthotripsy

 

Traditional Surgery

 

 

 

 

 

 

 

 

 

Anesthesia

 

 

Local or IV sedation

 

 

General anesthesia or spinal

 

 

 

 

 

 

 

 

 

Procedure Time

 

 

< 30 Minutes

 

 

1 Hour (approx.)

 

 

 

 

 

 

 

 

 

Incision

 

 

No

 

 

Yes

 

 

 

 

 

 

 

 

 

Post-op Status

 

 

Heel pad

 

 

Boot cast, crutches

 

 

 

 

 

 

 

 

 

Complications

 

 

Bruising, occasional slight
numbness

 

 

Bleeding, wound infection,
compromised foot function,
nerve damage

 

 

 

 

 

 

 

 

 

Recovery Time

 

 

2-3 Days

 

 

2-3 Months

 

 

 

 

 

 

 

 

 

Post-op Analgesia

 

 

Minimal

 

 

In quantity

 

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Growing Clinical Acceptance
and Clinical Data

 

 

 

Clinical Data

 

 

 

 

Significant number of positive clinical studies published worldwide

 

 

 

 

Limited number of negative studiespublished worldwide

 

 

 

 

NO negative studiesusing HealthTronics’current treatment protocol

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Media Coverage

Media Coverage

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OssaTron Trained Physicians

OssaTron Trained Physicians

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Treatment Locations

 

 

 

1997

 

 

1998

 

 

1999

 

 

2000

 

 

2001

 

 

2002

 

 

2003

 

 

 

 


 

 


 

 


 

 


 

 


 

 


 

 


 

Lithotripsy

 

 

5

 

 

22

 

 

36

 

 

46

 

 

53

 

 

80

 

 

90

 

Orthotripsy

 

 

 

 

 

 

 

 

 

 

 

  3

 

 

45

 

 

49

 

 

57

 

Prostate

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  2

 

 

  6

 

 

20

 

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Service Locations

Service Locations

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Patient Treatments

 

 

 

1998

 

 

1999

 

 

2000

 

 

2001

 

 

2002

 

 

2003

 

 

 

 


 

 


 

 


 

 


 

 


 

 


 

Lithotripsy

 

 

5,000

 

 

11,000

 

 

15,000

 

 

17,850

 

 

34,018

 

 

34,847

 

Orthopaedics

 

 

 

 

 

 

 

 

100

 

 

2,700

 

 

5,226

 

 

8,766

 

Prostate

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,470

 

 

3,410

 

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Revenues
(in thousands)

 

 

1996

 

1997

 

1998

 

1999

 

2000

 

2001

 

2002

 

2003

 

 

 



 



 



 



 



 



 



 



 

Revenues

 

$

2,870

 

$

5,062

 

$

14,682

 

$

24,414

 

$

33,846

 

$

43,882

 

$

87,192

 

$

88,406

 

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Management

Argil Wheelock, M.D. – Chairman & CEO since 1996

 

20 years experience in physician-related business activities. Practicing urologist, 1979-1996. Public company consultant, 1991-1996.

 

 

Martin McGahan – President and COO; Previous CFO since 2001

 

15 years experience in healthcare finance, business development and corporate finance with various public and private companies.

 

 

Price Dunaway – COO of Lithotripsy Operations since 2003

 

20 years experience in healthcare. Former CEO of biotech company and former CFO of urological device and services company.

 

 

Andreas Baenziger, M.D. – COO of Sales & Services since 2004

 

Orthopaedic surgeon with 16 years experience in healthcare companies. Former CEO of HMT Holding AG.

 

 

Ron Gully – SR VP of Orthopaedic Division since 2001

 

17 years experience in healthcare services. Former CEO of Ascension Corporation, a healthcare billing and management firm.

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Stock Profile

Nasdaq:

 

HTRN

Share Price:

 

$6.00

52 Week Range:

 

$11.67 – $5.10

Shares Outstanding:

 

11.6 Million

Market Capitalization:

 

$69.6 Million

Average Daily Volume:

 

96,000

2001 EPS:

 

$0.28

2002 EPS:

 

$0.55*

2003 EPS:

 

$0.45

*GAAP earnings were $.73, which  includes gain on sale of $.18 from disposition of USL

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Reasons to Invest in HTRN

Rapidly growing innovator with the first FDA-approved device for orthopaedic shock wave surgery

 

 

Addressing large untapped orthopaedic market that could exceed $2 billion

 

 

Steady cash flow from kidney lithotripsy business financing new opportunities in orthopaedics and urology

 

 

Physician network that will be leveraged to offer additional products and services

 

 

Record of strong growth in sales and earnings

 

 

Globally experienced management team

 

 

Strong technology and product pipeline

 

 

Promising new scientific activities

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HealthTronics Logo

A Leading Provider of
Orthopaedic and Urologic
Non-Invasive Medical Devices
and Medical Services