Odne Archives - Dentistry Today https://www.dentistrytoday.com/tag/odne/ Tue, 27 Aug 2024 15:16:27 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.1 https://www.dentistrytoday.com/wp-content/uploads/2021/08/cropped-logo-9-32x32.png Odne Archives - Dentistry Today https://www.dentistrytoday.com/tag/odne/ 32 32 Odne Clean Receives FDA Clearance for Revolutionary Root Canal Disinfection https://www.dentistrytoday.com/odne-clean-receives-fda-clearance-for-revolutionary-root-canal-disinfection/ Tue, 27 Aug 2024 15:16:27 +0000 https://www.dentistrytoday.com/?p=117460 Today, Odne announced that it received clearance from the U.S. Food & Drug Administration for its endodontic debridement device, Odne Clean. The FDA regulates such devices as Class II medical devices, which are subject to premarket notification via the 510(k) pathway.

odne

Odne Clean—with its 190 µm tip, the thinnest dental fluid-delivery tip on the market.

Odne Clean offers a novel approach to root canal disinfection, simplifying and accelerating the process. It creates a hydrodynamic cavitation cloud inside the root canal using only saline solution (sodium chloride) as the main irrigation medium. The cavitation jet removes debris inside the canals and tubules and increases the effectiveness of the final disinfection rinse with NaOCl. Odne Clean has the potential to reduce the risk of adverse events caused by harsh chemical disinfectants commonly used during root canal disinfection. With its 190 µm tip—the thinnest dental fluid-delivery tip on the market—Odne Clean supports minimally invasive root canal treatments, enabling endodontists and dentists to preserve as much tooth structure as possible. Initial clinical study results indicate that Odne Clean results in less postoperative pain compared to other techniques.

Odne’s Chief Operating Officer and co-founder, Mark Bispinghoff, commented, “With the clearance of Odne Clean, we now have U.S. market approval for our complete product portfolio for Root Canal Preservation (RPT). We are very proud of our team for going the extra mile and would like to thank our partners for their efficient collaboration in performing the extensive testing the FDA requires.”

In 2023, Odne received FDA clearance for Odne Fill, its innovative root canal obturation technique. Odne Fill is the first light-curing root canal filler that instantly photo-cures upon applying Odne Cure, a high-precision laser curing light. Together, these three Odne products represent a game-changing technology platform for minimally invasive Root Preservation Therapy (RPT), allowing endodontists and dentists to accelerate treatment and increase patient comfort.

“We are thrilled to now integrate Odne Clean into our Priority Access Program and make it available to our U.S. customer base,” said Andreas Schmocker, CEO and co-founder. “Our goal with the program is to continue to build strong clinical evidence, and, together with our clinicians, we will transform endodontics with a passion for innovation, scientific advancement, and clinical excellence.”

Odne recently initiated its Priority Access Program for innovative Root Preservation Therapy (RPT) at the AAE annual meeting in Los Angeles. The PAP will form the core of Odne’s scientific and clinical community, transforming endodontics. One initiative of the PAP is to establish a clinical case registry, collecting further knowledge on the clinical use of Odne’s devices for root canal treatment. Participating endodontists get the privilege of being among the first users of Odne’s devices and provide valuable user-related and scientific feedback.

1 Internal pre-clinical and clinical data on file.

About Odne

Odne AG (formerly Lumendo AG) has its roots in a groundbreaking collaboration between two renowned Swiss institutions: the Swiss Federal Institutes of Technology in Lausanne and Zürich (EPFL & ETH Zürich). Founded in 2018, Odne’s journey began by licensing cutting-edge technology assets from these esteemed institutes.

Odne is committed to pioneering the future of endodontics through advanced technology and innovative solutions. Endodontics, the field of dental medicine that deals with root canal treatments, has been marred by complexity and unpredictability. Odne is on a mission to change that.

Root canal treatments have long posed challenges for dentists, with traditionally low success rates ranging from 46% to 91%. With over 60 million annual treatments worldwide, these failures result in significant healthcare costs. Odne’s technology platform seeks to address these issues by offering treatment options for both dentists and their patients. Odne’s medical device portfolio, launched in the U.S. in April 2024, tackles problems such as the debridement and obturation of complex root canal morphologies. Recently, Odne Inc, USA, was founded to support the U.S. launch.

Odne is backed by venture capital funds focusing on healthcare and dental sectors. These include Revere Partners (NY), an independent venture fund providing capital for cutting-edge innovations in oral and systemic health, and NV Capital (LIE), a family-owned venture capital boutique that led the Series A financing. Alongside the lead investors, other renowned funds, such as Dental Innovation Alliance (DIA), Plug&Play, Hatcher, Züricher Kantonalbank, as well as various family offices and angel investors, are supporting Odne’s U.S. market launch.

Odne’s technology platform for Root Preservation Therapy (RPT) includes the first hydrodynamic cavitation device using saline as the main debridement medium and the first all-in-one, light-cured filling material.

Disclaimer: Odne Fill, Odne Cure, and Odne Clean are cleared for use in the U.S.A. only.

For more information, visit odne.co.

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Odne Appoints Steve Fanning as Member of the Board https://www.dentistrytoday.com/odne-appoints-steve-fanning-as-member-of-the-board/ Wed, 12 Jun 2024 13:40:08 +0000 https://www.dentistrytoday.com/?p=116093 Andreas Schmocker, CEO of Odne, proudly announces the appointment of Steve Fanning as an independent board member.

“Steve is joining us with vast leadership experience in dental and endodontics, bringing innovation to the market,” said Schmocker. “We are currently in the process of launching the Odne system in the United States, and Steve’s background in building businesses in endodontics will be a tremendous asset as we look to expand Odne’s presence.”

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Stephen C. Fanning, member of the board, Odne

“I am honored and energized to be collaborating with the talented team at Odne to bring innovation to dentistry/endodontics,” said Fanning. “It is an exciting time to become a part of the Odne team as we look to transform endodontics. The Odne system has the potential to empower clinicians to perform endodontic procedures with more confidence and enable them to provide patients with better outcomes. I couldn’t be prouder of the team and the work they are doing.”

Odne has recently launched a Priority Access Program (PAP) for its innovative Root Preservation Therapy (RPT) at the AAE annual meeting in Los Angeles. The PAP will form the core of Odne’s scientific and clinical community, transforming endodontics. One initiative of the PAP is to perform a clinical case registry, collecting further knowledge on the clinical use of Odne’s devices for root canal treatment. Participating Endodontists get the chance to be amongst the first users of Odne’s devices and provide valuable use-related and scientific feedback.

Odne Fill is the first FDA-cleared light-curing, injectable endodontic obturation material. Odne Fill is a hydrogel, a class of biomaterials known for their excellent biocompatibility and hydrophilicity. Due to its water-like viscosity and the ultra-high hydrophilicity in its uncured state, it can flow into complex endodontic structures, such as isthmuses, deltas, and C-shaped canals. Once cured with Odne Cure, the corresponding micro-laser curing device, it provides gap-free root canal sealing and long-term obturation.

OdneClean aims to establish a non-instrumented approach to RPT. A debridement tip as thin as 190µm creates a hydro-dynamic cavitation cloud using physiological saline solution inside the root canal. The cavitation jet removes debris inside the canals and tubules. FDA clearance for OdneClean is expected in H2/2024.

About Steve Fanning

Steve has over 25 years of commercial and general management experience in healthcare, delivering consistent results driving growth with mature businesses and building growth playbooks for newer businesses. In his early career, Steve worked at Johnson & Johnson on the Tylenol, Splenda, and Neutrogena brand businesses. In 2010, he joined Danaher (now Envista) and was promoted to vice president/general manager for the infection prevention and specialties business for Danaher’s Dental Division in 2014. Steve moved to Henry Schein in 2018 as vice president/general manager over the restoratives and endodontics business unit, delivering high-growth results. Recently, Steve worked as CEO at a healthcare startup.

Steve holds a BBA from the University of Michigan with a concentration in marketing and finance, as well as an MBA from the Wharton School at the University of Pennsylvania with a concentration in strategy and marketing.

About Odne

Odne AG (formerly Lumendo AG) has its roots in a groundbreaking collaboration between two renowned Swiss institutions: the Swiss Federal Institutes of Technology in Lausanne and Zürich (EPFL & ETH Zürich). Founded in 2018, Odne’s journey began by licensing cutting-edge technology assets from these esteemed institutes.

Odne is committed to pioneering the future of endodontics through advanced technology and innovative solutions. Endodontics, the field of dental medicine that deals with root canal treatments, has been marred by complexity and unpredictability. Odne is on a mission to change that.

Root canal treatments have long posed challenges for dentists, with traditionally low success rates ranging from 46% to 91%. With over 60 million annual treatments worldwide, these failures result in significant healthcare costs. Odne’s technology platform seeks to address these issues by offering treatment options for both dentists and their patients. Odne’s medical device portfolio, launched in the US in April 2024, tackles problems such as the obturation of complex root canal morphologies.

Recently, Odne Inc, USA, was founded to build the organization to support the US launch.

Odne is backed by venture capital funds focusing on healthcare and dental. These include Revere Partner (NY), an independent venture fund providing capital for cutting-edge innovations in oral and systemic health, and NV Capital (LIE), a family-owned venture capital boutique led by the Series A1 financing. Alongside the lead investors, other renowned funds, such as Dental Innovation Alliance (DIA), Plug&Play, Hatcher, Züricher Kantonalbank, as well as various family offices and angel investors, are supporting Odne’s US market launch.

Odne’s technology platform for Root Preservation Therapy (RPT), including: the first hydro-dynamic cavitation device using saline as the main debridement medium, and the first all-in-one, light-cured filling material.

Disclaimer: Odne Fill and Odne Cure are cleared for use in the USA only. All other Odne devices are currently in development and have not received clearance for clinical use.

For more information, visit www.odne.co.

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DIA Announces Fifth Strategic Investment in Odne https://www.dentistrytoday.com/dia-announces-fifth-strategic-investment-in-odne/ Tue, 16 Jan 2024 15:43:31 +0000 https://www.dentistrytoday.com/?p=112359 Dental Innovation Alliance (DIA), an investment firm dedicated to fostering innovation within the dental and health sectors, is pleased to announce its latest investment in Odne (previously known as Lumendo), a Swiss company revolutionizing root canal treatment. Odne’s innovative root preservation therapy reduces the reliance on bleach and allows for greater treatment speed in endodontic therapy. The minimally invasive approach prioritizes both patient safety and comfort, while aiming to preserve tooth structures and ensure long-term treatment outcomes.

dental innovation alliance, dia, odne

Root canal treatments have long posed challenges for dentists, with traditionally low success rates ranging from 46% to 91%. With over 60 million annual treatments worldwide, these failures result in significant healthcare costs. Odne’s technology platform addresses these issues by offering treatment options for both, dentists and their patients. Its products, slated for launch in 2024, tackle problems such as the obturation in complex morphologies.

DIA recognizes the significance of Odne’s commitment to advancing dental technology while prioritizing patient well-being. The bleach-free and faster solution aligns with DIA’s dedication to scaling technologies that promote safer and more efficient practices within the dental industry. Several Dental Support Organizations (DSOs) affiliated with DIA are poised to be early adopters of Odne’s latest product, which has FDA approval and is set to launch in Q1 2024.

“DIA is on a continuous global pursuit to identify and invest in the most innovative and exciting tech companies in the dental sector. Odne’s progress to date has been impressive, and we are enthusiastic about partnering with them to help facilitate their U.S. launch,” said Thomas Sharpe, co-founder and managing partner of DIA.

“We are thrilled to access DIA’s network. I’m confident that their collective knowledge and expertise will uniquely help our company expand launch in the United States. DIA is committed to supporting innovation that leads to improved practice efficiencies and better clinical results helping providers and patients. At Odne, we develop products that do exactly that. We are honored that Odne is the DIA’s latest investment,” adds Andreas Schmocker, PhD, CEO, and co-founder of Odne.

DIA looks forward to a successful collaboration with Odne and anticipates the positive impact this partnership will have on DIA’s mission of accelerating dental technology innovations for the betterment of all stakeholders.

About DIA

Dental Innovation Alliance (DIA) is a close group of dental industry executives that funds, advises and propels the success of early-stage companies building the future of dentistry through technology. Its investor base includes executives and experts from some of the largest and most innovative dental support organizations and other dental businesses.

DIA has offices in New York, Nashville, and Research Triangle Park, NC.

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