Réjuve Recognized by Notified Body as a Class IIB Medical Device
LEXINGTON, KY, October 1, 2014 Intralink Spine, Inc. (ILS) is pleased to announce it has received written Pre-Assessment Notification that ILS is correct to proceed with the micro-invasive Réjuve as a Class IIB Medical Device.
According to ILS CEO, Lyle Hawkins, “This notification further validates our timeline to the CE mark. This important milestone comes approximately two-weeks ahead of schedule; but, we’re not sitting and celebrating. We’re continuing to move full speed ahead towards CE certification.”
In one of the three videos found on the ILS website, Elsa Abruzzo, founder of Cygnus Regulatory and VP at Intralink Spine spoke about why she felt so confident in the regulatory path. The Pre-Assessment decision by the Notified Body confirms what Ms Abruzzo expressed in the video.
And, per Mr. Hawkins,”Our early interest from European Distributors continues to grow. So, we’re excited about the pre-assessment and what the future holds for ILS employees and investors.”
According to Dr. Tom Hedman, CSO of Intralink Spine and a leading researcher in soft-tissue biomechanics, “Réjuve is a tissue revitalization technique that in over 15 years of preclinical studies has demonstrated to be effective in treating large avascular load-supporting tissues such as the spinal disc. The Réjuve device is designed to provide physicians with the ability to safely augment the crosslinking of fibrous proteins, primarily collagen, to reinforce and rejuvenate the spinal disk tissue via a simple injection performed under image guidance.”
About 80 percent of the adults in the U.S. experience significant back pain at some point in their life and most back pain sufferers find no relief. In fact, low back pain (LBP) is a challenging condition to treat and one of the most common health problems in the United States for a host of reasons including obesity, an aging population, job related activities or inactivity, and smoking. And, unlike Réjuve, most minimally invasive treatments being used today, such as steroid injections or nerve blocks, are temporary and palliative. So, acute and chronic back pain continues to be a growing part of the US health landscape.