OrthoFXTM Announces Nationwide Availability Of The First and Only FDA Cleared Aligners Designed Explicitly For Shorter Wear Time

NiTime Is Designed For Improved Predictability and Compliance and the Only Clear Aligner That Offers Patented HyperElastic ^TM Polymer With Airshell ^TM Technology, Requiring Only 9 to 12 Hours of Wear Time To Straighten Teeth.

FREMONT, Calif., May 1, 2024 --Founded by a team of industry pioneers, OrthoFX^TM, today announced the new generation of advanced clear aligner polymer, NiTime^TM Clear Aligners. NiTime is the first and only clear aligner system explicitly designed for shorter wear time and cleared by the U.S Food and Drug Administration (FDA) 510(k), and is now available nationwide for doctors to treat all classes of dental malocclusions. OrthoFX will showcase the new breakthrough material at the AAO (American Association of Orthodontists) Annual Meeting in New Orleans, May 3-6, 2024.

The NiTime Clear Aligner Is Unlike Conventional Aligners In the Market:

• Shorter Wear Time - Designed for 9 to 12 hours of shorter wear time without extended
  treatment duration versus the standard 22 hours required by leading aligner brands*.
• Greater Movement Efficiency - NiTime outperforms the industry standard of 22 hours
  wear for almost all orthodontic movements, demonstrating up to 30% greater movement
  efficiency compared to other leading clear aligners*.
• Predictable Precision - Designed for better predictability and compliance, 92% of
  NiTime Aligner treatments were completed without refinements*.
• Nearly Eliminates Refinements - Standard leading aligners exhibit a 14% predictability of
  tooth movement compared to the treatment plan. Whereas, NiTime’s AirShell Technology demonstrated an astonishing 86% predictability, nearly eliminating the need for refinements throughout the entire treatment plan*.
• Patented & FDA-cleared - The first and only FDA-cleared aligner optimized explicitly for shorter wear time*.
  • Patented HyperElastic^TM polymer maintains biologically favored force levels, allowing predictable tooth movement with only 9 to 12 hours of wear time.
  • The HyperElastic polymer, featuring AirShell^TMtechnology is designed to provide sustained optimal forces delivery, supporting natural bone tissue remodeling at its natural pace to straighten teeth and to compensate against daytime relapse.
  • NiTime Aligners are meticulously designed to support favorable cellular physiology, fostering an ideal environment for biological tissue remodeling. This process involves the orchestrated activity of osteoclasts and osteoblasts, the key cells responsible for bone remodeling, ensuring optimal treatment outcomes.

Clear aligners became a mainstream orthodontic modality in the late 1990s, yet patient compliance continues to be a headache for patients due to interference with eating, drinking, and for some patients–speech challenges–throughout their day.

“NiTime Clear Aligners are truly the most advanced innovation the category has seen in polymer science in decades. It's a testament to our commitment to solving real treatment challenges faced by providers and their patients. OrthoFX is the only aligner manufacturer for this proprietary polymer material compared to leading aligner manufacturers who are using off the shelf materials like Zendura A and Zendura FLX,” said OrthoFX Co-founder, Ren Menon. “Our patented technology behind NiTime Aligners make patient compliance effortless by reducing wear time in half, and nearly eliminating the need for extended treatment time given most cases do not need refinements."

“OrthoFX has disrupted the orthodontic industry by developing a real solution for lack of patient compliance with their NiTime Clear Aligners,” said Dr. Neil Warshawsky. “Their distinctive and patented method, from polymer formulation to aligner design to manufacturing processes, effectively mitigates drastic drops in appliance pressure. NiTime Clear Aligners are as gentle as NiTi wires commonly used in orthodontics due to
its exceptional springiness and working range, meaning high elasticity at a relative constant force. The force levels applied by NiTime’s HyperElastic polymer are significantly lower than conventional aligners. As a result, my patients almost feel no discomfort while in treatment. I am seeing outcomes consistent with my treatment plans without the need for multiple refinements.”

OrthoFX will showcase NiTime and their other proprietary polymer innovations, with product demos including OrthoFX Clear and Bright at AAO, booth #1437.

The NiTime Aligner system became available to a limited group of orthodontic practices in 2023, and is now available nationwide for doctors to provide patient treatment. To see how NiTime Aligner technology works, watch the OrthoFX NiTime Explainer Video and for more information about how to become an OrthoFX provider, visit https://www.orthofx.com/aao2024.

About OrthoFX

OrthoFX^TM was founded by a team of clear aligner industry pioneers who played a critical role in innovating and scaling the first and second-generation aligner materials and systems. OrthoFX continues to lead the next-generation advancements in orthodontics aligner treatments through innovations in polymers, software and services. OrthoFX products include NiTime^TMClear Aligners – the first and only FDA cleared aligner system for shorter wear time, OrthoFX Clear^TM Aligners – designed to exert optimal pressure resulting in maximum comfort, and Bright^TM Aligners – created to enhance the appearance of your teeth during treatment. To learn more about OrthoFX innovative products and services, visit www.orthofx.com. For more information about how to become an OrthoFX provider, visit https://www.orthofx.com/aao2024.

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*Data on file at OrthoFX