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June 29, 2022

SpineX begins participant enrolment in clinical trial of SCONE Device

The pivotal trial will evaluate the SCONE Device’s effectiveness and safety to treat neurogenic bladder.

Clinical stage bioelectric medtech firm SpineX has announced the enrolment of the first participant in a pivotal trial of the SCONE Device.

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The SCONE trial has been designed to assess the effectiveness and safety of the device to treat neurogenic bladder.

It is said to be the first large-scale pivotal trial to test a non-invasive spinal neuromodulation technology that has been developed to treat neurogenic bladder.

SpineX stated that the first participant was enrolled at Rancho Research Institute, Rancho Los Amigos National Neurorehabilitation Center’s research arm.

Neurogenic bladder is the most common comorbidity in people after paralysis.

Its effect goes beyond the inability to void when required or the necessity for daily repeating catheterisations to empty the bladder for the rest of one’s life.

People with neurogenic bladder will have symptoms like low capacity of bladder, lost sensation of bladder fullness, a constant fear of uncontrolled urine leakage, and frequent urination cycles during the day and night.

SpineX co-founder Dr Evgeniy Kreydin said: “For a person in a wheelchair, the inability to walk is the most obvious functional loss, but the impact on quality of life due to neurogenic bladder is unparalleled.”

The company said that the SCONE therapy has been designed to treat each of these symptoms.

The device provides proprietary modulated waveforms of changing currents to designated areas of the spine in a specific sequence through hydrogel electrodes directly over the skin.

Due to this, the user will not have any pain or discomfort.

SCONE is designed for the treatment of neurogenic bladder caused due to spinal cord injury, stroke, or multiple sclerosis.

SpineX CEO Dr Parag Gad said: “The initiation of the SCONE trial is an important milestone in bringing the world’s first non-invasive treatment modality for neurogenic bladder to market.

“We are committed to transforming bladder management into a catheter free and leak free world.”

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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