Early-Stage Technologies In Brief
This article was originally published in The Gray Sheet
Executive Summary
Biowave DeepTreat: Initial 510(k) clearance is likely in second quarter of 2004 for pain-blocking technology, Norwalk, Conn. firm tells potential investors during recent Medtech Insight conference in Boston. The product is similar to implanted neuromodulation devices, but can be done in a physician's office at a lower cost, according to Biowave. In clinical studies of the device, which incorporates a disposable, percutaneous electrode array with 3,600 microneedles that deliver an electric field signal into deep tissue, patients report an average 80% reduction in pain at one hour post-treatment. DeepTreat thus reduces the need for painkillers, the company says. The product is reimbursed at $125-$320 per treatment, and a CPT code is expected as early as Q1 2004. Biowave is seeking $7 mil. to complete development...