Biotech Values

[ghmm]

OK Dew I took the challenge rather then file it in my nice to do "one day" list. I’ll caveat this with its 4-6AM and I don’t do my best thinking then and am on the tired (and lazy) side to clean this up but here are some notes.

My (early) conclusion is this has some improvements over surgical options but I don’t see it as gaining wide adoption. It has some efficacy but leaves a lot of the fibroids (both treated and the ones that aren’t targeted) and does not seem to do well against larger fibroids (which are probably the patients most likely to seek treatment sooner). There is an article (link below) which gave some optimism for improving outcome on larger fibroids. Not clear to me but seems there is some subset of patients (not sure how large) where this procedure will not work because of various reasons (see feasibility Study below). I would also speculate this requires pretty specialized centers and the more highly qualified the doc (or technician/specialist) the better the outcome.


Company Website http://www.insightec.com/
ExAblate® 2000 http://www.insightec.com/447-2278-en-r10/ExAblate-2000.aspx

MR Imaging–guided Focused Ultrasound Surgery of Uterine Leiomyomas: A Feasibility Study[\b]
Good Journal Article (Early study of patients who had the treatment and then a hysterectomy they were going to have one and agreed to this treatment[\i]):
http://radiology.rsnajnls.org/cgi/content/full/226/3/897?maxtoshow=&HITS=10&hits=10&RESU...


Positives
Company Listed Benefits:
* Non-invasive outpatient procedure.
* No hospitalization
* Next day return to normal activity
* Limited conscious sedation.
* No ionizing radiation
* Low rate of complications

Well tolerated:
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6W9P-493NYSR-C&_coverDate=07%2F31%...

Potential to improve:
Pretreatment of leiomyomata with gonadotrophin-releasing hormone (GnRH)
http://www.greenjournal.org/cgi/content/abstract/108/1/49
Seems to have better outcome treated 49 women with leiomyomata in excess of 10 cm 3-month course of GnRH agonists followed by the ultrasound.
Results: “45% reduction in median symptom severity score at 6 months and 48% at 12 months posttreatment, with 83% of women achieving at least a 10-point reduction in symptom scoring at 6 months and 89% at 12 months (P < .001). There was an average reduction in target leiomyoma volume of 21% overall at 6 months (P < .001) and 37% at 12 months (P < .001). No serious infective complications or emergency operative interventions were recorded.”

Negatives
Limited Availability: http://www.insightec.com/146-en-r10/Fibroid-TreatmentLocations.aspx

Limited Adoption: (2200 patients since approval through November 2006) http://www.insightec.com/15-2434-en-r10/NewsInsightec.aspx

Limited to smaller sized fibroids:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&l...

Limited reduction in fibroid size:
http://www.ajronline.org/cgi/content/abstract/183/6/1713