Drive adoption of QUELIMMUNE for ultra-rare pediatric AKI, expanding revenue and doubling the customer base Advance SeaStar Medical’s first-in-class SCD therapy for the adult AKI indication – a potential $4.5 billion market – through completion of enrollment of the NEUTRALIZE-AKI pivotal trial and initiation of the PMA process Progress the clinical development of the SCD therapy in patients with severe heart failure Leverage rapid pathways to commercialization of the SCD therapy through additional FDA Human ...

Core Insights - Orchestra BioMed is collaborating with Medtronic to develop and commercialize AVIM Therapy for treating uncontrolled hypertension in patients indicated for a pacemaker [1][4] - The company presented at the 2025 Innovation in Cardiology Intervention meeting, focusing on AVIM Therapy and Virtue Sirolimus AngioInfusion™ Balloon [1][2] Company Overview - Orchestra BioMed is a biomedical innovation company that accelerates high-impact technologies through strategic collaborations with leading medical device companies [4] - The two flagship products, AVIM Therapy and Virtue SAB, represent multi-billion-dollar annual global market opportunities [4] AVIM Therapy - AVIM Therapy is designed to lower blood pressure significantly and persistently in patients with hypertension who are also indicated for a pacemaker [5][6] - Pilot studies showed net reductions of 8.1 mmHg in ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [6] - The BACKBEAT global pivotal study is currently evaluating the safety and efficacy of AVIM Therapy in patients with systolic blood pressure above target despite anti-hypertensive medication [6] Virtue Sirolimus AngioInfusion™ Balloon (Virtue SAB) - Virtue SAB is a novel drug delivery system designed for coronary artery disease treatment, utilizing a non-coated microporous AngioInfusion™ Balloon [3][7] - The system delivers a proprietary extended-release formulation of sirolimus, achieving sustained tissue levels above the therapeutic concentration required to inhibit restenosis [7] - Virtue SAB has shown positive three-year clinical data in coronary in-stent restenosis and has received Breakthrough Device Designation from the FDA for multiple indications [7]

Core Insights - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][3] - The company will present at NobleCon21 on December 3, 2025, highlighting its advancements and products [1][2] Company Overview - SeaStar Medical is a commercial-stage healthcare company with a focus on critically ill patients [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury (AKI) in critically ill pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] - The company is conducting a pivotal trial for its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the U.S. annually [3]

Core Insights - Orchestra BioMed Holdings, Inc. reported strong financial results for Q3 2025, securing nearly $150 million in capital to advance its pivotal-stage programs [3][4][5] - The company is actively enrolling patients in the Virtue Trial, which compares its Virtue® Sirolimus AngioInfusion™ Balloon to commercially available options [3][4] - The company has expanded its strategic collaborations with Medtronic and Terumo, enhancing its business model and financial position [3][4][5] Financial Highlights - Cash and cash equivalents and marketable securities totaled $95.8 million as of September 30, 2025, with a cash runway extended into Q4 2027 [10] - Revenue for Q3 2025 was $0.9 million, a slight decrease from $1.0 million in Q3 2024 [10] - The net loss for Q3 2025 was $20.8 million, or $0.40 per share, compared to a net loss of $15.4 million, or $0.41 per share, in Q3 2024 [10][19] Strategic Partnerships - The company secured $71.6 million in committed capital from Medtronic and Ligand, along with $30 million from Terumo, which includes a right of first refusal agreement [3][4] - The collaboration with Medtronic aims to develop AVIM Therapy-enabled leadless pacemakers, while the agreement with Terumo provides strategic options for the Virtue SAB [4][5] Clinical Development - The BACKBEAT study is expected to complete enrollment by mid-2026, while the Virtue Trial aims for completion by mid-2027 [4][5] - AVIM Therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension, targeting a significant patient population in the U.S. [7][11] - Virtue SAB is designed to deliver a proprietary sirolimus formulation and has also received FDA Breakthrough Device Designation for multiple indications [12]

Core Insights - CapsoVision, Inc. has submitted an application to the FDA for Breakthrough Device Designation for its CapsoCam UGI capsule endoscopy system aimed at early detection of pancreatic ductal adenocarcinoma, a highly fatal cancer [1][5] - The CapsoCam UGI system is designed to expand the company's diagnostic capabilities beyond the small bowel, addressing significant challenges in gastroenterology [2][8] - Pancreatic ductal adenocarcinoma has a low five-year survival rate of only 8%, primarily due to late-stage diagnosis, highlighting the urgent need for effective early screening tools [2][6] Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection [8] - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel [8] - The company is also developing CapsoCam Colon™, which aims to enhance non-invasive colon imaging and polyp detection [8] Industry Context - Pancreatic cancer is the third leading cause of cancer-related deaths in the U.S., despite representing only about 3% of all cancer cases [6] - Approximately 80% of pancreatic cancer diagnoses occur at advanced stages, limiting treatment options [6] - Current diagnostic methods are invasive and costly, lacking the sensitivity needed for early-stage detection, which underscores the need for innovative, non-invasive technologies [6][7]

Core Insights - SeaStar Medical Holding Corporation will report its third quarter financial results on November 13, 2025, after market close [1] - The company focuses on transforming treatments for critically ill patients facing organ failure [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to critically ill patients with organ failure [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury (AKI) in pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating faster approval and better reimbursement dynamics [3] - A pivotal trial is currently underway for SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), affecting over 200,000 adults annually in the U.S. [3]

Core Insights - Orchestra BioMed Holdings, Inc. announced financial results for Q2 2025, highlighting significant capital raised and regulatory achievements [1][2][3] Financial Highlights - The company secured over $111 million in proceeds from strategic transactions and equity offerings, including $71 million from Medtronic and Ligand [4][5] - Cash and cash equivalents totaled $33.9 million as of June 30, 2025, with an estimated position of $101 million as of August 12, 2025, after recent financing [11] - Revenue for Q2 2025 was $0.8 million, unchanged from Q2 2024, while net loss increased to $19.4 million, or $0.50 per share, compared to a net loss of $16.0 million, or $0.45 per share, in the prior year [11][20] Regulatory Milestones - The FDA granted Breakthrough Device Designation for AVIM therapy aimed at treating uncontrolled hypertension, which may enhance future regulatory submissions and reimbursement pathways [4][6] - The BACKBEAT study protocol was updated and approved by the FDA, significantly expanding patient enrollment criteria [4][6] - IDE approval was received for the Virtue SAB U.S. pivotal trial, which will compare Virtue SAB with commercially available paclitaxel-coated balloons [4][6] Strategic Collaborations - The company has expanded its collaboration with Medtronic to develop AVIM therapy-enabled leadless pacemakers [5] - Ligand Pharmaceuticals committed $35 million for a tiered revenue interest in future royalties from AVIM therapy and Virtue SAB [5] Product Development - AVIM therapy has shown promising results in pilot studies, demonstrating significant reductions in blood pressure [12] - Virtue SAB is designed to deliver sirolimus effectively, with positive clinical data supporting its use in treating coronary in-stent restenosis [13]

Core Viewpoint - Orchestra BioMed Holdings, Inc. announced a significant update to the BACKBEAT study protocol, approved by the FDA, which expands patient eligibility criteria for evaluating AVIM therapy in patients with uncontrolled hypertension who require pacemakers [1][5]. Summary by Relevant Sections Patient Eligibility Expansion - The updated protocol increases the eligible patient pool by more than 24-fold compared to the original protocol, supporting the company's target for mid-2026 completion of enrollment [2][5]. - New eligibility criteria include hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements [5][6]. Clinical Implications - The expanded criteria align the study population with the characteristics of the FDA Breakthrough Device Designation for AVIM therapy, potentially representing millions of U.S. patients needing better options for managing elevated systolic blood pressure [3][4]. - AVIM therapy is designed specifically for older, higher-risk hypertensive patients who may also require a pacemaker, reflecting its transformative potential [3][8]. Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through partnerships with leading medical device companies, with AVIM therapy as its lead product candidate for uncontrolled hypertension [4]. - The company has received four Breakthrough Device Designations from the FDA for its core programs, indicating significant potential to address unmet needs in cardiovascular care [4].

Core Points - SeaStar Medical has successfully enrolled 125 out of 200 anticipated patients in the NEUTRALIZE-AKI pivotal clinical trial, achieving over 60% enrollment [1][4] - The company has activated a new clinical trial site at Methodist Hospital Metropolitan in San Antonio, Texas, bringing the total to 16 sites [1][3] - An interim analysis of the first 100 patients is expected in the third quarter of 2025, conducted by the independent Data Safety Monitoring Review Board (DSMB) [2][4] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [10] - The company's Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation from the FDA for six indications, including treatment for adult AKI requiring continuous renal replacement therapy (CRRT) [8][10] - SeaStar's first commercial product, QUELIMMUNE (SCD-PED), was approved by the FDA in 2024 for treating life-threatening acute kidney injury (AKI) in critically ill pediatric patients [10] Clinical Trial Details - The NEUTRALIZE-AKI trial aims to enroll up to 200 adult patients with AKI requiring CRRT, with a primary endpoint of 90-day mortality or dialysis dependency [4][5] - Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year [4] - The trial's interim analysis will assess the primary endpoint when approximately 50% of patients have completed the 90-day follow-up [5] Technology and Treatment - The SCD therapy is designed to neutralize over-active immune cells and mitigate hyperinflammation, which can lead to multi-organ dysfunction [9] - This therapy is integrated with existing CRRT systems to selectively target proinflammatory monocytes and promote a reparative state [9] - The SCD therapy has potential applications in multiple acute and chronic kidney and cardiovascular diseases, addressing a significant unmet medical need [9]

Core Insights - Castle Biosciences, Inc. announced that its DecisionDx-Melanoma test received Breakthrough Device designation from the FDA, aimed at improving patient care for those diagnosed with stage I-III cutaneous melanoma [1][3] Company Overview - Castle Biosciences is a diagnostics company focused on innovative tests that guide patient care, with a mission to transform disease management by prioritizing patients, clinicians, employees, and investors [5] - The company has a portfolio that includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, and is engaged in R&D for additional tests in high clinical need areas [6] Product Details - DecisionDx-Melanoma is a gene expression profile test that assesses a patient's risk of sentinel lymph node positivity and melanoma recurrence/metastasis, integrating tumor biology with clinical factors [4] - The test has been validated through over 10,000 patient samples and is supported by more than 50 peer-reviewed studies, demonstrating its clinical value and association with improved patient survival [4] - As of March 31, 2025, DecisionDx-Melanoma has been ordered over 200,000 times for patients diagnosed with cutaneous melanoma [4]