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nthalmic: Innovations in Ophthalmic Technology and Eye Care Solutions

POSTED: 26 Sep, 2024

nthalmic is a privately held, early-stage, Research & Development (R&D) organisation, on a quest to deliver solutions for ophthalmic challenges. Established in 2019 and headquartered in Sydney, developing and commercialising innovative products to address unmet needs in the rapidly emerging fields of global eye care, with a focus on myopia management and dry eye disease.

nthalmic are working towards building an innovation ‘center of excellence’ bringing together an exceptional multi-disciplinary team, which shall serve as an incubation hub to facilitate realisation of ideas to products and close the existing gap between ‘bench’ and ‘real-life’ following our 5-step mantra (I-P-P-V-C).

1. Ideate
2. Protect
3. Prototype
4. Validate
5. Commercialise

 

nthalmic team comprises world-class scientists and clinicians have a track record in developing ophthalmic technology solutions. All scientists and clinicians have had their research training at premier universities with some holding visiting academic and professorial positions with distinguished universities including UNSW. They have collectively published more than 150+ peer-reviewed papers.

nthalmic positions itself as an incubator and disruptor for change. The company has the capability to identify, patent, build, test, and translate ideas. They regularly review, critique, evaluate, and analyse the latest research, conference posters, and abstracts to identify research trends and guide their priorities. With the expertise to swiftly move ideas along the product development pipeline, their engineers develop innovative hardware and software platforms to test ideas. Additionally, the clinicians boast 20 years of experience in developing and implementing clinical trials. nthalmic also houses in-house clinical trials facilities equipped with the latest clinical and biometric equipment, software systems, electronic data capturing systems, and database infrastructure operating under GCP standards.


nthlamic team celebrating 5th anniversary | Sydney HQ

This year, on its 5th anniversary, nthalmic acknowledges its team’s accomplishments, including:

  • taking six product prototypes (novel contact lenses, spectacles and optical films) into large-scale efficacy clinical trials around the world in Australia, China, India, and Spain. These trials enrolled 750+ participants across various global research institutes, major eye hospitals, universities, and optometry clinics.
  • Additionally, nthalmic has been granted 19 patents and has 90+ patents pending across 12+ countries for various technologies, including novel contact lenses, spectacles, and optical film designs for myopia management, as well as a novel apparatus to manage dry eye disease.

 


 

In 2024, nthalmic attained ISO 13485 certification for the design and development of non-active ophthalmic devices aimed at myopia management. This certification signifies that nthalmic has established a robust Quality Management System (QMS) ensuring the safety and efficacy of its medical devices. Compliance with ISO 13485 is a regulatory mandate for market entry in numerous global regions. Beyond regulatory adherence, their QMS facilitates continuous process improvement, risk management, and enhanced documentation practices. Looking ahead to 2025, nthalmic plans to expand its QMS scope to encompass active devices, a significant progression given the heightened risks and stringent safety requirements associated with these devices. nthalmic remains dedicated to mastering QMS implementation and proudly celebrates this pivotal certification milestone.

Meiboleyes® represents nthalmic innovative at-home medical device solution for treating meibomian gland dysfunction (MGD), the leading cause of evaporative dry eye disease. The meibomian glands line both the upper and lower eyelids, producing oils to coat the eye surface and prevent tear evaporation. MGD occurs due to abnormalities in the glands causing the production of stagnant oils and resultant gland obstruction. Without healthy oils, people can experience irritation, discomfort and vision disturbances. MGD and dry eye disease poses an increased risk with age and affects up to 50% of the world population. Some of the Meiboleyes® related R&D efforts were in collaboration with the Functional Materials and Microsystems team at RMIT, partially supported by the ARC Research Hub for Connected Sensors for Health.

nthalmic aims to create a device to deliver sustained and therapeutic heating to the eyes and provide the first dry eye device with a connected mobile app. Temperature sensor integrated into the device help with maintenance and regulation of therapeutic temperature and pressure sensors help maintain a comfortable and safe position on eye. Treatment compliance is integral to treatment success. The connected mobile app helps increase compliance through actively engaging the user to stay on treatment course and collects treatment frequency to provide key statistics to aid in knowledge of treatment progress.

The R&D efforts of the Meiboleyes project have led to the development of a functional prototype currently, which is currently undergoing a pilot study trialled within the UNSW School of Optometry’s Dry Eye Clinic. nthalmic looks forward to continually pushing the boundaries of connected health leveraging active technology and improving health outcomes in the ophthalmic field on a global scale.

Learn more about nthalmic here