WHAT IS PHASIX™ MESH?

Phasix™ Mesh is a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived, fully resorbable material.

• Monomer form (4HB) is a naturally occurring human metabolite found in the brain, heart, liver, kidney, and muscle
• Predictably resorbs through hydrolysis, as P4HB metabolizes into biocompatible byproducts (CO₂ and H₂O)¹

^{1 Martin, DP. et al. “ Medical applications of poly-4-hydroxybutyrate:a strong flexible absorbable biomaterial. Biochemical Engineering Journal. 2002; December 9.}

THE NEXT PHASE IN HERNIA REPAIR

Repairs ^*
The open monofilament mesh scaffold provides early integration and repair strength^*

Remodels^*
Preclinical testing confirms vascular integration and incorporation, with abundant mature collagen at 52 weeks. Gradually transfers load to native tissue over time^*

Restores^*
As Phasix™ Mesh is remodeled, it is replaced with functional tissue, ultimately resulting in a strong repair at one year^*

^{* Preclinical data on file. Results may not correlate to clinical performance in humans.}

^{1 Preclinical data on file. Results may not correlate to clinical performance in humans.
2 Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.” Surgical Endoscopy 25.5 (2010): 1541-552.
3  Estimated from Standard Curve in (Martin DP, et al. “Characterizationof poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research.  2013; (184): 766-773.}

MATERIAL STRUCTURE¹

Material structure can impact host response.² Consider these features of monofilament versus multifilament structures:

• Monofilament mesh design allows for a prompt fibroblastic response through the open interstices of the mesh¹
• Material designs with complex architecture can have greater surface area and niches that bacteria can use as a haven from tissue ingrowth, neovascularization, antibiotic treatment, and host inflammatory response³
• It has been reported that the surface area of multifilament material is 157% higher than monofilament materials³

^{1 Preclinical data on file; results may not correlate to clinical performance in humans.
2 Amid PK, Shulman AG, Lichtenstein IL, Hakaha M. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archive Chir. 1994; 379(3): 168-71.
3 Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus aureus Infection
Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques. J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.}

TISSUE INCORPORATION¹

Study objective: Evaluate material strength and histopathology of Phasix™ Mesh.

Study design: A 3-centimeter round defect was created in the ventral abdominal wall of 25 Yucatan mini-pigs (average weight 38 kg). Phasix™ Mesh was fixated directly over the defect with SorbaFix™ resorbable tacks. Ball burst testing and histopathology were conducted at 6, 12, 26, and 52 weeks.

Results: Early tissue ingrowth, vascular integration, and incorporation of Phasix™ Mesh into the ventral abdominal wall, plus abundant mature collagen formed around the remaining fibers at 52 weeks.

^{1 Preclinical data on file; results may not correlate to clinical performance in humans.}