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Happy Belated Easter my Friend. Been busy with the new property in Texas
Did they even has products? What kind of product is that? S…..in the box….wow…..
SCAM
$ECOR electroCore, Inc. Announces Product Registration in Indonesia, Malaysia and South Africa
Source: GlobeNewswire Inc.
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the receipt of a license to import, distribute and market gammaCore Sapphire™, non-invasive vagus nerve stimulator (nVNS) in Indonesia. This follows the equivalent license approvals received in Malaysia in September 2022 and in South Africa in March 2023.
“Gaining wider global approvals and opening supply routes for gammaCore further validates the clinical evidence portfolio we have behind our technology, and more importantly, broadens the geographical access for patients and clinicians,” said Iain Strickland, SVP, Global Sales and Strategy at electroCore. “The product registration in Indonesia, South Africa and Malaysia represent the first registrations we have in both the Far East and the African continent.”
Mr. Strickland continued, “It’s an exciting time to be building new clinician networks and we look forward to supporting our distributors Kromax South Asia and Byond Healthcare as they launch in their respective territories. These regions have a combined population of 367 million and represent a significant market opportunity supported by local key opinion leaders, to whom we are grateful for their ongoing support and desire to include gammaCore nVNS, in their treatment considerations for headache patients.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving outcomes through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients. gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.
Forward-Looking Statements
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 as a potential alternative to opioids for pain management; its pipeline or potential markets for its technologies including treatment as a non-pharmaceutical therapeutic option for a variety of pain conditions; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in Indonesia, Malaysia and South Africa, and other new markets 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.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore, Inc. Announces Product Registration in Indonesia, Malaysia and South Africa
Source: GlobeNewswire Inc.
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the receipt of a license to import, distribute and market gammaCore Sapphire™, non-invasive vagus nerve stimulator (nVNS) in Indonesia. This follows the equivalent license approvals received in Malaysia in September 2022 and in South Africa in March 2023.
“Gaining wider global approvals and opening supply routes for gammaCore further validates the clinical evidence portfolio we have behind our technology, and more importantly, broadens the geographical access for patients and clinicians,” said Iain Strickland, SVP, Global Sales and Strategy at electroCore. “The product registration in Indonesia, South Africa and Malaysia represent the first registrations we have in both the Far East and the African continent.”
Mr. Strickland continued, “It’s an exciting time to be building new clinician networks and we look forward to supporting our distributors Kromax South Asia and Byond Healthcare as they launch in their respective territories. These regions have a combined population of 367 million and represent a significant market opportunity supported by local key opinion leaders, to whom we are grateful for their ongoing support and desire to include gammaCore nVNS, in their treatment considerations for headache patients.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving outcomes through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients. gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.
Forward-Looking Statements
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 as a potential alternative to opioids for pain management; its pipeline or potential markets for its technologies including treatment as a non-pharmaceutical therapeutic option for a variety of pain conditions; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in Indonesia, Malaysia and South Africa, and other new markets 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.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
Thank you
$ECOR low float play and lots of potential for their products to use worldwide
$ECOR low float play and lots of potential for their products to use worldwide
$ECOR electroCore, Inc. Announces Product Registration in Indonesia, Malaysia and South Africa
Source: GlobeNewswire Inc.
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the receipt of a license to import, distribute and market gammaCore Sapphire™, non-invasive vagus nerve stimulator (nVNS) in Indonesia. This follows the equivalent license approvals received in Malaysia in September 2022 and in South Africa in March 2023.
“Gaining wider global approvals and opening supply routes for gammaCore further validates the clinical evidence portfolio we have behind our technology, and more importantly, broadens the geographical access for patients and clinicians,” said Iain Strickland, SVP, Global Sales and Strategy at electroCore. “The product registration in Indonesia, South Africa and Malaysia represent the first registrations we have in both the Far East and the African continent.”
Mr. Strickland continued, “It’s an exciting time to be building new clinician networks and we look forward to supporting our distributors Kromax South Asia and Byond Healthcare as they launch in their respective territories. These regions have a combined population of 367 million and represent a significant market opportunity supported by local key opinion leaders, to whom we are grateful for their ongoing support and desire to include gammaCore nVNS, in their treatment considerations for headache patients.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving outcomes through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients. gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.
Forward-Looking Statements
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 as a potential alternative to opioids for pain management; its pipeline or potential markets for its technologies including treatment as a non-pharmaceutical therapeutic option for a variety of pain conditions; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in Indonesia, Malaysia and South Africa, and other new markets 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.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore, Inc. Announces Product Registration in Indonesia, Malaysia and South Africa
Source: GlobeNewswire Inc.
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the receipt of a license to import, distribute and market gammaCore Sapphire™, non-invasive vagus nerve stimulator (nVNS) in Indonesia. This follows the equivalent license approvals received in Malaysia in September 2022 and in South Africa in March 2023.
“Gaining wider global approvals and opening supply routes for gammaCore further validates the clinical evidence portfolio we have behind our technology, and more importantly, broadens the geographical access for patients and clinicians,” said Iain Strickland, SVP, Global Sales and Strategy at electroCore. “The product registration in Indonesia, South Africa and Malaysia represent the first registrations we have in both the Far East and the African continent.”
Mr. Strickland continued, “It’s an exciting time to be building new clinician networks and we look forward to supporting our distributors Kromax South Asia and Byond Healthcare as they launch in their respective territories. These regions have a combined population of 367 million and represent a significant market opportunity supported by local key opinion leaders, to whom we are grateful for their ongoing support and desire to include gammaCore nVNS, in their treatment considerations for headache patients.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving outcomes through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients. gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.
Forward-Looking Statements
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 as a potential alternative to opioids for pain management; its pipeline or potential markets for its technologies including treatment as a non-pharmaceutical therapeutic option for a variety of pain conditions; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in Indonesia, Malaysia and South Africa, and other new markets 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.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
I think I see huge dump today with the volume
$ECOR electroCore, Inc. Announces gammaCore Non-Invasive Vagus Nerve Stimulator Available Through the Carrick Institute
Source: GlobeNewswire Inc.
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) will be available for purchase by clinicians through the Carrick Institute for Graduate Studies which provides clinical neuroscience education.
“The Carrick Institute offers courses and programs to help educate clinicians on the application of functional neurology,” says President Tricia Carrick of the Carrick Institute. “To date, the Carrick Institute has trained more than 19,000 scholars through different programs. gammaCore nVNS is a unique therapy that can be used as yet another tool for clinicians to practice neurorehabilitation and provide the greatest outcomes for their patients.”
“We are excited to be working with the Carrick Institute as we expand patient access to our therapy through non-allopathic focused clinicians,” commented Dan Goldberger, electroCore’s Chief Executive Officer. “The Carrick Institute has a reputation of providing its scholars with world class clinical neuroscience education through programs and training, and we are excited that Carrick has chosen the gammaCore Sapphire nVNS stimulator as a device that can be utilized as a way for sufferers of primary headaches to find relief.”
About The Carrick Institute
Carrick Institute has been a world leader in clinical neuroscience education for over 40 years. Carrick Institute offers courses to help clinicians prepare for their next big steps in education, career, grow personally and professionally, and transform their future.
For more information, visit www.carrickinstitute.com.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general well-being and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients. gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.
Forward-Looking Statements
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 Company’s business prospects through the Carrick Institute and other new corporate accounts or other new markets 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.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore, Inc. Announces gammaCore Non-Invasive Vagus Nerve Stimulator Available Through the Carrick Institute
Source: GlobeNewswire Inc.
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) will be available for purchase by clinicians through the Carrick Institute for Graduate Studies which provides clinical neuroscience education.
“The Carrick Institute offers courses and programs to help educate clinicians on the application of functional neurology,” says President Tricia Carrick of the Carrick Institute. “To date, the Carrick Institute has trained more than 19,000 scholars through different programs. gammaCore nVNS is a unique therapy that can be used as yet another tool for clinicians to practice neurorehabilitation and provide the greatest outcomes for their patients.”
“We are excited to be working with the Carrick Institute as we expand patient access to our therapy through non-allopathic focused clinicians,” commented Dan Goldberger, electroCore’s Chief Executive Officer. “The Carrick Institute has a reputation of providing its scholars with world class clinical neuroscience education through programs and training, and we are excited that Carrick has chosen the gammaCore Sapphire nVNS stimulator as a device that can be utilized as a way for sufferers of primary headaches to find relief.”
About The Carrick Institute
Carrick Institute has been a world leader in clinical neuroscience education for over 40 years. Carrick Institute offers courses to help clinicians prepare for their next big steps in education, career, grow personally and professionally, and transform their future.
For more information, visit www.carrickinstitute.com.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general well-being and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients. gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.
Forward-Looking Statements
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 Company’s business prospects through the Carrick Institute and other new corporate accounts or other new markets 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.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
Let me know the company name and I will buying it. Family is all good. It is all about ROI so anything we can support and help the company, the people and ourselves. I am all in
I dumped this one because it is a scam and legit company I will support but not this scam
Congrats
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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 adolescents (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in 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 if they:
Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
Adolescent patients with congenital cardiac issues
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 (less than 12 years)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat Traumatic Bain Injury, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
Primary Logo
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
https://finance.yahoo.com/news/electrocore-reports-results-pre-clinical-120000807.html
$ECOR electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
https://finance.yahoo.com/news/electrocore-reports-results-pre-clinical-120000807.html
I agreed
Is this scam company still alive?
Settle down in Texas now
$ECOR electroCore, Inc. (ECOR) Q4 2022 Earnings Call Transcript
https://www.stockilluminati.com/ecor/display.php?url=https%3a%2f%2fwww.stockilluminati.com%2fecor%2fsanews.html
$ECOR electroCore, Inc. (ECOR) Q4 2022 Earnings Call Transcript
https://www.stockilluminati.com/ecor/display.php?url=https%3a%2f%2fwww.stockilluminati.com%2fecor%2fsanews.html
$ECOR Record full year 2022 net sales of $8.6 million increased 58% over $5.5 million for full year 2021
$ECOR Record full year 2022 net sales of $8.6 million increased 58% over $5.5 million for full year 2021
$ECOR electroCore Announces Fourth Quarter and Full Year 2022 Financial Results
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR) (the “Company”), a commercial-stage bioelectronic medicine and wellness company, today announced fourth quarter and full year 2022 financial results and provided an operational update.
Fourth Quarter 2022 and Recent Highlights
Reported record full year 2022 net sales of $8.6 million, representing an increase of 58% over $5.5 million for full year 2021
Fourth quarter net sales of $2.6 million, an increase of 72% over $1.5 million for the fourth quarter of 2021
Launched two new brands: TAC-STIM™ under the Air Force BOOST program and Truvaga™ wellness product for stress, anxiety, and sleep
Announced distribution agreement with Joerns Healthcare, LLC
Dan Goldberger, Chief Executive Officer of electroCore, commented: “This past year we have made great progress advancing gammaCore and further developing our nVNS technology for various uses. We reported record sales of $8.6 million for the year ended December 31, 2022, representing a 58% increase over the prior year. Additionally, we had a record fourth quarter of $2.6 million in sales. In December 2022, we announced the launch of Truvaga, our direct-to-consumer wellness product for stress, anxiety, and sleep, and in April 2022, we announced the launch of TAC-STIM, our Human Performance initiative in collaboration with the Air Force Research Laboratory (AFRL). Looking forward, we are excited about driving awareness to make non-invasive vagus nerve stimulation technology more accessible to people who can benefit.”
Fourth Quarter and Full Year 2022 Financial Results
For the quarter ended December 31, 2022, electroCore reported record net sales of $2.6 million, which represents a 72% rate of growth compared to $1.5 million in the same period of 2021. For the full year of 2022, the Company reported net sales of $8.6 million, which represents a 58% rate of growth as compared to net sales of $5.5 million for the full year of 2021. The increase of $3.1 million is due to an increase in net sales across all major channels, including the U.S. Department of Veteran Affairs, U.S. commercial channel, and sales from outside the U.S., which includes licensing revenue of $139,000.
Three months ended
December 31,
Three months ended
December 31,
Year ended
December 31,
Year ended
December 31,
Channel 2022 2021 % Change 2022 2021 % Change
Department of Veteran Affairs (VA) and Department of Defense (DoD) $ 1,627 $ 859 89 % $ 5,224 $ 3,261 60 %
United States Commercial 504 271 86 % 1,750 679 158 %
Outside the United States 384 361 6 % 1,479 1,511 -2 %
Licensing Revenue 45 — N/A 139 — N/A
$ 2,560 $ 1,491 72 % $ 8,592 $ 5,451 58 %
Gross profit for the fourth quarter of 2022 was $1.9 million as compared to $1.2 million for the fourth quarter of 2021. Gross margin for the fourth quarter of 2022 was 75%, as compared to 80% in the fourth quarter of 2021. Gross profit for the full year of 2022 was $7.0 million compared to $4.1 million for the full year of 2021. Gross margin for the full year of 2022 was 81%, as compared to 75% for the full year of 2021. The fourth quarter of 2022 included a charge of $217,000 to gross profit related to the change in the estimated useful life for certain of the Company's licensed products. Gross margin excluding the change in the estimated useful life charge would have been 84% for the quarter ended December 31, 2022.
Total operating expenses in the fourth quarter of 2022 were $7.8 million as compared to $6.7 million in the fourth quarter of 2021. Total operating expenses for the full year of 2022 were $29.9 million, as compared to $24.1 million for the full year of 2021.
Research and development expense in the fourth quarter of 2022 was $1.6 million, as compared to $742,000 for the same period in 2021. Research and development expenses for the full year of 2022 were $5.5 million, as compared to $2.5 million for the full year of 2021. This increase was primarily due to targeted investments to support the future iterations of our therapy delivery platform, including the use of our intellectual property around the delivery of smart phone-integrated and smart phone-connected non-invasive therapies.
Selling, general and administrative expense in the fourth quarter of 2022 was $6.2 million, as compared to $5.9 million for the same period in 2021. Selling, general and administrative expense for the full year of 2022 was $24.3 million, as compared to $21.6 million for the full year of 2021. This increase is primarily due to targeted investments to support our commercial efforts, particularly around sales and marketing efforts for our cash pay initiatives.
GAAP net loss in the fourth quarter of 2022 was $5.8 million as compared to a GAAP net loss of $4.9 million in the fourth quarter of 2021. GAAP net loss for the full year of 2022 was a loss of $22.2 million, as compared to a GAAP net loss of $17.2 million for the full year of 2021.
Adjusted EBITDA net loss in the fourth quarter of 2022 was a loss of $4.7 million as compared to a loss of $4.4 million in the fourth quarter of 2021. Adjusted EBITDA net loss for the full year of 2022 was a loss of $19.0 million, as compared to an adjusted EBITDA net loss of $15.8 million for the full year of 2021.
The Company defines adjusted EBITDA net loss as GAAP net loss, adjusting to exclude non-operating gains/losses, depreciation and amortization, stock-compensation expense, write-off of right of use operating lease, inventory reserve charges, legal fees associated with stockholders’ litigation, and provision/benefit from income taxes. A reconciliation of GAAP net loss to Non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in this press release.
Net cash used in operating activities the quarter ended December 31, 2022, was $4.0 million, as compared to $4.4 million in the fourth quarter of 2021. Net cash used in operating activities for the full year of 2022 was $16.6 million, as compared to net cash used of $13.6 million reported in 2021. This increase is primarily due to the increase in our net loss from operations.
Cash, cash equivalents and restricted cash at December 31, 2022 totaled $18.0 million, as compared to $34.7 million as of December 31, 2021.
Financial Guidance
electroCore today introduced the following preliminary unaudited financial guidance for the first quarter of 2023 and revenue guidance for full-year 2023:
The Company expects net revenue for the full year 2023 to be in the range of $14.0 - $15.0 million. The Company believes that its legacy headache channels will again grow by more than 50% to at least $12 million in net revenue for the full year and that net revenue from new products in its Truvaga and TAC-STIM brands could be more than $2 million for the full year.
The Company expects net cash usage in the first quarter 2023 to increase as compared to the fourth quarter of 2022, largely due to seasonal factors affecting working capital and increased investment in product evolution.
Webcast and Conference Call Information
electroCore’s management team will host a conference call today, March 8, 2023, beginning at 4:30 pm EST. Investors interested in listening to the conference call or webcast may do so by dialing 877-269-7756 for domestic callers or 201-689-7817 for international callers, using conference ID: 13736452, or click through the following link:
https://event.choruscall.com/mediaframe/webcast.html?webcastid=bHYAWnTU.
An archived webcast of the event will be available on the “Investors” section of the Company’s website at: www.electrocore.com.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
Forward-Looking Statements
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; business prospects around new and potential products, including those for human performance and wellness, financial guidance for the first quarter of 2023 and revenue guidance for the full-year of 2023, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," and 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™, TAC-STIM™, and Truvaga™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, inflation and currency fluctuations, 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 economic and 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.
Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
electroCore, Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
Three months ended Year ended
December 31, December 31,
2022 2021 2022 2021
Net sales $ 2,560 $ 1,491 $ 8,592 $ 5,451
Cost of goods sold 640 292 1,616 1,385
Gross profit 1,920 1,199 6,976 4,066
Operating expenses
Research and development 1,628 742 5,520 2,536
Selling, general and administrative 6,209 5,929 24,330 21,573
Total operating expenses 7,837 6,671 29,850 24,109
Loss from operations (5,917 ) (5,472 ) (22,874 ) (20,043 )
Other (income) expense
Gain on extinguishment of debt — — — (1,422 )
Gain on termination of joint venture — (549 ) — (549 )
Interest and other income (142 ) (3 ) (287 ) (11 )
Other expense 1 1 6 8
Total other (income) expense (141 ) (551 ) (281 ) (1,974 )
Loss before income taxes (5,776 ) (4,921 ) (22,593 ) (18,069 )
(Provision) benefit from income taxes (14 ) (26 ) 431 851
Net loss $ (5,790 ) $ (4,947 ) $ (22,162 ) $ (17,218 )
Net loss per share of common stock - Basic and Diluted $ (1.22 ) $ (1.05 ) $ (4.69 ) $ (4.36 )
Weighted average number of common shares outstanding - Basic and Diluted 4,744 4,711 4,729 3,945
All common stock share and per share data reflects the reverse stock split effective February 15, 2023.
electroCore, Inc.
Consolidated Balance Sheet Information
(Unaudited)
(in thousands)
December 31, 2022 December 31, 2021
Cash and cash equivalents $ 17,712 $ 34,689
Restricted cash $ 250 $ —
Total assets $ 24,756 $ 42,833
Current liabilities $ 7,045 $ 5,485
Total liabilities $ 7,670 $ 6,185
Total equity $ 17,086 $ 36,648
(Unaudited) Use of Non-GAAP Financial Measure
The Company is presenting adjusted EBITDA net loss because it believes this measure is a useful indicator of its operating performance. electroCore management uses this non-GAAP measure principally as a measure of the Company’s core operating performance and believes that this measure is useful to investors because it is frequently used by the financial community, investors, and other interested parties to evaluate companies in the Company’s industry. The Company also believes that this measure is useful to its management and investors as a measure of comparative operating performance from period to period. Additionally, the Company believes its use of non-GAAP adjusted EBITDA net loss from operations facilitates management’s internal comparisons to historical operating results by factoring out potential differences caused by gains and charges not related to its regular, ongoing business, including, without limitation, non-cash charges and certain large and unpredictable charges such as restructuring expenses.
The Company defines adjusted EBITDA net loss as GAAP net loss, adjusting to exclude non-operating gains/losses, depreciation and amortization, stock-compensation expense, write-off of right of use operating lease, inventory reserve charges, legal fees associated with stockholders’ litigation, and provision/benefit from income taxes. A reconciliation of GAAP net loss to Non-GAAP adjusted EBITDA net loss is provided in the financial statement table below.
Three months ended Year ended
December 31, December 31,
(in thousands) 2022 2021 2022 2021
GAAP net loss $ (5,790 ) $ (4,947 ) $ (22,162 ) $ (17,218 )
Depreciation and amortization 148 95 548 382
Stock-based compensation 587 761 2,682 3,302
Inventory reserve charge 217 70 217 70
Gain on extinguishment of debt — — — (1,422 )
Gain on termination of joint venture — (549 ) — (549 )
Gain on lease settlement — (57 ) — (57 )
Legal fees associated with stockholders’ litigation 251 187 400 581
Interest and other income / expense (141 ) (2 ) (281 ) (3 )
Provision (benefit) from income taxes 14 26 (431 ) (851 )
Adjusted EBITDA net loss $ (4,714 ) $ (4,416 ) $ (19,027 ) $ (15,765 )
The Company’s use of a non-GAAP measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of its results as reported under GAAP. Some of these limitations are: (i) the non-GAAP measure does not reflect interest or tax payments that may represent a reduction in cash available; (ii) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and the non-GAAP measure does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; (iii) the non-GAAP measure does not reflect the potentially dilutive impact of equity-based compensation; and (iv) the non-GAAP measure does not reflect changes in, or cash requirements for working capital needs; other companies, including companies in electroCore’s industry, may calculate adjusted EBITDA net loss differently, effectively reducing its usefulness as a comparative measure.
Because of these and other limitations, you should consider the non-GAAP measure together with other GAAP-based financial performance measures, including various cash flow metrics, net loss, and other GAAP results. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the preceding financial statements table of this press release.
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$ECOR electroCore Announces Fourth Quarter and Full Year 2022 Financial Results
Source: GlobeNewswire Inc.
electroCore, Inc. (Nasdaq: ECOR) (the “Company”), a commercial-stage bioelectronic medicine and wellness company, today announced fourth quarter and full year 2022 financial results and provided an operational update.
Fourth Quarter 2022 and Recent Highlights
Reported record full year 2022 net sales of $8.6 million, representing an increase of 58% over $5.5 million for full year 2021
Fourth quarter net sales of $2.6 million, an increase of 72% over $1.5 million for the fourth quarter of 2021
Launched two new brands: TAC-STIM™ under the Air Force BOOST program and Truvaga™ wellness product for stress, anxiety, and sleep
Announced distribution agreement with Joerns Healthcare, LLC
Dan Goldberger, Chief Executive Officer of electroCore, commented: “This past year we have made great progress advancing gammaCore and further developing our nVNS technology for various uses. We reported record sales of $8.6 million for the year ended December 31, 2022, representing a 58% increase over the prior year. Additionally, we had a record fourth quarter of $2.6 million in sales. In December 2022, we announced the launch of Truvaga, our direct-to-consumer wellness product for stress, anxiety, and sleep, and in April 2022, we announced the launch of TAC-STIM, our Human Performance initiative in collaboration with the Air Force Research Laboratory (AFRL). Looking forward, we are excited about driving awareness to make non-invasive vagus nerve stimulation technology more accessible to people who can benefit.”
Fourth Quarter and Full Year 2022 Financial Results
For the quarter ended December 31, 2022, electroCore reported record net sales of $2.6 million, which represents a 72% rate of growth compared to $1.5 million in the same period of 2021. For the full year of 2022, the Company reported net sales of $8.6 million, which represents a 58% rate of growth as compared to net sales of $5.5 million for the full year of 2021. The increase of $3.1 million is due to an increase in net sales across all major channels, including the U.S. Department of Veteran Affairs, U.S. commercial channel, and sales from outside the U.S., which includes licensing revenue of $139,000.
Three months ended
December 31,
Three months ended
December 31,
Year ended
December 31,
Year ended
December 31,
Channel 2022 2021 % Change 2022 2021 % Change
Department of Veteran Affairs (VA) and Department of Defense (DoD) $ 1,627 $ 859 89 % $ 5,224 $ 3,261 60 %
United States Commercial 504 271 86 % 1,750 679 158 %
Outside the United States 384 361 6 % 1,479 1,511 -2 %
Licensing Revenue 45 — N/A 139 — N/A
$ 2,560 $ 1,491 72 % $ 8,592 $ 5,451 58 %
Gross profit for the fourth quarter of 2022 was $1.9 million as compared to $1.2 million for the fourth quarter of 2021. Gross margin for the fourth quarter of 2022 was 75%, as compared to 80% in the fourth quarter of 2021. Gross profit for the full year of 2022 was $7.0 million compared to $4.1 million for the full year of 2021. Gross margin for the full year of 2022 was 81%, as compared to 75% for the full year of 2021. The fourth quarter of 2022 included a charge of $217,000 to gross profit related to the change in the estimated useful life for certain of the Company's licensed products. Gross margin excluding the change in the estimated useful life charge would have been 84% for the quarter ended December 31, 2022.
Total operating expenses in the fourth quarter of 2022 were $7.8 million as compared to $6.7 million in the fourth quarter of 2021. Total operating expenses for the full year of 2022 were $29.9 million, as compared to $24.1 million for the full year of 2021.
Research and development expense in the fourth quarter of 2022 was $1.6 million, as compared to $742,000 for the same period in 2021. Research and development expenses for the full year of 2022 were $5.5 million, as compared to $2.5 million for the full year of 2021. This increase was primarily due to targeted investments to support the future iterations of our therapy delivery platform, including the use of our intellectual property around the delivery of smart phone-integrated and smart phone-connected non-invasive therapies.
Selling, general and administrative expense in the fourth quarter of 2022 was $6.2 million, as compared to $5.9 million for the same period in 2021. Selling, general and administrative expense for the full year of 2022 was $24.3 million, as compared to $21.6 million for the full year of 2021. This increase is primarily due to targeted investments to support our commercial efforts, particularly around sales and marketing efforts for our cash pay initiatives.
GAAP net loss in the fourth quarter of 2022 was $5.8 million as compared to a GAAP net loss of $4.9 million in the fourth quarter of 2021. GAAP net loss for the full year of 2022 was a loss of $22.2 million, as compared to a GAAP net loss of $17.2 million for the full year of 2021.
Adjusted EBITDA net loss in the fourth quarter of 2022 was a loss of $4.7 million as compared to a loss of $4.4 million in the fourth quarter of 2021. Adjusted EBITDA net loss for the full year of 2022 was a loss of $19.0 million, as compared to an adjusted EBITDA net loss of $15.8 million for the full year of 2021.
The Company defines adjusted EBITDA net loss as GAAP net loss, adjusting to exclude non-operating gains/losses, depreciation and amortization, stock-compensation expense, write-off of right of use operating lease, inventory reserve charges, legal fees associated with stockholders’ litigation, and provision/benefit from income taxes. A reconciliation of GAAP net loss to Non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in this press release.
Net cash used in operating activities the quarter ended December 31, 2022, was $4.0 million, as compared to $4.4 million in the fourth quarter of 2021. Net cash used in operating activities for the full year of 2022 was $16.6 million, as compared to net cash used of $13.6 million reported in 2021. This increase is primarily due to the increase in our net loss from operations.
Cash, cash equivalents and restricted cash at December 31, 2022 totaled $18.0 million, as compared to $34.7 million as of December 31, 2021.
Financial Guidance
electroCore today introduced the following preliminary unaudited financial guidance for the first quarter of 2023 and revenue guidance for full-year 2023:
The Company expects net revenue for the full year 2023 to be in the range of $14.0 - $15.0 million. The Company believes that its legacy headache channels will again grow by more than 50% to at least $12 million in net revenue for the full year and that net revenue from new products in its Truvaga and TAC-STIM brands could be more than $2 million for the full year.
The Company expects net cash usage in the first quarter 2023 to increase as compared to the fourth quarter of 2022, largely due to seasonal factors affecting working capital and increased investment in product evolution.
Webcast and Conference Call Information
electroCore’s management team will host a conference call today, March 8, 2023, beginning at 4:30 pm EST. Investors interested in listening to the conference call or webcast may do so by dialing 877-269-7756 for domestic callers or 201-689-7817 for international callers, using conference ID: 13736452, or click through the following link:
https://event.choruscall.com/mediaframe/webcast.html?webcastid=bHYAWnTU.
An archived webcast of the event will be available on the “Investors” section of the Company’s website at: www.electrocore.com.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
Forward-Looking Statements
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; business prospects around new and potential products, including those for human performance and wellness, financial guidance for the first quarter of 2023 and revenue guidance for the full-year of 2023, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," and 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™, TAC-STIM™, and Truvaga™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, inflation and currency fluctuations, 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 economic and 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.
Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
electroCore, Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
Three months ended Year ended
December 31, December 31,
2022 2021 2022 2021
Net sales $ 2,560 $ 1,491 $ 8,592 $ 5,451
Cost of goods sold 640 292 1,616 1,385
Gross profit 1,920 1,199 6,976 4,066
Operating expenses
Research and development 1,628 742 5,520 2,536
Selling, general and administrative 6,209 5,929 24,330 21,573
Total operating expenses 7,837 6,671 29,850 24,109
Loss from operations (5,917 ) (5,472 ) (22,874 ) (20,043 )
Other (income) expense
Gain on extinguishment of debt — — — (1,422 )
Gain on termination of joint venture — (549 ) — (549 )
Interest and other income (142 ) (3 ) (287 ) (11 )
Other expense 1 1 6 8
Total other (income) expense (141 ) (551 ) (281 ) (1,974 )
Loss before income taxes (5,776 ) (4,921 ) (22,593 ) (18,069 )
(Provision) benefit from income taxes (14 ) (26 ) 431 851
Net loss $ (5,790 ) $ (4,947 ) $ (22,162 ) $ (17,218 )
Net loss per share of common stock - Basic and Diluted $ (1.22 ) $ (1.05 ) $ (4.69 ) $ (4.36 )
Weighted average number of common shares outstanding - Basic and Diluted 4,744 4,711 4,729 3,945
All common stock share and per share data reflects the reverse stock split effective February 15, 2023.
electroCore, Inc.
Consolidated Balance Sheet Information
(Unaudited)
(in thousands)
December 31, 2022 December 31, 2021
Cash and cash equivalents $ 17,712 $ 34,689
Restricted cash $ 250 $ —
Total assets $ 24,756 $ 42,833
Current liabilities $ 7,045 $ 5,485
Total liabilities $ 7,670 $ 6,185
Total equity $ 17,086 $ 36,648
(Unaudited) Use of Non-GAAP Financial Measure
The Company is presenting adjusted EBITDA net loss because it believes this measure is a useful indicator of its operating performance. electroCore management uses this non-GAAP measure principally as a measure of the Company’s core operating performance and believes that this measure is useful to investors because it is frequently used by the financial community, investors, and other interested parties to evaluate companies in the Company’s industry. The Company also believes that this measure is useful to its management and investors as a measure of comparative operating performance from period to period. Additionally, the Company believes its use of non-GAAP adjusted EBITDA net loss from operations facilitates management’s internal comparisons to historical operating results by factoring out potential differences caused by gains and charges not related to its regular, ongoing business, including, without limitation, non-cash charges and certain large and unpredictable charges such as restructuring expenses.
The Company defines adjusted EBITDA net loss as GAAP net loss, adjusting to exclude non-operating gains/losses, depreciation and amortization, stock-compensation expense, write-off of right of use operating lease, inventory reserve charges, legal fees associated with stockholders’ litigation, and provision/benefit from income taxes. A reconciliation of GAAP net loss to Non-GAAP adjusted EBITDA net loss is provided in the financial statement table below.
Three months ended Year ended
December 31, December 31,
(in thousands) 2022 2021 2022 2021
GAAP net loss $ (5,790 ) $ (4,947 ) $ (22,162 ) $ (17,218 )
Depreciation and amortization 148 95 548 382
Stock-based compensation 587 761 2,682 3,302
Inventory reserve charge 217 70 217 70
Gain on extinguishment of debt — — — (1,422 )
Gain on termination of joint venture — (549 ) — (549 )
Gain on lease settlement — (57 ) — (57 )
Legal fees associated with stockholders’ litigation 251 187 400 581
Interest and other income / expense (141 ) (2 ) (281 ) (3 )
Provision (benefit) from income taxes 14 26 (431 ) (851 )
Adjusted EBITDA net loss $ (4,714 ) $ (4,416 ) $ (19,027 ) $ (15,765 )
The Company’s use of a non-GAAP measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of its results as reported under GAAP. Some of these limitations are: (i) the non-GAAP measure does not reflect interest or tax payments that may represent a reduction in cash available; (ii) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and the non-GAAP measure does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; (iii) the non-GAAP measure does not reflect the potentially dilutive impact of equity-based compensation; and (iv) the non-GAAP measure does not reflect changes in, or cash requirements for working capital needs; other companies, including companies in electroCore’s industry, may calculate adjusted EBITDA net loss differently, effectively reducing its usefulness as a comparative measure.
Because of these and other limitations, you should consider the non-GAAP measure together with other GAAP-based financial performance measures, including various cash flow metrics, net loss, and other GAAP results. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the preceding financial statements table of this press release.
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Happy Sunday Mick
I agreed and selling shares only
Now time to get back to the reverse split play
Yeah
$T AT&T Stock Loses $10 Billion in Value After Newsmax Drop
https://www.newsmax.com/us/directv-at-t-stock/2023/02/11/id/1108254/?dkt_nbr=6F1212r9kwed