Bioelectronics Corp (OTCMKTS:BIEL) is working on the device that can indicate musculoskeletal pain. For that purpose, the company needs a data requirement that can be met. In the last quarter of 2016, Bioelectronics Corp held a meeting with several members of FDA. These included senior management members from Division of Neurological and Physical Medicine Devices of the FDA. The meeting was held among the company and FDA members, viz. Deputy Division Director, three reviewers for the ActiPatch® Musculoskeletal Pain Therapy 51O(k) premarket notification, Acting Branch Chief of the Physical Medicine and Neurotherapeutic Devices Branch and assigned statistician.
Inclusions from the company
Bioelectronics Corp said that the 51O(k) premarket notification for the ActiPatch® Musculoskeletal Pain Therapy composed of the clinical studies surrounding plantar fasciitis and knee fasciitis. Also, it included the working mechanism and action course of the device. The inclusions were meant to support musculoskeletal pain relief indications.
Meanwhile, the FDA believed that the company should also facilitate clinical data sourcing from anatomical application area as well.
The company ready to facilitate real-time evidence of working mechanism of ActiPatch®
ActiPatch® from Bioelectronics Corp is meant as an effective treatment for chronic back pain. The company says that it is geared up for facilitating real-time evidence regarding the working of this device. Additionally, it supports the clinical data with the backup of 5,660 back pain users. According to the company, apart from this real world data of 5,660 back pain users, it can also facilitate fresh data from Observational Study conducted on a total of 117 subjects who used ActiPatch® therapy for around 6 months duration.
With this, the Director of Clinical Research at the company, Ian Rawe said, “We are hopeful that the data will meet the Agency’s acceptance criteria and will expedite over-the-counter market clearance for musculoskeletal pain relief.”
If Bioelectronics Corp brings the device to success in the market, it would fetch it revenues of the desired figure.
