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MiMedx Group, Inc. Message Board

  • strut1702 strut1702 Sep 25, 2013 3:28 PM Flag

    FDA implementing recommendations of the Tissue Reference Group?

    From FDA website. Who knew? There are quite a few regarding allografts and section 361 "minimally manipulative." Clues to how the meeting shall go?

    Allogeneic cryopreserved amniotic membrane powder is more than minimally manipulated because processing alters the original relevant characteristics of the tissue relating to its utility for ocular repair and would not be considered a 361 HCT/P

    Allogeneic decellularized, human dermis when extracted to create a solubilized collagen preparation would not be considered a 361 HCT/P because the original relevant characteristics of the dermis related to its utility are altered by the processing and this constitutes more than minimal manipulation.

    Autologous cultured epithelial cells isolated from skin biopsies and processed by a contract manufacturer are considered to be 351 biological products because they are more than minimally manipulated.

    A cartilage allograft that is homogenized is more than minimally manipulated because the processing alters the structural and mechanical characteristics of the tissue relating to its utility for the reconstruction, repair or replacement of cartilage and would not be considered a 361 HCT/P.

    Allogeneic demineralized bone matrix combined with human collagen derived from the same donor is a medical device. Processing of the carrier alters the original relevant characteristics of the demineralized bone matrix and this constitutes more than minimal manipulation.

    Allogeneic decellularized dehydrated amniotic membrane advertised for improved wound healing of venous ulcers on the leg in conjunction with compression therapy is considered to be a biological product subject to investigational new drug applications (INDs) and biologic license applications (BLAs) because processing would have a meaningful bearing on how the tissue performs, thereby altering the original relevant characteristics of the HCT/P and constituting more than minimal manipulation.

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    • Well the key for the MiMedx tissue grafts is the fact that they have proven they do not "decellularize" the grafts when processing. That is why EpiFix and AmnioFix were never questioned.

    • Government agencies don't need or use scientific data when developing regulatory rules. An employee is charged with developing rules/guidelines and that person often lacks expertise, but doesn't et that get in the way of establishing guidelines. I remember years ago OSHA decided they were going to heavily regulate dentistry with new rules. They even called the autoclave an industrial boiler, saying it could blow up and cause injury. Their reign of tyranny was short lived when Charlie Norwood, who oversaw their funding, told them to clean up their act or else.

    • Umbilical cord stem cells treated with enzyme to increase engraftment are considered biological products and are subject to INDs and BLAs because this processing constitutes more than minimal manipulation.

      Allogeneic dehydrated and decellularized amniotic membrane is considered to be a minimally-manipulated 361 HCT/P when the product is intended to be used as a wound covering. When intended for wound repair or wound healing, additional characteristics of the HCT/P are relevant (e.g., the presence of cytokine-containing cells). Since dehydration and decellularization alter these relevant characteristics, dehydration and decellularization constitute more than minimal manipulation and the product, when intended for wound repair or wound healing, would not be considered a 361 HCT/P (clarification of 2003 recommendation).

      Allogeneic decellularized urinary bladders for replacement of damaged bladder tissue is not considered a 361 HCT/P because they are more than minimally manipulated.

      Cultured allogeneic skin cells applied with gauze are considered a 351 biological product because they are more than minimally manipulated.

      Autologous cultured epithelial cells isolated from skin biopsies and processed by a contract manufacturer are considered to be 351 biological products because they are more than minimally manipulated.

      • 1 Reply to strut1702
      • My assumption (I know its limitations) is that before management claimed the 361 exception, they relied on experienced professionals who had insight into how the FDA would rule on the micronized product. Their reliance must have been well founded as the December FDA letter did not take exception with their marketing injectables. To this economics major, it sure seems that micronizing placental tissue is more than minimally manipulating it but I'm counting on the reliance by the company on experts who are paid to know the difference.

 
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