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Superior drug penetration using the
Physion EMDA® system for the treatment of  Non-Muscle Invasive Bladder Cancer and of Functional  Urological Disorders
 

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What is EMDA®

EMDA® is a device-assisted therapy that increases drug transport across biological membranes under the influence of an electric field

EMDA® is characterized by a combination of different electromolecular interactions  that  improves drug absorption from 4 to 7 times:

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  • Iontophoresis

  • Electrophoresis/Electrosmosis

  • Electroporetion

The deeper drug penetration and the greater drug bioavailability result in an increased clinical effectiveness.

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EAU Guidelines NMIBC 2021

7.2.1.3 Options to improving efficacy of intravesical chemotherapy

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7.2.1.3.2 Device- assisted intravesical chemotherapy Electromotive Drug Administration

«The efficacy of MMC using EMDA® sequentially combined with BCG in patients with high-risk tumours has been demostrated in one small RCT (Di Stasi, 2006)» page 25

 

7.2.3  Combination therapy

7.2.3.1. Intravesical BCG + chemotherapy vs BCG alone

«In a RCT (Di Stasi, 2006) using MMC with EMDA®, a combination of BCG and MMC with EMDA® showed an improved recurrence-free interval and reduced progression rate compared to BCG monotherapy» page 28

 

7.4.3 Treatment of BCG unresponsive tumours and patients with BCG intolerance

«Currently, several bladder preservations strategies are being investigated such…device assisted instillations (Racioppi, 2018)» page 31

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EMDA® versus Conventional Therapy  

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TRADITIONAL THERAPY

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EMDA® ENHANCED

With EMDA® drug concentration is increased from 4 to 7 times

Di Stasi et al, Cancer Research 1999

ElectroKinetic Phenomena  

  • Iontophoresis

Is the active transport of ionised drug molecules into the target tissue by the application of an electric current through the intravesical solution
containing the ions to be delivered.

  • Electrophoresis

Describes the active transport of non-ionised solutes associated with the bulk transport of water.

•URO-ONCOLOGY

• HIGH-RISK

• INTERMEDIATE RISK

• BCG FAILURE

•FUNCTIONAL UROLOGY

Clinical Benefits of EMDA®

  • Deeper drug penetration into the target tissue  compared to conventional therapy

  • Significant reduction in disease recurrence and/or progression

  • Significant increase in disease-free interval

  • Highly cost-effective

  • Emda improve patient's quality of life

Safety

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  • The applied electric current causes no biological damage to tissue and no chemical modification of drug

  • Drug plasma levels remain well below toxic levels

  • Well tolerated

  • Excellent safety record

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EMDA® treatment requires 20 minutes for each sessions, it is easy to use and safe

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EMDA® is twice as efficace as the traditional therapy. The charts below compare the success and survival rates of patients treated with BCG only and BCG combined with EMDA® + Mitomycin.

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EMDA® field of application  

WHY EMDA®

A unique technology  to augment the effect of intravesical chemotherapy by creating an electric field across the bladder wall which increase urothelium’s permeability

“EMDA® device-assisted drug delivery using the BCG/MMC sequential protocol is a viable option to offer patients than radical cystectomy, particularly in BCG failure or intolerance or when other options are not viable”

Read More

  • The Physion EMDA® system has been proved excellent results in trating high-risk patients with non-muscular invasive bladder cancer

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  • Several thousand treatment cycles have been performed with complete safety following TURBT. Significantly reduced recurrence and progression with increased DFI

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  • Reports from hundreds of cases with the DiStasi sequential BCG/MMC+EMDA® regim:

  • Twice the efficacy of standard of care BCG alone have been reported in high grade Ta/T1 disease and TIS.

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  • More data on EMDA® now available than any other device assisted drug delivery system available.

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  • Viable treatment alternative with Mitomycin-C when BCG is in short supply using a 9-week treatment protocol.

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  • Also helps conserve limited supplies of MMC.

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  • Proven deeper tissue penetration of MMC with EMDA® compared to passive administration.
     

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Emda® in the World

50

COUNTRIES

5

CORE TEAMS

60

STUDIES

200.000

PATIENTS TREATED