Nerivio, a novel wireless neuromodulation wearable from Theranica for drug-free acute treatment of migraine, features an electronic housing molded in a Thermolast M custom-colored medical-grade thermoplastic elastomer compound from Kraiburg TPE. The device has passed clinical testing, is FDA-authorized and conforms to all applicable IEC/EN 60601 standards for medical devices, and nerve stimulators. The TPE material provides ISO 10993 certified biocompatibility and is supplied in line with new VDI 2017 guidelines.
Kraiburg TPE is a global manufacturer of thermoplastic elastomers. From its beginning in 2001 as subsidiary of the historical Kraiburg Group founded in 1947, Kraiburg TPE has pioneered in TPE compounds, today being the competence leader in this industry. With production sites in Germany, the US, and Malaysia, the company offers a broad range of compounds for automotive, industrial, consumer, and strictly regulated medical sectors.
Theranica Bio-Electronics is a prescribed digital therapeutics company dedicated to creating effective, safe, affordable, low-side effect electroceuticals for idiopathic pain conditions.
Non-pharmacological treatment of migraine and other pain conditions has become a challenge, not just in remote areas without ready access to outpatient care facilities, but also under the constraints of social distancing amid the current Covid-19 pandemic. Theranica (Netanya, Israel) has developed an innovative neuromodulation device – Nerivio – addressing both issues with a convenient wearable solution for personalized, app-controlled acute treatment of migraine. The electroceutical device is worn on the arm and uses electronic pulses for inducing a drug-free pain inhibition mechanism. The user-friendly app is available for Android and iOS smartphones and includes a migraine diary that can be shared with healthcare professionals to better manage this disabling disease.
“For the outer layer of the Nerivio, we tested a variety of different biocompatible materials to find the best combination of soft feel, certified dermatological tolerance, processability and surface quality,” says Alon Ironi, president and chief executive officer of Theranica. “Furthermore, the compound had to provide long-term adhesion to double-sided sealing tape, without delamination.”
In close cooperation with AiT Chemicals, a leading local supplier of polymers and Kraiburg TPE’s distributor in Israel, Theranica selected a Thermolast M medical-grade thermoplastic elastomer (TPE) that offered the ultimate property profile for this device. It claims to deliver a smooth and velvety surface ‘as molded’, with durable abrasion resistance to the securing armband and strap of the device. It is biocompatible and offers irritation-free characteristics while meeting cytotoxicity requirements, which have been certified respectively to ISO 10993-10 and ISO 10993-5 standards. According to customer requirements, the compound is pre-colored ex works to match the stylish grey surface texture of the armband. Also, many of Kraiburg TPE’s portfolio compounds are documented in FDA Drug Master Files. This helps the end customers to speed up regulatory approvals and time-to-market.
“Thanks to our long-standing partnership with AiT Chemicals and our early inclusion in this application project, we were able to supply a custom-tailored TPE that meets all the specifications and requirements of Theranica, from ease of processing to biocompatibility and color,” says Oliver Kluge, advisor for Medical Products at Kraiburg TPE.
Following complete clinical clearance, the Nerivio device received a De Novo approval from the US Food and Drug Administration (FDA) for clinical use in May 2019. The FDA classified the wearable as a trunk and limb electrical stimulator to treat headaches. It conforms to all applicable IEC/EN 60601 standards for the safety and electromagnetic compatibility of medical electrical equipment, nerve, and muscle stimulators.
In the United States, Nerivio is already available as a prescribed wearable, including through telemedicine platforms UpScript and Cove. It is expected to be launched in Europe and other regions in 2021.