PolyPhotonix names Prevail Partners as its lead US investor whose affiliate will lead Noctura 400 FDA clinical trials
sponsored by PolyPhotonix
PolyPhotonix, the manufacturer of the Noctura 400 Sleep Mask, a treatment for diabetic retinopathy, has entered into an agreement with Prevail Partners who has agreed to invest significantly in PolyPhotonix as lead investor in a US$10 million Series A investment round. In addition, Prevail InfoWorks Inc. will lead the management of FDA regulated human clinical trials of Noctura 400. The successful completion of the FDA clinical trial will open the US market to the treatment.
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-19 pandemic found that 98 percent 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 (1).
PolyPhotonix’s new strategic partner, Prevail InfoWorks Inc, is a global company based in Philadelphia, Pennsylvania, US, providing biotech, pharmaceutical, medical device and diagnostics companies with the most innovative and complete technology and service solutions for its 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.
Jack Houriet, Chief Executive, Prevail InfoWorks, says: “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 percent of diabetic patients suffering from diabetic retinopathy.’
Charles C. Wykoff, Director of Research at Retina Consultants of Texas, US, comments: “There is more need than ever for a noninvasive modality to treat diabetic retinopathy. Current treatment options are excellent, but carry the challenge of being invasive and requiring repeated injections over time. Having a safe treatment option which was much less invasive, such as Noctura 400, when validated, would likely translate into substantially more patients initiating treatment earlier in the disease process before vision threatening complications develop.”
Richard Kirk, Chief Executive of PolyPhotonix, says, “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.”
PolyPhotonix’s recent investment success marks the latest chapter in the company’s international expansion plans; with the mask already in use in Europe including the UK, France, and Portugal.
- U Meyer-Bothling et al., “A real-world single-centre study of patients with diabetic macular oedema who wore a home-use sleep mask (Noctura 400) for one year,” J Ophthalmol (2021). PMID: 34258049.