There are more than 40,000 OB/Gyns in the US working in over 12,000 clinics. The recent expansion in treatment technology for intrauterine procedures and the demand by women for less invasive alternatives to hysterectomy and female sterilization has created a need for tools allowing gynecologists to diagnose and implement treatment in both the surgery center and office setting.
Based on market research and recent global market analysis, we expect an annual rate of 6MM-8.5MM hysteroscopy procedures, diagnostic and therapeutic, that would occur in the US market, with an expected global CAGR of 4.5% (2016-2022).
When these procedures are performed in the office, reduced anesthesia may be used, which is a benefit for both physicians and patients. Clinical review suggests that with a multifaceted approach to office anesthesia/analgesia, most patients will tolerate and actually prefer both diagnostic and operative hysteroscopic procedures in the office.* Once approved for use, these can be achieved with the use of the Luminelle DTx Hysteroscopy System.
* Wortman M(1), Daggett A, Ball C. Operative hysteroscopy in an office-based surgical setting: review of patient safety and satisfaction in 414 cases. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):56-63. doi: 10.1016/j.jmig.2012.08.778.
Now 510(k) Cleared for both Hysteroscopy and Cystoscopy.