Healthcare Industry News: U.S. Food and Drug Administration
News Release - November 29, 2017
electroCore Completes $70 Million Series B Funding RoundInvestment to fund commercialization of gammaCore® and further clinical development of nVNS
BASKING RIDGE, N.J., Nov. 29, 2017 -- (Healthcare Sales & Marketing Network) -- electroCore, a U.S.-based bioelectronic medicine healthcare company advancing better patient therapies through superior approaches to neuromodulation, announced today it completed its Series B financing that has brought in just over $70 million of capital to the company. The financing was led by Core Ventures II, an investment group that previously participated in the Company's Series A round. The Series B financing also included significant participation from another Series A investor, Merck's Global Health Innovation Fund, a venture capital arm of Merck & Co. Inc. Investors participating in recent Series B closings included Gakasa, an affiliate of Knoll Capital Management, as well as American Investment Holdings LLC and the Vinik Family Foundation, both of which are affiliated with Jeffrey Vinik, former manager of the Fidelity Magellan Fund. Paulson Investment Company assisted electroCore with this financing. The proceeds of this Series B financing will be used for the commercial launch and expansion via scientific exploration of the company's gammaCore therapy into the primary headache market, as well as the continued clinical and scientific development of the company's non-invasive, vagus nerve stimulation (nVNS) therapy.
"The ongoing support from Core Ventures and Merck's Global Health Innovation Fund shows continued confidence and enthusiasm for our mission to bring vagus nerve stimulation into the mainstream of medicine," said Francis R. Amato, CEO of electroCore. "The investments from Jeff Vinik's and Knoll Capital's groups are excellent confirmations that we have built a compelling platform for the future."
Following the U.S. Food and Drug Administration (FDA) de novo release in April of gammaCore for the acute treatment of pain associated with episodic cluster headache in adult patients, electroCore has embarked on a commercial registry in the U.S., working with expert headache centers across the country to distribute up to 1,200 gammaCore units to patients free of cost for the first two months. The company has filed for a 510(k) label expansion for the acute treatment of migraine, and is continuing to partner with KOLs and other research organizations to study the use of nVNS therapy in several other potential indications.
"electroCore is leading the way for the future of medicine through the development of non-invasive, self-administered nVNS therapy," said JP Errico, co-Founder and Chief Science and Strategy Officer of electroCore and Manager for the Core Ventures group of funds. "The field of neuromodulation is the next great market in healthcare, but until now it has been limited by the route of administration that has required surgery. We are thankful for the opportunity to continue supporting electroCore as it expands the applicability of nVNS to give patients access to this safe and effective treatment in a cost effective way that can so positively impact the healthcare system."
electroCore, LLC is a U.S.-based neuroscience and technology company dedicated to improving patient outcomes through technological advancement and focused on developing non-invasive vagus nerve stimulation therapy for the treatment of multiple conditions in neurology, inflammation, and metabolic syndrome. The company's initial target is the treatment of primary headache (migraine and cluster headache) and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society.
electroCore has raised over $150 million through multiple rounds of funding, including $32 million into its seed common round, $55 million in a Series A Round led by Merck GHI and Core Ventures, and most recently $70 million in its Series B financing.
For more information, visit electrocore.com.
©2017 electroCore, LLC. All rights reserved.
electroCore, the electroCore logo, gammaCore, and The NeuroScience Company are trademarks of electroCore, LLC.
gammaCore® (nVNS) is the first non-invasive, hand-held medical device applied at the neck that acutely treats the pain associated with episodic cluster headache in adult patients through the transmission of a mild electrical stimulation to the vagus nerve 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 standard of care. 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 released/cleared in the U.S. for the acute treatment of pain associated with episodic cluster headache in adult patients. gammaCore is currently in use outside of the U.S., including in the European Union, where it is CE-Marked.
IMPORTANT SAFETY INFORMATION REGARDING GAMMACORE
The safety and effectiveness of the gammaCore non-invasive vagus verve stimulator has not been established in the acute treatment of chronic cluster headache.
This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
The long-term effects of the chronic use of the device have not been evaluated.
Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is NOT indicated for:
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)
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)
Note: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.
gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
About Merck Global Health Innovation Fund
With a vision that data will be the currency in healthcare, Merck GHI is building a carefully integrated portfolio of investments that are outside of Merck's core pharmaceuticals and vaccines businesses. As a strategic growth investor, GHI's goal is to grow emerging health care solutions into meaningful businesses.
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