Ekso Bionics (EKSO) Stock Rockets On FDA Approval News

Ekso Bionics EKSO Stock News

Ekso Bionics Holdings Inc (NASDAQ: EKSO) is making a run for the top in the market this morning, trading on gains of more than 80% early on. The gains come after the company announced that it has received FDA Clearance to market a new product. Here’s what’s going on:

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EKSO Stock Climbs On Approval News

In the press release, Ekso Bionics announced that it has received 501(k) clearance from the FDA to market its EksoNRTM robotic exoskeleton for use in patients with acquired brain injury.

Importantly, EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use with ABI. EKSO said that the approval significantly expands the device’s indication to a broader group of patients.

EksoNR is the next generation device of the most clinically used robotic exoskeleton. The product was previously cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016. At the time, the device was the first of its kind to receive a stroke indication.

Importantly, ABI is the broadest category of brain injury. The category involves both traumatic brain injury and non traumatic injuries. Common injuries in this category include stroke, aneurysms, brain tumors, anoxia, degenerative and metabolic conditions, infections, surgical injuries and more.

This creates a massive audience. In fact, the incidence of TBI and stroke alone represent a patient population of 3.7 million in the United States and 84 million globally.

In a statement, Jack Peurach, CEO at EKSO, had the following to offer:

At Ekso Bionics, we are committed to maximizing patient access to our technology. With the expanded indications to include the broad category of acquired brain injuries, the EksoNR has the potential to mobilize significantly more patients and improve patient recovery. Based on their experience with EksoNR, customers at leading rehabilitation centers have acknowledged the benefits our technology can offer during recovery from brain injuries. We are excited to see the device used more widely in neurorehabilitation.

This Is Huge News

The news released by Ekso Bionics today is overwhelmingly positive for the company and its investors. After all, the expanded indication approved by the FDA greatly expands the patient population that will benefit from this device.

As we know, larger patient populations open the door to stronger revenue streams. With both traumatic and non-traumatic brain injury now included in indications for the product, the patient population is massive, opening the door to exceptional revenues ahead. All in all, EKSO stock is one worth watching closely.

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