BioLight Life Sciences reported operational and financial results for the year ended December 31, 2015. Results were characterized by continued development and commercial progress in multiple markets, and the achievement of all previously announced 2015 milestones.
- Completed an upsized private investment and signed a strategic partnership with Rock-One International Holdings Ltd. designed to help BioLight maximize its presence within China, the second largest healthcare market in the world after the United States.
- Reported first IOPtiMate™ System sales and procedures for a total of 1.4 million NIS (or approx. $360,000) in selected markets, enhanced worldwide marketing platform, and increased installed based, focusing on KOLs as the basis for expanding product sales going forward.
- Completed a joint equity financing agreement pursuant to which two Asia-based venture capital firms invested in BioLight subsidiary, IOPtima, for an aggregate amount of US$6.0 million, representing an approx. US$21 million post-money valuation for IOPtima, primarily to enhance IOPtiMate™ sales and marketing efforts, as well as to initiate a regulatory approval pathway process for the IOPtimate™ system with the U.S. FDA.
- Signed a collaboration agreement with Ora, Inc., a world-leading independent, full-service ophthalmic contract research organization and product development firm, pursuant to which the Company and Ora will work together to advance the clinical, regulatory and commercial development of BioLight’s novel TeaRx™ multi-assay diagnostic test for dry eye syndrome (“DES”).
- Completed two positive U.S. clinical studies which assessed the TeaRx™’ test’s effectiveness in assessing tears of healthy subjects as well as patients with DES, providing the basis for regulatory submissions in the U.S and Europe in 2016.
- Progressed with patient enrollment into an ongoing U.S. Phase 1/2a clinical study of Eye-D™ VS-101, BioLight’s latanoprost insert product based on its ground-breaking in-office insertable platform that provides for controlled release of ophthalmic medications over time, the results of which are expected to be obtained in the second half of 2016.
- Expanded BioLight’s balanced and diverse pipeline of ophthalmic products and product candidates with OphRx, a joint-venture that is developing a non-invasive, eye-drop-based ophthalmic drug delivery technology as an alternative to current delivery modalities, such as intravitreal injections.
- Reported positive clinical studies results for its CellDetect™ and BRONJ cancer diagnostics, and obtained CE Mark for the CellDetect™ bladder cancer test, enabling the product to be marketed and sold in Europe and other territories.