Financial Data and Key Metrics Changes - The company reported total revenues of $99 million for Q1 2025, reflecting a 4% increase compared to Q1 2024 [21] - Adjusted EBITDA increased approximately 1% from $17.3 million to $17.5 million in Q1 2025 [21] - Adjusted EBITDA margin was 17.7% in Q1 2025, relatively flat compared to Q1 2024 [22] - Gross margins decreased to 64.2% in Q1 2025 from 64.6% in Q1 2024 due to lower revenue from higher margin preservation services [23] Business Line Data and Key Metrics Changes - Strength graft revenues grew 19% on a constant currency basis in Q1 2025 compared to the same period last year [10] - On X revenue increased by 11% year over year on a constant currency basis [13] - BioGlue revenues grew 9% on a constant currency basis compared to the same period last year [14] - Tissue processing revenues declined 23% year over year on a constant currency basis due to the backlog caused by a cybersecurity incident [14] Market Data and Key Metrics Changes - Revenues in Latin America increased by 26%, EMEA increased by 14%, Asia Pacific increased by 8%, while North America declined by 6% compared to Q1 2024 [22] - Latin America and Asia Pacific delivered constant currency revenue growth of 268% respectively in Q1 2025 [15] Company Strategy and Development Direction - The company is focused on ramping up On X supply and clearing the tissue processing backlog, with expectations to be fully caught up by the end of Q3 2025 [9][15] - The ongoing launch of AMDS in the U.S. is a key growth driver, with approximately 150 facilities actively seeking IRB and Value Analysis Committee approvals [12][13] - The company aims to capitalize on the $100 million market expansion opportunity for mechanical valves based on new clinical data [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion [20] - The company raised its full-year 2025 revenue guidance to expect constant currency growth of between 11% to 14% [26] - Management noted that the unfavorable impact of preservation services in Q1 will be fully caught up by the end of Q3, with AMDS sales expected to grow sequentially each quarter [27] Other Important Information - The company incurred approximately $4.7 million in Q1 2025 associated with the cybersecurity incident, which is excluded from adjusted EBITDA [23] - The net leverage at the end of Q1 was 4.0, down from 4.5 in the prior year [26] Q&A Session Summary Question: Contribution of AMDS to growth and onboarding of facilities - Management indicated that AMDS contributed to the growth but did not break out specific numbers, and the onboarding of facilities is progressing well with a 100% hit rate on targeted accounts [39][41] Question: Tissue growth expectations for the year - Management expects tissue growth to return to mid-single digits for the full year, with the backlog from the cybersecurity incident being cleared [43][45] Question: Cash flow expectations for the year - Management anticipates being free cash flow positive for the year, with Q1 typically being the worst quarter for cash flow due to seasonal expenses [56][58] Question: Growth rates for On X and stent grafts - Management expects On X to continue double-digit growth and stent grafts to grow at a mid-teens rate, with AMDS expected to improve overall growth rates by 1-2 percentage points [66] Question: Timing for potential acquisition of Endospan - The option to acquire Endospan will trigger upon FDA approval, with a decision required within 90 days of approval [76][78] Question: Nexus data and its implications - Management expressed optimism about the Nexus data and its potential for FDA approval, which would trigger the acquisition option [76][80]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $99 million, reflecting a 4% increase compared to Q1 2024 [20] - Adjusted EBITDA increased approximately 1% from $17.3 million to $17.5 million in Q1 2025 [20] - Adjusted EBITDA margin was 17.7%, relatively flat compared to the previous year [21] - Gross margins decreased to 64.2% from 64.6% year over year due to lower revenue from higher margin products [22] Business Line Data and Key Metrics Changes - Strength graft revenues grew 19% on a constant currency basis in Q1 2025 [8] - On X revenue increased by 11% year over year on a constant currency basis [11] - BioGlue revenues grew 9% on a constant currency basis [12] - Tissue processing revenues declined 23% year over year due to the backlog caused by a cybersecurity incident [12] Market Data and Key Metrics Changes - Latin America and Asia Pacific saw constant currency revenue growth of 268% and 14% respectively in Q1 2025 [13] - North America revenues declined by 6% compared to Q1 2024 [21] - EMEA revenues increased by 14% year over year [21] Company Strategy and Development Direction - The company is focused on ramping up On X supply and clearing the tissue processing backlog, with expectations to be fully caught up by the end of Q3 2025 [7][13] - The ongoing launch of AMDS in the U.S. is a key growth driver, with approximately 150 facilities actively seeking approvals [10][11] - The company aims to leverage positive clinical data to expand market share for On X valves, particularly among younger patients [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth and twice that rate for EBITDA in the future [19][29] - The company raised its full-year 2025 revenue guidance to a constant currency growth range of 11% to 14% [24] - Management noted that the impact of the cybersecurity incident is being resolved, with expectations for a return to normalcy in operations [6][29] Other Important Information - The company incurred approximately $4.7 million in Q1 related to the cybersecurity incident, which is excluded from adjusted EBITDA [22] - The net leverage ratio improved to 4.0 from 4.5 year over year [24] - The company does not anticipate the need to raise additional capital to fund its operations in the foreseeable future [22] Q&A Session Summary Question: Contribution of AMDS to growth and onboarding of facilities - Management indicated that AMDS contributed to the strong growth but did not break out specific numbers. They are encouraged by the reception from the clinical community and the onboarding process is progressing well [36][38] Question: Expectations for tissue growth recovery - Management expects to return to mid-single-digit growth for tissue processing by the end of the year, with the backlog being cleared in Q2 and Q3 [40][42] Question: Cash flow expectations for the year - Management expects to be free cash flow positive for the year, despite Q1 being seasonally high in expenses [54][56] Question: Growth rates for On X and stent grafts - Management expects On X to continue double-digit growth and stent grafts to grow at a mid-teens rate, with AMDS expected to improve overall growth rates [64][66] Question: Timing for acquiring Endospan - The option to acquire Endospan will trigger upon FDA approval, expected in the second half of 2026, with a decision required within 90 days of approval [72][74] Question: Feedback on Nexus data and market opportunity - Management expressed optimism about the Nexus data and its potential market impact, noting that the mortality benefits could lead to increased adoption [80][82]

Financial Performance - Artivion reported Q1 2025 revenue of $99 million[10] - The company achieved 4% year-over-year constant currency revenue growth in Q1 2025[10] - Adjusted EBITDA for Q1 2025 was $175 million, a 1% increase year-over-year[10] - The company raised the midpoint of FY25 revenue guidance to a range of $423 million to $435 million, representing 11% to 14% year-over-year growth[13] - The company expects FY25 adjusted EBITDA to be in the range of $84 million to $91 million, growing 18% to 28% over FY24[13] Product and Geographic Growth - Stent grafts showed 19% year-over-year constant currency revenue growth[11] - On-X saw 11% year-over-year constant currency revenue growth[11] - BioGlue experienced 9% year-over-year constant currency revenue growth[11] - Latin America experienced 26% constant currency revenue growth[17] Clinical Trial and Regulatory Updates - The NEXUS TRIOMPHE trial demonstrated a 63% reduction in major adverse event rate compared to the reference performance goal[12, 18] - PMA approval for NEXUS TRIOMPHE is expected in the second half of 2026[12] - 30-day data demonstrate AMDS induced positive aortic remodeling in over 80% of patients[29]

Financial Performance - Total revenues for Q1 2025 were $99.0 million, a 2% increase on a GAAP basis and a 4% increase on a non-GAAP constant currency basis compared to Q1 2024[7]. - Net loss for Q1 2025 was $(0.5) million, or $(0.01) per fully diluted share, compared to net income of $7.5 million, or $0.18 per fully diluted share in Q1 2024[8]. - Adjusted EBITDA for Q1 2025 increased by 1% to $17.5 million compared to $17.3 million in Q1 2024[5]. - Total revenues for the three months ended March 31, 2025, were $98,978, a 4% increase from $97,431 in the same period of 2024[25]. - Adjusted EBITDA for the three months ended March 31, 2025, was $17,548, compared to $17,312 in the same period of 2024[29]. - For the three months ended March 31, 2025, the company reported a net loss of $505 million compared to a net income of $7,533 million in the same period of 2024[31]. - The diluted loss per common share for the current quarter was $(0.01), a decrease from $0.18 in the prior year[31]. - Adjusted net income, non-GAAP, was $2,494 million, slightly down from $2,632 million in the previous year[31]. - The adjusted diluted income per common share, non-GAAP, remained stable at $0.06 for both periods[31]. Revenue Growth - Stent grafts revenue grew by 14%, On-X by 10%, and BioGlue by 7% year-over-year, with constant currency growth rates of 19%, 11%, and 9% respectively[4]. - Aortic stent grafts revenue increased by 14% to $36,602 from $32,103 year-over-year[27]. - The company raised its full-year 2025 revenue guidance to a range of $423 to $435 million, representing growth of 11% to 14% on a constant currency basis compared to 2024[9]. Expenses and Liabilities - General, administrative, and marketing expenses increased to $54.7 million in Q1 2025 from $30.7 million in Q1 2024[19]. - Cash and cash equivalents decreased to $37,693 as of March 31, 2025, from $53,463 at the end of 2024[23]. - Total current liabilities decreased to $51,940 from $66,823 year-over-year[23]. - Long-term debt remained stable at $314,611 compared to $314,152 year-over-year[21]. Cybersecurity Incident - The company experienced a significant cybersecurity incident, which contributed $4,746 million to the adjustments in the income statement[31]. Clinical and Regulatory Updates - 30-day data from Endospan's NEXUS TRIOMPHE IDE trial showed a 63% reduction in the major adverse event (MAE) rate compared to reference performance goals[5]. - The clinical module of the pre-market approval application (PMA) for the AMDS Hybrid Prosthesis has been submitted to the FDA[5]. - The company anticipates NEXUS to be on track for FDA approval in the second half of 2026[6]. Cash Flow and Other Financial Metrics - Free cash flows for the three months ended March 31, 2025, were $(20,591), compared to $(9,104) in the same period of 2024[29]. - Total assets increased to $791,163 as of March 31, 2025, from $789,101 at the end of 2024[21]. - Business development, integration, and severance income showed a notable improvement, with a reduction in losses from $(17,387) million to $(3,057) million[31]. - The company incurred a non-cash interest expense of $543 million, slightly down from $580 million in the previous year[31]. - The income tax benefit for the current quarter was $(1,790) million, compared to an expense of $5,248 million in the same quarter last year[31].

Core Insights - Artivion, Inc. reported a total revenue of $99.0 million for Q1 2025, reflecting a 2% increase on a GAAP basis and a 4% increase on a non-GAAP constant currency basis compared to Q1 2024 [4][14] - The company experienced a net loss of $(0.5) million, or $(0.01) per diluted share, compared to a net income of $7.5 million, or $0.18 per diluted share in the same quarter of the previous year [5][25] - Artivion raised its full-year revenue guidance for 2025, now expecting revenue between $423 million and $435 million, which represents an 11% to 14% growth on a constant currency basis compared to 2024 [6][15] Financial Performance - Product revenue growth was driven by stent grafts (14% growth), On-X (10% growth), and BioGlue (7% growth) year-over-year, with constant currency growth rates of 19%, 11%, and 9% respectively [2][14] - Preservation services revenue decreased by 23% due to a backlog in tissue processing operations caused by a cybersecurity incident [2][14] - Adjusted EBITDA for Q1 2025 was $17.5 million, a 1% increase from $17.3 million in Q1 2024 [14][24] Market Developments - Endospan presented positive clinical data for its NEXUS aortic stent graft system, showing a 63% reduction in major adverse event rates compared to reference performance goals, with expectations for FDA approval in the second half of 2026 [3][14] - The company continues to focus on strategic growth initiatives while recovering from the impacts of the cybersecurity incident [2][3] Revenue Breakdown - Total revenues for Q1 2025 included $78.8 million from products and $20.2 million from preservation services [21] - Geographically, revenue distribution was $47.8 million from North America, $37.0 million from Europe, the Middle East, and Africa, $8.2 million from Asia Pacific, and $5.9 million from Latin America [21][23] Financial Outlook - Artivion expects adjusted EBITDA growth of 18% to 28% for the full year 2025, resulting in an expected range of $84 million to $91 million [7][15] - The company is not revising its foreign exchange assumptions despite potential upside from current exchange rates due to ongoing volatility [6][15]

Core Insights - The NEXUS TRIOMPHE trial data shows a 63% reduction in Major Adverse Event (MAE) rates compared to the reference performance goal, indicating significant clinical improvement for patients with chronic aortic dissection [1][3]. Clinical Outcomes - The trial involved a cohort of 54 patients at high risk for open surgical repair, demonstrating a MAE rate of 13% against a performance goal of 35% (p < 0.001) [4]. - Technical failure rates were reported at 1.9%, significantly lower than the 30% performance goal (p < 0.001) [4]. Device Performance - The NEXUS device is presented as a minimally invasive alternative to open aortic arch replacement, particularly beneficial for high-risk patients [5]. - The trial results are expected to support the clinical module of the PMA filing after one year of follow-up with the primary cohort [6]. Company Overview - Artivion, Inc. specializes in medical devices for cardiac and vascular surgery, focusing on aortic diseases, and markets products in over 100 countries [7].

Financial Performance - Total revenues for 2024 reached $388.5 million, an increase of 9.8% from $354.0 million in 2023[371]. - Product revenues increased to $290.2 million, up 11.1% from $261.2 million in 2023[371]. - Operating income for 2024 was $38.9 million, significantly higher than $5.7 million in 2023[371]. - Net loss decreased to $13.4 million in 2024 from $30.7 million in 2023, reflecting a reduction of 56.3%[371]. - Basic loss per share improved to $(0.32) from $(0.75) in 2023[371]. - Net loss for the year ended December 31, 2024, was $13,359 million, a decrease from a net loss of $30,690 million in 2023[373]. - Net cash flows provided by operating activities increased to $22,236 million in 2024 from $18,825 million in 2023[373]. - Total current assets increased to $290.1 million in 2024, up from $280.7 million in 2023[367]. - Total liabilities rose slightly to $512.9 million in 2024 from $510.6 million in 2023[369]. - Cash and cash equivalents decreased to $53.5 million in 2024 from $58.9 million in 2023[367]. Employee Relations and Workforce - The company had approximately 1,600 employees as of December 31, 2024, with a focus on attracting and retaining qualified personnel in a competitive market[146]. - The company has never experienced a work stoppage or interruption due to labor disputes, indicating good relations with employees worldwide[146]. - The company has programs in place to enhance compensation and benefits to attract and retain talent in the medical device and tissue processing industries[148]. - The company emphasizes a strong and collaborative culture, with core values focused on collaboration, results-driven performance, and customer focus[149]. Internal Controls and Compliance - The company maintains effective internal control over financial reporting as of December 31, 2024, based on the COSO criteria[359]. - The company’s independent auditor, Ernst & Young, LLP, issued an unqualified opinion on the effectiveness of internal controls over financial reporting as of December 31, 2024[347]. Risks and Sensitivities - The company’s operations are subject to risks from interest rate fluctuations and foreign currency exchange rate changes, which could significantly impact financial results[332][334]. - A hypothetical increase of one percentage point in interest rates on the company's variable rate debt portfolio would decrease pre-tax operating results by an estimated $2.0 million over a twelve-month period[333]. - A hypothetical 10% change in foreign currency exchange rates would decrease pre-tax operating results by an estimated $8.0 million over a twelve-month period[335]. Capital Expenditures and Investments - Capital expenditures for 2024 were $11,188 million, up from $9,752 million in 2023[373]. - The company completed the acquisition of Ascyrus Medical LLC to enhance the company's product offerings in the treatment of acute Type A aortic dissections[440]. - The total potential purchase consideration for the Ascyrus acquisition is up to $200.0 million, including cash payments and stock issuance upon achieving specific milestones[441]. Revenue and Market Performance - North America generated $197.9 million in revenue for 2024, up from $187.6 million in 2023, representing a growth of 7.2%[506]. - EMEA revenue increased to $131.5 million in 2024 from $114.8 million in 2023, reflecting a growth of 14.6%[506]. Stock and Equity - The company authorized a total of 10,045,000 shares under its stock plans as of December 31, 2024, with 2,742,000 shares available for grant[507]. - In 2024, the company authorized stock awards totaling 781,000 shares with an aggregate grant date market value of $16.2 million[508]. - The company did not authorize any grants of stock options during 2024, while 110,000 shares were granted in 2023[515]. Tax and Deferred Assets - Total deferred tax assets were $41.87 million as of December 31, 2024, down from $43.14 million in 2023, with a net deferred tax liability of $19.12 million[470]. - The company maintained a valuation allowance against deferred tax assets of $32.61 million as of December 31, 2024, compared to $32.86 million in 2023[470]. - As of December 31, 2024, the uncertain tax liability was $5.1 million, with $4.0 million expected to affect the tax rate if recognized[475]. Debt and Financing - The total principal debt as of December 31, 2024, was $320.2 million, with total debt amounting to $314.3 million after accounting for unamortized debt issuance costs[480]. - The company entered into a credit agreement for $350.0 million, including a $190.0 million secured term loan facility and a $60.0 million revolving credit facility[483]. - The stated interest rate for the Term Loan Facility was 11.09% as of December 31, 2024, with an effective interest rate of 11.86%[489]. - The company is in compliance with its debt covenants, which require a total net leverage ratio not greater than 6.25x for certain periods[487].

4Q and Full Year 2024 Earnings Presentation February 24, 2025 1 © 2025 Artivion, Inc. FORWARD-LOOKING STATEMENTS Statements made in this presentation that look forward in time or that express management's beliefs, expectations, or forecasts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include our beliefs and expectations about ou ...

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were $97.3 million, up 3% compared to Q4 2023 [34] - Adjusted EBITDA increased approximately 15% from $15.3 million to $17.6 million in Q4 2024 [34] - For the full year, total revenues were $388.5 million, up 9.4% in constant currency and 10% excluding PerClot [35] - Adjusted EBITDA grew 32% for the full year, resulting in adjusted EBITDA margins of 18%, a 310 basis point improvement from 2023 [35][36] Business Line Data and Key Metrics Changes - On-X revenue increased 10% year-over-year on a constant currency basis [13] - Stent graft revenues grew 8% on a constant currency basis in Q4 compared to the same period last year [15] - BioGlue grew 7% on a constant currency basis compared to the same period last year [16] - Tissue processing declined 8% year-over-year on a constant currency basis in Q4 [18] Market Data and Key Metrics Changes - Latin America and Asia-Pacific delivered constant-currency revenue growth of 26% and 11% for the full year, respectively [19] - The company anticipates strong revenue growth for both regions over the coming years [19] Company Strategy and Development Direction - The company aims for sustained double-digit revenue growth and EBITDA growth at least twice the rate of revenue growth [7][31] - The Humanitarian Device Exemption (HDE) for AMDS represents a significant milestone, allowing for commercial distribution prior to PMA approval [21] - The company is focused on expanding its product pipeline and leveraging regulatory approvals to drive growth [20][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in recovering lost revenue from the cyber incident throughout 2025, citing strong underlying demand [77][81] - The company expects constant currency growth of between 10% and 14% for the full year 2025, with reported revenue ranging from $420 million to $435 million [51] - Management noted that the cyber incident would not have a meaningful impact on the business for the full year 2025 [38] Other Important Information - The cyber incident had an estimated negative impact of approximately $4.5 million on Q4 revenue and $2 million on adjusted EBITDA [9][37] - The company expects to incur additional cyber-related expenses in 2025 [45] - Free cash flow was $8.7 million in Q4 2024, with approximately $53.5 million in cash and $314.3 million in debt as of December 31 [48][49] Q&A Session Summary Question: Early AMDS commercial progress - Management reported that the U.S. commercial team is actively pursuing AMDS accounts, with 55 feet on the street [72] Question: Confidence in recovering lost revenue - Management expressed confidence that demand exceeds supply, and they expect to catch up on lost revenue due to normal donation levels [76][77] Question: PMA timeline delay for AMDS - The delay is due to new testing requirements from the FDA, which will add two quarters to the timeline [86] Question: Number of implanting sites for AMDS - There are about 1,000 centers that perform DeBakey type 1 dissections, with a focus on the top 600 centers for initial penetration [92] Question: Operational impact of the cyber incident - The incident required manual processing of tasks that would normally be automated, extending lead times [95] Question: Q1 adjusted EBITDA expectations - Q1 is expected to be the lowest adjusted EBITDA of the year, with revenue timing differences impacting results [98]

Revenue Performance - Total revenue for Q4 2024 was $97.3 million, a 4% increase on a GAAP basis compared to Q4 2023[5]. - Full year 2024 revenue reached $388.5 million, representing a 10% increase on a GAAP basis compared to 2023[7]. - Revenue growth in Q4 2024 was driven by On-X (10%), stent grafts (10%), and BioGlue (8%) compared to Q4 2023[3]. - Product revenues for the year ended December 31, 2024, reached $290,230,000, compared to $261,185,000 in 2023, reflecting a year-over-year increase of 11.1%[20]. - Total revenues for the three months ended December 31, 2024, were $97,308 million, representing a 3% increase from $93,670 million in the prior year[30]. - Aortic stent grafts revenue increased by 8% to $30,145 million from $27,437 million year-over-year[30]. - North America revenue for the year ended December 31, 2024, was $197,940 million, a 6% increase from $187,603 million in 2023[30]. - Europe, the Middle East, and Africa revenue increased by 13% to $131,518 million for the year ended December 31, 2024, compared to $114,814 million in 2023[30]. - Latin America revenue for the year ended December 31, 2024, increased by 26% to $21,877 million from $18,010 million in the prior year[30]. Profitability and Loss - Adjusted EBITDA for Q4 2024 increased by 15% to $17.6 million, while full year adjusted EBITDA rose by 32% to $71.3 million[3]. - Net loss for Q4 2024 was $(16.5) million, or $(0.39) per fully diluted share, compared to a net loss of $(4.0) million in Q4 2023[6]. - The net loss for the year ended December 31, 2024, was $13,359,000, compared to a net loss of $30,690,000 in 2023, representing an improvement of 56.4%[20]. - For the three months ended December 31, 2024, the net loss was $16,483 million, compared to a net loss of $3,975 million for the same period in 2023, representing a significant increase in losses[34]. - The diluted loss per common share for the year ended December 31, 2024, was $0.32, compared to $0.75 for the year ended December 31, 2023, indicating a reduction in loss per share[34]. - Adjusted net income for the year ended December 31, 2024, was $10,768 million, up from $8,426 million in 2023, reflecting a year-over-year increase of approximately 27.7%[34]. Expenses and Costs - Operating income for the year ended December 31, 2024, was $38,874,000, a decrease from $5,742,000 in 2023, showing a significant decline[20]. - Research and development expenses for the year ended December 31, 2024, totaled $28,452,000, slightly down from $28,707,000 in 2023[20]. - The company incurred a cybersecurity incident expense of $4,583 million in 2024, which was not present in 2023, highlighting a new challenge faced by the company[34]. - Business development, integration, and severance expenses totaled $29,269 million for the year ended December 31, 2023, compared to a gain of $6,102 million in 2024, indicating a significant shift in expenses[34]. - The company reported a non-cash interest expense of $3,866 million for the year ended December 31, 2024, compared to $1,858 million in 2023, indicating a rise in interest-related costs[34]. - The total income tax expense for the year ended December 31, 2024, was $5,845 million, down from $9,104 million in 2023, reflecting a decrease in tax obligations[34]. Cash and Assets - Cash and cash equivalents at the end of the year on December 31, 2024, were $53,463,000, down from $58,940,000 at the end of 2023, a decrease of 8.4%[26]. - Total current assets increased to $290,080,000 as of December 31, 2024, compared to $280,668,000 in 2023, reflecting a growth of 3.0%[22]. - Total liabilities as of December 31, 2024, were $512,901,000, compared to $510,617,000 in 2023, indicating a slight increase of 0.4%[24]. Future Outlook - The company expects 2025 revenues to be between $420 million and $435 million, indicating a growth of 10% to 14% on a constant currency basis compared to 2024[9]. - Adjusted EBITDA for 2025 is projected to grow between 18% and 28%, resulting in an expected range of $84 million to $91 million[10]. - The company anticipates that the November 2024 cybersecurity incident will not significantly impact its business for the full year 2025[4]. - The company received a Humanitarian Device Exemption from the FDA for the AMDS Hybrid Prosthesis, facilitating its market entry[4].