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

BioWave’s Proven and Trusted Smarter Pain Blocking Technology® will now be available to help millions of people throughout the U.K., Europe and Middle East Norwalk, Conn.–June 8, 2021–BioWave Corporation, a U.S. health technology company revolutionizing pain management with its proprietary Smarter Pain Blocking Technology®,is excited to announce receipt of CE Marks under class IIa medical devices for its BioWaveGO®, BioWaveHOME® and BioWavePRO® Non-Surgical Peripheral Nerve Stimulation systems as well as for its proprietary BioWave® Percutaneous Electrodes. The company has also been awarded ISO 13485:2016 certification. These certifications endorse the quality, efficacy and safety necessary for providing a first course, non-opioid, long lasting pain treatment solution for chronic, acute and postoperative pain pathologies.“Being granted the CE Mark 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 for an efficacious, easy-to-use, non-opioid, first course pain treatment therapy. With these certifications, BioWave is now a global corporation and in combination with its strategic partner P14 Medical Ltd., is ready to launch BioWave’s entire line of smarter pain-blocking technology products to help the millions of patients in pain throughout the U.K., Europe and Middle East.” “The vision of Steve Dechan, President of P14 Medical Ltd., and the diligence of the teams led by Brad Siff and Ben Fear have led to this tremendous opportunity for both P14 and BioWave,”said Rob Adler, Chairman of BioWave. “We can now bring BioWave’s Smarter Pain Blocking Technology to more patients around the globe.” Steve Dechan said, “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 pain without 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 now there to support patients, improving quality of life and productivity in countries across the world. 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 FDA cleared and CE approved medical devices, all based on its patented, high-frequency Non-Surgical Peripheral Nerve Stimulation technology 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 BioWave GO RX a small wearable device which is now covered 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 the Vietnam Veterans of America (VVA). BioWave’s OTC device, BioWaveGO is available at biowavego.com, Amazon.com, Walmart.com, and at the FSA/HSA Store. BioWave products are available under Federal Supply Schedule contract number V797D-70205. See BioWave Clinical Research &

Studies at: www.biowave.com/clinical.Connect with the companyonFacebookor atBioWave.com.