Lineage Announces Worldwide License Agreement With Immunomic Therapeutics For An Allogeneic Cell-Based Cancer Immunotherapy Based On Its Vac Platform

 

electroCore, Inc. Announces Exclusive Distribution Agreement with East Agency For Qatar

 

ROCKAWAY, NJ, 
April 20, 2021 (GLOBE NEWSWIRE) —  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with East Agency to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) to patients suffering from primary headache disorders in 
Qatar.

“East Agency is a dedicated healthcare company focusing on high-end technologies and innovations targeting the Qatari market, and the addition of such an innovative technology in electroCore’s nVNS therapy is a matter of pride for us” said Mohammed Abdul Moqeeth, Head of the 
Medical Division of East Agency. “nVNS therapy can save patients from traumatic situations with no present solutions and it is always exciting to offer solutions rather than just products. 
East Agency is determined to honor its commitment to establish gammaCore in the region.”

“We are excited to be working with 
East Agency as we bring our nVNS therapy to the 
Middle East region initially in the State of Qatar” said Iain Strickland, electroCore’s Vice President of European Operations. “East Agency is experienced in introducing innovative medical technologies within 
Qatar and we look forward to supporting them in introducing our nVNS therapy, gammaCore Sapphire, in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions, including minimum purchase commitments.

        
About East Agency

East Agency was founded in 1997 as a sister concern of 
AlAli Holdings. The company is privately owned and has diversified business activities marking its presence in almost every sector of the medical industry.

East Agency has been providing quality healthcare services to 
Qatar in government, Public and Private sectors dealing in Dental, Medical Devices, Hospital consumables, Pharma, Derma, Lab Chemicals and Diagnostic Equipment & Reagents.

For more information, visit http://medical.eastagency.com/about-us.html

About electroCore, Inc.

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

For more information, visit www.electrocore.com.

About gammaCore^TM

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

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

• gammaCore is contraindicated for patients with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric
  • Patients (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
    
    

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 Company’s business prospects in 
Qatar 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.

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

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Genprex to Receive Inaugural “License of the Year” Award from University of Pittsburgh Innovation Institute in Recognition of Advances Made with Gene Therapy Program in Diabetes

 

Genprex to Receive Inaugural “License of the Year” Award from University of Pittsburgh Innovation Institute in Recognition of Advances Made with Gene Therapy Program in Diabetes

 

electroCore, Inc. Announces Exclusive Distribution Agreement with East Agency For Qatar

 

ROCKAWAY, NJ, 
April 20, 2021 (GLOBE NEWSWIRE) —  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with East Agency to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) to patients suffering from primary headache disorders in 
Qatar.

“East Agency is a dedicated healthcare company focusing on high-end technologies and innovations targeting the Qatari market, and the addition of such an innovative technology in electroCore’s nVNS therapy is a matter of pride for us” said Mohammed Abdul Moqeeth, Head of the 
Medical Division of East Agency. “nVNS therapy can save patients from traumatic situations with no present solutions and it is always exciting to offer solutions rather than just products. 
East Agency is determined to honor its commitment to establish gammaCore in the region.”

“We are excited to be working with 
East Agency as we bring our nVNS therapy to the 
Middle East region initially in the State of Qatar” said Iain Strickland, electroCore’s Vice President of European Operations. “East Agency is experienced in introducing innovative medical technologies within 
Qatar and we look forward to supporting them in introducing our nVNS therapy, gammaCore Sapphire, in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions, including minimum purchase commitments.

        
About East Agency

East Agency was founded in 1997 as a sister concern of 
AlAli Holdings. The company is privately owned and has diversified business activities marking its presence in almost every sector of the medical industry.

East Agency has been providing quality healthcare services to 
Qatar in government, Public and Private sectors dealing in Dental, Medical Devices, Hospital consumables, Pharma, Derma, Lab Chemicals and Diagnostic Equipment & Reagents.

For more information, visit http://medical.eastagency.com/about-us.html

About electroCore, Inc.

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

For more information, visit www.electrocore.com.

About gammaCore^TM

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

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

• gammaCore is contraindicated for patients with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric
  • Patients (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
    
    

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 Company’s business prospects in 
Qatar 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.

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

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

 

Lineage Announces Worldwide License Agreement With Immunomic Therapeutics For An Allogeneic Cell-Based Cancer Immunotherapy Based On Its Vac Platform

 

 

Understanding the FDA Medical Device Approval Pathways Helps Investors

 

In order to be marketed in the US, medical devices must submit an application to the FDA (Food and Drug Administration) for marketing clearance or approval.   The FDA has developed different regulatory pathways for device manufacturers, depending on the type and classification of the device, the use of the device, and the risk associated with the device. These different pathways must be understood for the approval process to be navigated correctly and expeditiously.

Defining Medical Device

First, it must be determined whether a company indeed has a medical device that it wishes to market. So, what exactly is a medical device? According to Section 201(h) of the Food, Drug, and
Cosmetic Act (FD&C), enacted in 1938, a device is:  An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. Intended to affect the structure or any function of the body of man or animals, and does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Excluded from the definition of “device” is software functions pursuant to section 520(o) of the FD&C where software is intended for administrative support, serving as patient records, or transferring and storing data.

Essentially, a device can be any product that is not a service or a pharmaceutical and can be as simplistic as a bedpan, as complex as an ICD (defibrillator) and everything in between, including in vitro diagnostic next-generation sequencing tests and X-Rays.  The FDA also considers certain software, mobile applications, artificial intelligence (AI), and machine learning (ML) technologies as devices.  There will be more on this later.

Pathway Selection

Determining that the product is a device is fairly straightforward, but what regulatory approval pathway should be taken?  Medical devices are categorized into three classes of risk.  Class I devices present minimal, low potential for harm, while Class II moderate risk is higher than Class I and includes devices like catheters and syringes. Class III devices represent the highest risk with the greatest potential for harm.  Typically, these Class III devices are implanted (pacemakers, defibrillators) or support and sustain life, will require investigational trials, and many times require outside panel review and post-marketing studies.

There are five FDA device marketing classification pathways addressing risk levels and currently marketed product similarities.

1. The most strenuous, stringent, and difficult pathway is the Premarket
   Approval (PMA) classification.  Once a PMA filing is made, the average time to approval is 243 days. As previously indicated, the FDA considers Class III devices high risk requiring a PMA classification. If it’s unclear whether the device requires a PMA, the FDA provides the ability to search its database for substantially equivalent previously approved devices. Once approved, any substantial changes to a PMA must have a PMA supplement reviewed and approved by the FDA
2. For Class II moderate-risk devices and where most have a predicate device cleared, the FDA often requires a Premarket Notification 510(k) clearance before marketing.  Despite the 510(k) process being less onerous, it still takes an average of 177 days to receive marketing clearance. Like the PMA, if it’s unclear whether the device requires a 510(k), searching the FDA database for already marketed products with substantial equivalence will help.   Similar to a PMA supplement, a new 510(k) application must be submitted if substantial product changes affect the safety and effectiveness of the cleared device.  
   1. Most low-risk Class I devices like
      tongue depressors, and some Class II devices like hearing aids and catheter
      guide wires are exempt from a 510(k) requirement.
3. Novel and low to moderate risk (Class I or II) devices would follow a De Novo classification pathway.  This pathway addresses devices that do not have a valid marketed equivalent. Upon benefit/risk review, the FDA may determine a classification for future similar products.
4. In limited use for rare disease conditions, the Humanitarian Device
   Exemption (HDE) might be used as a pathway. Congress included a provision in the Safe Medical Devices Act of 1990 to create this pathway for treatments in small populations if the product/device will not expose a patient to significant risk of illness or injury, and the device would not be available without the HDE. A Humanitarian Use
   Device (HUD) with an HDE intends to treat fewer than 8000 individuals annually. Importantly, there are HDE profit restrictions unless the product is labeled for pediatric patients or adult patients where pediatric applications are impossible or unsafe.
5. Emerging from the Investigational Device (IDE) program was the Pre-Submission
   pathway. The Pre-Submission is where the applicant seeks feedback from the FDA about a planned marketing application. Keep in mind an IDE should not be confused with the clearance or approval pathways above.  IDEs are required to allow a device to be used in clinical studies to support future marketing applications.

Now that the basic pathways have been covered, do non-traditional AI and machine-learning software and mobile applications fit in as medical devices? If so, what pathways do they use?

 

 

Medical Software

In 1993, the International Medical Device Regulators Forum (IMDRF) developed definitions for Software as a Medical Device (SaMD) given the advances using healthcare technology platforms.  Among other things, the IMDRF created two definitions.

1. software in a medical device
2. software as a medical device (SaMD)

The second SaMD category is defined as the medical device. SaMD had to be capable of running on non-medical platforms and was not part of or embedded in a hardware medical device to make the hardware device work. If the software was embedded, then it would fall into the first category and not be considered a medical device.

The FDA piggybacked off these definitions and in September 2019 the FDA produced non-binding recommendations in its Policy for Device Software Functions and Mobile Medical Applications. In this Policy, the FDA did not expect to regulate software or mobile apps that do not meet the IMDRF or the FD&C definitions of a device. For instance, mobile apps that promote a healthy lifestyle, or meal planners, or daily activity trackers would not meet the device definition.  But if meeting the device definition, the high-, moderate- and low-risk factor classifications outlined earlier would determine the type of marketing application.

The regulatory pathway is still evolving as the FDA adapts to new AI and ML technologies. AI/ML-based SaMD capabilities come from the ability to continuously learn, where the adaptation or change to the algorithm is realized after the SaMD is distributed for use and has gained real-world experience. The FDA first produced a proposed regulatory framework for AI and ML software as a medical device in April 2019. In February 2020, the FDA announced the first marketing authorization, through the De Novo pathway, of the first AI cardiac ultrasound software built by Caption Health (private) using the principle of Predetermined Change Control Plan. This plan reflected the anticipated modifications for the SaMD. Most recently, advancing the process to utilize adaptive technologies, the FDA produced an Action Plan in January 2021 that would include the types of anticipated algorithm modifications (SaMD Pre-Specifications) and methodologies used. 

 

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Photo:  Medical Imaging and Therapeutics, surgical suite for minimally invasive procedures

 

Virtual Road Show Series – Wednesday April 21 @ 1:00pm EST Join PDS Biotechnology CEO Frank Bedu-Addo, CMO Lauren Wood, and CFO Seth Van Voorhees for this exclusive corporate presentation, followed by a Q & A session moderated by Robert LeBoyer, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level. Register Now  |  View All Upcoming Road Shows

 

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PDS Biotech Announces Participation in Noble Capital Markets Virtual Road Show Series

 

Florham Park, NJ, April 19, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced their participation in Noble Capital Markets’ Virtual Road Show Series, presented by Channelchek, scheduled for April 21, 2021.

The virtual roadshow will feature a corporate presentation from PDS Biotech President and CEO Dr. Frank Bedu-Addo, Chief Medical Officer Dr. Lauren Wood and Chief Financial Officer Seth Van Voorhees followed by a question and answer session proctored by Noble Senior Research Analyst Robert LeBoyer, featuring questions submitted by the audience.

The live broadcast of the virtual roadshow is scheduled for April 21, 2021, at 1 PM EDT. Registration is free and open to all investors, at any level. Register Here.

Noble’s research, as well as news and advanced market data on PDS Biotechnology is available on Channelchek.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Versamune^® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 36 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email: contact@noblecapitalmarkets.com

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email: contact@channelchek.com

CONTACT: Investor Contact:
Rich Cockrell
CG CAPITAL
404.736.3838
PDSB@cg.capital

Company Contact:
Deanne Randolph
PDS Biotech
Phone: 908.517.3613
drandolph@pdsbiotech.com

 

PDS Biotech Announces Participation in Noble Capital Markets Virtual Road Show Series

 

Florham Park, NJ, April 19, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced their participation in Noble Capital Markets’ Virtual Road Show Series, presented by Channelchek, scheduled for April 21, 2021.

The virtual roadshow will feature a corporate presentation from PDS Biotech President and CEO Dr. Frank Bedu-Addo, Chief Medical Officer Dr. Lauren Wood and Chief Financial Officer Seth Van Voorhees followed by a question and answer session proctored by Noble Senior Research Analyst Robert LeBoyer, featuring questions submitted by the audience.

The live broadcast of the virtual roadshow is scheduled for April 21, 2021, at 1 PM EDT. Registration is free and open to all investors, at any level. Register Here.

Noble’s research, as well as news and advanced market data on PDS Biotechnology is available on Channelchek.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Versamune^® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 36 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email: contact@noblecapitalmarkets.com

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. channelchek.vercel.app email: contact@channelchek.vercel.app

CONTACT: Investor Contact:
Rich Cockrell
CG CAPITAL
404.736.3838
PDSB@cg.capital

Company Contact:
Deanne Randolph
PDS Biotech
Phone: 908.517.3613
drandolph@pdsbiotech.com

Ocugen Inc. Announces John Paul Gabriel as Senior Vice President, Manufacturing and Supply Chain

 

MALVERN, Pa., April 14, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that John Paul (J.P.) Gabriel will be joining as Senior Vice President (SVP), Manufacturing and Supply Chain.

John Paul (J.P.) Gabriel is a seasoned biopharmaceutical manufacturing professional with over 25 years of industry experience. Over the course of his career, Mr. Gabriel has held leadership positions with Sanofi Pasteur (formerly Connaught Laboratories), Pfizer Vaccines (formerly Wyeth), Genentech/Roche, and most recently with Ultragenyx Pharmaceutical, where he was Vice President of Biologics and mRNA Manufacturing.

“We are pleased to welcome J.P. to the Ocugen team as we continue to plan for COVAXIN manufacturing in the US. As an established biopharma and vaccines operations leader, J.P. brings a wealth of manufacturing experience that will be instrumental in the technology transfer from Bharat Biotech for manufacturing in the U.S. market,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“I’m thrilled to be part of the Ocugen team and share the team’s dedication to save lives from COVID-19. Bringing COVAXIN to the US market will be an important addition to our national arsenal of vaccines against COVID-19,” said J.P. Gabriel, SVP, Manufacturing and Supply Chain of Ocugen.

In addition to his expertise in biomanufacturing, Mr. Gabriel led teams in quality and validation and has extensive experience interacting with various international health authorities. He has broad international business knowledge gained from work assignments in Canada, Switzerland, Japan, Mexico, and the United States. Mr. Gabriel earned an Honors Bachelor of Science in Biological Sciences with a Major in Microbiology and Minor in Biotechnology from the University of Guelph in Canada and an Advanced Certificate in Regulatory Affairs from the University of California San Diego. 

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and develop a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 978-395-5970

Ocugen Inc. Announces John Paul Gabriel as Senior Vice President, Manufacturing and Supply Chain

 

MALVERN, Pa., April 14, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that John Paul (J.P.) Gabriel will be joining as Senior Vice President (SVP), Manufacturing and Supply Chain.

John Paul (J.P.) Gabriel is a seasoned biopharmaceutical manufacturing professional with over 25 years of industry experience. Over the course of his career, Mr. Gabriel has held leadership positions with Sanofi Pasteur (formerly Connaught Laboratories), Pfizer Vaccines (formerly Wyeth), Genentech/Roche, and most recently with Ultragenyx Pharmaceutical, where he was Vice President of Biologics and mRNA Manufacturing.

“We are pleased to welcome J.P. to the Ocugen team as we continue to plan for COVAXIN manufacturing in the US. As an established biopharma and vaccines operations leader, J.P. brings a wealth of manufacturing experience that will be instrumental in the technology transfer from Bharat Biotech for manufacturing in the U.S. market,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“I’m thrilled to be part of the Ocugen team and share the team’s dedication to save lives from COVID-19. Bringing COVAXIN to the US market will be an important addition to our national arsenal of vaccines against COVID-19,” said J.P. Gabriel, SVP, Manufacturing and Supply Chain of Ocugen.

In addition to his expertise in biomanufacturing, Mr. Gabriel led teams in quality and validation and has extensive experience interacting with various international health authorities. He has broad international business knowledge gained from work assignments in Canada, Switzerland, Japan, Mexico, and the United States. Mr. Gabriel earned an Honors Bachelor of Science in Biological Sciences with a Major in Microbiology and Minor in Biotechnology from the University of Guelph in Canada and an Advanced Certificate in Regulatory Affairs from the University of California San Diego. 

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and develop a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 978-395-5970

electroCore Provides Business Update and Select First Quarter 2021 Financial Guidance

 

• First-quarter 2021 revenue expected to be more than $1.1 million
  
• Net cash used for the first quarter 2021 of approximately $4.1 million 

ROCKAWAY, NJ, April 13, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an operating and business update as well as select unaudited preliminary financial guidance for the first quarter of 2021.

“We are pleased to announce a return to strong sequential revenue growth in the first quarter of 2021,” stated  Dan Goldberger, Chief Executive Officer of electroCore. In addition to strong performances in 
the United States and the 
United Kingdom, our new OUS distributor relationships have begun generating revenue with initial orders totaling approximately 
$45,000 from 
Eastern Europe and 
Australia, and initial revenue from our new Canadian distributor is expected in the second quarter. Additionally, we have recently announced an exclusive distribution agreement with Silvert Medical who will distribute gammaCore™ in the Western European countries of 
Belgium, Luxembourg, 
the Netherlands, and 
France. We look forward to supporting our new OUS distribution relationships and growing the use of gammaCore as a therapeutic option for multiple forms of primary headache by expanding global distribution throughout 2021.”

Operational:

Government Channels: During the first quarter of 2021, we began to see clinician meetings with our staff increase within the 
Department of Veterans Affairs (“VA”), as the number of COVID-19 cases decreased within the system. There have been a total of 79 
VA and 
Department of Defense (“DoD”) military treatment facilities that have purchased gammaCore products through Q1 2021, as compared to 71 through the fourth quarter of 2020 and 64 through the first quarter of 2020. Also, during the first quarter of 2021, the company shipped approximately 1,768 paid months of therapy pursuant to 
VA and 
DoD originating prescriptions, compared to 1,232 during the fourth quarter of 2020 and 1,084 during the first quarter of 2020. 

Outside of the U.S.: During the first quarter of 2021, electroCore shipped approximately 1,156 paid months of therapy outside of 
the United States directly to patients, as compared to 1,123 during the fourth quarter of 2020 and 1,008 during the first quarter of 2020. Note the newly engaged distributors around the world are not included in this metric.

In 
January 2021, 
NHS England and 
NHS Improvement announced that gammaCore would be included in their new long-term reimbursement scheme titled “NHS Improvement MedTech Funding Mandate Policy 2021/22”, which became effective on 
April 1, 2021. We are working with 
NHS England to transition providers and commissioners from the 
NHS Innovation and Technology Program (ITP) to the MedTech Funding Mandate policy.

Similarly, in 
January 2021 Health Improvement Scotland (“HIS”) published a 
Scottish Health Technology Group (“SHTG”) adaptation of our NICE Medical Technology Guidance (MTG46) for 
NHS Scotland on the use of gammaCore for cluster headache. The SHTG adaptation is now being disseminated across 
NHS Scotland health boards to inform the use of gammaCore for cluster headache.

In 
February 2021, gammaCore’s listing in the 
NHS Supply Chain catalogue was extended for an additional two years through 
June 3, 2023. The 
NHS Supply Chain helps 
NHS deliver clinically assured, quality products at the best value to its patients and the inclusion of gammaCore in the catalogue allows hospitals to purchase gammaCore Sapphire™ for their primary headache patients, taking into account their own budgetary restrictions. The listing of gammaCore Sapphire as an e-Direct product marks an important milestone in the Company’s provision of its medical technologies to 
UK patients, in an easy, cost-effective way.

In recent months, we took meaningful steps to expand gammaCore’s global availability. In December, we announced an exclusive distribution agreement with Pro Medical Baltic to distribute gammaCore in 
Eastern Europe, including 
Lithuania, 
Latvia, 
Belarus, 
Kazakhstan, 
Ukraine, and most recently, 
Romania. In January, we entered into a similar agreement with RSK Medical in 
Canada, and in February, we announced an agreement with Medistar to serve as the exclusive distributor for gammaCore in 
Australia. Most recently, in 
March 2021 we announced an exclusive distribution agreement with Silvert Medical to make gammaCore therapy available in certain 
Western Europe countries such as 
Belgium, Luxembourg, 
the Netherlands, and 
France. We look forward to further expanding our global network with leading medical technology distribution partners to make gammaCore more broadly available outside the 
USA throughout 2021.

Commercial: The company continues to make measured investments in its Commercial channel.

In 
January 2021, we announced that CMS published its most recent Level II Healthcare Common Procedure Coding System, commonly known as HCPCS, establishing a unique code “K1020” for “Non-invasive vagus nerve stimulator.” All final coding decisions for the second biannual 2020 Coding Cycle for non-drug and non-biological items and services went into effect on 
April 1, 2021. We view the establishment of a unique HCPCS code for non-invasive vagus nerve stimulation (“nVNS”) as an important differentiator, and a potentially significant step forward in obtaining additional coverage of our proprietary nVNS therapy within the medical benefit pathway.

Research and Development: During the first quarter of 2021, we announced that the FDA cleared our 510(k) submission to expand the gammaCore label to include the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age.

In 
February 2021, we announced that full enrollment had been achieved in the investigator-initiated TR-VENUS study evaluating the utility of nVNS for the acute treatment of stroke. We look forward to reporting data from the TR-VENUS trial later this year.

Also, in 
February 2021, we announced publication of a study in the journal Colorectal Disease that further demonstrates the broad potential of nVNS. The study evaluated the effectiveness of nVNS in preventing post-operative ileus following major elective colorectal surgery. The results detailed in this paper strongly support continued development in this indication and a larger study funded by the 
National Institute for Health Research in England is ongoing.

Lastly, we recently announced preliminary results from 110 hospitalized patients enrolled in the investigator-initiated SAVIOR-1 trial in 
Valencia, Spain, which is evaluating nVNS as a potential treatment for COVID-19. nVNS was well tolerated with no major device-related adverse events and the results suggest nVNS that could be a viable treatment for patients and possibly help decrease symptoms early in the course of the disease. Full results are expected to be published in a peer-reviewed journal later this year.

We will continue to provide updates on the progress of ongoing gammaCore investigator-initiated trials in a variety of conditions as they become available.

Financial Guidance:

electroCore today announced the following preliminary unaudited financial guidance for the first quarter of 2021:

First Quarter 2021 Revenue: electroCore anticipates that first quarter 2021 revenue will be more than 
$1.1 million, representing greater than 50% growth over first quarter 2020 revenue of 
$0.7 million and greater than 20% growth over fourth quarter 2020 revenue of 
$0.9 million.

March 31, 2021 cash: The company ended the first quarter of 2021 with approximately 
$25.5 million of cash, cash equivalents and marketable securities, compared to 
$22.6 million as of 
December 31, 2020. The company raised 
$6.9 million during the quarter under a stock purchase agreement. That stock purchase agreement was voluntarily terminated by the company before the end of the first quarter. This capital raise was offset by net cash used of approximately 
$4.1 million to fund operations during the first quarter of 2021.

The company intends to provide a detailed operational and financial update during its first quarter 2021 earnings call in May.

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^TM

gammaCore^TM (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, 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 contraindications include but are not limited to:

• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Patients with a metallic device, such as a stent, bone plate or bone screw, implanted at or near the neck
• Patients who 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 of age)
• 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.

The 
U.S. FDA has cleared the gammaCore Sapphire CV (nVNS) device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient’s neck.

gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.

More information can be found at:

Letter of authorization: https://www.fda.gov/media/139967/download

Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download

Patient information sheet: https://www.fda.gov/media/139969/download

Instructions for use of gammaCore: https://www.fda.gov/media/139970/download

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 about electroCore’s expectations for revenue and cash used in operations during the first quarter of 2021, its expectations for future performance, as well as electroCore’s business prospects and clinical and product development plans for 2021 and beyond, its pipeline or potential markets for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of nVNS in COVID-19-19 patients in 
Spain, the 
U.S., or elsewhere, and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government funding arrangements (including those relating to 
NHS England, HIS and SHTG) 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™, 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:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com