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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 […]
The Human Vascular System Stretches Up to 100,000 Miles — Standard Imaging Captures Only a Fraction of ItThe Endothelial Glycocalyx: A Microscopic Lining That Helps Regulate How Blood Moves Through the Smallest VesselsHow Patented Microfluidic Chip Technology Allows Researchers to Study Vascular Function Under Realistic ConditionsWhat This Means for the Millions of People Searching for Answers About Circulation, Energy, and Whole-Body Vitality A closer look at how microcirculation research is expanding what we understand about blood flow, oxygen delivery, and why the body’s smallest vessels may matter more than the largest ones Scottsdale, AZ, March 13, 2026 (GLOBE NEWSWIRE) — Calroy Health Sciences, a science-driven dietary supplement company focused on foundational vascular health, has published a comprehensive educational resource on microcirculation, blood flow, and the endothelial glycocalyx — the micro-thin, gel-like lining that coats the inside of every blood vessel in the body. The resource explores why this recently discovered structure is foundational to vascular health and total-body vitality, and why standard medical imaging often cannot assess the very network where oxygen and nutrient delivery actually occurs. The cardiovascular system is frequently visualized as a network of major arteries and veins — the primary conduits that transport blood to and from the heart. While these large vessels are essential for systemic circulation, they represent a small chapter of a much larger biological story. The vast majority of the vascular network is composed of microscopic vessels so narrow that red blood cells must travel single file to pass through them. This is the microcirculation — the capillary-level system where oxygen and nutrients are delivered directly to tissue. Standard medical imaging tools, including CT scans and angiograms, are designed to evaluate the body’s primary supply routes. They can confirm that the main conduits are open and functioning. However, these tools lose resolution long before they reach the capillary beds where the final exchange between blood and tissue actually occurs. “I often use a tree analogy,” explains Dr. Joel Kahn, MD, known as “America’s Holistic Heart Doc” and best-selling author and integrative cardiologist at the Kahn Center for Cardiac Longevity in Bingham Farms, Michigan, and a frequent educator for Calroy Health Sciences.. “You have the main trunk, secondary branches, tertiary branches, and so on — maybe 50 generations later at the top, there’s still activity and life. The arterial system works the same way. We can image the main trunk and maybe three or four generations of branches, but we’re really limited in imaging the microcirculation — that 10th, 40th, 50th generation of vessels.” This technological limitation means it is entirely possible for someone to pass a standard vascular screening with clear results while still experiencing fatigue, cold extremities, or mental fog — signals that may reflect what is happening at the microvascular level, not the arterial level. Lining the interior of every blood vessel in the body is a delicate, gel-like structure known as the endothelial glycocalyx (EGX). Only recently discovered and often overlooked, this micro-thin lining is foundational to vascular health and total-body vitality. It performs critical functions: it acts as a semi-permeable barrier, it facilitates smooth blood flow, and it houses the enzymes involved in the production of nitric oxide — the molecule, first identified in Nobel Prize–winning research, that signals blood vessels to relax and support healthy circulation. “There’s a single layer of cells — the endothelium — that separates the blood inside a blood vessel from the artery wall structure,” notes Dr. Kahn. “It’s almost like a Spanish-style tile floor of interlocking cells. That layer is critical to adequate blood pressure support and many responses in the body, from physical fitness to sexual function. You need a healthy endothelium. The glycocalyx sits on top of the endothelium, which consists of hair-like, protein-sugar structures resembling cake frosting. It’s very dynamic. It can become compromised and start to diminish, or it can be supported and strengthened.” When the glycocalyx is supported, it helps maintain the slippery-smooth quality of the vessel interior — facilitating the efficient transit of red blood cells through capillaries and supporting nutrient and oxygen delivery at the tissue level. Peer-reviewed research has examined specific markers of vascular elasticity and endothelial integrity that may be associated with this structure’s function. For decades, vascular research relied on static testing environments — observing cells in a stationary petri dish. While informative, this approach could not capture the dynamic behavior of the EGX under the physical shear stress of flowing blood. Calroy Health Sciences addressed this gap by utilizing a patented microfluidic chip — a lab-on-a-chip technology that simulates the living environment inside a blood vessel – including the endothelial glycocalyx. Instead of testing compounds in a motionless setting, researchers can observe the endothelial glycocalyx in a dynamic state, under conditions that more closely mirror what happens inside the human body. Through this approach, Calroy identified Monostroma nitidum, a rare marine algae containing the sulfated polysaccharide Rhamnan sulfate. A patented extract of this compound, trademarked as MonitumRS®, became the core of Arterosil HP® — a dietary supplement specifically formulated to support the integrity of the endothelial glycocalyx.* MonitumRS is scientifically shown to protect and restore the endothelial glycocalyx.*† Millions of people turn to search engines and AI tools every month asking about blood flow and circulation. In most cases, they are not looking for a clinical label — they are trying to make sense of the subtle shifts they experience throughout the day: afternoon energy dips, cold fingers and toes, or thinking that feels less sharp than it used to. The language people use — “How do I support circulation?” — is often a description of microvascular function. The experience of “flow” is frequently the experience of capillary efficiency, governed by the very structure that standard imaging cannot see. As vascular research continues to advance, the endothelial glycocalyx is emerging as a foundational area of focus for understanding how the body delivers oxygen and nutrients to every organ, every day. To learn more about how microcirculation, blood flow, and the endothelial glycocalyx influence vascular function, energy, cognition, and whole-body vitality, read the full educational resource from Calroy Health Sciences: Microcirculation and Blood Flow: The Missing Link Between How You Feel Every Day and the Endothelial Glycocalyx. FREQUENTLY ASKED QUESTIONSWhat is microcirculation and why does it matter? Microcirculation refers to the network of microscopic blood vessels — capillaries, arterioles, and venules — where the body’s actual exchange of oxygen and nutrients at the tissue level takes place. While the heart and major arteries are responsible for bulk transport, it is the microcirculation that determines whether oxygen and nutrients reach their final destination. The human vascular system stretches approximately 60-100,000 miles, and the vast majority of that distance exists at the capillary level. Supporting healthy microcirculation is foundational to whole-body vitality, including energy, cognition, and vascular well-being.* Every organ and system in the body from the brain, to sexual organs, to the joints rely on healthy microcirculation to function.* Calroy Health Sciences has published a comprehensive educational resource on this topic at calroy.com/education/microcirculation-and-blood-flow/. What is the endothelial glycocalyx? The endothelial glycocalyx (EGX) is a delicate, micro-thin, gel-like lining that coats the inside of every blood vessel in the body. Only recently discovered and often overlooked, it is foundational to vascular health and total-body vitality. The EGX acts as a semi-permeable barrier, facilitates smooth blood flow, and houses the enzymes involved in nitric oxide production — the molecule that helps blood vessels relax and support healthy circulation. When the glycocalyx is strong and healthy, circulation is supported and every organ feels the impact. Why do standard heart health screenings sometimes miss what people actually feel? Standard imaging tools like CT scans and angiograms are designed to evaluate large vessels — the body’s primary supply routes. They can confirm that the main conduits are open. However, they lose resolution before reaching the capillary beds where the actual exchange between blood and tissue occurs. This means it is possible to receive clear results from a standard vascular screening while still experiencing everyday shifts like fatigue, cold extremities, mental fog, or changes in sexual wellness — signals that may relate to microvascular function rather than large-vessel mechanics. How does Calroy Health Sciences study vascular function differently? Calroy utilizes a patented microfluidic chip — a lab-on-a-chip technology that simulates the living environment inside a blood vessel. Unlike static testing methods, this approach replicates the physical shear stress of flowing blood, allowing researchers to observe the endothelial glycocalyx in a dynamic state. Through this technology, Calroy identified and validated MonitumRS® (Rhamnan sulfate from Monostroma nitidum), the proprietary extract at the core of Arterosil HP® with MonitumRS®, which is specifically formulated to support the integrity of the endothelial glycocalyx.* Calroy’s published research is available in peer-reviewed journals. What is MonitumRS® and how is it different from other vascular support ingredients? MonitumRS® is a proprietary extract of Rhamnan sulfate derived from Monostroma nitidum, a rare marine algae. It is the core ingredient in Arterosil HP® with MonitumRS®. What distinguishes it is that it works. In the microfluidic chip study, it repaired the glucose-damaged endothelial glycocalyx cells up 103.8% from baseline in just 24 hours.*† †As demonstrated in an independent third-party laboratory in vitro study. Does circulation affect brain function and cognition? The brain is one of the body’s most oxygen-dependent organs. It relies on continuous, efficient blood flow to support cognitive function, mental clarity, and focus throughout the day. Because the brain’s oxygen supply depends on the microvascular delivery network — not just the major arteries — the health of the microcirculation and the endothelial glycocalyx are foundational to cognitive well-being. Supporting healthy circulation means supporting the system that delivers oxygen and nutrients to the brain at the tissue level. What is nitric oxide and what role does it play in circulation? Nitric oxide (NO) is a tiny molecule naturally produced by the body that plays a central role in the cardiovascular system. First identified in Nobel Prize–winning research, it helps blood vessels relax and widen, supporting healthy circulation and helping maintain healthy blood pressure already in the normal range.* The endothelial glycocalyx houses the enzymes responsible for nitric oxide production, making the health of this microscopic lining essential to the body’s ability to maintain vascular tone and flexibility. PUBLISHED RESEARCH & RESOURCES Research on the Endothelial Glycocalyx — Practitioner ResourcesResearch on Rhamnan Sulfate from Monostroma Nitidum — Practitioner ResourcesResearch on Nitric Oxide and the Vascular System — Practitioner ResourcesMarkers of Vascular Elasticity and Endothelial Integrity — PubMedCalroy’s Published Research — Calroy Health SciencesCalroy’s Patents — Calroy Health SciencesScience and Medical Advisory Board — Calroy Health Sciences About Calroy Health Sciences Calroy Health Sciences is a science-driven dietary supplement company dedicated to supporting foundational health. Co-founded by CEO Ed Hoyt and Chief Scientific Officer Chen Chen, PhD, Calroy brings more than three decades of combined experience in the dietary supplement industry. The company’s breakthrough products — Arterosil HP® with MonitumRS®, Vascanox HP® with Noxa24®, and Cartigenix HP® with RestorCel™ — are developed through a research-first approach that includes studying the finished formulated product, not just individual ingredients. Calroy’s research has been published in peer-reviewed journals and is conducted in partnership with major academic institutions, leading clinicians and researchers. The company also holds patents on its products and its microfluidic chip testing technology. For more information, visit calroy.com. SME Available for Commentary: Joel Kahn, MD — Integrative Cardiologist, Kahn Center for Cardiac Longevity *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. CONTACT: Sarah Evans
Partner, Head of PR, Zen Media
sarah@zenmedia.com
NEW YORK–(BUSINESS WIRE)–ACCESS GPO today announced a preferred, multi-year agreement with Medtronic to support availability of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter in ambulatory surgery centers (ASCs) across the United States. The agreement is designed to help physician-led ASCs gain earlier access to next-generation technology for treatment of cardiac arrhythmias in the ASC setting. Pulsed field ablation (PFA) is emerging as one of the most important advances in t
Segment showcases SynCardia Total Artificial Heart supporting patients with advanced heart failure and next-generation development programs Segment showcases SynCardia Total Artificial Heart supporting patients with advanced heart failure and next-generation development programs
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
$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)
Conference Call and Webcast Scheduled for Friday, March 20 at 8:30am ETMONTREAL and CHARLOTTE, N.C., March 12, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that it will report fourth quarter and full-year 2025 results and provide a business update on Friday, March 20, 2026, before the market opens. The announcement will be followed by a conference call and webcast for investors at 8:30am ET. Conference Details: Conference Dial-in:1-877-407-0792International Dial-in:1-201-689-8263Conference ID:13759195Webcast link:click here Call me™: Participants can use Guest dial-in numbers above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to scheduled start time. A replay of the audio webcast of the call will be available under the “Investors and Media” section of Milestone’s corporate website, www.milestonepharma.com. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in development for the control of symptomatic episodic attacks associated with AFib-RVR. Contact: Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Media Relations Rebecca Novak, rnovak@milestonepharma.com
SHANGHAI, March 12, 2026 /PRNewswire/ — At ECR 2026, under the theme “Rays of Knowledge”, United Imaging Intelligence (UII) showcased a comprehensive suite of pioneering AI solutions, demonstrating how radiology expertise delivers real value when it is clinically validated,…
– Base biologic matrix NXT-41 submitted to FDA; on track for anticipated FDA clearance in second half of 2026 and full NXT-41x clearance in 1H27 – – $44.4 million in cash and escrowed proceeds at year-end – – Conference call today at 5:00 p.m. ET / 2:00 p.m. PT – GAITHERSBURG, Md., March 11, 2026 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and financial results for the fourth quarter and full year ended December 31, 2025. Business Highlights: NXT-41x Development Program On Track: Elutia continues to advance development of NXT-41x, a next-generation antibiotic-eluting biomatrix for plastic and reconstructive surgery. The Company has submitted the 510(k) application for the base biologic matrix, NXT-41, to FDA and anticipates clearance later this year. Clearance for the full NXT-41x drug-eluting biologic is anticipated in the first half of 2027. Surgeon engagement and feedback continue to support the potential of NXT-41x in the $1.5 billion U.S. breast cancer surgery market, where post-operative infection rates remain at 15–20%.Leadership and Commercial Readiness: Elutia strengthened its Board and leadership team to support commercialization of the NXT-41x platform. Guido J. Neels, Operating Partner at EW Healthcare Partners and former Chief Operating Officer of Guidant Corporation, joined the Company’s Board of Directors. Pete Ligotti joined the Company as Chief Commercial Officer following a 20-year career at Integra Life Sciences and will lead the Company’s overall commercialization strategy and launch readiness activities.BioEnvelope Sale Closed: On October 1, 2025, Elutia closed the $88 million cash sale of its EluPro™ and CanGaroo BioEnvelope business to Boston Scientific Corporation, validating the strength of the Company’s proprietary drug-eluting biologics platform and providing capital to fund development and launch of NXT-41x.Transformed Balance Sheet: During the fourth quarter, the Company repaid the full $26.9 million in outstanding principal, accrued interest, and accrued exit fees associated with its loan facility with SWK Holdings. As of December 31, 2025, cash on hand was $36.4 million with an additional $8.0 million held in escrow related to the BioEnvelope divestiture, expected to be released in the fourth quarter of 2026.SimpliDerm Strategic Process Initiated: Given the progress and growing confidence in the NXT-41x program, Elutia has initiated a process to explore strategic options for its patented SimpliDerm product line. The process aims to sharpen the company’s time and resources on the upcoming launch and commercialization of NXT-41x. “2025 was the year we proved our drug-eluting biologic platform works, and the market wants it,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “With the $88 million BioEnvelope divestiture to Boston Scientific, we were able to remove debt and legacy distractions and transform Elutia into a high-velocity organization that’s about to shake up the stagnant $1.5 billion breast cancer surgery market. The current standard of care fails one in three women, and to us, that’s unacceptable. We are Ridiculously Relentless about ensuring that when a woman undergoes reconstruction, her recovery isn’t hijacked by a preventable complication, and we think NXT-41x will do just that. I want to thank the Elutia CRU for an outstanding year and welcome our new members to the team as we fight to ensure our mothers and daughters thrive without compromise.” Fourth Quarter 2025 Financial ResultsNet sales and operating results discussed below reflect continuing operations and exclude the divested BioEnvelope business. For the three-month period ended December 31, 2025, as compared to the same period of 2024: Overall net sales were $3.3 million, compared to $2.8 million in Q4 2024, an increase of 16%.Net sales of SimpliDerm were $2.1 million, compared to $2.3 million in Q4 2024.Net sales of Cardiovascular products were $1.2 million, compared to $0.5 million in Q4 2024.Gross margin on a GAAP basis was 58.5%, compared to 46.9%.Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 66.8%, compared to 56.5%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $8.5 million, compared to $8.8 million.Loss from continuing operations was $6.6 million, compared to $7.5 million.Net loss from continuing operations was $6.5 million, compared to a loss of $7.2 million.Income from discontinued operations was $77.3 million, primarily reflecting the gain on the sale of the BioEnvelope business to Boston Scientific Corporation.Net income (which includes the gain on the sale of the BioEnvelope business) was $70.8 million, compared to a net loss of $9.1 million.Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $4.2 million, compared to a loss of $3.4 million. A reconciliation of net income (loss) to adjusted EBITDA is included in the accompanying financial tables.Cash balance as of December 31, 2025, was $36.4 million. An additional $8.0 million related to the BioEnvelope divestiture is held in escrow and is expected to be released in the fourth quarter of 2026.As of December 31, 2025, there were 42.8 million shares of Class A common stock outstanding with an additional 4.5 million pre-funded warrants outstanding. Full Year 2025 Financial ResultsNet sales and operating results discussed below reflect continuing operations and exclude the divested BioEnvelope business. For the year ended December 31, 2025, as compared to the same period of 2024: Overall net sales were $12.3 million, compared to $14.5 million, reflecting the changes in the SimpliDerm and cardiovascular distribution models.Net sales of SimpliDerm were $9.1 million, compared to $11.6 million.Net sales of Cardiovascular products were $3.2 million, compared to $2.9 million.Gross margin on a GAAP basis was 53.7%, compared to 46.4%.Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 62.4%, compared to 53.9%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $33.5 million, compared to $37.4 million.Net loss from continuing operations was $15.9 million, compared to a loss of $45.3 million.Income from discontinued operations was $69.3 million, primarily reflecting the gain on the sale of the BioEnvelope business.Net income (including the gain on the sale of the BioEnvelope business) was $53.4 million, compared to a net loss of $53.9 million.Adjusted EBITDA was a loss of $12.8 million, compared to a loss of $11.2 million. A reconciliation of net income (loss) to adjusted EBITDA is included in the accompanying financial tables. Conference CallElutia will host a conference call today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its fourth quarter and full year 2025 financial results and performance. The conference call can be accessed using the following information: Webcast: Click here Dial-In: Click here To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial-out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register. Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/. About ElutiaElutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Non-GAAP DisclosureIn addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it believes to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding loss from discontinued operations, stock-based compensation, FiberCel and other Viable Bone Matrix (VBM) litigation costs, loss or gain on revaluation of warrant liability, loss on early repayment of debt, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.” Forward-Looking StatementsThis press release contains “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. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information regarding the future success of new products in Elutia’s breast reconstruction business. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: risks associated with shifting focus to our drug-eluting biomatrix solutions in the breast reconstruction area and away from our BioEnvelope business; our ability to successfully execute or achieve expected benefits from the divestiture of our BioEnvelope business; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x; our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates, including NXT-41 and NXT-41x; our ability to achieve or sustain profitability; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our former FiberCel and other VBM products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our dependence on a limited number of third-party suppliers and manufacturers; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Elutia Investor Relationsir@elutia.com ELUTIA INC.CONSOLIDATED STATEMENT OF OPERATIONS(Unaudited, in thousands, except share and per share data) Three months ended December 31, Twelve months ended December 31, 2025 2024 2025 2024 Net sales$3,271 $2,816 $12,293 $14,467 Cost of goods sold 1,357 1,494 5,697 7,752 Gross profit 1,914 1,322 6,596 6,715 Operating expenses: Sales and marketing 1,902 1,197 5,765 4,988 General and administrative 4,288 4,245 15,080 18,073 Research and development 1,215 727 4,163 2,998 Litigation costs, net 1,070 2,611 8,499 11,368 Total operating expenses 8,475 8,780 33,507 37,427 Loss from continuing operations (6,561) (7,458) (26,911) (30,712)Interest (income) expense, net (345) 138 (387) 934 Other expense (income), net 305 (443) (10,666) 13,692 Loss from continuing operations before provision for income taxes (6,521) (7,153) (15,858) (45,338)Income tax expense (benefit) (11) 2 13 7 Net loss from continuing operations (6,510) (7,155) (15,871) (45,345)Income (loss) from discontinued operations 77,301 (1,906) 69,251 (8,604)Net income (loss)$70,791 $(9,061) $53,380 $(53,949) Net income (loss) per share – basic$1.66 $(0.26) $1.29 $(1.86)Net income (loss) per share – diluted$1.48 $(0.26) $0.87 $(1.86) Weighted average shares outstanding – basic 42,721,201 34,845,672 41,416,850 29,071,113 Weighted average shares outstanding – diluted 47,243,564 34,845,672 45,942,787 29,071,113 ELUTIA INC.CONSOLIDATED BALANCE SHEET DATA(Unaudited, in thousands) Assets December 31, 2025 December 31, 2024Current assets: Cash and cash equivalents$36,350 $13,239 Accounts receivable, net 1,734 2,276 Inventory 2,617 1,931 Insurance receivables of litigation costs 4,846 4,760 Prepaid expense and other current assets 10,271 1,986 Current assets of discontinued operations – 1,980 Total current assets 55,818 26,172 Property and equipment, net 2,511 671 Intangible assets, net 1,529 2,600 Operating lease right-of-use assets, and other 2,492 179 Noncurrent assets of discontinued operations – 6,505 Total assets$62,350 $36,127 Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable, accrued expenses and other$9,143 $11,253 Current portion of long-term debt – 1,250 Current portion of revenue interest obligation 4,400 4,400 Contingent liability for legal proceedings 11,241 20,432 Current operating lease liabilities 355 145 Current liabilities of discontinued operations – 315 Total current liabilities 25,139 37,795 Long-term debt – 22,603 Long-term revenue interest obligation 2.828 5,490 Warrant liability 3,124 16,076 Other long-term liabilities 3,587 16 Noncurrent liabilities of discontinued operations – 407 Total liabilities 34,678 82,387 Stockholders’ equity (deficit): Common stock 43 35 Additional paid-in capital 203,842 183,298 Accumulated deficit (176,213) (229,593)Total stockholders’ equity (deficit) 27,672 (46,260)Total liabilities and stockholders’ equity (deficit)$62,350 $36,127 ELUTIA INC.NON-GAAP RECONCILIATIONS OF ADJUSTED GROSS PROFIT AND ADJUSTED GROSS MARGIN(Unaudited, in thousands, except share and per share data) Three months ended December 31, Twelve months ended December 31, 2025 2024 2025 2024 Net sales$3,271 $2,816 $12,293 $14,467 Gross profit 1,914 1,322 6,596 6,715 Intangible asset amortization expense 270 270 1,077 1,077 Adjusted gross profit (Non-GAAP)$2,184 $1,592 $7,673 $7,792 Gross margin 58.5% 46.9% 53.7% 46.4%Adjusted gross margin (Non-GAAP) 66.8% 56.5% 62.4% 53.9% ELUTIA INC.NON-GAAP RECONCILIATIONS OF EBITDA AND ADJUSTED EBITDA(Unaudited, in thousands, except share and per share data) Three months ended December 31, Twelve months ended December 31, 2025 2024 2025 2024 Net income (loss)$70,791 $(9,061) $53,380 $(53,949)Interest (income) expense, net(1) (345) 138 (387) 934 Provision (benefit) for income taxes (11) 2 13 7 Depreciation and amortization 297 281 1,174 1,124 EBITDA (Non-GAAP) 70,732 (8,640) 54,180 (51,884) (Income) loss from discontinued operations (77,301) 1,906 (69,251) 8,604 Stock-based compensation 947 1,162 4,397 7,043 Litigation costs, net(2) 1,070 2,611 8,499 11,368 (Gain) loss on revaluation of warrant liability(3) (906) (443) (13,424) 14,878 Loss on early repayment of debt(4) 1,287 – 1,287 – Warrant issuance expenses – – 105 257 Loss (gain) on revaluation of revenue interest obligation(5) – – 1,443 (1,443)Adjusted EBITDA (Non-GAAP)$(4,171) $(3,404) $(12,764) $(11,177) (1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation. (2) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance, indemnity and contribution agreements for such costs. (3) Represents the non-cash revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering in September 2023 and registered direct offerings in June 2024 and February 2025. (4) Represents the loss recognized on the full repayment of the SWK loan facility prior to maturity through the proceeds from the sale of our BioEnvelope business. (5) Represents the non-cash revaluation of the revenue interest obligation. At each reporting period, the value of the revenue interest obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method.
PHOENIX, March 11, 2026 /PRNewswire/ — Trinity Capital Inc. (Nasdaq: TRIN) (“Trinity”), a leading international alternative asset manager, today announced the commitment of $20 million in growth capital to Emboline, Inc. (“Emboline”), a MedTech company focused on reducing strokes and…
