Advanced Medical Solutions Ltd.

ROCHESTER HILLS, Mich.--( BUSINESS WIRE )-- InfuSystem Holdings, Inc. (NYSE American:INFU) (“InfuSystem” or the “Company”), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, today reported financial results for the second quarter ended June 30, 2024. 2024 Second Quarter Overview: Net revenues totaled $33.7 million, an increase of 6% vs. prior year. Patient Services net revenue was $20.2 million, an increase of 5% vs. prior year. Device Solutions net revenue was $13.5 million, an increase of 8% vs. prior year. Gross profit was $16.7 million, an increase of 5% vs. prior year. Gross margin was 49.5%, a slight decrease of 0.4% vs. prior year. Patient Services gross margin was 66.4%, an increase of 5.1% vs. prior year. Device Solutions gross margin was 24.0%, a decrease of 8.1% vs. prior year. Net income increased 64.8% to $0.7 million, or $0.03 per diluted share vs. prior year net income of $0.4 million, or $0.02 per diluted share. Adjusted earnings before interest, income taxes, depreciation, and amortization (“Adjusted EBITDA”) (non-GAAP) was $6.1 million, an increase of 5% vs. prior year. Adjusted EBITDA margin was 18.0% vs. 18.2% prior year. Net operating cash flow was up 17% to $2.7 million, as of June 30, 2024. Company liquidity totaled $40.5 million, as of June 30, 2024. Management Discussion Richard DiIorio, Chief Executive Officer of InfuSystem, said, “ We are pleased with our second quarter financial results, which included setting a new record high quarterly revenue of $33.7 million, an increase of 6% over the prior year period, a 17% increase in net operating cash flow, and the anticipated significant sequential increase in Adjusted EBITDA margin to 18%. This quarter marked our 10 th consecutive record-breaking revenue achievement out of the last 12 quarters.” “ We are continuing to identify and implement strategic partnerships that we believe will grow and diversify our business. Most recently, this included entering into a new distribution agreement with Smith+Nephew, a global leader in medical technology. This collaboration expands our portfolio of medical equipment and increases our opportunities in wound care. InfuSystem is quickly becoming a diversified healthcare service provider, leveraging our service platforms to offer unique capabilities that enhance patient care both at home and in acute care facilities.” As we look ahead, we see momentum building into the second half of this year and into 2025. In Patient Services, Oncology continues to be strong, we continue to make progress in developing Wound Care, and Pain Management is ready for reimbursement to come through the NOPAIN Act. Device Solutions secured a new pump rental business win and in biomedical services, we undertook a significant device remediation project for one of our important partners, a large medical device manufacturer. We remain focused on enhancing our margin and profitability profile. We believe we are well positioned for sustainable long-term growth and profitability in the coming quarters and years,” concluded Mr. DiIorio. 2024 Second Quarter Financial Review Net revenues for the quarter ended June 30, 2024 were $33.7 million, an increase of $2.0 million, or 6.2%, compared to $31.7 million for the quarter ended June 30, 2023. The increase included higher net revenues for both the Patient Services and Device Solutions segments. Patient Services net revenue of $20.2 million increased $0.9 million, or 4.8%, during the second quarter of 2024 compared to the prior year period. This increase was primarily attributable to additional treatment volume and increased third-party payer collections totaling $2.1 million, offset partially by $1.2 million lower revenue from sales-type leases of NPWT pumps. The improved volume and collections benefited Oncology revenue by $1.5 million or 8.9%, Pain Management revenue by $0.3 million, or 28.9%, and Wound Care treatment revenue by $0.3 million, or 188.0%. Sales-Type Lease revenue of NPWT pumps, which had a tough comparison to an unusually strong prior year amount, decreased by $1.2 million. Device Solutions net revenue of $13.5 million increased $1.0 million, or 8.3%, during the second quarter of 2024 compared to the prior year period. This increase included higher biomedical services revenue, which increased by $0.5 million, or 13.6%, higher rental revenue totaling $0.4 million, or 9.2%, and higher disposable medical supplies revenue which increased by $0.4 million, or 20.4%. These increases were partially offset by lower medical equipment sales which decreased by $0.3 million, or 18.8%. The increased biomedical revenue was mainly attributable to increased revenue from the master services agreement that we entered into in April 2022. The increases in rental revenue and disposables are mainly attributable to a new customer added during the period. Lower medical equipment sales reflects normal shipment timing for large contracts. Gross profit for the second quarter of 2024 of $16.7 million increased by $0.8 million, or 5%, compared to the second quarter of 2023. This increase was due to the increase in net revenues offset partially by a lower gross profit percentage of net revenue (“gross margin”). During the second quarter of 2024, we identified and corrected an immaterial error in our accrued liabilities associated with travel expenses resulting in an unfavorable cumulative expense adjustment to cost of revenues totaling $0.6 million during the second quarter of 2024. The lower gross margin was attributable to this adjustment which represented 1.6% of net revenue for the second quarter of 2024. Gross margin was 49.5% during the second quarter of 2024 compared to 49.9% during the prior year period, a decrease of 0.4%. Gross profit and gross margin increased in the Patient Services segment, but were both lower in the Device Solutions segment. Patient Services gross profit was $13.4 million during the second quarter of 2024, representing an increase of $1.6 million compared to the prior year period. The increase reflected the higher net revenue and higher gross margin, which increased from the prior year by 5.1% to 66.4%. The increase in gross margin reflected increased third-party payer collections, favorable gross margin mix, lower pump disposal expenses and improved coverage of fixed costs from higher net revenue. The favorable gross margin mix was mainly related to the decrease in revenue related to NPWT equipment leases which have a lower average gross margin than other Patient Services revenue categories. Pump disposal expenses, which include retirements of damaged pumps and reserves for missing pumps, decreased by $0.1 million during the second quarter of 2024 compared to the prior year period. Device Solutions gross profit during the second quarter of 2024 was $3.2 million, representing a decrease of $0.8 million, or 19.1%, compared to the prior year. This decrease was due to the $0.6 million error correction and a decrease in gross margin. These decreases were partially offset by higher net revenue. The Device Solutions gross margin was 24.0% during the current quarter, which was 8.1% lower than the prior year period, which included a 4.1% reduction related to the error correction. The remaining decrease was due to unfavorable sales mix favoring lower margin products including disposable medical supplies. Selling and marketing expenses were $3.0 million for the second quarter of 2024, representing an increase of $0.1 million, or 1.9%, compared to the prior year. Selling and marketing expenses as a percentage of net revenues decreased to 9.0% compared to 9.4% in the prior year period. This decrease reflected a reduction in sales team members and improved coverage of fixed costs from higher net revenues. General and administrative (“G&A”) expenses for the second quarter of 2024 were $11.5 million, an increase of 1.5% from $11.4 million for the second quarter of 2023. G&A expenses as a percentage of net revenues for the second quarter of 2024 decreased to 34.2% compared to 35.8% for the prior year period, mainly reflecting improved net revenue leverage over fixed costs. Net income for the second quarter of 2024 was $0.7 million, or $0.03 per diluted share, compared to net income of $0.4 million, or $0.02 per diluted share, for the second quarter of 2023. Adjusted EBITDA, a non-GAAP measure, for the second quarter of 2024 was $6.1 million, or 18.0% of net revenue, and increased by $0.3 million, or 5.4%, compared to Adjusted EBITDA for the same prior year quarter of $5.8 million, or 18.2% of prior period net revenue. Balance sheet, cash flows and liquidity During the six-month period ended June 30, 2024, operating cash flow increased to $2.7 million, a $0.4 million, or 17%, increase over operating cash flow during the same prior year six-month period. The increase reflected lower working capital growth during 2024 as compared to 2023. Capital expenditures during the first half of 2024 included purchases of medical devices totaling $8.8 million, which was $1.8 million, or 26%, higher than the amount purchased during the same prior year period. As of June 30, 2024, available liquidity for the Company totaled $40.5 million and consisted of $40.3 million in available borrowing capacity under its revolving line of credit plus cash and cash equivalents of $0.1 million. Net debt, a non-GAAP measure (calculated as total debt of $34.2 million less cash and cash equivalents of $0.1 million) as of June 30, 2024 was $34.0 million representing an increase of $5.1 million compared to net debt of $28.9 million as of December 31, 2023 (calculated as total debt of $29.1 million less cash and cash equivalents of $0.2 million). Our ratio of Adjusted EBITDA to net debt (non-GAAP) for the last four quarters was 1.53 to 1.00 (calculated as net debt of $34.0 million divided by Adjusted EBITDA of $22.3 million). Full Year 2024 Guidance InfuSystem is reaffirming its annual guidance for the full year 2024 with net revenue growth estimated to be in the high-single-digit range and forecasting Adjusted EBITDA margin (non-GAAP) to be in the high-teens, exceeding the Company's margin of 17.8% in 2023. The full year 2024 guidance reflects management’s current expectation for operational performance, given the current market conditions. This includes our best estimate of revenue and Adjusted EBITDA. These estimates now include expected expenses related to planned upgrades of the Company's information technology and business applications. Our previous guidance excluded these amounts. The Company and its businesses are subject to certain risks, including those risk factors discussed in our most recent annual report on Form 10-K for the year ended December 31, 2023, filed on April 10, 2024. Conference Call The Company will conduct a conference call for all interested investors on Thursday, August 8, 2024, at 9:00 a.m. Eastern Time to discuss its second quarter 2024 financial results. The call will include discussion of Company developments, forward-looking statements and other material information about business and financial matters. To participate in this call, please dial (833) 366-1127 or (412) 902-6773, or listen via a live webcast, which is available in the Investors section of the Company’s website at https://ir.infusystem.com/ . A replay of the call will be available by visiting https://ir.infusystem.com/ for the next 90 days or by calling (877) 344-7529 or (412) 317-0088, replay access code 6530466, through August 15, 2024. Non-GAAP Measures This press release contains information prepared in conformity with GAAP as well as non-GAAP financial information. Non-GAAP financial measures presented in this press release include EBITDA, Adjusted EBITDA, Adjusted EBITDA Margin, net debt and Adjusted EBITDA to net debt ratio. The Company believes that the non-GAAP financial measures presented in this press release provide useful information to the Company’s management, investors and other interested parties about the Company’s operating performance because they allow them to understand and compare the Company’s operating results during the current periods to the prior year periods in a more consistent manner. This non-GAAP information should be considered by the reader in addition to, but not instead of, the financial statements prepared in accordance with GAAP, and similarly titled non-GAAP measures may be calculated differently by other companies. The Company calculates those non-GAAP measures by adjusting for non-recurring or non-core items that are not part of the normal course of business. A reconciliation of those measures to the most directly comparable GAAP measures is provided in the accompanying schedule, titled "GAAP to Non-GAAP Reconciliation" below. Future period non-GAAP guidance includes adjustments for items not indicative of our core operations, which may include, without limitation, items included in the accompanying schedule below. Such adjustments may be affected by changes in ongoing assumptions and judgments, as well as non-core, nonrecurring, unusual or unanticipated changes, expenses or gains or other items that may not directly correlate to the underlying performance of our business operations. The exact amounts of these adjustments are not currently determinable but may be significant. It is therefore not practicable to provide the comparable GAAP measures or reconcile this non-GAAP guidance to the most comparable GAAP measures and, therefore, such comparable GAAP measures and reconciliations are excluded from this release in reliance upon applicable SEC staff guidance. About InfuSystem Holdings, Inc. InfuSystem Holdings, Inc. (NYSE American:INFU), is a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers. INFU services are provided under a two-platform model. The first platform is Patient Services, providing the last-mile solution for clinic-to-home healthcare where the continuing treatment involves complex durable medical equipment and services. The Patient Services segment is comprised of Oncology, Pain Management and Wound Therapy businesses. The second platform, Device Solutions, supports the Patient Services platform and leverages strong service orientation to win incremental business from its direct payer clients. The Device Solutions segment is comprised of direct payer rentals, pump and consumable sales, and biomedical services and repair. Headquartered in Rochester Hills, Michigan, the Company delivers local, field-based customer support and also operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada. Forward-Looking Statements The financial results in this press release reflect preliminary results, which are not final until the Company ’ s quarterly report on Form 10-Q for the quarter year ended June 30, 2024 is filed. In addition, certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, such as statements relating to future actions, our share repurchase program and capital allocation strategy, business plans, strategic partnerships, growth initiatives, objectives and prospects, future operating or financial performance, guidance and expected new business relationships and the terms thereof (including estimated potential revenue under new or existing contracts). The words “ believe, ” “ may, ” “ will, ” “ estimate, ” “ continue, ” “ anticipate, ” “ intend, ” “ should, ” “ plan, ” “ goal, ” “ expect, ” “ strategy, ” “ future, ” “ likely, ” variations of such words, and other similar expressions, as they relate to the Company, are intended to identify forward-looking statements. Forward-looking statements are subject to factors, risks and uncertainties that could cause actual results to differ materially, including, but not limited to, our ability to successfully execute on our growth initiatives and strategic partnerships, our ability to enter into definitive agreements for the new business relationships on expected terms or at all, our ability to generate estimated potential revenue amounts under new or existing contracts, the uncertain impact of the COVID-19 pandemic, our dependence on estimates of collectible revenue, potential litigation, changes in third-party reimbursement processes, changes in law, global financial conditions and recessionary risks, rising inflation and interest rates, supply chain disruptions, systemic pressures in the banking sector, including disruptions to credit markets, the Company's ability to remediate its previously disclosed material weaknesses in internal control over financial reporting, contributions from acquired businesses or new business lines, products or services and other risk factors disclosed in the Company ’ s most recent annual report on Form 10-K and, to the extent applicable, quarterly reports on Form 10-Q. Our strategic partnerships are subject to similar factors, risks and uncertainties. All forward-looking statements made in this press release speak only as of the date hereof. We do not undertake any obligation to update any forward-looking statements to reflect future events or circumstances, except as required by law. Additional information about InfuSystem Holdings, Inc. is available at www.infusystem.com . FINANCIAL TABLES FOLLOW INFUSYSTEM HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three Months Ended June 30, Six Months Ended June 30, (in thousands, except share and per share data) 2024 2023 2024 2023 Net revenues $ 33,698 $ 31,735 $ 65,693 $ 62,105 Cost of revenues 17,030 15,903 32,551 31,323 Gross profit 16,668 15,832 33,142 30,782 Selling, general and administrative expenses: Amortization of intangibles 247 247 495 495 Selling and marketing 3,042 2,985 6,418 6,209 General and administrative 11,524 11,352 25,219 22,937 Total selling, general and administrative 14,813 14,584 32,132 29,641 Operating income 1,855 1,248 1,010 1,141 Other expense: Interest expense (484 ) (620 ) (940 ) (1,104 ) Other (expense) income (63 ) 2 (60 ) (33 ) Income before income taxes 1,308 630 10 4 (Provision for) benefit from income taxes (591 ) (195 ) (405 ) 107 Net income (loss) $ 717 $ 435 $ (395 ) $ 111 Net income (loss) per share: Basic $ 0.03 $ 0.02 $ (0.02 ) $ 0.01 Diluted $ 0.03 $ 0.02 $ (0.02 ) $ 0.01 Weighted average shares outstanding: Basic 21,299,089 20,955,048 21,262,429 20,904,315 Diluted 21,711,198 21,600,346 21,262,429 21,565,667 INFUSYSTEM HOLDINGS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS SEGMENT REPORTING (UNAUDITED) Three Months Ended June 30, Better/ (Worse) (in thousands) 2024 2023 Net revenues: Patient Services $ 20,246 $ 19,319 $ 927 Device Solutions 15,194 14,097 1,097 Less: elimination of inter-segment revenues (a) (1,742 ) (1,681 ) (61 ) Total Device Solutions 13,452 12,416 1,036 Total 33,698 31,735 1,963 Gross profit: Patient Services 13,444 11,845 1,599 Device Solutions 3,224 3,987 (763 ) Total $ 16,668 $ 15,832 $ 836 (a) Inter-segment allocations are for cleaning and repair services performed on medical equipment. Six Months Ended June 30, Better/ (Worse) (in thousands) 2024 2023 Net revenues: Patient Services $ 38,837 $ 38,093 $ 744 Device Solutions 30,311 27,323 2,988 Less: elimination of inter-segment revenues (a) (3,455 ) (3,311 ) (144 ) Total Device Solutions 26,856 24,012 2,844 Total 65,693 62,105 3,588 Gross profit: Patient Services 25,718 23,386 2,332 Device Solutions 7,424 7,396 28 Total $ 33,142 $ 30,782 $ 2,360 (a) Inter-segment allocations are for cleaning and repair services performed on medical equipment. INFUSYSTEM HOLDINGS, INC. AND SUBSIDIARIES GAAP TO NON-GAAP RECONCILIATION (UNAUDITED) NET INCOME (LOSS) TO EBITDA, ADJUSTED EBITDA, NET INCOME (LOSS) MARGIN AND ADJUSTED EBITDA MARGIN: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2024 2023 2024 2023 GAAP net income (loss) $ 717 $ 435 $ (395 ) $ 111 Adjustments: Interest expense 484 620 940 1,104 Income tax provision (benefit) 591 195 405 (107 ) Depreciation 2,786 2,846 5,438 5,801 Amortization 247 247 495 495 Non-GAAP EBITDA $ 4,825 $ 4,343 $ 6,883 $ 7,404 Stock compensation costs 998 1,016 2,055 1,736 Medical equipment reserve and disposals (1) 231 336 127 766 Management reorganization/transition costs — 72 108 72 Cooperation Agreement payment and associated legal expenses — — 649 — Certain other non-recurring costs 20 (6 ) 109 18 Non-GAAP Adjusted EBITDA $ 6,074 $ 5,761 $ 9,931 $ 9,996 GAAP Net Revenues $ 33,698 $ 31,735 $ 65,693 $ 62,105 Net Income (Loss) Margin (2) 2.1 % 1.4 % (0.6 )% 0.2 % Non-GAAP Adjusted EBITDA Margin (3) 18.0 % 18.2 % 15.1 % 16.1 % (1) Amounts represent a non-cash (recovery) expense recorded to adjust the reserve for missing medical equipment and is being (deducted) added back due to its similarity to depreciation. (2) Net Income (Loss) Margin is defined as GAAP Net Income (Loss) as a percentage of GAAP Net Revenues. (3) Non-GAAP Adjusted EBITDA Margin is defined as Non-GAAP Adjusted EBITDA as a percentage of GAAP Net Revenues. INFUSYSTEM HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (UNAUDITED) As of (in thousands, except par value and share data) June 30, 2024 December 31, 2023 ASSETS Current assets: Cash and cash equivalents $ 146 $ 231 Accounts receivable, net 21,325 19,830 Inventories, net 6,839 6,402 Other current assets 4,603 4,157 Total current assets 32,913 30,620 Medical equipment for sale or rental 6,980 3,049 Medical equipment in rental service, net of accumulated depreciation 36,262 34,928 Property & equipment, net of accumulated depreciation 4,174 4,321 Goodwill 3,710 3,710 Intangible assets, net 6,951 7,446 Operating lease right of use assets 5,845 6,703 Deferred income taxes 8,644 9,115 Derivative financial instruments 1,714 1,442 Other assets 1,334 1,581 Total assets $ 108,527 $ 102,915 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 9,940 $ 8,009 Other current liabilities 5,940 7,704 Total current liabilities 15,880 15,713 Long-term debt, net of current portion 34,165 29,101 Operating lease liabilities, net of current portion 4,995 5,799 Total liabilities 55,040 50,613 Stockholders’ equity: Preferred stock, $0.0001 par value: authorized 1,000,000 shares; none issued — — Common stock, $0.0001 par value: authorized 200,000,000 shares; 21,315,046 issued and outstanding as of June 30, 2024 and 21,196,851 issued and outstanding as of December 31, 2023 2 2 Additional paid-in capital 111,493 109,837 Accumulated other comprehensive income 1,295 1,088 Retained deficit (59,303 ) (58,625 ) Total stockholders’ equity 53,487 52,302 Total liabilities and stockholders’ equity $ 108,527 $ 102,915 INFUSYSTEM HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) Six Months Ended June 30, (in thousands) 2024 2023 OPERATING ACTIVITIES Net (loss) income $ (395 ) $ 111 Adjustments to reconcile net (loss) income to net cash provided by operating activities: Provision for doubtful accounts (194 ) 47 Depreciation 5,438 5,801 Loss on disposal of and reserve adjustments for medical equipment 316 828 Gain on sale of medical equipment (1,036 ) (1,402 ) Amortization of intangible assets 495 495 Amortization of deferred debt issuance costs 39 78 Stock-based compensation 2,055 1,736 Deferred income taxes 405 (106 ) Changes in assets - (increase)/decrease: Accounts receivable (1,203 ) (506 ) Inventories (437 ) (885 ) Other current assets (446 ) (994 ) Other assets 914 (1,719 ) Changes in liabilities - (decrease)/increase: Accounts payable and other liabilities (3,265 ) (1,183 ) NET CASH PROVIDED BY OPERATING ACTIVITIES 2,686 2,301 INVESTING ACTIVITIES Purchase of medical equipment (8,796 ) (6,994 ) Purchase of property and equipment (519 ) (494 ) Proceeds from sale of medical equipment, property and equipment 2,201 2,098 NET CASH USED IN INVESTING ACTIVITIES (7,114 ) (5,390 ) FINANCING ACTIVITIES Principal payments on long-term debt (26,744 ) (29,451 ) Cash proceeds from long-term debt 31,769 32,585 Debt issuance costs — (229 ) Common stock repurchased as part of share repurchase program (283 ) (153 ) Common stock repurchased to satisfy statutory withholding on employee stock-based compensation plans (624 ) (523 ) Cash proceeds from exercise of options and ESPP 225 829 NET CASH PROVIDED BY FINANCING ACTIVITIES 4,343 3,058 Net change in cash and cash equivalents (85 ) (31 ) Cash and cash equivalents, beginning of period 231 165 Cash and cash equivalents, end of period $ 146 $ 134

DUBLIN--( BUSINESS WIRE )--The "Global Markets for Drug-Device Combinations" report has been added to ResearchAndMarkets.com's offering. This report highlights drug-device combinations' current and future market potential and a detailed competitive environment analysis. It covers the regulatory scenario, drivers, restraints, challenges, opportunities, emerging technologies and sustainability in drug-device combinations. A combination product is a composite of two or more distinct products, called constituent parts, that are different product types. Drug-Device combination products are comprised of two or more regulated components that are physically, chemically or otherwise combined or mixed as a "single entity." Two or more separate products that are packaged together in a single package or sold as a unit are referred as "co-packaged" products. Where drugs, devices, or biological products are packaged separately, which is used to plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, this is often referred to as a "cross-labeled" combination product. These products are regulated under 21 CFR Part 3.2. The global market for drug-device combination is a rapidly expanding healthcare industry segment, encompassing products that integrate pharmaceutical drugs with medical devices to enhance treatment efficacy and patient convenience. The current report provides a comprehensive introduction and delves into the market for drug-device combinations. It examines market trends of these products, utilizing data from 2021, estimates for 2024 and projections of compound annual growth rates spanning 2024 through 2029 (forecast period) and regional markets of the drug-device combination product market. Drug-device combinations are used in drug delivery in various disease treatments. Thus, the increasing prevalence of chronic diseases is another factor driving this market. According to U.S. Census estimates, people aged 65+ will make up nearly a quarter of the U.S. population by 2060. Studies show that nearly 60% (150 million) of Americans have at least one chronic disease, and 45% (100 million) have more than one. It is estimated that by 2023, the number of chronic disease cases will increase to 230 million (42% of the total U.S. population). The report also covers market projections for 2029 and the market share for key market players. The report informs all market players, potential entrants, government agencies and other interested parties. It covers geographic regions in detail, so companies interested in expanding their geographic reach will also find this study helpful. Report Includes 40 data tables and 43 additional tables Overview of the global markets for drug-device combination (DDC) products and biological devices Analyses of global market trends, with market revenue data from 2021 to 2023, estimates for 2024, and projected CAGRs through 2029 Estimate of the current market size and revenue prospects of the global market, along with a market share analysis by product type, application (disease area), and region Facts and figures pertaining to the market dynamics, current and emerging technologies, regulations, prospects, product recalls, pipeline products, and the expected impact of macroeconomic factors Review of the industry supply chain, using the Porter's Five Forces model, to analyze the micro and macro environmental factors prevailing in the marketplace Overview of ESG developments and sustainability trends in the industry, with a focus on consumer attitudes, companies' ESG score rankings and their ESG practices An analysis of the industry structure, including companies' market shares, alliances, M&A activity and venture funding outlook Profiles of the leading market players, including Medtronic, Boston Scientific Corp., Stryker, Abbott, and BD Company Profiles 3M Abbott B. Braun Se BD Boston Scientific Corp. Johnson & Johnson Services Inc. Medtronic Smith+Nephew Stryker Terumo Corp. Key Topics Covered: Chapter 1 Executive Summary Market Outlook Scope of Report Market Summary Chapter 2 Market Overview Market Insights Regulatory Landscape Patent Review Product Recalls Product Pipeline Chapter 3 Market Dynamics Market Dynamics Snapshot Drivers Wide Range of Potential Applications of Combinations Products Growing Prevalence of Chronic Diseases Empowering Patients: Integrating Homecare Trends with Drug Delivery Advancements Restraints Device Reliability and Robustness Human Factors Testing Drug and Device Integration Accommodating Different Volumes Challenges Biological Safety Challenges in Drug-Device Combinations Regulatory Challenges Opportunities Technology advancements and Innovative Product Launches Continuous Growth Key Players Focusing on Inorganic Strategies in the Drug-Device Combination Products Market Chapter 4 Market Segmentation Analysis Segmentation Breakdown Drug-Device Combinations Market by Product Type Drug/Biologic-Device Combination Products Drug-Biologic Drug-Device Combination Products Drug, Device and Biologic Combination Products Drug-Device Combinations Market by Application Cardiovascular Diseases Metabolic Disorders Respiratory Diseases Wound Care Oncology Orthopedic Conditions Others Geographic Breakdown Drug-Device Combinations Market, by Region North America Europe Asia-Pacific Rest of the World Chapter 5 Emerging Trends and Technologies Overview AI in Drug-Device Combination Nanotechnology Computational Models and Simulation Human Organs-on-Chips: Revolutionizing Medical Research Implantable Drug Delivery Systems Wireless Implants Smart Drug Delivery Devices for 3D Printing Recent Approvals and Launch of Novel Drug-device Combination Products Chapter 6 ESG Development Introduction ESG Sustainability in Drug-Device Combinations Market ESG Risk Ratings WHO Guidelines and Global Initiatives Publisher Viewpoint Chapter 7 Competitive Landscape Company Share Analysis Mergers, Acquisitions and Collaborations Strategic Alliances Chapter 8 Appendix For more information about this report visit https://www.researchandmarkets.com/r/q8p3jg About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Strong and secure, LIQUIFIX is the first approved adhesive-based product to affix mesh without penetrating patient tissueMALVERN, Pa., March 21, 2024 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the U.S. launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices. LIQUIFIX FIX8 is indicated for minimally invasive femoral and inguinal hernia repairs; and LIQUIFIX Precision is indicated for open femoral and inguinal hernia repairs. The LIQUIFIX devices are the only FDA-approved devices that affix mesh and approximate peritoneal tissue with liquid anchors. Based on market research, there are over 1.2 million hernia procedures performed each year in the United States (U.S.), the most common being inguinal hernia repair. LIQUIFIX hernia mesh fixation devices eliminate the need for penetrating mechanical tacks, sutures, or staples by delivering a liquid adhesive that allows for precise and controlled mesh fixation. The products are designed to reduce risk of mechanical tissue trauma as they do not breach patient tissue, allowing surgeons to affix the mesh and minimize risks of complications. The LIQUIFIX products may offer greater utility for surgical mesh in inguinal hernia repair by enabling mesh fixation to sensitive areas, such as the “triangle of doom” and “triangle of pain” – regions containing sensitive arteries, veins, and nerves where traditional traumatic fixation methods could result in major vascular or nerve injuries leading to chronic pain. “Aligned with our mission to prioritize the preservation and restoration of the patient’s own anatomy, this novel device is a natural addition to our fast-growing commercial portfolio,” said Antony Koblish, President and Chief Executive Officer of TELA Bio. “We’re excited to help surgeons across the U.S. advance the future of hernia repair fixation in robotic, laparoscopic, and open cases with this atraumatic approach.” “Based on my experience, the device is easy to use and is safe and effective,” said Mr. Paul Wilson, Consultant General Surgeon, who has used LIQUIFIX in over 1500 laparoscopic hernia repairs in the United Kingdom (U.K.). “The fixation strength is very impressive. I have seen a significant benefit to the patient, with a major reduction in both acute post-op pain and chronic pain after surgery. This has been a game-changer for me.” LIQUIFIX products are manufactured by U.K.-based Advanced Medical Solutions Limited (AMS), a world-leading specialist in tissue-healing technologies. AMS entered into an agreement with TELA Bio in 2023 to commercialize the LIQUIFIX products in the U.S., leveraging the company’s rapidly expanding hernia repair specialty salesforce and its focus on new technologies. “Given the consistent strong performance of the LIQUIFIX products in Europe and other international markets over the past three years, we look forward to working with TELA Bio to grow adoption in the U.S.,” said Chris Meredith, Chief Executive Officer of AMS. To learn more, visit liquifix.liquiband.com About TELA Bio, Inc.TELA Bio, Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient's own anatomy. The Company is committed to providing surgeons with advanced, economically effective soft-tissue reconstruction solutions that leverage the patient's natural healing response while minimizing long-term exposure to permanent synthetic materials. For more information, visit www.telabio.com. About LIQUIFIX™ Devices Indications for UseThe LIQUIFIX FIX8™ device is intended for use in laparoscopic surgical repair of groin (femoral and inguinal) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall and the approximation of the peritoneum. The LIQUIFIX Precision™ Open Hernia Mesh Fixation device is intended for use in open surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall. Contraindications The LIQUIFIX FIX8™ and LIQUIFIX Precision™ devices are not intended for use when prosthetic material fixation is contraindicated. Do not use on patients with a hypersensitivity to cyanoacrylate adhesives, formaldehyde or D&C Violet No. 2 dye. Do not use for the fixation of meshes constructed with polytetrafluoroethylene (PTFE) or materials other than polypropylene or polyester. Do not use the devices for closure or fixation of cerebral tissues, blood vessels or peripheral nerves. Relevant Warnings The use of LIQUIFIX is limited to those healthcare providers who are qualified to perform laparoscopic and open hernia repairs. A thorough understanding of the operating principles, risks versus benefits, and hazards involved in utilizing an endoscopic approach or surgical approach is necessary to avoid possible hazards to the user and/or patient. It is recommended that any healthcare provider who intends to use LIQUIFIX read the instructions for use in full, including directions, precautions, and warnings. Accidental bonding of unwanted tissue may occur due to misapplication of adhesive. Potential Adverse Effects of the Device on HealthAs with the majority of implanted devices, adverse reactions associated with the use of this device may include transient local irritation at the implant site and a transitory inflammatory foreign body response. Advanced Medical Solutions has determined the potential adverse effects (e.g. complications) listed below may be associated with the use of the LIQUIFIX device. These potential adverse events include, but are not limited to, the following: Toxic reactionAllergic reaction Reference the LIQUIFIX FIX8™ Laparoscopic Hernia Mesh Fixation Device and LIQUIFIX Precision™ Open Hernia labeling for Additional Important Safety Information. Caution Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of TELA's management, including with respect to the launch of LIQUIFIX Non-Penetrating Fixation products. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others the impact to our business from macroeconomic conditions, including the impact of pandemics or epidemics, recessionary concerns, banking instability, and inflationary pressures, potentially impacting our ability to market our products, demand for our products due to the deferral of elective procedures, the labor and staffing environment in the healthcare industry, disruption in our supply chain, or pricing pressures concerning our products or the procedures using our products; our ability to achieve or sustain profitability; our ability to gain market acceptance for our products and to accurately forecast and meet customer demand; our ability to compete successfully; that data from earlier studies related to our products and interim data from ongoing studies may not be replicated in later studies or indicative of future data; that data obtained from clinical studies using our product may not be indicative of outcomes in other surgical settings; our ability to enhance our product offerings; development and manufacturing problems; capacity constraints or delays in production of our products; maintenance of coverage and adequate reimbursement for procedures using our products; product defects or failures. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and TELA assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. Investor ContactGreg Chodaczek347-620-7010ir@telabio.com Media ContactLisa Novy-Wikowski484-354-6782lnovywikowski@telabio.com