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Sonoma Pharmaceuticals Gains FDA Clearance for Enhanced Microcyn Hydrogel

• Sonoma Pharmaceuticals has received FDA 510(k) clearance for its Microcyn-based hydrogel, enhancing its wound care applications. • The new clearance includes improved biocompatibility and extends the product's shelf life to 24 months for 50mL bottles. • Microcyn Hydrogel is approved for managing wounds, burns, diabetic ulcers in professional settings, and minor skin irritations over-the-counter. • This regulatory milestone positions Sonoma in the $8.6 billion global wound care market, expanding its reach to both institutional and retail sectors.

Sonoma Pharmaceuticals (NASDAQ:SNOA) has secured FDA 510(k) clearance for its Microcyn technology-based hydrogel, marking a significant advancement in wound care management. The clearance encompasses enhanced biocompatibility and an extended 24-month shelf life for the 50mL formulation, broadening the product's utility in both clinical and consumer settings. This development allows healthcare professionals to utilize Microcyn Hydrogel for managing wounds, dermal irritations, first and second-degree burns, and diabetic ulcers, while also providing an over-the-counter (OTC) option for minor skin irritations, lacerations, abrasions, and sunburns.

Enhanced Biocompatibility and Shelf Life

The updated 510(k) clearance involved more stringent biocompatibility testing, ensuring the hydrogel meets high safety standards. The extended shelf life to 24 months enhances the product's practicality for healthcare providers and consumers alike, reducing waste and improving cost-effectiveness.

Clinical and Over-the-Counter Applications

Microcyn Hydrogel is now indicated for use under the supervision of healthcare professionals for managing wounds associated with dermal irritation, sores, injuries, ulcers, first and second-degree burns, diabetic ulcers, and mechanically or surgically debrided wounds. Its OTC applications include relief from minor skin irritations, lacerations, abrasions, and minor burns, including sunburns.

Executive Insight

"This new 510(k) clearance from the FDA demonstrates the superior safety and efficacy of Sonoma's wound care products," said Amy Trombly, CEO of Sonoma. "Our Microcyn technology-based hydrogel is effective for the management of both wounds and skin irritations, and we are pleased to see it has passed the more rigorous testing required by the FDA. Our commitment to innovation and the high standards we set for our products sets us apart in the industry."

Market Positioning

Sonoma Pharmaceuticals' Microcyn Hydrogel is poised to compete in the $8.6 billion global wound care market. The dual professional and OTC pathways could facilitate market penetration across institutional and retail sectors. However, significant marketing investments will be necessary to gain a substantial market share, given the competitive landscape.
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Reference News

[1]
Sonoma Pharma Secures FDA Clearance for Enhanced Wound Care Hydrogel Technology
stocktitan.net · Nov 11, 2024

Sonoma Pharmaceuticals received new FDA 510(k) clearance for Microcyn-based hydrogel with improved biocompatibility and ...

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