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STAODYN'S CONTRESS INCONTINENCE DEVICE: REGULATORY STATUS

This article was originally published in The Gray Sheet

Executive Summary

STAODYN'S CONTRESS INCONTINENCE DEVICE: REGULATORY STATUS will be discussed by the company and FDA in a meeting scheduled for late February, according to the firm. In October 1992, Staodyn submitted a 510(k) for use of the neuromuscular electrical simulation device in the treatment of female incontinence. However, the agency on Feb. 1 requested "additional information" about the product. According to the manufacturer of transcutaneous electrical nerve stimulation and NMES devices, FDA wants the firm to conduct clinical trials to support marketing of the device. The company feels that clinical trials are unnecessary. In a recent filing with the Securities and Exchange Commission, Staodyn describes Contress as "a new electrotherapeutic product, which includes a proprietary intravaginal electrode." The company notes that "NMES has been shown to be effective for strengthening the pelvic muscles using an intravaginal electrode." Because Contress can be set to provide varying numbers of contractions and levels of intensity, "different types of incontinence can be treated." If cleared, Contress will compete directly with Hollister Inc.'s Microgyn II and the more recently introduced Innova, which has been marketed by Empi for approximately a year ("The Gray Sheet" Oct. 14, 1991, p. 22). The SEC filing, which registers 1.3 mil. units for sale, also provides details of the firm's November acquisition of Technical Medical Devices ("The Gray Sheet" Feb. 15, p. 13). Prior to the acquisition, TMD was the company's largest wholesaler, accounting for 23% of Staodyn's revenues for the nine months ending Nov. 30, 1992. For that period, Staodyn's net sales totaled $5.8 mil., a 3.9% decrease from its sales of $6.1 million for the same period in 1991. The company's net loss for the nine months ending Nov. 30, 1992 was $549,605, a 37.3% increase over its $400,324 loss for the nine months ending Nov. 30, 1991. Staodyn products constituted approximately 40% of TMD's preacquisition sales. When existing inventories are depleted, TMD's 42-person retail sales force will market exclusively Staodyn-manufactured or -distributed products. TMD does not manufacture any of the products it distributes. Staodyn recently announced that Lynda Dreiling has been named the firm's first chief operating officer, in addition to her current role as executive vice president.
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