BioWave Corporation Receives CE Mark Clearance and ISO 13485 Certification for all BioWave® Neurostimulators and BioWave® Percutaneous Electrodes

BioWave’s Provenand Trusted SmarterPain Blocking Technology® will now be available to help millions of people throughout the U.K., Europe and Middle EastNorwalk, Conn.–June 8, 2021–BioWaveCorporation, a U.S. health technology companyrevolutionizing pain management with its proprietarySmarter Pain Blocking Technology®,isexcited to announce receipt of CEMarks under class IIa medical devices for its BioWaveGO®,BioWaveHOME®and BioWavePRO®Non-Surgical Peripheral Nerve Stimulationsystems as wellas for its proprietary BioWave®Percutaneous Electrodes. The company has also been awardedISO 13485:2016 certification. These certifications endorse the quality, efficacy and safety necessary for providing a first course,non-opioid,long lasting pain treatment solution forchronic, acute and postoperative pain pathologies.“Being granted the CEMark and ISO 13485 certification is an exciting and important milestone for the company. I am proud of our achievements and would like to thank the whole team involved in this huge effort,” said Brad Siff, Founder & President of BioWave.Siff continued,“There is a significant unmet need foranefficacious,easy-to-use,non-opioid,first course pain treatment therapy. With these certifications,BioWave is now a global corporation and incombinationwith its strategic partner P14 Medical Ltd., is ready to launch BioWave’sentire line of smarter pain-blocking technology products to help the millions of patients in pain throughoutthe U.K., Europe and Middle East.”“The vision of Steve Dechan, President of P14 Medical Ltd., and the diligence of the teams ledby Brad Siffand Ben Fear have led to this tremendous opportunity for both P14 and BioWave,”saidRob Adler, Chairman of BioWave. “We can now bring BioWave’s Smarter PainBlockingTechnologyto more patients around the globe.”Steve Dechansaid,“We are delighted that all of the BioWave’s devices have been granted CE marks and approved for use in the U.K. and Europe. It’s terrific news for the millions who are suffering in chronic pain.” Steve continued, “Finally, one of my ambitions is becoming reality, that the general population can now have easy access to a device that effectively treats chronic painwithout the need for powerful and often addictive prescription drugs. At a time when millions are waiting for medical procedures like new joints and cancer treatments, BioWave is nowthere to support patients, improving quality of life and productivity in countries across theworld.Our next step is more clinical studies, particularly on how BioWave can significantly help women’s pain.”


BioWave’s patented high frequency signal-mixing technology is designed totravel through skin into deep tissue directly targeting nerve fibers, blocking pain signals at the source.BioWave isvery easy to use, delivers a comfortable deep soothing sensation, and daily 30-minute treatments can provide long lasting pain relief.BioWave recently conducted an Open-Label Pilot StudyonNoninvasive High-FrequencyPeripheral Nerve Fiber Stimulation in Chronic Painon 463 individuals.The study was published in the peer-reviewed journal pain Practicefrom the World Institute of Pain.BioWave is also asponsor of Continuing Medical Education (CME) courses involving the management of chronic pain for various locations on the body as well as courses that cover the latest non-opioid pain treatment therapies. About BioWave Corp.BioWave is a health technology company that manufactures and sells a variety of FDAclearedand CE approved medical devices,all based on its patented, high-frequencyNon-SurgicalPeripheral Nerve Stimulationtechnology for natural, non-opioid,long lasting pain relief.Products include BioWavePRO and BioWavePENS,for use in a physician’s office,BioWaveHOME, a home prescription portable version, and BioWaveGORXa small wearable device which is snowcovered by most insurance plans.BioWave’s prescription and  OTC products have been used in and prescribed by many VA hospitals, active military bases, pain and orthopedic clinics, not to mention prescribed to over 500 professional athletes and used by hundreds of professional and college sports teams.BioWave devices have also been officially recommended by theVietnam Veterans of America (VVA).BioWave’s OTC device, BioWaveGOis available,,,and at theFSA/HSA Store.BioWaveproducts are available under Federal Supply Schedule contract number V797D-70205.See BioWave Clinical Research & Studies at: with the companyonFacebookor

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