PolyPhotonix Limited, developer of a patented noninvasive treatment for diabetic retinopathy, has entered a global strategic alliance with Prevail InfoWorks, Inc. to lead management of FDA regulated human clinical trials of PolyPhotonix’s Noctura 400 Sleep Mask.
Prevail Partners, LLC, an affiliate of InfoWorks, has agreed to invest significantly in PolyPhotonix upon the commencement of the FDA clinical trial as lead investor in a $10M Series A investment round. Successful completion of the FDA clinical trial will open the US market to the treatment.
The Noctura 400 Sleep Mask has the potential to treat and prevent diabetic retinopathy, a condition of diabetic patients that can lead to blindness. Diabetic retinopathy represents a significant burden of disease for both patients and healthcare systems globally and is a significant cause of blindness in the working-age population.
Worn at night, the sleep mask treatment reduces and reverses the effects of diabetic retinopathy by delivering light therapy during a patient’s normal hours of sleep in a home-based setting. The Noctura 400 administers low-level light to reduce the risk of hypoxia and retinal damage in the diabetic patients’ eyes.
A recent UK NHS Real World Evaluation undertaken during the COVID pandemic found that 98% of eyes achieved positive clinical outcomes using the Noctura 400 Sleep Mask. The results have been published in The Journal of Ophthalmology, one of the sector’s leading publications.
PolyPhotonix’s new strategic partner, Prevail InfoWorks Inc, is a global company based in Philadelphia in the United States, providing biotech, pharmaceutical, medical device and diagnostics companies with the most innovative and complete technology and service solutions for their clinical development. The deal will leverage Prevail InfoWorks’ capabilities and technological expertise for achieving the highest quality data in the shortest possible time to expedite the clinical trial process.
Richard Kirk, Chief Executive of PolyPhotonix, said, “Our new global strategic partnership with Prevail InfoWorks will be a valuable asset to our vital work in tackling diabetic retinopathy worldwide. We are delighted to be working with such a major player in the industry and hope to break into the US market in the very near future. The investment and the forthcoming FDA trial will help support and develop the evidence base for Noctura 400’s clinical effectiveness for diabetic retinopathy patients at risk of losing their sight. This multimillion-pound deal will accelerate the clinical trial process and advance other indications in our biotechnology pipeline. At a time when health services across the globe are struggling to bounce back from the COVID-19 crisis, our sleep mask can be used by patients at home, reducing the pressure on frontline hospital services.”
Jack Houriet, Chief Executive Prevail InfoWorks said, ‘The extraordinary visionaries and scientists at PolyPhotonix are making major advances in the treatment of diabetic retinopathy. We are delighted to be working with PolyPhotonix to take the treatment through to successful FDA regulatory approval as quickly as possible with our technologies and clinical services. Early-stage treatments are more urgently required than ever with more than 40% of diabetic patients suffering from diabetic retinopathy.’
Polyphotonix recent investment success marks the latest chapter in their international expansion plans; with the mask already in use in Europe including the UK, France and Portugal.