electroCore Inc. Announces Exclusive Distribution Agreement with Medistar Following Regulatory Approval in Australia
Australian Therapeutic Goods Administration approved gammaCore Sapphire family of products
ROCKAWAY, N.J., Feb. 28, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that it has entered into an agreement with Medistar2 PTY Limited (“Medistar”) whereby Medistar will serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) in Australia, supplying therapy to patients suffering with primary headache disorders. The announcement follows the granting of regulatory approval from the Australian Therapeutic Goods Administration (TGA) for the promotion and sale of the gammaCore Sapphire family of products.
“We are delighted to welcome Jeneth Boughen, Owner and General Manager of Medistar, and the team at Medistar into our growing network of select distribution partners,” said Iain Strickland, electroCore’s Vice President of European Operations. “Medistar has demonstrable expertise in medical device distribution in Australia and we are incredibly excited to have its team working on behalf of electroCore.”
“Medistar is very excited to be partnering with electroCore to help Australians access gammaCore Sapphire (nVNS) therapy and assist healthcare professionals to add this treatment option to their medical practice,” said Jeneth Boughen, Owner and General Manager of Medistar. “Our mission is to partner with suppliers and health professionals to provide education and support for innovative technologies that improve efficiencies, patient well-being and outcomes. We see strong alignment between ourselves, electroCore and its non-pharmacological therapy for Australians who do not tolerate or respond well to current headache therapies.”
The initial term of the agreement is three years and contains customary terms and conditions, including minimum purchase commitments. Medistar will be officially launching gammaCore Sapphire at the 2021 ANZHS Headache Annual Scientific Meeting, which will be held on March 13-14. For more information on the ANZHS Headache Annual Scientific Meeting, please visit: https://anzheadachesociety.org/events/
“This is a welcome addition to the armamentarium in the treatment of refractory headache syndromes. We have good evidence of the efficacy of gammaCore, and being drug free, it reduces the medication side effect burden patients experience,” commented Dr. Marc Russo, Specialist Pain Medicine Physician and Director-at-Large of the Neuromodulation Society of Australia and New Zealand. “Beside this, gammaCore is an exciting tool to explore interfacing with the vagus nerve and the anti-inflammatory pathway. Treating headache may just be the tip of the iceberg of what we can do with this device.”
Medistar is an Australian independent medical device distributor recognised for supplying cutting edge technologies to health and veterinary professionals in Australia and New Zealand. The company represents best in class medical devices in the pain management, ultrasound and neurological sectors.
For more information, visit https://medistar.com.au
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
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 FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.
- gammaCore is contraindicated for patients with:
- An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
- 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 (younger than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
This press release and other written and oral statements made by representatives of electroCore 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 clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the business, operating or financial impact of such studies; the commercial potential of nVNS generally and gammaCore in particular in Australia 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™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, 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 SEC available at www.sec.gov.