Four things to know:
1. Ortho RTi began a 6-month preclinical study in January to provide data and address FDA requirements to finalize the phase I/II procedures.
2. The in-life portion of the study and its data is completed.
3. Final reporting and IND requirements related to manufacturing and stability are expected in the fall.
4. The IND filing is expected by the end of the fiscal year.
More articles on biologics:
Misonix ultrasonic device earns CE Mark approval — 4 insights
Laser Spine Institute co-founders now owe ex-business partner $300M+, judge rules
Academic panel to define best practices for outpatient stem cell procedure
