The U.S. FDA has cleared the way for Physiq Inc., of Naperville, Ill., to market its continuous ambulatory respiratory rate algorithm, adding to the company's portfolio of cloud-based analytics for biopharma and health insurance companies. The 510(k) notification will allow Physiq to boost its higher-level artificial intelligence (AI) platform with validated vital signs inputs.

"Accurate and precise vital signs are an essential component of a clinical grade remote intelligence solution but, ultimately, these vital signs are an input into the higher-level AI-based analytics for which Physiq is known," said Chairman and CEO Gary Conkright. He added that obtaining clearance of respiration as a core component of cardiopulmonary functionality will hasten the development of additional AI analytics.

Founded in 2013, Physiq is applying its analytics to wearable sensor data. The Physiq platform gathers raw telemetry from wearable devices and uploads it to the cloud where analytics translate the biosignals into vital signs. In addition to the respiratory rate formula, the company's line of FDA-cleared algorithms includes QRS detection, a measure of electrical activity in the heart, heart rate, heart rate variability, atrial fibrillation detection and a personalized physiology change detection analytic. The tools are available within Physiq's Pinpointiq monitoring solution, which combines clinical-grade wearable biosensors, mobile cloud computing and analytics to provide clinicians with continuous insight for at-risk patients.

Amplifying vital signs

Changes in respiration rate and other vital signs can provide important clues about a person's overall health, but competing noise from the surrounding environment can compromise the data wearable sensors collect. AI-powered analytics aim to tease out the extraneous noise to provide a truer reading of the patient's vital signs. Physiq's latest clearance adds another critical piece to the clinical profile, giving clinicians more actionable insights to guide treatment and follow-up of patients.

When it comes to insights from wearable sensing technologies, vital signs are just the beginning, Chris Economos, chief commercial officer of Physiq, told BioWorld MedTech. "The real power comes when you run streaming ambulatory vital signs through sophisticated artificial intelligence analytics. These analytics are capable of characterizing a person's physiology and detecting subtle changes that can indicate physiological deterioration or improvement."

But having good data is key. "As they say, garbage-in-garbage-out. You need high-quality vital signs to ensure the higher-level sophisticated analytics are producing a quality output."

Besides adding to a persons' clinical profile, respiration rate is a key component of Physiq's Multivariate Change Index (MCI) analytic, which was FDA-cleared in 2015 to detect subtle changes in a patient's vital signs based on a personalized baseline assessment. The MCI is able to track variations during normal daily routines and activities, indicating issues such a worsening condition that could lead to hospitalization or the effects of a clinical study drug.

Strategic partnerships

"Biopharma companies are using our platform and analytics to create novel data sets that support their clinical trial endpoints," Economos said. "We are also working with them to develop novel biomarkers that are allowing them to pursue new commercial models related to real-world evidence and new clinical models," he added. Examples include novel algorithms with the potential to replace optimal oxygen uptake measurements, replace six-minute walking distance tests and provide continuous clinical assessment of multiple diseases."

Physiq is also collaborating with medical device companies. Earlier this year, the company partnered with Omron Healthcare Inc., of Lake Forest, Ill., to integrate Omron's FDA-cleared wearable blood pressure monitor, called Heartguide, into the Pinpointiq platform to monitor at-risk patients in an outpatient setting. (See BioWorld MedTech, Feb. 7, 2019.)

Remote patient monitoring is one of three "buckets" Physiq envisions for its platform. In a previous interview with BioWorld MedTech, Conkright said he sees a second bucket in the health and fitness space. The third bucket is the OEM business relationship, targeting medical devices that collect patient vital signs. (See BioWorld MedTech, July 28, 2014.)

To date, Physiq has deployed its platform in more than 17 countries worldwide. The company has raised a total of $19.9 million in venture financings, the most recent in a series B round in July 2017, which raised $8 million. Asked about future financings or a potential exit strategy, Economos said Physiq is focused on building a "sustainable company" and, to that end, is "pursuing investment and strategic partnerships to fuel our growth in this rapidly expanding space."