StockWireNews
BSGM Update: Breaking News Today Is Bringing In Serious Buzz To This NASDAQ MedTech Profile
*At Least One Analyst Gives This Idea A $17 Price Target*
Currently Up An Approx. 5% With An $11.15 H.O.D.
June 17th
Good Morning,
Major news just came out this AM from the BSGM camp. Read it here:
ViralClear Opens Enrollment with First Patient Dosing in Phase II Human Trial of Anti-Viral MMPD Oral Solution for Treatment of CV-19
Initiation of randomized, double-blind, placebo-controlled Phase II trial of merimepodib, an orally administered broad-spectrum anti-viral, in combination with intravenous remdesivir in patients with advanced CV-19 (hospitalized and requiring oxygen)
Westport, CT, June 17, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has commenced patient enrollment with the dosing of the first patient in its Phase II trial for merimepodib, a broad-spectrum, orally administered anti-viral drug candidate for the treatment of CV-19 in adult patients. Confirmed trial sites include 3 sites from the Mayo Clinic including Rochester, MN, Jacksonville, FL, Phoenix, AZ and St. David’s South Austin Medical Center in Austin, TX and the Atlantic Health System -Overlook Hospital in Summit, NJ and Morristown Medical Center in Morristown, NJ.
The Phase II trial is titled “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients With Advanced C-virus Disease 2019 (CV-19)”. A description of this clinical trial can be accessed via www(dot)clinicaltrials(dot)gov.
Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed reduction in [...] replication to undetectable levels.
Read The Full Article Here.
Could this be the news that sends BSGM towards its analyst provided price targets?
Currently, it is up an approximate 5% and has hit a high of $11.15.
If you haven't yet, read my initial BSGM report below and get it on your radar quickly.
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Today, I'm bringing back to your attention a past champ NASDAQ profile with significant upside potential.
Previously, I released this profile on April 9th when it was trading around $4.85. By the time May 12th rolled around, it had climbed to a stunning high of $12.43.
Overall, that short-term move accounted for an approximate 153% surge!
With several new potential catalysts since the last time I made you aware of this NASDAQ idea, this stock could be headed for another breakout.
Right now, I want you to get BioSig Technologies, Inc. (NASDAQ: BSGM) on your radar.
BioSig Technologies, Inc., a medical technology company, engages in developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace.
At this moment, BSGM has several potential catalysts starting to bring serious buzz to this NASDAQ MedTech idea. Here they are:
#1 BSGM Potential Catalyst - Significant Price Targets
According to CNN's website, BSGM has two analyst provided price targets.
The first is a $13 target which gives BSGM upside potential of approximately 27% from Tuesday's closing valuation of $10.21.
The second is a $17 target which gives BSGM upside potential of approximately 66% from that same closing valuation yesterday.
If you are looking for a weighted average, it would be a $15 target which gives BSGM upside potential of approximately 46% from yesterday's close.
We haven't seen $13 breached yet in 2020, but if that does happen, $17 could be the next high it climbs to based on at least one analyst's opinion.
#2 BSGM Potential Catalyst - Bullish Technical Indicators
BSGM comes into Wednesday with several triggered technical indicator within the short, medium, and long-term.
Here are the recommended "BUY" technicals according to Barchart.com:
- 20 - 50 Day MACD Oscillator
- 20 - 100 Day MACD Oscillator
- 20 - 200 Day MACD Oscillator
- 50 Day Moving Average
- 50 - 100 Day MACD Oscillator
- 50 - 150 Day MACD Oscillator
- 50 - 200 Day MACD Oscillator
- 100 Day Moving Average
- 150 Day Moving Average
- 200 Day Moving Average
Those 10 triggered technical indicators could be indicative of a continued surge towards previous highs or beyond.
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#3 BSGM Potential Catalyst - Early June News
ViralClear adds St. David's HealthCare in Austin, Texas, to its Planned Phase II trial for its Broad-Spectrum Oral Anti-Viral Candidate for CV-19
Randomized, double-blind, placebo-controlled Phase II trial of merimepodib to be conducted in adults with CV-19 who are hospitalized and require supplemental oxygen or are on non-invasive ventilation or high-flow oxygen devices
Westport, CT, June 05, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has expanded its patient enrollment centers to include St. David’s South Austin Medical Center in Austin. The hospital is part of St. David’s HealthCare, one of the largest healthcare systems in Texas. The Company intends to commence its Phase II clinical trial for merimepodib, its broad-spectrum oral anti-viral candidate for the treatment of CV-19 in adult patients in the coming weeks.
The clinical trial team consists of Brian Metzger, M.D., MPH, Medical Director of Infectious Diseases at St. David's Medical Center, who is is the principal investigator, as well as Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., Cardiac Electrophysiologist and Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, and Matthew Robinson, M.D., Medical Director of Infectious Diseases at St. David's South Austin Medical Center, who are co-investigators for the study.
“The safety and quality of treatment for our patients is our top priority, and we take numerous measures to ensure the highest level of care. As such, we remain steadfast in the pursuit against the c-virus, and we look forward to working with ViralClear on the Phase II trial of its antiviral candidate as a potential solution against this virus,” commented Dr. Metzger.
“Adding St. David’s South Austin Medical Center as an investigating center in the ViralClear clinical trial with merimepodib has the potential to allow the Company to accelerate clinical development and generate results from a more diverse population of patients," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. and Director at ViralClear Pharmaceuticals, Inc. “We have been innovating with Dr. Andrea Natale since we started BioSig over eleven years ago. His guidance has been vital to us through all stages of product development and in the early commercialization of our PURE EP(tm) System. We are thankful for Dr. Natale’s leadership during these unprecedented times and look forward to collaborating with the whole St. David’s team on this important mission.”
The Phase II randomized, double-blind, placebo-controlled study is designed to enroll adult patients with advanced C-virus Disease 2019 (CV-19). A description of this clinical trial can be accessed via www.clinicaltrials.gov.
Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed reduction in [...] replication to undetectable levels. Peer reviewed publication of these findings can be found at F1000 Research: f1000research.com/articles/9-361
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#4 BSGM Potential Catalyst - PURE EP System Update
BioSig Technologies’s PURE EP System to be Presented in Heart Rhythm Society 2020 Science Sessions
Company’s flagship biomedical signal processing platform highlighted in two scientific sessions presented by key opinion leaders from Mayo Clinic
Westport, CT, June 04, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), 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, today announced that two scientific sessions highlighting PURE EP(tm) System have been accepted into Heart Rhythm Society 2020 Science.
The two part set of videos titled ‘Cardiac Signal Acquisition and Clinical Considerations for Accurate Interpretation’ will be presented during the HRS Rhythm Theater Sessions on June 12 and July 1, 2020. The sessions will cover the challenges of acquiring clean signals in the EP lab environment, foundational principles of cardiac signal acquisition and clinical implications of applying filters to cardiac signals. The content of the series will be complemented by the clinical examples acquired by PURE EP(tm) System. The series will be presented by Samuel J. Asirvatham, M.D., Cardiac Electrophysiologist, Professor of Medicine at Mayo Clinic Rochester, MN and K.L. Venkatachalam, BSEE, M.D., Cardiac Electrophysiologist, Associate Professor of Medicine at Mayo Clinic’s Florida campus.
“The annual Heart Rhythm Society conventions are the highlights in our industry calendars, and we are pleased that the HRS committee is bringing the electrophysiology community together through its virtual scientific sessions this summer,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “BioSig has been busy seeking to generate vast amounts of clinical data and initiating new installations, and we are particularly thankful to Drs. Asirvatham and Venkatachalam for their commitment to innovation and their ongoing support of our clinical efforts.”
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#5 BSGM Potential Catalyst - A Huge Update On Merimepodib
ViralClear Closes $10.8Mn Equity Financing for Development of CV-19 Broad-Spectrum Oral Anti-Viral Candidate Merimepodib
Westport, CT, May 20, 2020 (GLOBE NEWSWIRE) --
- Funding completed in subsidiary without dilution to BioSig common stock
- Phase II human trials for merimepodib, a broad-spectrum oral anti-viral treatment of adult hospitalized patients with CV-19, are planned to commence at three Mayo Clinic sites
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced the closing of a $10.8 million common stock financing. ViralClear plans to use the proceeds of this offering for the development, including phase II human clinical trials, of its product candidate merimepodib, a broad-spectrum anti-viral agent. The financing was completed at a $100Mn pre-money valuation.
“The successful completion of this funding in these challenging times represents the investor’s confidence and support of our clinical program,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. and Director of ViralClear Pharmaceuticals, Inc. “With the FDA clearing our Investigational New Drug application earlier this week, we intend to deploy these proceeds toward our clinical trials – and what we hope will be timely solution to the current public health crisis.”
On May 18, 2020, ViralClear announced the FDA’s clearance of its IND to proceed with a proposed phase II study of merimepodib in CV-19 patients. The human clinical trials are planned to be conducted under leadership of Dr. Andrew D. Badley, Professor and Chair of the Department of Molecular Medicine and the Enterprise Chair of the CV-19 Task Force at Mayo Clinic.
Introducing broker, Laidlaw & Company (UK) Ltd. participated in the transaction.
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#6 BSGM Potential Catalyst - Major FDA News Update
FDA Clears the Investigational New Drug Application to Enable the Phase II Trial of ViralClear’s Merimepodib, Oral Solution to Treat Adult Patients with Advanced CV-19, to Proceed
Westport, CT, May 18, 2020 (GLOBE NEWSWIRE) --
- Phase II clinical trial expected to be conducted at multiple centers in the United States, including three Mayo Clinic sites under the leadership of Andrew D. Badley, M.D., Enterprise Chair of CV-19 Task Force
- Randomized, double blind, placebo-controlled clinical trial to be conducted in adults with CV-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices
BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), today announced that the U.S. Food and Drug Administration (FDA) has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with CV-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.
This study will be a randomized, double blind, placebo-controlled trial to evaluate the efficacy and safety of merimepodib as an orally administered treatment. The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen.
“I’m very pleased to be involved in this planned Phase II study of merimepodib for the treatment of patients with CV-19 disease,” said Andrew D. Badley, M.D., Professor and Chair of Department of Molecular Medicine and the Enterprise Chair of CV-19 Task Force. “We are grateful to the FDA for their prompt response in helping accelerate opp's to find treatments for the novel c-virus. We plan to begin enrollment of this trial as soon as practicable given the importance of finding solutions to this pandemic.”
“FDA clearance for our proposed phase II trial to proceed is an important step for the development of merimepodib,” commented Jerome B. Zeldis, M.D., Ph.D, Executive Chair, co-founder and acting Chief Medical Officer of ViralClear Pharmaceuticals, Inc. “We intend to conduct Phase II evaluations of our drug both in the hospital and outpatient settings as part of our clinical development plan.”
“We thank the Mayo Clinic for collaborating with us to conduct the trials under the leadership of Professor Badley,” said Nick Spring, Chief Executive Officer of ViralClear Pharmaceuticals, Inc. “Of the therapies that are currently being evaluated as treatments and can be available in the short term, we believe that a broad-spectrum antiviral that is orally administered and widely available could be very helpful in addressing the CV-19 pandemic. We further believe it can play a pivotal role in helping manage this type of public health crisis.”
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BioSig Technologies, Inc. (BSGM)
BioSig Technologies, Inc., a development stage medical device company, engages in developing a proprietary biomedical signal processing technology platform to extract information from physiologic signals.
Its product is PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP System, a surface electrocardiogram and intracardiac multichannel recording and analysis system that acquires, processes, and displays electrocardiogram and electrograms required during electrophysiology studies and catheter ablation procedures. It is also developing a library of software tools that are designed to be configured to fit the needs of electrophysiologists in various settings and for arrhythmia treatments. The company was founded in 2009 and is headquartered in Los Angeles, California.
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More About BioSig Technologies, Inc.
From the company website:
BioSig: A Pioneer in Signal Processing Solutions
At BioSig, we're working to develop and deliver the advanced signal processing solutions that will unlock the future of bioelectronic medicine, starting with the PURE EP™ System.
We built BioSig to achieve this vision – with a strong commitment to research, a world-class leadership team, and a network of expert partners. We are now achieving important milestones as we prepare to enter the fast-growing electrophysiology market, but our aspirations reach even further: to lead one of the most innovative and most promising frontiers in healthcare.
Our Path from Research to Growth
Since our founding in 2009, BioSig has built an impressive scientific and business track record. In less than 10 years, we have developed a first-of-its-kind technology, attracted significant investment, conducted pre-clinical studies with centers of excellence, signed a 10-year strategic agreement with Mayo Clinic, and developed a robust IP strategy.
We are now poised to commercialize our first product: the PURE EP™ System. In 2018, we received FDA 510(k) clearance for PURE EP™, began market launch, and BioSig was uplisted to the NASDAQ national exchange. In 2019, we plan to begin first-in-human trials, introduce PURE EP™ to medical centers nationwide, collect our first revenues, and further develop our IP and R&D. Looking further ahead, we expect to publish trial results, grow internationally, and expand our product pipeline.
Tapping the Fast-Growing EP Market
Initially, we are targeting the $4.6Bn electrophysiology (EP) market, which is growing at more than 10% annually and expected to exceed $8.5Bn by 2024*. Ultimately, we hope to expand the applications of our technology to new disease areas and markets - helping to bring the promise of bioelectronic medicine to millions of patients worldwide.
Building for the Long Term
We are building BioSig for long-term impact and growth. This intent guides every decision we've made: from our culture and team to our financing and research. Our goal is nothing less than to transform the treatment of the most challenging diseases today.
To achieve this goal, we have created a culture that values the highest quality work, thorough research and scientific expertise, and deep collaboration with leaders in our field. Our exceptional culture and ambitious vision are already attracting high-powered new hires and partners for the next stage of our growth.
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