MUMBAI, India, Sept. 19, 2024 /PRNewswire/ -- OrthoFX™, a leading innovator in orthodontic solutions, proudly announces the official launch of its advanced NiTime™ Clear Aligners in India.
NiTime Clear Aligners, the first and only aligner system explicitly designed for shorter wear times, received clearance from the U.S. Food and Drug Administration (FDA) under 510(k) and are now available for doctors to treat all classes of dental malocclusions. OrthoFX is set to showcase this breakthrough material at the 58th Indian Orthodontic Conference by the Indian Orthodontic Society in Bengaluru (Clarks Exotica), from September 20-22, 2024.
"NiTime Clear Aligners represent the most significant advancement in polymer science that the orthodontic industry has seen in decades. This innovation reflects our commitment to addressing real treatment challenges faced by providers and their patients," said Ren Menon, Co-founder of OrthoFX. "Unlike leading aligner manufacturers who use off-the-shelf materials such as Zendura A and Zendura FLX, OrthoFX is the only manufacturer utilizing this proprietary polymer material with AirShell™ technology. Our patented technology behind NiTime Aligners is designed to improve predictability and enhance patient compliance, helping to reduce unplanned refinements as only 22% require more than one refinement."
What Sets NiTime Clear Aligners Apart:
• Shorter Wear Time: Designed for 9 to 12 hours of continuous wear daily, eliminating the need for extended treatment durations compared to the 22 hours required by leading aligner brands.
• Improved Movement Efficiency: NiTime Aligners outperform the industry standard, demonstrating up to 30% greater movement efficiency across nearly all orthodontic tooth movements. *
• Minimized Refinements: While standard leading aligners exhibit a 14% predictability of tooth movement compared to the treatment plan, NiTime's AirShell™ technology delivers an 78% predictability rate, nearly eliminating the need for more than one refinement throughout the entire treatment duration.
• FDA-Cleared and Patented: NiTime is the first and only FDA-cleared aligner system designed specifically for shorter wear time.
The patented HyperElastic™ polymer with AirShell™ technology maintains biologically favorable force levels, allowing for predictable tooth movement with just 9 to 12 hours of continuous wear time. Additionally, the AirShell™ technology ensures sustained optimal force delivery, supporting natural bone tissue remodeling at its natural pace to straighten teeth while compensating against daytime relapse.
NiTime Aligners are meticulously designed to support favorable cellular physiology, creating an ideal environment for biological tissue remodeling. This process involves the coordinated activity of osteoclasts and osteoblasts, the key cells responsible for bone remodeling, ensuring optimal treatment outcomes.
"OrthoFX has truly revolutionized the orthodontic industry with NiTime Clear Aligners," said Dr. Neil Warshawsky, a respected orthodontist. "Their patented approach, from polymer formulation to aligner design and manufacturing processes, effectively addresses the challenge of patient compliance. NiTime Aligners, with their exceptional springiness and working range, offer high elasticity at a relatively constant force. This results in a comfortable treatment experience, with outcomes that consistently align with my treatment plans and without the need for multiple refinements."
OrthoFX will be showcasing NiTime Aligners and its other proprietary line of polymer innovations, such as FXTetra™, Rescue™, and Bright™ Aligners, at the 58th Indian Orthodontic Conference.
To learn more about the science of NiTime Aligner, watch OrthoFX NiTime Video. For more information about becoming an OrthoFX premier provider, visit www.orthofx.in.
About OrthoFX:
OrthoFX™ was founded by a team of clear aligner industry pioneers who played a crucial role in developing and scaling the first and second-generation aligner materials and systems. OrthoFX continues to lead next-generation advancements in orthodontic aligner treatments through innovations in polymers, software, and services. OrthoFX products include NiTime™ Clear Aligners—the first and only FDA-cleared aligner system for shorter wear time, OrthoFX Clear™ Aligners—designed to exert optimal pressure resulting in maximum comfort, and Bright™ Aligners—created to enhance the appearance of your teeth during treatment. To learn more about OrthoFX's innovative products and services, visit www.orthofx.in.
Data as per FDA clearance documents and on file.
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