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

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:

Iontophoresis
Electrophoresis/Electroosmosis
Electroporetion

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

EAU Guidelines NMIBC 2025

7.4.2.3 Measures to improve the efficacy of intravesical chemotherapy

7.4.2.3.2 Device-assisted intravesical chemotherapy

Electromotive Drug Administration

"The efficacy of MMC using electromotive drug administration (EMDA) sequentially combined with BCG in patients with high-risk tumours has been demonstrated in one small RCT (Di Stasi, 2006)" p. 29

7.4.4 Combination therapy

7.4.4.1 Intravesical BCG plus chemotherapy vs BCG alone

"In a RCT 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 (Di Stasi, 2006)" p. 33

7.5 Intravesical chemoablation and neoadjuvant treatment

Neoadjuvant

"Hypothesis-generating findings from an older RCT comparing immediate pre-operative device-assisted (EMDA) MMC with post-operative SI with MMC and TURB only, showed improved long-term RFS among patients treated prior to TURB (Di Stasi, 2011), and thus even suggest a long-term effect after neoadjuvant instillations" p. 34

7.9.2.2 Treatment of BCG-unresponsive tumours

"Currently, several bladder preservation strategies are being investigated such as ... device assisted instillations (Racioppi, 2018)" p. 38

7.9.2.2.2 Intravesical device assisted and combination chemotherapies

A prospective Phase II single-arm study evaluating the efficacy and safety of the EMDA-MMC treatment in 26 consecutive patients with BCG refractory HG NMIBC at three-year follow-up, demonstrated DFRs of 75, 71.4, 50 and 25%, for TaG3, T1G3, Cis, Ta/T1G3 + CIS, respectively (Racioppi, 2018)" p. 38

EMDA® versus Conventional Therapy

TRADITIONAL THERAPY

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/Electroosmosis

Is the transport of non-ionized drug molecules associated with the transport of water

Electroporetion

Implies increasing the permeability of biological membranes under the influence of an electric field

•URO-ONCOLOGY

• HIGH-RISK

• INTERMEDIATE-RISK

• BCG FAILURE

•FUNCTIONAL UROLOGY

EMDA® field of application

Treatment Modality

A urogenic 16F electrode-catheter is inserted into the bladder
The bladder is drained to remove residual electrolytes
The drug solution is administered
Two dispersive electrodes are placed on the sides of the navel with an abundante layer of conductive gel
A micro-current is applied for 20 minutes

EMDA® treatment is quick, easy to use and safe

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® improves patients' quality of life

Safety

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

Scientific evidence:

numerous clinical trials with long term follow-up have been conducted, focused on efficacy and safety of EMDA®

EMDA® FOR NON-MUSCLE INVASIVE BLADDER CANCER

The charts below compare the success and survival rates of patients treated with BCG only and BCG combined with EMDA® + Mitomycin

Sequential treatment BCG/EMDA® + Mitomycin

has an excellent oncologic efficacy and is twice as efficace as the traditional therapy

Di Stasi et al, The Lancet Oncology, 2006

Gan, O’Brien et al, The Journal of Urology, 2016

Guy’s and St.Thomas’ Hospital NHS Foundation Trust, 2019

WHY EMDA®

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

EMDA® device-assisted drug delivery is a viable option to offer patients than radical cystectomy, particularly in BCG failure or intolerance or when other options are not viable

Racioppi et al, BMC Cancer, 2018

The Physion EMDA® system has been proved excellent results in treating high-risk and intermediate-risk patients with non-muscle invasive bladder cancer.

EMDA® + Mitomycin treatment is an efficacy tool in the long term conservative strategy of high-risk unresponsive to BCG as a “bladder sparing” therapy.

Several thousand treatment cycles have been performed with complete safety following TURBT: significantly reduced recurrence and progression with increased disease-free interval.

EMDA® can be used with all type of Mitomycin and in sequential treatment EMDA® + Mitomycin is combined with BCG.

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

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

In according to EAU Guidelines 2021.