Tag: Cerapedics
Cerapedics files final module of PMA application for new P-15 peptide...
Cerapedics has today announced that it has filed the final module in a premarket approval (PMA) application with the US Food and Drug Administration...
Cerapedics announces long-term data from pivotal study of i-FACTOR bone graft
Cerapedics has announced long-term follow-up data from its pivotal investigational device exemption (IDE) study of the i-FACTOR peptide-enhanced bone graft. Published data demonstrate fusion...
Cerapedics completes enrolment of pivotal IDE study for P-15L bone graft
Cerapedics has announced that it has completed enrolment of the ASPIRE study—a pivotal US Food and Drug Administration (FDA) investigational device exemption (IDE) study—which...
i-FACTOR peptide enhanced bone graft is cost-effective compared to local autograft...
Cerapedics has announced the publication of the results of a study to evaluate the cost-effectiveness of i-FACTOR peptide enhanced bone graft compared to autograft...
Cerapedics granted breakthrough device designation for P-15L bone graft
Cerapedics has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its investigational P-15L bone...
i-FACTOR clinical results show higher fusion rate compared to allograft
Cerapedics has announced the publication of results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery in The...
Cerapedics announces FDA approval of PMA supplement based on two-year clinical...
Cerapedics today announced that the US Food and Drug Administration (FDA) has approved the company's premarket approval (PMA) supplement for i-FACTOR peptide enhanced bone...
Cerapedics announces expansion of Colorado headquarters
Cerapedics has announced the expansion of the company's headquarters located in the Denver metropolitan area. Over the past 18 months, Cerapedics has grown from...
ISASS bone grafting policy statement features i-FACTOR peptide enhanced bone graft
The International Society for the Advancement of Spine Surgery (ISASS) recently issued a new bone grafting policy that features i‑FACTOR peptide enhanced bone graft...
Cerapedics announces first patients enrolled in IDE clinical trial of P-15L...
The first patients have been enrolled in an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the next-generation P-15L peptide...
Cerapedics announces closing of US$22 million financing
Cerapedics has announced that the company completed a US$22 million financing led by KCK Group, a family investment fund that focuses on innovative medical...
Use of i-FACTOR peptide enhanced bone graft more than doubles fusion...
The use of i-FACTOR peptide enhanced bone graft (Cerapedics) resulted in a 50% fusion rate, compared to a 20% fusion rate using allograft in...
Cerapedics receives FDA approval to initiate IDE study of P-15L bone...
Cerapedics, a privately-held orthobiologics company, has announced the company received approval from the US Food and Drug Administration (FDA) to initiate an investigational device...
i-FACTOR™: Small peptide, big impact
This article is sponsored by Cerapedics, Inc.
A FAST, RELIABLE AND PROVEN ALTERNATIVE TO AUTOGRAFT
i-FACTOR peptide-enhanced bone graft is challenging the gold standard in bone...
Peptide-enhanced bone graft outperforms autograft at two years
A prospective, multicentre trial has found that a peptide-enhanced bone graft is non-inferior compared to local autograft bone. In addition, the bone graft outperformed...
Two-year results show statistical superiority of Cerapedics’ I-Factor to autograft in...
Cerapedics has announced the publication of two-year follow-up data from a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial of...
Cerapedics awarded group purchasing agreement with Premier for I-Factor
Cerapedics has been awarded a group purchasing agreement with Premier, a healthcare improvement company.
The new agreement allows Premier members, at their discretion, to take...