Locally Developed Platform Bringing Heart Rate Variability Measurement to Physicians Nationwide

Inmedix Inc., a medical-diagnostics company pioneering the measurement of autonomic nervous system, or ANS, biology within the brain, today announced the nationwide commercial launch of its CloudHRV platform following its approval by the Food and Drug Administration last year.

The company has a physical office in Renton and was started in Seattle’s Normandy Park by Dr. Andrew J. Holman, a rheumatologist, clinical professor of medicine at the University of Washington, and Inmedix CEO and co-founder. The organization has begun delivering its devices to medical practices across the country, making its proprietary CloudHRV available to clinicians in all 50 states, with hundreds already on the waitlist, according to a news release. HRV stands for heart rate variability.

The CloudHRV System measures the function of the ANS — the body’s fight-or-flight (sympathetic) and rest/recovery (parasympathetic) activity — and delivers objective point-of-care data to physicians in the exam room. It represents a milestone in modern HRV assessment, with scalability, precision, and affordability for both patients and clinicians in the clinical setting, according to the release.

As of July, a limited number of U.S. physicians had conducted more than 1,950 procedures. Inmedix did a soft launch of its technology last year in five clinics in Washington, Oregon, Michigan, and Florida. Washington physicians participating in the soft launch included Drs. Viviane Bunin, a rheumatologist at the RheumCenter in Bellevue, and Jeff Peterson, a rheumatologist in Bothell, Holman said in an interview. The FDA approved the technology last year.

The nationwide launch addresses a long-standing gap across many disease states. One example is autoimmune diseases and fibromyalgia, which affect roughly 15 million Americans. Yet an estimated 75% of treatments fail, according to the release, adding that patients are left in trial-and-error cycles, which contributes to billions of dollars spent on therapies that don’t work.

“During my career as a rheumatologist, I saw seemingly identical patients respond differently to the same treatment,” Holman said in the release. “ANS biology appeared to be the missing vital sign. Now we can measure it with precision in just a few minutes, in the exam room, and give physicians something they’ve never had before: objective ANS indices to guide decisions.”

CloudHRV measures the ANS resting state through a simple, non-invasive, in-office process. A patient lies down for five minutes with standard ECG pads on their wrists and ankles. The device captures the variation in time between heartbeats, transmits it to the Inmedix cloud for proprietary analysis, and returns it to the physician’s screen in approximately 10 seconds.

Dr. Kevin J. Tracey, president and CEO of Feinstein Institutes for Medical Research and an Inmedix adviser and board director, added in the release, “Understanding how the nervous system controls and even inhibits inflammation has reshaped how we think about autoimmune disease. Treating it is one half of the equation; measuring it is the other. Inmedix has built a way to bring that measurement into the exam room in minutes. This is a major advance for Neuroimmunology, and for patients.”

Inmedix’s research and independent clinical publications have shown that ANS state at rest can be a key determinant of severity and treatment response. Yet medicine has had no reliable way to measure it, the release added. Proprietary, precision CloudHRV in the clinic changes that reality in a convenient and actionable way, it said.

Dr. Lee Simon, rheumatologist, biopharmaceutical consultant, and former FDA division director of analgesic, anti-inflammatory, and ophthalmologic drug products, added in a statement, “As we learn more and more about the ANS, an understanding of a single person’s HRV becomes increasingly important. To approach patients with precision therapies, this is required knowledge. The CloudHRV System is a recently FDA-cleared medical device that provides precision medical-grade HRV measurements. In analyzing various syndromes as well as established diseases, the ability to perform such precision assessment of HRV provides important insight into the state of the ANS.”

The technology draws on more than 20 years of research by Holman. His research into the role of ANS function in treatment response helped establish “immuno-autonomics” as a recognized term in medical literature, validated across 15 clinical studies involving nearly 1,500 patients, according to the release.

The Inmedix CloudHRV System is intended to acquire, display, and record electrocardiographic information to measure heart rate variability. These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician, the release noted.

In the interview, Holman called data from the measurement a vital sign that should be as ubiquitous as blood pressure.