A simple, novel solution to identify and protect ureter during surgery

AllotropeMedical, a Houston based medical startup has devised StimSite, a novel, hand-held, single use device that precisely identifies ureter during surgery; thus, eliminating the need for ureteral stenting.

It is specifically useful in all gynecological, colorectal and oncosurgeries. Gynecological surgery accounts for 50% of all iatrogenic ureteric injuries.

It is estimated that around 3 million surgeries performed in US annually, require an identification of ureter. The rate of ureteric injuries is around 2% with disastrous consequences and the total healthcare burden of this complication is about $3.2B every year.

It is also estimated that about 30% surgical time is spent on identifying the ureter.

The surgeon can simply place the tip of the device in the vicinity of the ureter and with a push of a button, the ureter goes into contraction and the full length of ureter towards kidney and bladder can be identified.

There is no other smooth muscle structure in that anatomical region, so the device specifically identifies ureter only.

The device is single use, battery operated and avoids additional procedures like cystoscopy on the operation table.

Allotrope aims to initially market the device for two high volume procedures, Hyterectomy (750,000 in US) and colon resection (300,000 cases). The current alpha prototype is a hand held, stand alone device that can be used in both open and minimal invasive surgeries. The company plans to enter the Robotic market in future by designing device for their platforms.  

Currently, StemSite is at pre-FDA state, but plans to get FDA clearance through the 510(k) pathway, and entering the marketplace by first quarter of 2019.

Allotrope has recently won second place in MedTech Innovator’s 2017 competition, among 600 startups.

Here is a video by Allotrope showing the functioning of the device.