BETA
Israeli wound-care company commercializing SilverStream solution and gel for wound management and moisturizing, with prescription and OTC labeling.
SilverStream Medical, formerly EnzySurge, is an Israeli wound-care company founded in 2001 by Prof. Amihay Freeman. Its current public company profile lists Caesarea as headquarters; earlier regulatory records use Rosh Ha’Ayin. Eyal Nouri serves as co-owner and CEO.
The current human-care portfolio includes SilverStream Solution and SilverStream Gel, supported by U.S. 510(k) decisions from 2009 and 2020. Prescription labeling includes specified chronic and postsurgical wounds, while OTC labeling concerns minor wounds. The company also describes international distribution and veterinary formulations, which are outside this profile’s U.S. human-device counts.
SilverStream was named one of three winners of the 2026 ADA Innovation Challenge. Its published evidence collection includes small observational reports and case studies; these require separate assessment from marketing claims about infection prevention, faster healing and limb preservation. Current revenue and verified financing totals remain unconfirmed.
Solution K093227 and gel K200767 were filed by EnzySurge. FDA decision letters identify unclassified FRO wound-dressing devices; chronic wound indications apply to prescription use, while OTC labeling is limited to minor wounds. [22][20][1][6][5][21][16][19][2]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [11][8]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Hypertonic aqueous wound-management formulation containing a surfactant and silver preservative. Current sterile bottle formats include 100, 250 and 500mL. Rx and OTC labeling differ. [22][18][1][17][16]
FDA-clearedMarketed in current human wound-care portfolio; country-specific availability and label apply.
Gel formulation for wound management and maintaining moisture between dressing changes. The silver component acts as a preservative; the clearance does not establish all antimicrobial treatment claims. [19][20]
FDA-clearedMarketed in current human wound-care portfolio; country-specific availability and label apply.
Older EnzySurge dressing permits introduction of topical wound treatments while supporting a moist healing environment. Current commercial supply is not established. [21]
Commercial availability not establishedEarlier clearance verified; current supply unconfirmed.
Company activity includes geographic expansion and research around wound care and surgical-site infection prevention. A company-hosted six-person observational report does not establish comparative effectiveness or universal infection resolution. ADA recognition reflects innovation selection rather than clinical endorsement. [17][23][19]
ADA’s own coverage identifies SilverStream among three winners at the June 6, 2026 event. Recognition is not FDA authorization or proof of reduced amputations. [23]
K200767 cleared SilverStream Gel for prescription and OTC wound management and moisturizing uses. [20]
K093227 covers SilverStream prescription and DermaSept OTC solution with different labeled-use scopes. Current Silverstream OTC listing links to this decision. [22]
K060046 cleared an occlusive dressing system. Its current portfolio status remains unresolved. [21]
Company traces its origins to Amihay Freeman’s establishment of EnzySurge in 2001. [15]
Accessed 10/20/2026