Magic Race / Kitalpha Medical
The Neocontrol Treatment Chair
ExMI Treatment Chair/2012 2
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
ExMI Treatment Chair/2012 3
Device
ExMI Treatment Chair/2012 4
The Neocontrol chair applies ExMI therapy; it has a proven track record with patients suffering from incontinence
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.
Executive Summary
Executive Summary
ExMI Treatment Chair/2012 5
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.
Mode of Operation
Control Unit
Treatment Chair
ExMI™: Nerve Impuls Contraction of Pelvic Floor and Sphincter Muscles
Magnetic Field
Motor-
Neuron
Induced
Nerve Impuls
Pelvic Floor Muscle
Motor End Plate
ExMI Treatment Chair/2012 6
The Neocontrol chair addresses therapy needs of a broad patient pool
• 20 – 23% of the adult population in the developed world suffer from some degree of incontinence
• Incontinence incidence with the female population in the US is at ~ 7%
Continence Care
• Stress Incontinence, Mixed Incontinence
• Incontinence after Radical Prostatectomy Surgery
• Pregnancy After-Care: Recovery of the Vaginal Tonus after Delivery
• Feces Incontinence
• Cystitis Interstitialis
Sexual Dysfunctions
• Erectile Dysfunction (ED)
• Ejaculation Problems
• Orgasm Problems
Neocontrol Chair: Areas of Application
• Globally, about 150 million women and men are estimated to suffer from some kind of the sexual dysfunctions mentioned above
Patient Potential Patient Potential
Source: Townsend et al. (2007): Incidence and Remission of Urinary Incontinece in Middle-aged Women, in: American Journal of Obstet. and Gynecol.
Areas of Application / Patient Pool
ExMI Treatment Chair/2012 7
Patients readily accept ExMI-based treatments as they are non-invasive and painless
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.
Unique Selling Propositions
Source: Results from clinical studies (cf. following page); patient questionnaires
Unique Selling Propositions of the Neocontrol Chair
Proven medical efficacy, financial benefits for the doctor as well as a high patient compliance set Neocontrol apart from other incontinence therapies
ExMI Treatment Chair/2012 8
Clinical studies and field reports confirm the medical efficacy of treating incontinence with the ExMI technology
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 Extra-
corporeal 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)
Study Results
Selected Study Results: Incontinence Treatment
(1) RPx = Radical Prostatectomy
ExMI Treatment Chair/2012 9
Due to its patented technology, only the Neocontrol chair achieves the therapeutically necessary penetration depth
Competitor 1: M-Cube (Korea) Competitor 2: QRS (Liechtenstein)
Neocontrol Chair: Proven Efficacy
• “Air-Core technology”
• Achieves only 1.5 - 2 cm penetration depth – not suited for treating incontinence
• Therapeutic efficacy not proven
• Only the patented ExMI™ technology allows for nerve stimulation depth in excess of 7cm; this depth is vital for successfully treating incontinence
• 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)
Competitive Landscape
Quelle: Product leaflets, laboratory test results conducted by Neotonus Inc., clinical study results (cf. page 6)
Competitive Landscape / Comparison with Neocontrol
• 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
Distance (cm)
V/m
ExMI™ Technology
Competitor (Air-Core)
ExMI Treatment Chair/2012 10
Alternative treatment methods are often painful, highly invasive and inconvenient
Therapy Method
Description Degree of
Invasiveness
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 Non-invasive
The listed alternatives comprise all the well-established conservative (i.e. non-surgical) therapy options. Source: www.inkontinenz-selbsthilfe.com
Alternative Treatment Options to the Neocontrol Chair
Competitive Landscape
Example: Electrical Stimulation
Alternatives are uncomfortable, highly invasive, and often not sufficiently
effective
ExMI Treatment Chair/2012 11
Independent scientific studies from numerous countries prove the success of ExMI therapy
The full reports are available online by clicking on the WWW-Link (active internet connection required).
Selected Study Results I/II
Brief Summary of Study Results Full Version
UK 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“
AT, I, GR, D
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.“
AT
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.“
D
Dr. Jens Wöllner at the Johannes-Gutenberg University Clinic Mainz, writes 2008: „Das ExMI-Verfahren 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
MEX
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.“
(Study)
(Presentation)
Appendix
ExMI Treatment Chair/2012 12
Patient Satisfaction after ExMI™ Therapy
Dr. Wöllner observes that patients need significantly fewer pads after undergoing ExMI™ treatment
Example Study Results Dr. Wöllner (Excerpt)
Source: Dr. Jens Wöllner, Johannes-Gutenberg University Clinic, Mainz, Germany, DGU Conference Presentation, 2008
• 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
• 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.
%
# o f R e q u i r e d P a d s p e r D a y
100 After ExMI™ Before ExMI™
Proportion (%)
On average 4.3 pads / day
On average 1.9 pads / day
79% 63%
Appendix
Significant Reduction of Pads Required
ExMI Treatment Chair/2012 13
Growth opportunities lie in targeting new market segments outside of urology…
(1) Interstitial cystitis = common form of bladder pain syndrome
Growth Opportunities
• 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
Urology Gynecology Orthopedics Sports medicine
Vision
ExMI™ Platform Technology
NEW NEW NEW
Neocontrol Chair Neocontrol Chair New Devices New Devices
Market penetration Market development Market development Market development
• Thrombosis
(also preventative)
• Osteoporosis
• Osteoarthritis
• Carpal tunnel syndrome
• Nerve stimulation
(e.g. after an accident or
operation)
• 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)
Product
Strategy
Area
Ind
ica
tion
s1
Growth in New Market Segments
ExMI Treatment Chair/2012 14
…and by expanding geographically, especially to emerging markets such as China, India, Brazil
Growth Opportunities
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
Growth by Further Geographic Expansion
Number of urologists: 8.000 Number of gynecologists: 20.000
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
EU BIG-5: D, F, E, UK, IT
ExMI Treatment Chair/2012 15
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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