Renuva Scientific Timeline

In-Vitro Study

Kokai et al. (2019) Injectable Allograft Adipose Matrix Support Adipogenic Tissue Remodeling in the Nude Mouse and Human

Objective | Bench top tests to make sure cells will respond to Renuva and function.

Methodoloy | Adipose-Derived Stem Cells were layered on top of the matrix to simulate what happens in the body.

0 Days

Scanning Electron Microscope (SEM) picture of Renuva honeycomb structure (no cells added)

< 7 days

Red staining of the cell cytoskeleton indicates cell attachment and infiltration in the adipose scaffold

7 - 14 Days

ADSCs differentiate into adipocytes, secrete matrix proteins (SEM) (left) and accumulate intracellular lipid (green fluorescence = Bodipy, stains for lipid) (Blue fluorescence = DAPI – strain for nuclei) (right)

Result | Confirmation that the matrix supports the repopulation of adipocytes.

In-Vivo Study

Kokai et al. (2019) Injectable Allograft Adipose Matrix Support Adipogenic Tissue Remodeling in the Nude Mouse and Human

Objective | In vivo verification that Renuva supports blood vessel formation and adipogenesis.

Methodoloy | Renuva was injected subcutaneously in athymic mice and evaluated histologically at 24 weeks.

24 Weeks

presence of adipocytes in the injected material

24 Weeks

adipogenesis confirmed with perilipin A

Result | Angiogenesis was observed initially. Adipogenesis was evident for up to 24 weeks.

Dorsal Wrist Study

Kokai et al. (2019) Injectable Allograft Adipose Matrix Support Adipogenic Tissue Remodeling in the Nude Mouse and Human

Objective | Assess Renuva safety, short term volume retention, local skin changes, subcutaneous fat changes.

Methodoloy | Dr. Sydney Coleman and Dr. Roger Khouri perform clinical, and local injection site assessments. Study conducted over 16 weeks.

Single injection in dorsal wrist (2.5-5.5cc).

Hematoxylin and eosin (H&E - left) and Perilipin A (right) staining of a tissue biopsy at 16 months confirmed the presence of clusters of adipocytes where Renuva had been injected.

Result | No significant adverse events. All patients presented apparent thickening and enhancement of quality of the skin through completion. The prominence of veins and tendons diminished after injection and up to a year for returning patients.

Panniculectomy Study

Kokai et al. (2020) Clinical Evaluation of an Off-the-Shelf Allogeneic Adipose Matrix for Soft Tissue Reconstruction.

Objective | Evaluate the remodeling of Renuva injected into the subcutaneous tissues.

Methodoloy | 6 injection sites per patient (20cc each).

Result | Renuva can be injected as a 20cc bolus and still be populated - unlike fat. Renuva is easy to use, off-the-shelf, safe, and remodels into adipose tissue.

Temple Study

Gold et al. (2020). A multi-center, open-label, pilot stud of allograft adipose matrix for the correction of atrophic temples. J Cosmet Dermatol.

Objective | Evaluate clinical safety and retention of Renuva following injection in patients with bilateral atrophic temples.

Methodoloy | Up to 3cc injected per temple. Dr. Gold, Dr. Kinney, Dr. Kaminer and Dr. Rohrich evaluted results over 24 weeks.

Result | Renuva is safe and well-tolerated in the face. Adipogenesis and angiogenesis was observed, along with improved skin quality. Retention at least 6 months.

Face Study

Manuscript in preparation.

Objective | Evaluate skin quality before and after Renuva injection. Evaluate longevity of result for up to 24 weeks. Evaluate safety for up to 24 weeks.

Methodoloy | Up to 2cc (malar), 2cc (pre-jowl), re-injection option at 12 weeks up to 1cc each. Half of the patients Half of the patients were treated with a regular concentration of Renuva and half with a diluted concentration of Renuva. 6 month follow-up.

Clinical Studies

4 prospective clinical studies as of today

  • Renuva has been demonstrated to be safe in all studies
  • Angiogenesis and adipogenesis have been observed
  • Volume correction retained up to 6 months
  • Continuing investment and new studies being designed and initiated.

Retrospective studies for craniofacial applications,
continuing investment

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