On October 2nd, 2023, IceCure Medical (NASDAQ: ICCM) shares surged by over 50% following exciting news presented at a major medical event, the European Society of Breast Imaging. Their cutting-edge ProSense® System, designed for minimally invasive cryoablation, is marketed and sold worldwide for its cleared indications in the U.S., Europe, and China. More recently they gained approvals in India, and Brazil and have additional distribution through MC Medical to continue expanding in Europe. More importantly, the latest independent study confirms that the technology is a safe & effective outpatient procedure for breast cancer, with 96.8% success rate.

More Background:

Their system has the potential to revolutionize cancer treatment not only for breast cancer, but also for kidney, bone, and lung cancers. To date, the system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.

During the event, Dr. Lucía Graña-López, a radiologist specializing in breast and women’s imaging, led an independent study. The study explored cryoablation as a viable alternative to surgery for early-stage breast cancer in patients who preferred a non-surgical route. The results were promising, suggesting that cryoablation could be a successful treatment option, particularly for patients hesitant about traditional surgery.

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Clinical Study:

The study involved 31 patients with early-stage breast cancer who opted out of surgery, and the outcomes showed that cryoablation was well-tolerated with no major complications. This alternative approach could potentially be a game-changer, especially for breast cancer, which is one of the most prevalent cancers globally. Many patients, particularly older individuals, are seeking less invasive alternatives to surgery, making cryoablation an appealing option.

Dr. Graña-López envisions cryoablation becoming a significant alternative to surgery, particularly for early-stage breast cancer in post-menopausal women. Moreover she believes this technology could reshape how we approach treatment in other indications, particularly for kidney, lung, and thyroid gland cancers.

These results from this independent study are are in line with the ongoing ICE3 study, the largest of its kind in the U.S., set to conclude in early 2024.

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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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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 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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