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UNOS Applauds House Action to Improve Air Transport of Donor Organs

United Network for Organ Sharing

Today, the U.S. House of Representatives approved its 2023 Federal Aviation Administration (FAA) reauthorization bill, which includes a provision aimed at improving safety and efficiency in the transportation of donor organs through the nation's commercial aviation system. Section 834 of H.R. 3934, the Securing Growth and Robust Leadership in American Aviation Act, requires the Secretary of the Department of Transportation (DOT), in consultation with the FAA Administrator, to convene a working group to develop best practices for the transportation of an organ in the cabin of an aircraft. Before the September 11 attacks, organs – primarily kidneys – were transported within a commercial flight’s cabin, under supervision of the aircrew. Packaged organs were placed in or near the cockpit just before departure and quickly retrieved after landing. The attacks prompted significant changes to airport protocols, including no longer allowing transplant professionals without an airplane ticket to accompany an organ through security. As a result, organs currently travel in the cargo hold. Action by the House promises to review and possibly reverse that long standing practice. “I applaud the actions taken by the House today. I offer my profound thanks to those working with us to make this change a reality, namely Rep. Bruce Westerman and Rep. Greg Stanton from the House Transportation and Infrastructure Committee, and their colleagues Rep. Tracey Mann, Rep. Dusty Johnson, and Rep. Beth Van Duyne,” said United Network for Organ Sharing (UNOS) CEO Maureen McBride, Ph.D. “Today’s news is the result of collaborative efforts on behalf of patients waiting for the gift of life, while also honoring generous donors and their families. There is more work to be done as we ensure this legislation is enacted, but this is a critical step.” While not a common occurrence, any logistical delays heighten the risk that an organ cannot be transplanted. The post-September 11 relegation of organs to the cargo hold created challenges navigating cargo hours and cargo lock-out times - the cut-off time for receiving shipments before the scheduled departure of an aircraft. Not all airlines accept cargo, so options are limited for transporting organs by air, especially to areas served by smaller, regional airports. ”Any organ not ultimately transplanted represents a profound loss, both for the selfless donor’s family and the patient waiting,” said Dianne LaPointe Rudow, ANP-BC, DNP, FAAN, President of UNOS. “Our donation and transplant community is called to honor the gift of life, and that commitment includes not only publicly identifying the issue, but seeking substantive solutions to address it. We owe our patients nothing less.” The provision included in the House version of the FAA reauthorization bill is the result of ongoing advocacy by UNOS, Organ Procurement Organizations (OPOs) and other members of the nation’s organ donation and transplant community. Since December of 2022, UNOS has engaged with the FAA leadership, the Transportation Security Administration (TSA), the Department of Transportation (DOT), and members of both the House and Senate to pursue this reform. “The organ donation and transplant community rallied behind this cause, knowing that it represents major progress for our patients and selfless donors,” said Jerry McCauley, M.D., M.P.H., Immediate Past President of UNOS. “This change is also a cornerstone of the UNOS Action Agenda, a series of improvements we know will strengthen the U.S. donation and transplant system.” To further reduce risk of delay, damage or loss in organ transport, UNOS is recommending changes in the next contract for the Organ Procurement and Transplantation Network that would require the use of physical trackers for unaccompanied donor organs recovered for transplant, and the establishment of a centralized organ tracking system. The Senate Commerce Committee could mark up its reauthorization legislation as soon as next week. The Senate provision would require the FAA to establish regulations ensuring that donor organs transported via commercial flight can once again travel in the plane’s cabin, as opposed to traveling in cargo. “We look forward to supporting the passage of the provision in the Senate Commerce Committee and on the Senate floor,” said McBride. Sen. Maria Cantwell, Chair of the Senate Commerce Committee, Sen. Ron Wyden, Chair of the Senate Finance Committee, and Sen. Ted Cruz, Ranking Member of the Senate Commerce Committee, are supporters of the Senate provision. Actions to move organs back to the airplane cabin and out of cargo were widely endorsed by the donation and transplant community, including the American Association of Kidney Patients, American Foundation for Donation & Transplantation, American Society of Histocompatibility and Immunogenetics, American Society of Nephrology, American Society of Transplantation, American Society of Transplant Surgeons, Association of Organ Procurement Organizations, Donate Life America, Donate Life Virginia, Kidney Care Partners, Kidney Transplant Collaborative, National Kidney Foundation, Nationwide Organ Recovery Transport Alliance, North American Transplant Coordinators Organization, Organ Donation Advocacy Group, Renal Physicians Association, Transplant Recipients International Organization, Transplant Families, Transplant Unwrapped, and Waitlist Zero. Congress will need to advance reauthorization legislation before the current FAA authorization expires on September 30, 2023. About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

July 20, 2023 11:45 AM Eastern Daylight Time

PathAI Launches AIM-HER2 Breast Cancer, an Artificial Intelligence-Powered HER2 Scoring Algorithm for Biopharma Research and Clinical Labs

PathAI

PathAI, a leading provider of AI-powered pathology tools to advance precision medicine, today announced the availability of AIM-HER2 Breast Cancer [i] for research use by clinical laboratories, researchers, and drug developers. AIM-HER2 Breast Cancer delivers automated digital HER2 scoring and is the market’s first algorithm to use additive multiple instance learning (aMIL) heatmaps to visualize the slide features driving the algorithm’s predicted score. AIM-HER2 will be available to biopharma researchers and clinical research lab pathologists on PathAI’s AISight TM [i] digital pathology platform in both the clinical research lab and clinical trial setting. “HER2 IHC assays have provided immense impact to patients by allowing for a widely available test to establish drug eligibility,” said Mike Montalto, Chief Scientific Officer at PathAI. “With AIM-HER2 Breast Cancer, we at PathAI sought to build upon the success of HER2 testing by assisting pathologists in their ability to more confidently score HER2, especially in borderline cases that can be the most challenging and time consuming to review. We also look forward to partnering with drug developers who may be interested in enhancing the scoring of the more recently described HER2 low assay as an important emerging patient population.” In addition to predicting slide-level HER2 score, AIM-HER2 Breast Cancer’s visualizations on AISight utilize additive multiple instance learning (aMIL) heatmaps to deliver a more interpretable and explainable prediction, diminishing the ‘black box’ challenges typically associated with understanding how AI predictions are made. “Our interpretable heatmaps are critical to driving utilization and adoption of AI – because it’s not about blind trust,” said Eric Walk, Chief Medical Officer at PathAI. “The results can be interpreted, explained – and confirmed – by humans. It also streamlines workflow as it allows pathologists to hone in on specific features to confirm the algorithm score and output vs. needing to analyze the entire slide.” AIM-HER2 Breast Cancer was developed using 157,000 tissue annotations and consensus scores on a dataset of over 4,000 slides (collected from more than 65 expert breast pathologists). In addition to slide-level HER2 scoring, AIM-HER2 Breast Cancer quantifies invasive carcinoma and provides a comprehensive analysis of the entire WSI without necessitating manual selection of the region of interest (ROI). To learn more about AIM-HER2 Breast Cancer, register for our webinar on Thursday, July 27, at 11:00am Eastern Time or visit www.PathAI.com Footnotes [i] Both AISight™ and the AIM-HER2 Breast Cancer Algorithm are intended for research-use only. Not for use in diagnostic procedures. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

July 20, 2023 10:00 AM Eastern Daylight Time

UNOS Embraces Reform of the U.S. Donation and Transplant System

United Network for Organ Sharing

Ahead of today’s U.S. Senate Committee on Finance hearing on the nation’s organ donation and transplant system, United Network for Organ Sharing (UNOS) reiterates its commitment to modernizing and reforming the nation’s organ donation and transplant system and working with Congress to achieve measurable results for patients. UNOS is the mission driven non-profit that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the Health Resources & Services Administration (HRSA). “As long as there is a waitlist, it is our moral obligation to ensure we are promoting progress and increasing equitable access to lifesaving transplants,” said UNOS CEO Maureen McBride, Ph.D. “Patients and families are counting on us to pursue improvements that increase transparency, strengthen accountability, and save more lives. We support calls for patient-focused improvements and want to be part of the solution.” The UNOS Action Agenda After being appointed interim CEO in October 2022, McBride immediately began to work on a series of proposed changes that were announced in January 2023 as the UNOS Action Agenda. The Action Agenda drives UNOS’ continued advocacy efforts and outlines critical reforms in eight different areas. These areas include patient empowerment, equity, IT improvement, transportation, transparency, and governance. Many of these reforms have been endorsed by federal partners, members of Congress, and the wider organ donation and transplant community. Numerous components of the UNOS Action Agenda align with HRSA’s Modernization Initiative announced in March 2023. “We are committed to working with HRSA, the U.S. Department of Health and Human Services, Congress and others who care about this system so deeply to assist in carrying out these reforms and to do our part to improve how we serve America’s organ donors, transplant patients and their families,” said McBride. In support of a competitive bidding process, UNOS publicly announced in June that it does not oppose the Senate’s Securing the U.S. Organ Procurement and Transplantation Act, which would allow HRSA to increase competition for the management of the OPTN. Advancing Equity in Transplant UNOS’ Action Agenda includes calls to collect pre-waitlist data, an important change UNOS is advocating for with HRSA and Congress. Increases in transplant rates for minority patients are important and encouraging, but to eliminate inequities in access, more data is needed to understand and reduce inequities around which patients are added to the waiting list in the first place. “Equity in access to transplant begins well before a patient is added to the waitlist,” McBride says. “To address equity holistically, we also need to understand the barriers patients with end-stage organ failure face when it comes to being referred for transplant.” Maximizing The Gift Of Life While some Action Agenda proposals require collaboration with HRSA and the federal government, UNOS has advanced efforts to the extent of its authority since McBride became CEO. This includes work to improve the efficiency of the organ donation and transplant system. “Each organ donation represents a precious opportunity to save a life, and it is a tragic loss when a donor’s generosity does not result in another life saved,” said McBride. “We have been working on robust solutions to maximize the potential of donated organs by developing tools to make it easier for transplant hospitals to say ‘yes’ to an organ and by getting these organs to their destination more safely and quickly.” To address organ non-use – when an organ is recovered but not ultimately transplanted – UNOS and the OPTN have given transplant programs several tools to make it easier to say “yes” to an organ. At its June meeting, the OPTN Board of Directors approved the default use of offer filters for deceased donor kidney offers. These screening filters aim to speed up kidney acceptance rates and increase the number of transplants by sending time-sensitive organ offers automatically to programs most likely to accept organs with certain characteristics. Additionally, the OPTN recently launched a predictive analytics tool, and just concluded a national collaborative, aimed at improving organ acceptance rates at individual hospitals. To reduce the risk of delay and loss of organs traveling by commercial air, UNOS and the donation and transplant community advocated for and are supporting provisions in the next Federal Aviation Administration (FAA) reauthorization that would enable the transportation of a donated organ in the passenger cabin instead of in the cargo hold of an airplane. Because of a post-9/11 change, organs are currently transported as cargo, which does not operate around the clock like the lifesaving organ donation system does. Provisions in both the House and Senate FAA reauthorization bills could possibly reverse that long-standing practice. “As CEO of UNOS, I have sought a new level of collaboration and engagement with members of the nation’s organ donation and transplant community, our federal partners and elected officials,” said McBride. “UNOS is an organization that has not only embraced, but proposed, substantive reforms, and I look forward to working together to create a system that works better for every patient in need.” About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

July 20, 2023 09:30 AM Eastern Daylight Time

Evgen Pharma CMO highlights "very aggressive" disease on Glioblastoma Awareness Day

Evgen Pharma PLC

Evgen Pharma PLC (AIM:EVG) chief medical officer Dr Glen Clack takes the opportunity presented by Glioblastoma Awareness Day to speak with Thomas Warner from Proactive about the disease, which is the most common type of malignant brain tumour in adults. Dr Clack describes glioblastoma as "always very aggressive" and one of the biggest killers of under-40s in the western world, partly because its "vague" symptoms make it difficult to diagnose. He says common symptoms are headaches, loss of appetite, loss of balance, mood swings, nausea, vomiting, personality and behaviour changes, problems with speaking and memory problems. There is currently no cure for the disease, but treatments are available to manage symptoms and improve patients' quality of life. He says around 250,000 new cases of glioblastoma are diagnosed each year worldwide. Evgen Pharma has been studying the effects of SFX-01 in treating glioblastoma and has seen promising results in preclinical models. The company aims to continue research and raise awareness for glioblastoma to support funding for a cure. Dr Clack encourages viewers to visit braintumourresearch.org for more information. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 20, 2023 03:00 AM Eastern Daylight Time

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IQ-AI Limited shares latest progress from Phase I glioblastoma clinical trial

IQ-AI Ltd

Dr Jennifer Connelly, the Principal Investigator (PI) of the IQ-AI Limited sponsored Phase I Clinical Trial that is being conducted at the Medical College of Wisconsin, joins Proactive's Natalie Stoberman to discuss the latest updates from its treatment for recurring glioblastoma patients. IQ-AI Ltd, the parent company of Wisconsin-based Imaging Biometrics, LLC (IB), is focused on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

July 19, 2023 01:03 PM Eastern Daylight Time

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Race Oncology announces deal with manufacturer Ardena to develop company’s new IV formulation RC220

Race Oncology Ltd

Race Oncology CEO Damian Clark-Bruce joined Steve Darling from Proactive to share significant news about the company's recent agreements and partnerships. Firstly, Race Oncology has signed an agreement with Ardena Holding, a global contract development and manufacturing organization. This collaboration will provide additional Good Manufacturing Practice -standard manufacturing capability for its flagship IV formulation of bisantrene, RC220. Ardena is a fully integrated CDMO known for its expertise in assisting biopharma companies throughout the drug development life cycle, including the production of sterile injectable products for clinical development. Clark-Bruce further explained to Proactive that this partnership with Ardena strengthens Race Oncology's existing manufacturing programs, as it establishes a primary source for EU-compliant supplies of RC220. This is particularly important for EU clinical studies, ensuring the availability of high-quality, GMP-compliant formulations of RC220. Additionally, Clark-Bruce shared news about an exclusive license agreement with City of Hope, a prominent US cancer research and treatment organization. Through this agreement, Race Oncology gains access to City of Hope's intellectual property, which highlights bisantrene as a potent inhibitor of the human fat mass and obesity-associated protein. This discovery opens up new possibilities for exploring the therapeutic potential of bisantrene beyond its established use as an anti-cancer agent. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 19, 2023 12:52 PM Eastern Daylight Time

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Futura Medical "absolutely delighted" with US commercialisation agreement

Futura Medical PLC

Futura Medical PLC (AIM:FUM, OTC:FAMDF) CEO James Barder speaks to Thomas Warner from Proactive London after announcing the signing of an agreement with Haleon to market Futura's topical, gel-based erectile dysfunction treatment MED3000. Barder says he's absolutely delighted with the agreement, which gives Futura access to the world's largest market for erectile dysfunction treatments. He gives a brief overview of the agreement, highlighting a $4 million upfront payment and milestone payments ranging from $5 million to $45 million. Barder emphasised the achievability of these milestones and mentioned that a royalty on all sales was also part of the agreement. In related news, Futura Medical announced a change in leadership with Non-Executive Chairman John Clarke stepping down to be succeeded by existing Non-Executive board member, Jeff Needham. Barder says that Needham has "real, relevant experience as we look to launch in the biggest market in the world with MED3000." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 19, 2023 10:52 AM Eastern Daylight Time

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New Policy Aims to Speed Kidney Acceptance Rates, Increase Transplants

United Network for Organ Sharing

The OPTN Board of Directors unanimously approved a new policy, that will help more patients receive a lifesaving kidney transplant by getting the right organ to the right patient faster. United Network for Organ Sharing (UNOS) is the non-profit organization that contracts with the federal government to serve as the nation’s Organ Procurement and Transplantation Network (OPTN). The new policy will improve the use of the OPTN offer filter tool, allowing offers of donor kidneys to arrive quicker to transplant programs that are most likely to accept them. The OPTN Offer Filters tool, which has been available to all U.S. kidney transplant programs since 2022 as an “opt in” resource, allows transplant teams to filter out organ offers that they don’t intend to accept. This allows time-sensitive offers to automatically go to patients at programs that have a history of accepting more medically complex organs. Currently, 60% of kidney programs have at least one filter turned on. The new “opt out” policy passed by the OPTN Board will automatically turn on offer filters specific to each kidney transplant program, based on the program’s acceptance history. Transplant programs will have the option to use these filters, remove them and create their own filters. Due to the continuously increasing number of organs recovered, as well as the diverse acceptance practices across transplant programs, some organ offers are extended to programs that may have never considered organs with certain clinical or donor characteristics. The use of offer filters is one strategy to help Organ Procurement Organizations (OPOs) allocate in the most efficient manner, while ensuring that transplant programs only receive offers that they have a history of considering and would legitimately consider. “The ongoing development of the offer filter tool is driven not only by feedback from the donation and transplant community, but by our own firmly held belief that we can never be satisfied with the status quo,” said Maureen McBride, UNOS CEO. “This new policy and the impact it will have on patients waiting for the gift of life is a critical step in our never-ending effort to drive improvement and save more lives.” Default filters are the first phase in a potential transition to mandatory offer filters, which were recommended by the National Academies of Sciences, Engineering and Medicine in its February 2022 report on the nation’s organ donation and transplantation system. The report identified offer acceptance as a “key area for improvement for transplant centers.” As the number of available organs continues to grow, so does the rate of organ non-use, particularly for kidneys, which are recovered before being accepted. By empowering transplant hospital staff with innovative new tools like offer filters and collaborative best practices, UNOS and the OPTN intend to maximize the potential of every donated organ and ultimately save more lives. Additional efforts to increase organ use Predictive Analytics utilizes waitlist and transplant candidate data at the time of a kidney offer to project when patients would receive additional offers, along with the patients’ likelihood of survival during that time without the initial offer. This information enables transplant teams to make informed decisions about the impacts of accepting or declining an organ offer. Transplant programs that participated in the predictive analytics pilot program demonstrated a 2.9 percentage point increase in offer acceptance compared to earlier. Transplant Vision (TxVx ), currently in early stages of development by UNOS Labs and a digital product development company, will leverage augmented reality technology to scan and digitally reconstruct recovered kidneys. This will help standardize high-quality organ imagery and other long-distance evaluation measurements, such as size and mass used by transplant center teams, to help determine whether to accept an organ offer. The Offer Acceptance Collaborative is an effort led by UNOS in its role as the OPTN. The collaborative has brought together transplant professionals from more than 80 adult and pediatric transplant programs to share effective practices and provide education on new data and analytical tools. Offer acceptance rates vary widely across the country. The collaborative seeks to bring together larger and small transplant programs from every region to learn from one another, improve organ offer evaluation and acceptance practices, and increase system efficiencies. Long-term results stemming from this work can help inform innovative solutions to organ non-use. By maximizing the utilization potential of each organ, we can increase the lifesaving impact that each deceased donor can make on the system. UNet Image Sharing is a digital platform developed by UNOS that allows organ procurement organizations (OPOs) to securely upload, view and share high-quality medical imaging studies with transplant hospitals. It is made available through UNet, the technology at the core of the donation and transplant system that powers patient registrations, donor referrals, organ matching and other essential functions used every day by transplant professionals. UNet Image Sharing was designed with community input that included a robust pilot program and is currently used by 79 percent of OPOs. It enables quicker, more confident decision-making by surgeons evaluating organ offers, which can increase organ acceptance rates and reduce inefficiencies during the organ allocation process. About UNOS United Network for Organ Sharing (UNOS) is a non-profit, charitable organization that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government. The OPTN helps create and define organ allocation and distribution policies that make the best use of donated organs. This process involves continuously evaluating new advances and discoveries so policies can be adapted to best serve patients waiting for transplants. All transplant programs and organ procurement organizations throughout the country are OPTN members and are obligated to follow the policies the OPTN creates for allocating organs. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

July 19, 2023 10:44 AM Eastern Daylight Time

Oxford Cannabinoid Technologies announces "potential breakthrough" in field of oncology

Oxford Cannabinoid Technologies Holdings PLC

Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTCQB:OCTHF) Clarissa Sowemimo-Coker speaks to Thomas Warner from Proactive London after announcing what the prescription cannabinoid medicine company calls a "potential breakthrough" for the treatment of solid tumours. Sowemimo-Coker gives an overview of the announcements, highlighting promising early-stage data, promising, and says Oxford Cannabinoid Technologies is aiming to provide a convenient oral dose form for patients, significantly reducing costs and improving accessibility. The expansion into oncology aligns with OCT's strategy to explore various realms of medicine beyond their initial focus on pain. Sowemimo-Coker says that the company's collaboration agreement with Canopy Growth has already borne fruit, with more potential derivatives waiting to be explored. She also touches on the recent appointment of Dr. Tim Corn as Chief Medical Officer, with a view to advancing clinical trials and overall progress, and concludes by saying that an investor meeting is being held later this week. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 19, 2023 10:19 AM Eastern Daylight Time

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