Cocrystal Pharma’s COVID-19 Oral and Intranasal/Pulmonary Protease Inhibitors Exhibit Powerful In Vitro Potency Against the SARS-CoV-2 Omicron Variant

Research, News, and Market Data on Cocrystal Pharma

 

Antiviral activity now confirmed against SARS-CoV-2 and all variants of concern
including Omicron, Delta, Alpha, Beta and Gamma 

BOTHELL, Wash., Dec. 22, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that in vitro studies demonstrate its oral and intranasal/pulmonary SARS-CoV-2 main protease inhibitors exhibit antiviral potency against the Omicron variant. The Company earlier confirmed that its protease inhibitors demonstrated broad-spectrum antiviral activity against SARS-CoV-2 and all major previously identified variants including Delta, Alpha, Beta and Gamma. Cocrystal expects to initiate Phase 1 clinical studies with its COVID-19 intranasal/pulmonary protease inhibitor CDI-45205 and an oral COVID-19 protease inhibitor as rapidly as possible.

To confirm the antiviral activity of its protease inhibitors against SARS-CoV-2 Omicron variant, Cocrystal conducted an analysis of SARS-CoV-2 lineages covering all reported Omicron variant sequences including those from South Africa, Europe, Asia and North America, and identified one prevalent mutation in the SARS-CoV-2 main protease. Using its proprietary platform technology and assays, the Company further confirmed in vitro antiviral activity of its protease inhibitors against the Omicron variant.

“Our ability to develop highly sensitive in vitro assays and X-ray crystals within a month is particularly important to evaluate the broad-spectrum activity of our SARS-CoV-2 main protease inhibitors against a heavily mutated Omicron variant,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “Our protease inhibitors bind to a highly conserved region of the active site of the protease that is required for SARS-CoV-2 viral replication. We believe that, due to their novel mechanism of action, our protease inhibitors will be effective against newly emerging SARS-CoV-2 variants. We are also highly encouraged by promising safety profiles of our SARS-CoV-2 oral protease inhibitors from 7-day mouse oral dosing toxicity studies. Our goal is to rapidly advance two protease inhibitors into first-in-human studies as rapidly as possible.”

“Omicron has been identified as a variant of concern by both the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), and is spreading rapidly. Since being identified in the U.S. just three weeks ago, Omicron is now the dominant strain in the U.S. according to the CDC,” said James Martin, CFO and interim co-CEO. “Our protease inhibitors are being developed to show broad-spectrum activity against SARS-CoV-2 infections regardless of the variant, with the added feature of high barriers to viral resistance.”

CDI-45205 is one of three COVID-19 programs underway at Cocrystal. In the second COVID-19 program, the Company plans to begin a Phase 1 study also as rapidly as possible with an orally administered protease inhibitor. In the third COVID-19 program, Cocrystal is using its unique structure-based technology platform to discover replication inhibitors for oral administration.

About CDI-45205
CDI-45205 is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our goals of initiating Phase 1 clinical studies as rapidly as possible, our attempts to discover replication inhibitors for oral administration, and the potential efficacy of antiviral inhibitors against existing and new variants of COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current contract research organizations (CROs) and future CROs and contract manufacturing organizations , the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, the impact of the COVID-19 pandemic including new variants on the national and global economy, the duration of presently discovered COVID-19 variants and our ability to treat new variants, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

BioSig Technologies, Inc. Selects Access Strategy Partners to Accelerate Commercial Sales

News and Market Data on BioSig Technologies

 

Leading healthcare management firm to enhance the Company’s market access strategy as it expands the installation base of its signal processing technology for arrhythmia care

Westport, CT, Dec. 21, 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 appointed Access Strategy Partners, Inc. to advise on the next phase of the commercial roll-out.

Led by medical device sales experts, Boston-based Access Strategy Partners brings to BioSig deep expertise in commercialization, contract management, execution, and value proposition optimization. The company’s Co-Founder and President, Jim Walker, is a healthcare executive with more than 30 years of experience in sales, marketing, sales operations, and national accounts management in some of the leading companies in the medical device sector, including Boston Scientific Corporation (BSC) and Johnson & Johnson. His experience spans domestic and international responsibilities, focusing on strategic market development and key customer management. During his 18-year career with Boston Scientific Corporation, Mr. Walker established the organization as a recognized leader with Group Purchasing Organizations. He created a world-class Corporate Sales organization that represented the full BSC portfolio to supply chain executives across every level of market aggregation, including group purchasing organizations (GPOs), national and regional integrated delivery networks (IDNs), and National and Regional Purchasing Alliances. Mr. Walker was the company’s lead strategic pricing advisor and gained the support of the executive management team to invest in and develop an enterprise-wide contract management system that provides global pricing intelligence and profitability analysis capabilities.

“ASPI was founded to provide strategic relationship management for emerging medical device companies,” said Jim Walker. “Our sales conversations are all about delivering excellent clinical and economic value. BioSig and its breakthrough PURE EP(TM) product bring meaningful benefits to physicians and patients that we are thrilled to introduce to healthcare providers.”

Under the terms of the new collaboration, Access Strategy Partners will advise BioSig on all aspects of commercial strategy, including economic value modeling, hospital administration engagement, and contracting.

“Jim and his highly accomplished team at Access Strategy Partners brings us proven success strategies in accelerating commercialization. Look closely at ASPI’s track record in helping emerging medical device companies, and you will see what we saw – strong revenue growth rates with sustainability. We look forward to learning from some of the brightest minds in medical device sales as we leverage the key insights from our initial commercial efforts to bring our disruptive technology to the next level of hospitals nationwide,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

The PURE EP(TM) is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, over 70 physicians have completed over 1750 patient cases with the PURE EP(TM) System.

Clinical data acquired by the PURE EP(TM) 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(TM)  signals over conventional sources.

The Company recently appointed a former Abbott senior sales leader Mr. Gray Fleming as its Chief Commercial Officer. BioSig is in a targeted commercial launch of the PURE EP(TM) System in the Northeast, Texas, and Florida and is in regular use in some of the country’s leading centers of excellence, including the Mayo Clinic in Rochester, MN, and St. David’s Medical Center in Austin, TX.

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(TM) 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.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Green Farms Road
Westport, CT 06880, US
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

BioSig Technologies, Inc. Selects Access Strategy Partners to Accelerate Commercial Sales

News and Market Data on BioSig Technologies

 

Leading healthcare management firm to enhance the Company’s market access strategy as it expands the installation base of its signal processing technology for arrhythmia care

Westport, CT, Dec. 21, 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 appointed Access Strategy Partners, Inc. to advise on the next phase of the commercial roll-out.

Led by medical device sales experts, Boston-based Access Strategy Partners brings to BioSig deep expertise in commercialization, contract management, execution, and value proposition optimization. The company’s Co-Founder and President, Jim Walker, is a healthcare executive with more than 30 years of experience in sales, marketing, sales operations, and national accounts management in some of the leading companies in the medical device sector, including Boston Scientific Corporation (BSC) and Johnson & Johnson. His experience spans domestic and international responsibilities, focusing on strategic market development and key customer management. During his 18-year career with Boston Scientific Corporation, Mr. Walker established the organization as a recognized leader with Group Purchasing Organizations. He created a world-class Corporate Sales organization that represented the full BSC portfolio to supply chain executives across every level of market aggregation, including group purchasing organizations (GPOs), national and regional integrated delivery networks (IDNs), and National and Regional Purchasing Alliances. Mr. Walker was the company’s lead strategic pricing advisor and gained the support of the executive management team to invest in and develop an enterprise-wide contract management system that provides global pricing intelligence and profitability analysis capabilities.

“ASPI was founded to provide strategic relationship management for emerging medical device companies,” said Jim Walker. “Our sales conversations are all about delivering excellent clinical and economic value. BioSig and its breakthrough PURE EP(TM) product bring meaningful benefits to physicians and patients that we are thrilled to introduce to healthcare providers.”

Under the terms of the new collaboration, Access Strategy Partners will advise BioSig on all aspects of commercial strategy, including economic value modeling, hospital administration engagement, and contracting.

“Jim and his highly accomplished team at Access Strategy Partners brings us proven success strategies in accelerating commercialization. Look closely at ASPI’s track record in helping emerging medical device companies, and you will see what we saw – strong revenue growth rates with sustainability. We look forward to learning from some of the brightest minds in medical device sales as we leverage the key insights from our initial commercial efforts to bring our disruptive technology to the next level of hospitals nationwide,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

The PURE EP(TM) is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, over 70 physicians have completed over 1750 patient cases with the PURE EP(TM) System.

Clinical data acquired by the PURE EP(TM) 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(TM)  signals over conventional sources.

The Company recently appointed a former Abbott senior sales leader Mr. Gray Fleming as its Chief Commercial Officer. BioSig is in a targeted commercial launch of the PURE EP(TM) System in the Northeast, Texas, and Florida and is in regular use in some of the country’s leading centers of excellence, including the Mayo Clinic in Rochester, MN, and St. David’s Medical Center in Austin, TX.

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(TM) 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.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Green Farms Road
Westport, CT 06880, US
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

Tuesday, December 21, 2021

Lineage Cell Therapeutics (LCTX)
Genentech Licensing Agreement For OpRegen Begins Transformation

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) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in 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.

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

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

OpRegen Licensing and Collaboration With Genentech Announced.  Lineage Cell and Genentech/Roche (RHHBY, $50.89, Not Rated) announced a licensing agreement covering OpRegen, the retinal pigment epithelial (RPE) cell transplant currently in Phase 1/2a development. Under the agreement Genentech will assume responsibilities and expenses for developing OpRegen through commercialization in exchange for $50 million in upfront payments, $620 million in milestones, and royalties on sales.


Financial Terms Include $50 Million in Up-Front Payments Plus $620 Million in Milestones and Sales Royalties.  The agreement includes an up-front signing fee of $50 million plus undisclosed milestone payments of up to $620 million, and double-digit royalties on sales. Lineage Cell is obligated to make payments to the originators of the technology, which we estimate to be about $22 million, for net …

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. 

Monday, December 20, 2021

Stem Holdings (STMH)(STEM:CA)
What Do Friday’s Announcements Mean?

Stem Holdings Inc is engaged in the purchasing, improving, and leasing of properties and finance assets which are operated by third parties and are used for the cultivation and retail sale of marijuana. Its properties includes 42nd Street, and Mulino Farm which are used for agriculture. The company generates its revenue in the form of rental income from tenants.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

New Direction. After the market close on Friday, Stem Holdings announced it is divesting Driven Deliveries, the e-commerce and delivery platform that was acquired about twelve months ago. According to the press release, the move is a reflection of significantly increased competition in the key California market and reduced price per pound for cannabis, resulting in a consistent low margin business.


Management Changes.  In addition, Adam Berk resigned as CEO, effective immediately. Co-founder and current CFO Steve Hubbard has been named interim CEO. Mr. Berk’s resignation comes on the heels of the late November departure of COO Ellen Deutsch …

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. 

	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.