VICTORIA, British Columbia, March 4, 2019 – StarFish Medical’s manufacturing and New Product Introduction (NPI) client, LumiThera Inc., today announced it is a recipient of a small business innovative research (SBIR) phase II grant from the National Institute of Health (NIH) and the division of the National Eye Institute (NEI).
The phase II grant supports a prospective, randomized, multi-center human clinical trial in U.S. subjects diagnosed with dry age-related macular degeneration (dry AMD.) The LIGHTSITE III trial, which is subject to FDA Investigational Device Exemption (IDE) approval, will test vision and examine disease pathology in the eye following PBM treatments using the Company’s Valeda™ Light Delivery System. Subjects will be followed for up to two years. In 2018, LumiThera obtained a CE mark to commercialize the Valeda™ Light Delivery System in Europe for the treatment of dry AMD. A companion post-marketing study (LIGHTSITE II) is being readied for Europe.
StarFish Medical COO, John Walmsley, offers his best wishes to the Lumithera and StarFish device teams “Congratulations to LumiThera in their continued success in securing support to bring the Valeda™ Light Delivery System to market. We are proud they are using StarFish processes and systems to manufacture their medical device with full regulatory compliance as they scale up to address the debilitating impact of Age-related Macular Degeneration.”
Read the full Lumithera press release here.
Read the LumiThera – StarFish Medical case study here.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of acute and chronic ocular diseases and disorders. The company is developing the office-based Valeda™ Light Delivery System to be used by eye care specialists as medical treatments.
The Valeda™ Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda™ is not approved for use by the Food & Drug Administration (FDA) in the USA. Visit the Company’s website at www.lumithera.com.
About StarFish Medical
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StarFish Medical is a full service Medical Device Design company offering design, development, and manufacturing services based in Toronto and Victoria. We use our Pathfinder™ process to reduce wasted effort and increase success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System and an FDA registered manufacturing and clean room facility. www.starfishmedical.com
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