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12

Before and after Synergo treatment

Safe and simple procedure Performed on an out-patient basis Deep drug penetration into bladder tissue

SYNERGO CLINICAL DATA

Starting as early as 1992 and continuously to date clinical trials have been conducted to study the benefits of combined treatment of Synergo® over chemotherapy and immunotherapy alone for people who suffer from NMIBC.  

  • provides a uniform and prolonged contact of the bladder walls with the drug, thus enhancing the effectiveness of the treatment.

  • produces homogenous diffused microwave radiation and controlled temperature thermal elevation of the bladder tissue. The radiation exerts a direct and selective effect on tumors and activates an antitumoral effect of the heated drugs. This is a selective effect on tumors that causes necrosis (i.e. kills the tumors) of the necessary tissue while safeguarding the normal tissue.

  • allows the drug solution to be kept at optimal conditions throughout the treatment session in terms of volume, concentration and temperature.

  • Increases drug penetration by 5-10 times more, accelerating the reaction rate by a factor of 10-50.

 

Clinical results from Synergo articles:
  • Multinational RCT Synergo® Vs. BCG : Synergo 78.1% disease-free at 2-year follow-up vs. 64.8 [Arends et al., Eur Urol. 2016].

  • In 2001, a multicenter RCT demonstrates the efficacy of Synergo® and its superiority over mitomycin instillations: Synergo 83% disease-free at 2-year follow-up vs. 43% [Colombo et al., J Clin Oncol. 2003]. 

  • Long-term follow-up on RCT performed in 2001 (> 10 years follow up): Synergo 53% disease-free at 10-year follow-up vs. 15% of MMC arm [Colombo et al., BJU Int. 2011].

  • Patients who failed treatment with BCG, candidates for cystectomy: 69.6% disease-free 2 year follow-up [Luedecke et al., April 2013], 72% disease-free at 2-year follow-up [Nativ et al., J Urol. 2009],  85% and 48% disease-free at 1 and 2 year respectively [Volpe et al., Urol Int. 2012].

  • T1G3 patients: 57.1% disease-free at 2-year follow-up [Halachmi et al. Urol Oncol. 2011]. 

  • Complete response rates (ablative therapy) detected with a Synergo® neo-adjuvant treatment: 72%, 80.6% [Luedecke et al. EAU, 2015], 79% [Moskovitz et al. Ann Oncol. 2005], 92% [Witjes et al. World J Urol. 2009], 75% [Gofrit et al. Urology. 2004].

  • Bladder preservation rate following Synergo 81.4%[Sooriakumaran et al. Urol Int. 2016], 87.6%[Lammers et al. Eur Urol. 2011]

 

SYNERGO TREATMENT PROTOCOLS & INDICATIONS 

The Synergo® System enables 2 treatment modalities for Non-Muscle Invasive Bladder Cancer   

Adjuvant (Prophylactic) Treatment

Aimed to prevent tumour recurrence after complete Transurethral Resection of Bladder Tumour (TURBT) in intermediate and high-risk patients, according to the European Association of Urology guidelines*.​

VIEW GUIDELINES (chapter 6 table 6.3) >>

Neo-adjuvant (Ablative) Treatment

Eradication of tumour(s) by Synergo® alone or by a single TURBT/TUF following tumour burden reduction with Synergo®. Eradication of CIS tumours, extensive tumour areas in the bladder resulting in high tumour burden which are difficult to remove in a single procedure, patients with tumours in problematic anatomic locations (bladder neck or retropubic),patients suffering from very frequent tumours, and for patients at high operative risk.

The Synergo® system has been successfully used in leading medical centres routinely since 2001. Thousand of patients have been treated over the years and were carefully monitored for any side effects and complications. Most side effects and complications witnessed are well known and have been documented and were published in leading scientific journals. Side effects that were observed were transient events that normally had no lasting effect on bladder function, superficial, resolved with minimal medical intervention and without significant residual effects during the course of the treatment. The complications observed were successfully treated with standard procedures. Similar side effects were witnessed during Adjuvant (Prophylactic) and Neo-Adjuvant (Ablative) Synergo® treatments.

 

THE SCIENCE BEHIND RF ENERGY

Synergo combines local radio-frequency (RF) energy (the lower limit of microwave electromagnetic radiation) with simultaneous instillation of a cooled chemotherapeutic drug.

The target of the RF energy is to enable higher drug penetration and accelerate drug-DNA reactions.
Tissue RF radiation should be adjusted per patient and dynamically maintained during treatment while the tissue temperature is constantly measured and closely followed, against the blood flow's active cooling.
Since the bladder wall acts as a good thermal insulator, heat penetration from heated liquid is not efficient (conduction/convection heating). On the other hand, during microwave heating the energy is absorbed directly in the tissue to enable efficient homogeneous heating, real-time measurement and follow-up on the tissue temperature (as confirmed on 5 different locations in a Synergo treatment) and dynamic adjustment of the transmitted energy (W) for each patient over time (e.g. when blood flow in tissue is increased due to heating).
Published papers show that RF radiation is a a key protagonist in the Synergo treatments. RF is not limited to its hyperthermic property; the drug's molecules diffuse actively by the Foucault currents associated with RF radiation (giving a higher probability of DNA-drug bonding at any given second). Radiated by RF, cancer cells also change their phenotype, characteristics, and their ability to repair themselves.Their membranes become permeated by micropores enabling an increased uptake of drug molecules into cancer cells selectively, and in turn enhances probability of drug-DNA bonding. Moreover, the RF-related loosening of inter-cellular adhesive bonds by retraction of cancer cell cytoplasm, enables homogeneous distribution of the cytotoxic drug throughout the malignant tissue also into deeper, hidden locations.

Read more on:

Synergo local RF and chemotherapy (Thermo chemotherapy) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive

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