Financial

BridgeBio Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Commercial Update

– As of February 17, 2025, 1,028 unique patient prescriptions for Attruby™ have been written by 516 unique prescribers since FDA approval – Attruby (acoramidis), the first and only near-complete TTR stabilizer (≥90%) was approved by the FDA to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients on November 22, 2024 – Acoramidis was approved as BEYONTTRA™ in the EU on February 10, 2025, achieving a $75 million milestone payment and ongoing royalties in a tiered structure beginning in the low-thirties percent on sales in the EU – Acoramidis demonstrated a 59% hazard reduction on the composite endpoint of all-cause mortality and first cardiovascular-related hospitalization in the variant ATTR-CM population by month 30; to the Company’s knowledge, this benefit is the largest and the only statistically significant result in this patient population, which has an aggressive phenotype and poor prognosis – Fully enrolled three global registrational studies – FORTIFY (BBP-418 for LGMD2I/R9), CALIBRATE (encaleret for ADH1), and PROPEL 3 (infigratinib for achondroplasia) – with last participant – last visit expected for each study before the end of 2025 – The Company ended the fourth quarter with $681 million in cash, cash equivalents, and short-term restricted cash. Further, the Company expects to receive $105 million in regulatory milestones in 1H 2025 from acoramidis Europe and Japan approvals PALO ALTO, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases announced today its financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on Attruby’s commercial progress. Commercial Progress: As of February 17, 2025, 1,028 unique patient prescriptions for Attruby have been written by 516 unique healthcare providers since FDA approval. ”I am very encouraged by the strength of the Attruby launch, with prescriptions being successfully filled across all patient types,” said Matt Outten, Chief Commercial Officer of BridgeBio. “In conversations with healthcare providers and patients, we have repeatedly heard that Attruby’s category-leading results – time to separation of just three months, along with a 42% reduction in all-cause mortality and recurrent hospitalizations and a 50% reduction in cardiovascular hospitalizations at 30 months – set it apart as a clinically meaningful advancement for ATTR-CM. Combined with our industry-leading patient support programs, we believe Attruby is delivering a much-needed change in the treatment landscape.” Pipeline Overview: ProgramStatusNext expected milestone Acoramidis for ATTR-CMApproved in U.S. and EUJapan approval in 1H 2025BBP-418 for LGMD2I/R9 FORTIFY, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Encaleret for ADH1CALIBRATE, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Infigratinib for achondroplasiaPROPEL 3, Phase 3 study enrollment completed Last Participant – Last Visit in 2H 2025Infigratinib for hypochondroplasiaACCEL, run-in for Phase 2 study ongoingEnrollment completion date to be announcedBBP-812 for Canavan diseaseCANaspire Phase 1/2 study ongoingEnrollment completion date to be announced Key Program Updates: “It is exciting to see patients, physicians, and payers resonate with our message that the greater levels of TTR stabilization that Attruby delivers can be of benefit to the patients we serve and that the TTR protein is clinically important, not toxic.” said Neil Kumar, Ph.D., Founder and CEO of BridgeBio. “We look forward to continuing to partner with the community to ensure that we find all patients that can be helped and ease their path to getting on therapy, when appropriate, as much as possible.” Attruby (acoramidis) – the first approved, near-complete (≥90%) TTR stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): On November 22, 2024, the U.S. Food and Drug Administration (FDA) approved Attruby (acoramidis), a near-complete TTR stabilizer (≥90%), to reduce cardiovascular death and cardiovascular-related hospitalization (CVH) in adult patients with ATTR-CM.On February 10, 2025, the European Commission approved BEYONTTRA (acoramidis) for use in adult patients with ATTR-CM in the EU.Preliminary results from the ongoing ATTRibute-CM open-label extension (OLE) study of Attruby in ATTR-CM were simultaneously published in Circulation and presented at the American Heart Association Scientific Sessions, showing that Attruby demonstrated statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at month 36 within the OLE, and 46% (p

VitalConnect, Inc. Secures $100 Million in Financing

SAN JOSE, Calif.–(BUSINESS WIRE)–VitalConnect®, Inc., a leader in biosensor technology, specializing in ambulatory cardiac monitoring, today announced the closing of $100 million in financing through a combination of equity and debt capital. The equity financing was led by new investor Ally Bridge Group, with significant participation from the Company’s existing […]

BIOTRONIK and Egg Medical Form Strategic Alliance to Improve Radiation Protection for Interventional Healthcare Workers

BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, today announced it is partnering with Egg Medical, Inc., a global leader in radiation protection technology, to co-sell Egg Medical’s EggNest™ Radiation Protection Systems for healthcare workers in the United States. The EggNest Systems (EggNest XR, EggNest Protect & EggNest Complete) are […]

OrphAI Therapeutics Announces Appointment of Dr. Aaron Waxman to Board of Directors

Leading clinician and researcher in Pulmonary Disease TherapeuticsNEW HAVEN, Conn., Feb. 19, 2025 (GLOBE NEWSWIRE) — OrphAI Therapeutics Inc. (“OrphAI”), a clinical-stage biopharmaceutical company developing novel therapeutics for diseases with unmet needs, announced today the appointment of Aaron B. Waxman, M.D., Ph.D. to its Board of Directors. Waxman is a distinguished clinician and researcher specializing in pulmonary disease, with a particular focus on pulmonary hypertension (PH). He has authored over 150 peer-reviewed publications, including more than 70 in the field of PH. Dr. Waxman has served as a principal investigator for numerous clinical trials evaluating investigational treatments for PH, including Sotatercept and Treprostinil. His research contributions span key areas including inflammatory mediators driving vascular remodeling, early disease phenotyping, and the application of invasive cardiopulmonary exercise testing for diagnosis and disease monitoring. In addition to his research, Dr. Waxman is the Executive Director of the Center for Pulmonary Heart Disease, and the Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital and an Associate Professor of Medicine at Harvard Medical School. He has a dual appointment at Mass General Brigham in Cardiovascular Medicine and Pulmonary and Critical Care. His work has significantly advanced understanding of the pathophysiology of pulmonary vascular diseases and has led to innovative approaches in both clinical care and therapeutic development. Dr. Aaron Waxman holds a Ph.D. in Anatomy and Neuroscience from Albany Medical College and an M.D. from Yale University School of Medicine. He completed his residency in internal medicine at Yale New Haven Hospital, followed by two fellowships: one at the Howard Hughes Medical Institute and another in pulmonary and critical care medicine at Yale University school of Medicine and Yale New Haven Hospital. Dr. Waxman is board certified in internal medicine, pulmonary disease, and critical care medicine. “Dr. Aaron Waxman provides a wealth of expertise and leadership in the study and development of new and approved agents in the pulmonary vascular disease armamentarium. His guidance and insights will be invaluable as we progress LAM-001 in pulmonary hypertension and other indications. After working with Aaron on our clinical trial of LAM-001 in pulmonary hypertension, it is an honor to now have him join our Board of Directors,” said Dr. Brigette Roberts, CEO and Director of OrphAI. “I am delighted to join the OrphAI Therapeutics’ Board of Directors,” said Dr. Waxman. “I look forward to working with their team to develop new, innovative therapies for pulmonary vascular diseases.” ”We are excited to welcome Dr. Aaron Waxman to our Board of Directors,” said David Scheer, Chairman of the Board of Directors at OrphAI. “His clinical leadership will be an important contribution to the company as we advance our programs through clinical development towards commercialization.” About OrphAI Therapeutics OrphAI Therapeutics’ mission is to transform the lives of patients in need of safe and effective disease modifying therapeutics. The company is currently developing two investigational therapies across multiple indications: LAM-001, a proprietary inhaled form of rapamycin, currently in Phase 2 for Groups 1 and 3 pulmonary hypertension and bronchiolitis obliterans syndrome (BOS); and AIT-102, a proprietary analogue of mithramycin, in preclinical development, for the treatment of transcriptionally dysregulated tumors. To learn more, please visit: OrphAI-Therapeutics.com CONTACT: MEDIA CONTACT:
info@orphai-therapeutics.com

Endovascular Engineering Raises $42 Million in Series B Financing to Advance the Treatment of Pulmonary Embolism

MENLO PARK, Calif., Feb. 18, 2025 /PRNewswire/ — Endovascular Engineering, Inc. (“E2”) has secured $42 million in an oversubscribed Series B financing to advance its next generation clot removal technology platform for venous thromboembolism (VTE). The round was co-led by 415 Capital and…

Kestra Medical Technologies, Ltd. Appoints Al Ford as Chief Commercial Officer

KIRKLAND, Wash., Feb. 18, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies Ltd. (“Kestra”), a wearable medical device and digital healthcare company, announced today that Al Ford is joining the company as Chief Commercial Officer (CCO). Mr. Ford will be responsible for advancing sales strategies and leading the Kestra commercial team. “We are pleased to welcome Al to the team,” said Brian Webster, President and Chief Executive Officer at Kestra. “With significant experience managing strategic sales and commercial operations, he brings valuable knowledge, perspective, and leadership to our organization. Al also has deep experience in the underlying defibrillation technologies that are central to the ASSURE® system. We are confident that he will be an impactful addition as we continue to drive adoption of our lifesaving system.” Mr. Ford brings 20 years of experience in MedTech organizations to his new role at Kestra. Most recently, he served as Chief Commercial Officer at Axonics where he led the development and execution of their commercialization strategy. Prior to that, he was Chief Commercial Officer at Cardiac Science Corporation. “I am honored to join Kestra in a commercial leadership role that aligns seamlessly with my experience,” said Mr. Ford. “The innovative Cardiac Recovery System® portfolio, and its ability to positively impact the lives of a meaningfully underserved patient population, were significant factors in my decision to join Kestra. I look forward to working with the team to execute on our commitment to patients and their prescribers.” About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using diagnostic monitoring and therapeutic technologies that are intuitive, intelligent, and connected. Kestra was founded in 2014 by leaders from the external (AED) and implantable (ICD) defibrillation industries. For more information, visit www.kestramedical.com. INVESTOR CONTACTMarissa Bych or Webb CampbellGilmartin Groupinvestor.relations@kestramedical.com MEDIA CONTACTRhiannon PickusKestra Medical Technologies, Inc.Rhiannon.Pickus@kestramedical.com

Orchestra BioMed Appoints Vivek Reddy, M.D. as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of Bioelectronic Therapies Scientific Advisory Board

The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy for patients who have uncontrolled hypertension and a pacemaker indicationA globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai NEW HOPE, Pa., Feb. 18, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the appointment of Vivek Reddy, M.D., as Executive Chairman of the Company’s BACKBEAT Study Steering Committee and Chairman of its Bioelectronic Therapies Scientific Advisory Board. In these roles, Dr. Reddy will provide critical leadership in continuing to execute the BACKBEAT global pivotal study and further develop scientific evidence and clinical value for the Company’s bioelectronic therapies portfolio. Dr. Reddy commented, “I believe strongly in the transformative potential of AVIM therapy to help address uncontrolled hypertension in populations with increased cardiovascular risk such as the pacemaker-indicated patients we are focusing on in the BACKBEAT study. Hypertension is a critical global health challenge affecting hundreds of millions of patients worldwide. For patients with increased cardiovascular risk, the prospect of integrating an always-on, adjustable hypertension treatment that doesn’t rely on patient adherence is truly exciting. I am dedicated to driving the successful completion of the BACKBEAT study and synchronizing efforts among Orchestra BioMed’s clinical advisors to fully realize the potential of AVIM therapy for hypertension populations with increased cardiovascular risk. I’m also excited about exploring other therapeutic applications for which we believe there is potential utility for this novel technology.” “We are thrilled to have Dr. Vivek Reddy assume these key leadership roles to help drive successful completion of the BACKBEAT global pivotal study and maximize the clinical value AVIM therapy can potentially offer to patients with uncontrolled hypertension worldwide,” said David Hochman, Chairman, Chief Executive Officer, and Founder of Orchestra BioMed. “While Dr. Reddy has been a long-standing advisor to this exciting program, his expanded role will allow him to further engage in establishing awareness of AVIM therapy in the clinical community and drive effective communication across our distinguished team of clinical advisors. We believe his leadership will be instrumental in educating the clinical community about the BACKBEAT study and AVIM therapy, ultimately helping us and our colleagues at Medtronic deliver this exciting device-based treatment option to patients worldwide. We also look forward to collaborating closely with Dr. Reddy as we continue research and development of our proprietary bioelectronic therapies for additional indications such as heart failure.” Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai. Dr. Reddy has led groundbreaking work in catheter ablation for atrial fibrillation and ventricular tachycardia, as well as leadless pacing and has been at the forefront of device therapies for stroke prevention, positioning him as one of the most respected experts in electrophysiology. Under his leadership, Mount Sinai has served as the lead investigational site for many pioneering clinical trials, and in 2014 implanted the world’s first leadless pacemaker. Dr. Reddy’s commitment to advancing medical innovation and his track record in clinical study leadership will play a pivotal role in the continued success of Orchestra BioMed’s efforts to revolutionize device-based cardiovascular solutions. About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (“AVIM”) therapy for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. 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 potential efficacy and safety of the Company’s commercial product candidates, additional indications of the Company’s proprietary bioelectronic therapies, implementation of the Company’s ongoing BACKBEAT global pivotal study, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs, strategic partnerships and plans to expand its product pipeline. 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 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, 2023, which was filed with the U.S. Securities and Exchange Commission on March 27, 2024, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q. 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 ContactSilas NewcombOrchestra BioMed (908) 723-4489 Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMed(484) 682-4892Kkirkellis@orchestrabiomed.com

Biotricity Announces Cashflow Breakeven with Biggest Quarter in History and a Revenue Increase of 11%

REDWOOD CITY, Calif., Feb. 17, 2025 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB: BTCY) (“Biotricity” or the “Company”), a Technology-as-a-Service (TaaS) company operating in the remote cardiac monitor sector of consumer healthcare, today provided guidance on its financial results for the third quarter of fiscal 2025 year and (unaudited) ended December 31, 2024.