In a letter to shareholders, Andrew J. Whelan, president of BioElectronics, emphasized a four-part growth strategy initiated in the last year.
The first initiative is a global marketing program. Sales of ActiPatch Therapy products are steadily increasing in Boots, the dominant pharmacy chain in the U.K. The successful sales growth experience at Boots will facilitate and accelerate getting ActiPatch Therapy in more retail outlets around the world. Boots pharmacies are a strategic member of the Boots-Alliance, a global pharmacy-led health and well-being enterprise that includes Walgreens, the largest drugstore chain in the U.S.
The second initiative was in developing political and public support to induce the FDA to recognize BioElectronics’ therapeutic solutions. In February, FDA recommendations included Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses. By reclassifying this technology to reflect its safety and efficacy, the FDA appears to be making scientific evidence the determinant for additional market clearances, not out-dated categorizations.
Once the FDA finally makes a ruling, the company plans to submit new 510(K) applications with extensive clinical data. With the new FDA approach to classification, the company is hopeful that it will get equivalent U.S. market clearances to those earned in Canada and the European Common Market.
The third initiative involved continuing clinical research to further substantiate clinical efficacy and establish more indications of use. Since the last company shareholder report, BioElectronics has successfully completed three clinical studies, some observational studies and collected a growing body of consumer testimonials and pain data. The double-blind, placebo-controlled studies were for osteoarthritis of the knee, long-term plantar fasciitis and lower back pain.
The fourth and final initiative focused on lowering costs of capital to finance expansion. There are a number of potential applications of BioElectronics’ underlying technology that has had to put on the back burner because of resource issues. One way to reduce the cost of capital is by partnering in specific key markets with companies that have established sales and marketing presence.