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Regenscientific obtains CE mark approval for Renú soft tissue implant

Regenscientific has obtained CE mark approval for its Renú soft tissue (volumising) implant to treat lipoatrophy, vocal fold insufficiency and soft tissue augmentation.

The approval allows the firm to market the implant in 32 member states of the European Union, as well as seven cooperating countries of the European Economic Area and other countries hat accept CE mark.

Renú injectable implant was developed based on bio-ceramic particles of Calcium Hydroxyapatite (CaHA), which are claimed to offer better augmentation effect.

The CaHA particles are said to suspend in a buffered hydrogel, which facilitates easy injections.

The company has filed an investigational device exemption (IDE) application with the US Food and Drug Administration (FDA) for Renú, and plans to begin clinical study of Renú for aesthetic medicine in 2016 to get FDA approval.

Regenscientific CEO Dr William Hubbard said: "Our organization is patient focused in everything we do, and this includes making high-quality cost-effective products available to physicians who practice aesthetic medicine and otolaryngology, and to our ultimate customers: their patients."

The firm will also unveil Renú filler for aesthetic medicine at the IMCAS World Congress in Paris, France, which will be held from 28 to 31 January 2016.

In addition, the company will introduce its Renú otolaryngology products in Europe at various congresses and events in 2016.