Medical device company Electro-Optical Sciences (MELA) has come one step closer to realizing its goal of offering clinicians a tool, which will help them detect melanoma while it is still in its earliest, most curable stages. The FDA has accepted the company's Pre-Market Approval application for MelaFind, a non-invasive system to aid in the early diagnosis of melanoma, the leading cause of death from skin cancer.
Melanoma is the deadliest form of skin cancer, responsible for approximately 80% of skin cancer fatalities. The melanoma rate has continued to increase with an estimated 120,000 new cases projected in 2009, according to the company.
The company submitted its pre-market approval application for MelaFind in June. The application was based on the final analysis of the data from a pivotal study, the largest prospective clinical study ever conducted in melanoma detection. According to the data, for all subgroups analyzed, the accuracy of MelaFind was greater than 95% and MelaFind specificity was statistically significantly higher than that of study clinicians. Since the FDA has also confirmed that the Pre-Market Approval application will receive expedited review and processing, the decision date is expected in December.
Since MelaFind detected more melanomas than dermatologists, including skin cancer experts in studies, the company believes that MelaFind could become an integral part of the standard of care in melanoma detection.
Advanced stage melanoma is costly to treat and is responsible for approximately 90% of the total spending on melanoma treatment in the US, costing up to $170,000 per patient. If diagnosed early, however, melanoma is almost always cured by simple resection at a cost of approximately $1,800 per patient, according to Electro-Optical.
Electro-Optical shares were added to the Russell 2000 and Russell 3000 indexes, as recently as June, which could help in generating additional attention to the company. The company does not have any commercialized product and since its inception, has generated significant losses.
MELA, which has thus far hit a 52-week low of $2.29 and 52-week high of $8.75, closed Monday's trade at $7.30.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.