UCI Health Partner with Sierra Donor Services to Expand Kidney Transplant Opportunities Utilizing Paragonix KidneyVault Preservation Technology
WALTHAM, Mass.--(BUSINESS WIRE)-- Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today a groundbreaking initiative with Sierra Donor Services and UCI Health to place high-risk donor kidneys, expanding transplant opportunities for patients in need.
, a nonprofit organ procurement organization (OPO) serving more than 2.8 million people across 13 counties in Northern California and Nevada, is leveraging this collaboration to successfully place kidneys that were previously deemed high risk due to donor complications, geographic limitations, and other logistical considerations.
Utilizing Paragonix's latest innovation—the KidneyVault Portable Renal Perfusion System —Sierra Donor Services has facilitated the transplantation of complex donor kidneys that had initially been declined due to factors such as donor age, cause of death, and underlying medical conditions. Through this technology, UCI Health has been able to transplant these organs successfully, demonstrating the transformative potential of advanced organ preservation in expanding the donor pool. The cutting-edge preservation system aims to combat key transplantation challenges by ensuring superior organ protection during transport and providing real-time monitoring of organ conditions and location.
UCI Health, one of California's largest academic health systems, is the clinical enterprise of the University of California, Irvine and one of the fastest growing kidney transplant centers on the west coast. UCI Health is at the forefront of transplant innovation, seeking new opportunities and technologies to both improve access to donor organs and post-transplant outcomes.
The lifesaving initiative is playing a critical role in addressing California's organ shortage by enabling the safe and effective utilization of kidneys that may have otherwise been potentially discarded. 'Currently, nearly 20,000 Californians are on the waiting list for a transplant, with 85% of them in need of a kidney. Last year over 9,000 kidneys recovered for transplant were ultimately unable to be used for a life saving transplant,' said Donna Smith, Chief Clinical Officer at Sierra Donor Services. 'The portable renal perfusion technology provided by KidneyVault gives us greater flexibility to place these much-needed organs, offering a second chance at life to patients who might not have otherwise received one.'
Dr. Robert R. Redfield, Chief of Transplantation at UCI Health, emphasized the importance of this innovative preservation system in expanding transplant opportunities. 'UCI Health is proud to have the oldest and largest kidney transplant program in Orange County, with survival outcomes exceeding the national average,' said Dr. Redfield. 'This technological improvement allows transplant centers like ours to consider more complex organs, as donations that must travel greater distances can now be perfused throughout the entire transplant journey.'
President of Paragonix Technologies, Dr. Lisa Anderson, PhD, echoed this sentiment, highlighting the company's commitment to honoring the gift of organ donation. 'Every organ donation is an incredible gift, and we believe it should be treated as such every single time,' said Dr. Anderson. 'With the KidneyVault Portable Renal Perfusion System, OPOs and transplant centers can confidently offer this life-saving gift to more patients by utilizing organs that previously would have gone unused.'
For more information about Paragonix Technologies, please visit paragonix.com
About Sierra Donor Services
Sierra Donor Services (SDS) serves nearly three million people in Northern California and Northern Nevada. We are an exceptional team of professionals dedicated to saving and improving lives by connecting organ and tissue donation to the patients who need them. We strive to extend the reach of each generous donor's gift to those who are always profoundly grateful for them. For more information, visit www.sierradonor.org.
About Paragonix Technologies
Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation.
A Getinge company, Paragonix Technologies provides Advanced Organ Preservation ('AOP') devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.
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About BRUKINSA ® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets in at least one indication, and more than 200,000 patients have been treated globally. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström's macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. 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Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. 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Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding physicians and patients trust in BRUKINSA; whether the new tablet formulation for BRUKINSA will result in better patient experience; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' 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IBTROZI is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. "The FDA approval of IBTROZI marks a major milestone in the evolution of targeted therapy for advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We believe one of the greatest threats to ROS1-positive lung cancer patients is disease progression, especially in the first-line setting. In pivotal trials, IBTROZI delivered high response rates with sustained durability—truly meaningful benefits for patients. With its clinically proven efficacy and safety profile, we believe IBTROZI has the potential to become a new standard for what targeted therapies can achieve in this type of lung cancer. With approvals for IBTROZI now in the U.S. and China, and additional global filings underway, we remain committed to delivering innovative therapies that help patients stay ahead of their disease." ROS1+ NSCLC is a rare and aggressive form of lung cancer, accounting for approximately 2% of new NSCLC cases, or about 3,000 new diagnoses of advanced disease annually in the U.S. The median age at diagnosis for patients with this type of lung cancer is approximately 50 years old, and the disease is more likely to occur in people who have never smoked. Brain metastases are common and a leading cause of disease progression and mortality in this population. 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The median duration of response (DOR) was not yet reached for either trial, based on a cutoff date that is nearly five months later than that of the pooled TRUST-I and TRUST-II analysis published in April in the Journal of Clinical Oncology. For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and ongoing. For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and ongoing as of October 2024. Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label. Across the pivotal studies, consistent results were also observed among patients who were previously treated with a ROS1 TKI (TKI-pretreated). In TRUST-I, treatment with IBTROZI achieved a cORR of 52% and median DOR of 13.2 months for TKI-pretreated patients, with median follow-up for responses of 33 months. In TRUST-II, treatment with IBTROZI achieved a cORR of 62%, and as of October 2024 the median DOR was 19.4 months in these patients, with a median follow-up for responses of 19 months. Brain metastases are among the most common and devastating complications in advanced ROS1+ NSCLC. IBTROZI was designed to penetrate the central nervous system (CNS) and has demonstrated consistent intracranial responses in patients with measurable brain metastases at baseline. An intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24). "Patients living with advanced ROS1+ non-small cell lung cancer and their healthcare providers are in need of new treatment options," added Nathan Pennell, M.D., Ph.D., TRUST study investigator and Professor of Medicine at the Cleveland Clinic. "IBTROZI's durability of response and ability to effectively penetrate the brain, coupled with a well-characterized and manageable safety profile, further addresses these critical needs for patients. I believe this now-approved therapy offers providers and patients a promising new option for the treatment of advanced ROS1+ non-small cell lung cancer." Dr. Pennell is a compensated member of Nuvation Bio's advisory committee. IBTROZI was generally well-tolerated, with most adverse events being low grade, transient and manageable. Patients infrequently (7%) discontinued treatment due to treatment-emergent adverse events (TEAEs). The most common adverse reactions (≥20%) included diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). Overall, the majority of CNS events were mild to moderate (~90%) and resolved within days, and dose modifications due to these events were low (~5%). Approximately 90% of reported cases of dizziness were Grade 1 (mild) and transient. Liver enzyme elevations (AST 87%/ALT 85%) and QT prolongation (19%) were manageable with standard monitoring and dose modifications. IBTROZI is approved as a 600 mg once-daily oral dose, supported by a half-life of approximately 66 hours and broad tissue distribution, including the brain, enabling sustained systemic and CNS exposure. Nuvation Bio also announced the launch of NuvationConnect, a program designed to support patients prescribed IBTROZI. The program will offer financial assistance, access to resources and personalized support for eligible patients. Prescribers can learn more at or by calling 1-877-NUV-CON1 (1-877-688-2661). Conference Call & Business Update Nuvation Bio will host a conference call on June 12, 2025 at 7:30 a.m. EDT / 4:30 a.m. PDT, where company executives will provide an overview of the FDA approval of IBTROZI and our plans to now bring this medicine to patients. As a reminder to investors, the approval, together with the first commercial sale, makes the funding secured from Sagard Healthcare Partners in March fully available to the company. Nuvation Bio expects that this finances the launch of IBTROZI in full and provides further resources to continue advancing our pipeline in areas of unmet need. Investors and the general public are invited to register and listen to a live webcast of the event through the company website at Those unable to register can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access code 783971. A replay of the event will be available shortly after the conclusion. About ROS1+ NSCLC Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing CNS metastases. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options. About IBTROZI IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive non-small cell lung cancer. Learn more at About the TRUST Clinical Program The TRUST clinical program evaluating IBTROZI for the treatment of adult patients with advanced ROS1+ NSCLC included two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, which enrolled 173 patients, and TRUST-II (NCT04919811), a global study, which enrolled 164 patients. The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, duration of response, progression-free survival, and safety. Indication IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZITM (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc. Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman. ADVERSE REACTIONS Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes IBTROZI (taletrectinib), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). 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 are sometimes 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, our expectations regarding IBTROZI's therapeutic potential in advanced ROS1+ NSCLC and its potential to become a new standard of care. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 7, 2025 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. View source version on Contacts Media and Investor ContactsNuvation Bio Investor Contact ir@ Nuvation Bio Media Contact media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
4 hours ago
- Business Wire
Australia's SkyJuice Foundation Wins Top Global Prize for Emergency Water Innovation
DUBAI, United Arab Emirates--(BUSINESS WIRE)--SkyJuice Foundation from Australia has been awarded the Innovative Crisis Solutions Award during the fourth cycle of the Mohammed bin Rashid Al Maktoum Global Water Award. The foundation was honoured for its SkyHydrant Emergency Safe Water Solution, a rapid-response water treatment system providing potable water in humanitarian crises and disaster zones. Supervised by the UAE Water Aid Foundation (Suqia UAE), under the umbrella of the Mohammed bin Rashid Al Maktoum Global Initiatives, the award carries a total prize pool of USD 1 million and supports breakthrough technologies that address global water challenges through sustainability and resilience. The GEM Rapid Response Pack, SkyHydrant's flagship emergency solution, can deliver up to 10,000 litres of safe drinking water per day using passive ultrafiltration. Requiring no power, chemicals or technical expertise, the system can be assembled on-site within two to three hours for rapid global deployment. Its patented 'Shake 'n Flush' cleaning system ensures a lifecycle of up to four years. Used by over 25 NGOs and deployed in 74 countries, SkyHydrant units have supported disaster-affected populations in places such as Turkey, Ukraine, Haiti, Lebanon, the Philippines and Myanmar. Designed for displaced communities of 500 to 1,000 people, the system treats water from non-saline sources like rivers, streams and swamps, effectively removing bacteria, viruses, turbidity, algae and coliforms. With capital costs between USD 1,500 and USD 3,000, the system offers a highly cost-effective solution, often less than 50 cents per person annually based on a daily consumption of 50 litres. Maintenance involves basic monthly membrane cleaning, and the entire unit can be redeployed as needed in other emergency settings. 'What we need are decentralised, low-cost, sustainable solutions based on nature and embracing biomimicry that are distributed to poor communities so they can own and operate them. The sooner we can provide everybody with safe drinking water – whether they be refugees, displaced people or people in developing countries – the closer we move towards better equality throughout the world. Receiving this award is a great accolade for all the people that work within the foundation. It validates the meaningfulness of our work, highlights that it is appreciated and also helps to introduce us to other partners,' said Rhett Butler, Chairman and Founder of SkyJuice Foundation.
