WESTMINSTER, Colo., Oct. 17, 2023 /PRNewswire/ — Cerapedics Inc., a commercial-stage orthopedics firm devoted to redefining the usual of take care of bone restore, in the present day introduced long-term follow-up knowledge from its pivotal IDE examine of i-FACTOR Peptide-Enhanced Bone Graft. Printed knowledge demonstrated fusion charges in single-level Anterior Cervical Discectomy and Fusion (ACDF) of 98.6% after six years in sufferers handled with i-FACTOR and reinforces Cerapedics’ dedication to capturing long-term medical proof. Specifically, the outcomes additional assist the security and efficacy profile of i-FACTOR at one and two years, as revealed in Backbone and Neurosurgery.
i-FACTOR has confirmed statistical superiority vs. native autograft in general success* at one and two-year endpoints for single-level ACDF. i-FACTOR additional demonstrated spine fusion charges of 89.7%, 97.3%, and 98.6% at one, two, and 6 years, respectively, versus 85.8%, 95.8%, and 97.3% for native autograft, with outcomes revealed in Backbone and Neurosurgery. 220 of the unique 319 sufferers have been noticed over six years or 72 months.
The six-year outcomes, revealed earlier this yr in Neurosurgery, have been primarily based on a single blinded, randomized managed potential examine of i-FACTOR in comparison with native autograft in single-level ACDF, which included a complete of 220 affected person topics with 106 within the i-FACTOR group and 114 within the native autograft management arm. Of the 22 websites from the unique IDE examine, 17 participated on this six-year post- approval examine.
“Clinicians are on the lookout for long-term security and efficacy knowledge to assist decision-making concerning the most secure and simplest spine applied sciences,” mentioned Professor Paul Arnold, CARLE Illinois Faculty of Drugs, principal investigator and creator of the examine’s 12-, 24-, and 72-month publications. “On this distinctive long-term follow-up knowledge from a pivotal IDE examine, i-FACTOR met all 4 FDA-mandated non-inferiority success standards and demonstrated security and efficacy in single-level anterior cervical discectomy and fusion in comparison with autograft at 12, 24, and 72 months.”
“These outcomes clearly display the efficacy charges and security profile of i-FACTOR over an prolonged interval and likewise mirror Cerapedics’ dedication to producing the best high quality proof on using our merchandise,” mentioned Valeska Schroeder, Chief Government Officer of Cerapedics. “Mixed with the IDE examine outcomes, these knowledge add to the medical understanding of i-FACTOR’s efficacy and security. Though there are quite a few different bone graft choices, many haven’t undergone the identical stage of testing. This knowledge is impactful for insurance coverage payers who search Stage 1 proof as they make protection choices.”
i-FACTOR is out there within the US by means of a premarket approval. It’s the most stringent sort of system advertising and marketing utility required by the FDA and entails the method of scientific and regulatory evaluate to judge the security and effectiveness of Class III medical gadgets primarily based on Stage 1 medical trials. Cerapedics is at the moment conducting its second medical randomized managed trial for a transforaminal lumbar interbody fusion (TLIF) indication with 290 topics, which is registered on clinicaltrials.gov.
About i-FACTOR Peptide-Enhanced Bone Graft i-FACTOR is a Class III FDA permitted bone graft backed by rigorous Stage 1 human medical knowledge from an IDE examine revealed in Backbone and Neurosurgery. It’s the solely spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, with a exact bone-building mechanism.** i-FACTOR has a demonstrated security profile and is as secure as native autograft in single-level ACDF with confirmed statistical superiority in general success* at one and two years.
i-FACTOR Peptide Enhanced Bone Graft is indicated to be used in skeletally mature sufferers for reconstruction of a degenerated cervical disc at one stage from C3-C4 to C6-C7. i-FACTOR Peptide Enhanced Bone Graft should be used inside an allograft bone ring and with supplemental anterior plate fixation. For extra info, full description of the indication to be used, contraindications, security warnings, and many others. about i-FACTOR , please go to our web site: https://www.cerapedics.com/websites/default/recordsdata/2023-08/40002-07-4percent20Puttypercent20USA.pdf
About Cerapedics Cerapedics is a worldwide, commercial-stage orthopedics firm that aspires to redefine the usual of take care of bone restore by therapeutic bones quicker and at greater charges, with out compromising security, in order that sufferers can dwell their healthiest lives. Bone grafts, together with Cerapedics’ merchandise, are utilized in over 4 million annual spine, orthopedics, trauma, and interventional procedures worldwide. i-FACTOR is a Class III FDA-approved product indicated for single-level ACDF. Cerapedics’ new “P-15 Bone Graft” product is at the moment being evaluated to be used in lumbar interbody fusion by means of ASPIRE, a pivotal medical examine, and has been granted a Breakthrough Gadget Designation by the FDA. Cerapedics is headquartered in Westminster, CO.
For extra info, go to us at www.cerapedics.com.
Media Contact: Ten Bridge Communications TBCCerapedics@tenbridgecommunications.com
*Outlined as assembly Fusion, Operate (Neck Incapacity Index), Neurological and Security endpoints **Floor-bound mechanism of motion