Orthobiologics company Cerapedics received FDA approval to reduce the number of patients required for its P-15L bone graft clinical trial.
Four things to know:
1. The company is exploring the safety and efficacy of P-15L in single-level transforaminal lumbar interbody fusion surgery.
2. The number of patients participating in the investigational device exemption study has decreased from 364 to 270 patients, according to Cerapedics President and COO Jeffrey Marx, PhD.
3. Cerapedics hopes the reduced enrolment will result in an earlier premarket approval submission.
4. Results of the company's i-Factor peptide enhanced bone graft clinical trial were featured in The Spine Journal in May. The study showed that older adult patients treated with i-Factor plus local bone achieved a higher fusion rate compared to allograft.