Strata Critical Medical (NasdaqCM:BLDE) 2025 Investor Day November 17, 2025 02:00 PM ET Company ParticipantsKeith Trepanero - Chief Safety OfficerAndrew Murrill - Director of Business DevelopmentScott Silvestri - Organ Recovery and Service Line Champion and Medical DirectorMatt Schneider - VP of Finance and Investor Relations and CFO of Clinical ServicesScott Wunsch - CEO of LogisticsJustin Wang - Equity Research AssociateEric Moore - VP of Software Development and EngineeringChristie Campbell - VP of Clini ...

Core Points - The company United Therapeutics has completed the first clinical trial of gene-edited pig kidney transplantation into humans at NYU Langone Medical Center, marking the official launch of large-scale clinical trials [1] - This trial is the first FDA-approved human transplantation of gene-edited pig kidneys, aimed at systematically evaluating the safety and efficacy for patients with end-stage renal disease [1] Summary by Sections - **Trial Details** - The initial phase of the study includes 6 participants, with surgeries performed at two transplant centers [1] - An independent data monitoring committee will review safety and efficacy data after at least 12 weeks post-surgery to decide on the continuation of the next phase, potentially expanding the participant pool to about 50 [1] - **Participant Criteria** - Participants are aged between 55 and 70 years, all diagnosed with end-stage renal disease and have undergone dialysis for at least 6 months [1] - Following the transplantation, participants will be monitored for 24 weeks to assess kidney function, survival rates, quality of life, and safety, along with long-term monitoring for organ function and potential animal-source infection risks [1] - **Genetic Modifications** - The gene-edited pig kidneys developed by the company underwent 10 genetic modifications, removing 4 genes that could cause human rejection and adding 6 human genes to enhance compatibility with the human immune system [1]

Core Points - The 7th International Live Liver Transplantation Society Academic Conference and the 7th Eastern Organ Transplantation Conference will be held in Shanghai from October 17 to 19, 2025, marking the first time that mainland China has hosted a high-level international organ transplantation conference [2] - The event signifies the increasing international influence of China's organ transplantation, particularly in live liver transplantation, with over 800 experts and scholars from 34 countries and regions attending for high-quality academic exchanges and experience sharing [2] Summary by Sections - The conference will feature 38 content sections, including 160 thematic reports, specialized forums, and youth forums, inviting top experts and scholars in the transplantation field to discuss cutting-edge technologies, complication management, and long-term prognosis improvement [4]

Core Insights - The 2025 Nobel Prize in Physiology or Medicine was awarded to three scientists for their groundbreaking discoveries in peripheral immune tolerance, which have significant implications for the treatment of autoimmune diseases and cancer [10][13]. Group 1: Key Discoveries - The three laureates, Mary Brunkow, Fred Ramsdell, and Shimon Sakaguchi, identified regulatory T cells that prevent the immune system from attacking the body’s own cells, thus avoiding "internal wars" within the immune system [8][13]. - Sakaguchi's research in 1995 established that regulatory T cells are a special subset of T cells that protect against autoimmune diseases [14][16]. - Brunkow and Ramsdell's 2001 study linked mutations in the FOXP3 gene to rare autoimmune diseases, highlighting its critical role in the development of regulatory T cells [17][20]. Group 2: Clinical Implications - The discoveries have opened a new research field in peripheral immune tolerance, which could advance treatments for cancer, autoimmune diseases, and organ transplantation [10][13]. - Current data indicates that autoimmune diseases, such as type 1 diabetes and rheumatoid arthritis, affect approximately 10% of the population, underscoring the clinical significance of these findings [24].

Summary of Terumo's Acquisition of Organox Company Overview - **Company Involved**: Terumo Corporation (TRUM.Y) - **Acquisition Target**: Organox, headquartered in Oxford, UK - **Acquisition Date**: Agreement signed on August 23, 2025 - **Acquisition Value**: $1,500,000,000 for 100% of Organox's outstanding shares [4][5][6] Core Points and Arguments - **Strategic Importance**: The acquisition marks Terumo's entry into the organ transplantation market, specifically focusing on organ preservation technology [4][8][10] - **Market Demand**: Global organ transplants exceed 150,000 annually, with a waiting list of approximately 470,000 patients, indicating a significant unmet need for transplant organs [10][11] - **Organox's Technology**: Organox's METRA device utilizes normothermic machine perfusion (NMP) to preserve livers, allowing for longer preservation times (up to 12 hours in the US and 24 hours in Europe) compared to traditional methods [14][15] - **Growth Potential**: Organox's sales revenue was $71,000,000 in 2024, with projections to reach JPY 100,000,000,000 (approximately $670 million) within the next decade [7][18] - **Synergies with Terumo**: The acquisition is expected to create synergies with Terumo's existing product portfolio, enhancing overall corporate value and expanding into new growth domains [8][20][22] Financial Implications - **Positive Impact on Earnings**: The acquisition is anticipated to positively affect adjusted operating profit and earnings per share starting next fiscal year [19][20] - **Growth Model**: Organox has achieved positive adjusted EBITDA just one year after its US launch, which is rare for startups, indicating a strong business model [18][20] Market Dynamics - **Challenges in Organ Transplantation**: The market faces challenges such as a low utilization rate of donated livers and a shortage of donors, particularly from donation after circulatory death (DCD) [12][13] - **Technological Advantage**: Organox's NMP technology addresses these challenges by improving the preservation and assessment of organ viability, potentially increasing the number of transplantable organs [14][15][16] Future Outlook - **Expansion Plans**: Terumo plans to expand beyond liver transplantation into kidney transplants, targeting a launch around 2030 [16][17] - **Long-term Growth Strategy**: The acquisition is part of Terumo's broader strategy to achieve significant growth and address the critical shortage of transplant organs [8][22] Additional Insights - **Cultural Fit and Synergy**: The acquisition aligns with Terumo's strategic direction, emphasizing the importance of groundbreaking technology and cultural compatibility [24][25] - **Regulatory Approvals**: Organox's METRA device has received CE marking and FDA approval, facilitating its market entry and growth [6][10] This summary encapsulates the key points from the conference call regarding Terumo's acquisition of Organox, highlighting the strategic importance, market dynamics, financial implications, and future growth potential.

Core Viewpoint - The successful completion of China's first combined heart-liver transplant surgery at Huazhong University of Science and Technology's Tongji Medical College Union Hospital marks a significant advancement in the field of organ transplantation, overcoming complex medical challenges [1][2]. Group 1: Medical Achievement - The combined heart-liver transplant surgery is referred to as the "Mount Everest" of organ transplantation, highlighting its complexity and significance in medical science [1]. - The patient, Li Lei, suffered from severe congenital heart disease and was diagnosed with end-stage heart failure, severe liver cirrhosis, and liver cancer, necessitating simultaneous organ transplantation [1]. - The surgical team faced significant challenges, including the interdependence of heart and liver functions and severe tissue adhesions from previous surgeries [1]. Group 2: Surgical Process - The surgical procedure involved a meticulous 143-minute operation to remove the diseased heart and successfully implant the donor heart, followed by the removal of the diseased liver and implantation of the donor liver [2]. - A multidisciplinary team of over 20 experts collaborated to navigate various critical phases of the surgery, including infection control, rejection management, respiratory support, and nutritional care [2]. Group 3: Institutional Performance - As of now, the Union Hospital has completed three combined heart-liver transplants, accounting for one-third of the total cases in the country [2]. - The hospital has performed over 1,200 heart transplants in the past 30 years, achieving a five-year survival rate of 89.1% [2].

Core Insights - Researchers have successfully cultivated human heart cells within pig embryos, marking a significant advancement in the field of organ transplantation and regenerative medicine [1][2][4] Group 1: Research Findings - The embryos containing human cells survived for 21 days, during which the small hearts began to beat [1][4] - The research involved reprogramming human stem cells to enhance their survival in pig embryos by introducing genes that prevent cell death and promote growth [3][4] - The team previously succeeded in cultivating early human kidneys in pig embryos, which survived for a month, and aimed to achieve similar results with the heart [2][3] Group 2: Methodology - Specific genes essential for heart development were knocked out in the pig embryos, allowing human stem cells to be injected during the early embryonic stage [3][4] - The human cells were marked with fluorescent biological markers to identify them within the developing heart [4][5] Group 3: Future Implications - The research could potentially address the global shortage of transplantable organs by creating animal models that can grow human organs [2][6] - There is a need for further analysis to confirm the composition of the heart cells, as complete human cell integration is crucial for successful transplantation [6][7]

Core Insights - The article discusses a groundbreaking study published in Nature, where researchers successfully cultivated a small human heart within a pig embryo, which was able to beat and survive for 21 days [1][4]. Group 1: Research Findings - Scientists have previously transplanted gene-edited pig organs (kidneys, hearts) into humans, and are now exploring the creation of human-animal chimeras to address global organ transplant shortages [4]. - The research team, led by researcher Lai Liangxue, reported the cultivation of a humanized heart in pig embryos, marking a significant advancement in xenotransplantation [5][6]. - The pig is considered a suitable donor species due to its organ size and anatomical similarities to humans [6]. Group 2: Methodology - The team utilized a method involving the creation of pig embryos lacking specific genes necessary for heart development, followed by the injection of human stem cells to promote the formation of the heart [5][6]. - The embryos were implanted into a sow for further development, and the resulting hearts reached a developmental stage comparable to that of a human heart at 21 days [7]. Group 3: Observations and Future Directions - The chimeric pig embryos could grow for a maximum of 21 days, after which they could not survive, potentially due to human cells disrupting pig heart function [7]. - The study did not disclose the proportion of human cells within the hearts, although previous research indicated that human cells constituted 40%-60% in pig kidneys [7]. - For future developments, it is essential that the heart is entirely composed of human cells to prevent immune rejection in human recipients [9].

Core Viewpoint - The article discusses a groundbreaking study published in Nature, where researchers successfully cultivated a small human heart within a pig embryo, which was able to beat and survive for 21 days [1][4]. Group 1: Research Background - Scientists have previously succeeded in transplanting gene-edited pig organs (kidneys, hearts) into humans, and are now exploring the creation of human-animal chimeras to address global organ transplant shortages [3]. - A method to create chimeric animals involves generating embryos lacking specific genes necessary for certain organs and injecting human stem cells into these embryos [4][6]. Group 2: Research Findings - The research team, led by researcher Lai Liangxue, reported the first instance of cultivating a humanized heart in pig embryos, which began beating during the 21-day survival period [4][6]. - The team enhanced the survival of human stem cells in pigs by reprogramming them with genes that prevent cell death and promote growth, and then created pig embryos with two key heart development genes knocked out [7]. Group 3: Observations and Implications - The chimeric pig embryos grew for a maximum of 21 days, after which they could not survive, potentially due to human cells disrupting pig heart function [8]. - The hearts developed to a size comparable to that of a human heart at 21 days and were observed to be beating, although the proportion of human cells in the heart was not disclosed [8][10]. - For future development of transplantable hearts for humans, it is crucial that the organ is composed entirely of human cells to prevent immune rejection [10].

Industry Overview - Regenerative medicine (RM) utilizes biological and engineering theories to promote self-repair and regeneration of the body, or to construct new tissues and organs for repairing, regenerating, and replacing damaged tissues and organs [1][4] - The global regenerative medicine market is expanding, with the market size projected to grow from $20.04 billion in 2021 to $35.82 billion in 2024 [1][12] Market Status - Regenerative medicine is considered the "third medical revolution" following drug and surgical treatments, becoming a core component of life science strategies globally [6][12] - The industry includes upstream raw materials and equipment supply, midstream product R&D and production, and downstream application through medical institutions and aesthetic organizations [4][12] Policy and Regulatory Environment - Various countries have implemented policies to promote the development of regenerative medicine, such as the U.S. "21st Century Cures Act" and the EU's regulations on biotechnology [7][9] - In China, policies have been established to support the clinical application of regenerative medicine technologies, including the management of stem cell therapies and the promotion of innovative medical technologies [9][23] Market Competition - The regenerative medicine sector has attracted numerous companies, with major players including Johnson & Johnson, Bard, Geistlich, and domestic firms like Zhenghai Biological, Guanhou Biological, and Maipu Medical [16][18] - The market is characterized by a diverse range of products and applications, with companies focusing on specific therapeutic areas such as cancer treatment, tissue repair, and organ transplantation [18][20] Development Trends - The industry is witnessing technological integration and innovation, with advancements in 3D bioprinting, gene editing, and artificial intelligence enhancing treatment efficacy [22][24] - The dual drive of policy support and capital investment is accelerating the commercialization of regenerative medicine, with increasing coverage of medical insurance for regenerative products [23][24]