10-K: Anteris Technologies Advances DurAVR Trial, Secures $320M Funding

Anteris Technologies Global Corp. reported significant R&D investments and net losses in 2025, while successfully initiating its pivotal PARADIGM Trial and securing substantial capital raises in late 2025 and early 2026.

Summary

• Anteris Technologies Global Corp. (ATGC) is a structural heart company focused on developing the DurAVR THV System for aortic stenosis, a novel biomimetic transcatheter heart valve.
• The DurAVR THV System utilizes proprietary ADAPT anti-calcification tissue, clinically demonstrated to be calcium-free for up to 10 years in other indications, and the ComASUR Delivery System for precise valve placement.
• As of December 2025, over 130 patients worldwide have been implanted with the DurAVR THV, showing promising early clinical and echocardiographic outcomes, including single-digit mean gradients, large effective orifice areas (EOAs), and 97% freedom from prosthesis-patient mismatch (PPM) in a pooled analysis of 100 patients.
• The global pivotal PARADIGM Trial formally initiated in October 2025 with the first European regulatory approval in Denmark and subsequent patient enrollment and treatment.
• In November 2025, the FDA granted Investigational Device Exemption (IDE) approval for the PARADIGM Trial, authorizing staged enrollment of the first 200 patients in the United States.
• The company reported a net loss of $94.2 million for the year ended December 31, 2025, an increase from $76.0 million in 2024.
• Research and development (R&D) expenses increased by 34% to $69.1 million in 2025, driven by manufacturing upscaling, quality capabilities, and PARADIGM Trial preparatory activities.
• Net sales decreased by 29% to $1.9 million in 2025, primarily due to the expiration of the LeMaitre Transition Services Agreement in January 2025.
• Subsequent to year-end, in January 2026, Anteris completed a public offering raising $230.0 million and a private placement with Medtronic plc raising $90.0 million, significantly strengthening its capital position.
• The company identified material weaknesses in its internal control over financial reporting for 2025 and 2024, related to a lack of appropriately designed procedures and controls, and deficiencies in segregation of duties, with remediation efforts ongoing.

Sentiment

Score: 6

Explanation: StockSavvy.ai views this filing with cautious optimism. While the company continues to incur significant losses and cash burn, the successful initiation of the pivotal PARADIGM Trial and substantial capital raises in early 2026 provide critical funding and validation for its long-term development strategy. The Medtronic investment is a notable positive, but the company remains in a high-risk development stage.

Positives

• Formal initiation of the global pivotal PARADIGM Trial in October 2025, with the first European regulatory approval in Denmark.
• Received Investigational Device Exemption (IDE) approval from the FDA in November 2025 for staged enrollment of the first 200 patients in the PARADIGM Trial.
• DurAVR THV has been implanted in over 130 patients worldwide, demonstrating favorable early clinical and hemodynamic outcomes, including single-digit mean gradients, large EOAs (2.2 cm²), no moderate or severe paravalvular leaks, and 97% freedom from prosthesis-patient mismatch (PPM).
• Proprietary ADAPT tissue has been clinically demonstrated to be calcium-free for up to 10 years post-procedure and used in over 55,000 patients globally in other indications.
• Secured significant capital raises in January 2026, totaling approximately $320.0 million, which is expected to fund operations for at least 12 months.
• Medtronic plc beneficially owns 16.1% of the company's common stock as of January 22, 2026, indicating a strategic investment from a major industry player.
• Strengthening of operational infrastructure, including quality management system buildout and expansion of clean room capacity, to support clinical activities and future ISO 13485 certification.
• The TAVR market is projected to grow significantly, with the total global market opportunity expected to reach $9.9 billion for severe aortic stenosis and $2.5 billion for ViV procedures by 2028.

Negatives

• Reported a net loss of $94.2 million for the year ended December 31, 2025, an increase of 24% from $76.0 million in 2024.
• Experienced negative cash flows from operating activities of $77.8 million in 2025, an increase of 27% from $61.2 million in 2024.
• Accumulated deficit increased to $370.5 million as of December 31, 2025, from $276.4 million in 2024.
• Net sales decreased by 29% to $1.9 million in 2025, primarily due to the expiration of the LeMaitre Transition Services Agreement.
• R&D expenses increased by 34% to $69.1 million in 2025, contributing to higher operating losses.
• Identified material weaknesses in internal control over financial reporting for 2025 and 2024, indicating risks in financial reporting accuracy and timeliness.
• The company has a history of operating losses and does not anticipate achieving profitability in the foreseeable future, requiring substantial additional future financing.
• Reliance on a limited number of single-source suppliers for critical raw materials and components, posing supply chain risks.
• The 4C Agreement, a supply and license agreement, will terminate on June 1, 2026, potentially impacting future revenue from regenerative tissue products.

Risks

• History of operating losses and may not achieve or maintain profitability in the future.
• Unsuccessful clinical trials or procedures relating to products could have a material adverse effect on future prospects.
• Inability to successfully identify, develop, obtain and maintain regulatory clearance or approval for and ultimately commercialize any current or future products, or experiencing significant delays in doing so.
• Even if a product receives regulatory clearance or approval, it may still face development and regulatory difficulties that could delay or impair future sales.
• Profitability may be impacted by ongoing coverage and reimbursement determinations by government health care programs and other third-party payors.
• Products in development may not achieve market acceptance, if approved, limiting growth.
• Difficulty enrolling patients in clinical trials, or patients discontinuing participation, could delay or prevent trials and increase costs.
• Operating in a highly competitive and rapidly changing industry, with potential harm if not competing effectively.
• Success of many products may depend upon the knowledge and experience of certain key physicians and heart valve centers.
• Reliance on third parties to conduct clinical trials and preclinical studies, with risks of delays or substandard performance.
• Exposure to various risks relating to international activities, including currency fluctuations and changes in foreign currency exchange rates.
• Failure to protect information technology infrastructure and products against cyber-based attacks, network security breaches, service interruptions, artificial intelligence, or data corruption.
• Artificial intelligence technologies could present business, compliance, and reputational risks.
• Increased emphasis on environmental, social, and governance (ESG) matters may have an adverse effect on business and reputation.
• Exposure to product liability claims that could harm business, with potential inability to obtain adequate insurance coverage.
• Use of products in unapproved circumstances could expose to liabilities.
• Products and operations are subject to extensive government regulation, including environmental, health, and safety regulations, which could result in substantial costs.
• Healthcare policy changes may have a material adverse effect.
• Tax laws, regulations, and enforcement practices are evolving and may have a material adverse effect on results of operations.
• Dependence on ability to protect intellectual property and proprietary technology.
• Intellectual property rights of third parties could adversely affect ability to commercialize products.
• Reliance on third parties requires sharing trade secrets, increasing risk of discovery or misappropriation.
• Obtaining and maintaining patent protection depends on compliance with various procedural requirements, and patent protection could be reduced or eliminated for non-compliance.
• Difficulty with protecting intellectual property could diminish the value of intellectual property rights.
• Medtronic plc beneficially owns a significant equity interest, and its interests may conflict with other stockholders.
• Requires substantial additional future financing, and cash burn may be higher than anticipated, with potential inability to raise sufficient capital.
• Market price and trading volume of Common Stock may continue to fluctuate and remain limited in terms of liquidity.
• Charter and Bylaws contain anti-takeover provisions that could delay or discourage takeover attempts.
• Future equity financings and sales by existing holders could adversely affect voting power or value of Common Stock.
• Failure to meet Nasdaq's continued listing requirements could result in delisting.
• As a holding company, depends on subsidiaries to support operations.
• Bylaws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain actions, limiting stockholders' ability to obtain a favorable judicial forum.
• Ability to use United States net operating loss carryforwards to offset future taxable income may be subject to certain limitations.
• Ability to use Australian net operating and capital loss carryforwards to offset future taxable income are subject to the satisfaction of loss tests.
• Sales of a substantial number of shares of Common Stock in the public market by existing stockholders could cause the price to fall.

Future Outlook

Anteris Technologies expects to continue incurring losses for the foreseeable future as it invests in the development and potential commercialization of the DurAVR THV System. The company anticipates that data from the ongoing PARADIGM Trial will provide the clinical evidence required for global regulatory approvals, including premarket approval in the United States and CE Mark approval in Europe. Future capital requirements are substantial and will depend on the scope, timing, and costs of clinical trials, regulatory approvals, and establishing marketing and sales capabilities. The company believes it has significant growth potential in the large and underpenetrated TAVR market, which is expected to reach $9.9 billion for severe aortic stenosis and $2.5 billion for ViV procedures by 2028.

Management Comments

• "We are a development stage company and have incurred net losses each year since operation, however, we believe that we have significant growth potential in a large, underpenetrated and growing TAVR market."
• "Our first in class DurAVR THV is a single-piece valve with a novel, biomimetic design that aims to replicate the normal blood flow of a healthy human aortic valve as compared to traditional three-piece aortic valves."
• "We expect the data from the PARADIGM Trial could provide the clinical evidence required for regulators to approve commercialization."
• "We continued strengthening our operational infrastructure during the year, advancing quality management system buildout to support upcoming clinical activities and future ISO 13485 certification."
• "All production has been, and will continue to be, scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity relative to 2024 capacity levels."
• "The gold-standard ADAPT tissue for the DurAVR THV will be sourced from both the United States and Australia moving forward to help mitigate supply chain risks."
• "Management has concluded that no substantial doubt exists regarding the Group's ability to continue as a going concern for at least 12 months from the date these financial statements are issued [February 26, 2026]."

Industry Context

StockSavvy.ai notes that Anteris Technologies operates in the highly competitive and rapidly evolving cardiovascular device market, specifically the Transcatheter Aortic Valve Replacement (TAVR) segment. The global TAVR market is projected for substantial growth, driven by an aging population and increasing incidence of heart diseases. Anteris's DurAVR THV, with its biomimetic, single-piece ADAPT tissue design, aims to differentiate itself from traditional three-piece valves offered by major competitors like Edwards Lifesciences Corporation and Medtronic. The focus on improved hemodynamics and durability positions Anteris to address the growing demand for longer-lasting solutions, particularly for younger, low-risk patients now eligible for TAVR. The strategic investment and collaboration rights with Medtronic could provide a significant competitive advantage and market access, although Medtronic also remains a competitor.

Comparison to Industry Standards

• DurAVR THV's biomimetic design aims to replicate normal aortic blood flow, a potential improvement over traditional three-piece TAVR valves that do not restore normal aortic flow.
• Early clinical data from the EMBARK study and EFSs showed single-digit mean gradients and large effective orifice areas (EOAs) of 2.2 cm², which are favorable hemodynamic outcomes compared to typical severe aortic stenosis patients with EOA ≤ 1 cm² and MPG ≥ 40 mmHg.
• The DurAVR THV demonstrated 97% freedom from prosthesis-patient mismatch (PPM), a significant improvement given that PPM affects a substantial proportion of TAVR patients, especially those with small aortic annuli, and is associated with impaired long-term survival following surgical aortic valve replacement (SAVR).
• The ADAPT anti-calcification tissue has been clinically demonstrated to be calcium-free for up to 10 years, suggesting potentially superior durability compared to other xenograft tissues used in heart valves, which are prone to calcification and structural valve deterioration over time.
• The ComASUR Delivery System is designed to achieve precise commissure alignment, a feature not consistently achieved in competitive delivery systems, which is crucial for optimal hemodynamics and future coronary access.

Management Changes

Corporate Governance

Legal Proceedings

• The company is not party to any material legal proceedings, and no such proceedings are, to management's knowledge, threatened against it.

Related Party Transactions

• In April 2023, the company purchased 30% of the equity capital stock of v2vmedtech, inc. and entered into development agreements to provide engineering, clinical, regulatory, marketing, and executive management resources. The company contributed $2.6 million to v2vmedtech in 2025, bringing total contributions to $6.2 million as of December 31, 2025.
• ATGC and ATPL are party to a deed of cross guarantee dated December 20, 2024, for Australian statutory reporting purposes, which had no impact on the consolidated financial statements for 2025.
• The company has entered into agreements to indemnify its directors and executive officers for certain expenses, judgments, fines, and settlement amounts.
• On January 20, 2026, the company entered into a stock purchase agreement with Covidien Group S. r.l., a wholly owned subsidiary of Medtronic plc, to issue and sell 15,652,173 shares of Common Stock for $90.0 million. Medtronic plc beneficially owns approximately 16.1% of the company's total Common Stock as of January 22, 2026.
• In connection with the Medtronic Private Placement, the company entered into a Registration Rights Agreement and an Investor Rights Agreement with Medtronic, granting Medtronic participation rights in future equity issuances, transfer restrictions, collaboration rights, customary standstill provisions, a non-voting board observer right, and a right to negotiate certain acquisition proposals.

Stakeholder Impact

• **Shareholders:** Dilution from recent and potential future equity financings, but also potential for long-term value creation if DurAVR THV achieves commercial success. Medtronic's significant ownership and associated rights could influence corporate actions and strategic direction.
• **Employees:** Increased R&D headcount and investments in talent management and development programs, including a new Manager Essentials Program, indicate a focus on employee growth and retention. Stock-based compensation plans aim to align employee interests with stockholders.
• **Customers (Future):** The DurAVR THV System aims to provide a better quality of life for aortic stenosis patients through improved hemodynamics and durability compared to current standard of care, potentially benefiting a broader patient population, including younger and less-active individuals.
• **Suppliers:** Continued reliance on single-source suppliers for critical materials (e.g., bovine pericardia from Harvey Industries Group) poses supply chain risks, but efforts to source from multiple regions (U.S. and Australia) aim to mitigate this.
• **Regulatory Bodies:** Ongoing engagement with the FDA and European regulatory authorities for the PARADIGM Trial and future commercialization approvals. Compliance with extensive government regulations is critical for product development and market access.

Next Steps

• Continue to enroll patients and collect data for the global pivotal PARADIGM Trial.
• Request authorization to expand enrollment for the remaining subjects in the PARADIGM Trial through an IDE supplement.
• Advance quality management system buildout to support upcoming clinical activities and future ISO 13485 certification.
• Progress manufacturing scale-up activities, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development.
• Obtain premarket approval for the DurAVR THV System in the United States and CE Mark approval in Europe based on PARADIGM Trial data.
• Continue development of the v2vmedtech heart valve repair device through Stages 2-5, including manufacturing and testing prototypes, non-clinical bench lab testing, preclinical animal studies, and a first-in-human study.
• Arrangements are ongoing to extend the Taurus Supplier Quality Agreement beyond its February 15, 2026, expiry.
• Further examination of loss carryforwards is being performed following the capital raises in January 2026 to assess potential limitations under Section 382 of the Internal Revenue Code.
• File a registration statement covering the resale of Common Stock sold to Medtronic in the private placement no later than 18 months following January 22, 2026.

Key Dates

Recommendation

Anteris Technologies is a high-risk, high-reward development-stage company. While the significant capital raises in early 2026 provide crucial funding for the pivotal PARADIGM Trial and alleviate immediate liquidity concerns, the company continues to incur substantial operating losses and is not expected to achieve profitability in the foreseeable future. The successful initiation of the PARADIGM Trial and promising early clinical data for DurAVR THV are positive indicators, but regulatory approval and market acceptance are still uncertain and years away. The material weaknesses in internal controls also present a concern. Given the long development timeline, high R&D costs, and inherent risks of clinical trials and regulatory approvals in the medical device industry, a 'hold' recommendation is appropriate for investors who already have exposure, acknowledging the long-term potential but also the significant uncertainties and execution risks. New investors should approach with extreme caution, considering the speculative nature of the investment.

Keywords

Aortic Stenosis, TAVR, Transcatheter Heart Valve, DurAVR THV System, ADAPT Tissue, ComASUR Delivery System, Clinical Trials, PARADIGM Trial, Medical Device, Biomimetic Valve, Cardiovascular, FDA Approval, SEC Filing, Biotechnology, Medtronic