electroCore Announces New Patent Expanding Claims Related to Delivery of Non-Invasive Vagus Nerve Stimulation Therapy Using Mobile Devices

ROCKAWAY, NJ, 
Sept. 15, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office has issued US Patent No. 11,097,102 to electroCore, relating to devices, systems and methods integrated with, or coupled to, smartphones that allow patients to self-treat medical conditions, such as migraine headache, by electrical non-invasive stimulation of nerves. The ‘102 patent is the 8^th US patent issued to ECOR in the company’s mobile connectivity platform, with additional US and International matters pending.

electroCore is building a portfolio of Intellectual Property (IP) around smartphone-integrated and smartphone connected non-invasive therapy. This IP may provide a foundation for combining the company’s clinically proven non-invasive Vagus Nerve Stimulation (nVNS) with application-based digital health platforms that could enable health care providers to use Remote Patient Monitoring or Remote Therapeutic Monitoring reimbursement codes. That combination, in turn, may enable future business models and revenue streams for the company’s products.

“This latest patent supports our IP portfolio focused on using mobile phone systems and methods to deliver non-invasive therapy,” said JP Errico, founder, board member and investor of electroCore, and co-inventor of the new patent. “By merging smartphones and medical devices, we hope to change how external neuromodulation devices are configured to deliver therapy, creating the potential for connected devices and/or smartphones that can not only monitor biomarkers like EKGs and EEGs, but can actually deliver therapy, thereby expanding the potential reach of our platform non-invasive vagus nerve therapy to millions of patients across the globe.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (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, the treatment of paroxysmal hemicrania and hemicrania continua in adults, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients 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:

• 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
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

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 issuance of US and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential combining of nVNS and smartphone or application-based technologies; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular 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.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Data From Ongoing Clinical Trial Continues to Demonstrate a Single Administration of OpRegen® Can Provide Anatomical and Functional Improvements in Patients With Dry AMD With Geographic Atrophy

• First Reported Case of Retinal Tissue Restoration Showed Zero Growth of Atrophy at 33 Months
• Second Case of Retinal Tissue Restoration Exhibited a 10% Reduction in Atrophy Size at 8 Months
• Third Case of Retinal Restoration is 18 Letters Above Baseline at Last Available Time Point
• Average Difference in BCVA Between Treated and Untreated Eyes Was More Than Two ETDRS Lines (10.8 Letters Read) in Cohort 4 Patients at 9-12 Months Post-Treatment

CARLSBAD, Calif.–(BUSINESS WIRE)–Sep. 15, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported updated interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells, administered in a single surgery to the subretinal space, for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). These updated results include a minimum of 9 months of follow-up in all 12 patients treated in Cohort 4, which as a group had better baseline vision and smaller areas of GA at baseline than earlier cohorts. Overall, in the study (N=24), OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events not previously reported.

“I am particularly encouraged by the OCT findings in the second retinal restoration patient. Based on historical growth patterns, we knew this patient was a slower progressor than many other patients enrolled, and therefore less likely to benefit from treatment. Despite this, we have been able to demonstrate a reduction in the atrophic area as quickly as 2 months post-treatment and a marked slowing of disease progression,” stated Jordi Monés, M.D., Ph.D., Director of the Institut de la Màcula and 
Barcelona Macula Foundation. “Further, even in patients with an incomplete coverage of OpRegen over the primary area of atrophy, we have observed resolution of not only lesions of iRORA (incomplete retinal pigment epithelial and outer retinal atrophy), but also resolution of areas with features of cRORA, which is a state of complete loss of the RPE and outer retinal tissue. Additionally, the structural benefits may help explain the improvement in visual acuity. I eagerly look forward to new data as they are collected.”

“While competing efforts are focused on reducing the growth rate of geographic atrophy, Lineage has reported several patients whose areas of atrophy have stabilized or reduced in size. These observations, which are present across clinically-meaningful periods, indicate a reversal of the degeneration of critical retinal tissue layers which support vision, consistent with the proposed mechanism of an RPE cell transplant. Importantly, all three of the patients exhibiting restoration had confirmed historic growth rate in these areas and these data have been collected using multiple imaging modalities. The durability of the improvements to visual acuity, when coupled with the clear structural improvements we’ve seen in patients which received fuller coverage of OpRegen across their GA, strongly suggest that cell therapy may be able to achieve therapeutic benefits that are beyond the reach of targeted drugs or antibodies,” added  Brian M. Culley, Lineage CEO. “We are extremely pleased that our data is moving in a positive direction with each interim update we provide. We will continue to collect follow up data and work towards a meeting with FDA to discuss key aspects of our program. Our objective with OpRegen is to demonstrate the potential for allogeneic cell therapy to deliver the best available clinical outcomes and apply our technology to additional areas such as cancer, spinal cord injury, and other attractive opportunities.”

OpRegen Phase 1/2a Interim Clinical Results

• Overall, 8/12 (67%) of the Cohort 4 patients’ treated eyes were at or above baseline visual acuity at their last assessment, based on per protocol scheduled visits ranging from 9 months to over 3 years post-transplant. Conversely, 9/12 (75%) of the patients’ untreated eyes were below baseline visual acuity at that assessment.
• Improvement in best corrected visual acuity (BCVA) reached up to +24 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for a Cohort 4 patient.
• Comparing all treated eyes to all fellow (untreated) eyes showed an average difference of 10.8 letters read in Cohort 4 patients at their last assessment.
• In those Cohort 4 patients with a benefit in treated as compared with fellow eye (10/12), the average difference between treated and untreated eyes was 13.6 letters read at the last assessment, which exceeded 3 years post-transplant for some patients.
• Among the six Cohort 4 patients treated between September and 
  November 2020, three (50%) continue to exhibit marked improvements in BCVA, ranging from +5 to +18 to +24 letters read at the patient’s last scheduled assessment, which was at least 9 months post-transplant.
• Among the other three Cohort 4 patients treated in the Fall of 2020, one patient showed a gain of +1 letter read and two patients measured -2 and -6 letters below baseline at their last assessment.
• Across the study, in patients with previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes have continued to be present.
• Evidence of durable engraftment of OpRegen RPE cells has extended to more than 5 years in the earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.

Retinal Tissue Restoration Update

• Three patients with evidence of retinal restoration and confirmed history of GA growth continue to demonstrate areas of retinal restoration as of their last per protocol assessments, ranging from 9 months to 33 months following treatment.
• The first Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, demonstrated zero growth in atrophy (GA) 33 months following treatment with OpRegen.
• The second patient with evidence of restoration of critical retinal structures showed a 10% reduction at approximately 8 months after treatment, as assessed by square root transformation (SQRT).
  • Based on historical images of the patient’s treated eye taken ~2 years prior to treatment, the area of GA had increased from approximately 2.39 mm to approximately 2.81 mm at baseline.
  • Following OpRegen transplantation, the atrophic lesion measured approximately 2.28 mm at the patient’s month 2 per protocol assessment visit, which was smaller than the historical size of 2.39 mm from the image taken ~2 years prior to treatment.
  • Additional follow-up showed the lesion size calculated as approximately 2.53 mm at the patient’s month 8 per protocol assessment visit, which continued to be smaller than baseline.
• The third case of restoration demonstrated clinically meaningful improvements in visual acuity, having gained +18 letters on the ETDRS chart since OpRegen transplantation, supporting the view that the changes in retinal structure observable on Optical Coherence Tomography (OCT) can result in functional benefit.

As previously described, outer retinal layer restoration was observed using clinical high-resolution OCT. To be considered as suggestive of retinal restoration, new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment, had to be present post-treatment with OpRegen. These findings, observed in 3 Cohort 4 patients, suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of these cells. These effects were most prominent in the transitional areas around the primary area of atrophy. The use of OCT allows for a more precise determination of changes in retinal thickness, organization, and overall health of the retina in areas of potential atrophy, benefits which are possible with cell transplant therapy.

The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as atrophic AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which led to a presumption that progression of GA may someday be slowed or halted but could not be reversed. The unique findings from the ongoing OpRegen clinical study support a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. The totality of these findings supports the view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable.

About OpRegen
OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with BCVA of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration (FDA), or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

electroCore Announces 510(k) Clearance of gammaCore™ Non-Invasive Vagus Nerve Stimulation (nVNS) to Treat Paroxysmal Hemicrania and Hemicrania Continua

ROCKAWAY, NJ, 
Sept. 14, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that on September 10, 2021 the company received Section 510(k) clearance from the United States Food and Drug Administration (FDA) of the company’s submission to expand the label of gammaCore nVNS to include the treatment of Paroxysmal Hemicrania (PH) and Hemicrania Continua (HC) in adults.

PH and HC are both rare forms of trigeminal autonomic cephalalgias (TAC), that are typically debilitating and difficult to treat. The most common type of TAC is cluster headache. gammaCore is also indicated for both the acute and preventative treatment of cluster headache, where it is considered a first-line treatment option.

The label expansion was based on data collected from multiple clinical audits and case series/case reports that included patients with PH or HC. These included a total of 14 patients with PH and 19 patients with HC. 79% of the patients experienced clinically meaningful benefits from gammaCore for each indication, including decreases in the severity of persistent pain and/or reductions in the frequency, severity, and/or duration of exacerbations or attacks. Many subjects reported more than one clinical benefit. There were no serious or unexpected adverse events reported.

Professor  Peter Goadsby MD, PhD, DSc, President of the 
American Headache Society and Professor of Neurology at the 
University of California, Los Angeles commented, “Paroxysmal hemicrania and hemicrania continua have not been thoroughly studied leaving clinicians with few treatment options. gammaCore, which can be used to decrease the frequency, duration or intensity of PH and HC attacks, represents an important new treatment option for these patients.”

“gammaCore (nVNS) is the first treatment, drug or device, to be indicated for the treatment of paroxysmal hemicrania or hemicrania continua,” said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “The rare ability of nVNS to address several of the mechanistic pathways that contribute to the pain and symptoms of headache allows gammaCore to be used by patients as a treatment option for most forms of primary headache. We would like to thank the Division of Neuromodulation and Physical Medicine Devices and their colleagues at the FDA for their efforts to review and clear these new indications for gammaCore.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (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, the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and the treatment of paroxysmal hemicrania and hemicrania continua in adults. 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:

• 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
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

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 availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat Paroxysmal Hemicrania and Hemicrania Continua and related disorders 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.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

electroCore Announces 510(k) Clearance of gammaCore™ Non-Invasive Vagus Nerve Stimulation (nVNS) to Treat Paroxysmal Hemicrania and Hemicrania Continua

ROCKAWAY, NJ, 
Sept. 14, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that on September 10, 2021 the company received Section 510(k) clearance from the United States Food and Drug Administration (FDA) of the company’s submission to expand the label of gammaCore nVNS to include the treatment of Paroxysmal Hemicrania (PH) and Hemicrania Continua (HC) in adults.

PH and HC are both rare forms of trigeminal autonomic cephalalgias (TAC), that are typically debilitating and difficult to treat. The most common type of TAC is cluster headache. gammaCore is also indicated for both the acute and preventative treatment of cluster headache, where it is considered a first-line treatment option.

The label expansion was based on data collected from multiple clinical audits and case series/case reports that included patients with PH or HC. These included a total of 14 patients with PH and 19 patients with HC. 79% of the patients experienced clinically meaningful benefits from gammaCore for each indication, including decreases in the severity of persistent pain and/or reductions in the frequency, severity, and/or duration of exacerbations or attacks. Many subjects reported more than one clinical benefit. There were no serious or unexpected adverse events reported.

Professor  Peter Goadsby MD, PhD, DSc, President of the 
American Headache Society and Professor of Neurology at the 
University of California, Los Angeles commented, “Paroxysmal hemicrania and hemicrania continua have not been thoroughly studied leaving clinicians with few treatment options. gammaCore, which can be used to decrease the frequency, duration or intensity of PH and HC attacks, represents an important new treatment option for these patients.”

“gammaCore (nVNS) is the first treatment, drug or device, to be indicated for the treatment of paroxysmal hemicrania or hemicrania continua,” said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “The rare ability of nVNS to address several of the mechanistic pathways that contribute to the pain and symptoms of headache allows gammaCore to be used by patients as a treatment option for most forms of primary headache. We would like to thank the Division of Neuromodulation and Physical Medicine Devices and their colleagues at the FDA for their efforts to review and clear these new indications for gammaCore.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (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, the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and the treatment of paroxysmal hemicrania and hemicrania continua in adults. 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:

• 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
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

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 availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat Paroxysmal Hemicrania and Hemicrania Continua and related disorders 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.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Helius Medical Technologies, Inc. Appoints Paul Buckman to its Board of Directors

NEWTOWN, Pa., Sept. 14, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the appointment of Paul Buckman to its Board of Directors, effective September 10, 2021. Mr. Buckman will serve as Chair of the Company’s Audit Committee and as a member of its Compensation and Nominating & Governance Committees.

“Paul is a highly accomplished executive with more than 30 years of experience in the medical device sector, including senior leadership positions at some of the most well-regarded companies in the industry,” said Blane Walter, Chairman of Helius’ Board of Directors. “I am pleased to welcome him to the Helius Board of Directors and look forward to his contributions as we pursue our next phase of growth and development.”

“I am excited to join the Helius Board of Direction at such an important stage in the Company’s history,” said Mr. Buckman. “I believe Helius is uniquely positioned in the market, with a novel and truly differentiated approach to treating underserved patients suffering from chronic, neurological conditions, leveraging its U.S. de novo classification and clearance for the treatment of patients with Multiple Sclerosis and the recent receipt of FDA Breakthrough Device Designation for stroke-induced gait and balance deficits. I look forward to working with my fellow Directors and the Helius leadership team as we build upon the Company’s recent progress and position it for long-term growth and value creation.”

Mr. Buckman is currently the President, North America for LivaNova, PLC (Nasdaq: LIVN), a global medical technology company that designs, develops, manufactures and sells innovative therapeutic solutions in the fields of neuromodulation and cardiovascular disease, a position he has held since 2017. In addition, he currently serves on the Board of Directors of several public and private medical device companies.

Prior to joining LivaNova, Mr. Buckman served as Chief Executive Officer of Conventus-Flower Orthopedics, a privately-held medical device company specializing in orthopedic and wound care products from September 2013 to March 2017. During the course of his 30+ year career in the medical device industry, Mr. Buckman has led numerous companies as the Chief Executive Officer of SentreHEART, Inc., Pathway Medical Technologies, Inc., Devax, Inc., ev3, LLC, and also served as President of the Cardiology division at both St. Jude Medical, Inc. and Boston Scientific Corporation.

Mr. Buckman received a B.B.A. and a M.B.A. from Western Michigan University in Kalamazoo, Michigan.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in Australia (“AUS”) and is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “will,” “goal,” “aim to” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future growth and operational progress, including its potential for long-term growth and value creation .

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program resulting from the 60-day deferral of the program implementation, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.