Image Credit: Kentucky National Guard (Flickr)

A Sensor Based on Quantum Physics Would Detect SARS-CoV-2 Virus Instantly

 

David L. Chandler | 
MIT
News Office

A novel approach to testing for the presence of the virus that causes Covid-19 may lead to tests that are faster, less expensive, and potentially less prone to erroneous results than existing detection methods. Though the work, based on quantum effects, is still theoretical, these detectors could potentially be adapted to detect virtually any virus, the researchers say.

The new approach is described in a paper published Thursday in the journal Nano Letters, by Changhao Li, an MIT doctoral student; Paola Cappellaro, a professor of nuclear science and engineering and of physics; and Rouholla Soleyman and Mohammad Kohandel of the University of Waterloo.

Existing tests for the SARS-CoV-2 virus include rapid tests that detect specific viral proteins, and polymerase chain reaction (PCR) tests that take several hours to process. Neither of these tests can quantify the amount of virus present with high accuracy. Even the gold-standard PCR tests might have false-negative rates of more than 25 percent. In contrast, the team’s analysis shows the new test could have false negative rates below 1 percent. The test could also be sensitive enough to detect just a few hundred strands of the viral RNA, within just a second.

The new approach makes use of atomic-scale defects in tiny bits of diamond, known as nitrogen vacancy (NV) centers. These tiny defects are extremely sensitive to minute perturbations, thanks to quantum effects taking place in the diamond’s crystal lattice and are being explored for a wide variety of sensing devices that require high sensitivity.

The new method would involve coating the nanodiamonds containing these NV centers with a material that is magnetically coupled to them and has been treated to bond only with the specific RNA sequence of the virus. When the virus RNA is present and bonds to this material, it disrupts the magnetic connection and causes changes in the diamond’s fluorescence that are easily detected with a laser-based optical sensor.

The sensor uses only low-cost materials (the diamonds involved are smaller than specks of dust), and the devices could be scaled up to analyze a whole batch of samples at once, the researchers say. The gadolinium-based coating with its RNA-tuned organic molecules can be produced using common chemical processes and materials, and the lasers used to read out the results are comparable to cheap, widely available commercial green laser pointers.

While this initial work was based on detailed mathematical simulations that proved the system can work in principle, the team is continuing to work on translating that into a working lab-scale device to confirm the predictions. “We don’t know how long it will take to do the final demonstration,” Li says. Their plan is first to do a basic proof-of-principle lab test, and then to work on ways to optimize the system to make it work on real virus diagnosis applications.

 

Using mathematical simulations, researchers have shown it’s possible to design a sensor to detect SARS-CoV-2 virus

 

The multidisciplinary process requires a combination of expertise in quantum physics and engineering, for producing the detectors themselves, and in chemistry and biology, for developing the molecules that bind with the viral RNA and for finding ways to bond these to the diamond surfaces.

Even if complications arise in translating the theoretical analysis into a working device, Cappellaro says, there is such a large margin of lower false negatives predicted from this work that it will likely still have a strong advantage over standard PCR tests in that regard. And even if the accuracy were the same, this method would still have a major advantage in producing its results with a matter of minutes, rather than requiring several hours, she says.

The basic method can be adapted to any virus, she says, including any new ones that may arise, simply by adapting the compounds that are attached to the nanodiamond sensors to match the generic material of the specific target virus.

“The proposed approach is appealing both for its generality and its technological simplicity,” says David Glenn, senior research scientist at Quantum Diamond Technologies Inc., who was not associated with this work. “In particular, the sensitive, all-optical detection technique described here requires minimal instrumentation compared to other methods that employ nitrogen vacancy centers,” he says.

He adds that for his company, “we’re very excited about using diamond-based quantum sensors to build powerful tools for biomedical diagnostics. Needless to say, we will be following along with great interest as the ideas presented in this work are translated to the lab.”

 

Suggested Reading:

There is More than Just a Covid Variant Weighing on Investors

Dip Buying in 2021 Has Consistently Paid-Off, is it Different this Time?

EV SPAC Activity Accelerated in 2021

Why Zoom Meetings Can Leave You Fatigued

 

Sources:

https://pubs.acs.org/doi/full/10.1021/acs.nanolett.1c02868

https://news.mit.edu/2021/quantum-sensor-detect-covid-1220

 

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Lineage Establishes Exclusive Worldwide Collaboration With Genentech for the Development and Commercialization of OpRegen® RPE Cell Therapy for the Treatment of Ocular Disorders

 

• Genentech Will Pay Lineage $50 Million Upfront
• Eligible to Receive a Total of $670 Million in Upfront and Milestone Payments
• Conference Call to Discuss Collaboration Planned for 8 a.m. ET

CARLSBAD, Calif.–(BUSINESS WIRE)–Dec. 20, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), today announced that Lineage and its subsidiary, 
Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and 

Genentech
, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA).

Genentech will assume responsibility for further clinical development and commercialization of Lineage’s OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation clinical safety and efficacy study in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which enrollment is complete, and perform certain manufacturing activities. 
Genentech will pay Lineage a 
$50 million upfront payment and Lineage is eligible to receive up to 
$620 million in additional development, approval and sales milestone payments, in addition to tiered double- digit royalties.

“Genentech is a clear global leader in ophthalmology and has demonstrated a longstanding commitment to patients, innovative research and successful product development,” said  Brian M. Culley, Lineage’s CEO. “Their desire to combine our cell therapy technology with their ophthalmology expertise and capabilities will help advance the OpRegen program more rapidly and we believe successfully to patients with serious ocular disorders, such as dry age-related macular degeneration. Lineage’s objective is to pioneer a new branch of regenerative medicine, based on transplanting whole cells into the body to restore activity lost to aging, injury or disease. We believe the results we have demonstrated to date with OpRegen represent a paradigm change many did not believe possible with cell therapy, by restoring retinal tissue and potentially halting or reversing the expansion of geographic atrophy. I am incredibly proud of what the Lineage team has accomplished with the OpRegen program and look forward to joining forces with the 
Genentech team as they work to take this program to the next level and potentially to patients in need of treatment.”

Mr. Culley continued, “Looking ahead, Lineage will remain focused on advancing our spinal cord injury and oncology programs as well as announcing new disease settings where we plan to deploy our technology, either on our own or through strategic alliances. All of us at Lineage are immensely proud to have the opportunity and responsibility to advance a new and exciting branch of medicine, and our aim is to make a profound impact on the patients who serve as our inspiration.”

“Genentech has a longstanding commitment to discovering and developing novel drugs for the treatment of serious eye disorders such as with advanced dry AMD with GA, which is one of our focus areas within ophthalmology,” said  James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. “We are excited to partner with 
Lineage Cell Therapeutics to advance potential new therapies in an area of high unmet medical need.”

Conference Call Information

Lineage will host a live conference call and webcast today beginning at 
8 a.m. ET to discuss the collaboration with the Roche Group and 
Genentech. Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
December 27, 2021, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 5174206.

About OpRegen

OpRegen has been developed in part through contributions and financial grants made by 
Hadasit Medical Research Services and Development Ltd. (“Hadasit”) and the 
Israeli Innovation Authority (the “IIA”). Lineage is obligated to pay a portion of upfront, milestone and royalty payments it receives to Hadasit and the IIA. 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 a best corrected visual acuity (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 was 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 related to OpRegen or study procedures that have not been previously reported.

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,” “aim,” “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 collaboration and license agreement with Roche and 
Genentech and activities expected to occur under the collaboration and license agreement, the upfront, milestone and royalty consideration payable to Lineage, the potential benefits of treatment with OpRegen, and Lineage’s plans to advance its spinal cord injury and oncology programs and announce new disease settings where it plans to deploy its technology. 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 the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen, which could materially adversely affect the milestone and royalty payments payable to Lineage under the collaboration and license agreement, the risk that Roche and 
Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction, and 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
Mike Biega
(Mbiega@soleburytrout.com)
(617) 221-9660

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.

Lineage Establishes Exclusive Worldwide Collaboration With Genentech for the Development and Commercialization of OpRegen® RPE Cell Therapy for the Treatment of Ocular Disorders

 

• Genentech Will Pay Lineage $50 Million Upfront
• Eligible to Receive a Total of $670 Million in Upfront and Milestone Payments
• Conference Call to Discuss Collaboration Planned for 8 a.m. ET

CARLSBAD, Calif.–(BUSINESS WIRE)–Dec. 20, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), today announced that Lineage and its subsidiary, 
Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and 

Genentech
, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA).

Genentech will assume responsibility for further clinical development and commercialization of Lineage’s OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation clinical safety and efficacy study in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which enrollment is complete, and perform certain manufacturing activities. 
Genentech will pay Lineage a 
$50 million upfront payment and Lineage is eligible to receive up to 
$620 million in additional development, approval and sales milestone payments, in addition to tiered double- digit royalties.

“Genentech is a clear global leader in ophthalmology and has demonstrated a longstanding commitment to patients, innovative research and successful product development,” said  Brian M. Culley, Lineage’s CEO. “Their desire to combine our cell therapy technology with their ophthalmology expertise and capabilities will help advance the OpRegen program more rapidly and we believe successfully to patients with serious ocular disorders, such as dry age-related macular degeneration. Lineage’s objective is to pioneer a new branch of regenerative medicine, based on transplanting whole cells into the body to restore activity lost to aging, injury or disease. We believe the results we have demonstrated to date with OpRegen represent a paradigm change many did not believe possible with cell therapy, by restoring retinal tissue and potentially halting or reversing the expansion of geographic atrophy. I am incredibly proud of what the Lineage team has accomplished with the OpRegen program and look forward to joining forces with the 
Genentech team as they work to take this program to the next level and potentially to patients in need of treatment.”

Mr. Culley continued, “Looking ahead, Lineage will remain focused on advancing our spinal cord injury and oncology programs as well as announcing new disease settings where we plan to deploy our technology, either on our own or through strategic alliances. All of us at Lineage are immensely proud to have the opportunity and responsibility to advance a new and exciting branch of medicine, and our aim is to make a profound impact on the patients who serve as our inspiration.”

“Genentech has a longstanding commitment to discovering and developing novel drugs for the treatment of serious eye disorders such as with advanced dry AMD with GA, which is one of our focus areas within ophthalmology,” said  James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. “We are excited to partner with 
Lineage Cell Therapeutics to advance potential new therapies in an area of high unmet medical need.”

Conference Call Information

Lineage will host a live conference call and webcast today beginning at 
8 a.m. ET to discuss the collaboration with the Roche Group and 
Genentech. Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
December 27, 2021, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 5174206.

About OpRegen

OpRegen has been developed in part through contributions and financial grants made by 
Hadasit Medical Research Services and Development Ltd. (“Hadasit”) and the 
Israeli Innovation Authority (the “IIA”). Lineage is obligated to pay a portion of upfront, milestone and royalty payments it receives to Hadasit and the IIA. 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 a best corrected visual acuity (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 was 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 related to OpRegen or study procedures that have not been previously reported.

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,” “aim,” “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 collaboration and license agreement with Roche and 
Genentech and activities expected to occur under the collaboration and license agreement, the upfront, milestone and royalty consideration payable to Lineage, the potential benefits of treatment with OpRegen, and Lineage’s plans to advance its spinal cord injury and oncology programs and announce new disease settings where it plans to deploy its technology. 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 the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen, which could materially adversely affect the milestone and royalty payments payable to Lineage under the collaboration and license agreement, the risk that Roche and 
Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction, and 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
Mike Biega
(Mbiega@soleburytrout.com)
(617) 221-9660

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.

Helius Medical Technologies, Inc. Partners with the Medical University of South Carolina in Pilot Trial on Stroke

Research, News, and Market Data on Helius Medical Technologies

 

NEWTOWN, Pa., Dec. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced its partnership with Dr. Steve Kautz, on an investigator-initiated study, conducted at the Medical University of South Carolina (“MUSC”), to evaluate cranial-nerve non-invasive neuromodulation (“CN-NINM”) and dynamic balance in chronic stroke survivors. As part of the study, some patients will receive CN-NINM, which will be delivered using PoNS therapy.

“Falls are a major post-stroke complication and developing an optimal rehabilitation program to improve dynamic balance is critical for reducing stroke related morbidity and economic burdens,” stated Steve Kautz, Ph.D., Chair, Department of Health Sciences and Research, College of Health Professions, MUSC. “Our study aims to evaluate the effects of PoNS therapy on the recovery of gait and postural stability and, in teaming with Helius, we hope to provide a framework for an innovative rehabilitation protocol.”

“MUSC is at the forefront of research in rehabilitation for stroke and other disabling neurologic conditions and we are delighted to support this pilot trial in stroke with our PoNS devices,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer. “Now that the FDA has granted Breakthrough Designation to PoNS for the treatment of dynamic gait and balance deficits in patients with stroke, this collaboration will provide important information to inform our clinical research and upcoming registrational program, allowing us to observe the functional outcomes of PoNS therapy in stroke patients in a real-world clinical setting. We look forward to working with Dr. Kautz and MUSC on this and future studies.”

The study will be a placebo-controlled experimental design in which stroke survivors will participate in balance and gait training for 3 sessions per week, 40 minutes per session, for 4 weeks. MUSC anticipates enrolling twelve participants beginning in early 2022.

About MUSC 

Founded in 1824 in Charleston, MUSC is home to the oldest medical school in the South as well as the state’s only integrated academic health sciences center, with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. MUSC brought in more than $328 million in biomedical research funds in fiscal year 2021, continuing to lead the state in obtaining this funding. For information on academic programs, visit www.musc.edu.

As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality and safe patient care while training generations of compassionate, competent health care providers to serve the people of South Carolina and beyond. Close to 25,000 care team members provide care for patients at 14 hospitals with approximately 2,500 beds and 5 additional hospital locations in development, more than 300 telehealth sites and nearly 750 care locations situated in the Lowcountry, Midlands, Pee Dee and Upstate regions of South Carolina. In 2021, for the seventh consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit www.muschealth.org.

MUSC and its affiliates have collective annual budgets of $4.4 billion. The more than 25,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. 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 Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. 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. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy.

PoNS is also authorized for sale in Canada for two indications: (i) PoNS is authorized as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) PoNS is authorized for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

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,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding expected enrollment, timing and other details of the investigator-initiated study, its ability to provide a framework for an innovative rehabilitation protocol and important information to inform the clinical research and upcoming registrational program, expected enrollment, patient participation, centers of excellence and other details of the TEP study and expected time to begin commercialization of the PoNS device in the U.S.

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, 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 September 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.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Helius Medical Technologies, Inc. Partners with the Medical University of South Carolina in Pilot Trial on Stroke

Research, News, and Market Data on Helius Medical Technologies

 

NEWTOWN, Pa., Dec. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced its partnership with Dr. Steve Kautz, on an investigator-initiated study, conducted at the Medical University of South Carolina (“MUSC”), to evaluate cranial-nerve non-invasive neuromodulation (“CN-NINM”) and dynamic balance in chronic stroke survivors. As part of the study, some patients will receive CN-NINM, which will be delivered using PoNS therapy.

“Falls are a major post-stroke complication and developing an optimal rehabilitation program to improve dynamic balance is critical for reducing stroke related morbidity and economic burdens,” stated Steve Kautz, Ph.D., Chair, Department of Health Sciences and Research, College of Health Professions, MUSC. “Our study aims to evaluate the effects of PoNS therapy on the recovery of gait and postural stability and, in teaming with Helius, we hope to provide a framework for an innovative rehabilitation protocol.”

“MUSC is at the forefront of research in rehabilitation for stroke and other disabling neurologic conditions and we are delighted to support this pilot trial in stroke with our PoNS devices,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer. “Now that the FDA has granted Breakthrough Designation to PoNS for the treatment of dynamic gait and balance deficits in patients with stroke, this collaboration will provide important information to inform our clinical research and upcoming registrational program, allowing us to observe the functional outcomes of PoNS therapy in stroke patients in a real-world clinical setting. We look forward to working with Dr. Kautz and MUSC on this and future studies.”

The study will be a placebo-controlled experimental design in which stroke survivors will participate in balance and gait training for 3 sessions per week, 40 minutes per session, for 4 weeks. MUSC anticipates enrolling twelve participants beginning in early 2022.

About MUSC 

Founded in 1824 in Charleston, MUSC is home to the oldest medical school in the South as well as the state’s only integrated academic health sciences center, with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. MUSC brought in more than $328 million in biomedical research funds in fiscal year 2021, continuing to lead the state in obtaining this funding. For information on academic programs, visit www.musc.edu.

As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality and safe patient care while training generations of compassionate, competent health care providers to serve the people of South Carolina and beyond. Close to 25,000 care team members provide care for patients at 14 hospitals with approximately 2,500 beds and 5 additional hospital locations in development, more than 300 telehealth sites and nearly 750 care locations situated in the Lowcountry, Midlands, Pee Dee and Upstate regions of South Carolina. In 2021, for the seventh consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit www.muschealth.org.

MUSC and its affiliates have collective annual budgets of $4.4 billion. The more than 25,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. 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 Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. 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. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy.

PoNS is also authorized for sale in Canada for two indications: (i) PoNS is authorized as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) PoNS is authorized for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

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,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding expected enrollment, timing and other details of the investigator-initiated study, its ability to provide a framework for an innovative rehabilitation protocol and important information to inform the clinical research and upcoming registrational program, expected enrollment, patient participation, centers of excellence and other details of the TEP study and expected time to begin commercialization of the PoNS device in the U.S.

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, 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 September 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.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

BioSig Expands Its Clinical Footprint In Florida

News and Market Data on BioSig Technologies

 

The Company’s signal processing technology for arrhythmia care is being installed in a leading HCA Healthcare-operated facility in Southeast Florida

Westport, CT, Dec. 16, 2021 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it is installing a PURE EP™ System for an evaluation at the HCA Healthcare-operated Westside Regional Medical Center in Plantation, FL.

Westside Regional Medical Center is an award-winning 250-bed hospital recognized for providing a wide array of services to the residents of Broward County, South Florida, and visitors from around the world. The hospital’s electrophysiology program is one of the most frequented in Broward County, offering advanced diagnostic services and multiple modalities for diagnosing and treating arrhythmia.¹. In addition to its comprehensive cardiovascular services, Westside Regional Medical Center is certified as a Comprehensive Stroke Center by the Agency for Health Care Administration (ACHA). Westside Regional Medical Center is a facility of HCA East Florida, the most extensive healthcare system in Eastern Florida and an affiliate of Hospital Corporation of America (HCA). HCA East Florida has 14 hospitals, multiple ambulatory surgery centers, physician practices, free-standing emergency care facilities, and a supply chain center, and an integrated regional lab.²

“Our new installation agreement with Westside Regional Medical Center increases our clinical reach across the state, with an installation in both the north and south regions of Florida. We are thrilled to partner with another leading HCA Healthcare-operated institution and continue to solidify our commitment to arrhythmia patient care across the state of Florida,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

To date, 73 physicians have completed over 1750 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida. The Company’s most recent evaluation adds to its clinical footprint in Florida, which also includes Mayo Clinic’s Florida Campus, a national Medical Center of Excellence.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

About 2,300 Americans die from heart disease each day – an average of one death every 38 seconds³. In 2016, 1.6 million Texas adults reported that they had been diagnosed with heart disease or stroke⁴. There were 336,462 hospitalizations of adult Texans related to heart disease in 2016, at an age-adjusted rate of 124.0 per 10,000 adults⁵. The direct and indirect costs of heart disease and stroke in the U.S. are estimated to be $329.7 billion, and the cost is projected to increase to $749 billion by 2035⁶.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Arrhythmia Specialties – Westside Regional Medical Center: westsideregional.com

² Hospital News and Healthcare Report – 2020: southfloridahospitalnews.com

³ Heart disease and stroke statistics – 2018 update: a report from the American Heart Association

⁴ Texas Behavioral Risk Factor Surveillance System Public Use Data File, 2016, Center for Health Statistics, Texas Department of State Health Services

⁵ Texas Hospital Inpatient Discharge Public Use Data, Texas Health Care Information Collection, 2016, Center for Health Statistics, Texas Department of State Health Services

⁶ Heart disease and stroke statistics – 2018 update: a report from the American Heart Association

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

ProMIS Neurosciences Issues Chairman’s Memorandum

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Mass., Dec. 16, 2021 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, issued today a Chairman’s Memorandum commenting on the Company’s progress over the past year and outlook for 2022.

“ProMIS has never been in a better substantive position than we find ourselves now at the end of 2021”, stated Eugene Williams, Chairman and CEO of ProMIS Neurosciences. “We started the company with the mission to apply our unique technology to developing breakthrough therapies for patients and families affected by Alzheimer’s disease, ALS (amyotrophic lateral sclerosis), and other devastating diseases caused by mis-folded proteins. We are now making significant progress toward that goal.”

Key points from the memorandum are outlined below:

• 2021 was a very successful year for ProMIS in terms of capital formation as we raised $27MM US, with the support of prestigious investors, and are well capitalized for the foreseeable future;
• Shareholder support was very strong for a resolution enabling the Board to consolidate shares, in a manner that could qualify us for listing on a major North American stock exchange;  
• Our lead program PMN310 is moving full speed ahead through the IND enabling work necessary to initiate our first in human clinical trial. The clinical readouts in the amyloid field continue to strongly support our scientific hypothesis that selectively targeting the neurotoxic amyloid oligomer will be key to optimal therapeutic safety and efficacy;
• Our existing portfolio of highly selective antibodies targeting pathogenic mis-folded alpha synuclein, TDP-43 (Tar DNA Binding Protein-43), RACK1 (Receptor for Activated C Kinase 1), and tau is moving forward at an accelerated pace given our capital position;
• ProMIS is very well positioned to be a leader in the new area of therapies targeting protein misfolding. We are pursuing several new targets in diseases like schizophrenia and expect significant progress in expanding our portfolio in 2022.
  
  

“We are very bullish about the prospects for ProMIS in 2022 and beyond and continue to believe that the neurodegenerative disease field has turned a corner,” concluded Eugene Williams. “Our unique, selective antibodies could be valuable contributors to making real progress against these devastating diseases and we remain committed to making that happen.”

To access the Chairman’s memorandum, please visit www.promisneurosciences.com or click on this direct link: https://www.promisneurosciences.com/cm122021

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery platform is based on the use of two complementary thermodynamic, computational discovery engines – ProMIS and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

ProMIS Neurosciences Issues Chairman’s Memorandum

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Mass., Dec. 16, 2021 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, issued today a Chairman’s Memorandum commenting on the Company’s progress over the past year and outlook for 2022.

“ProMIS has never been in a better substantive position than we find ourselves now at the end of 2021”, stated Eugene Williams, Chairman and CEO of ProMIS Neurosciences. “We started the company with the mission to apply our unique technology to developing breakthrough therapies for patients and families affected by Alzheimer’s disease, ALS (amyotrophic lateral sclerosis), and other devastating diseases caused by mis-folded proteins. We are now making significant progress toward that goal.”

Key points from the memorandum are outlined below:

• 2021 was a very successful year for ProMIS in terms of capital formation as we raised $27MM US, with the support of prestigious investors, and are well capitalized for the foreseeable future;
• Shareholder support was very strong for a resolution enabling the Board to consolidate shares, in a manner that could qualify us for listing on a major North American stock exchange;  
• Our lead program PMN310 is moving full speed ahead through the IND enabling work necessary to initiate our first in human clinical trial. The clinical readouts in the amyloid field continue to strongly support our scientific hypothesis that selectively targeting the neurotoxic amyloid oligomer will be key to optimal therapeutic safety and efficacy;
• Our existing portfolio of highly selective antibodies targeting pathogenic mis-folded alpha synuclein, TDP-43 (Tar DNA Binding Protein-43), RACK1 (Receptor for Activated C Kinase 1), and tau is moving forward at an accelerated pace given our capital position;
• ProMIS is very well positioned to be a leader in the new area of therapies targeting protein misfolding. We are pursuing several new targets in diseases like schizophrenia and expect significant progress in expanding our portfolio in 2022.
  
  

“We are very bullish about the prospects for ProMIS in 2022 and beyond and continue to believe that the neurodegenerative disease field has turned a corner,” concluded Eugene Williams. “Our unique, selective antibodies could be valuable contributors to making real progress against these devastating diseases and we remain committed to making that happen.”

To access the Chairman’s memorandum, please visit www.promisneurosciences.com or click on this direct link: https://www.promisneurosciences.com/cm122021

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery platform is based on the use of two complementary thermodynamic, computational discovery engines – ProMIS and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

BioSig Expands Its Clinical Footprint In Florida

News and Market Data on BioSig Technologies

 

The Company’s signal processing technology for arrhythmia care is being installed in a leading HCA Healthcare-operated facility in Southeast Florida

Westport, CT, Dec. 16, 2021 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it is installing a PURE EP™ System for an evaluation at the HCA Healthcare-operated Westside Regional Medical Center in Plantation, FL.

Westside Regional Medical Center is an award-winning 250-bed hospital recognized for providing a wide array of services to the residents of Broward County, South Florida, and visitors from around the world. The hospital’s electrophysiology program is one of the most frequented in Broward County, offering advanced diagnostic services and multiple modalities for diagnosing and treating arrhythmia.¹. In addition to its comprehensive cardiovascular services, Westside Regional Medical Center is certified as a Comprehensive Stroke Center by the Agency for Health Care Administration (ACHA). Westside Regional Medical Center is a facility of HCA East Florida, the most extensive healthcare system in Eastern Florida and an affiliate of Hospital Corporation of America (HCA). HCA East Florida has 14 hospitals, multiple ambulatory surgery centers, physician practices, free-standing emergency care facilities, and a supply chain center, and an integrated regional lab.²

“Our new installation agreement with Westside Regional Medical Center increases our clinical reach across the state, with an installation in both the north and south regions of Florida. We are thrilled to partner with another leading HCA Healthcare-operated institution and continue to solidify our commitment to arrhythmia patient care across the state of Florida,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

To date, 73 physicians have completed over 1750 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida. The Company’s most recent evaluation adds to its clinical footprint in Florida, which also includes Mayo Clinic’s Florida Campus, a national Medical Center of Excellence.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

About 2,300 Americans die from heart disease each day – an average of one death every 38 seconds³. In 2016, 1.6 million Texas adults reported that they had been diagnosed with heart disease or stroke⁴. There were 336,462 hospitalizations of adult Texans related to heart disease in 2016, at an age-adjusted rate of 124.0 per 10,000 adults⁵. The direct and indirect costs of heart disease and stroke in the U.S. are estimated to be $329.7 billion, and the cost is projected to increase to $749 billion by 2035⁶.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Arrhythmia Specialties – Westside Regional Medical Center: westsideregional.com

² Hospital News and Healthcare Report – 2020: southfloridahospitalnews.com

³ Heart disease and stroke statistics – 2018 update: a report from the American Heart Association

⁴ Texas Behavioral Risk Factor Surveillance System Public Use Data File, 2016, Center for Health Statistics, Texas Department of State Health Services

⁵ Texas Hospital Inpatient Discharge Public Use Data, Texas Health Care Information Collection, 2016, Center for Health Statistics, Texas Department of State Health Services

⁶ Heart disease and stroke statistics – 2018 update: a report from the American Heart Association

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

 

Research, News, and Market Data on Ocugen

 

• Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection
• Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses
• Memory T and B cells persisted for at least 6 months post vaccination
• Data suggest COVAXIN™ (BBV152) may provide protection against current and future variants
• Effectiveness of COVAXIN™ (BBV152) against the Omicron variant is currently being studied
  

MALVERN, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that data analyzing immune response following two doses of the vaccine candidate, COVAXIN™ (BBV152), from a third-party study were published on the preprint server, medRxiv. The data compared the immune memory response of 71 vaccinated and 73 naturally infected subjects with SARS-CoV-2, including variants of concern, for up to six months. The study found that COVAXIN™ (BBV152) generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells.  

In addition to controlling infections, the adaptive immune system creates immunological memory, such as memory B and T cells, to enable long-term protection against a virus. In the analysis, COVAXIN™ (BBV1542) generated T-cells against both spike and nucleocapsid proteins in nearly 85 percent of subjects that persisted for at least 6 months. This data supports previous findings that COVAXIN™ (BBV152) is able to induce long-term memory.

“As a whole-virion inactivated vaccine, we anticipated COVAXIN™ would produce an immune response against multiple antigens present in the SARS-CoV-2 virus, such as spike and nucleoprotein antibodies,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

“The results of this analysis are extremely important findings as we continue to learn about how the virus is mutating and how we can address variants of concern with vaccines, especially with the emergence of Omicron,” said David Fajgenbaum, MD, MBA, MSc, FCPP, Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania and member of Ocugen’s Vaccine Scientific Advisory Board. “Given that current variants of concern exhibit mutations concentrated in the spike protein of the virus, vaccines like COVAXIN™ that can generate broad immune memory beyond the spike protein are a promising tool to protect us from emerging variants of concern.”  

Ocugen is currently evaluating COVAXIN™ (BBV152) against the Omicron variant and plans to share the data as soon as they are available.

Earlier this year, Ocugen’s co-development partner, Bharat Biotech, announced data from a Phase 3 trial that included nearly 25,800 participants. In the study, published in The Lancet, COVAXIN™ (BBV152) demonstrated 77.8% overall efficacy, 93.4% efficacy against severe illness (which requires hospitalization, intensive care and/or a ventilator) and 65.2% efficacy against the Delta variant. Adverse events reported in the trial were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, which is consistent with data from other vaccines that apply whole-virion technology. Both adverse events and serious adverse events reported in the vaccine group were reported at similar rates to the placebo group.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 125 million doses having been administered to adults outside the U.S., COVAXIN™ is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™. The trade name COVAXIN™ has not been evaluated by the FDA.

About Ocugen, Inc. 
Ocugen, Inc. is 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. 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. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. 

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.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 forward-looking statements include statements about data published on the preprint server, medRxiv, which found that COVAXIN™ generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells, and our expectation that COVAXIN can generate potential long-term immunological memory. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the risk that the data published on medRxiv, which is preliminary and subject to ongoing peer review, may not be accepted for publication without changes, if at all, may contain errors that render the reported information erroneous, or may not be accepted by the scientific or medical community; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that inversely impact our ability to advance the development of COVAXIN™ in the United States, the implications that this clinical hold may have for our request for emergency use authorization for COVAXIN for pediatric use; commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA) or emergency use authorization (EUA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial which is currently subject to clinical hold; any additional chemistry, manufacturing and controls information that we may be required to submit to the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. 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: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com 

New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

 

Research, News, and Market Data on Ocugen

 

• Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection
• Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses
• Memory T and B cells persisted for at least 6 months post vaccination
• Data suggest COVAXIN™ (BBV152) may provide protection against current and future variants
• Effectiveness of COVAXIN™ (BBV152) against the Omicron variant is currently being studied
  

MALVERN, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that data analyzing immune response following two doses of the vaccine candidate, COVAXIN™ (BBV152), from a third-party study were published on the preprint server, medRxiv. The data compared the immune memory response of 71 vaccinated and 73 naturally infected subjects with SARS-CoV-2, including variants of concern, for up to six months. The study found that COVAXIN™ (BBV152) generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells.  

In addition to controlling infections, the adaptive immune system creates immunological memory, such as memory B and T cells, to enable long-term protection against a virus. In the analysis, COVAXIN™ (BBV1542) generated T-cells against both spike and nucleocapsid proteins in nearly 85 percent of subjects that persisted for at least 6 months. This data supports previous findings that COVAXIN™ (BBV152) is able to induce long-term memory.

“As a whole-virion inactivated vaccine, we anticipated COVAXIN™ would produce an immune response against multiple antigens present in the SARS-CoV-2 virus, such as spike and nucleoprotein antibodies,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

“The results of this analysis are extremely important findings as we continue to learn about how the virus is mutating and how we can address variants of concern with vaccines, especially with the emergence of Omicron,” said David Fajgenbaum, MD, MBA, MSc, FCPP, Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania and member of Ocugen’s Vaccine Scientific Advisory Board. “Given that current variants of concern exhibit mutations concentrated in the spike protein of the virus, vaccines like COVAXIN™ that can generate broad immune memory beyond the spike protein are a promising tool to protect us from emerging variants of concern.”  

Ocugen is currently evaluating COVAXIN™ (BBV152) against the Omicron variant and plans to share the data as soon as they are available.

Earlier this year, Ocugen’s co-development partner, Bharat Biotech, announced data from a Phase 3 trial that included nearly 25,800 participants. In the study, published in The Lancet, COVAXIN™ (BBV152) demonstrated 77.8% overall efficacy, 93.4% efficacy against severe illness (which requires hospitalization, intensive care and/or a ventilator) and 65.2% efficacy against the Delta variant. Adverse events reported in the trial were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, which is consistent with data from other vaccines that apply whole-virion technology. Both adverse events and serious adverse events reported in the vaccine group were reported at similar rates to the placebo group.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 125 million doses having been administered to adults outside the U.S., COVAXIN™ is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™. The trade name COVAXIN™ has not been evaluated by the FDA.

About Ocugen, Inc. 
Ocugen, Inc. is 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. 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. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. 

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.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 forward-looking statements include statements about data published on the preprint server, medRxiv, which found that COVAXIN™ generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells, and our expectation that COVAXIN can generate potential long-term immunological memory. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the risk that the data published on medRxiv, which is preliminary and subject to ongoing peer review, may not be accepted for publication without changes, if at all, may contain errors that render the reported information erroneous, or may not be accepted by the scientific or medical community; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that inversely impact our ability to advance the development of COVAXIN™ in the United States, the implications that this clinical hold may have for our request for emergency use authorization for COVAXIN for pediatric use; commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA) or emergency use authorization (EUA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial which is currently subject to clinical hold; any additional chemistry, manufacturing and controls information that we may be required to submit to the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. 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: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com 

Tuesday, December 14, 2021

Genprex (GNPX)
Reqorsa Could Be The First Systemic Gene Therapy

Genprex Inc is a U.S.-based clinical-stage gene therapy company. It is engaged in developing a new approach to treating cancer based on its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy. Oncoprex, which has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis in cancer cells and modulates the immune response against cancer cells.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Genprex Has Developed a Proprietary System For Gene Delivery.  The Oncoprex technology uses nanoparticles to deliver genes using intravenous administration rather than a viral vector delivered directly to the tumor site. The company’s first product, Reqorsa, uses the Oncoprex system to deliver a tumor suppressor gene. Reqorsa began a Phase 1/2 clinical trial in non-small cell lung cancer (NSCLC) and is expect to being a Phase 1/2 immunotherapy combination trial in early 2022.


Gene Therapy With A Tumor Suppressor Reqorsa was developed to deliver TUSC2 gene, a tumor suppressor gene.  TUSC2 has been shown to stop pathways of cancer cell proliferation and start pathways that lead to cell death (apoptosis). These pathways may be additive or synergistic with actions of other drugs that act through intracellular signaling …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Helius Medical Technologies, Inc. Announces Issuance of U.S. Patent for Wireless PoNS®

Research, News, and Market Data on Helius Medical Technologies

 

Patent Readies Company for Next Generation of PoNS Therapy

NEWTOWN, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (Helius or the Company), a neurotech company focused on neurological wellness, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,197,994, which is directed to systems for providing non-invasive neurorehabilitation of a patient. The patent is similar in scope to prior Helius patents for the Portable Neuromodulation Stimulator (PoNS) device but expressly recites that the communications between the mouthpiece and controller are done wirelessly.

“We are pleased to announce our new patent, which will allow for a wireless connection between the mouthpiece and controller of our PoNS device,” said Dane Andreeff, President and Chief Executive Officer of Helius. “PoNS is the first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to reduce symptoms of neurological disease or trauma, and this patent is an important building block for future generations of PoNS therapy.”

Helius now owns 34 U.S. and 46 foreign patents expiring between 2026 and 2036, and exclusively licenses nine U.S. medical method patents expiring between 2029 and 2031.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. 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. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP).

PoNS is also authorized for sale in Canada for two indications: (i) PoNS is authorized as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) PoNS is authorized for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, visit www.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,” “expect,” “continue,” “will,” “future,” “goal,” “aim” and similar expressions.

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 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 September 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.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com