Restoring Movement, Renewing Lives

Fortis’s patented cueStim device, which has been designated a Breakthrough Technology by the FDA, is a non-invasive solution for Parkinson’s Freezing of Gait. cueStim helps patients lower the risk of falls, regain independence, and improve quality of life*

Expected to be First of its Kind Class II De Novo Solution* for Parkinson’s Patients Impacted by Debilitating Episodes of Freezing of Gait (FoG)

Validated/ Peer Reviewed

cueStim delivered a 72% reduction in FoG in an independently assessed peer reviewed clinical study

Primary Functionality

  • Gait & Movement detection to deliver Smart Cueing.
  • FoG & Falls detection
  • Patient Customized Cueing
  • Patient Progress & Compliance Monitoring via Data Analytics

Health Insurance Cover

Candidate for TCET* CMS Program that provides for accelerated Medicare insurance coverage

 

 

*Fortis has submitted a letter of intent to CMS noting that cueStim is eligible for TCET and that Fortis wishes to be considered for the program.

The cueStim system is composed of:

  • Two Wearable Stimulation Units (WSUs)

  • Disposable electrical stimulation electrodes that attach to each WSU

  • Charging station

  • Patient Android or iOS phone App for patient control of device

  • Clinician Tablet application which a clinician can use to set up and monitor the use of the system on a patient-by-patient basis

  • Secure cloud / Web Portal facility that receives data from each user’s system on compliance, gait events, etc. These data can be used by the clinician to analyze and follow a patient's progress over time

cueStim Functionality

cueStim dynamically senses if the Person with Parkinson’s (PwP) is sitting, walking or trying to initiate movement and dynamically assesses gait patterns. The device delivers patient-specific electrical stimulation aimed at reducing FoG events and their duration. Stimulation parameters (e.g. voltage, pulse duration, frequency +7 others) are initially set by the clinician, within a range considered safe, so as to customize the patient’s therapy - every patient is different. These parameters can be changed by the PwP’s health care provider as the patient’s condition changes over time. The PwP also has the ability to change a limited number of stimulation parameters between clinical visits.

The Wearable Stimulation Units are self-contained within a plastic injection molded housing that holds the electronics, measurement sensors, rechargeable battery, communication and control elements that provide the intelligence behind the stimulation. The sensor pack built into each WSU measures and reports a body's specific position, acceleration and angular velocity.

Each WSU has the power to process the data delivered dynamically by its sensors such that how stimulation is delivered, as the patient moves from the sitting position to walking at various paces, can be dynamically managed.

Advanced Features

In addition to cueStim’s core capabilities, which provide a PwP’s healthcare team with a broad range of stimulation parameters to choose from, there are a number of capabilities built into the system that provide enhanced value:

Detection and Reporting of FoG Events

Fortis Medical Devices has developed, via the use of proprietary Machine Learning Algorithms, the capability to post-process, on a daily basis, data uploaded to its cloud facility by cueStim to estimate the occurrence and duration of FoG experienced by each patient. The historical report that can be generated is critical in evaluating a patient’s progress and the degree to which the stimulation parameters might be changed to further improve the efficacy of the cueStim treatment regimen as the patient’s condition changes.

Detection of Falls

Using similar Machine Learning Algorithms as those used in the detection of FoG events, Fortis has developed the capability to estimate the number of falls a PwP has experienced. Falls are a major issue that can result in serious injury, and monitoring this aspect of a patient’s progress over time is a critical aspect of a PwP's healthcare.

Compliance Tracking

Patient compliance with prescribed therapies can be a major problem. cueStim will collect and report, via its cloud facility, a PwP’s hours of use of the cueStim system – providing the clinician with another valuable tool in ensuring PwPs are getting the best out of the cueStim system.

Advanced Features

Fortis has a pipeline of new features under development that it believes will further enhance the cueStim system’s efficacy and ease of use.

The diagram below shows how the different components of the cueStim system work together to provide the patient and healthcare providers they work with a closed loop system that enables a regimen of continuous therapy optimization.

Regulatory Status

Fortis is pursuing a De Novo pathway to bring cueStim to market, with clinical trials expected to begin in first half of 2025. Based on discussions with regulatory partners, Fortis expects FDA to grant clearance to market cueStim 15-18 months after the clinical trial is funded, paving the way for commercialization in early 2026. Our collaboration with the FDA, as part of the TAP program which provides extensive access to a designated FDA team, has been instrumental in helping us to define an efficient path to market and insuring that cueStim meets all safety and efficacy standards required to meet Class II status.

cueStim has received FDA Breakthrough Technology Device Designation, a recognition given to products with the potential to offer significant advantages over existing treatments for life-threatening or irreversibly debilitating conditions. 

In addition to Breakthrough Technology status, cueStim has been included in the FDA's TAP (Total Product Life Cycle Advisory Program) pilot program, which aims to accelerate the development and approval of critically needed medical devices. This designation allows Fortis to work closely with FDA experts, payers, and providers to support efficient progression through the regulatory process. As of July 2024, there are fewer than 50 devices in the FDA’s TAP program, emphasizing the unique potential of cueStim to address an unmet medical need.

Fortis intends to quickly follow its introduction of cueStim into the US market, post FDA approval, with entry into Germany, France, Italy, Spain and other key EU territories post regulatory approval in each of those territories.

Clinical Evidence

In clinical studies reviewed by the FDA as part of the Breakthrough Devices Program, cueStim demonstrated remarkable results:

  • 72.4% Reduction in the percentage of time spent freezing.

  • 52.6% Reduction in the occurrence of freezing episodes.

A Platform Technology With Many Applications

Fortis Medical Devices holds 10 issued patents, with broad applications beyond Parkinson’s Disease. This technology can be adapted for other neurological conditions, such as post-stroke rehabilitation and multiple sclerosis, creating significant future market opportunities.