FDA Clears Geistlich’s Particulate Collagen

Geistlich has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its particulate collagen, which will be commercialized in the second quarter under the DermaForm brand by StimLabs, the company’s exclusive U.S. wound care partner.

The two companies’ partnership began with StimLabs’ 2024 appointment as the exclusive distributor of Geistlich’s U.S. wound care portfolio, beginning with the advanced wound matrix Derma-Gide.

DermaForm is a particulate collagen product for chronic and acute wounds, developed and manufactured by Geistlich in Wolhusen, Switzerland. The unique particulate format allows for a versatile application process and conforms to large, irregular, and complex wounds, according to Geistlich.

“Geistlich developed DermaForm by applying our regeneration expertise to expand upon the proven clinical performance of Derma-Gide now with a new particulate form for ease of use,” Geistlich Chief Science Officer Mark Spilker stated.

At the core of the Geistlich-StimLabs partnership is a clear, shared mission: to meaningfully improve the quality of life for people living with complex wounds. “Geistlich has continued to demonstrate their skill in innovation and commitment to quality, which are core values at StimLabs,” StimLabs Founder/CEO John Daniel said. “We look forward to working with them to bring another solution to our patients and providers.”

“DermaForm is the start of building together an attractive portfolio of solutions for clinicians to effectively treat more patients. By leveraging our research innovation with StimLabs’ commercial strength, this partnership is poised to set new standards in regenerative medicine,” Geistlich Vice President of Regenerative Technologies David Wemans added.

Geistlich is a global developer of advanced regenerative medicine solutions. The company also provides comprehensive clinical support in regenerative medicine through scientific research, innovative developments, and educational programs. Geistlich is a Swiss family-owned company with tradition since 1851. With 15 subsidiaries and 120 distributors, the company reaches more than 100 markets and employs around 900 people.