Here are five details:
1. IDCT is an off-the-shelf treatment that offers a non-surgical therapeutic option for patients with degenerative disc disease.
2. DiscGenics plans to begin a prospective, double-blinded, sham-controlled, multicenter clinical study to evaluate the safety and preliminary efficacy of IDCT in patients with single-level lumbar degenerative disc disease.
3. The company will enroll 38 patients in the trial, which is expected to start in the first half of 2019.
4. DiscGenics is along conducting a phase 1/2 prospective, randomized double-blinded, vehicle- and placebo-controlled, multicenter clinical study of IDCT in the U.S. in patients with single-level, symptomatic lumbar degenerative disc disease.
5. In the U.S., IDCT is being evaluated as an investigational new drug for FDA approval. It will be regulated as a drug-biologic through a therapeutics biologics application.
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