The Next Generation of Soft Tissue Support

The Galatea scaffold collection is designed to provide immediate soft tissue support, allow robust tissue ingrowth, and bioresorb in a predictable, steady manner. The ingrown tissue remodels and gains strength over a period of months. Therefore, it is important that the scaffold retains sufficient strength during the tissue regeneration process, such that the critical strength loss as the scaffold degrades is offset by tissue ingrowth and remodeling. Through a gradual process, the mechanical loads initially borne by the scaffold can be transitioned to new, well vascularized tissue.

Watch the Galatea Scaffold Collection Overview.

Preclinical studies have indicated that Galatea scaffold starts out strong and maintains about 70% of its strength at 12 weeks in vivo and is essentially fully resorbed by 18-24 months. [7]

After implantation, the biomaterial distributes the mechanical load across a large surface area for a strong surgical repair during the critical healing period.

Over time, Galatea scaffold slowly and predictably bioresorbs concurrent with tissue ingrowth. This regenerative mechanism of Galatea scaffold has resulted in a repair that is 3 to 5 times stronger than the tissue prior to the procedure. [7,15]

Galatea repair strength graph

Galatea scaffold degrades primarily by bulk hydrolysis wherein water molecules diffuse into the P4HB™ polymer, and cleave the polymer chains. [23]

Hydrolysis cross-sectionAn enzyme catalyzed hydrolysis may cause a small amount of surface erosion initially; however, the dominant bulk hydrolytic pathway results in a predictable steady loss of polymer molecular weight and decrease in strength retention over time. P4HB degrades into 4-hydroxybutyrate (4HB), a natural metabolite present in humans and other animals, as well as certain foods. In the mammalian body, 4HB is found in a wide variety of tissues, including brain, heart, kidney, liver, lung, muscle and brown fat. [25] Its half-life of just 27 min is relatively fast, [26] and means that 4HB released from a degrading implant of P4HB will be rapidly metabolized. The metabolism of 4HB has been well studied. 4HB is catabolized via the Krebs cycle (also known as the citric acid cycle or tricarboxylic acid cycle), and is broken down in vivo and eliminated as carbon dioxide and water. Consequently, P4HB implants such as Galatea scaffold are completely transitory with no polymer metabolites remaining after the degradation process is complete.[33]

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