Neocontrol Chair

Magic Race / Kitalpha Medical
The Neocontrol Treatment Chair
Company Background
 Started as Neotonus in 1994
 Device introduced at American Urology Conference in 1999
 Technology and patents acquired in 2009
• Prof. Dr. Michael Jordan. MD sole owner
 510(k) approved
 In excess of 2,300 devices installed in over 57 countries
 Neuro-stimulation device used to treat urinary incontinence
 Strong IP protection
 Seeking distribution partners and capital for 2nd generation design
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Device
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Executive Summary
The Neocontrol chair applies ExMI therapy; it has a proven
track record with patients suffering from incontinence
Executive Summary
 ExMI™ is a patented technology for magnetic nerve stimulation.
 The Neocontrol chair applies this technology to treat incontinence patients. This adjuvant
therapy is 100% non-invasive. Other indications comprise pregnancy after-care, erectile
dysfunction (ED), orgasm problems, interstitial cystitis.
 Neocontrol therapy is approved by the FDA; the Neocontrol chair is also CE certified.
 The main USPs of the Neocontrol chair are the high patient compliance, its proven efficacy
and success (documented in clinical studies) as well as its financial appeal for the doctor
operating the chair.
 Growth opportunities in emerging markets (e.g. China) have not been exploited yet.
 There are only two competitors (M-Cube and QRS), but both have not managed to penetrate
the market, as their technology is by far inferior to the patented ExMI technology (competitor
technology does not reach necessary penetration depth). There are no high-ranking clinical
studies that could prove the competitors’ efficacy in treating incontinence.
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Mode of Operation
The Neocontrol Chair applies the ExMI technology to
persistently strengthen the pelvic floor muscles
ExMI™-Technology: Mode of Operation
• ExMI™ produces a highly focused time varying magnetic
field which penetrates deep into the perineum, activating
the pelvic floor muscles by stimulating all branches of the
pudendal and splanchnic nerves. The contractions
strengthen the pelvic floor; muscle tonus (vaginal and
anal sphincter muscles) builds up:
• ExMI™ produces pulses of steep gradient magnetic flux that are
focused by a specially designed therapy head.
• A time varying magnetic field creates an electrical potential which
causes ion flow, or Eddy currents, in the soft tissues of the pelvic
floor. This ion flow results in a brief depolarization of resting motor
neurons.
• When a threshold is reached, an action potential is initiated for that
neuron. This action potential then propagates naturally down the
axon via the usual Na+ and K+ ion flows.
• Once these impulses reach the motor end plates, the muscles of the
pelvic floor respond by contracting at a equal to the output pulse rate
of the therapy head.
• The muscles contract and relax with each pulse, unless the output
pulse rate exceeds the muscles’ ability to contract and relax,
resulting in a constant, or tetanic contraction on the muscles.
Control Unit
Treatment Chair
Magnetic Field
Induced Nerve
Impuls
MotorNeuron
Motor End Plate
Pelvic Floor Muscle
ExMI™: Nerve Impuls  Contraction of Pelvic Floor and Sphincter Muscles
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Areas of Application / Patient Pool
The Neocontrol chair addresses therapy needs of a broad
patient pool
Neocontrol Chair: Areas of Application
Continence Care
Sexual Dysfunctions
• Stress Incontinence, Mixed Incontinence
• Erectile Dysfunction (ED)
• Incontinence after Radical Prostatectomy
Surgery
• Ejaculation Problems
• Pregnancy After-Care: Recovery of the
Vaginal Tonus after Delivery
• Orgasm Problems
• Feces Incontinence
• Cystitis Interstitialis
Patient Potential
• 20 – 23% of the adult population in the
developed world suffer from some degree of
incontinence
Patient Potential
• Globally, about 150 million women and men
are estimated to suffer from some kind of the
sexual dysfunctions mentioned above
• Incontinence incidence with the female
population in the US is at ~ 7%
Source: Townsend et al. (2007): Incidence and Remission of Urinary Incontinece in Middle-aged Women, in: American Journal of Obstet. and Gynecol.
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Unique Selling Propositions
Patients readily accept ExMI-based treatments as they are
non-invasive and painless
Unique Selling Propositions of the Neocontrol Chair
USP
Competitive Advantage in Detail
1. High Patient Compliance
• 100% Non-invasive; patient does not have to actively engage in treatment
– Patient sits fully clothed on the Neocontrol chair and can e.g. read a newspaper. No skin contact,
no gel, no probes…
• No side effects; complementary to medication-based therapy
– Patient only feels a slight tickling during treatment; some patients may experience light muscle
ache after a therapy session
• Suitable for every age group
• Only little time investment necessary: after 20 treatment sessions the pelvic floor muscles
have regained their necessary strength
– 2 sessions per week, 20 minutes each, achieve the desired training outcome.
2. Proven Medical Success
• Cleary reduced number of leakage episodes (cf. incontinence study results on page 6)
• High patient satisfaction as quality of life increases sharply
• Only standardized pelvic floor therapy on the market: we strive to get the adjuvant, non-invasive
therapy with listed in the guidelines for incontinence care.
• Therapy success lasts at least 12 months; thereafter we recommend 5 refreshment sessions / year.
Proven medical efficacy, financial benefits for the doctor as well as a high
patient compliance set Neocontrol apart from other incontinence therapies
Source: Results from clinical studies (cf. following page); patient questionnaires
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Study Results
Clinical studies and field reports confirm the medical
efficacy of treating incontinence with the ExMI technology
Selected Study Results: Incontinence Treatment
Therapy Result
Study Findings
Authors (Excerpt)
Reduction of
voiding frequency
• Voiding frequency significantly reduced
• Continence can be regained more quickly after RPx1 as
compared to common pelvic floor gymnastics.
• Reduction of voiding frequency already sets in after the
first month of treatment (quick therapy result)
• Nowak, Martina et al. (2007): Prospective Study of ExMI
Therapy vs. Standard Pelvic Floor Training Following
Radical Prostatectomy
• MacDonald Roderick et al. (2007): Pelvic floor muscle
training to improve UI after RPx: a systematic review of
effectiveness
Reduction of
required pads
• If ExMI therapy is started within the first 12 months after
RPx, the number of required pads can be reduced to
1/3rd (median).
• Moderate cases do not need any pads anymore
• McCammon, Kurt (2008): Multi-Center Study of Extracorporeal Innervation for Treatment of UI following RP
• Wöllner, Jens (2008): Therapie der Harninkontinenz mit
Extracorporeal Magnetic Innervation (ExMI)
No or significantly
reduced involuntary
urine leakage
• Patients are able to better control the act of urination;
proven by weight analysis of used pads before and after
the therapy (degree of wetness)
• Marschall-Kehrel, Daniel (2008): The Magic Magnetic
Chair – How to Facilitate Best
• Gruenwald, I. et al. (2001): The Efficacy of ExMI in the
Treatment of Stress and Urge Incontinence
Increased
Quality of Life
• Changes in patients’ perceived quality of life have been
tracked by standardized questionnaires: patients
experience a significant increase in their personal quality
of life.
• Bourcier, Alain: The French Experience on
Extracorporeal Magnetic Innervation
• Madersbacher, Helmut: Was bringt die hochenergetische
Magnetfeldtherapie? – Ergebnisse einer randomisierten,
prospektiven Studie
High patient
satisfaction
• Patients appreciate the non-invasive nature of the
therapy, that they do not have to undress
• Patients confirm efficacy in their feedback
• Therapy is painless
• Marschall-Kehrel, Daniel (2008): The Magic Magnetic
Chair – How to Facilitate Best
• Wöllner, Jens (2008): Therapie der Harninkontinenz mit
Extracorporeal Magnetic Innervation (ExMI)
(1) RPx = Radical Prostatectomy
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Competitive Landscape
Due to its patented technology, only the Neocontrol chair
achieves the therapeutically necessary penetration depth
Competitive Landscape / Comparison with Neocontrol
Competitor 1: M-Cube (Korea)
• “Air-Core technology”
• Achieves only 1.5 - 2 cm
penetration depth – not suited
for treating incontinence
• Therapeutic efficacy not
proven
Competitor 2: QRS (Liechtenstein)
• Multi-purpose device (oxygen
therapy, light therapy, pelvic floor
stimulator)
• Also achieves only 1.5 – 2cm
penetration depth
• Therapeutic efficacy not
proven
Comparative Study: Test Results
Neocontrol Chair: Proven Efficacy
• Only the patented ExMI™ technology allows for nerve
stimulation depth in excess of 7cm; this depth is vital for
successfully treating incontinence
ExMI™
Technology
Competitor
(Air-Core)
Distance (cm)
• Targeted activation of all incontinence-relevant nerve
groups allows for training all relevant muscle groups in the
pelvic floor as well as the vaginal sphincter
• Therapeutic efficacy proven by clinical studies (cf. page 7)
Quelle: Product leaflets, laboratory test results conducted by Neotonus Inc., clinical study results (cf. page 6)
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Competitive Landscape
Alternative treatment methods are often painful, highly
invasive and inconvenient
Alternative Treatment Options to the Neocontrol Chair
Therapy
Method
Description
Electrical
Stimulation
Electrical stimulation probes are inserted rectally or
vaginally to innervate the pelvic floor and sphincter
muscles. Highly invasive treatment; has to used twice
daily for 20 minutes each over at least 6 months.
Biofeedback
Training
Extension to conventional pelvic floor gymnastics: by
inserting a vaginal probe, the patient receives an acoustic
or visual feedback informing her whether she is training
the correct muscles. Requires professional instruction.
Vaginal
Pessary
Patient inserts a vaginal pessary. Pulling on the pessary
forces it apart and to enlarge. The resulting pressure lifts
the ureter and thus achieves continence. Uncomfortable
and invasive treatment option.
Vaginal Weight
Cones
Patient inserts vaginal weight cones that are similar in
shape to sanitary tampons. The patient learns to hold the
weights by tensing her sphincter muscles. Addition to
conventional pelvic floor gymnastics.
Pelvic Floor
Gymnastics
Patient performs gymnastic exercises to strengthen the
pelvic floor and sphincter muscles. Requires a lot of
patience and perseverance. Success is largely
dependent upon physical mobility and age of the patient.
Highly invasive
Degree of
Invasiveness
Example: Electrical
Stimulation
Alternatives
are uncomfortable,
highly invasive, and
often not sufficiently
effective
Non-invasive
The listed alternatives comprise all the well-established conservative (i.e. non-surgical) therapy options.
Source: www.inkontinenz-selbsthilfe.com
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Appendix
Independent scientific studies from numerous countries
prove the success of ExMI therapy
Selected Study Results I/II
Brief Summary of Study Results
UK
AT, I,
GR,
D
AT
D
MEX
Full Version
Rowe et al. (Department of Urology, St. Mary‘s Hospital, London, 2005) write:
„The novel use of pelvic floor electromagnetic therapy may be a promising new noninvasive
option for chronic pelvic pain syndrome in men“
Nowak et al. Write 2007: „ExMI offers a novel medical treatment strategy following radical
prostatectomy that provides earlier recovery of continence (at 3 months). At 6 and 12 months
post-RPE continence rates were significantly superior to those undergoing PF treatment alone.
Thus, ExMI treatment seems to offer a new adjunctive strategy for men with post RPE
incontinence and should further be investigated in conjunction with anticholinergic agents.“
Prof. Dr. Madersbacher at the Landeskrankenhaus Innsbruck writes: „[…] urodynamisch wurde bei
der Magnetfeldtherapie eine deutliche Zunahme des Harnröhrenverschlussdruckes festgestellt.
[…] Die Vorteile der hochenergetischen Magnetfeldtherapie mittels Magnetstuhl liegen in der
einfachen, schmerzfreien Anwendung, sowie fehlender Nebenwirkungen und einer damit
verbundenen hohen Akzeptanz auch bei älteren Betroffenen.“
Dr. Jens Wöllner at the Johannes-Gutenberg University Clinic Mainz, writes 2008: „Das ExMIVerfahren stellt ein effizientes, wirksames und nicht invasives Verfahren in der Therapie der
Inkontinenz dar.“
Furthermore, Dr. Wöllner presents his study results at the 60. congress of the German Urological
Association. The presentation is available online (in German only): :
www.abstractserver.de/dgu2008/video/vortrag_116/index.htm
Martinez et al. (Centro de Urologia Avanzada, Cd. Delicias, Chihuahua, Mexico) write 2008: „This
study provides evidence of the positive impact of electromagnetic wave therapy, increasing
patient orgasmic capacity not related to the couples‘ sexual conduct. Our hypothesis is that there
is a reactivation of the neuromuscular union or of the afferent fibers as a result of the
electromagnetic effect with an increase in the sensorial function of the pelvic floor.“
The full reports are available online by clicking on the WWW-Link (active internet connection required).
(Study)
(Presentation)
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Appendix
Dr. Wöllner observes that patients need significantly fewer
pads after undergoing ExMI™ treatment
Example
Study Results Dr. Wöllner (Excerpt)
Significant Reduction of Pads Required
100
Before ExMI™
After ExMI™
On average
4.3 pads / day
On average
1.9 pads / day
Proportion
(%)
Patient Satisfaction after ExMI™ Therapy
%
79%
63%
• About 80% of
those patients
that began
treatment within
12 months after
their first leakage
episode were
highly satisfied
with ExMI™
treatment
outcome.
• A later therapy
start still yields
very satisfactory
results.
# of Required Pads per Day
• Good results especially with stress incontinence; high patient satisfaction
• Significant reduction in pad usage, especially when therapy is started early
• Outpatient therapy, non-invasive, painless, no side-effects
Source: Dr. Jens Wöllner, Johannes-Gutenberg University Clinic, Mainz, Germany, DGU Conference Presentation, 2008
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Growth Opportunities
Growth opportunities lie in targeting new market segments
outside of urology…
Growth in New Market Segments
Vision
Urology
Product
Neocontrol Chair
Neocontrol Chair
New Devices
New Devices
Strategy
Market penetration
Market
development
Market
development
Market
development
• Incontinence after radical
prostatectomy
• Erectile dysfunction
• Ejaculation problems
• Stress incontinence, mixed
incontinence
• Feces incontinence
• Acute und chronic pelvic
pain
• Interstitial cystitis1
• Stress incontinence, mixed
incontinence
• Feces incontinence
• Pregnancy after-care:
Strengthening of vaginal
sphincter tonus
• Orgasm problems
• Acute und chronic pelvic
pain
• Interstitial cystitis1
Indications1
Area
Gynecology
NEW
Orthopedics
NEW
• Thrombosis
(also preventative)
• Osteoporosis
• Osteoarthritis
• Carpal tunnel syndrome
• Nerve stimulation
(e.g. after an accident or
operation)
Sports medicine NEW
• Muscle build-up e.g. after a
lesion
• Foster blood circulation
• Treatment and prevention
of thrombosis
• Osteoporosis
• Osteoarthritis
• Carpal tunnel syndrome
• Nerve stimulation
(e.g. after an accident or
operation)
ExMI™ Platform Technology
(1) Interstitial cystitis = common form of bladder pain syndrome
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Growth Opportunities
…and by expanding geographically, especially to emerging
markets such as China, India, Brazil
Growth by Further Geographic Expansion
Number of urologists:
8.000
Number of gynecologists: 20.000
EU BIG-5: D, F, E, UK, IT
Number of urologists:
11.000
Number of gynecologists: 27.000
Number of urologists:
8.000
Number of gynecologists: 15.000
Total of Private Practitioners in EU-Big5, US and Japan:
about 89,000
Source: German Medical Association (Bundesärztekammer); United States Department of Labor; American Urological Association; The Japanese
Urological Association; Ministerio de Sanidad, Política Social e Igualdad; The National Health Service Information Centre UK
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Summary
 Proven, patented, Neuro-stimulation device used to treat urinary incontinence
 In excess of 2,300 devices installed in over 57 countries
 510(k) approved
 Made in the USA
 Seeking distribution partners and capital for 2nd generation design
 Contact:
Katan Associates, Inc.
Prof. Dr. Michael Jordan, MD
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