Market Potential

It is not easy to get an exact figure on AROM (artificial rupture of membranes) frequency. Partly because of how records are kept, partly because of the use of the procedure to both start and augment labor. At the same time it is not hard to estimate how many procedures and thus how many devices might be sold in a best case scenario where Amni-Nik® had 75% or more of the market.

Estimating from Available Data

In the 2013 HCUP report AROM is listed as ninth most frequently preformed medical procedure.
10th most frequent is dialysis, normally done 3x per week. Annually an average of 400k people are receiving dialysis. Therefore 1.2 million dialysis are performed each year and AROM is more then that. About 4 million babies are born each year and AROM is probably performed in about half of births to either induce or augment labor. The HCUP records use to 'assist delivery' but it is hard to determine if this is the entire use.  AROM is billable as a separate procedure however many care providers use a universal billing code for obstetrics and the procedure may not be accurately recorded in available data.

We think it is safe to say the entire market in the USA is between 1.5 and 2.5 million per year.

Safer devices have historically replaced antiquated technology and chances of capturing the entire market and becoming a new standard of care in a few years are good.

FDA class 1

Today I got the following email from the FDA

Based on the device description you provided, our office of device evaluation believes this device does not seem to exceed the limitations of exemption; it can be regulated as a class I exempt device under 884.4530 as long as the device is remains in accordance with the class 1 exemption as explained in 21 CFR 844.4530.
ODE does not have any special labeling requirement specific to these devices.

This is what I anticipated hearing, that this device requires no specific labeling or regulatory over site and we can go ahead and make it in a proper manufacturing facility and sell it through distribution channels appropriate for sterile medical equipment. Getting this confirmation is very satisfying.