03.26.14
Cesca Therapeurtics Inc. has submitted a pre-IDE (Investigational Device Exemption) information packet to the U.S. Food and Drug Administration (FDA) for the use of the Surgwerks CLI therapy designed to treat no-option patients with late stage critical limb ischemia (CLI).
“In conjunction with the pre-IDE package, we have requested a meeting with the FDA during the summer of 2014 to work cooperatively on the clinical and regulatory plan of the pivotal trial,” said CEO Matthew Plavan. “The pre-IDE submission with the FDA is a significant milestone on our path to advance SurgWerks-CLI towards commercialization in the United States. Following feedback from the upcoming meeting with the FDA, we plan to initiate the pivotal clinical trial for Surgwerks-CLI in multiple U.S.-based hospital sites.”
The Surgwerks collection of therapy kits are intended to contain all of the devices, ancillary drugs and reagents for harvesting, manufacturing (selecting and concentrating), testing and redelivering the appropriate effective dose to the patient in under 60 minutes for whatever indication that particular kit is appropriate for.
The pre-IDE documentation has been submitted to the FDA in order to obtain the agency’s guidance on several key criteria regarding the regulatory pathway; the proper approach to refine the clinical and statistical plan considering the no-option status of the prospective subjects; the consideration of the combination of several devices into a single kit to ensure proper dosing and quality; and to ensure Cesca Therapeutics is working closely and cooperatively with the FDA review team. The basis for pre-IDE submission is data from an analysis of the 17-patient dataset collected in Cesca’s feasibility/Phase Ib trial announced this past January. Pre-IDE submissions and meetings are strictly voluntary and any comments or recommendations made in the review of protocols or during these meetings are not binding on the FDA or the company.
Cesca Therapeutics is focused on autologous cell-based therapeutics for use in regenerative medicine.
“In conjunction with the pre-IDE package, we have requested a meeting with the FDA during the summer of 2014 to work cooperatively on the clinical and regulatory plan of the pivotal trial,” said CEO Matthew Plavan. “The pre-IDE submission with the FDA is a significant milestone on our path to advance SurgWerks-CLI towards commercialization in the United States. Following feedback from the upcoming meeting with the FDA, we plan to initiate the pivotal clinical trial for Surgwerks-CLI in multiple U.S.-based hospital sites.”
The Surgwerks collection of therapy kits are intended to contain all of the devices, ancillary drugs and reagents for harvesting, manufacturing (selecting and concentrating), testing and redelivering the appropriate effective dose to the patient in under 60 minutes for whatever indication that particular kit is appropriate for.
The pre-IDE documentation has been submitted to the FDA in order to obtain the agency’s guidance on several key criteria regarding the regulatory pathway; the proper approach to refine the clinical and statistical plan considering the no-option status of the prospective subjects; the consideration of the combination of several devices into a single kit to ensure proper dosing and quality; and to ensure Cesca Therapeutics is working closely and cooperatively with the FDA review team. The basis for pre-IDE submission is data from an analysis of the 17-patient dataset collected in Cesca’s feasibility/Phase Ib trial announced this past January. Pre-IDE submissions and meetings are strictly voluntary and any comments or recommendations made in the review of protocols or during these meetings are not binding on the FDA or the company.
Cesca Therapeutics is focused on autologous cell-based therapeutics for use in regenerative medicine.