FDA Okays Cyberonics AspireSR Generator for Epilepsy Cure

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Medical technology provider Cyberonics, Inc.’s CYBX novel AspireSR generator, which supports the company’s pioneering Vagus Nerve Stimulation (VNS) Therapy system, recently received the FDA nod for its commercial launch in the U.S. market. Management will provide updates on the AspireSR generator’s commercialization in the U.S. market in its upcoming earnings report, slated to be released on June 4, 2015.

Cyberonics’ VNS Therapy system is an FDA-approved medical device that offers unique cure for treating drug-resistant epilepsy and treatment-resistant depression (TRD). Statistically, epilepsy is the fourth most common neurological disorder and one in every 26 people has a chance of developing epilepsy at some point in their lifetime. This reflects the huge growth potential Cyberonics currently has in the epilepsy therapeutic market.

It is worth noting that epilepsy therapeutic is a large specialty market at present, with almost 50 million people suffering from this disease worldwide. As per business intelligence provider GBI research, the global epilepsy therapeutic market value will be $4.5 billion by 2019, with a modest Compound Annual Growth Rate (CAGR) of 3.9%. This fact encourages us to believe that Cyberonics, post receipt of the aforementioned FDA approval, will be able to capture a large share of this market; in days ahead.

Moreover, epilepsy patients suffer from recurrent seizures, which is again associated with an increased heart-rate observed in them. Per recent studies, 82% of epilepsy patients have experienced increased heart-rate when suffering from a seizure. This represents the need for epilepsy therapeutic system that will act timely in response to a patient’s increased heart-rate.

In this context we note that, apart from offering the benefits of conventional VNS therapy, Cyberonics’ AspireSR generator constitutes an added feature: automatic stimulation in response to detection of a seizure. More specifically, this device utilizes an individualized cardiac-based algorithm to deliver additional stimulation automatically by responding to a patient’s increased heart-rate.

Further, considering that seizure timings in epilepsy patients is mostly unpredictable, healthcare providers find it rather difficult to treat such patients. A seizure can occur at any time, which leaves little or no option for prior preparation of the treatment.

With the AspireSR generator, U.S. physicians will now be able to use this minimally invasive approach to treat their patients in real time, thereby facilitating improved treatment of drug-resistant epilepsy.

Interestingly, in Europe, where the AspireSR generator already received CE Mark in Feb 2014, reduced seizure frequency, seizure severity and improved postictal recovery have been observed in many patients treated with this device. This further validates the device’s significance in the epilepsy therapy market.

Considering the abovementioned developments, we believe Cyberonics will be a significant beneficiary of this modest growth trend within the global epilepsy therapeutic market. The benefits of the same should soon be reflected in its AspireSR unit sales, going ahead.

Currently, the company bears a Zacks Rank #3 (Hold). Some better-ranked medical instrument stocks are Cepheid CPHD, Ekso Bionics Holdings, Inc. EKSO and Electromed, Inc. ELMD. All the three stocks carry a Zacks Rank #2 (Buy).

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