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 periocream-03 |
| Knokke-Heist (Belgium), 11 August 2025, 6:00 a.m.; bonyf NV (Ticker: MLBON), a leader in dental consumer goods, professional dental consumables and dermatological solutions, is preparing to launch Periocream, a groundbreaking dental treatment designed exclusively for dental professionals. At bonyf, we expect our Notified Body to release the final report shortly, confirming the product’s readiness for market. This unique product, protected by a European patent and with a U.S. patent pending, is poised to transform the management of dental procedures. |
| The Periocream 2025 Project, involving 30 patients across multiple clinical centers, demonstrated clinically significant improvements in healing and patient-reported comfort. The unique NitrAdine®-based oxidative mechanism in Periocream effectively disrupts biofilm formation, supporting rapid mucosal recovery and superior post-treatment outcomes. |
| bonyf is currently finalizing the regulatory process to obtain Class IIa Medical Device registration covering the entire European market. Simultaneously, the company will submit Periocream to the U.S. Food and Drug Administration (FDA), with approval expected within approximately five months. |
| Interest in Periocream is already strong, with Dental Depots distributors from five European countries expressing their intention to partner with bonyf for the product’s rollout. In addition, bonyf’s U.S. partner will act as the exclusive importer for the vast U.S. market, while discussions are underway with a major Japanese distributor to cover Japan. |
| Timeline: • Q3 2025: Expected Notified Body approval and European market readiness. • Q4 2025: Commercial launch in initial European countries. • Q1 2026: Anticipated FDA clearance and entry into the U.S. market. • 2026: Expansion to Japan and production under license in India through Group Pharmaceuticals Ltd., enabling large-scale manufacturing and distribution in the Indian and Southeast Asian markets. |
| “This high-end, margin-rich product will change the outlook of our company within 18 months,” stated, Jean Pierre Bogaert, CEO of bonyf. “Periocream represents not only a significant milestone in our R&D pipeline but also a key driver of future growth for bonyf. We are committed to making this the biggest winner in the history of the bonyf group of companies”. |
| bonyf invites investors and partners to join this exciting journey via Euronext Paris under the ticker MLBON. |
| bonyf’s strengths Products with patented formulations Produced in Switzerland compliant with stringent international quality regulations Proven clinical efficacy Commercial presence in 37 countries Prospects for solid growth and rapid profitability A fast-growing oral and dental care market |
| About bonyf bonyf is a European innovator in oral and dermatological care, developing clinically validated solutions for dental professionals, pharmacies, and consumers. Listed on Euronext Paris (MLBON), bonyf is headquartered in Knokke, Belgium, and operates with a growing global presence across Europe, Asia, and the Americas. |
| For more information, visit bonyf.com or contact investor@bonyf.com. |
| bonyf Jean-Pierre Bogaert investor@bonyf.com |
