BOSTON, June 28, 2023 /PRNewswire/ — Intrinsic Therapeutics, Inc., a medical device company focused on preventing reherniation and reoperation following lumbar discectomy, today has announced the publication of results from a post-market study that the use of Barricaid in high-risk patients results in significantly fewer reherniations and reoperations when compared to patients treated with discectomy alone.
The study, conducted by Nunley, Strenge, et. al compared the results of their 55-patient, single-arm, post-market, study to the 554 patient, level-1, randomized, superiority PMA trial. The results of this study demonstrated a statistically significant reduction of reherniation or reoperation (p<0.05) when utilizing bone-anchored annular closure.
“These study results conclusively show that patients with herniated discs and large annular defects that receive the Barricaid procedure are less likely to suffer reherniation and reoperation than patients treated with discectomy alone. So rarely is scientific evidence reproduced in new studies. These investigators confirmed what the RCT investigators found and, building on their experience, we were able to improve outcomes in our patients,” said Dr. Pierce Nunley, Director of the Spine Institute of Louisiana, and a Principal Investigator in this trial. He continued, “Given these results, patients are further justified in demanding this treatment if properly indicated.”
Dr. K. Brandon Strenge, founder of The Orthopedic Institute of Western Kentucky and Principal Investigator, added, “With the expectation that I can lower the risk of reherniation and get my patients back to their lives faster than if they are not treated with the Barricaid, I now evaluate all of my patients with herniated lumbar discs to determine if they are candidates for the Barricaid procedure.” Strenge noted, “I am thrilled that the results from our study confirmed the benefits found in the tightly-controlled randomized trial that was performed for FDA approval.”
This study also provided evidence that the Barricaid procedure can lower opioid use and costly hospital readmissions by reducing reherniations. Another key metric was that nearly all the Barricaid patients returned to work in under three weeks.
Cary Hagan, CEO of Intrinsic added, “Publication of this study further validates the already robust body of clinical evidence for Barricaid and is the eighth distinct patient population studied and recorded in the scientific literature. There is sufficient evidence to support medical necessity and for payors to remove the label of ‘investigational/experimental’ and differentiate Barricaid from prior annular repair technologies”, as recently recognized by Cigna in their positive coverage policy. “I expect other private insurers will begin to update their coverage policies for Barricaid based on this confirmatory evidence.”
To access the full post-market study, visit https://info.barricaid.com/post-market-study
About Barricaid
Barricaid is a proprietary technology designed to prevent reherniation and reoperation in patients with large annular defects following lumbar discectomy surgery. Barricaid has been implanted in more than ten thousand patients and is supported by clinical studies in 8 distinct patient populations, including two randomized controlled trials and six single armed trials. A multicenter level I RCT demonstrating superior outcomes to discectomy alone with 5-year results was published in JAMA.
In 2019, Barricaid received FDA Pre-Market Approval. In 2020, Centers for Medicare and Medicaid Services (CMS) issued a C-code for hospitals and surgery centers to report for billing and payment, and in late 2022, the Centers for Disease Control issued ICD-10 codes to track and monitor defect size in discectomy patients.
For full benefit-risk information, please visit www.Barricaid.com
Media Contact:
Jake Tanner, VP of Marketing
760-525-9739
[email protected]
Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.
SOURCE Intrinsic Therapeutics, Inc.