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With Mayo Clinic in its Corner, BioSig Aligns for Commercialization of PURE EP System Improving Catheter Ablations for AFib and VT Patients

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Over the last three decades, significant progress has been made in gaining a better understanding of atrial fibrillation (AF, AFib), a complex cardiac arrhythmia once considered essentially benign that is now directly linked to morbidity and death, mostly due to stroke.  As researchers have been able to better define the pathophysiology of AF, treatment options have advanced as well, including catheter ablation procedures becoming routine.  Technology is playing a key role, albeit for spotting AF, as the Apple Watch is trumpeted to do (and Stanford is looking to evaluate), or giving cardiologists better tools to improve outcomes for ablation procedures, such as the PURE EP™ System of BioSig Technologies (NASDAQ: BSGM).

AF is the most common arrhythmia today, affecting over 33 million people globally, including up to 6 million people in the U.S.  Estimates are that the number of Americans affected will rise to over 12 million by 2030.  How many people actually could be diagnosed with AF is a little bit of a guessing game.  While prevalence increases with aging (9% of people over 65 have AF), it is indiscriminate and can present at any age and in people with varying lifestyles.  Just ask Ed Dentel, a 46 year old man that works out regularly and hadn’t even heard of the condition before his Apple Watch pegged his AFib in December.

With AFib, the steady contractions of muscle fibers in the atria (upper chambers of heart) aren’t coordinated with those of the heart’s lower chambers (the ventricles) because disordered electrical signals cause rapid and chaotic contractions in the atria.  Consequently, the blood isn’t emptied from the upper chambers to the lower chambers as it should, meaning that blood may pool in the atria.  This can lead to serious complications, including stroke (risk increased 4-5x), blood clots and heart failure, in addition to short-term issues with shortness of breath, dizziness and weakness.

During a catheter ablation to try and remedy the discombobulated electrical signals, a cardiologist uses extreme heat or cold to scar heart tissue in a bid to mute the stray electrical signals causing the arrhythmia.  Simply, the scarred tissue doesn’t have the ability to transmit the abnormal electrical impulses, which can eliminate the problem.

It is not a perfect world, though, and often times multiple ablation procedures are required and sometimes the AFib never completely goes away.

The cardiologist doesn’t simply look to destroy heart tissue without using all available efforts to isolate the source of rapidly discharging electrical triggers (called “hot spots”).  A mapping catheter and other technology help point to the spots within the atria to ablate.  However, there are limitations to today’s electrophysiology technology to precisely locate hot spots, limitations that could potentially be overcome with BioSig’s PURE EP™ System.

In its efforts, BioSig has brought together leading physicians, executives and engineering experts from top medical centers, healthcare programs, Fortune 500 companies and elite educational systems, including Mayo Clinic, Mount Sinai Medical Center, UCLA, Johnson & Johnson, Nasdaq and Prudential Securities.

The BioSig system is a combination of advanced hardware and software that offers a broader dynamic range and real-time processing to provide the cardiologist a raw cardiac signal with sharper clarity and less “noise” than anything on the market today.  Utilizing superior data is believed to improve outcomes from ablations for treating not only AFib, but also Ventricular Tachycardia (VT), a condition rarer than AFib, but responsible for about 300,000 sudden cardiac deaths in the U.S. annually.  Similar to AF, VT is characterized by electrical signals firing incorrectly.  Because the ventricles are contracting too quickly, the atria doesn’t have time to refill, so blood is not getting pumped properly through the body.

In July, BioSig was recognized by The Silicon Review as one of the Top 50 Innovative Companies to Watch in 2018 as it progressed with its technology serving an unmet need in the $4.6 billion electrophysiology marketplace.

The following month, the U.S. Food and Drug Administration gave BioSig the green light to proceed with human testing as it aligns to meet its goal of a commercial launch of the PURE EP™ System later this year.  In November, BioSig inked an agreement with Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Austin, Texas to conduct First-in-Human studies using the system.  Only days after signing that agreement, a separate one was penned with Mayo Clinic to also conduct First-in-Human studies.

Mayo Clinic has extensive knowledge of the potential of the PURE EP™ System, having previously conducted 12 pre-clinical studies, results which have been published in a number of industry journals.  In March 2017, BioSig and Mayo Clinic signed a 10-year collaboration agreement for the purpose of developing new, advanced features for the system, looking to build upon what is already a significant improvement for the good of patients and doctors.

Online Media Group, Inc. is not registered with any financial or securities regulatory authority and holds no investment licenses and does not provide, nor claims to provide, investment advice. We are a publisher of original and third party news and information. This article is sponsored content and is neither an offer nor recommendation to buy, sell or hold any security. The views expressed are our own and not intended to be the basis for any investment decision. Investing intrinsically involves substantial risk and readers are reminded to consult an investment professional and complete their own due diligence, including SEC filings, when researching any companies mentioned in this release. This release is based upon publicly available information and, while vetted, is not considered to be all-inclusive or guaranteed to be free from errors. With respect to Section 17(B) of the Securities Act of 1933 and in the interest of full disclosure, we call the reader’s attention to the fact that Online Media Group, Inc. received $1,333 in compensation from IRTH Communications for content creation, advertising and distribution services related to this material. �b@�

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Citius Insiders Invest Heavy in $10 Million Capital Raise; World’s First Therapy for Salvaging CVCs in Situ in Phase 3 Clinical Trials

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With about 7 million used in the U.S. alone annually, central venous catheters (CVCs) are integral to healthcare as lifesaving access ports for patients needing extended intravenous therapy. To that point, market intelligence firm Future Market Insights forecasts the global CVC market will grow at a steady 5.1% compound annual growth rate in the decade to 2026, with North America continuing to dominate the space.

As critical as CVCs are to therapy for an array of diseases and conditions, they do have one serious flaw: infections. Each year in the U.S., about 472,000 catheters become contaminated, leading to life-threatening infections known as catheter related bloodstream infections (CRBSIs) and central line-associated bloodstream infections (CLABSIs). While there are clear distinctions between the two, they are often used in the same breath because of their similarities as intravascular devices and the fact that they cumulatively result in thousands of deaths annually and billions of dollars in added expense to the U.S. healthcare system.

When a CVC becomes infected, today’s standard of care is to remove and replace the catheter. That may sound simple enough, but the fact is that it is a surgical procedure, meaning that it is accompanied by all the associated risks and costs. When considering that the patients requiring the procedure are typically very sick already and sometimes seriously immunocompromised, the risks become exacerbated.

As detailed in a recent presentation on the popular website Virtual Investor Conferences, Citius Pharmaceuticals (NASDAQ: CTXR) is at the head of innovation to address CRBSIs and CLABSIs with its Mino-Lok, the world’s first experimental therapy to sterilize and salvage CVCs in place. Citius is developing Mino-Lok, a combination of minocycline, edetate and ethyl alcohol, under a Fast Track designation from the U.S. Food and Drug Administration as a Qualified Infectious Disease Product (QIDP) providing it with expedited review and additional protection from competition if it makes it to market.

The lock solution was initially developed by the venerable experts at the M.D. Anderson Cancer Center, followed by Citius licensing the technology in 2014 and finalizing a worldwide license in 2016.

Data from a 90-patient successfully completed Phase 2b clinical showed a 100% efficacy rate in eradicating infection from the CVC while it remained in the patient. Furthermore, there were zero complications or serious adverse events in the Mino-Lok group, versus an 18% complication rate in the control group where the CVC was removed and replaced.

Citius has advanced Mino-Lok into a 700-patient Phase 3 trial. According to Citius President and CEO Myron Holubiak, who previously was President of Roche Laboratories, the enrollment process is going well at this point, with 20 of 50 planned investigational sites initiated and 15 more in “start up” mode as documentation is finalized.

Citius will be looking for the Mino-Lok group to outperform the control group with regards to the primary endpoint of the portion of intent to treat patients that achieve success (eradication of pathogen, stabilization in infections symptoms, catheter salvage and survival) at the end of 8 weeks of treatment.

Holubiak and Chairman Leonard Mazur have provided tangible proof of their belief in Mino-Lok (as well as Citius’ Phase 2 experimental hemorrhoid treatment CITI-002) as evidenced in a recent $10 million capital raise to fund the company and its pipeline. Of the $10 million, Holubiak and Mazur invested $1 million and $4 million, respectively. Founders and insiders have consistently supported the company, contributing over $23 million in capital since inception.

Online Media Group, Inc. is not registered with any financial or securities regulatory authority and holds no investment licenses and does not provide, nor claims to provide, investment advice. We are a publisher of original and third party news and information. This article is sponsored content and is neither an offer nor recommendation to buy, sell or hold any security. The views expressed are our own and not intended to be the basis for any investment decision. Investing intrinsically involves substantial risk and readers are reminded to consult an investment professional and complete their own due diligence, including SEC filings, when researching any companies mentioned in this release. This release is based upon publicly available information and, while vetted, is not considered to be all-inclusive or guaranteed to be free from errors. With respect to Section 17(B) of the Securities Act of 1933 and in the interest of full disclosure, we call the reader’s attention to the fact that Online Media Group, Inc. received $1,333 in compensation from IRTH Communications for content creation, advertising and distribution services related to this material.

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Colorado Marijuana Posts Record $1.5 Billion Performance

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Legal cannabis sales in the Centennial State Rose up to $1.5 billion, in a metric that encompasses both medical and recreational cannabis markets. The data was released to the public by the State‘s Department of Revenue.The closing number for 2016 was $1.3 billion in sales which, at the time, also set a record. The comparison of performances shows the state‘s sales have experienced a 15% rise year-on-year. In 2015, $996.5 million in sales were registered.

At the start of 2017, even with dwindling marijuana prices that had dropped 33%, the state had already started to set monthly records for sales, which ultimately led to the bar-setting performance for the sector by the end of the annum.

A breakdown of the numbers shows us that adult recreational use rose to $1.09 billion over the year. The remaining $416.5 million came from the medical marijuana sector.

Last year, Colorado needed only eight months to break the $1 billion sales threshold — yet another record-breaking performance. It took the state 10 months over the prior year to reach the number.

The addition of PTSD to the list of treatable conditions served as a boost for the sales of MMJ back in June of last year.

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New Treatment for Pediatric Ulcerative Colitis Submitted for FDA Orphan Drug Classification

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A New, Non-Corrosive, Non-Irritating Treatment for Pediatric Ulcerative Colitis Has Been Submitted for FDA‘s Orphan Drug Classification

Financial Press Commentary

(FinancialPress) — The US Federal Drug Administration (FDA) has received an orphan drug designation request from Vitality Biopharma Inc. (OTCQB: VBIO)—a cannabinoid prodrug pharma corporation in the process of developing its flagship asset VITA-100, targeting the treatment of pediatric ulcerative colitis.

A positive response from the FDA’s Office of Orphan Products Development stands to benefit the company as it continues to develop the treatment.

The drug could potentially serve to alleviate the pediatric condition – which holds a rare disease classification itself.

VITA-100 holds the particular distinction of being based on Vitality’s proprietary “cannabosides” technology—a delivery system aimed to deliver therapeutic-grade cannabinoids (THC and CBD) directly to the targeted area in the gastro-intestinal tract without the composite entering the bloodstream. The benefit of this delivery method is the avoidance of all psychoactive effects traditionally associated with it.

“In young children, ulcerative colitis can often be hyperactive and difficult to control using existing FDA-approved medications,” said Robert Brooke, CEO and Co-Founder of the company.

“Given the mounting clinical data documenting use of cannabinoids for treatment of gastrointestinal disorders, we are very excited about the potential of VITA-100 and our cannabosides platform to provide a meaningful impact for these patients, helping them to stabilize their disease and avoid debilitating surgeries,” he added. 

The cannabosides technology has already been tested and demonstrated as effective by the company—particularly in preclinical models of colitis.

The non-intoxicant formulation also helped reduce the side effects that often come with similar treatments such as weight loss, damage to the colon and overall improved GI health when compared to placebos.

The restricted delivery-drug, enabled by the company’s know-how in enzymatic glycosylation, is geared up to be available as an oral pharmaceutical.

Formerly a stevia-focused company, Vitality is one of the few companies operating in the cannabinoid pharmaceutical sector.

It found its niche in obtaining its own intellectual properties in the aforementioned delivery system.

Their inaugural discovery in the field came as it attempted to make stevia taste better. They found a much better – and more exploitable – result in lieu.

Therapeutic synthetic THC, AKA dronabinol, has been an instrumental factor in giving companies such as Vitality a head start over the rest of the medicinal cannabis sector, as the FDA‘s 2016 approval has allowed them to delve deeper into the medical uses and benefits of the cannabinoid.

The legal THC sector has been making waves ever since the approval, with companies such as Valeant Pharmaceuticals, Inc. (NYSE: VRX) (TSX: VRX) and INSYS Therapeutics, Inc. (NASDAQ: INSY) releasing their products Marinol and Syndros respectively – both of which use the cannabis derivate as the active ingredient. GW Pharmaceuticals plc (NASDAQ: GWPH) is also expected to have its Sativex (naxibimol) product approved soon.

Vitality‘s submission brings it one step closer to tapping into the massive medicinal cannabinoid market, putting it neck and neck with the giants of the sector while having only a fraction of, for example, GW‘s $3.723 billion market cap.

POTENTIAL COMPARABLES

Valeant Pharmaceuticals, Inc. (NYSE: VRX) (TSX: VRX)

Valeant operates as a pharmaceutical and medical device company worldwide. Among its many products, the company offers Uceris to get ulcerative colitis under control; and Zegerid to treat certain stomach and esophagus problems; Tobramycin and Dexamethasone ophthalmic suspension for steroid responsive inflammatory ocular conditions; and Latanoprost medicines to treat a type of glaucoma. The company was founded in 1983 and is headquartered in Laval, Canada.

INSYS Therapeutics, Inc. (NASDAQ: INSY)

Insys Therapeutics, Inc., is a specialty pharmaceutical company, which develops and commercializes supportive care products. The company markets SUBSYS, a sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant cancer patients in the United States. Its lead product candidate is SYNDROS, an orally administered liquid formulation of dronabinol for treating CINV and anorexia associated with weight loss in patients with AIDS. The company is also developing Cannabidiol Oral Solution, a synthetic cannabidiol for childhood catastrophic epilepsy syndromes; and other product candidates, including other dronabinol line extensions and sublingual spray product candidates. Insys Therapeutics, Inc. is headquartered in Chandler, Arizona.

GW Pharmaceuticals plc (NASDAQ: GWPH)

GW is a biopharmaceutical company, engaging in discovering, developing, and commercializing cannabinoid prescription medicines derived from the Cannabis plant. GW markets Sativex, for the treatment of spasticity due to multiple sclerosis, which is also in Phase II trials for neuropathic pain. Their product pipeline includes Epidiolex, which is in Phase III clinical development to treat dravet syndrome, lennox-gastaut syndrome, tuberous sclerosis complex, and infantile spasms. GW Pharmaceuticals plc was founded in 1998 and is based in the UK.

About Vitality Biopharma (OTCQB: VBIO)

Vitality Biopharma is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. For more information, visit: www.vitality.bio. Follow us on Facebook, Twitter and LinkedIn


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