Updated mid-term results of RAPPER II clinical studies

Publisher:Maxhealth  DATE:2016-7-22

• Mid-term results analysis of phase II clinical studies was presented at the Symposium on Military Health Systems Research in the United States. 

• 96% of the patients were treated successfully without serious adverse events.

• The clinical test results of quadriplegia patients were good.

• Clinical trials are coming to an end - primary and secondary endpoints have been reached

• The final results, including quality of life assessment data, will be published in November 2016.
   

On August 18, 2016, Rex Bionics Plc (AIM: RXB) was pleased to announce the excellent empirical data obtained by REX in the mid-term results of RAPPER II clinical research. RAPPER II is a multicenter, international clinical study to assess the feasibility and safety of REX and REX customized training programs and their impact on quality of life (including sleep, pain and spasm).

Dr. Nick Birch of the Orthopaedic Branch of the Royal College of Surgeons, the main researcher of this study, published the data at the Symposium on Military Health Systems Research in Florida, USA (15-18 August 2016). The data are from six international clinical trial centers, three in the UK, two in New Zealand and one in Australia.

The results of this mid-term study are consistent with those of the first analysis - indicating that REX can be used safely by patients with spinal cord injury. Fifty-one of the 53 volunteers (96%) were able to complete the main endpoint set by the study, transfer-walking-training ("treatment success"), and no serious adverse events occurred.

The results of 15 patients with quadriplegia and 38 patients with paraplegia were essentially consistent. Re-validation showed that REX could benefit patients with high injury, such as patients with C4-7 spinal cord injury and other patients with severe nerve injury.

Ninety-five percent of the volunteers said they wanted to use REX once a week.

With the participation of 53 volunteers, RAPPER II is by far the largest clinical trial of mobile robot auxiliaries.

Researchers have now agreed that the trial could be terminated ahead of schedule because of the extremely strong and clear clinical data. The final part of RAPPER II, Quality of Life Assessment, will be presented at the 93rd Annual Conference of American Rehabilitation Medicine (Chicago, USA, October 30-November 4, 2016). The results will also be published in peer-reviewed journals in 2017.

There are two main clinical strategies for the next stage of REX: to confirm that REX has definite medical effects for patients with spinal cord injury, but also accompanied by economic benefits; clinical trials for other indications, such as multiple sclerosis, muscular dystrophy, brain trauma, etc. At least one new clinical research plan will be announced by the end of 2016.

Rex Bionics's mission is to use robotic-assisted rehabilitation as a treatment standard for nervous system injuries or diseases. Dr Nick Birch, the lead researcher, said: "The clinical outcomes of RAPPER II exceed the expectations of the clinical team. REX is indeed worth considering for many wheelchair users who are looking for new technologies to better manage the neurological damage in their lives!"

Crispin Simon, CEO of Rex Bionics, said: "We are very pleased with these positive results. It also greatly strengthens the confidence of the payers - Commercial insurance, the government, and philanthropists who are considering donating REX to local rehabilitation centers that REX has obvious clinical benefits!”

“I'm very much looking forward to the release of quality of life data later this year. More positive results will further show that REX can not only stand and walk - although it's a remarkable function in itself, it also has a definite therapeutic effect!”