Manufacturer Information
Manufacturer and distributor information is presented separately from the portal’s independent literature classification. Product-specific technical and regulatory information is sourced from manufacturer-controlled documentation. In case of discrepancy, the current IFU and product labelling prevail.
SENNEX® is manufactured by BIONMED TECHNOLOGIES GmbH, Saarbrücken, Germany, operating under an EN ISO 13485 quality-management system. DGMed Medikal distributes the system in Türkiye, Azerbaijan, Cyprus and Northern Cyprus.
For information about portal governance and commercial relationships, see About and Governance.
Relayed from the manufacturer’s instructions for use
The manufacturer’s instructions for use (V1.16.9 EN, 2024-12-04) state the intended purpose as follows: SENNEX®, with electroporation/electrochemotherapy (EPT/ECT), is used to treat cutaneous and subcutaneous tumours and metastases where palliative treatment is appropriate. The tumours are treated from the skin surface with minimally invasive needle electrodes and the procedure is combined with chemotherapy.
The same document states that the procedure may be carried out only in clinics, by academically trained physicians. Under indications it lists cutaneous and subcutaneous malignant tumours and metastases.
Corpus records whose source text names the device, grouped by publication type
Publications in which the device was applied to patients, verified from the publication's own full text.
Publications in which the device was used in an animal, cell or model study, verified from the publication's own full text.
Reviews, consensus documents and device-landscape records; mentions reported in the studies a review covers; names appearing in a manufacturer or device discussion; and records whose role could not be settled. These do not show that the device was used in those studies.
General ECT literature is classified independently throughout the portal. Inclusion of literature on this page indicates that SENNEX is explicitly identified in the source; it does not transfer aggregate study outcomes to the device unless device-specific results are reported separately. Each record keeps the portal's normal literature classification in its own drawer.
Publication titles are reproduced as published and do not represent claims made by DGMed or the manufacturer.
| Feature | As stated by the manufacturer |
|---|---|
| Electrode handles | LINEAR handle with 4 needle electrodes (Art. 70104-Q/L); PENTAGON handle with 6 needle electrodes (Art. 70106-H) |
| Needle electrodes | Supplied sterile, single use. The handle is not supplied sterile and is disinfected before each application. |
| Pulse count and amplitude | 8 pulses per application, up to 1,000 V |
| Pulse duration and repetition | 100 µs pulse duration, 10 pulses per second, 100 ms interpulse pause |
| Control channel | Passive galvanic element, up to 1 V DC. The instructions state that the measurement shows a tendency only and does not report a physical quantity with a defined measurement accuracy. |
| Electrical classification | Protection class I, type BF applied part; 100–240 V AC, 50/60 Hz, approximately 90 W |
The values are taken from the manufacturer’s instructions for use and technical data sheet. Physical dimensions are stated differently in the two documents and are therefore not published here. A feature listed here does not thereby form part of an approved intended purpose.
Bleomycin, or cisplatin as another frequently used chemotherapeutic agent, is injected around the tumour.
The invasive electrodes are positioned on the affected part of the skin. The instructions state that it is vital in this process for the electric field to enclose the tumour completely.
The electrodes are charged with high voltage for several split seconds: 8 impulses of a maximum duration of 100 µs and 1,000 V amplitude are directed into the tumour.
According to the instructions, small pores emerge in the outer membranes of the cells in reaction to extremely short pulses of high voltage. The pores disappear after a short time; in the meantime it is possible for various substances to access the interior of the cells.
Relayed from section 4 of the instructions for use. The general, device-independent mechanism of electroporation is set out on the portal’s own Mechanisms page; the account here reflects a single manufacturer’s document and is not a statement of effectiveness.
The instructions carry a list of contraindications. In the document’s own words the list is not exhaustive; the attending physician decides on contraindications and treatment criteria.
| Assessment | As stated in the instructions |
|---|---|
| Pacemaker and implants | The presence of a pacemaker precludes treatment on the anterior chest wall. |
| Bleomycin sensitivity | Sensitivity to bleomycin or a history of pulmonary fibrosis precludes the administration of intravenous bleomycin. |
| Anticoagulant use | If the patient takes anticoagulants, the INR and prothrombin time are checked. |
| Anaesthetic allergy | Allergy against local anaesthesia, for example lidocaine, is asked about. |
| ECG | In cases of manifest or paroxysmal cardiac arrhythmias or previous cardiac events, an ECG before treatment is highly recommended. |
| Haematology | An INR above 1.5 precludes invasive electrode application. If the thrombocyte concentration is below 70,000/mm³, the decision to treat is made on the basis of the haematological opinion regarding the risk of bleeding versus the benefit of the therapy. |
| Biochemistry | If bleomycin is used intravenously, creatinine should be below 150 µmol/l to ensure adequate renal clearance. |
| Measurement of nodules | Nodules are measured and their local spreading recorded; photographic documentation is recommended before, during and after treatment. |
Relayed from section 8.2 of the instructions for use. The table is not a patient selection criteria list and is not sufficient for clinical decision-making; the binding text is the manufacturer’s current instructions for use.
The instructions state that treatment can be repeated, and that on repetition the needles, handle and connection cable must be disinfected. If the bleomycin dose of 60,000 IU/m² is exceeded, a pulmonary function test is performed in order to detect a possible looming pulmonary fibrosis.
For follow-up the instructions ask the patient to return to the surgery within four weeks of treatment at the latest, and state that this period is sufficient for evaluating the effects of the treatment and deciding on further strategies. Convalescence is given as 4 to 8 weeks with small tumours and 10 weeks for lesions larger than 1.25 cm².
Relayed from sections 8.3.4 and 8.3.4.1 of the instructions for use. This summary does not replace an operating instruction; the procedure is carried out only in clinics, by physicians trained on the system, and the binding text is the manufacturer’s current instructions for use.
| Field | As stated by the manufacturer |
|---|---|
| Device class (MDD) | IIb (Annex IX, 93/42/EEC; conformity assessment under Annex II) |
| Manufacturer | BIONMED TECHNOLOGIES GmbH |
| Basic UDI-DI | 42624218470100KG |
| Notified body | Medical Device Certification GmbH (mdc), 0483 |
| MDR transition status | Under the transitional provisions; the basis is the notified body's confirmation letter D1235100021, valid until 31 December 2028. A confirmation letter is not an MDR certificate. |
The values are taken from the manufacturer's declaration of conformity (2024-05-15). The pictogram section of the instructions for use refers to Regulation (EU) 2017/745; the documentation reviewed shows the device as Class IIb under the MDD and within the notified body's transitional framework. The portal does not state that MDR certification has been completed. Approval and licensing status in your country is not assessed here; consult the record of your competent authority. The citations are on the Clearance and Assessment Documents page.
Corpus records whose full text names the device
| Year | Publication | Study type | Model |
|---|---|---|---|
| 2025 | Eisele · J Oncol Res Ther | Clinical Study | Human |
| 2022 | Landström et al · Melanoma Manag | Case Report | Human |
| 2021 | Landström et al · Anticancer Res | Case Report | Human |
| 2021 | Landström et al · Anticancer Res | Case Report | Human |
| 2016 | Heppt et al · Cancer Immunol Immunother | Retrospective Clinical Study | Human |
| 2015 | Kreuter et al · J Dtsch Dermatol Ges | Retrospective Clinical Study | Human |
| Year | Publication | Study type | Model |
|---|---|---|---|
| 2025 | Spiliotis et al · Cancers (Basel) | Animal Study | Animal (In Vivo) |
| 2024 | Spiliotis et al · Sci Rep | Animal Study | Animal (In Vivo) |
| 2024 | Spiliotis et al · – | Animal Study | Animal (In Vivo) |
| 2024 | Universitat des Saarlandes · – | Animal Study | Animal (In Vivo) |
| 2023 | Spiliotis et al · Cancers (Basel) | Animal Study | Animal (In Vivo) |
| Year | Publication | Study type | Model |
|---|---|---|---|
| 2026 | Miklavcic et al · Radiol Oncol | Review | Literature Analysis |
| 2025 | Tan et al · Cancers (Basel) | Systematic Review / Meta-Analysis | Literature Analysis |
| 2023 | Gabay et al · Ann Biomed Eng | In Silico / Modelling | Computational Model |
| 2021 | Chlebopaseviene ve Satkauskas · Health Sciences | – | – |
| 2020 | Pirc et al · Journal of Medical Devices | Review | Literature Analysis |
| 2020 | Cvetkoska et al · IEEE Instrum. Meas. Mag. | Review | Literature Analysis |
| 2018 | Tunikowska J, Kulbacka J, Michel O, Kiełbowicz Z · Weterynaria w Praktyce | Review | belirsiz |
| 2015 | Landström FJ · – | Review | Literature Analysis |
The list is not maintained by hand: the full text of the 2,821 records in the portal’s corpus is searched and the records naming the device are collected here; at present 19 records meet that condition. General electrochemotherapy literature is not presented as evidence for this device: only publications naming the device are listed. Where a study used more than one system, its aggregate outcomes are not attributed to a single system; in a multicentre cohort some patients may have been treated with another system. The content of the publications, response rates and risk of bias are not assessed by the portal.
Fields as reported in each publication's full text
The fields below are relayed as reported in the full text of the publications; no value is published unless it can be matched verbatim to its source. There is no human curation on this page. In 10 records there is Methods-section evidence that the device was used in that study; in the remaining records the device is named but there is no evidence of use. The portal does not assess these numbers, it relays them; the publication itself is the binding source.
Miklavcic et al · Radiol Oncol · 2026
Role of SENNEX in this publication: in a manufacturer or device discussion
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Eisele · J Oncol Res Ther · 2025
Role of SENNEX in this publication: used in this study · more than one system was used: SENNEX, four prong applicator
Source (methods): The generator in use was the CE-certified SENNEX® system (Bionmed Technologies GmbH, 66123 Saarbrücken, Germany)
Source (methods): 1000 I.U. Bleomycin ... per cm3 tumor volume was injected intralesionally
Source (methods): capable of delivering 8 successive pulses each with 80 µs duration. The reliable field strength is 1000 V/cm
Source (results): Complete (CR) or partial response (PR) was 0 % in p and 60 % (CR) or 40 % (PR) in c, respectively
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Spiliotis et al · Cancers (Basel) · 2025
Role of SENNEX in this publication: used in this study
Source: ECT was performed using the Sennex® Tumor System (BIONMED® Technologies GmbH, Saarbrücken, Germany).
Source (methods): BLM (BLEO-cell® 15 mg, STADAPHARM GmbH, Bad Vilbel, Germany) was administered through i.v. at a concentration of 4 U/kg body weight
Source (methods): Eight electric pulses, each with a duration of 100 µs, were delivered between the two electrodes three minutes after chemotherapy administration. ... the Sennex® Tumor System delivered a voltage of…
Source (results): BLM group exhibited the highest proportion of necrotic tissue, accounting for 82.6 ± 0.1% of the treated area
Source (methods): Twenty-four WAG/Rij rats (males: n = 12, females: n = 12)
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Tan et al · Cancers (Basel) · 2025
Role of SENNEX in this publication: reported in the included studies
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Spiliotis et al · Sci Rep · 2024
Role of SENNEX in this publication: used in this study
Source (methods): ECT was performed with the Sennex® Tumor System (BIONMED® Technologies GmbH, Saarbrücken, Germany)
Source (methods): BLM (BLEO-cell® 15 mg, STADAPHARM GmbH) was administered as an i.v. bolus injection at a concentration of 4 U/kg body weight
Source (methods): Eight electric pulses of 100 μs duration were applied between the two electrodes 3 min after the BLM injection
Source (results): The i.v. and i.v. + i.t. groups exhibited a 44.0% and 46.6% reduction in oxygen saturation of the tumor tissue when compared to pretreatment values
Source (methods): Twenty-four WAG/Rij rats of both gender (males: n = 12, females: n = 12)
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Spiliotis et al · – · 2024
Role of SENNEX in this publication: used in this study
Source (not found): ECT was performed with the Sennex® Tumor System (BIONMED® Technologies GmbH, Saarbrücken, Germany)
Source (not found): BLM (BLEO-cell® 15 mg, STADAPHARM GmbH) was administered as an i.v. bolus injection at a concentration of 4 U/kg body weight
Source (not found): Eight electric pulses of 100 µs duration were applied between the two electrodes 3 min after the BLM injection
Source (not found): Twenty-four WAG/Rij rats of both gender (males: n = 12, females: n = 12)
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Universitat des Saarlandes · – · 2024
SENNEX was used in this study
Source (methods): mit einem elektrischen Impulsgenerator (Sennex® Tumor Therapie System, BIONMED® Technologies GmbH, Saarbrücken, Germany) verbunden
Source (methods): erhält BLM (BLEO-cell® 15 mg, STADAPHARM GmbH) in einer Dosis von 4 Einheiten pro kgKG (U/kgKG)
Source (methods): acht elektrische Impulse mit einer Dauer von 100 μs zwischen den beiden Elektroden erzeugt (SERSA et al., 2002). Die Spannung zwischen dem Elektrodenpaar ist auf 1000 V eingestellt, was einer…
Source (results): Der prozentuale Anteil des nekrotischen Gewebes in der BLM-Gruppe betrug 82,6 ± 0,1%
Source (methods): Die Tiere werden in drei Gruppen (n1=8, n2=8, n3=8) randomisiert und verteilt.
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Gabay et al · Ann Biomed Eng · 2023
Role of SENNEX in this publication: reported in the included studies
Source (not found): 40 pulses, 40 μs, and 4 Hz pulses were delivered at 750, 500, or 250 V. In the second step, 40 pulses, 10 ms, and 4 Hz pulses were delivered at 50 V.
Source (not found): 10 pathologically confirmed BCC lesions excised from 10 patients
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Spiliotis et al · Cancers (Basel) · 2023
Role of SENNEX in this publication: used in this study
Source (methods): The electrodes were inserted in a plastic holder and connected to the electric pulse generator (Sennex® Tumor System, BIONMED® Technologies GmbH, Saarbrücken, Germany)
Source (methods): BLM (BLEO-cell® 15 mg, Stadapharm GmbH, Bad Vilbel, Germany) was administrated as an intravenous bolus injection at a concentration of 4 U/kg body weight
Source (methods): Eight electric pulses of 100 µs duration were applied between the two electrodes 3 min after the BLM injection. According to the European guidelines for the utilization of ECT, the Sennex® Tumor…
Source (results): The histological analysis revealed a higher rate of tumor necrosis in the ECT group, which was estimated at 87.2 ± 3.1%
Source (methods): Thirty-two WAG/Rij rats of both gender (males n = 16, females n = 16) with a body weight of 265.0 ± 14.5 g and an age of 46.0 ± 1.9 weeks were used for the experiments
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Landström et al · Melanoma Manag · 2022
Role of SENNEX in this publication: used in this study
Source: Electroporation was then performed using the Sennex electroporation system (Bionmed, Saarsbrucken, Germany) with 16 complete applications using the six-needle applicator.
Source (methods): Local injection of 18 ml cisplatin (Sandoz, Copenhagen, Denmark) with a concentration of 1 mg/ml in accordance with the ESOPE protocol was administered
Source (methods): The Sennex system delivers eight 0.1 ms square-wave pulses per application with electric field strength 1100 V/cm
Source (abstract): a 68-year-old woman with a large therapy resistant inguinal lymph node melanoma metastasis
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Chlebopaseviene ve Satkauskas · Health Sciences · 2021
Role of SENNEX in this publication: reported in the included studies
Source: Aprašomas 80 metų vyro ligos atvejis
Landström et al · Anticancer Res · 2021
Role of SENNEX in this publication: in a manufacturer or device discussion · more than one system was used: MedPulser, Cliniporator
Source (not found): intratumoral bleomycin injection
Source (not found): eight 0.1 ms square wave pulses with approximately 1.000 V/cm field strength
Source (not found): two such cases are reported
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Landström et al · Anticancer Res · 2021
Role of SENNEX in this publication: used in this study · more than one system was used: Cliniporator, SENNEX
Source (not found): After bleomycin administration electroporation was performed with either the Cliniporator (IGEA, Carpi, Italy) or the Sennex (Bionmed, Saarbrucken, Germany) electroporation systems.
Source (not found): bleomycin was administered intratumorally including a 1 cm margin of macroscopically normal tissue. The dose was 1000 IE per cm3 of tumor volume
Source (not found): There was one recurrence recorded in the 56-month follow-up period.
Pirc et al · Journal of Medical Devices · 2020
Role of SENNEX in this publication: in a manufacturer or device discussion
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Cvetkoska et al · IEEE Instrum. Meas. Mag. · 2020
Role of SENNEX in this publication: in a manufacturer or device discussion
Source (not found): For each pulse delivering, 8 square-wave pulses of 100 μs with pulse amplitude of about 1000 V (1000 V up to 1300 V) across an 8 mm distance between plate electrodes should be delivered at repetition…
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Tunikowska J, Kulbacka J, Michel O, Kiełbowicz Z · Weterynaria w Praktyce · 2018
Role of SENNEX in this publication: background mention
Source (not found): Bleomycynę podaje się w stężeniu 3 mg/ml w dawce wynoszącej 30 mg/m2 powierzchni ciała
Source (not found): Większość urządzeń służących do ECT składa się z elektroporatora, generującego serię 8 impulsów elektrycznych trwających 100 μs o częstotliwości 1 Hz oraz natężeniu 1300 V/cm lub 1000 V/cm
Heppt et al · Cancer Immunol Immunother · 2016
Role of SENNEX in this publication: used in this study · more than one system was used: Cliniporator, SENNEX
Source (methods): High-voltage pulses (730–1000 V) were applied to cutaneous target lesions with a Cliniporator™ (IGEA, Carpi, Italy) or Sennex® (BIONMED Technologies, Saarbrücken, Germany) pulse generator
Source (methods): Bleomycin was used for ECT in all cases at doses of 15,000 IU/m2 body surface area if given intravenously and at 250–500 IU/cm3 of tumor tissue if applied intralesionally.
Source (methods): High-voltage pulses (730–1000 V) were applied to cutaneous target lesions with a Cliniporator™ (IGEA, Carpi, Italy) or Sennex® (BIONMED Technologies, Saarbrücken, Germany) pulse generator 8–28 min…
Source (abstract): The local overall response rate (ORR) was 66.7 %. The systemic ORR was 19.2 and 40.0 % in the ipilimumab and PD-1 cohort, respectively.
Source (abstract): A total of 33 patients from 13 centers were identified with a median follow-up time of 9 months.
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Landström FJ · – · 2015
This record is a review; SENNEX appears in the studies it covers
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
Kreuter et al · J Dtsch Dermatol Ges · 2015
Role of SENNEX in this publication: used in this study · more than one system was used: Cliniporator, SENNEX
Source: Two devices were used for ECT: Cliniporator (IGEA GmbH, Frankfurt am Main, Germany) in 50 patients and Sennex (BIONMED Technologies GmbH, Saarbrücken, Germany) in six patients.
Source: 56 patients treated with electrochemotherapy
This record does not cover the whole text of the publication, so an empty field does not necessarily mean the publication failed to report it.
For questions about the system, training and implementation support, contact DGMed Medikal at info@dgmed.com.tr.
The commercial presentation of the product is on the DGMed corporate site: dgmed.com.tr/products/sennex. This portal does not repeat that page’s promotional copy; all product information here comes from the manufacturer’s controlled documentation.
If you believe any information on this page does not match the manufacturer’s current document, write to the same address; corrections are permanent and are not reintroduced by a data refresh.
