Cytophil and Merz Settle Patent Dispute

MILWAUKEE, July 1, 2019 /PRNewswire/ -- Merz North America, Inc. and Cytophil, Inc. announced that they have reached an agreement settling all claims between them.  As part of the settlement, Merz has granted Cytophil's Renu® Voice product a royalty-bearing license to U.S. Patent No. 6,537,574 for the remaining ten months of the patent.  In addition, the two companies have agreed to an immediate dismissal of all pending litigation and have released each other from all existing legal claims.

Cytophil is represented by Jansson Munger McKinley & Kirby Ltd. of Racine, Wisconsin.

Cytophil's wholly-owned RegenScientific unit has been selling the FDA-cleared Renu® Voice in the United States for several years.  Renu® Voice is a resorbable implant for long-term vocal fold augmentation in patients with vocal fold paralysis. Another injectable, Cytophil's Renu® Gel, is for short-term vocal fold augmentation in patients with suspected vocal fold paresis, or as a trial injectable prior to long-term therapy with Renu® Voice.

In the United States, Cytophil's exclusive distribution partner is InHealth, a company with a long and deep commitment to ENT physicians and their patients.

Cytophil President and CEO Greg Johnson said, "We are a customer and patient focused company, and we are pleased to provide the highest quality and most cost-effective products available to ENT doctors and their patients in the United States.  We are excited also to be in Europe and to be expanding the future availability of our ENT products to physicians and patients around the world."

Mr. Johnson continued, "InHealth Technologies, a Freudenberg Medical LLC company, is the exclusive US distributor for our ENT products.  They are a strong ENT business partner, and we look forward to expanding our collaboration to include the care of ever more patients in the future."

Bethany Anke, Vice President & General Manager, InHealth Technologies, FREUDENBERG, Freudenberg Medical, said, "InHealth is pleased to be exclusive US distributor for Renu® Voice and Renu® Gel and to continue collaborating with Cytophil to serve the needs of laryngologists and their patients."

In Europe, Renu® Voice is distributed by Soluvos BV of the Netherlands.

Cytophil's Renu® Dermal Filler has European regulatory approval for aesthetic soft tissue augmentation and is currently available in Europe via Netherlands-based RegenScientific BV.

Cytophil is "fully committed" to obtain clearance for the same aesthetic uses in the United States, said Mr. Johnson of Cytophil.  "We have started work with the FDA to secure the Investigational Device Exemption (IDE) required for a US clinical trial and are currently looking for US investigators."

About REGENSCIENTIFIC:

REGENSCIENTIFIC, a wholly owned business unit of Cytophil, Inc., an ISO 13485 certified company, is dedicated to providing physicians and patients with high-quality, safe, efficacious, and cost-effective tissue augmentation implants. The company has CE-Mark for its Renú^® Soft Tissue (Volumizing) Implant for Lipoatrophy, Vocal Fold Insufficiency and Soft Tissue Augmentation in Europe. The Company has FDA 510k clearances for its Renú^® Gel and Renú^® Voice otolaryngology products indicated for vocal fold injection augmentation.  Renú^® is a registered trademark of Cytophil, Inc. REGENSCIENTIFIC™ and the REGENSCIENTIFIC logo, RegenOsteo™ and RegenPerio™ are trademarks of Cytophil, Inc.

Contact REGENSCIENTIFIC - Cytophil, Inc.:

Greg Johnson
President / Chief Executive Officer
Tel: (262) 215-6779
Email: [email protected]

SOURCE REGENSCIENTIFIC

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