>Ray, I am also optimistic about the near-term future of BSD's 2000 series machines. Based on what I see, I think it is possible for submission to the FDA this year.<
New people here probably need some input re the FDA submissions for the BSD-2000. While trials for the product have continued, the initial submission for a Premarketing Approval (“PMA”; needed before marketing can be done) was dropped, in order to request a Humane Device Exemption (HDE):
“Regulation also provides for the submission of a humanitarian device exemption (HDE) application. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. The (HDE) application is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.”
As explained by the company, this change in approval strategy was made because an HDE submission was likely to gain prompt approval – which happened. And. later submission for a PMA can be done, when suitable. Meanwhile, the trials (now Phase III) necessary for a PMA approval continue (with excellent success).
An HDE is only for a specific treatment situation (cervical cancer for the BSD-2000) with some limitations, and the cohort must be less than 4000 patients. However, because safety must be proven for an HDE, the machine can then be used for treating other cancers with only an approval by a local medical board (which most hospitals have). Such “off label” use is normally frequent, so an HDE will expedite later PMA approvals, when they are re-submitted. BSD M is also pursuing other HDEs for the BSD-2000. And, of course, the BSD-2000 has, for quite some time, been approved in European countries and other countries.
In passing, the BSD-500 and the MTX-180 have FDA approvals for marketing – as well as the TMX-1000 (for enlarged-prostate treatments) that was sold off. My point is simply that “newbies” to BSD Medical should be aware that the company is much further along to success than a brief glance would indicate. They re-read your post – and go to the BSD Medical website and read about many more trials progressing with excellent results.
>IMO, I don't think the FDA can deny approval on the next submission.<
YES! That would be the re-submission for the BSD-2000. And, when granted, “510k”s for the whole 2000-series will quickly follow more-or-less automatically (based on similarity to the already approved machines). |
