READ THE FULL ECOR RESEARCH REPORT
Since Our Last Update
Since our last report, electroCore Inc. ECOR has provided several updates including announcement of a new patent, publications, multiple new distribution agreements, Breakthrough Device Designation for nVNS1 in PTSD2, and the launch of US and UK ecommerce stores.
Highlights since our last report include:
➢ New patent for stroke and TIA treatment - December 2021
➢ PTSD publication in Journal of Affective Disorders Reports - December 2021
➢ Launch of UK ecommerce shop - December 2021
➢ Distribution agreements with Melidonia, Cyrus and Medexsol - December 2021
➢ Publication of PREMIUM II trial results for migraine prophylaxis - January 2022
➢ Launch of US telehealth portal and online store - January 2022
➢ nVNS receives Breakthrough Device Designation for PTSD - January 2022
Commercial
Distribution Agreements
On December 16, 2021, electroCore announced the addition of three new distribution agreements. electroCore entered into exclusive distribution agreements with Melidonia Health Services (Melidonia), Cyrus Medical Technologies (Cyrus), and Express Medical Solutions LLC (Medexsol) for distribution of gammaCore in Cyprus, the United Arab Emirates and Oman, and Saudi Arabia and Bahrain, respectively. These add to the existing list of international distribution partners spanning North America, Europe, the Middle East, Asia, and Oceania. The initial term of the Melidonia agreement is three years and Cyrus and Medexsol agreements have initial terms of five years. We've summarized the various agreements announced to date in the exhibit below.
Launch of UK E-Commerce Shop
On December 15, 2021, electroCore announced that it had launched a new online shop in the UK. Through the site, UK patients can purchase gammaCore Sapphire online after completing a questionnaire. The first product launched on the UK online shop will treat menstrual migraine. In addition to the online clinical assessment, the product is delivered to the patient's door and treatment training is conducted via video calls with an electroCore UK customer service team member. The cost of the therapy is borne by the patent and this effort reflects electroCore's concerted effort to provide gammaCore for indications that may not be covered by payors or fall into a reimbursement gap. Pricing for gammaCore Sapphire is £220 for three cycles of therapy.
Launch of US Telehealth Portal and Online Store
The success of the UK e-commerce shop presaged the launch of a similar effort in the United States. On January 11, 2022, electroCore announced the launch of its US website. Through this portal, US patients can complete a telehealth consult in order to receive a prescription to purchase gammaCore Sapphire online. The US online store will feature gammaCore for FDA-cleared indications such as migraine and cluster headache, and is powered by Vytal, LLC that allows patients to obtain a prescription via telehealth consult, purchase the therapy directly from the site delivered to their door, and have a member of the US electroCore customer service team provide video training. The online store continues to advance electroCore's strategic advancement of a cash pay, direct-to-consumer model that provides for more simplicity and less friction than the alternative insurance reimbursement model.
Regulatory
Breakthrough Device Designation for nVNS in PTSD
On January 12, 2022, electroCore announced that nVNS had received Breakthrough Device Designation from the FDA for the treatment of PTSD. The Breakthrough Devices Program provides an accelerated development, assessment and review pathway towards approval. The candidate must provide more effective treatment or diagnosis than existing approaches and meet one of the following criteria:
➢ Represents Breakthrough Technology
➢ No approved or cleared alternatives exist
➢ Offers significant advantages over existing approved or cleared alternatives
➢ Device availability is in the best interest of patients
The designation will help the electroCore team obtain feedback from the FDA in order to gain 501k clearance.
Receipt of the Designation was supported in part by research by Drs. Bremner and Inan from the Emory University School of Medicine and Georgia Institute of Technology, respectively, showing that nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in PTSD patients, modulates brain responses to traumatic memory, and reduces PTSD symptoms by 31% when compared to sham stimulation. The Breakthrough Device Program features accelerated development, assessment and prioritized review for devices that provide ‘more effective treatment or diagnosis for life-threatening or irreversibly debilitating human disease or conditions.
Publications & Patents
nVNS in PTSD
On December 14, 2021, electroCore announced the December 6th publication in the Journal of Affective Disorders Reports featuring results from a trial that enrolled 20 patients suffering from PTSD. These subjects were exposed to personalized traumatic scripts and then were immediately treated with active or sham nVNS. Results showed that three months of treatment with nVNS led to a 31% reduction (p < 0.013) in PTSD symptoms compared to sham as evaluated by the PTSD Checklist. Results also demonstrated a significant decrease in hyperarousal symptoms (p = 0.008) and decrease in overall and somatic anxiety. Patients who continued treatment in the three-month open-label period showed significant improvement in overall symptoms as measured by the Clinical Global Index (p = 0.003) and had levels of IL-6 that did not increase (p < 0.05). electroCore is conducting two studies of nVNS in PTSD in collaboration with the Veteran's Administration. One of them addresses posttraumatic stress with 88 subjects at the San Diego VA Healthcare System, and the other measures sympathetic overactivity in PTSD with 100 subjects at the Atlanta VA Medical Center.
PREMIUM II Results, nVNS in Migraine Prophylaxis
On January 10, 2022, electroCore announced the publication of "Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial" in Cephalalgia. The paper reported results of PREMIUM II, a randomized, double-blind, sham-controlled trial conducted at twenty-seven sites across the United States that had originally been powered for 400 subjects, but was closed early due to COVID-19 after enrolling only 231 subjects.
Despite lower than intended enrollment, PREMIUM II, which was intended to evaluate the safety and efficacy of nVNS for migraine prophylaxis, achieved statistically significant superiority versus sham on several measures. Statistical significance was not achieved for PREMIUM II's primary endpoint, mean reduction in migraine days per month. No serious device-related adverse events were reported. Migraineurs with aura were of particular interest, experiencing a therapeutic gain of over 100% compared to sham, which further reinforced nVNS' role in this particular patient subtype.
New Patent for nVNS in Stroke and TIA7 Treatment
On December 13, 2021, electroCore announced that it had been granted US Patent No. 11,191,953 relating to the treatment of stroke symptoms. The patent describes methods of treating acute symptoms of stroke and TIA with the application of a transcutaneous, non-invasive electrical impulse or stimulation. Earlier in 2021, electroCore announced full enrollment for its TR-VENUS study of nVNS in acute treatment of stroke.
Summary
Since our last report, electroCore has posted numerous updates including a new patent, publications, multiple new distribution agreements, Breakthrough Device Designation for nVNS in PTSD, and the launch of US and UK ecommerce stores. electroCore announced the addition of three new distribution agreements Melidonia, Cyrus, and Medexsol for Cyprus, the United Arab Emirates and Oman, and Saudi Arabia and Bahrain, respectively, adding to its growing global list of distribution partners. electroCore also launched two ecommerce platforms, one in the UK and one in the US where patients can receive prescriptions and can purchase gammaCore directly online. On the regulatory front, electroCore received Breakthrough Device Designation for gammaCore in PTSD, supported by recent research that was published in the Journal of Affective Disorders Reports. PREMIUM II trial results were also published in Cephalalgia, and achieved statistical significance in some endpoints despite being closed early due to COVID-19. Finally, electroCore was granted patent 11,191,953 relating to the use of transcutaneous, non-invasive electrical impulse or stimulation in treating acute symptoms of stroke and TIA.
electroCore has many factors in its favor which are helping to expand its presence globally to support its attractive profile. Additional indications are also longer-term opportunities such as those in Parkinson's disease, opioid use disorder, respiratory distress, post-traumatic headache, mild traumatic brain injury, PTSD, stroke and inflammatory diseases.
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1. Non-invasive Vagus Nerve Stimulation
2. Post-Traumatic Stress Disorder
3. Compiled by Zacks' analysts using mapchart.net
4. electroCore, Inc. Provides Update on Global Distribution Partners | electroCore. Compiled by Zack's analysts.
7. Transient Ischemic Attack
8. electroCore Corporate Presentation November 2021
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