CEO: Raymond Cohen
Based: Irvine, California
Axonics Modulation Technologies has developed a miniaturized, implantable device to treat overactive bladder (OAB), allowing incontinent individuals to lead a more normal, comfortable life and, crucially, serve “a growing population whose treatment needs have never been met adequately,” according to CEO Raymond Cohen.
Its approach is based on a technique known as sacral neuromodulation, which treats OAB by delivering electrical stimulation to the sacral nerve, helping to correct erroneous messages sent between the bladder and the brain. It’s not a new concept, as the technology has been used for more than a decade to treat an estimated 200,000 patients with urinary or fecal incontinence, but Axonics’ spin is to develop a smaller, rechargeable device that is more patient-friendly.
What makes Axonics fierce
“Axonics identified the need for a smaller device that could last for years, meet the expectations of patients who can benefit from a smaller, more user-friendly device, and improve the long-term cost of care for the healthcare system,” says Cohen. Its already picked up a CE mark and Canadian approval for its Sacral Neuromodulation System (SNM), which is just about to start a pivotal U.S. study intended to support FDA approval and is entering a market estimated to be worth around $1 billion a year.
The SNM system comprises a four-electrode-tined lead, remote control, wireless charging system and a touchscreen tablet for lead placement and programming, and was developed with the help of 20 leading physicians in urology and urogynecology who provided insights and guidance on how the product should perform in order to be the best in its segment, according to Cohen, who tells us that the result was “innovations across the board in materials science, circuit design, wireless communication and transcutaneous battery charging.”
Proprietary inventions in materials science allow for the miniaturization of the device by incorporating medical-grade ceramic and metal alloy into a unitary housing, which allows for a smaller internal battery. Added to that innovations in circuit and antennae design allow for efficient current delivery and wireless communication between the implanted neurostimulator and peripheral device, which include the patient remote control, clinician programmer and battery charging system. It is designed to be current-controlled, which means it automatically adjusts current delivery to maintain steady therapy levels, without requiring reprogramming by the physician as is a common problem in voltage-controlled systems today.
The result is a device that is 5.5 cubic centimeters in volume, which Cohen says makes it 60% smaller than the competing device on the market—Medtronic's FDA-approved InterStim SNM implant—and means patient comfort should be improved because the recipient is unlikely to see or feel any bump from the under the skin. Its battery lasts approximately three times longer than its rival, with a recharging time that takes just an hour or so every two weeks, and the device is also qualified to last 15 years inside the body, which makes it the longest-lived device of its type in the medical industry.
Taken together, these characteristics result in significantly lower costs per patient for treatment of OAB, says Axonics, and because it doesn’t have to be replaced as frequently other devices, the risk to the patient for complications associated with surgery is reduced.
What to look for
During 2017 and 2018 the company will be making a number of announcements regarding its U.S. FDA study, which is beginning enrollment this month, as well as on its commercialization plans in Europe, investigator-initiated case studies using the Axonics device and additional financing activities. The latter could include an initial public offering in the mid-term, according to Cohen.