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BioElectronics Corp. (OTCPINK: BIEL) Heating Up as ActiPatch® and RecoveryRx® Gain Traction & Co Looks to Expand into New Markets

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BioElectronics Corp. (OTCPINK: BIEL) has been trending up in recent months and it looks as if this may be the beginning of something. The stock has a long history of big moves skyrocketing to $0.007 in summer 2021. Microcapdaily has been reporting on BIEL for years and covered them in triple digits back in November shortly after the Company received CE (Conformité Européenne) Mark for its ActiPatch® and RecoveryRx®.  These wearable devices can now be sold over the counter in 33 European Union (EU) countries, and many other non-EU countries like Australia that recognize the CE mark. This comes shortly after the Company acquired three 510(k) clearances from the U.S. Food & Drug Administration (FDA). Biotech’s are among the most explosive stocks in penny stocks and BIEL has a significant gap to fill from $0.07 highs of February 2021. The stock has a large investor following that will buy in significantly as soon as BIEL starts running northbound i earnest. 

There is a lot going on at BioElectronics; according to the July 22 update the Conapny has completed and undertaken additional clinical research and has received the initial stocking purchase order from its distribution partner, Stada. BIEL recently completed a randomized, double-blind, placebo-controlled (RCT) study on providing pain relief and improving functionality for dogs suffering from osteoarthritis (OA). The owners of the dogs receiving the active device reported their dogs showed a 45% reduction in pain within 14 days compared to the dogs who received the placebo device. The Company is investigating how best to enter this multi-billion-dollar market in the near future. Also, a recent case study was published that used RecoveryRx medical device to help relieve phantom limb pain. It found that 67% of the users got pain relief after using this device. Also in a recently published paper, a RCT study of temporomandibular joint disorders (TMD) found that BIEL medical device, ActiPatch, provided better and longer pain relief than a combination of an NSAID and a commercially available muscle relaxant, Myospas. TMD affects approximately 5%–12% of the overall population and thus represents another potential market that we plan to explore. 

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BioElectronics Corp. (OTCPINK: BIEL) is a leader in the field on non-invasive electroceutical medical devices. BioElectronics is the maker of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Therapy for postoperative pain and chronic wound care. The Company ActiPatch works by modulating the body’s nerve activity to dampen the pain perception, which reduces drug use. The neuromodulation basis of PSWT presents significant opportunities for BioElectronics to develop optimized technology for diabetic neuropathy, postoperative surgery, chronic wounds, and other applications. In February 2017, BioElectronics announced that it received over-the-counter use market clearance from the US FDA for ActiPatch® for the adjunctive treatment of musculoskeletal pain related to plantar fasciitis of the heel, and osteoarthritis of the knee. 

BioElectronics Pain Relief ProductsThe Company’s current OTC product line includes ActiPatch® Musculoskeletal Pain Therapy, Allay® Menstrual Pain Therapy, Smart Insole™ Heel Pain Therapy, and RecoveryRx® Post-operative and Chronic Wounds Therapy. The US FDA clearance is for BioElectronics flagship product the ActiPatch® Musculoskeletal Pain Therapy, developed to relieve chronic pain. ActiPatch is a drug-free, wearable nonprescription medical device that provides 720-hours (90, 8-hour treatments) of on/off therapy. Most users obtain relief with only 8 hours per day of use, so the device will generally last several months, depending on use. 

In February 2020, BioElectronics obtained a new 510(k) clearance from the U.S. FDA, granting overthe-counter marketing clearance for the drug-free ActiPatch® medical device, to cover all musculoskeletal pain complaints. This paves the way for new products to treat all medical claims for musculoskeletal pain, including in the back, knee, hips, wrists, elbow, and ankle. 

In November 2020, the Company received the CE (Conformité Européenne) Mark for its ActiPatch® and RecoveryRx® Pulsed Shortwave Therapy (PSWT) medical devices. The ActiPatch is indicated for the treatment of general musculoskeletal/soft-tissue pain, while the RecoveryRx is indicated for the treatment of postoperative pain. These wearable devices can now be sold over the counter in 33 European Union (EU) countries, and many other non-EU countries like Australia that recognize the CE mark. The certification for the CE mark is valid until May 2024, and the Company’s updated quality management system will ensure prompt recertification. 

BioElectronics has focused attention on international customers to expand its distributions and sales. The Company has established distribution agreements with distributors in the United Kingdom, Sweden, Southeast Asia, South Africa, Australia, Spain, Kuwait, and Italy.  In November 2020, the Company announced the execution of a commercial partnership agreement with Scott Specialties Inc. (http://scottspecialties.com) to bring their innovative pain management devices to the retail consumer marketplace under the DonJoy® (DJO www.djoglobal.com) 

The commercial partnership will leverage the Actipatch’s broad indications for use and offer active-passive treatment combination products to treat pain, increase physical functionality and improve overall quality of life. The new products will be marketed under DJO’s DonJoy Advantage (DJA) line of orthopedic appliances and sold as an EME Knee Wrap and an EME Back Wrap, “powered by Actipatch”. 

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BIEL

On July 22 BIEL announced via a Shareholder’s update that the Company has completed and undertaken additional clinical research and has received the initial stocking purchase order from its distribution partner, Stada.  The update is below: 

Richard Staelin, Ph.D.: Dear Shareholders, 

I would like to take this opportunity to discuss some new developments and their possible implications for the Company. Let me start by again stating our guiding principles, that is, our core capabilities are in innovation with pulsed shortwave therapy (PSWT) and manufacturing an affordable medical device. With this in mind, I would like to provide information on a few very promising new developments. 

Canine Osteoarthritis 

We recently completed a randomized, double-blind, placebo-controlled (RCT) study on providing pain relief and improving functionality for dogs suffering from osteoarthritis (OA). The owners of the dogs receiving the active device reported their dogs showed a 45% reduction in pain within 14 days compared to the dogs who received the placebo device. (Pain levels were measured via eight behavioral indicators.)  In addition, these treatment dogs exhibited increased range of motion while the placebo dogs showed no such increase. (A paper describing this study is in preparation for submission to a veterinary journal and will be posted on our website by the end of this month). 

These results have at least two major implications. First, canine OA is found in at least 80% of older dogs and represents a new market for BIEL with few good competitive options for dog owners. We plan to investigate how best to enter this multi-billion-dollar market in the near future.  Second, because we placed the device on the dog’s neck near the cervical spinal cord and not near the arthritic joint, it provides new evidence on how PSWT works. This latter knowledge is extremely important since it provides insights into coming up with new applications. 

Phantom Limb Pain 

A recent case study was published that used our RecoveryRx medical device to help relieve phantom limb pain. It found that 67% of the users got pain relief after using this device. This is particularly encouraging since all of these patients had tried multiple other therapies and failed to find any relief. The doctor who is leading this study plans to conduct a larger RCT study to further document possible relief. More details can be found at the following link.   

Temporomandibular Joint Disorder (TMD) 

In a recently published paper, a RCT study of temporomandibular joint disorders (TMD) found that our medical device, ActiPatch, provided better and longer pain relief than a combination of an NSAID and a commercially available muscle relaxant, Myospas. TMD affects approximately 5%–12% of the overall population and thus represents another potential market that we plan to explore. More details about the study can be found at the following link.

New Distributor Agreement 

We have continued our efforts to expand our markets internationally. We recently signed an agreement with Stada, a leading manufacturer of high-quality pharmaceuticals, who will be distributing ActiPatch to augment their non-prescription consumer healthcare products. We are now in the process of meeting the demand for their first order. 

Summary 

The Company has continued to develop strong business partners with major marketing firms while also scanning the environment for new markets and opportunities. Conducting sound research and documenting new applications is part of our DNA and should provide the Company with a successful future.  Again, we thank our shareholders for their continued support and look forward to further announcements, both in terms of new research findings and new market opportunities. 

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Currently trading at a $19 million market valuation BIEL is an exciting story developing in small caps. The stock has a long history of big moves skyrocketing to $0.007 in summer 2021. Microcapdaily has been reporting on BIEL for years and covered them in triple digits back in November shortly after the Company received CE (Conformité Européenne) Mark for its ActiPatch® and RecoveryRx®.  These wearable devices can now be sold over the counter in 33 European Union (EU) countries, and many other non-EU countries like Australia that recognize the CE mark. This comes shortly after the Company acquired three 510(k) clearances from the U.S. Food & Drug Administration (FDA). Biotech’s are among the most explosive stocks in penny stocks and BIEL has a significant gap to fill from $0.07 highs of February 2021. The stock has a large investor following that will buy in significantly as soon as BIEL starts running northbound i earnest. There is a lot going on at BioElectronics; according to the July 22 update the Conapny has completed and undertaken additional clinical research and has received the initial stocking purchase order from its distribution partner, Stada. BIEL recently completed a randomized, double-blind, placebo-controlled (RCT) study on providing pain relief and improving functionality for dogs suffering from osteoarthritis (OA). The owners of the dogs receiving the active device reported their dogs showed a 45% reduction in pain within 14 days compared to the dogs who received the placebo device. The Company is investigating how best to enter this multi-billion-dollar market in the near future. Also, a recent case study was published that used RecoveryRx medical device to help relieve phantom limb pain. It found that 67% of the users got pain relief after using this device. Also in a recently published paper, a RCT study of temporomandibular joint disorders (TMD) found that BIEL medical device, ActiPatch, provided better and longer pain relief than a combination of an NSAID and a commercially available muscle relaxant, Myospas. TMD affects approximately 5%–12% of the overall population and thus represents another potential market that we plan to explore. We will be updating on BIEL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with BIEL.

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Disclosure: we hold no position in  BIEL either long or short and we have not been compensated for this article

BioPharma

Organogenesis (NASDAQ: ORGO): Latest Developments and Future Growth Prospects

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Organogenesis Holdings (NASDAQ: ORGO), a top regenerative medicine company dedicated to advanced wound care, surgical, and sports medicine solutions, gains over 30% during intraday trading and after hours combined after their latest release. According to the release, three Medicare Administrative Contractors (MACs) decided to withdraw certain coverage rules that were meant to start on October 1. These rules related to products for treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

More Background:

Organogenesis serves a range of clients, from hospitals and wound care centers to doctors’ offices. The MACs’ initial rules, set on August 9, caused concern. They specified that covered products must be particular types of skin substitutes. Unfortunately, this excluded five products from Organogenesis, impacting their financial outlook.

Fast forward, the MACs pulled back these rules just in time, preventing potential harm to Organogenesis. Even before these rules, the company was facing challenges. In the second quarter, revenue was slightly down compared to the same period last year. Despite this, the company is doing better than the previous year in a six-month comparison.

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Gary S. Gillheeney, Sr., the head of Organogenesis, expressed deep gratitude for the MACs and the Centers for Medicare & Medicaid Services (CMS). He praised their thoughtful consideration of stakeholder concerns and putting patients first. This decision will positively affect the lives of many.

He also thanked the stakeholders, including doctors, patient advocacy groups, and various associations. Their unified support played a vital role in challenging these rules, considering the potential harm they could cause patients. Their advocacy shed light on the possible negative health outcomes and treatment disparities, especially for those with higher rates of diabetes and related conditions. Their collective efforts made a significant difference.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Vaccitech (NASDAQ: VACC) Gains Unprecedented Support—What’s Behind It?

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On September 25, 2023, Vaccitech (NASDAQ: VACC) experienced a jaw-dropping 90% surge in its stock price in just one day of trading. Now, this kind of jump usually happens when a company drops a major announcement or puts out a significant SEC filing. But, surprise, surprise—there was nothing of that sort this time .So naturally we did some digging, explored further online and guess what? Turns out retail traders were also not on a main reason for this rollercoaster ride. Curious to uncover what’s really behind this financial rollercoaster? Before we go any further, let’s get to know Vaccitech a bit better. There’s some pretty important aspects on the company you might like.

 

Background:

Vaccitech operates as a clinical-stage biopharmaceutical company, dedicated to discovering and developing innovative T cell immunotherapies. These therapies are crafted to leverage the immune system’s potency for treating conditions like chronic infectious diseases, cancer, and autoimmune disorders.

What sets Vaccitech apart is their distinctive, multi-platform approach, demonstrating the capacity to generate higher quantities of T cells compared to alternative technologies. This places Vaccitech in a unique position to cater to the needs of substantial, yet underserved patient populations. Their diverse clinical-stage pipeline includes potential treatments for severe diseases with limited available treatments, presenting significant public health risks.

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Among their lead product candidates are VTP-300, an immunotherapeutic designed to contribute to a potential functional cure for chronic hepatitis B viral (HBV) infection. Additionally, VTP-200 is a non-invasive, early-stage investigational treatment targeting persistent, high-risk human papillomavirus (HPV). VTP-850 stands out as a novel T cell investigational therapy aimed at prostate cancer, while VTP-1000, a preclinical T cell therapeutic candidate, focuses on reinstating immune tolerance in celiac disease.

Vaccitech possesses well-established expertise in drug development and scientific knowledge within the immunization realm. Notably, they co-developed a COVID-19 vaccine in collaboration with the University of Oxford. As many of you know, their vaccine has been successfully approved and holds an exclusive license worldwide with AstraZeneca.

What happened:

The one and only thing that happened today was Alliance Global Partners adding coverage of Vaccitech with a favourable buy recommendation.What’s truly eye-catching are the projections made, suggesting some pretty significant upside. The average one-year price target for Vaccitech is $12.24. Forecasts within this period have a bit of a spectrum, reaching from a low estimate of $7.07 to a high of $15.75. With that said, from today’s closing price that’s nearly 400% gain.

What’s The Big Deal?:

Alliance Global Partners giving the green light to cover Vaccitech is like a thumbs-up from a respected expert. It’s like a top-tier food critic saying, “This restaurant is a must-try.”

Think of it as Vaccitech stepping into the spotlight. It’s like a talented musician getting featured on a famous music blog—suddenly, more people start paying attention.

When a big player like Alliance Global Partners says, “Hey, this stock is a good buy,” it’s like a friend recommending a must-watch movie. You’re more likely to check it out based on that suggestion.

This kind of recommendation can also affect the stock price. It’s similar to when a popular influencer talks about a cool product—lots of people want to try it.

In a nutshell, this coverage is like a stamp of approval, making Vaccitech catch the attention of more potential investors and possibly giving the stock a boost. But it’s important to mention that just because a well established financial firm gives a price target, does not mean it’s accurate. In fact, tons of these projections are made daily with many being totally off the mark. Always do your own due diligence.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

We will update you on ELUT when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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