PRODUCT PRESENTATION

BTL Emsella Toronto: OVER 25 YEARS OF INNOVATION

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Growing to meet your needs

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Emsella Toronto

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Represents a New Category of Technology


A Breakthrough Treatment for Pelvic Health

EMSELLA THE NAME

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•EM stands for Electro-Magnetic technology


•SELLA means chair in Latin

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EMSELLA POWERED BY HIFEM® TECHNOLOGY

EMSELLA works on the principle of patented* High Intensity Focused Electromagnetic Technology (HIFEM).


This is an extremely powerful focused electromagnetic field. Its high intensity enables to reach muscle contractions, while the patient comfortably sits on the EMSELLA applicator.

*This product, the methods of its manufacture and the use are covered by one or more US and foreign patents or pending patent applications.

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Emsella Toronto — SAY NO TO INCONTINENCE

US FDA cleared to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

Additional side effects
•Temporary increase of local circulation
•Increased sensitivity during intercourse

EMSELLA TORONTO — BENEFITS FOR THE PATIENT

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PHYSICIANS SAY “YES” TO EMSELLA

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Once the therapy is started, there is no need for an additional operator activity.
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GROWING DEMAND FOR INTIMATE HEALTH

•The number of feminine procedures grows by 27% per year*


•Over 19 million US women and 200 million people worldwide suffer from incontinence**


•45% of incontinent women reported the loss of intimacy**

•54% of cases report the loss of confidence**


•5 out of 10 women do not seek help


•6.5 years on average from first symptoms to seeking help

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MEN ARE AFFECTED TOO

•Incontinence is not only a women’s issue


•Worldwide prevalence of UI in male population is up to 11%*


•78% of male patients are not aware about the non-invasive solution to UI**


•UI is commonly associated with other intimate health issues

THE COSTS OF URINARY INCONTINENCE

Urinary incontinence is associated with substantial routine care costs and patients are willing to pay for significant resolution of their symptoms.

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THE INCONTINENCE MARKET GROWTH

Incontinence is the fastest growing category in the intimate health market. Billions of dollars are spent on adult incontinence products.*

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Among the main growth drivers are population aging and rising awareness connected with higher standards of life

EMSELLA TORONTO — INCONTINENCE

MEET THE PATIENT

Postpartum and postmenopausal women represent the largest female patient population.


Elderly men and men after prostatectomy represent the largest male patient population.

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Urinary incontinence (UI) is an involuntary leakage of urine caused by:

•Aging
•Vaginal delivery
•Menopause
•Damaged nerves
•Enlarged prostate
•Other

TYPES OF URINARY INCONTINENCE

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DISTINGUISH BETWEEN:

Stress urinary incontinence is associated with activities increasing intra-abdominal pressure (e.g. coughing, sneezing, laughing).


Urge Urinary incontinence involves an involuntary loss of urine occuring when a person has a strong, sudden need to urinate


Mixed urinary incontinence involves symptoms of stress and urge urinary incontinence

INCONTINENCE ISSUES

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•According to NAFC – Stress urinary incontinence, the most prevalent form of incontinence among women, affects an estimated 15 million adult women in the U.S.


•According to GFI* – Most women suffer from SUI, Most men suffer from OAB/Urge incontinence

EMSELLA TORONTO — THE CLINICAL BACKGROUND

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TREATMENT OPTIONS

•Behavioural changes
•Kegel exercises
•Biofeedback/PT
•Transvaginal Electrical stimulation
•Laser and RF treatments for SUI
•EMSELLA
•Surgery

THE ROLE OF PELVIC FLOOR MUSCLES IN INCONTINENCE

•The pelvic floor muscles are formed by several group of muscles
•These muscles forms a sling-like support for the lower pelvic organs
•The pelvic floor muscles are responsible for control of continence

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CAUSES AND CONSEQUENCES

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Click here to know more: CLINICAL BACKGROUND of BTL Emsella Toronto

EMSELLA TORONTO — SCIENTIFIC BACKGROUND

CLINICAL EVIDENCE RESULTS (as of 2/2020)

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• 7 completed clinical studies
• More clinical studies in the process
• Over 500 study patients
• Three types of urinary incontinence
• 95% satisfaction and significant
improvement in patients’ quality of life
• 65 % – average improvement of UI
symptoms
• Results confirmed by 6-month
follow-up

HIFEM TECHNOLOGY CAN IMPROVE QUALITY OF LIFE OF INCONTINENT PATIENTS – PILOT STUDY

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Joseph Berenholz, MD, Michigan, USA
Tracey Sims, MD; George Botros, MD, Liverpool, UK


•30 patients; all types of urinary incontinence
•6 therapies; scheduled 2x a week
•Standardized King´s Health Questionnaire, Number of used hygienic pads


Results:
•95% of treated patients improved quality of life
•67% of treated patients totally eliminated or decreased the use of hygienic pads
•The results were maintained during 6-month follow-up

Click here to know more: SCIENTIFIC BACKGROUND of BTL EMSELLA TORONTO

EMSELLA THERAPY RECOMMENDATIONS

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NUMBER OF THERAPIES
•6 tx


THERAPY TIME
•28 minutes each session


FREQUENCY
•Scheduled twice a week


RESULTS DURABILITY
•Confirmed by 6-month follow-up


RIGHT CANDIDATE
•Stress, urge and mixed urinary incontinence

CONTRAINDICATIONS

•Cardiac pacemakers
•Implanted defibrillators, implanted neurostimulators
•Electronic implants
•Pulmonary insufficiency
•Metal implants
•Drug pumps
•Application in the head area
•Application in the heart area
•Malignant tumor
•Fever
•Pregnancy

PATIENT POSITIONING

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COURSE OF THE TREATMENT

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•Let patient comfortable sit in the center of the chair


•Set chair at height that feet are flat on the ground and knees are at a 90-degree angle


•Use THERAPY TARGETING MODE to find the right position


•Have patient to move forward or backward until they feel the pulses and contractions at the perineum and pelvic floor


•If patient feels energy in the inner thighs have them separate legs further apart

COURSE OF THE TREATMENT

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•Once the patient is seated in correct position, then start the treatment


•Increase intensity slowly until patient feel pelvic floor muscle contractions


•Patient should feel intense contractions but never pain

PROTOCOLS

PROTOCOL U1
•Gentle and gradual stimulation of the pelvic floor
•“Exercising with light weights”
•Muscle facilitation, Muscle strengthening, Muscle relaxation


PROTOCOL U2
•Intense protocol for further strengthening of the pelvic floor
•“Exercising with heavy weights”
•Muscle strengthening, Blood flow enhancement, Muscle relaxation

EMSELLA TORONTO — DO NOT TAKE OUR WORD FOR IT TAKE THEIRS

KEY OPINION LEADERS AND CUSTOMERS

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INTERNATIONAL KEY OPINION LEADERS

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AS SEEN BY EXPERTS

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GET INSPIRED

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“The results have been really rewarding. There are many patients who really call this a life-changing experience. When we treat the patients with EMSELLA, whether we are doing a RF treatment in conjunction or laser treatment in conjunction, one of the things I am most impressed with as a provider is how much their lives are changed.”


Julene B. Samuels, M.D.
Julene B. Samuels, MD, FACS
Louisville, KY

EMSELLA TORONTO — TREATMENT SOLUTIONS

CORE TO FLOOR THERAPY

Complete solution for the whole core

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Core to floor therapy utilizes two HIFEM therapies to strengthen, firm and tone the abdomen and pelvic floor muscles.

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CLINICAL FAQ

CLINICAL FAQ

HOW CAN PATIENTS BENEFIT FROM THE PROCEDURE?
EMSELLA helps patients to restore the control of their bladder, pelvic floor muscles and eliminate incontinence or any kind of intimate discomfort.
EMSELLA is a truly non-invasive procedure where patients remain fully clothed


HOW DOES EMSELLA COMPARE TO THE OTHER PROCEDURES THAT ARE OUT THERE?

EMSELLA is the only procedure that targets pelvic floor muscles and causes deep pelvic floor stimulation because of HIFEM technology. All other procedures such as intravaginal electrostimulation have a risk of burns and lack the effect as the electrical current treats tissue only superficially, not even mentioning the need to insert the disposable vaginal probe. Comparing to Kegels, patients are not able to properly contract pelvic floor muscles, build the routine to do Kegels at least 3x per day and do them in hundreds of repetitions to see some results.

Click here to know more: Frequently Asked Questions about BTL Emsella Toronto

APPENDIX

EMSELLA – Dimensions

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TYPES OF URINARY INCONTINENCE

DISTINGUISH BETWEEN:

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STRESS URINARY INCONTINENCE

Stress urinary incontinence (SUI) is associated with activities increasing intra-abdominal pressure (e.g. coughing, sneezing, laughing).

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CLASSIFICATION
•Type 0 – no objective incontinence, bladder neck and urethra closed at rest, opened during stress
•Type I – bladder neck and urethra closed at rest, open and descent during stress less than 2 cm, no cystocele
•Type IIa – bladder neck and urethra open and descend during stress more than 2 cm, evidence of cystocele
•Type IIb – bladder neck and uretra closed and below the pubis bone at rest, descend during stress with uretra opening
•Type III – bladder neck and urethra open at rest, occurs in the absence of detrusor contraction

URGE URINARY INCONTINENCE

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•Urge incontinence is usually a sign of an underlying problem (e.g. Diabetes)


•The bladder contracts when it should not, causing some urine to leak through the sphincter muscles holding the bladder closed


•Urge incontinence involves an involuntary loss of urine occuring when a person has a strong, sudden need to urinate

MIXED URINARY INCONTINENCE

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•Mixed urinary incontinence is a combination of the symptoms of the stress and urge incontinence


•Urinary leakage occurs during activities with increased intra-abdominal pressure or during strong, sudden need to urinate