Companies
Biocoat
continues to innovate with a non-PFAS lumen coating method and its HYDAK hydrophilic coating line for guidewires and peripheral vascular devices, responding to regulatory pressure to eliminate PFAS from medical surfaces.
- Country
- United States
Non-PFAS coating
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Coverage
| CN | EU | US | |
|---|---|---|---|
| diagnostics-medtech | — | ✓ | ✓ |
| regenerative-personalized | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | Strategic investment by GTCR in November 2022 | preqin.com · prnewswire.com |
| Headquarters | Horsham, Pennsylvania, United States | ceocfointerviews.com · gtcr.com |
| Production site | Horsham, Pennsylvania (HQ) and Copenhagen, Denmark (new European facility) | specialchem.com |
| Certification | ISO 13485 certified facility | biocoat.com |
| Regulatory approval | HYDAK UV technology has gained FDA 510(k) clearance for use on devices | ceocfointerviews.com · preqin.com |
Independent sources: ceocfointerviews.com · gtcr.com · preqin.com · prnewswire.com · specialchem.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Biocompatible coatings for medical devices | diagnostics-medtech | Low | → |
| Medical devices with biointerface | regenerative-personalized | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
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