CLINICAL DATA & SAFETY
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]
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.
Prof. Dr. med. J.A. Witjes PhD MD
Radboud UMC, Nijmegen, The Netherlands
“I have seen remarkable responses in these patients in spite of their being in the list for a cystectomy”
Dr. med. Gerson Lüdecke Head of Uro-Oncology section
University Clinics of Giessen-Marburg, Germany
"Synergo is a pioneering therapy ready for fast track implementation in urology. With more than 10 years of Synergo experiences in high risk NMIBC we achieved minimal recurrence rates using it alternatively to BCG with negligible side effects, and in BCG-failing patients who were externally discussed for cystectomy, we were impressed with the high bladder preservation rate"
Prof. Dr. med. Sanjeev Madaan PhD MS Dip NB FRCS (urol) FEBU
Dartford and Gravesham NHS Trust, Kent , UK
"I have been using Synergo RITE for many years and have found it extremely useful in the management of high-risk NMIBC patients who have failed intravesical BCG and are not keen or suitable for cystectomy"
Mr Ahmed Ali
MBChB, MSc Urology, FRCS Urol
Frimley Health NHS Foundation Trust UK
"The Synergo system has helped us deliver individualised cancer care for patients with high risk NMIBC. The long-term data supports the use of the technology in many indications and help patients making an informed choice in respect to bladder preservation treatment"
Prof. Dr. med. Renzo Colombo FEBU, BC Head of Lombardy Oncology Network
San Raffaele Hospital, Milan, Italy
"I have been working with the Synergo technology since it's development, and for over 20 years have seen very pleasing results in terms of oncological outcome and in the patients 'quality of life"
Prof. Dr. med. Shahrokh F. Shariat PhD MD
Professor and Chairman of Department of Urology, Medical University Vienna, Austria
“Having witnessed its clinical benefits for several years, I think that Synergo will play a significant role in the management of NMIBC.”
Prof. Dr. med. Ofer Nativ PhD MD,
Chairman of Urology Department Bnai-Zion Medical Center, Haifa, Israel
“I have been using Synergo technology for over a decade now and I am satisfied with the results, especially in high risk patients (CIS, T1, high grade and BCG failures). I was able to appreciate its ablative potency and remarkably low dropout rate.”
Prof. Dr. med. Dr. phil. Thomas Bschleipfer FEBU, PhD MD,
Head Urology Department
Klinikum Weiden, Weiden, Germany
“The Synergo® RITE is a highly effective instrument to lower the otherwise extraordinary hazard of high risk NMIBC. It assures an excellent treatment response and thus, gives many of our patients a much better quality of life.”
Mr Rami Issa MD FRCS (Urol) CABU FEBU
St George's University Hospitals, London, UK
"For more than 10 years in our hospital, Synergo proved to be a very helpful option for the difficult group of approx. 200 patients, so far, with High Risk NMIBC, who did not respond to other intravesical therapies. We've saved many bladders over these 10 years!"
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.
Synergo local RF and chemotherapy (Thermo chemotherapy) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive
SYNERGO TREATMENT MODALITY & 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) >>
Any finding of CIS whether pure or concomitant to a papillary tumour, should not be treated with prophylactic Synergo® RITE, but rather with the Ablative protocol.
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.
Synergo® RITE treatment should not be used in patients with clinical conditions that preclude treatment administration