CMS Withdraws Skin Substitute Coverage Determinations, MidMedx and Organogenesis Shares Drop
Shares of makers of wound-care products, including MidMedxand Organogenesis, are under pressure on Friday after the Centers for Medicare & Medicaid Services said in a press release that the Medicare Administrative Contractors are withdrawing the skin substitute Local Coverage Determinations, which were due to become effective on January 1, 2026. Craig-Hallum believes this will likely drive some level of disappointment from investors as the LCDs were considered a positive for MidMedx. Meanwhile, BTIG said the firm is more cautious on Organogenesis after CMS ruling on skin grafts, with its confidence on the stock as 2026 Top Pick now being reduced.BOMBSHELL FROM CMS:Craig-Hallum notes that After market close on December 24, the Centers for Medicare & Medicaid Services released "a bombshell" in the form of a very laconic press release announcing that the Medicare Administrative Contractors are withdrawing the skin substitute Local Coverage Determinations, which were due to become effective on January 1, 2026. Without further explanation given in the press release, investors will be wondering what is going on here, the firm argues, adding that this move is particularly surprising considering CMS released a press release just last week essentially confirming that the LCDs would be going into effect. This will likely drive some level of disappointment from investors as the LCDs were considered a positive for MidMedx, Craig-Hallum adds. The firm has a Buy rating on the shares with a price target of $13.MORE CAUTIOUS:BTIG keeps a Buy rating and $9 price target on Organogenesis but notes that the firm's confidence on the stock as 2026 Top Pick is being reduced. BTIG cites CMS announcing that it would not implement the final Skin-Sub LCDs on January 1, 2026, noting that this unexpected update comes just 9 days after CMS announced that the MACs would be implementing the LCDs but with products classified into 3 categories - covered, non-covered, and 12-month status quo - even though the firm still believes that low-cost providers such as Organogenesis will be best-positioned in the market, the firm tells investors in a research note.PRICE ACTION:Shares of MiMedx have slipped more than 3% to $6.84 on Friday, while Organogenesis' stock has fallen almost 10% to $5.30.
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MDXG Stock Fluctuates: 52-Week Low at $5.79
- Stock Fluctuation: MDXG's 52-week low is $5.79 per share, with a high of $9.71, and the last trade at $6.90 indicates significant price volatility, reflecting market uncertainty regarding the company's future performance.
- Market Trends: The current price of $6.90 is close to the 52-week low, which may impact investor confidence, particularly as the company faces competitive pressures and industry challenges, necessitating close monitoring of its subsequent performance.
- Technical Indicators: MDXG's stock has fallen below its 200-day moving average, suggesting potential further downside pressure in the short term, prompting investors to carefully assess holding risks.
- Investor Focus: As the stock approaches its 52-week low, investors may reconsider their investment strategies, especially amid increasing market volatility, highlighting the need to closely watch the company's future financial performance and market dynamics.

MiMedx (MDXG) Enters Exclusive Distribution Agreement for RegenKit-Wound Gel
- Exclusive Agreement: MiMedx has signed an exclusive agreement with Regen Lab USA to distribute the RegenKit-Wound Gel in the U.S., adding a differentiated option to its Advanced Wound Care portfolio with this autologous platelet-rich plasma and autologous thrombin serum solution.
- Clinical Validation: The RegenKit-Wound Gel has been validated by multiple published studies for its effectiveness in treating chronic wounds, and since its FDA approval in 2022, it has been nationally covered by CMS and LCD, enhancing its market competitiveness.
- Market Expansion Strategy: By introducing RegenKit, MiMedx continues to broaden its wound care product offerings, which is expected to provide patients and healthcare professionals with a wider array of proven solutions, thereby strengthening the company's position in the rapidly growing wound care market.
- Policy Advantage: The clarity on Local Coverage Determination (LCD) implementation set for January 1, 2026, positions MiMedx in an incredibly strong competitive stance as it prepares to enter the new year, further solidifying its market leadership.






