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Organicell Regenerative Medicine Inc (OTCMKTS: OCEL) Heating Up as Biotech Prepares for its Phase I/II Randomized, Double Blinded, Placebo Trial for Zofin

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Organicell Regenerative Medicine Inc (OTCMKTS: OCEL) is making an explosive move up the charts after the Company announced the Mayo Clinic will be the site for clinical trials on Chronic Obstructive Pulmonary Disease (COPD). Mayo Clinic in Phoenix, Arizona will be the clinical trial site for Organicell’s Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). 

Earlier this year the Company closed on an additional $1 million private stock purchase at $0.04 per share and secured a $10 Million Equity Line of Credit with Tysadco Partners, LLC. This capital raise brings the total amount of new funding deals to $16.5 Million. The Company has also been busy expanding its BOD and management team recently recruiting Ryan Likes as new Chief Operating Officer, David Aciego as Chief Information Officer, and Jacqueline (Jackie) Domenechas Director of Finance. 

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Organicell Regenerative Medicine Inc (OTCMKTS: OCEL) is a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and to provide other related services. The Company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Organicell RAAM Products and related services are principally used in the health care industry administered through doctors and clinics. 

Since May 2019, Organicell has operated a placental tissue bank processing laboratory in Miami, Florida for the purpose of performing research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers. 

The Company’s leading product, Zofin™ (also known as OrganicellTM Flow), is an acellular, biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues. 

To date, the Company has obtained certain Investigation New Drug (“IND”), and eighteen emergency IND (“eIND”) approvals from the FDA, including applicable Institutional Review Board (“IRB”) approvals which authorized the Company to commence clinical trials or treatments in connection with the use of Zofin™ and related treatment protocols. The Company is pursuing efforts to complete its already approved clinical studies (see below) as well as obtaining approval to commence additional studies for other specific indications it has identified that the use of its products will provide more favorable and desired health related benefits for patients seeking alternative treatment options than are currently available. The ability of the Company to succeed in these efforts is subject to among other things, the Company having sufficient available working capital to fund the substantial costs of completing clinical trials, which the Company currently does not have, and ultimately, obtaining approval from the FDA. 

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OCEL

On November 15 OCEL announced the Mayo Clinic will be the site for clinical trials on Chronic Obstructive Pulmonary Disease (COPD). Mayo Clinic in Phoenix, Arizona will be the clinical trial site for Organicell’s Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). 

Organicell completed the site activation and is ready to begin enrollments. Organicell aims to demonstrate the safety of Organicell’s lead extracellular vesicle biologic, Zofin, while concurrently investigating the drug’s potential long-term benefits for improved pulmonary function and quality of life measures in chronically ill COPD patients. Extracellular vesicle and exosome-based drugs, like Zofin, are becoming increasingly popular due to the number of anti-inflammatory and immune-modulatory effects. In chronic illnesses where inflammation is high, such as COPD, extracellular vesicles and exosomes offer an innovative solution for patients with unmet medical needs. 

COPD including emphysema and chronic bronchitis – a common airway disease that affects approximately 10% of individuals over 45 years of age, is a concern in patients who are infected with the Sars-Cov-2 viruses causing covid-19 disease. It is well known that COPD patients are prone to viral exacerbations and current evidence shows that COPD patients have increased pulmonary expression of ACE2, the SARS-CoV-2 receptor, providing a mechanism by which COPD patients may be more susceptible to COVID-19. COPD patients also demonstrate features of endothelial cell dysfunction and increased coagulopathy, which may predispose to increased risk of worse outcomes from COVID-19. 

Organicell’s Chief Medical Officer, Dr. George Shapiro said, “The association between COPD patients and Covid-19 is now clear. Based on the results I have seen in the numerous Emergency Investigative New Drug treatments we’ve conducted; this COPD trial was a natural progression of Organicell’s science. COPD patients who have Covid-19 are two and half times more likely to experience ICU admissions, invasive mechanical ventilation, or death. Clinical outcomes including requirement for mechanical ventilation and mortality appear to be worse in COPD patients resulting in a three-fold greater risk of mortality. If people with this underlying condition do get COVID-19, they are at high risk for complications and poorer outcomes. There is likely another round of COVID bound to hit this flu season. The timing of this trial couldn’t be more relevant to those suffering with COPD.” 

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Currently trading at $40 million market valuation OCEL OS is 1,479,126,390 with 535,327,372 shares in the public float. While the Company does carry $7 million in liabilities on the books, they have raised $16.5 million in new funding deals. OCEL has fast growing revenues recently reporting$1,713,214 in revenues for the 3 months ended July 31, 2021 up from $1,367,895 for the same period last year. Right now, is a very exciting time for OCEL as the Company begins its Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) at the Mayo Clinic in Phoenix, Arizona. OCEL has a long history of explosive moves skyrocketing to over $0.50 in 2020 and to over $0.60 in 2021. We will be updating on OCEL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with OCEL.

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

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T2 Biosystems (NASDAQ: TTOO) Breaks Ground: FDA Clearance, Market Trends, and Healthcare Impact

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Shares of T2 Biosystems (NASDAQ:TTOO) are soaring up over 20% today on the heels of receiving a 510(k) clearance for its T2Biothreat from the FDA. This unique test directly detects six biothreat pathogens from a blood sample.

Spotting Biothreats Faster:

T2Biothreat Panel is a game-changer, being the first and only FDA-approved product that can spot these critical biothreat pathogens simultaneously. T2 Biosystems proudly stands as the first U.S. company to achieve this milestone, reshaping the field of biothreat detection.

Big Investor Sells:

Interestingly while celebrating this achievement, a significant investor, CR Group (CRG), decided to sell off a substantial chunk of shares. This sell-off, totaling 24.81 million shares, took place between Sept. 20 and Sept. 26. The timing of this sell-off alongside the FDA clearance raises some eyebrows.

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New CDC Guidelines:

Regardless of CR Group selling, there still appears to be a massive opportunity according to many retail investors. Following new CDC guidelines, the U.S. government now mandates that all hospitals in the country must adopt rapid testing protocols to combat the sepsis pandemic by 2026, or risk losing Medicare funding.

Buying opportunity of the year!!! Update
byu/den1183 inTTOOstock

T2 Biosystems stands as the exclusive FDA-cleared product capable of achieving 100% accurate sepsis detection within 3 to 5 hours. Anticipating widespread adoption of T2 instruments in hospitals, the CEO foresees significant revenue generation, potentially reaching $1.3 billion annually, given the mandate.

This development drastically alters the landscape, potentially influencing the stock’s trajectory positively. With the ongoing surge in manufacturing hires and likely acceleration in orders, coupled with potential government contracts or international sales, many beleive T2 Biosystems presents an undervalued opportunity for investors.

What Borrowing Costs Tell Us:

Another interesting indicator to look at is the cost to borrow (CTB) fee. In terms of TTOO’s case, the stock has seen a massive surge in CTB fees, indicating a high demand from short sellers. When compared to the average CTB fee for other stocks, it’s pretty drastic. While this is typically not a very positive sign, retail investors seem to be buzzing with interest, given there also could be a potential short squeeze if enough buying comes in to trap the shorts.

Better News for Patients:

But let’s not forget the real impact and that’s what TTOO can do for patients. @ChengKeki a user from Twitter also shared an article about Butler Memorial Hospital and their approach to Sepsis. The hospital came up with a 2 step approach to expedite patient care.  They’re utilizing the Beckman Coulter automation line to identify changes in a person’s blood cells that might indicate the development of sepsis. Which apparently has only been used in Europe and they’re the first in the US with the technology. Then shortly after, they use T2 Biosystems panels that as you know, quicken the process from 36 hours, to just 3-5 hours.

Catching sepsis quickly is crucial because it’s a life-threatening condition that rapidly progresses throughout your body and can lead to death if not promptly diagnosed and treated. Sepsis occurs when the body responds improperly to an infection, causing widespread inflammation and potentially damages multiple organ systems. Early detection allows for immediate medical intervention.

Conclusion:

T2 Biosystems is hitting major milestones, not only in the market but in improving critical healthcare processes. The company is also a major hit with retail investors and continues to trade an astronomical amount of shares daily, the current average is ~115M shares. The FDA approval and its implications, along with the positive shift in sepsis diagnosis, showcase T2 Biosystems’ growing role in healthcare. Keep an eye on how this progresses—it’s exciting for both investors and patients alike.

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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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Femasys’ (NASDAQ: FEMY) FemaSeed Receives FDA Nod: A Game-Changer for Infertility Treatment

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Femasys Inc. (NASDAQ: FEMY) hit a massive milestone and saw shares soar by a whopping 346%. The reason? The United States Food and Drug Administration (FDA) has given the thumbs up for the commercialization of FemaSeed, a game-changing option for artificial insemination aiming to boost the natural fertilization process.

FemaSeed:

It’s a breakthrough treatment for infertility, designed to carry sperm right to where conception happens in a woman’s fallopian tube. This breakthrough could change the game in infertility treatments by offering a less invasive option compared to heavy hitters like in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), potentially reducing the risk of complications during the procedure.

Kathy Lee-Sepsick, Femasys’ founder and CEO, is beyond excited about the FDA’s green light for FemaSeed. She highlights how this could be a game-changer in providing infertility treatments that are less of a burden. The FDA clearance is a testament to successful teamwork with the FDA and a major step forward in making this new technology available to those struggling with infertility.

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The rising numbers of infertility cases in the United States (about 10 million women, as per the Center for Disease Control) show how crucial it is to have accessible and effective infertility treatments. FemaSeed is ready to meet this need by offering an affordable and efficient option for those dealing with infertility.

Here’s an interesting tidbit: FemaSeed works in harmony with FemVue, Femasys’ FDA-cleared diagnostic device. FemVue lets doctors perform an in-office ultrasound assessment of the fallopian tubes, helping diagnose infertility even before going for FemaSeed.

But wait, there’s more! Femasys isn’t just about FemaSeed. They’re also charging ahead with FemBloc, their lead candidate for permanent birth control in late-stage clinical development. Their commitment is to provide accessible solutions for women’s health, covering unmet needs with a range of innovative in-office products.

In a nutshell, Femasys is all about empowering women and couples facing fertility challenges. Their aim? To provide cost-effective and less invasive infertility treatments, backed by innovative diagnostic solutions. With this FDA clearance for FemaSeed, Femasys is a step closer to achieving this mission and leaving a lasting impact in the realm of women’s healthcare.

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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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