A Novel Approach

A primary goal of GENT is to rapidly and locally tether and support proteins in the extracellular collagen matrix of the intervertebral disc, using an injectable nano-tethering device. GENT provides structural support of the disc tissues and restores spinal joint stability to resist degenerative disc disease (DDD) and to reduce/eliminate associated low back pain.

Patient Audience

 

Back pain sufferers will be able to benefit with a GENT treatment earlier on in the progression of the disease. The typical patient would be an individual in their 20s, 30s or 40s, experiencing chronic episodes of low-back pain with MRI or other confirmation of degenerative disc disease. Older patients not having penetrating disc lesions would also be suitable, as studies have shown that the stabilization provided by GENT was greater in more degenerated discs.

Twelve-Month Patient Data
Safety Study: Initiated June 22, 2016

Opportunity

 

A significant opportunity exists to better serve both surgical and non-surgical patients by offering an injectable medical device solution that rapidly and permanently supports degraded collagen in the tissue matrix to provide a mechanically stronger and stable tear-resistant tissue, without the cost and risk of conventional surgery.

Disc Tethering

 

GENT is designed to provide rapid and long-term relief of pain by:

  •Strengthening annulus against tearing and delamination.

  •Increasing joint stability.

  •Reducing disc bulge.

 

Single, micro-invasive treatment that improves  (compared to biological approaches) joint stability and motion (over fusion, artificial discs, and other joint stabilizing options), while providing long-term pain relief (unlike ESI).

Patients with chronic low back pain are now enjoying a better quality of life from just one treatment of GENT. They’re enjoying activities like hiking, rock climbing, and golf.

 

•Twelve months after the GENT procedure, three of the five initial patients had no (zero) low back pain and no (zero) disability.  And, the other two patients had excellent results.

•These initial clinical results demonstrate a long-lasting, significant reduction or elimination of pain and disability, not just a slight reduction, and these benefits began within days of the initial procedure.

•ILS also has objective imaging data demonstrating the elimination of clinical instability.

These data/information represents 12-month post-procedure status for a small number (5) of patients.  Longer term results are not available at this time. These data are from only one clinical site and one investigator (with considerable experience in micro-invasive treatment of spinal discs). Réjuve is not an approved medical device. The clinical investigator received specialized training in the implementation of the Réjuve clinical protocol. Patient ages range from 24 to 43; 32.25 average age. The information contained herein is not intended to be a comprehensive review of data; rather, a snapshot of preliminary data. Actual results may vary.

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Regulatory

CE– Class IIb medical device. 

 

Patents And Papers

More than forty (40) issued patents. Thirty-two (32) peer-reviewed publications support the safety and efficacy of the device.

 

Availability

Available only to Intralink-Spine certified physicians and distributors.

 

*Attention: GENT is not available for sale in the US or Canada. Clinical studies are pending.

 

For More Information

If you would like to know more, please contact your distributor and ask about GENT.

 

Or if you're interested in providing the GENT treatment for low back pain to your patients, please “click” the button below and submit the Physician Information form to ILS for review.

© 2020 by Intralink-Spine Inc. 

Attention: The GENTIS medical device is not available for sale in the US, Canada, or EU. Clinical studies are being conducted In Australia.