SUZHOU, China, March 26, 2026 /PRNewswire/ — Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced its annual results for the year ended December 31, 2025 on March 25, 2026….
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Humacyte, Inc. Announces Pricing of $20 Million Registered Direct Offering of Common Stock
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WallabyPhenox Restructures Debt and Accelerates Global Growth
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InspireMD Reports Fourth Quarter and Full Year 2025 Financial Results
MIAMI, March 18, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced financial and operating results for the fourth quarter and year ended December 31, 2025.
Kestra Medical Technologies Reports Third Quarter Fiscal 2026 Financial Results
KIRKLAND, Wash., March 17, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, today reported financial results for the third quarter fiscal 2026, which ended January 31, 2026. Financial Highlights Generated revenue of $24.6 million in Q3 FY26, an increase of 63% compared to the prior year period.Expanded gross margin to 52.6% in Q3 FY26 compared to 43.4% in the prior year period.Increased FY26 revenue guidance to $93 million, representing growth of 55% compared to FY25. “Kestra delivered another strong quarter of financial performance, generating revenue growth of 63% while expanding gross margin to over 52%,” said Brian Webster, President and CEO. “We also continued to execute on several key operational objectives, including rapid growth of the commercial organization, release of compelling primary results from our FDA post-approval study, fortification of our balance sheet with an equity offering, and entrance into a strategic collaboration with Biobeat Technologies. As we progress on our journey to category leadership, our team remains focused on growing the wearable defibrillator market and executing on our commitments to patients and their prescribers.” Third Quarter Fiscal 2026 Financial Results Total revenue was $24.6 million, an increase of 63% compared to the prior year period. 5,462 prescriptions were written for the ASSURE® system, an increase of 58% compared to the prior year period.Revenue growth was driven by higher market share and wearable cardioverter defibrillator (WCD) market expansion. Revenue also benefited from a higher mix of in-network patients and improvements in revenue cycle management capabilities. Gross profit was $12.9 million compared to $6.5 million in the prior year period. Gross margin expanded to 52.6% compared to 43.4% in the prior year period, driven by volume leverage, a higher mix of in-network patients and cost improvement programs. GAAP operating expenses were $47.7 million and included $1.5 million of non-recurring costs. GAAP operating expenses were $27.1 million in the prior year period. Excluding non-recurring costs and share-based compensation expense, operating expenses were $36.1 million in Q3 FY26 compared to $24.8 million in Q3 FY25. The increase was attributable to growth in expenses related to accelerated commercial expansion and public company costs. GAAP net loss and comprehensive loss was $34.2 million compared to GAAP net loss and comprehensive loss of $21.8 million in the prior year period. Adjusted EBITDA* loss was $21.2 million compared to an adjusted EBITDA loss of $16.3 million in the prior year period. Cash and cash equivalents totaled $291 million as of January 31, 2026. Cash and cash equivalents includes the net proceeds Kestra received from an underwritten public offering of 6.9 million common shares, which closed on December 4, 2025. *Adjusted EBITDA is a non-GAAP financial measure. See “Use of Non-GAAP Financial Measures” below for additional information. A reconciliation of Adjusted EBITDA to the most directly comparable GAAP measure is included in this press release. Fiscal Year 2026 Revenue GuidanceKestra is increasing its FY26 revenue guidance to $93 million, which would represent growth of 55% compared to FY25. This compares to prior FY26 revenue guidance of $91 million and initial FY26 guidance of $85 million. Webcast and Conference CallKestra will host a conference call today at 4:30 p.m. ET to discuss financial results. A live and archived webcast of the event will be available in the “Events” section of the investor relations website. Use of Non-GAAP Financial MeasuresThis press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including Adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Kestra’s financial measures presented in this press release that are calculated and presented in accordance with GAAP. Adjusted EBITDA, which is calculated as net income (loss), as adjusted to exclude other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, share-based compensation expense, and non-recurring expenses, is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate the Company’s performance for both strategic and annual operating planning. Management believes that in order to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of Adjusted EBITDA, in addition to considering the Company’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of our ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare our period-over-period results. The non-GAAP financial measures used by Kestra may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Kestra’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of Adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of March 17, 2026. Statements in this press release and on the related teleconference that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects; and expectations for our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Kestra’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; risks and uncertainties related to market conditions; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025 and other filings filed or to be filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. About KestraKestra Medical Technologies, Ltd. is a leading wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except share and per share amounts)(unaudited) Three Months EndedJanuary 31, Nine Months EndedJanuary 31, 2026 2025 2026 2025 Revenue $24,552 $15,090 $66,488 $42,582 Cost of revenue 11,646 8,543 33,307 26,005 Gross profit 12,906 6,547 33,181 16,577 Operating expenses: Research and development 4,972 3,353 13,850 10,266 Selling, general and administrative 42,699 23,795 114,728 64,477 Total operating expenses 47,671 27,148 128,578 74,743 Loss from operations (34,765) (20,601) (95,397) (58,166)Other expense (income): Interest expense 1,888 1,783 5,702 5,974 Interest income (2,163) (628) (6,125) (1,543)Other expense (income) (359) (15) (2,299) 73 Net loss before provision for income taxes (34,131) (21,741) (92,675) (62,670)Provision for income taxes 35 18 102 33 Net loss and comprehensive loss (34,166) (21,759) (92,777) (62,703)Net loss attributable to non-controlling interest — (250) — (942)Net loss and comprehensive loss attributable to Kestra Medical Technologies, Ltd. (34,166) (21,509) (92,777) (61,761)Less: Undeclared preferred stock dividends — 3,324 — 9,030 Net loss attributable to common shareholders, basic and diluted $(34,166) $(24,833) $(92,777) $(70,791) Net loss per share attributable to common shareholders, basic and diluted $(0.61) $(1.25) $(1.76) $(3.56)Weighted-average shares of common shares outstanding, basic and diluted 55,848,413 19,885,382 52,843,097 19,885,382 RECONCILIATION OF GAAP NET LOSS AND COMPREHENSIVE LOSS TO ADJUSTED EBITDA(in thousands)(unaudited) Three Months EndedJanuary 31, Nine Months EndedJanuary 31, 2026 2025 2026 2025 GAAP Net loss and comprehensive loss $(34,166) $(21,759) $(92,777) $(62,703)Non-GAAP Adjustments: Interest expense 1,888 1,783 5,702 5,974 Interest income (2,163) (628) (6,125) (1,543)Other expense (income) (359) (15) (2,299) 73 Provision for income taxes 35 18 102 33 Depreciation expense 1,984 1,888 6,384 6,132 Share-based compensation expense 10,108 459 23,340 1,958 Non-recurring expenses 1,482 1,927 5,396 1,927 Adjusted EBITDA $(21,191) $(16,327) $(60,277) $(48,149) KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share and per share amounts)(unaudited) January 31, April 30, 2026 2025 Assets Current assets Cash and cash equivalents $291,321 $237,595 Accounts receivable, net 12,709 8,081 Disposable medical equipment supplies 6,829 6,572 Prepaid expenses and other current assets 3,204 3,080 Total current assets 314,063 255,328 Right-of-use assets 3,419 2,078 Deposits 1,847 2,021 Restricted cash 334 334 Property and equipment, net 53,799 34,830 Other long-term assets 5,880 1,153 Total assets $379,342 $295,744 Liabilities and Shareholders’ Equity Current liabilities Accounts payable $24,023 $23,961 Accrued liabilities 18,898 13,829 Operating lease liabilities, current portion 10 187 Total current liabilities 42,931 37,977 Operating lease liabilities, net of current portion 4,276 3,026 Warrant liabilities 1,745 8,097 Other long-term liabilities 140 140 Long-term debt, net 42,261 41,098 Total liabilities 91,353 90,338 Commitments and contingencies Shareholders’ equity Common Shares, $1.00 par value; 100,000,000 shares authorized as of January 31, 2026 and April 30, 2025; 58,349,053 issued and outstanding as of January 31, 2026 and 51,348,656 shares issued and outstanding as of April 30, 2025 58,349 51,349 Additional paid-in capital 842,666 674,306 Accumulated deficit (613,026) (520,249)Total shareholders’ equity 287,989 205,406 Total liabilities and shareholders’ equity $379,342 $295,744 KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands)(unaudited) Nine Months EndedJanuary 31, 2026 2025 Cash flows from operating activities Net loss $(92,777) $(62,703)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 6,384 6,132 Loss on disposal of property and equipment 727 882 Reserve for lost equipment and supplies 1,600 647 Provision for uncollectible accounts receivable 1,515 1,883 Interest paid-in-kind — 703 Amortization of debt discounts and issuance costs 1,406 1,031 Share-based compensation expense 23,340 1,958 Non-cash lease expense 273 330 Change in fair value of warrant liabilities (2,297) — Changes in operating assets and liabilities: Disposable medical equipment supplies (466) (2,823)Prepaid expenses and other current assets 421 (431)Accounts receivable (6,143) (7,814)Accounts payable (647) 3,665 Accrued liabilities 4,192 2,730 Operating lease liabilities (541) 228 Other long-term assets 30 30 Net cash used in operating activities (62,983) (53,552)Cash flows from investing activities Purchases of property and equipment (25,228) (15,547)Deposits for medical rental equipment (527) (627)Refund of deposits for medical rental equipment 184 270 Investment in equity security (5,000) — Net cash used in investing activities (30,571) (15,904)Cash flows from financing activities Proceeds from issuance of common stock 149,291 — Payment of equity issuance costs (1,986) (3,293)Deemed dividend for payments to third party on behalf of shareholder (25) (1,648)Proceeds from issuance of redeemable preferred stock — 103,400 Proceeds from issuance of stock to non-controlling interest — 17,100 Net cash provided by financing activities 147,280 115,559 Net increase in cash, cash equivalents and restricted cash 53,726 46,103 Cash, cash equivalents and restricted cash Beginning of period 237,929 8,583 End of period $291,655 $54,686 CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
Field Medical Names Mark A. Turco, MD, as Chief Executive Officer
CARDIFF-BY-THE-SEA, Calif., March 16, 2026 /PRNewswire/ — Field Medical, Inc., a clinical-stage medical technology company advancing second-generation pulsed field ablation (PFA) solutions for complex ventricular and atrial arrhythmias, today announced the appointment of Mark A. Turco,…
Unnatural Products Raises $45 Million Series B Financing to Advance Macrocyclic Peptide Therapeutics
Financing led by The Venture Collective with participation from Merck Global Health Innovation Fund, Artis Ventures, First Spark Ventures, argenx, Droia Ventures and existing investorsSANTA CRUZ, Calif., March 16, 2026 (GLOBE NEWSWIRE) — Unnatural Products, a biotech developing orally-delivered macrocyclic peptides to address previously undruggable targets, today announced the closing of a $45 million Series B financing led by The Venture Collective (TVC), with participation from argenx, Droia Ventures and existing investors Merck Global Health Innovation Fund, Artis Ventures, and First Spark Ventures. The funding will support development of the company’s proprietary drug discovery platform and advance its pipeline of macrocyclic peptide therapeutics designed to address historically difficult-to-drug or “undruggable” targets. Last month, Unnatural Products announced a licensing agreement with Novartis to develop macrocyclic peptide therapeutics for historically undruggable cardiovascular targets, including up to $100 million upfront and up to $1.7 billion in total potential milestones. “Macrocyclic peptides represent a powerful new therapeutic modality,” said Cameron Pye, Chief Executive Officer and Co-Founder, Unnatural Products. “Our platform unlocks the precision of biologics with the delivery advantages of small molecules, enabling us to target complex intracellular pathways that have historically been out of reach. We can also provide oral solutions to targets only currently addressable with costly injectables. This financing allows us to accelerate development of our pipeline and advance our lead programs toward the clinic.” “Unnatural Products has developed a differentiated platform capable of unlocking new therapeutic opportunities across challenging disease targets,” said Nicholas Shekerdemian, Founding Partner, The Venture Collective. “We believe the company’s approach to engineering synthetic macrocyclic peptides has the potential to create an important new class of medicines, and we are excited to support the team as they expand their pipeline and move programs toward clinical development.” Unnatural Products has developed an integrated discovery platform capable of repeatedly engineering synthetic macrocyclic peptides at scale. Macrocyclic peptides combine key attributes of both biologics and small molecules, enabling highly selective binding while retaining the potential for cell permeability and oral delivery. The company’s platform integrates advanced computational design, automated chemistry, and high-throughput biological testing to rapidly move from initial discovery hits to optimized drug candidates. The company is also advancing a pipeline of macrocyclic peptide therapeutics for the treatment of cardiometabolic, inflammatory and immunological diseases. Unnatural Products has also established collaborations with leading pharmaceutical and biotechnology companies including Novartis, Merck, BridgeBio and argenx to apply its macrocyclic platform across multiple therapeutic areas. About Unnatural Products, Inc.Unnatural Products, Inc. (UNP), a Santa Cruz, California biotech company, has developed a platform that addresses the complexities of medicinal chemistry in the macrocycle space through a combination of parallel experimentation and machine learning. Founded by macrocycle pioneers whose academic work uncovered how Nature’s macrocycles work, UNP is developing a portfolio of therapeutic macrocycles against high-value and traditionally difficult-to-drug targets. For more information, visit www.unnaturalproducts.com. For partnering opportunities, email: contact@unnaturalproducts.com.Media ContactKimberly HaKKH Advisors917-291-5744kimberly.ha@kkhadvisors.com
HeartBeam Reports Fourth Quarter and Full Year 2025 Results
HeartBeam Enters New Growth Phase Following FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment First Commercial Partner ClearCardio™ to Bring HeartBeam’s 3D ECG Technology to High-Growth Preventive Cardiology Market First Patients Enrolled in Heart Attack Detection Pilot Study, A Key Step Toward Future FDA Indication Expansion […]
XCath Secures $30 Million Series C to Improve Global Outcomes in Neurovascular Care
HOUSTON–(BUSINESS WIRE)–XCath, a medical device company pioneering neuro-endovascular surgical robotics, announced today that it has secured $30 million in Series C funding, bringing the total raised since the company’s inception to $92 million. The round was co-led by Crescent Enterprises and by Dr. Fred Moll, Chairman of the XCath Board of Directors. These latest funds will support XCath’s ongoing efforts to bring the world’s first commercially-practical endovascular robot to the market and
Orchestra BioMed Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update
$106.5 million cash position as of December 31, 2025 to be further enhanced by $35 million expected from Medtronic and Ligand in Q2 2026 from previously announced transactions, as well as Haemonetics’ Vivasure acquisition proceeds$33.5 million in 2025 non-recurring revenue primarily driven by impact of new Virtue SAB agreement with Terumo that was announced in October 2025Strong balance sheet supports focused execution of pivotal trials for both AVIM Therapy and Virtue SAB programs NEW HOPE, Pa., March 12, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today reported its full year 2025 financial results and provided a fourth quarter business update. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We are very proud of our significant clinical, strategic and financing accomplishments in 2025. We are now in an excellent financial and operational position to achieve upcoming value-driving milestones for both of our pivotal stage programs. In the second half of 2025, we leveraged our partnership-driven business model to substantially strengthen our financial position with nearly $150 million in new capital and capital commitments, including strategic transactions with Medtronic, Ligand and Terumo. With a strong balance sheet in place, we are fully focused on driving pivotal trial execution for both AVIM Therapy and Virtue SAB, high impact therapies designed to address major unmet needs in large, established global procedure markets.” Hochman continued, “As we enter 2026 with two pivotal trials underway, we remain focused on disciplined execution and long-term value creation for patients, clinicians and shareholders. We are encouraged by the accelerated pace of enrollment in the BACKBEAT global pivotal study following protocol amendments implemented in the fourth quarter and we plan to provide a substantive update in our next quarterly report. We are also pleased with the early progress of the Virtue Trial, which we initiated during the fourth quarter of 2025. We expect to provide additional updates on this trial, which is randomizing coronary in-stent restenosis patients to treatment with Virtue SAB versus the AGENT™ paclitaxel-coated balloon, as we gain further visibility into enrollment trends over the course of the year.” Q4 2025 and Recent Business Highlights: Accelerated patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in patients indicated for a pacemaker.Initiated patient enrollments in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”).Entered into an agreement with Terumo (“ROFR Agreement”) pursuant to which we and Terumo terminated our distribution agreement, and Orchestra BioMed granted Terumo a right of first refusal (the “ROFR”) with respect to certain strategic transactions relating to Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) for the treatment of coronary artery disease globally in exchange for a fee of $10.0 million. In connection with the ROFR Agreement, Terumo invested an additional $20.0 million in Orchestra BioMed through a new series of non-voting convertible preferred stock (the “Series A Preferred Stock”), which is convertible into common stock in the future, subject to certain conditions, at a minimum of $12 per share.Up to $21 million in total proceeds expected in connection with the acquisition of Vivasure Medical, previously a strategic holding of Orchestra BioMed, by Haemonetics. Orchestra BioMed expects to receive up to $10.7 million of these proceeds in 2026, including an initial upfront payment of $4.7 million received in January 2026 and the remainder expected later in the year as a first-milestone payment. The Company may receive additional proceeds in the future associated with potential revenue earnouts. Financial Results for the Year Ended December 31, 2025 Revenue for 2025 was $33.5 million, compared with $2.6 million for 2024, which represents an increase of 1,539%. The increase is primarily due to recognizing the remainder of the deferred revenue from our prior distribution agreement with Terumo of $15.4 million as a result of the termination of that agreement, $10.0 million in consideration for the ROFR, and $7.4 million associated with the premium paid above the fair market value of the Series A Preferred Stock.Research and development expenses for 2025 were $58.2 million, compared with $42.8 million for 2024, which represents an increase of 36%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for 2025 were $26.9 million, compared with $23.9 million for 2024, which represents an increase of 12%. The increase was primarily due to an increase in professional fees.Net loss attributable to common stockholders for 2025 was $52.7 million, or ($1.11) per share, compared with a net loss attributable to common stockholders of $61.0 million, or ($1.66) per share, for 2024 which represents a decrease of 14%. Net loss attributable to common stockholders for the year-ended 2025 included non-cash stock-based compensation expense of $12.0 million, compared with $10.6 million for the same period in 2024, representing an increase of 13%.Net cash used in operating activities and for the purchase of fixed assets excluding the payment for the ROFR and the Series A Preferred Stock premium, which was recognized as revenue, was $66.9 million during 2025, compared with $50.8 million for 2024, with the primary driver of this increase being increased cash outflows for research and development, including clinical trial activities, during 2025.Cash and cash equivalents and Marketable securities totaled $106.5 million as of December 31, 2025. The Company has commitments from Ligand and Medtronic to receive a combined $35.0 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties and subject to the conditions therein. Additionally, in January 2026, Haemonetics closed on the acquisition of Vivasure in which we expect to receive up to $10.7 million of proceeds in 2026, consisting of an upfront payment of approximately $4.7 million, which has already been received, and approximately $6.0 million expected to be received in a first milestone payment. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the proceeds expected to be received by the Company pursuant to the achievement of certain milestones in connection with the acquisition of Vivasure by Haemonetics; and the timing of any update on anticipated enrollment completion and potential primary endpoint results with respect to the BACKBEAT global pivotal study as well as the provision of any update on the Virtue Trial. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026.The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Balance Sheets(in thousands, except share and per share data)(unaudited) December 31, December 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $34,690 $22,261 Marketable securities 71,822 44,551 Accounts receivable, net 95 92 Inventory 310 173 Prepaid expenses and other current assets 994 2,094 Total current assets 107,911 69,171 Property and equipment, net 1,715 1,384 Right-of-use assets 1,496 2,103 Strategic investments 2,495 2,495 Deposits and other assets 1,240 1,020 TOTAL ASSETS $114,857 $76,173 LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $6,095 $5,134 Accrued expenses and other liabilities 9,890 6,084 Operating lease liability, current portion 751 550 Deferred revenue, current portion — 4,439 Total current liabilities 16,736 16,207 Deferred revenue, less current portion — 10,989 Royalty purchase agreement 16,482 — Loan payable 14,268 14,292 Derivative liability 2,749 — Operating lease liability, less current portion 936 1,687 Other long-term liabilities 308 40 TOTAL LIABILITIES 51,479 43,215 Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at December 31, 2025 and 0 issued and outstanding at December 31, 2024; aggregate liquidation preference of $20,000 at December 31, 2025 9,808 — STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value, 10,000,000 shares authorized; — — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 57,032,963 and 38,194,442 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively. 6 4 Additional paid-in capital 416,083 342,780 Accumulated other comprehensive income 60 52 Accumulated deficit (362,579) (309,878)TOTAL STOCKHOLDERS’ EQUITY 53,570 32,958 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $114,857 $76,173 ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited) Year Ended December 31, 2025 2024 Revenue: Partnership revenue $32,871 $2,005 Product revenue 611 633 Total revenue 33,482 2,638 Expenses: Cost of product revenues 190 204 Research and development 58,185 42,804 Selling, general and administrative 26,914 23,931 Total expenses 85,289 66,939 Loss from operations (51,807) (64,301)Other (expense) income: Interest (expense) income, net (1,148) 3,356 Change in the fair value of derivative liability 254 — Loss on fair value of strategic investments — (68)Other expense — (11)Total other (expense) income (894) 3,277 Net loss (52,701) (61,024)Adjustment to carrying value of Series A Preferred Stock (254) — Net loss attributable to common stockholders $(52,955) $(61,024) Net loss attributable to common stockholders per share Basic and diluted $(1.11) $(1.66)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted 47,747,078 36,821,042 Comprehensive loss Net loss $(52,701) $(61,024)Unrealized gain on marketable securities 8 62 Comprehensive loss $(52,693) $(60,962)



