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.
