Bambi Layne is the founder and chief scientific officer of sciLayne Inc., a new medical device company based in Providence that’s building a wearable device she says could help people with under-active thyroids and other thyroid issues.
Q: What is this wearable device that sciLayne is creating and how will it work?
Layne: We’re in the process of creating a series of devices under the YOM — which stands for Your Optimized Metabolism — wearables umbrella. They are thyroid-stimulating hormone detection devices where their sensors [from a watch, ring, or a disc inserted into a bra or waistband] sample a patient’s sweat. A patient will go on an app [syncT, which is also being developed by Layne’s company] to gauge whether they’ll need another dose of their thyroid-stimulating hormone supplement.
When are these devices going to be available to patients?
In 2025. We’re chipping away slowly. Our regulatory partners are submitting a risk-assessment packet to the US Food and Drug Administration soon.
Are you pitching any investors to help speed up the process?
We’re still self-funded, so I’ve brought in all the cash. This year alone, I’ve put $208,000 into the business. Even if someone was to come in and offer $3.4 million, which is what we need today to get this through clinical trials, they would only get 40 percent of the company.
How much do you hope this sensor will cost patients?
It’ll be competitive with Apple Watch. I don’t want to go as low as a Fitbit. We want this to be a fine-tuned asset so people are encouraged to recycle and up-cycle. I’m assuming it’s going to be in the mid-$200s.
When are clinical trials taking place?
IQVIA is handling the clinical trials, which are scheduled for next year. They’ll be decentralized clinical trials, which is better because then patients don’t have to go to a facility; they can live their daily lives without any restrictions.
We’ll take one initial blood draw just to compare their hormone levels to the sweat the sensor is reading.
Why did you start this company?
As a child, I had ulcerative colitis, had to have surgery, and I never wanted to return to the doctor’s again. I thought I had my one-and-done illness. And then I was diagnosed with thyroid cancer while I was about to get married, right before I turned 40. Because of the cancer, my thyroid was removed. My partner, Serge Njamfa, is the company’s CEO.
On a day-to-day basis, I have to monitor my thyroid-stimulating hormone levels to keep them in a normal range. So if I have a super busy day, if I’m going to go running or am extremely active, then I might be depleted by noon. That means I have to take another dose of medication.
What are thyroid-stimulating hormone levels, and why do they matter?
The thyroid is a butterfly-shaped gland that produces hormones that regulate just about every part of the body — from metabolism to mood, heartbeat, and temperature. When a patient’s thyroid is removed, most patients have to take a synthetic hormone, which recreates a thyroid’s function and suppresses the thyroid-stimulating hormone (also known as TSH). A patient’s TSH levels can change drastically.
It’s better to monitor ourselves every day. But there’s nothing on the market, other than the subjective part of how we feel on a day-to-day basis. [Or patients have to have blood drawn for samples to be tested.] The YOM sensors will be able to monitor these TSH levels, which patients can share directly with their providers.
Why do you think a sensor for those with thyroid issues is important right now?
It’s such a growing medical issue. Hyperthyroidism is on the rise. Thyroid cancer is on the rise. So that should be telling everyone, in general, that something has to be done.