TheNon-Surgical Treatment For

Low Back & Neck Pain

Consider These Facts OnBack Pain & Back Surgery…

FACTS:

• More money is spent on the treatment of chronic pain than is spent on heart disease, AIDS and cancer combined.

• Back pain is the number one cause of work absence after colds/flu.

• 5.4 million Americans are disabled annually due to back pain.

• 70% of patients who had lumbar back surgeries still complained of back pain. 23% complained of constant pain, and 35% were still under treatment.

• The average cost for back surgery is about $40,000.00

• Only 37% of patients undergoing their first back surgery returned to work. Only 27% of patients with more than one back surgery return to work.

The Birth of A Phenomenon:The Discovery of Spinal Decompression

In March of 1994 Dr. Allan Dyer along with neurosurgeon Dr. Gustavo Ramos and radiologist Dr. William Martin at the Departments of Neurosurgery and Radiology, Rio Grande Regional Hospital, McAllen, and Division of Neurosurgery, Health Sciences Center, University of Texas, undertook to measure the pressures inside the intervertebral disc as patients received VAX-D treatment.

With a fluoroscopically guided cannula/catheter and pressure monitoring equipment, they watched and measured the patients’ disc pressures drop to negative levels. Thus the birth of spinal decompression with VAX-D.

This discovery led to a landmark clinical study that showed for the first time it was possible to lower a intradiscal pressure in Vivo with a non-surgical treatment.

10075

0

-100

-150

VAX-D actuallylowers disc pressure to

negative levels

0 10 20 30 40 50 60 70 80 90 VAX-D TENSION (LBS)

DISC

PRESSURE

Effects of Vertebral Axial Decompression On Intradiscal Pressure

HCA HOSPITAL STUDYMcAllen Texas

Gustavo Ramos MD, William Martin MD Departments of Neurosurgery and Radiology

Journal of Neurosurgery 81: 350-353, 1994

INTRADISCAL PRESSURE MONITORING

CATHETER INSERTED VIA A CANNULA INTO THE NUCLEUS PULPOSUS

RECORDING INTRADISCAL PRESSURE CHANGES DURING VAX-D

Dr. RAMOS MONITORING PROCEDURE

DUAL RECORDING VAX-D TENSION AND INTRADISCAL PRESSURE

0

-150

+100

25 50 75

INTR

AD

ISC

AL

PR

ESSU

RE

- mm

Hg.

-

VAX-D - TENSION

Intradiscal Pressure Reduced to Negative LevelsDuring VAX-D Treatment

HOW DOES VAX-D WORK?

1. VAX-D Decompresses the intervertebral discs and neurological elements. This reduces the hydrostatic effects of the nucleus (protrusion, herniation, extrusion etc.) and the resulting compressive injury.

2. By reducing the disc pressure to negative levels, this increases the diffusion gradient from the vertebral endplate (into the disc), which brings oxygen, fluids, nutrients into the disc. The exchange of fluids reduces the concentration of catabolites and lactic acid.

3. Along with the increased flow of fluids into the disc, the flow of prescribed pharmaceutical agents will also be increased. All of this will serve to reduce the INFLAMMATORY CASCADE.

4. Reduction of inflammation in the disc and surrounding structures – means less pain for your patients, and will allow the disc to heal naturally.

Science & Medicine :VAX-D Decompression Treatment

-160 mm Hg

-40 mm Hg

-100 mm Hg

The Commissioner ofPatents and Trademarks

Has received an application for a patent for a new and useful invention. The title anddescription of the invention are enclosed. The requirements of law have been compliedwith, and it has been determined that a patent on the invention shall be granted underthe law.

Therefore, this

United States Patent

No. 6,039,737OPERATION OF A VERTEBRAL

AXIAL DECOMPRESSIONTABLE

Grants to the person(s) having title to this patent the right to exclude others frommaking, using, offering for sale, or selling the invention throughout the United States ofAmerica or importing the invention into the United States Of America for the term setforth below, subject to the payment of maintenance fees as provided by law.

If this application was filed prior to June 8, 1995, the term of this patent is the longer ofseventeen Years from the date of grant of this patent or twenty years from the earliesteffective U.S. filing date of the application, subject to any statutory extension.

If this application was filed on or after June 8, 1995, the term of this patent is twentyyears from the U.S. filing date, subject to any statutory extension. If the applicationcontains a specific reference to an earlier filed application or applications under 35 U.S. C120, 121 or 365(c), the term of the patent is twenty years from the date on which theearliest application was filed, subject to any statutory extension.

Commissioner of Patents and Trademarks

[11] Patent Number …... 6,039,737[45] Date of Patent ..Mar. 21, 2000Primary Examiner - Michael BuizAssistant Examiner - Jonathan D. GoldbergAttorney, Agent - Blackwell Sanders Peper Martin

[57] ABSTRACTA vertebral axial decompression table is operated byapplying a baseline tension to the two table parts, increasing tension to about 50% of the maximum above baseline, then logarithmically increasing tension to maximum tension. This cycle is repeated a programmed number of times to effect therapy 23 Claims, 8 Drawing Sheets

United States Patent [19]Dyer

[54] OPERATION OF A VERTEBRAL AXIAL DECOMPRESSION TABLE[76] Inventor: Allan E. Dyer[21] Filed: Oct. 29, 1998[30] Foreign Application Priority date Aug. 12, 1998 [AU] Australia .. 79929/98[51] Int. Cl 7 ……………………..A61b 17/56[52[ U.S. Cl………………………606/58; 606/54[58] Field of Search ……………..606/54; 53, 57[56] References cited U.S. Patent Documents 4,995,378 2/1991 Dyer ……128/75 5,115,802 5/1992 Dyer ……602/23

Fechners Law of Biological Response

VAX-D employs the inverse of this principle and applies the force (Tension) in a reverse Logarithmic curve. Applying the tension in this manner avoids stimulating the proprioceptors in the back and spine.

TIME - (Linear Scale)

LOGARITHM OF STIMULUS

THE MAGNITUDE OF THE SENSATION IS PROPORTIONAL TO THE LOGARITHM OF THE STIMULUS

Logarithmic Formula Exp [ C x Ln (Bti) ] = BTn + [ N x In ]

N

DECOMPRESSION

LOGARITHMIC PHASE

RETRACTIONLOGARITHMIC PHASE

VAX-D DOUBLE LOG THERAPY CURVE

30 60

100

80

60

40

20PERCENT MAXIMUM TENSION

90

PRETENSION

Seconds

Column traction devices fail to decompress the discs because:

1. The force is applied in a linear fashion, and proprioceptors recruit back and trunk muscles to contract and guard in a protective mode.

2. The use of chest harnesses and axillary restraints INCREASES intradiscal pressure by significant amounts.

TractionColumn Traction Devices

FORC

E

100

TRACTIONLinear Phase

RETRACTION Linear Phase

HOLD0

50

VAX-DPROPRIOCEPTOR THRESHOLD

150

100

50

0

-50

-100

-150

INTRADISCAL

PRESSURE-200

200

250

20 40 60 80 100TENSION - lbs.

VAX-D vs TRACTION

TRACTION

VAX-D® vs. TractionVAX-D® Traction

1. Effect of Vertebral Axial Decompression On Intradiscal Pressure. J Neurosurg 81: 1984.

2. Intervertebral Disc Pressures During Traction. Scand. J. Rehabil. Med. 9: 1983

3. An Overview of Vertebral Axial Decompression., Can. J. Clin. Med. , 5; 1998.

4. The Effect of Lactate and ph on Proteoglycan and Protein Synthesis rates in the Intervertebral Disc. Spine, 17: 1992.

5. Nutrition of the Intervertebral Disc: Solute Transport and Metab., Connective Tissue Research,8: 1981

•Intradiscal Pressure reduced to negative levels (1)

•Intradiscal Pressure unchanged or increased (2)•Negative IDP enhances

Oxygen and Nutrientdiffusion into the disc (3)

•Positive IDP inhibits diffusion with lactic acid accumulation (4)•Aerobic metabolism

fostersbio-physiological functionsand cellular repair activity (3,5)

•Anaerobic metabolism inhibits cellular activity and repair functions (5)

VAX-D Genesis G2 System

In 2007 VAX-D released the Genesis G2 System with true ‘Biofeedback Motion Control’ for absolute accuracy in decompression of the lumbar and cervical spine.

The equipment has a unique ability, in that the tensioning source can be programmed to move simultaneously in the horizontal plane and the vertical plane to follow the curves of the spine.

This system also accurately tracks the horizontal and vertical movement curves and adjusts position and tension (instantly) at the same time.

These advances are significant because variability in flexion or extension curves greatly increases patient comfort and muscle relaxation.

G2 Cervical: A System Like No Other

• Patients receiving VAX-D cervical treatment are treated wearing a harness with an integrated supportive cervical collar.

•The collar is designed to allow some mobility of the patient’s head and neck during decompression, while providing a circumferential lift system.

• The collar provides the necessary immobilization and protection for patients in the post treatment period when the muscle guarding reflexes have been reduced.

• Without the protection of the collar, head and neck movements will trigger muscle spasm, increased intradiscal pressure and neck pain.

• Patients wear the collar during the treatment and for 1-2 hours after to provide stability and to help the proprioceptors accommodate to movements of the head and neck.

Genesis Dynamic Mode for Cervical Decompression

The Genesis Dynamic Mode allows the operator to program the tensionometer to move synchronously in the horizontal and vertical plane in order to apply tension in a logarithmic time/force progression that can be designed to follow a curvature comfortable for the spine.

The tensionometer head moves in an ‘arc’ from the starting point to the end point. It can be programmed to move in an upward (flexion) or downward (extension) arc. Communication with the patient will determine the most comfortable settings for the Dynamic Mode.

Genesis ‘Dynamic’ Treatment for Cervical Herniated Disc

A lower angle of tension tends to place more force on the mandible and TMJ. A higher angle of pull tends to transfer more of the tensile forces to the occiput, because of the circumferential (collar) harness system.

Once the most comfortable treatment parameters have been established, they will be recorded and remembered by the system for future treatments.

- HERNIATED LUMBAR DISCSExtruded and/or SubligamentousOne or more levels

- DEGENERATED DISC DISEASE

- LUMBAR AND SCIATIC NERVE COMPRESSION

- FAILED BACK SURGERIES

- POSTERIOR FACET SYNDROMES

VAX-D Therapeutic Indications

MULTI-CENTER EFFICACY STUDY778 CASES

HERNIATEDAND

DEGENERATEDLUMBAR DISCS

NEUROLOGICAL RESEARCH JOURNALVOLUME 20, 1998

Drs. E. Gose, R. K. Naguszewski, W. K. Naguszewski

EXTRUDED

53%

MULTIPLE

72%

SINGLE

73%

FAILED BACK SURGERY

68%

DEGEN. DISC

72%

FACETSYNDROME

68%

Vertebral axial decompression therapy for pain associatedwith herniated or degenerated discs or facet syndrome:

An outcome study

Pain Remission 778 cases

100

75

50

25

PERCENT OF CASES

HERNIATED LUMBAR DISC

Vertebral Axial Decompression Therapy for pain Associated

with Herniated or Degenerated Discs or Facet Syndrome:

An Outcome Study._________________________________________________________

______Earl E. Gose, William K. Naguszewski and Robert

Naguszewski[ Journal of Neurological Research, April 1998 ]

Relief of pain and Disability

PERCENTAGE IMPROVEMENT

50 %

75 %

25 %

65 %

MOBILITY

71 %

PAIN

78 %

ACTIVITY

PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

VAX-D vs TENS

CHRONIC BACK & LEG PAIN

NEUROLOGICAL RESEARCH JOURNAL Volume 23, No. 7, 2001

Department of OrthopaedicsSidney University - Australia__________________________________

Eugene Sherry MD, FRCS

Peter Kitchener M.B., B.S., FRANZCR

Russel Smart M.B., Ch.B.

RANDOMIZED CONTROL TRIAL CHRONIC DISCOGENIC BACK & LEG PAIN

Statistical significance p < 0.001

6

5

4

3

2

1

0

VAS - PAIN SCALE

VAX-D vs TENS

PREVAX-D

5.59

POSTVAX-D

PRETENS

5.44

POSTTENS

5.97

1.69

Randomized Control Trial

VAX-D TENS

ADLDECLINED

-2%-17%

PAININCREASED

PAINDECREASED

69%

ADLIMPROVED

34%

60

80

0

20

40

-20

% CHANGE IN

INDICES

STATISTICAL SIGNIFICANCE - P < 0.001

BLUE CROSS SPONSORED296 CASES

Prospective Outcome Study________________

Activity-LimitingLow Back Pain

Arch. Phys. Med. Rehabil. : Vol 89, 2008

P.F. Beattie, R.M. Nelson, L.A. Michener, J. Cammarata, J. Donley

VAX-D Research Studies:Outcomes After a Prone Lumbar Decompression Protocol for Patients With Activity-Limiting Low Back Pain: A Prospective Case Series Study (2008) Paul F. Beattie, PhD, PT, OCS, Roger M. Nelson, PhD, PT, Lori A. Michener, PhD, PT, ATC, SCS, Joseph Cammarata, DC, Jonathan Donley, DPTSArchives of Physical Medicine And Rehabilitation, Volume 89, February 2008© 2008 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

• A two and one-half year study on the treatment of chronic back pain sponsored by Independence Blue Cross, a leader in the insurance industry, confirmed the effectiveness of VAX-D.

• The purpose of the study was to determine short- and long-term outcomes after VAX-D treatment in a large sample of patients with activity-limiting low back pain that had failed at least two previous, non-surgical treatments.

• A total of 296 subjects with low back pain and evidence of a degenerative and/or herniated intervertebral disk at 1 or more levels were enrolled in the study.

• In this study all subjects had pre-intervention imaging evidence of lumbar intervertebral disk degeneration and/or herniation.

• The study showed that patients had significantly improved pain and disability scores at end of treatment, at 30 days and at 180 days post-discharge.

6 MONTH FOLLOW-UP STUDY Blue Cross Sponsored Study

Arch. Phys. Med. Rehabil. , Vol 89, 20088

6

4

2VAS - PAIN SCALE

BEFORE VAX-D

STATISTICAL SIGNIFICANCE P < 0.01

5.8

EXIT 30 DAYS 180 DAYS AFTER VAX-D

3.53.73.4

PAIN

SIGNIFICANTLY REDUCED

6 MONTH FOLLOW-UP STUDY Blue Cross Sponsored Study Arch. Phys. Med. Rehabil. , Vol 89, 2008

12

8

6

4DISABILITY SCALE

BEFORE VAX-D

STATISTICAL SIGNIFICANCE P < 0.01

12.6

EXIT 30 DAYS 180 DAYS AFTER VAX-D

6.0

7.0

5.9

DISABILITY

SIGNIFICANTLY REDUCED

VAX-D Research Studies: VAX-D Reduces Chronic Discogenic Low Back Pain

FOUR YEAR FOLLOW UP STUDY

Anesthesiology News - Vol 29, March 2003

Odell R. H., MD, PhD. , Boudreau D. A., DO

FOUR YEAR FOLLOW-UP STUDY

8

6

4

2VAS - PAIN SCALE

BEFORE VAX-D

4 YRS AFTER VAX-D

STATISTICAL SIGNIFICANCE P < 0.001

7.41

1.57

FOUR YEAR FOLLOW-UP EMPLOYMENT STATUS

100 %

70 %

30 %

BEFORE VAX-D

4 YEARS LATER

UNABLE TO WORK

FULLY EMPLOYED

COMPARATIVE OUTCOME STUDY

Journal of Neurological Research Volume 26, April 2004

_______________________________

Valley Neurosurgical Center Center for Neurosurgical Sciences University of Texas

REGULAR PROTOCOL VS

REDUCED COURSE OF THERAPY

COMPARATIVE OUTCOME STUDYJournal of Neurological Research - Vol. 26,

April 2004

75

60

45

30

15PERCENTAGE OF CASES

10 DAILY SESSIONS 20 DAILY SESSIONS

COURSE OF THERAPY

43

REMISSION

24

PARTIALREMISSION 33

NEGATIVE

76

REMISSION

20

PARTIALREMISSION

5

NEGATIVE

20 vs 10 SessionsStatistical Significance P < 0.001

STANDING

100

FLEXED

150

LIFTING

220

FIRM

CHAIR

140

SOFT

CHAIR

185

BED

REST

75

LEGS

FLEXED

150

EXTENDED

180

CRUNCH

210

KNEES

FLEXED

140

TRACTION

130

EVERY DAY POSITIONS PHYSICAL THERAPY INDRADISCAL PRESSURES

INTERVERTEBRAL DISC PRESSURES

STANDING+100

BED

REST

+75

KNEES

FLEXED

+140

TRACTION+130

VAX-D

THERAPY

REAL SCIENCE

REAL STUDIES

REAL RESULTS

-150

QuickTime™ and aTIFF (LZW) decompressorare needed to see this picture.

DECOMPRESSION REPAIRS DISCS

Herniated Nucleus

Pulposus

Nucleus Retracted by

Vacuum Effect

Annular Fissure

Closed & Healing

BEFORE VAX-D

L4 -L5 left posterior large extruded disc

compressing thecal sac

AFTER VAX-D

“ This the most dramaticreduction of an extruded segment I have seen “

Curvel A. Ferrari MD

Left posterior - L4-L5 Extruded disc compressing & retro-displacing left nerve root

BEFORE VAX-D

Extruded disc retracted Left nerve root decompressed

Curvel A. Ferrari MD

AFTER VAX-D

ANATOMY OF ANNULUS FIBROSUS

DISTRACTION CLOSES OBLIQUE LAYERS AND RADIAL DIFFURES

Canadian Journal of Clinical Medicine

Vol. 5, No. 1, Jan. 1998

Frank Tilaro, M.D.

DISC DECOMPRESSION

PLUS

NEURO- DECOMPRESSION

RESEARCH PROOF

SCIATICPAIN

NEUROLOGICALDEFICIT

74

REMISSION

26

NEGATIVE

76

REMISSION

24

NEGATIVE

75

60

45

30

15PERCENTAGE OF CASES

CLINICAL OUTCOME

RADICULOPATHY RESPONSE TO VAX-D

An Overview of Vertebral Axial DecompressionF. Tilaro MD - Can. Jour. Clin. Med. Vol. 6, 1999

The Effects Of

Canadian Journal of Clinical Medicine Volume 6, Number 1, January 1999

Dr. Frank Tilaro & Dr. Dennis Miscovich

Vertebral Axial

Decompressionon

Sensory Nerve Dysfunction

BEFORE VAX-D

6.36

AFTERVAX-D

2.09

IMPROVEMENT SIGNIFICANT

P < 0.05

7.0

5.0

4.0

3.0

2.0

1.0

6.0

NEUROMETER GRADE

CURRENT PERCEPTION THRESHOLDEVALUATION OF SENSORY DEFICIT

THE EFFECTS OF VAX-D IN SENSORY NERVE DYSFUNCTION IN PATIENTS WITH LOW BACK PAIN AND RADICULOPATHY

J. CLINICAL MEDICINE - JANUARY 1999

JOURNAL OF NEUROLOGICAL RESEARCH

VOL 23, No. 3, November 2001

DERMATOMAL SOMATOSENSORY EVOKED POTENTIAL (DSSEP)

DEMONSTRATION OF NERVE ROOT DECOMPRESSIOINAFTER

VAX-D THERAPY

Naguszewski W. K., M.D.Naguszewski R. K., M.D.

Gose E., Ph.D.

DERMATOMAL SOMATOSENSORY EVOKED POTENTIAL ELECTRODE PLACEMENT

L5

S1

STIMULATING ELECTRODES -- ON FOOT

RECORDING ELECTRODES ----- ON SCALP

NERVE ROOT DECOMPRESSION (DSSEP) WITH VAX-D THERAPY

PERCENT - DSSEP READINGS

60

30

STATISTICAL SIGNIFICANCE - P < 0.0013

IMPROVED

61

SAME

29

NEGATIVE

10

ADJUSTMENT TO PRETENSION BASE LINE

RELAXATION PHASE

CONTROL CONSOLE

COMPUTER

Bio- feedback Loop

CONTROL CONSOLE

COMPUTER

LOWER BODY, PALLET, TENSIONOMETERCONTROLLED AS A

UNIFIED MOTION SEGMENT

DECOMPRESSION PHASE

BIO- FEEDBACKLOGARITHMIC MOTION CONTROL

BED REST

DIFFUSION GRADIENT

INTRADISCAL PRESSURES

100

75

50

25

0

-25

-50

-75

-100

-125

-150

-175

DIASTOLIC BP - 80 mm Hg.

VAX-D DIFFUSION GRADIENT > 200 mm Hg.

ACROSS THEVERTEBRAL END PLATE

VAX-D THERAPY

VAX-D DECOMPRESSION

“Vertebral distraction producing decompression creates a favorable

diffusion gradient across the endplate enhancing disc nutrient transfer promoting the natural healing process”

Kirkaldy-Willis - Managing Low Back pain

Non-steroidal Anti-inflammatory Drugs Naproxen Sodium (Aleve) 220mg bid Diclofenac (Voltaren) 50 mg bid Indomethacin (Indocin) 25mg tid or SR 75mg

VAX-D PROTOCOL • PHARMACOLOGICAL AGENTS

Analgesics - When necessary

Muscle relaxants - When necessary

Mucosal protective agents Misoprostol - Cytotec 100-200mg H2 Antagonist - Zantac 75 -150 mg

Steroid Methylprednisolone 4 - 8 mg 2-3 hrs before Tx (10 days) Prednisone 20 mg tid (10 days) Medrol Dosepak

INTERNAL DISC DISRUPTION VAX-D PROTOCOL

METHYLPREDNISOLONE - 4 TO 8 MG.

Taken orally 2 to 3 hours before each VAX-D sessionFirst week - One dose each daySecond week - One dose Monday,Wednesday & Friday

DOXYCYCLINE - 200 MG. (Matrix Metalloproteinase Inhibitor)

Taken orally 2 to 3 hours before each VAX-D sessionOne dose each day

NB: Doxycycline should not be used for patients allergic to Tetracyclines

For optimum absorption: Medications should be ingested on an empty stomachNo Antacids with Doxycycline

INTERNAL DISC DISRUPTION

HIZHIGH INTENSITY ZONE

Pathognomonic of IDD

DISCOGRAM DYE PENETRATES ANNULUS FIBROSUS INDICATES DISRUPTION OF INTERNAL STRUCTURES

INTERNAL DISC DISRUPTION

CONTRAINDICATIONS and PRECAUTIONS

1. Fracture

2. Neoplasm

3. Unstable Spondylolisthesis

4. Cauda Equina Syndrome

5. Ankylosing Spondylitis

6. Severe Osteoporosis

7. Rotator Cuff Tear

8. Arthrodesis with Instrumentation

NORMAL DISC HEIGHT &LATERAL FORAMEN

DEGENERATED DISC FACET SUBLUXATION NARROWSLATERAL FORAMEN

DEGENERATED DISC FACET HYPERTROPHY IMPINGES LATERAL FORAMEN

DEGENERATED DISC FACET HYPERTROPHYOSTEOPHYTIC SPURS IMPINGESLATERAL FORAMEN

-STENOSIS-LATERAL FORAMENAL ---------------------------------- disc hydration opens foramen

IATROGENIC FORAMINAL STENOSIS

Normal Lateral foramen

Post fusionStenotic foramen----------------------Refractory toDecompression

SPONDYLOLISTHESIS

SPONDYLOLYSIS

SPONDYLOLYSIS

0

20 K

40 K

60 K

80 K

100 K

120 K

140 K

160 K

Surgical Care

VAX-D after 4 wksStandard care

Medical

Disability

Total

A Graphic Comparison of CostsA Graphic Comparison of Costs

StandardConservative Care

$ Costs

$ Costs

Don’t Be Fooled By The Imposters:Real Decompression: Where Science & Technology Meet

How does VAX-D compare to its competitors?

VAX-D developed and patented the process of non-surgical spinal decompression (not NASA). VAX-D is the only equipment shown in studies to lower intradiscal pressure. VAX-D has demonstrated the retraction of herniations on post treatment MRI’s. VAX-D has established 75-85% success rates in 10 clinical studies, hospitals and private clinics. VAX-D is the only equipment shown to decompress nerve roots using DSSEP and CPT studies.

Why buy old technology?

Copycat equipment is based upon TRACTION technology that was introduced in 1986, and dressed up with fancy columns and tilt tables.

No other devices have published studies proving they decompress the spine.