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Innerscope Hearing Technologies Inc (OTCMKTS: INND) Breaking Out Northbound as Hearing Aid Pioneer Awaits Upcoming August 8 FDA Ruling on OTC Medical Devices

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Innerscope Hearing Technologies Inc (OTCMKTS: INND) is making an explosive move into copperland in recent trading up another 8% today on $1.3 million in dollar volume. The stock has runner in its blood skyrocketing to $0.098 highs in early 2021 and is looking to make another big move now. INND has a massive and very loyal shareholder base who see big things coming here. Of note is the August 8 FDA hearing (medical devices: ear, nose and through devices: establishing over the counter hearing aids and aligning other regulations) which will make INND hearing aids more readily available to the public. INND is starting to attract mainstream press including Fox Business News, Bloomberg and a 12-part series by Newsmax. Management has been working hard behind the scenes getting the filings up to date on its way to becoming and SEC filer and fully reporting OTCQB. Speculators in INND and there are a lot of them are looking for a breakout over $0.098 and well beyond. 

It’s easy to get excited about INND, a manufacturer, distributor, and retailer of FDA-Registered Direct-to-Consumer Self-Fitting-Self-Adjusting Hearing Aids. The Company recently launched its latest breakthroughs in Hearing Technology with its New Smartphone Controlled Direct-to-Consumer Self-Fitting-Self-Adjusting Rechargeable Hearing Aids with built-in Professional Remote Programming & Support Service. With the launch planned to begin spring of 2021, InnerScope as a wholesale vendor for Walmart and is also in best buy as well as BJ’s Wholesale Club. The Company has seen significant growth through acquisition acquiring both of iHear Medical Inc., as well as HearingAssist, an established leader in the direct-to-consumer hearing aid market with a customer base of over 400,000. These acquisitions, combined with a partnership with Atlazo Inc., a semiconductor innovator for next-generation A.I. smart devices, will allow InnerScope to better position itself in the direct-to-consumer hearing solutions market by selling advanced hearing products through Walmart and other major retailers. Earlier this year INND received a purchase order from Walmart USA in the amount of $9,462,232 for HearingAssist products. They also received another purchase order from Walmart for $1,583,922 for products launching in 1499 Walmart Vision Centers. The first purchase order of $1,583,922 of products is en route to Walmart USA Warehouse for immediate deployment. The second purchase order of $9,462,232 of products is in the final production phases for late June/July deployment. Check out INND app here.

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InnerScope Hearing Technologies (OTC: INND) operating from professional drive in Roseville, California, INND is a manufacturer, distributor, and retailer of FDA-Registered Direct-to-Consumer Self-Fitting–Self-Adjusting Hearing Aids, Self-Fitting–Self-Adjusting Personal Sound Amplifiers Products, Doctor-Formulated Dietary Hearing & Tinnitus Supplements, and Assorted Ear & Hearing Health-Related Products its mission is to improve the quality of life of the 70 million people in North America who suffer from hearing impairment and/or hearing-related issues. The management team of InnerScope is applying decades of industry experience and believes it is well-positioned to directly benefit from the Over-the-Counter Hearing Aid Act (expected to be enacted in early 2021). InnerScope with its Affordable Self-Fitting – Self-Adjusting Hearing Technology, combined with its innovative point of sale Hearing Screening Kiosks designed for consumers with mild-to-moderate hearing loss to purchase over-the-counter hearing aids without being seen by a hearing care professional.   

INND is led by CEO Matthew Moore who literally grew up in the hearing health industry, with having internships and mentorships beginning with his Grandfather who has personally helped over 20,000 hearing- impaired patients in his private hearing aid practice since the 1940s. At the age of 10, Matthew was working in the Marketing Department of his parents private hearing aid practice. By the age of 22, Matthew became a full partner in his parents hearing aid business, which then grew to one of the largest private hearing aid practices in the United States with over 70 locations and over 40,000 customers in a 10-year period. Several years ago, the family sold off the remaining locations for $14 million. As CEO of InnerScope, Mr. Moore has been making one big move after another recently forming distribution partnerships with Walmart, Sears, and other Big Box Retailers/Pharmacies as well as independent retailers and pharmacies for InnerScope’s Products and Services.  

INND operates in the booming hearing aids space; According to a report from Fortune Business Insights the global hearing aids market is set to gain impetus from the increasing adoption of telehealth among audiologists to prevent patient traffic. The report further states that the market size was USD 8.99 billion in 2019 and is projected to reach USD 13.38 billion by 2027, exhibiting a CAGR of 8.2% during the forecast period.  

InnerScope’s recent acquisition of iHear Medical Inc., a  DTCcloud-based hearing solution provider, gives the Company access to over 40 patents and an FDA-registered manufacturing and R&D facility. In addition, InnerScope has acquired HearingAssist, an established leader in the direct-to-consumer hearing aid market with a customer base of over 400,000. These acquisitions, combined with a partnership with Atlazo Inc., a semiconductor innovator for next-generation A.I. smart devices, will allow InnerScope to better position itself in the direct-to-consumer hearing solutions market by selling advanced hearing products through Walmart and other major retailers.

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INND

InnerScope Hearing Technologies (OTC: $INND) (@inndstock) / TwitterThe Company launched its hearIQ App in 172 countries in the Apple App Store for iOS devices and Google Play Store for Android devices. The hearIQ App is a multi-functional app, which offers to the general public a FREE Self-Administered Hearing Test to determine hearing loss (if any) and also provides a Bluetooth wireless connection (“App Controlled”) for InnerScope’s Direct-to-Consumer Self-Fitting-Self-Adjusting Hearing Aids. The hearIQ App is specifically designed to help with early detection of hearing loss for the 48+ million Americans as well as the 1.5 billion people worldwide who may have an undetected hearing loss or may be living with some degree of hearing loss, according to the World Health Organization (“WHO”). More importantly, if hearing loss is detected, the hearIQ App directly links to InnerScope’s Direct-to-Consumer Hearing Products. Since the hearIQ App became activated only nine days ago, it has already received over 440 reviews and has a FIVE-STAR RATING from Apple and Android users. 

FDA ruling coming on August 8: Medical devices: ear, nose and through devices: establishing over the counter hearing aids and aligning other regulations 

The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health. 

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(INND) InnerScope Hearing Technologies, an exciting Company makes a move on the booming $5 billion dollar hearing aid market is making a powerhouse run up the charts in recent days attracting legions of new shareholders and emerging as among the top most traded stocks in small caps. Currently under heavy accumulation with INND trading $1.3 million plus in dollar volume today alone, INND is looking to blaze a path along the likes of Enzolytics or Tesoro and break out into a whole new dimension, a break over $0.098 is the first step. INND is well-positioned to directly benefit from the Over-the-Counter Hearing Aid Act which is expected to be voted on, on August 8; Its easy to get excited about INND, a manufacturer, distributor, and retailer of FDA-Registered Direct-to-Consumer Self-Fitting-Self-Adjusting Hearing Aids. Recently INND laucned its latest breakthroughs in Hearing Technology with its New Smartphone Controlled Direct-to-Consumer Self-Fitting-Self-Adjusting Rechargeable Hearing Aids with built-in Professional Remote Programming & Support Service. INND is starting to attract mainstream press including Fox Business News, Bloomberg and a 12-part series by Newsmax. We will be updating on INND when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in INND 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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