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March 31, 2022

Olympic receives FDA 510(k) clearance for neuromodulation device

iTEAR100 is a connected device facilitating communication between patients and eye care providers.

Olympic Ophthalmics has received 510(k) clearance from the US Food and Drug Administration (FDA ) for its next-generation iTEAR100 neurostimulation device.

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The neuromodulation device is intended to increase tear production in 30 days in adult patients.

Claimed to facilitate patient access, the connected device will enable communication between patients and eye care providers.

Furthermore, it can help gather data and offers a platform between home and office, thereby optimising dry eye treatment.

It also offers telehealth tools, including the ability to download prescriptions, as well as activation through a mobile phone application.

The iTEAR100 device is claimed to be the only FDA -cleared at-home prescription medical device to boost natural tear production and serve as a bridge between the ophthalmic clinic and patients.

Additionally, the company announced three ongoing trials.

One trial is on patients with newly diagnosed dry eye disease using iTEAR100 as the first treatment. The second is a virtual telehealth trial, where the device is prescribed, monitored and measured by a physician without the patient needing to visit a clinic. The third is a label expansion study to optimise basal tear secretion as against reflex tearing to leverage its on-off and customisable treatment.

Olympic Ophthalmics founder and CEO Michael Gertner said: “After several months of slowed development due to supply chain constraints, we are ready to roll out the iTEAR100 with its associated features at scale, which will facilitate its usage in a telehealth environment.

“We are also excited to finish enrollment of our three Phase IV trials, which will further support our current label for iTEAR100.

“We are also pleased that the uniqueness of the iTEAR100 technology and treatment paradigms are being recognised by patent offices across the world.

“Neurostimulation approaches to Ocular Surface Disease have received FDA approvals and have also earned clinical acceptance by patients and clinicians.”

The company stated that it has been issued or allowed 12 patents regarding the device mechanism and treatment approaches.

Out of the 12 patents, nine are in the US, as well as one each in the EU, Japan and China.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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