Examining the body of law Created by the U.S. Government

U.S. Federal Law

Subscribe to U.S. Federal Law: eMailAlertsEmail Alerts newslettersWeekly Newsletters
Get U.S. Federal Law: homepageHomepage mobileMobile rssRSS facebookFacebook twitterTwitter linkedinLinkedIn

U.S. Federal Law Authors: Jason Bloomberg, marlin xp, Maureen O'Gara

Related Topics: U.S. Federal Law

News Feed Item

Study Supports Use of Cerapedics i-FACTOR™ Biologic Bone Graft as Alternative to Autograft in Common Spine Surgery for Chronic Back Pain

Results published in International Journal of Spine Surgery.

WESTMINSTER, Colo., Feb. 17, 2015 /PRNewswire/ -- Cerapedics, a privately-held orthobiologics company, today announced results of a study examining the efficacy and safety of the company's i-FACTOR™ biologic bone graft in posterior lumbar interbody fusion (PLIF), a common spine surgery to relieve chronic back pain. During the study, bridging bone inside hollow disc cages in the spine developed earlier with the use of i-FACTOR™ biologic bone graft when compared to autograft, while average pain decreased and function improved. Researchers led by Dr. Philippe Lauweryns, orthopedic surgeon at Sint-Trudo Ziekenhuis hospital in Belgium, concluded i-FACTOR™ biologic bone graft may be a viable alternative to autograft in PLIF procedures.

"There are alternatives to autograft and its associated risks, some of which may be more effective in the formation of bridging bone," said Dr. Lauweryns. "This study suggests that i-FACTOR™ biologic bone graft may have equal or greater efficacy at six and 12 months following PLIF procedures, and pain and functional improvements exceeded success criteria."

i-FACTOR™ biologic bone graft features synthetic small peptide (P-15) technology that supports bone growth through cell attachment and osteoblast differentiation. Dr. Lauweryns studied 40 patients undergoing PLIF surgery and assessed their progress using radiographs, CT scans, the Visual Analog Scale (VAS), and Oswestry Disability Index (ODI).

After six months, Dr. Lauweryns found intra-cage bridging bone occurred in 98 percent of patients treated with i-FACTOR™ biologic bone graft versus 59 percent of patients treated with local autograft. On average pain decreased 29 points and function improved 43 points.

"The use of autologous bone grafts in spinal fusion procedures has meaningful limitations including lack of availability of adequate volumes and quality of locally harvested bone. While the harvesting of autologous iliac crest bone can overcome these limitations, it creates the potential for complications including chronic pain and infection," said Glen Kashuba, CEO of Cerapedics. "We continue to lead the effort to identify and develop innovative biologic bone graft products that may replace or augment the use of autograft and this new study shows promise for our proprietary technology in PLIF patients."

Results of the study are published online by the International Journal of Spine Surgery in a paper titled, "Prospective Analysis of a New Bone Graft in Lumbar Interbody Fusion: Results of a 2- Year Prospective Clinical and Radiological Study."

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR™ peptide enhanced bone graft is the only biologic bone graft that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation at a lower cost compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

CAUTION: i-FACTOR™ biologic bone graft is currently not approved for commercial use in any indication in the United States and is limited by U.S. Federal Law to investigational use only.

Media contact:
Adam Daley
Berry & Company Public Relations
[email protected]

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/study-supports-use-of-cerapedics-i-factor-biologic-bone-graft-as-alternative-to-autograft-in-common-spine-surgery-for-chronic-back-pain-300036733.html

SOURCE Cerapedics

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.