The Rochester Startup Part Thirteen: Mayo Startup Sonex Health Creates Device for Minimally Invasive Carpal Tunnel Release Surgery

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“Starting up a company’s been one of the hardest things I’ve ever done in my life. But it’s one of the most satisfying, to see something from the back of a napkin all the way into patients,” said Aaron Keenan, Founder and Chief Financial Officer of the Mayo Clinic startup Sonex Health.

Sonex leadership team. From left to right: Darryl Barnes, Jay Smith, and Aaron Keenan.  Photo courtesy of Sonex Health.

Sonex leadership team. From left to right: Darryl Barnes, Jay Smith, and Aaron Keenan. Photo courtesy of Sonex Health.

Keenan and his physician cofounders Darryl Barnes and Jay Smith launched the company in 2014 to “contribute to the health of humanity with the creation of refined and simplified micro-invasive solutions for unique and unmet needs of the patient.” Late last month, the Sonex SX-One MicroKnife was used to perform the “first-in-man” ultrasound-guided carpal tunnel release surgery.

Keenan explained that his cofounders, Barnes and Smith, “find a lot of value in being inventor/doctors.” The trio go back a long way. Keenan originally recruited Barnes to work as a medical orthopedist at the Mayo Clinic Health Systems in Austin, Minn. where Keenan was an Operations Administrator. They launched a different medical device startup during that time, called Annulus Health. Barnes and Smith, an ultrasound guidance procedure expert, are next door neighbors in Byron, Minn.

“Darryl and Jay, in the summer when they’re on their back porch drinking, they don’t talk about football games. …They’re talking about medical devices,” joked Keenan.

SX-One MicroKnife.  Photo courtesy of Sonex Health.

SX-One MicroKnife. Photo courtesy of Sonex Health.

Keenan, Barnes, and Smith rolled over the idea for Sonex every Saturday for two months until they felt the concept was in the right place to move forward with and start to develop a minimal viable product. The first Sonex product, the SX-One MicroKnife, is a surgical device that enables minimally invasive carpal tunnel release surgery through a four to five-millimeter incision using ultrasound guidance.

Carpal tunnel syndrome affects over 12M Americans. The disease is caused by a pinched nerve, called the median nerve, which leads to tingling, numbness, and even weakening of the hand and arm muscles. Carpal tunnel symptoms can be relieved by wrist splinting and anti-flammatory drugs or corticosteroids. Severe or persistent syndromes are typically mediated through surgery. Cutting of the transverse carpal ligament (TCL) in the carpal tunnel- a narrow structure in the wrist that protects the median nerve- can relieve nerve compression and mitigate carpal tunnel symptoms.

The TCL is typically cut by endoscopic or open surgery. In the former option, a small incision is made in the palm and a very small camera is inserted inside the carpal tunnel through a tube to visualize and aid in cutting of the TCL. In open surgery, a much larger incision is made to access the TCL. Both procedures are effective but can lead to a lengthy recovery time and significant scarring.

SX-One MicroKnife cutting the TCL within the carpal tunnel.  Photo courtesy of Sonex Health.

SX-One MicroKnife cutting the TCL within the carpal tunnel. Photo courtesy of Sonex Health.

Sonex technology allows for carpal tunnel release surgery with less scarring, reduced pain, and faster recovery time than the current standard of care procedures. The startup uses ultrasound technology to visualize the TCL and guide the SX-One MicroKnife to the precise region. Once the device is in place, trademarked Meerkat technology inflates Stealth MicroGuard balloons within the carpal tunnel, isolating the TCL from surrounding structure like nerves and blood vessels. After the balloons are deployed, the SX-One MicroKnife blade is released, precisely cutting the TCL and relieving compression of the median nerve without causing unnecessary damage or slicing within the carpal tunnel.

Currently, the Sonex team is focused on expanding to key markets in a “slow, controlled launch.” They expect to have five physicians using the technology by the end of the quarter.

Keenan says that his team has found immense value in operating out of the Mayo Clinic Business Accelerator (MCBA) coworking facility. They needed a space in downtown Rochester to allow Barnes and Smith to spend time in their roles at both Mayo Clinic and Sonex. And they wanted a professional looking, cost-effective space where they could store equipment and meet with potential investors. The MCBA precisely met their needs. Once operations got running, Sonex rented out a small, private office in the facility. Since that time, the team has expanded into a larger office within the accelerator.

Sonex has found great connections in the MCBA where “you get to be in an environment with all of these people and be able to learn from one another and ask questions,” Keenan explained.

He says one of the biggest struggles that Sonex, and other startups in the city, face is lack of human capital and medical device sales experience in Rochester. In addition, the city remains risk averse. “There’s not a lot of people who want to take the risk of leaving Mayo Clinic or a fully benefitted, high paying job. …A lot of people thought that I was crazy [for leaving a Mayo Clinic Administrator position],” Keenan explained.

However, Keenan says he’s found great value in being an entrepreneur and seeing the direct contributions he makes to the company.

“Is this for everybody? Absolutely not. Does it have its positives? It absolutely does. It has a lot of cons, though, too.”

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