REGRANEX is a recombinant platelet-derived growth factor indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. REGRANEX is indicated as an adjunct to, and not a substitute for, good ulcer care. ​
​
We’re delighted to add Regranex® into the Lynch Regenerative Medicine family! Samuel Lynch, DMSc, DMD, has spent over 30 years studying and perfecting recombinant PDGF – Nature’s most prolific healing protein. Using recombinant technology, we produce a pure, potent, sterile, product that is consistent every time. PDGF is a widely studied growth factor that has been shown to be safe and effective in multiple therapeutic indications. It has been studied in over 1000 published papers and 100+ clinical trials. Recombinant pure PDGF is used in 4 FDA approved medical treatments (GEM 21S®, Augment®, Augment® Injectable, and Regranex®) and over 5 million patients have been treated with PDGF products in the last 15 years.
​
Select Safety Information for REGRANEX® Gel
REGRANEX is the only FDA-approved PDGF indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. REGRANEX is indicated as an adjunct to, and not a substitute for, good ulcer care practices.
Limitations of use:
• The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers.
• The effects of REGRANEX gel on exposed joints, tendons, ligaments, and bone have not been established in humans.
• REGRANEX gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.
​
Contraindication: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.
Warnings and Precautions: The benefits and risks of treatment should be carefully evaluated before prescribing in patients with known malignancy.
If application site reactions occur, consider the possibility of sensitization or irritation caused by parabens or metacresol. Interrupt treatment and evaluate (e.g. patch testing) as appropriate.
For complete product information, please see the REGRANEX Full Prescribing Information.​