Therapeutic Goods Administration requests additional clinical data on Mainstay Medical’s ReActiv8

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Mainstay Medical’s ReActiv8

Mainstay Medical, a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling chronic low back pain, has provided an update on its application for the admission of ReActiv8 to the Australian Register of Therapeutic Goods (ARTG), which the company filed in January 2017.

The Therapeutic Goods Administration (TGA) has requested additional clinical data with respect to ReActiv8. To provide the most meaningful clinical data possible, Mainstay Medical report that the company intends to rely on the clinical data being gathered as part of the ongoing ReActiv8-B clinical study. This clinical study is expected to be fully enrolled by the end of the second quarter of 2018, with a full data readout expected towards the end of 2018. Upon availability of the ReActiv8-B data, Mainstay Medical plan to submit a new application to the TGA seeking admission of ReActiv8.

The Therapeutic Goods Administration may request additional information during the review process. Review of an application for admission of a product to the ARTG has varied historically. The TGA is required to complete assessment of applications within approximately one year.

One of the recognised root causes of chronic low back pain is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from chronic low back pain. In the USA, ReActiv8 is limited by federal law to investigational use only.

People with chronic low back pain usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery.

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