Inito, a Bengaluru-based medical technology startup, is gearing up to sell its Fertility Monitor in the US after having secured approval by the US Food and Drug Administration (FDA).
“We are very proud of the fact that we have built something that is of a global standard and meets all the norms set out by the FDA. We are not just building for India, but building for the world from India,” Aayush Rai, co-founder of Inito, told indianexpress.com over a call.
So what does the US FDA approval imply for Inito? Rai explains they have got a class one approval, which is granted for devices with the lowest risks, though this still requires the company to showcase its clinical trials data, pass all manufacturing requirements and other stringent norms set by the US regulator.
Further, usability studies need to show that Inito is safe and accurate considering this is a home-based user testing product.
“We’re in the process of setting up the operations in the US, now that we have the approval. It’s not just about the product operation and customer support but we also need to meet regulatory standards in the US. For example, in the US warehouse we will need the right temperature controls, given we are using medical devices,” he said, adding that the company was setting up its US supply chain and operations in anticipation of the launch. Inito has been selling in India since 2018 after getting the Central Drugs Standard Control Organisation(CDSCO) clearance.
Entirely manufactured and designed in India, the Inito smart fertility monitor can connect to a user’s smartphone via the Android or iOS app and give them a clearer picture of the most fertile days for couples struggling to conceive. Unlike regular ovulation strips, Inito combines testing for both estrogen and Luteinizing Hormone (LH). Most regular ovulation testing kits will just look at LH levels as a rise in these usually indicates the onset of ovulation. The monitor connects to Inito’s app and can measure both estrogen and LH to showcase the fertility window for couples. The app claims to show a fertility window of six days, ranging from low, peak to high fertility, unlike the plain and simple tests which just indicate the presence of LH on the strip which is dipped in urine.
“This data across these days is very important for accuracy. Being smart is what differentiates us. With this data, a lot more insights are possible for the user. For example, someone might be trying to conceive but they might not know they have PCOD. Trends from our app could help indicate that,” Rai points out.
Infertility is a growing concern in India, especially in urban areas as many choose to marry late and conceive late. The Indian Society of Assisted Reproduction (ISAR) estimates that 10-14 per cent couples in the country are facing fertility issues, a number that is expected to rise.
Inito currently sells its monitor along with the strips on Amazon in India. While Bangalore is their biggest market, 60% of their revenue is from other tier one cities and they are seeing more growth in tier-2 and tier-3 cities as well. “Bangalore is the biggest one because it’s an early adopter market, people are very aware and educated. Since we started focusing on creating education around the product, our sales are actually really growing fast in tier-2 and tier 3,” he added. One particular area where the product does very well is North-East, according to Rai.
In India, though, the biggest challenge in getting word about their product out is education. “This is a topic, which faces an education deficit given the subject is taboo. We need to tell people about these devices. We have discovered that actually long-form videos work best with our educational content. That’s why our focus right now is basically creating high quality content on fertility in regional languages with YouTube as the major platform,” he explained.
For Inito, the other challenge is dealing with the user based errors because they can be unpredictable. “Really that’s the biggest difference between a home device and a lab device. For example, people will not dip the strip in urine for 15 seconds, but only five seconds. The fix to this problem is not to give a wrong value, but detect all the errors and see if something is wrong,” he points out. For example, if you don’t take a strip and dip it for 15 seconds in the urine sample, the app does not give you a zero, it says the strip was not dipped for the right amount of time. If you use an expired strip, the app shows a message saying so.
Inito has plans to add more tests, both in the fertility space and beyond it.
“Immediately after this for fertility, we are launching progesterone and FSH. One is to complete the fertility spectrum.There’s actually no test in the world that does both. We have already done all the trials, etc. We are just waiting to just finish, and launch it very soon,” Rai said.
The company also wants to focus on adding blood tests for thyroid, vitamin D, testosterone and HBa1c. “The idea of Inito is to be the single device that everyone in the family can use. They will have different strips to it, but Inito could be the single reader,” he explained.
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