Core Viewpoint - Sanara MedTech Inc. is set to present at the Planet MicroCap Showcase: VEGAS 2025, highlighting its focus on developing transformative medical technologies aimed at improving clinical outcomes and reducing healthcare costs in surgical, chronic wound, and skincare markets [1] Company Overview - Sanara MedTech Inc. specializes in medical technology, focusing on the development and commercialization of innovative products to enhance clinical outcomes and lower healthcare expenditures [3] - The company markets and distributes a range of surgical, wound, and skincare products primarily in the North American advanced wound care and surgical tissue repair markets [3] - Key products include CellerateRX® Surgical Activated Collagen®, FORTIFY TRG® Tissue Repair Graft, and various advanced biologic products such as ACTIGEN® Verified Inductive Bone Matrix and BIASURGE® Advanced Surgical Solution [3] - Sanara also offers telemedicine services for wound care and dermatology consultations, aiming to improve patient outcomes while managing costs [3] Upcoming Presentation - Management will present to investors on April 23, 2025, at approximately 3:30 p.m. Pacific Time during the Planet MicroCap Showcase [1] - Presentation materials will be available on the company's investor relations website prior to the event, along with a live audio webcast and an archive for later access [2]

Sanara MedTech Inc. (SMTI) shares ended the last trading session 8.1% higher at $29.20. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 15.5% loss over the past four weeks.The upside can be attributed to relief-rally across global markets following the announcement of a 90-day pause on tariff hike by the United States.This company is expected to post quarterly loss of $0.31 per share in its upcoming report, which r ...

Business Segments and Strategy - The company operates through two reportable segments: Sanara Surgical and Tissue Health Plus (THP) to enhance resource allocation and management focus [20]. - Sanara Surgical segment includes products like CellerateRX Surgical and BIASURGE, with CellerateRX Surgical primarily used for surgical wound management and BIASURGE launched in November 2023 [21][28]. - THP aims to introduce a value-based wound care program targeting Medicare Advantage payers, expected to launch a pilot program in Q2 2025 [24][33]. - THP's contracts are anticipated to have three-to-five-year terms, incorporating value-based pricing methodologies to align with payer financial goals [34]. - The company established a joint venture, SI Healthcare Technologies, with InfuSystem to enhance wound care solutions and improve patient outcomes [37]. - The company seeks partnerships and acquisitions to enhance its product and service offerings, particularly in value-based care models [41][42]. - The company plans to expand its geographic footprint and deepen market penetration in the surgical, wound, and skincare markets [39]. - New innovative products are under development to improve surgical site outcomes and treat chronic wounds, focusing on efficacy and cost-effectiveness [40]. Market Opportunities - Approximately 15% of the Medicare beneficiary population has chronic nonhealing wounds, indicating a significant market opportunity for the company's products [49]. - Over 34 million people in the U.S., or about 10% of the population, suffer from diabetes, which is associated with poor wound healing and presents a substantial market for diabetic foot ulcer treatments [50]. - Venous leg ulcers affect approximately 600,000 people annually in the U.S., highlighting another critical area for the company's wound care solutions [51]. - The surgical and wound care markets are expected to grow due to demographic trends and increasing healthcare costs, with the company positioned to benefit from this growth [44]. Product Development and Innovation - The company has a robust pipeline of surgical, wound, and skincare products expected to be marketed soon, with a focus on statistically significant clinical and health economic outcomes data to drive adoption and lower costs for payors [47]. - The company has demonstrated a 59% reduction in surgical site infection rates when using CellerateRX Surgical collagen in elective multispecialty surgical procedures, with a 69% decrease in clean cases [55]. - The company has a pipeline of product candidates aimed at addressing opportunistic pathogens and wound healing, but successful commercialization is uncertain [127]. - Future success relies on the ability to educate healthcare practitioners on the benefits and proper use of the company's products, which is critical for market acceptance [129]. Regulatory Environment - Medical devices must obtain FDA marketing clearance through the 510(k) premarket notification process, de novo classification, or PMA process, unless exempt [71]. - Class II devices generally require a 510(k) premarket notification, while most Class I devices are exempt from this requirement [72]. - The FDA must classify a de novo classification request within 120 days, and manufacturers must propose special controls for Class II devices [73]. - Class III devices require PMA approval, which involves extensive data demonstrating safety and effectiveness, and the FDA has 180 days to review the application [74]. - Clinical trials are often required for PMAs and sometimes for 510(k) submissions, with significant risk devices needing an IDE application [75]. - The company is subject to various governmental regulations that could impact the commercialization of new products, including delays in FDA approvals [116]. - The company faces significant challenges in complying with FDA regulations and maintaining good manufacturing practices, which could jeopardize product commercialization [124]. - Regulatory compliance is costly and time-consuming, impacting the development and marketing of products [146]. Financial Performance and Risks - The company has incurred net losses in most years since 2004 and plans to continue significant investments in its THP operating segment, which will substantially increase operating expenses [102]. - The company faces challenges in predicting revenue growth, and a shortfall in forecasted revenues may harm operating results [99]. - The company has experienced fluctuations in revenue and operating results, making future revenue growth difficult to predict [104]. - The company’s indebtedness could adversely affect its financial condition and limit its ability to fund operations and growth [117]. - The company anticipates that economic conditions and changes in reimbursement rates could impact its ability to sell products [108]. - The company expects pricing pressures due to increasing efforts by payors to limit healthcare costs, which may affect profitability [166]. Compliance and Legal Issues - The company is subject to extensive healthcare fraud and abuse laws, and noncompliance could result in substantial penalties [169]. - The company must comply with HIPAA regulations, which impose strict privacy and security standards for protected health information [90]. - The company may face civil and criminal penalties for violations of HIPAA, with significant repercussions for breaches affecting more than 500 individuals [91]. - The company faces risks from potential litigation related to intellectual property rights, which could divert resources and impact operations [145]. Corporate Governance and Shareholder Matters - The company has provisions in its Certificate of Formation that may limit shareholder actions against directors for breaches of fiduciary duties [198]. - The company has anti-takeover provisions that could delay or discourage favorable takeover attempts [199]. - A significant percentage of voting stock is controlled by a few shareholders, which may lead to conflicts of interest and affect corporate governance [195]. - The company has not paid cash dividends and does not plan to in the near future, limiting returns for shareholders [194]. Cybersecurity and Technology - The company has invested in cybersecurity measures, including growing its internal technology team and obtaining cybersecurity insurance [207]. - The company has not experienced any material adverse effects from cybersecurity threats to date [209].

Financial Performance and Key Metrics - The company generated net revenue of $86.7 million for the full-year 2024, representing growth of 33% year-over-year [7] - Adjusted EBITDA for 2024 was $2.7 million, an increase of $2.6 million compared to 2023 [8] - As of December 31, 2024, the company had $15.9 million in cash and $24.5 million available for future borrowings [9] Business Segment Performance - In the Sanara Surgical segment, net revenue increased by 39% year-over-year to $76.1 million, while bone fusion products saw a 6% increase to $10.5 million [7] - The Tissue Health Plus segment continued to incur losses as investments were made in preparation for commercialization [8][9] - Fourth quarter net revenue for the Sanara Surgical segment was $23.5 million, a 56% increase year-over-year [15] Market Data and Key Metrics - The company expanded its distributor network to over 350 partners by year-end 2024, up from more than 250 in 2023 [18] - Products were sold in over 1,300 facilities by year-end 2024, an increase from over 1,000 in 2023 [21] Company Strategy and Industry Competition - The company is focused on empowering physicians to improve patient outcomes while reducing healthcare costs, aiming for long-term growth and shareholder value [12] - A strategic partnership with Biomimetic Innovations was announced, which includes exclusive rights to market innovative products in the U.S. [29] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to enhance sales coverage and market penetration in 2025 [12] - The company plans to launch its first pilot program in the Tissue Health Plus segment during the second quarter of 2025 [27] Other Important Information - The company submitted 11 provisional patent applications in 2024, covering innovations in antimicrobial technologies and hydrolyzed collagen [11] - The company amended the terms of its CRG term loan to provide more flexibility for future borrowings [44] Q&A Session Summary Question: What is the game plan for ChemoMouthpiece in 2025? - Management indicated that the ChemoMouthpiece is being introduced to the market, with health economics and clinical study results expected soon [50][51] Question: How will success be measured for the THP pilot launch? - Success will be measured by the integration with the pilot customer's systems and the standardization of clinical workflows [56] Question: What business development efforts are in place beyond the initial pilot? - Significant efforts have been made in commercial development, including creating a value-based pricing model and recruiting a sales team [66]

Financial Results - Sanara MedTech Inc. announced preliminary financial results for Q4 and full year 2024 on January 21, 2025[5]. - The report does not include specific financial figures or performance metrics for Q4 or full year 2024[5]. - The report does not provide guidance for future performance or financial outlook[5]. Company Information - The company is listed on The Nasdaq Capital Market under the trading symbol SMTI[3]. - The company has not indicated whether it is an emerging growth company[4]. - The report is signed by Michael D. McNeil, Chief Accounting Officer and Chief Administrative Officer[10]. Report Details - The press release detailing financial results is included as Exhibit 99.1 in the report[5]. - The filing is made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934[1]. Strategic Initiatives - There is no mention of new product development or market expansion strategies in the current report[5]. - No information regarding mergers or acquisitions is included in the report[5].

Core Insights - Sanara MedTech Inc. reported a significant increase in net revenue for Q4 2024, rising 49% year-over-year to $26.3 million, driven primarily by strong sales in the soft tissue repair segment [7][10][19] - For the full year 2024, net revenue increased by 33% to $86.7 million compared to $65.0 million in 2023 [19][20] - The company experienced a net loss of $1.7 million in Q4 2024, compared to a net loss of $0.3 million in Q4 2023, and a full-year net loss of $9.9 million, up from $4.4 million in 2023 [16][20] Financial Performance - Q4 2024 net revenue was $26.3 million, an increase of $8.6 million or 49% from Q4 2023, with soft tissue repair product sales increasing by 56% [10][11] - Full year 2024 net revenue reached $86.7 million, a $21.7 million increase or 33% from 2023 [19] - Gross profit for Q4 2024 was $24.1 million, a 51% increase year-over-year, with a gross margin of 91% [12][13] Operational Highlights - The company appointed Keith Myers to its Board and expanded its executive leadership team with new appointments [5] - Sanara entered into an exclusive license and distribution agreement with Biomimetic Innovations Ltd for a synthetic injectable bone void filler [5] - The R&D team submitted 11 provisional patent applications in 2024, focusing on antimicrobial technologies and hydrolyzed collagen [6] Segment Performance - The Sanara Surgical segment generated a net income of $0.9 million in Q4 2024, compared to a net loss of $0.7 million in Q4 2023 [16] - The Tissue Health Plus segment reported a net loss of $2.6 million in Q4 2024, an increase in loss from $0.5 million in Q4 2023, primarily due to higher SG&A and R&D expenses [16] Future Outlook - The company plans to invest between $7.5 million to $10 million in the Tissue Health Plus segment in the first half of 2025, preparing for a pilot program launch [8] - Management remains focused on driving revenue growth and improving profitability in the Sanara Surgical segment while continuing to invest in the Tissue Health Plus segment [8]

Core Viewpoint - Sanara MedTech Inc. is set to report its fourth quarter and full year 2024 financial results on March 25, 2025, before the U.S. financial markets open [1] Group 1: Financial Reporting - The company will host a conference call and webcast on March 25, 2025, at 8:00 a.m. Eastern Time to discuss the financial results and hold a Q&A session [2] - A telephonic replay of the conference call will be available until April 8, 2025 [2] Group 2: Company Overview - Sanara MedTech Inc. focuses on developing and commercializing transformative technologies aimed at improving clinical outcomes and reducing healthcare costs in surgical, chronic wound, and skincare markets [4] - The company markets and distributes a range of surgical, wound, and skincare products, primarily in the North American advanced wound care and surgical tissue repair markets [4] - Sanara's product portfolio includes CellerateRX Surgical Activated Collagen, FORTIFY TRG Tissue Repair Graft, and various advanced biologic products [4] - The company is also involved in telemedicine services for wound care and dermatology consultations [4] - Sanara is actively seeking long-term strategic partnerships to enhance product offerings that improve outcomes at a lower cost [4]

Group 1 - The individual investor focuses on undercovered companies, particularly in technology, software, electronics, and energy transition sectors [1] - The investor has over 50 companies on their watchlist and has been investing personal capital for more than 7 years globally [1] - The investor holds a Master's degree in Electrical Engineering and works as an automotive battery R&D engineer in Sweden [1] Group 2 - The investor aims to identify asymmetric investment opportunities to achieve market-beating returns through diligent research of small to mid-cap companies [1]

Core Summary - Biomimetic Innovations Limited, an affiliate of PBC Biomed, has entered into an exclusive license and distribution agreement with Sanara MedTech Inc (NASDAQ:SMTI) for the commercialization of OsStic®, a synthetic injectable structural bio-adhesive bone void filler [1][3] - Sanara MedTech has acquired exclusive US marketing, sales, and distribution rights for OsStic®, along with a hardware-agnostic adjunctive internal fixation technology, under a five-year agreement with automatic renewal options [3] - OsStic® is a disruptive bio-adhesive bone void filler technology that received FDA Breakthrough Device Designation in December 2023, targeting periarticular fractures and defects [4][5] - Sanara MedTech has also made a minority cash investment in Biomimetic Innovations Limited as part of the agreement [1] Company Overview Biomimetic Innovations Limited and PBC Biomed - Biomimetic Innovations Limited is an affiliate of PBC Biomed, a medical device company specializing in design, development, and manufacturing [7] - PBC Biomed partners with innovators in medical devices, biologics, pharmaceuticals, and combination products to accelerate technology through product lifecycle stages [7] - The company provides regulatory, clinical, quality assurance, and commercial support, with ISO 13485 and ISO 9001 certified facilities for clean room manufacturing, packing, and sterilization [7] - PBC Biomed has a history of commercializing new technologies, including N-Force Fixation/iN3 Cement and ReFeel®, a nerve regeneration solution [7][8] Sanara MedTech Inc - Sanara MedTech is a medical technology company focused on developing and commercializing transformative technologies in surgical, chronic wound, and skincare markets [2][9] - The company markets and distributes a range of advanced biologic products for surgical tissue repair and wound care, including CellerateRX®, FORTIFY TRG®, and BIAKŌS® [9] - Sanara MedTech also offers wound care and dermatology virtual consultation services via telemedicine [9] - The company has a pipeline of transformative product candidates targeting wound re-epithelialization, necrotic tissue debridement, and biofilm mitigation [9] Product and Technology - OsStic® is a calcium phosphate-based synthetic technology designed to optimize fluidic dispersion, interdigitate with bone structures, and firmly adhere to bone surfaces, providing exceptional structural integrity [6] - The technology is uniquely suited for reducing periarticular fractures, achieving provisional fixation, and filling voids, addressing three critical clinical needs [6] - OsStic® is indicated for use in periarticular fractures or defects where standard fixation alone cannot provide sufficient support for functional mobilization [5] - The technology has the potential to address over 100,000 periarticular fractures annually in the US [6] Strategic Partnership - The partnership between Biomimetic Innovations and Sanara MedTech aims to commercialize OsStic® and bring transformative solutions to the market [6] - Sanara MedTech's market expertise, sales and distribution network, and existing customer relationships make it an ideal partner for Biomimetic Innovations [6] - The collaboration is expected to enhance the surgeon's treatment approach and improve patient outcomes [6]

Core Article Summary - Sanara MedTech Inc has entered into an exclusive license and distribution agreement with Biomimetic Innovations Ltd (BMI) for OsStic, a synthetic injectable structural bio-adhesive bone void filler, and related technologies [1][2] - The agreement includes an initial cash investment of €4.0 million by Sanara, with an additional €4.0 million contingent upon achieving development, clinical, and regulatory milestones [1] - OsStic has received Breakthrough Device Designation from the FDA, targeting over 100,000 periarticular fractures annually in the US [1][3] Agreement Details - Sanara acquires exclusive US marketing, sales, and distribution rights for OsStic and a hardware-agnostic adjunctive internal fixation technology [2] - The initial term of the agreement is five years, with options for successive two-year renewals at Sanara's discretion [2] Product and Market Potential - OsStic is designed to enhance fracture repair by optimizing fluidic dispersion, interdigitating with bone structure, and adhering firmly to bone surfaces, offering superior structural integrity compared to traditional materials [4] - The product is expected to complement Sanara's existing surgical portfolio and is anticipated to launch in the US market by Q1 2027 [4] Strategic and Financial Implications - The partnership leverages Sanara's existing commercial infrastructure and call points, enhancing its surgical product offerings [1] - The investment aligns with Sanara's strategy to improve clinical outcomes and reduce healthcare expenditures in the surgical and wound care markets [1][6] Industry and Company Background - Biomimetic Innovations Ltd, an affiliate of PBC Biomed, specializes in medical device development and commercialization, with a track record of bringing innovative technologies to market [5] - Sanara MedTech Inc focuses on transformative technologies in surgical, chronic wound, and skincare markets, with a robust product portfolio and pipeline [6]