ZimVie Announces FDA Clearance and U.S. Launch of GenTek® Restorative Components
ZimVie Inc. (Nasdaq: ZIMV) has announced the U.S. launch of its GenTek® Genuine Restorative Components product portfolio, following FDA 510(k) clearance. This launch expands ZimVie's end-to-end prosthetic offerings in the dental market. The GenTek portfolio, first introduced in Europe in 2019, includes Ti-Bases, pre-milled abutment blanks, screws, instruments, and ancillary products for digitally driven CAD/CAM restorations.
Designed to mate with ZimVie implant systems, GenTek components ensure a perfect fit and tight seal for long-term aesthetic and functional restorations. The company anticipates strong demand in the U.S. market, following the product's success in Europe.
ZimVie Inc. (Nasdaq: ZIMV) ha annunciato il lancio negli Stati Uniti della sua linea di Componenti Restorativi Genuine GenTek®, dopo aver ricevuto l'approvazione FDA 510(k). Questo lancio amplia l'offerta di protesi complete di ZimVie nel mercato dentale. Il portafoglio GenTek, presentato per la prima volta in Europa nel 2019, include Ti-Bases, abutment pre-millati, viti, strumenti e prodotti accessori per restauri digitalmente guidati CAD/CAM.
Progettati per adattarsi ai sistemi implantari ZimVie, i componenti GenTek garantiscono una vestibilità perfetta e una tenuta ermetica per restauri estetici e funzionali a lungo termine. L'azienda prevede una forte domanda nel mercato statunitense, in seguito al successo del prodotto in Europa.
ZimVie Inc. (Nasdaq: ZIMV) ha anunciado el lanzamiento en EE. UU. de su cartera de Componentes Restaurativos Generales GenTek®, tras la autorización 510(k) de la FDA. Este lanzamiento amplía la oferta de prótesis integral de ZimVie en el mercado dental. La cartera GenTek, introducida por primera vez en Europa en 2019, incluye Bases de Ti, bloques de soporte premecanizados, tornillos, instrumentos y productos auxiliares para restauraciones CAD/CAM impulsadas digitalmente.
Diseñados para acoplarse con los sistemas de implantes de ZimVie, los componentes GenTek aseguran un ajuste perfecto y un sellado hermético para restauraciones estéticas y funcionales a largo plazo. La empresa anticipa una fuerte demanda en el mercado estadounidense, tras el éxito del producto en Europa.
ZimVie Inc. (Nasdaq: ZIMV)는 GenTek® 정품 복원 구성품 제품 포트폴리오의 미국 출시를 발표했습니다. 이는 FDA 510(k) 승인을 받은 후 이루어진 것입니다. 이번 출시로 ZimVie의 전체적인 치과 프로세틱 제품군이 확대됩니다. GenTek 포트폴리오는 2019년 유럽에서 처음 선보였으며, Ti 베이스, 사전 가공된 어버트먼트 블랭크, 나사, 도구 및 부속 제품들로 구성되어 있습니다.
ZimVie 임플란트 시스템과 결합하도록 설계된 GenTek 구성품은 장기적인 미적 및 기능적 복원을 위해 완벽한 핏과 밀착 seal을 보장합니다. 회사는 유럽에서의 성공을 바탕으로 미국 시장에서 강력한 수요를 예상하고 있습니다.
ZimVie Inc. (Nasdaq: ZIMV) a annoncé le lancement aux États-Unis de sa gamme de Composants Restauratifs Authentiques GenTek®, suite à l'approbation 510(k) de la FDA. Ce lancement élargit l'offre complète de prothèses de ZimVie sur le marché dentaire. Le portefeuille GenTek, introduit pour la première fois en Europe en 2019, comprend des Ti-Bases, des blanks d'abutment pré-usinés, des vis, des instruments et des produits auxiliaires pour des restaurations guidées numériquement par CAD/CAM.
Conçus pour s'adapter aux systèmes d'implants ZimVie, les composants GenTek garantissent un ajustement parfait et un scellement hermétique pour des restaurations esthétiques et fonctionnelles à long terme. La société prévoit une forte demande sur le marché américain, suite au succès du produit en Europe.
ZimVie Inc. (Nasdaq: ZIMV) hat die Markteinführung seiner GenTek® echten restaurativen Komponenten Produktpalette in den USA angekündigt, nachdem die FDA die 510(k) Genehmigung erteilt hat. Dieser Launch erweitert das umfassende Prothesenangebot von ZimVie im Dentalmarkt. Das GenTek-Portfolio, das 2019 erstmals in Europa eingeführt wurde, umfasst Ti-Basen, vorgefräste Abutment-Rohlinge, Schrauben, Instrumente und Zubehörprodukte für digital gesteuerte CAD/CAM-Restaurierungen.
Die GenTek-Komponenten sind so konzipiert, dass sie mit ZimVie-Implantatsystemen kombiniert werden können und gewährleisten eine perfekte Passform sowie eine enge Abdichtung für langfristige ästhetische und funktionelle Restaurierungen. Das Unternehmen erwartet eine starke Nachfrage auf dem US-Markt, nachdem das Produkt in Europa erfolgreich war.
- FDA 510(k) clearance received for GenTek® Genuine Restorative Components
- Expansion of product portfolio with premium prosthetic components
- Enables digital workflows and patient-specific restorations
- Strong demand and success already seen in the European market
- None.
Insights
The FDA clearance and launch of GenTek® Restorative Components in the U.S. signifies a notable expansion for ZimVie. From a financial perspective, this development is likely to enhance ZimVie's revenue stream. The U.S. is the largest market for dental products and tapping into this market can provide substantial sales growth. ZimVie's prior success in Europe with the same product suggests a strong potential for replication of positive results in the U.S. market. Furthermore, FDA clearance adds a layer of credibility and trust to the product, which can be a significant selling point.
However, investors should watch for potential challenges such as market competition and integration into existing dental practices. Monitoring quarterly earnings following this launch will be important to assess the actual financial impact.
The introduction of GenTek® Restorative Components into the U.S. market addresses a key segment of the dental industry – digital workflows and patient-specific restorations. The market for dental implants and restorative components in the U.S. is highly competitive but also lucrative given the aging population and increasing demand for advanced dental care. ZimVie's strategy of broadening their product portfolio aligns well with market trends towards digital dentistry and customizable solutions.
Additionally, ZimVie's established presence and positive reception in Europe could act as a strong precedent, potentially easing market entry barriers in the U.S. Yet, it remains essential to keep an eye on how competitors respond and whether ZimVie can achieve a substantial market share. The adoption rate among dental professionals and feedback from initial U.S. users will be critical indicators to monitor.
From a medical research standpoint, the success of GenTek® Restorative Components in Europe bodes well for its U.S. launch. The components' compatibility with CAD/CAM technology and their promise of a 'genuine connection' ensuring a perfect fit and tight seal, is highly significant. This can lead to better clinical outcomes, increased patient satisfaction and potentially lower failure rates of dental implants. These factors are particularly important in the context of long-term aesthetic and functional restorations.
However, the adoption in the U.S. market will heavily depend on clinical validation and feedback from early adopters. It will be interesting to see peer-reviewed studies and real-world data emerging post-launch, which can further cement the product’s credibility and efficacy.
Addition of Premium Restorative Components Enhances ZimVie’s End-to-End Implant Offerings
PALM BEACH GARDENS, Fla., July 23, 2024 (GLOBE NEWSWIRE) -- ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental market, today announced the U.S. launch of its GenTek® Genuine Restorative Components product portfolio. The launch expands ZimVie’s portfolio of end-to-end prosthetic offerings and follows the recent receipt of FDA 510(k) clearance. ZimVie first launched the GenTek portfolio in Europe in 2019 and has seen tremendous success in that market to date.
The introduction of GenTek to the U.S. market brings a broad offering of differentiated restorative components to the ZimVie product family. The GenTek restorative portfolio is comprised of Ti-Bases, pre-milled abutment blanks, screws, instruments, and ancillary products to support digitally driven CAD/CAM restorations. Manufactured and designed to mate with ZimVie implant systems, the genuine connection* ensures a perfect fit and tight seal to support long-term aesthetic and functional restorations.
“We’re excited to expand our product portfolio with the introduction of GenTek premium prosthetic components, enabling digital workflows and patient-specific restorations for U.S. customers,” said Indraneel Kanaglekar, SVP, Chief Commercial Officer. “We have received excellent feedback and strong demand for GenTek in the European market, and we are optimistic that this product suite will be well received here in the U.S. – the largest market we serve.”
A Media Snippet accompanying this announcement is available by clicking on this link.
About GenTek®
Genuine connection components are designed and manufactured to minimize the micro-gaps and micro-movements for a robust and stable interface between the implant and abutment. GenTek CEREC® compatible (Sirona inCoris Meso Block) and angulated screw channel Ti-Bases, pre-milled abutment blanks, and scan bodies are part of a complete and open digital workflow. Products are available for ZimVie’s TSX®/ TSV®/Trabecular Metal®, T3® PRO/Certain®, and Eztetic® Dental Implant Systems.
For more information on our GenTek portfolio, visit https://www.zimvie.com/en/dental/restorative-products/gentek-genuine-restorative-components-na.html.
For more information on ZimVie Dental implants, suite of connected solutions, and continuing education, please visit https://www.zimvie.com.
*GenTek is manufactured by Zfx GmbH, a subsidiary of ZimVie.
About ZimVie
ZimVie is a global life sciences leader in the dental market that develops, manufactures, and delivers a comprehensive portfolio of products and solutions designed to support dental tooth replacement and restoration procedures. From its headquarters in Palm Beach Gardens, Florida, and additional facilities around the globe, ZimVie works to improve smiles, function, and confidence in daily life by offering comprehensive tooth replacement solutions, including trusted dental implants, biomaterials, and digital workflow solutions. As a worldwide leader in this space, ZimVie is committed to advancing clinical science and technology foundational to restoring daily life. For more information about ZimVie, please visit us at www.ZimVie.com. Follow @ZimVie on Twitter, Facebook, LinkedIn, or Instagram.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning ZimVie’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs, expectations, and assumptions of management and are subject to significant risks, uncertainties, and changes in circumstances that could cause actual outcomes and results to differ materially from the forward-looking statements. For a list and description of some of such risks and uncertainties, see ZimVie’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in ZimVie’s filings with the SEC. Forward-looking statements speak only as of the date they are made, and ZimVie disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers of this press release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary note is applicable to all forward-looking statements contained in this press release.
Media Contact Information:
ZimVie
Allison Johnson • Allison.Johnson@ZimVie.com
(774) 266-8046
ZimVie
Grace Flowers • Grace.Flowers@ZimVie.com
(561) 319-6130
Investor Contact Information:
Gilmartin Group LLC
Marissa Bych • Marissa@gilmartinir.com
FAQ
What is the GenTek® product portfolio that ZimVie (ZIMV) launched in the US?
When did ZimVie (ZIMV) receive FDA clearance for GenTek® components?
In which market did ZimVie (ZIMV) first launch the GenTek® portfolio?
How does the GenTek® portfolio enhance ZimVie's (ZIMV) dental implant offerings?
