Cerapedics announced the completion of enrollment for the ASPIRE study, a pivotal FDA Investigational Device Exemption study, evaluating the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery to treat degenerative disc disease.
P-15L Peptide Enhanced Bone Graft, which has been granted Breakthrough Device Designation by FDA, is Cerapedics’ next-generation P-15 technology platform candidate.
ASPIRE is a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study involving 290 subjects, including high-risk patients, across 36 clinical trial sites in the U.S. Outcomes will be evaluated at six months through a two-year follow-up.
“We want to thank all the patients, investigators, and their research teams who are participating in the ASPIRE study. Their hard work and dedication have resulted in a timely enrollment amid challenging circumstances presented by the COVID-19 pandemic. This speaks volumes about the interest to investigate the potential clinical benefits of the P-15L Bone Graft,” said Glen Kashuba, Chief Executive Officer.
Cerapedics announced the completion of enrollment for the ASPIRE study, a pivotal FDA Investigational Device Exemption study, evaluating the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery to treat degenerative disc disease.
P-15L Peptide Enhanced Bone Graft, which has been granted...
Cerapedics announced the completion of enrollment for the ASPIRE study, a pivotal FDA Investigational Device Exemption study, evaluating the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery to treat degenerative disc disease.
P-15L Peptide Enhanced Bone Graft, which has been granted Breakthrough Device Designation by FDA, is Cerapedics’ next-generation P-15 technology platform candidate.
ASPIRE is a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study involving 290 subjects, including high-risk patients, across 36 clinical trial sites in the U.S. Outcomes will be evaluated at six months through a two-year follow-up.
“We want to thank all the patients, investigators, and their research teams who are participating in the ASPIRE study. Their hard work and dedication have resulted in a timely enrollment amid challenging circumstances presented by the COVID-19 pandemic. This speaks volumes about the interest to investigate the potential clinical benefits of the P-15L Bone Graft,” said Glen Kashuba, Chief Executive Officer.
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