Signifier Medical Technologies developed an innovative daytime therapy leveraging neuromuscular electrical stimulation (NMES) to treat an underlying root cause of sleep apnea. The medical technology company’s goal is to give patients an alternative to the currently available sleep apnea therapies that only mask symptoms (for example, CPAP machines, mouth guards or wedge pillows), as well as to potentially reach more patients who suffer from mild sleep apnea. Signifier Medical’s clinically validated therapy, eXciteOSA, is associated with increased tongue muscle endurance, which was found to improve mild obstructive sleep apnea, snoring and quality of sleep.

Sleep apneas and hypopneas are caused by a collapse of the upper airway that interrupts an individual’s ability to breathe while they are sleeping. Studies have demonstrated that patients with obstructive sleep apnea (OSA) have reduced tongue muscle endurance. To specifically address this issue, Signifier Medical developed its eXciteOSA therapy to promote the endurance of the tongue muscles to prevent the collapse of the upper airway during sleep. Its therapy requires patients to use an NMES device, eXciteOSA, once daily for 20 minutes during the day for an initial six-week period to strengthen their tongue muscle and prevent the collapse of their upper airway.

Signifier Medical received FDA De Novo authorization in the U.S. to treat mild sleep apnea. At that time, the medical technology company’s leaders reached out to ZS to develop a product and commercial strategy that would support both its mild sleep apnea indication as well as explore opportunities for future indications in anticipation of market expansion in two to three years.

OSA is a condition that’s estimated to affect 25% of the adult U.S. population (ages 30-70). It’s a progressive disease that can lead to direct healthcare costs ranging from $1,379-$2,105 and indirect costs ranging from $1,036-$2,105, depending upon the diagnosis. Sleep apnea patients often have comorbidities that are worsened by the effects of regularly obstructed breathing. Despite the number of individuals affected, many are not receiving effective treatment today. That’s because OSA has a complex care pathway with significant patient fallout due primarily to poor patient experiences with adherence to existing therapies, among other challenges including high variations in coverage for treatments and high out-of-pocket expenses.

For those diagnosed with mild OSA, defined by five to 14 apnea events during their sleep, there are few treatment options and very limited or no medical coverage, unless the patient has a specific comorbidity. For those with moderate sleep apnea, defined by 15 to 30 events, a CPAP machine is the primary treatment modality, but adherence remains low, with estimates at 32%. Patients are left with few options for therapy, which can lead to poor experiences.

Signifier Medical entered this market with a unique treatment approach—a simple, daytime, low-patient-burden therapy—which has achieved a high adherence rate of 81%. This opened up the potential to address a serious health issue while offering patients a better experience. The medical technology company was looking to understand this opportunity, as well as what customers across the healthcare ecosystem would require to bring its eXciteOSA therapy into value-based arrangements and to achieve alternative payment methods. These customers range from primary care physicians and sleep specialists aiming to improve patient outcomes, to commercial payers and self-insured employers looking to enhance employee health benefits.

Ultimately, the goal was to give greater access to new therapies for patients suffering from mild sleep apnea.

A critical component on the path to commercial success for connected health devices is the ability to collect continuous outcome data and generate real-world evidence. Signifier Medical wanted to understand how collecting and combining clinically accepted data through its connected device and patient app could serve as a vehicle for continuous measurement of a sleep apnea patient’s health. This would address the medtech company’s need for real-world data and evidence collection to support eXcite OSA’s clinical and economic benefits.

Signifier Medical selected ZS as a partner to expand its commercial strategy because of ZS’s deep expertise in connected devices and digital therapeutics. The medtech company also valued ZS’s expertise in modeling health economics, payment models and mechanisms, and storytelling for customers including commercial payers and self-insured employers for both fee-for-service and value-based payment arrangements.

Phil Hess, COO of Signifier Medical Technologies, explained, “We considered several options to help build out our therapy roadmap. Where ZS stood out was its ability to translate the requirements of industry stakeholders into digital therapy experience.”

Given the complexity of the patient journey and associated health economics in sleep apnea, ZS’s approach was to:

• Create a working framework for the use of patient-reported outcomes and novel data points to support value-based arrangements or employer models through case study analysis of leading post-commercial digital health solutions.
• Identify distinct patient segments through a robust clinical and health economics model and create value propositions for what eXciteOSA is intended to do based on current and future regulatory approvals.
• Validate this strategy in market with key decision-makers to test the strategy’s overall resonance and priority value propositions, along with related product and high-level evidence requirements.
• Create a pitch deck featuring the most resonant value story to be used in Signifier Medical’s business development discussions.

Our analysis illuminated a framework for tailoring digital services and specific outcome measurements based on patient risks (clinical) and potential customer segments and priorities (economic).

ZS then developed a robust health economic model for the four distinct patient segments that Signifier Medical had identified, consisting of per-patient and total direct and indirect costs. The model identified 11 potential value propositions focused on improving patient outcomes and quality healthcare utilization to test in market with key decision-makers within Signifier Medical’s target customer segments.

Applying direct customer feedback and working in partnership with Signifier Medical’s leadership team, ZS charted a course to create a stepwise, outcome-based digital experience built around the patient segment, associated risk and the value it would create in the marketplace for an NMES OSA treatment. The plan covered what it would require to deliver tailored digital experiences for respective patient segments and respective patient-reported-outcomes with clinically validated instruments to measure targeted outcomes. Following this plan will set up Signifier Medical to leverage its connected platform for a larger number of covered lives leading to broader patient reach, as well as to measure the outcomes most relevant for each patient segment and create a compelling value-based story for eXciteOSA’s novel NMES therapy.

ZS’s framework and plan informed Signifier Medical’s current and future positioning in the marketplace in preparation for outcome-based arrangements and provided a specific plan for data collection to influence payers. ZS’s recommendations included a durable framework and roadmap for tailoring digital experiences and data collection for specific patient segments to drive outcomes and ongoing real-world data collection with specific, clinically validated, patient-reported-outcome instruments. In addition, ZS’s findings set the course for Signifier Medical’s evidence strategy and future indications.

Hess explained, “Our starting point, prior to engaging ZS, was a digital experience that served the patient well but was limited in its ability to produce data to accelerate market access. Following ZS’s guidance, our mobile app and cloud are now integral to generating the data that is necessary to influence payers.”

The potential for a new innovative therapy such as NMES to significantly improve OSA patient outcomes is high. By treating a root cause of OSA and significantly improving therapy adherence, it’s possible to reduce the number of apnea events for OSA patients, enhance their quality of life and improve symptoms of comorbidities related to fatigue, anxiety, depression and hypertension.