Core Insights - Sanara MedTech Inc. plans to launch OsStic Synthetic Injectable Structural Bio-Adhesive in the U.S. market in Q1 2027, following FDA clearance [1][2] - OsStic has received Breakthrough Device Designation from the FDA, indicating its potential to improve treatment for serious conditions [2] - The product is expected to be the first bone bioadhesive in the U.S. utilizing phosphoserine, α-TCP, and calcium silicate, offering significant advantages over traditional methods [2][3] Product Development and Regulatory Milestones - Sanara and Biomimetic Innovations Ltd (BMI) have achieved significant milestones in product development, clinical trials, and regulatory processes throughout 2025 [3] - The U.S. Patent and Trademark Office granted a patent for OsStic, ensuring protection of its key ingredients and applications until at least 2037 [3][6] - The partnership between Sanara and BMI includes an exclusive license and distribution agreement, enhancing Sanara's market position in orthopedic care [5][6] Market Need and Innovation - OsStic addresses critical limitations in current provisional fixation techniques, providing forty times stronger bonding than traditional calcium phosphate bone cement [2][3] - The product aims to meet the unmet clinical needs in complex joint reconstruction, offering a paradigm shift in treating previously non-repairable fractures [3] - Sanara's commitment to innovation is reflected in its collaboration with BMI to introduce OsStic as a new standard in bone bioadhesives [4]

Core Insights - Shares of Sanara MedTech Inc. (SMTI) have sharply declined following the release of the company's Q3 earnings, with a nearly 40% drop for the year [1] Company Performance - The surgical segment of Sanara MedTech has been fast-growing and profitable, but this growth has been overshadowed by recent stock performance [1]

Company Overview - Shares of Sanara MedTech Inc. (SMTI) have declined sharply, down nearly 40% for the year following the release of the company's Q3 earnings [1] Financial Performance - The company's fast-growing and profitable surgical segment has been overshadowed, indicating potential underlying issues despite growth in this area [1]

Core Insights - Holzer & Holzer, LLC is investigating whether Sanara MedTech Inc. complied with federal securities laws following the announcement of a strategic realignment that included discontinuing operations of Tissue Health Plus to improve operating efficiency and reallocate resources to its core surgical business [1] - The announcement led to a decline in Sanara's stock price [1] Company Overview - Sanara MedTech Inc. is publicly traded on NASDAQ under the ticker SMTI [1] - The company is focusing on enhancing its core surgical business by discontinuing less efficient operations [1] Legal Context - Holzer & Holzer, LLC is a law firm that specializes in representing shareholders and investors in securities litigation, including class action and derivative litigation [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Core Viewpoint - Glancy Prongay & Murray LLP has initiated an investigation into Sanara MedTech Inc. regarding potential violations of federal securities laws, indicating concerns about the company's compliance and the impact on investors [1]. Company Summary - Sanara MedTech Inc. (NASDAQ: SMTI) is currently under scrutiny for possible legal issues that may affect its investors [1]. - The investigation is aimed at assessing the extent of any violations and the implications for shareholders who may have incurred losses [1].

Core Viewpoint - Sanara MedTech Inc. is under investigation for potential violations of federal securities laws, which may impact investors who have incurred losses [1]. Investigation Details - The investigation is initiated by the Law Offices of Frank R. Cruz on behalf of investors [1]. - The announcement regarding the investigation was made on November 11, 2025, after market hours [1].

Core Viewpoint - Sanara MedTech Inc. is participating in the Piper Sandler 37th Annual Healthcare Conference, presenting on December 3, 2025, to discuss its transformative technologies aimed at improving clinical outcomes and reducing healthcare costs in the surgical market [1] Company Overview - Sanara MedTech Inc. focuses on developing and commercializing technologies that enhance clinical outcomes while lowering healthcare expenditures in the surgical market [3] - The company markets and distributes a range of surgical products, including CellerateRX Surgical Activated Collagen Powder and FORTIFY TRG Tissue Repair Graft, primarily in the North American surgical tissue repair markets [3] - Sanara aims to be a leading provider of innovative surgical solutions and is committed to expanding its product offerings for patients in the United States [3]

Core Insights - Sanara MedTech Inc. reported disappointing financial results for Q3 2025, with an EPS of -$3.40, missing the estimated EPS of -$0.24 [1][6] - The company's revenue for the quarter was $26.3 million, which is a 22% increase from $21.7 million in Q3 2024, but fell short of the expected $29.9 million [2][6] Financial Metrics - The company has a negative price-to-earnings (P/E) ratio of approximately -18.30, indicating current losses [3][6] - The price-to-sales ratio is about 1.93, suggesting investors are willing to pay $1.93 for every dollar of sales, while the enterprise value to sales ratio is around 2.23 [3] - SMTI's enterprise value to operating cash flow ratio is notably high at approximately 59.33, indicating a premium valuation compared to its cash flow [4] - The company has a negative earnings yield of about -5.47%, further highlighting its unprofitability [4] - The debt-to-equity ratio stands at approximately 1.28, suggesting a moderate level of debt compared to equity [4] Liquidity and Stability - SMTI's current ratio is around 2.26, indicating a strong ability to cover short-term liabilities with short-term assets [5]

Financing and Loans - Sanara MedTech reported a senior secured term loan of up to $55.0 million under the CRG Term Loan Agreement, with the first borrowing of $15.0 million used to repay an existing loan[200]. - The CRG Term Loan has a maturity date of March 30, 2029, with the option for additional borrowings before December 31, 2025[200]. - The CRG Term Loan Agreement provides for a senior secured term loan of up to $55.0 million, with $42.8 million of principal outstanding as of September 30, 2025[240][243]. - The company anticipates sufficient cash flow to fund operations and capital expenditures for at least the next 12 months[236]. - As of September 30, 2025, the company was in compliance with all debt covenants[248]. Revenue and Profitability - For the three months ended September 30, 2025, the company generated net revenue of $26.3 million, a 22% increase from $21.7 million in the same period of 2024[218]. - For the nine months ended September 30, 2025, net revenue reached $75.6 million, reflecting a 25% increase compared to $60.4 million for the same period in 2024[218]. - Gross profit for the three months ended September 30, 2025, was $24.5 million, a 24% increase from $19.7 million in the prior year[220]. - Gross profit for the nine months ended September 30, 2025, was $69.9 million, representing a 28% increase from $54.5 million in the same period of 2024[220]. - Adjusted EBITDA for the three months ended September 30, 2025, was $4.9 million, compared to $2.6 million in the same period of 2024[216]. - Net income from continuing operations was $0.8 million for the three months ended September 30, 2025, compared to a net loss of $0.2 million for the same period in 2024[228]. Expenses and Costs - Cost of goods sold for the three months ended September 30, 2025, was $1.9 million, down from $2.0 million in the same period of 2024[219]. - Selling, general and administrative expenses for the three months ended September 30, 2025, were $19.9 million, compared to $17.4 million in the prior year[222]. - Research and development expenses for the three months ended September 30, 2025, were $1.0 million, up from $0.8 million in the same period of 2024[223]. - Net loss from discontinued operations totaled $31.2 million for the three months ended September 30, 2025, compared to $2.7 million for the same period in 2024[227]. Acquisitions and Partnerships - The company acquired CarePICS for $2.0 million on April 1, 2025, and assumed $1.65 million in existing indebtedness[203]. - The company completed an asset purchase for $15.25 million on August 1, 2023, including $9.75 million in cash and $3.0 million in stock[237]. - The Applied Purchase Agreement includes an additional potential earnout of up to $10.0 million based on performance thresholds[238]. - The company entered into a licensing agreement with Tufts University to develop and commercialize 18 unique collagen peptides, with a minimum annual royalty of $50,000 starting from the first anniversary of the first commercial sale[199]. - Sanara MedTech acquired exclusive U.S. marketing rights for OsStic Synthetic Injectable Structural Bio-Adhesive Bone Void Filler through a licensing agreement with Biomimetic Innovations Limited[201]. - The company entered into the BMI License Agreement on January 16, 2025, acquiring exclusive U.S. marketing rights for OsStic and ARC, with a 3% royalty on OsStic net sales[249][251]. - The company made an initial cash investment of approximately $3.1 million in BMI, increasing its ownership to approximately 12.499% as of October 2, 2025[253]. Product Development and Innovation - Sanara MedTech established a 50/50 strategic alliance with InfuSystem Holdings, focusing on delivering a complete wound care solution aimed at improving patient outcomes and lowering care costs[198]. - The company’s lead product, CellerateRX Surgical, is a hydrolyzed collagen used for managing surgical wounds, particularly beneficial for patients with comorbidities[192]. - BIASURGE, a sterile no-rinse surgical solution, is indicated for wound irrigation and contains an antimicrobial preservative effective against a broad spectrum of microorganisms[194]. - FORTIFY TRG and FORTIFY FLOWABLE are advanced wound care products designed for various wound types, including pressure ulcers and surgical wounds, and are 510(k) cleared[195][196]. - Sanara MedTech's in-house research and development team, Rochal Technologies, is focused on an extensive pipeline of innovative products under development[189]. - The company aims to expand its offerings in the U.S. surgical tissue repair and advanced wound care markets, emphasizing long-term strategic partnerships[190]. Cash Flow and Investments - For the nine months ended September 30, 2025, net cash provided by operating activities was $2.8 million, a significant increase from net cash used of $1.0 million in the same period of 2024[260]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $12.5 million, primarily due to a $5.9 million investment in BMI and $2.1 million related to the CarePICS Acquisition[261]. - Net cash provided by financing activities decreased to $8.7 million for the nine months ended September 30, 2025, compared to $18.6 million in the same period of 2024[262]. - Total cash investment in THP was $4.0 million in Q3 2025, with projected winding down costs between $1.5 million and $2.5 million[234]. - Cash on hand as of September 30, 2025, was approximately $14.9 million, down from $15.9 million at December 31, 2024[234]. Impairments and Future Expectations - Following the discontinuation of the THP segment in September 2025, the carrying value of CarePICS technology was fully impaired to zero[204]. - The contingent earnout liability related to the CarePICS acquisition was assessed and reduced to zero due to the impairment of the technology developed by CarePICS[259]. - The company expects to incur additional costs related to potential acquisitions and product development in the future[235]. - The company anticipates annual minimum revenue of at least $60.0 million for the twelve-month period beginning January 1, 2024, increasing to $105.0 million for each twelve-month period thereafter[252]. - Inflation and changing prices have not had a material impact on the company's historical results and are not expected to affect future operations[267].

Core Insights - Sanara MedTech Inc. reported quarterly earnings of $0.09 per share, exceeding the Zacks Consensus Estimate of a loss of $0.24 per share, and showing improvement from a loss of $0.34 per share a year ago, resulting in an earnings surprise of +137.50% [1] - The company posted revenues of $26.33 million for the quarter ended September 2025, which was slightly below the Zacks Consensus Estimate by 1.19%, but an increase from $21.67 million in the same quarter last year [2] - Sanara MedTech has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in earnings performance [2] Future Outlook - The sustainability of the stock's price movement will largely depend on management's commentary during the earnings call and the company's earnings outlook for upcoming quarters [3][4] - The current consensus EPS estimate for the next quarter is -$0.19 on revenues of $31.45 million, and for the current fiscal year, it is -$0.98 on revenues of $107.37 million [7] - The estimate revisions trend for Sanara MedTech was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Products industry, to which Sanara MedTech belongs, is currently ranked in the bottom 33% of over 250 Zacks industries, which may impact the stock's performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which investors can track to gauge potential stock performance [5]