FDA REGULATIONS BIOLOGIC / 361 VS 351

Don F. Palme II, Ph.D., Sr Principal Product Development Strategist, Medical Research Scientist, Regulatory, NAMSA. His opinion is as follows:

Based on the wording and examples provided, Use of the Markman Surfacing Device does not change the risk or material, formulation or chemical composition of the materials. Based on this analysis, the changes induced by the Markman Surfacing Device does not reach the level of change considered a major change to the device so resubmission of the device should not be required. A letter to the device file describing the change(s) and justification of regulatory position should address the regulatory requirements.

HUMAN CLINICAL TRIALS: PHASE 1

BURN RECONSTRUCTION AFTER ACUTE INJURY 

• Study : In deep second and third degree burns the trial will test the clinical efficacy of Microsurfaced Cadaveric Grafts to establish burn wound healing in partial-thickness burns and wound bed preparedness for transfer of autogous skin in deep-partial and full-thickness burn wounds as compared to Control Smooth Cadaveric Grafts over a 6-week treatment period.  Clinicaltrials.gov Identifier  :   NCT04589442 

• Study : In superficial second degree burns the trial will  test the clinical efficacy of Microsurfaced Cadaveric Grafts to establish burn wound healing in partial-thickness burns and wound bed preparedness for possible skin transfer  in partial thickness burn wounds as compared to Control Smooth Cadaveric Grafts over a 4-week treatment period.

• In both Trials, there will be a period of follow up after to evaluate healing and scarring.

DENTAL SURGERY

• Study : The objective of this trial is to evaluate clinical healing outcomes of Microsurfaced cadaveric ADM (Acellular Dermal Matrix)  used in sites with gum recession  as compared to control cadaveric Smooth ADM.     Clinicaltrials.gov Identifier  :   NCT04614350 

HUMAN CLINICAL TRIALS: PHASE 2

DENTAL SURGERY

• Study : The objective of this trial is to evaluate clinical healing outcomes of Microsurfaced cadaveric ADM (Acellular Dermal Matrix)  used in sites with Dental implants as compared to control cadaveric Smooth ADM over.

dHAC  RECONSTRUCTION SURGERY

• Study : The objective of this pilot is to evaluate clinical healing outcomes of Microsurfaced  dHAC (decellular Human Amnion Chorion)  used for reconstruction as compared to control Smooth dHAC.