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Sientra Inc.’s (NASDAQ: SIEN) AlloX2 Pro Tissue Expander Rockets Shares 82%

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Sientra, Inc. (NASDAQ: SIEN) shares rocket 82% as the medical aesthetics company achieves a significant milestone with their AlloX2 Pro Tissue Expander.

Sientra, Inc. (NASDAQ: SIEN) shares rocket 82% as the medical aesthetics company achieves a significant milestone with their AlloX2 Pro Tissue Expander.

This groundbreaking product has received 510k clearance from the FDA, making it the first and only MRI-compatible tissue expander available on the US market. By utilizing proprietary dual port technology and reducing 95% of the metal typically associated with tissue expander ports, the AlloX2 Pro expands on the success of Sientra’s AlloX2 tissue expander. This innovative design allows the AlloX2 Pro to be labeled as MRI-conditional, enabling breast reconstruction patients to undergo magnetic resonance imaging, an essential screening tool. The AlloX2 Pro also boasts additional features, such as minimal interference with radiation therapy, faster port filling and drainage, and a softer drain for improved patient comfort.

Renowned plastic surgeon Dr. Thomas McClellan, the inventor of AlloX2, expressed pride in partnering with Sientra to bring the AlloX2 Pro to market. He acknowledged Sientra’s commitment to women’s health and technological advancements in breast reconstruction as crucial factors in realizing this critical innovation for post-mastectomy women.

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Dr. Thomas Davenport, a leading plastic surgeon specializing in reconstruction, hailed the AlloX2 Pro as a remarkable advancement in tissue expander technology. The dual ports and MRI compatibility of the AlloX2 Pro offer superior treatment options, improved safety, and expanded usage opportunities for patients who previously faced limitations.

The FDA clearance of the AlloX2 Pro tissue expander marks another significant achievement for Sientra. It underscores the company’s dedication to women’s health, innovation, and leadership in breast reconstruction. Ron Menezes, President and CEO of Sientra, highlighted the company’s track record of introducing innovative solutions for plastic surgeons and their patients, with the AlloX2 Pro being the third product cleared or approved by the FDA within the past year. Sientra aims to provide this groundbreaking technology to its customers and continue its market share growth in reconstruction, which has already reached a record high of 23% by the end of Q1.

What’s retail saying?

As is often the case with significant gains like this, it has garnered considerable attention from the retail crowd, leading many day traders to seek potential entry points actively. However, some traders exhibit caution due to specific emerging negative technical indicators.

Before today’s news, some traders knew $SIEN’s potential and scored an incredible 92% gain. However, it is essential to approach the trading landscape with a discerning eye. While reputable day traders offer valuable insights and guidance, it is crucial to exercise caution due to opportunistic individuals seeking to capitalize on unsuspecting investors for their own financial gain.

https://twitter.com/dbr_land/status/1666916557463642113?s=20

Some traders are eager to exploit the situation by trying to trap bearish investors and create a short squeeze. One trader specifically pointed out that about 1.5 million shorts are stuck in the stock, which represents over 15% of the total available shares for trading, estimated to be around 10 million. This means there’s a chance for a big jump in buying activity, causing the stock price to rise rapidly and forcing those who bet against it to scramble and cover their positions. It’s an interesting situation that could lead to exciting market action.

Overview of Sientra

Based in Irvine, California, Sientra is a medical aesthetics company focusing exclusively on plastic surgery. Their goal is to bring groundbreaking advancements to plastic surgeons, transforming how they approach their work and care for their patients. Sientra has built various products that stand out due to their unique technology and have undergone rigorous testing and clinical trials. Some of their notable products include Sientra round and shaped breast implants, the first fifth-generation implants approved by the FDA for sale in the United States. They have also developed the innovative AlloX2 breast tissue expander, featuring dual-port and integral drain technology. Additionally, Sientra offers the Viality system for enhanced fat transfer, the SimpliDerm Human Acellular Dermal Matrix, and BIOCORNEUM, a scar gel highly regarded and recommended by plastic surgeons.

Sientra’s recent update is an extraordinary accomplishment, as it marks the company’s third successful product clearance within a mere 12-month period. This consistent stream of successful product clearances highlights the company’s commitment to innovation and underscores its position as a leader in the industry. Furthermore, Sientra’s market share in the breast reconstruction segment has already surged to an impressive 23% by the end of the first quarter. This substantial market presence signifies the growing recognition and acceptance of Sientra’s offerings among healthcare professionals and patients. It serves as a testament to the company’s ability to deliver effective and sought-after solutions in the field of breast reconstruction.

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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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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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