electroCore Provides Business Update and Select First Quarter 2020 Guidance
“As we and the rest of the world grapple with the humanitarian crisis and economic uncertainties brought on by the ongoing COVID-19 pandemic, we continue to advance toward our goal of making our gammaCore Sapphire™ non-invasive vagus nerve stimulation (nVNS) technology available to the broadest possible patient population within our approved adult headache indications,” said
Expansion of the gammaCore label: On
Emergency Use Authorization (EUA) application: On
Federal Supply Schedule: Continuing a positive trend observed in prior quarters, 64
FSS encompasses over 10 million covered lives, some 400,000 of whom saw
Outside of the
Premium II: Premium II is a company-funded study designed to support electroCore’s proposed expansion of the gammaCore label into migraine prevention. As previously reported, the company has suspended enrollment in this study to further conserve cash. The company has initiated necessary steps to close the Premium II clinical trial and assess the data that has been collected from the trial to this point. As a result, there are currently no company-funded studies that are ongoing.
It should be noted, however, that a number of investigator-initiated clinical trials of gammaCore in new indications are progressing, including in respiratory distress secondary to COVID-19. These trials are largely funded by third party grants, and the company intends to report results from these studies as they become available.
electroCore today introduced the following preliminary unaudited financial guidance for the first quarter ended
Revenue: Management anticipates total revenue for the first quarter ended
As previously reported, management has suspended full-year revenue guidance until it can better understand the trajectory of the company’s business through the COVID-19 pandemic.
Q1 cash used in operations: During the first quarter, electroCore used approximately
The company intends to provide a more detailed operational and financial update during its first quarter conference call in mid-May.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore is CE-marked in the
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
-- Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
-- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
-- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
-- Pediatric patients
-- Pregnant women
-- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients should not use gammaCore if they:
-- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
-- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
In the US, the FDA has not cleared gammaCore for the acute treatment of chronic cluster headache.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and product development plans, providing revenue and other guidance with respect to its business, its pipeline or potential markets for its technologies, seeking to secure an EUA from the FDA for gammaCore in relation to COVID-19, the company’s expectations for its revenue and cash used in operations during the first quarter of 2020, its expectations for future cash burn, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the