Describe your device and how it will benefit healthcare.
Clinical studies show that 7% of all IV lines are dislodged. In the United States alone, there are over 200 million IV lines placed annually. IV dislodgment is estimated to cost the U.S. healthcare system nearly $1 billion a year. We are developing a new device to prevent catheter dislodgment called the SafeBreak IV. The current standard for preventing IV dislodgment is the use of tape or more expensive securement devices. While adhesives and securement are important, nothing can prevent dislodgment when a large force is applied to an IV line.
The SafeBreak IV fits in-between the patient's catheter and the IV tubing, and creates a sealed liquid connection. Its design allows moderate pull force but separates before the adhesive fails, keeping harmful trauma from being delivered to the patient's IV site. When the device separates, its patented technology prevents blood loss and triggers the IV pump's high pressure alarm to alert the nurse. Replacing a SafeBreak IV is painless and takes seconds, so the patient can quickly resume their medication therapy without having to experience the pain of a dislodged IV and the reinsertion of a new one. The nursing staff can spend their time working on value-added activities and the hospital saves money on supplies, labor, and patient satisfaction.
The Portable Neuromodulation Stimulator (PoNS) device is an innovative, investigational medical device designed to treat chronic neurological symptoms caused by disease or trauma. The PoNS is currently being studied for the rehabilitation of balance deficits caused by mild to moderate traumatic brain injury (TBI) and for the treatment of gait and balance disorder in patients with multiple sclerosis. The PoNS device delivers a mild electrical stimulation to the surface of the tongue at a rate of approximately 27 million impulses every 20 minutes. This stimulates the facial and trigeminal cranial nerves, which are tied directly to several structures in the brain stem. Researchers believe sustained stimulation of these structures induces neuroplasticity, which results in faster, stronger, and more effective changes in the brain. The personal devastation of TBI--including among military personnel and athletes--has become increasingly well-known and understood in the past two years. Approximately 5.3 million Americans are currently living with a TBI-related injury. Unfortunately, there are currently no effective rehabilitation options for patients suffering from chronic symptoms of brain injuries. Although physical and occupational therapy may be effective in the acute phases of treatment, treatment options are almost non-existent for chronic symptoms. Almost all patients are told they must cope with their symptoms for the remainder of their lives. If approved, the PoNS device--in conjunction with a PoNS therapy program--will create a therapeutic option for individuals with chronic neurological symptoms resulting from brain injury and disease.
How does your product differ from the competition?
Adhesives, tapes, and expensive securement devices have long been viewed as the last lines of defense in avoiding IV complications. While basic securement is essential, all securement devices will fail eventually, resulting in catheter dislodgment. Unlike basic securement devices, the SafeBreak IV creates a necessary separation in the IV line, allowing us to protect the IV catheter during extreme tension. The SafeBreak IV helps understaffed nurses avoid stressful and time consuming IV dislodgment, and keeps patients progressing through the continuum of care.
The PoNS is unique to the neurostimulation space because of how and where it delivers neurostimulation-- the tongue. When combined with targeted rehabilitative therapy, the result is believed to allow for powerful and effective symptom treatment. PoNS is also unique because it allows medical professionals to combine portable, noninvasive neurostimulation with any other typical form of therapy--physical, cognitive, emotional, behavioral, etc.
Do you have customers yet?
The device is not yet cleared for sale by FDA, but we will start our first clinical trial in the fall of 2016.
|PoNS is not commercially available yet. It is still in clinical trials.|
How much money have you raised?
Who are your investors?
Zero To 510 Medical Device Accelerator, venture capital firms, and angel investors
High net-worth individuals as well as institutional and retail investors
What is the next milestone for your device?
FDA 510(k) clearance is the next milestone for our device. We will be submitting our 510(k) in the fall of 2016.
We recently announced that a pilot study investigating the safety and effectiveness of the PoNS for the rehabilitation of chronic symptoms caused by multiple sclerosis successfully met its research objectives. We are currently investigating PoNS in an FDA registration trial (i.e., pivotal trial) exploring its safety and effectiveness for the rehabilitation of chronic balance deficits in subjects with mild to moderate traumatic brain injury. This study is sponsored in part by the Department of Defense. We expect to complete this study and submit results to FDA this year.