This article was originally published in The Gray Sheet
Investigational device exemption is slated for submission by the end of the second quarter for the Ablatherm high-intensity focused ultrasound system for the treatment of prostate cancer. Edap's proposed clinical trial protocol would study patients not responsive to radiation therapy. Ablatherm uses high-temperature ultrasound delivered via a rectal probe to ablate cancerous prostate cells. The firm also has a premarket approval application supplement pending with the agency for a "compact version" of its Prostatron transurethral microwave thermotherapy treatment for benign prostate hyperplasia. The device will be sold to smaller hospitals and to the urology office market at a reduced price compared to current versions of the system. Bard's Urological Division, which co-markets the current Prostatron line, also will co-market the compact system...
You may also be interested in...
Cilta-cel maintained high response rates in longer-term multiple myeloma data, but ide-cel causes less cytokine release syndrome and severe neurotoxicity – and it has a March decision date at the US FDA.
Our updated graphic tracker of key developments from the leading vaccine candidates.
Pathway open for drug as post-covalent BTK option as Loxo gears up for "risky" Phase III head-to-head study in Q1 2021.