The Memo: StimAire Re-imagining Sleep Apnea Therapy With a Wireless Injectable Device

Under the direction of Founder and CTO Tarek Makansi, StimAire is developing a surgery-free neuromodulation platform to treat obstructive sleep apnea (OSA) without surgery, CPAP machines, or daily maintenance.

Origin Story

Tarek Makansi is no stranger to solving big problems with elegant engineering. With a BS from Cornell and a PhD from UC Berkeley in electrical engineering, he began his career in data storage at IBM, where he rose to executive leadership and eventually served as CTO for IBM’s Venture Capital Group. “I was scouting the world for startup companies for IBM to acquire,” he said. “Then I left after 20 years and started Tempronics, which was sold to a Fortune 500 company.”

In 2017, after observing the bulky nature of neuromodulation systems, which typically involve large pacemaker-like implants wired to peripheral nerves, Makansi saw an opportunity to rethink the model entirely. “I noticed that for neuromodulation, people were using a large implant in the chest or the back and running a wire to the nerve,” he explained. “As a professional electrical engineer, I became curious. How much electricity was really needed at the nerve? It turned out that it was a very small amount. So I thought: there must be a way to miniaturize this.”

That curiosity led to the formation of StimAire and a platform concept centered around injectability and wireless activation, enabling office-based treatment for sleep apnea patients without the need for surgery. “I was able to get it to work,” he said. “Now I’m very passionate about bringing neuromodulation therapy to people without having to put them under major surgery.”

The Current Landscape

Obstructive sleep apnea affects an estimated one billion people globally, and while awareness has grown, treatment adoption remains low. According to LSI’s Compass platform, the sleep therapy devices and diagnostics market reached $6.2 billion in 2024 and is forecasted to grow at a 7.4% CAGR over the next five years, outpacing the broader medtech market. Much of today’s market is driven by CPAP devices and consumables, but future growth is being fueled by wearables, diagnostics, and next-generation implantables.

StimAire aims to unlock a significantly underserved segment of the market: patients who reject CPAP and are unwilling to undergo surgery for existing neuromodulation options. “50% of the patients who have a CPAP refuse to use it,” Makansi explained. “And only a trickle of patients go through surgical procedures because of the risks and recovery time. Sleep apnea is something that can kill you, but slowly, and it’s easy to ignore until it’s too late.”

By offering an injectable, wireless therapy, StimAire is positioning itself as the middle path: a solution with the efficacy of implantables but none of the friction. “Our device is silent, easy to travel with, and lets you sleep in any position,” Makansi said. “Compared to surgical devices, we eliminate general anesthesia, reduce costs by a factor of five, and offer immediate recovery.”

Inside the Innovation

StimAire’s platform consists of two core components: a tiny injectable stimulator and a wearable activation patch. The injectable device is roughly the size of a grain of rice and is delivered via a 17-gauge needle under local anesthesia, guided by ultrasound to the hypoglossal nerve. Once in place, the patient applies a peel-and-stick wearable to initiate stimulation and keep their airway open throughout the night.

The technology is deeply rooted in Makansi’s electrical engineering expertise. “There are two major things that matter here: battery life and wireless transmission,” he said. “We picked a modulation technique that consumes very little power, and we use magnetic fields, not RF or ultrasound, to transmit the signal. Magnetic fields penetrate the body the same way they penetrate air, so we get very consistent performance.”

Achieving this level of performance in such a small form factor presented its own challenges. “It’s easy to do wireless transmission from one flat coil to another,” he said. “But to do it from a wearable to a long, thin injectable device that flows through a needle, that took a lot of engineering.”

StimAire holds multiple issued patents covering the injectable, wearable, and introducer system, with additional patents to come.

Progress and Milestones

StimAire has already completed a first-in-human clinical trial in Australia, indicating acute safety and efficacy of the injectable device. “Our patient fell asleep shortly after the injection,” Makansi said. “With surgical devices, they don’t even turn them on for four to six weeks because the nerve needs to heal.”

The company is now conducting long-term animal studies to assess chronic performance, stability, and the success rate of repeated injections. “We’re now ten out of ten successful injections in animals,” he reported. “We’re also seeing very stable behavior at six months, with no signs of significant migration.”

On the engineering front, StimAire is developing a fully hermetic design of the injectable to enable long-term implantation. “We can demonstrate hermeticity with helium leak testing, and that’s a major milestone for us,” Makansi added.

With Breakthrough Device Designation already secured from the FDA, the next steps include:

• A 30-patient pre-pivotal trial
• A pivotal study with over 100 patients
• Simultaneous regulatory pathways for FDA and CE mark approval

To support these efforts, the company is currently raising a Series B, with plans for a Series C following the pre-pivotal trial. “We want to use the data from the pre-pivotal study as a motivator for the Series C fundraise,” he said.

Join Us at LSI USA ‘26

Makansi has been selected to present at LSI USA ‘26 next March 16th–20th in front of hundreds of global medical technology companies. Join us in welcoming him to the event in Dana Point, CA, where he will share the latest updates on StimAire’s technology and development.