University of Iowa Hospitals & Clinics

Key Studies Examined the Benefits of Intraoperative Imaging Using Investigational Agent LUMISIGHT™ in Combination with Lumicell™ Direct Visualization System (DVS) NEWTON, Mass.--(BUSINESS WIRE)--Lumicell Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer detection during surgery, highlights presentations from clinical studies examining the use of investigational LUMISIGHT™ (pegulicianine) in combination with Lumicell™ Direct Visualization System (DVS) at the Society of Surgical Oncology Annual Meeting in Atlanta, Georgia, March 20-23, 2024. This press release features multimedia. View the full release here: Barbara Smith, M.D, PhD., presented results from the INSITE study during the Breast Cancer Hub Zone talk during the SSO Annual Meeting 2024. (Photo: Business Wire) The posters presented at SSO 2024 can be found here and are listed below: Kelly K. Hunt, M.D., Department of Breast Surgery at MD Anderson Cancer Center, shared patient satisfaction via BREAST-Q survey from Patient Reported Outcomes from a Multi-Site, Prospective Pivotal study Evaluating Pegulicianine Fluorescence-Guided surgery (pFGS) for Breast Cancer Lumpectomy Procedures using the Lumicell™ Direct Visualization System (DVS). Carlos HF Chan, M.D., PhD., Associate Professor, Department of Surgery, University of Iowa Hospitals and Clinics, shared interim results from Feasibility of the Pegulicianine Fluorescence Guided Surgery for Detection of Peritoneal Surface Malignancies. Irene Wapnir, M.D., Professor of Surgery, Stanford University Medical Center shared results from a randomized, two-arm study, Positive Pegulicianine Fluorescence in the Lumpectomy Cavity Correlates with Tumor Distance to Margins. Additionally, Barbara Smith, M.D., Ph.D., Director of the Breast Program at Massachusetts General Hospital, delivered a Breast Cancer Hub Zone talk titled, Seeing Cancer in a Different Light: Human Trials of Intraoperative Molecular Imaging in Surgical Oncology which featured results from the INSITE study. “It’s so energizing to see such a diversity of surgeons across different specialties come together to advance the collective field of surgical oncology,” said Jorge Ferrer, M.D., PhD, Chief Scientific Officer, Lumicell. “Our goal with LUMISIGHT and Lumicell DVS is to provide surgeons with a powerful tool that will detect cancer tissue in real-time for removal during surgery, to achieve more complete resections and decrease the emotional and physical toll for patients.” Lumicell submitted a new drug application (NDA) for LUMISIGHT for use in patients with breast cancer undergoing a lumpectomy in 2023 along with a premarket approval (PMA) application for Lumicell™ DVS. Most recently, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of the benefit-risk pro LUMISIGHT™ (pegulicianine) during its March 5, 2024 meeting. The FDA is expected to make a decision on Lumicell’s NDA and PMA in the near future. About LUMISIGHT™ and Lumicell™ Direct Visualization System (DVS) LUMISIGHT™, an optical imaging agent, is used in combination with Lumicell™ DVS, a fluorescence-guided imaging system, and is designed for real-time fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery, also known as breast conserving surgery. LUMISIGHT™ and Lumicell™ DVS are for investigational use only and are not commercially available. About Lumicell Inc. Lumicell is a privately held company focused on improving surgical outcomes and reducing healthcare costs by utilizing its innovative fluorescence-guided surgical technologies to enable a more complete resection of cancer that may otherwise be left behind. The company’s lead products in development are LUMISIGHT and Lumicell DVS which are designed to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit and follow the company on Facebook, X, and LinkedIn.

- Dr. Zeiher brings more than 20 years of drug development experience in areas with serious unmet treatment needs at companies including Astellas Pharma, Pfizer, Eli Lilly and Company, and Merck CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the addition of Bernhardt G. Zeiher, MD, FCCP, FACP, to its Board of Directors (“Board”). Dr. Zeiher brings more than 20 years of drug development experience where, in his various roles, he oversaw the approval of 15 new treatments that addressed people’s unmet needs in serious diseases with few to no treatment options. Most recently, he served as Chief Medical Officer (“CMO”) of Astellas Pharma, where he led early- and late-stage drug development, medical and regulatory affairs, pharmacovigilance, and quality assurance. “This is a pivotal time for Amylyx, and we are thrilled to welcome Dr. Zeiher to our Board to share his perspectives and expertise as the company continues to build a pipeline supporting our collective mission to one day end the suffering of neurodegenerative diseases,” said George M. Milne, Jr., PhD, Chairman of Amylyx’ Board. “Dr. Zeiher's insights of the intricacies and complexities of drug development and innovation in diseases with clear unmet need will be valuable as we continue to serve neurodegenerative disease communities impacted by these devastating diseases.” Dr. Zeiher is a recognized industry leader who spent more than 10 years at Astellas Pharma, holding multiple roles of increasing responsibility in the drug development division, leading up to his role as CMO from 2018 to 2022. Prior to his time at Astellas, Dr. Zeiher held various roles leading drug development at other pharmaceutical companies including Pfizer, Eli Lilly and Company, and Merck. Dr. Zeiher also practiced medicine at a tertiary medical center in Indianapolis and has held a range of board appointments since 2014, including positions at PhRMA Biomedical Advisory Committee, TransCelerate Biopharma, Biotechnology Innovation Organization, Astellas Global Health Foundation, and most recently, Entrada Therapeutics, which he joined in 2023. “We are seeing a transformation in neurodegenerative diseases, both in potential new treatments and what we’re learning through research, and I believe Amylyx is a catalyst in that change,” said Dr. Zeiher. “The company’s community-centric values, steadfast commitment to following the science, and beyond-therapy approaches and support for the neurodegenerative disease community are a few examples of why I am excited for the future and what we can accomplish to support those living with these devastating diseases and their loved ones.” “Dr. Zeiher brings to the Board his distinguished drug development background in overseeing the approval of 15 medicines, and his first-hand experience as a physician. On behalf of the entire Amylyx team, we are delighted to welcome him onboard as we continue to advance our mission to one day end the suffering caused by neurodegenerative diseases,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “We have several important milestones that we’re working toward this year where Dr. Zeiher’s expertise will be key, including our goal to bring our antisense oligonucleotide AMX0114, developed in-house, to the clinic for ALS, continuing to research the potential of AMX0035 in diseases like Wolfram syndrome and progressive supranuclear palsy, and sharing additional insights, learnings, and next steps from our Phase 3 PHOENIX trial in ALS.” Dr. Zeiher received a B.S. in biology from the University of Toledo and an MD from Case Western Reserve University School of Medicine. He completed his internal medicine residency and chief residency at University Hospitals of Cleveland and then finished his physician training as a Pulmonary and Critical Care Fellow at University of Iowa Hospitals and Clinics. About Amylyx Pharmaceuticals Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative disease community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada, EMEA, and Japan. For more information, visit amylyx.com and follow us on LinkedIn and X, formerly known as Twitter. For investors, please visit investors.amylyx.com. Forward-Looking Statements Statements contained in this press release and related comments in our earnings conference call regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, the Company’s expectations of contributions from its board of directors; the Company’s beliefs regarding the benefits of AMX0035 in neurodegenerative diseases; expectations regarding the continued research of AMX0035 in progressive supranuclear palsy and Wolfram syndrome; the Company’s potential announcement of additional insights, learnings, and next steps from the Phase 3 PHOENIX trial; the Company’s expectations with respect to its progress through IND-enabling studies of AMX0114; the Company’s expectations with respect to its early-stage ALS diagnostic test; and expectations regarding the Company’s longer-term strategy. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include the risks and uncertainties set forth in Amylyx’ filings with the Securities and Exchange Commission (“SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Subject to any obligations under applicable law, Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Peer-reviewed publication from Broeckel, et al. describes the second phase of a multisite evaluation of optical genome mapping (OGM) in 627 samples (597 unique samples and 30 replicates)Overall, for the entire study, OGM data have been collected from 1,000 samples, including 404 samples from phase 1 of the studyConcordance for pathogenic variants in all combined samples against standard of care (SOC) methods – 99.5% (995 out of 1,000 samples)When compared to the rate of finding pathogenic or likely pathogenic variants with SOC methods, OGM increased the rate by a factor of 6% to as much as 50% depending on the patient population SAN DIEGO, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO), today announced a peer-reviewed publication detailing results from the second phase of a large multisite clinical study designed to support establishing optical genome mapping (OGM) as part of the standard of care (SOC) in diagnosis of genetic disease for postnatal patients. The clinical study is designed to compare OGM to current SOC techniques, including concordance, reproducibility, technical success rate and the rate of detecting reportable findings in cases. The published first phase of this multisite study demonstrated OGM’s technical performance and reproducibility across sites versus SOC analysis. This second phase extended the study to include additional samples to further assess the technical performance and clinical utility of OGM for postnatal constitutional disorders and to evaluate OGM in prospective samples and in samples from subjects with neurodevelopmental disorders, including developmental delay, intellectual disability and autism spectrum disorder (ASD). The sites conducting the study and their principal investigators are as follows: University of Rochester Medical Center (Dr. M. Anwar Iqbal)Medical College of Wisconsin (Dr. Ulrich Broeckel)Columbia University Medical Center (Dr. Brynn Levy)Greenwood Genetic Center (Dr. Roger Stevenson)Medical College of Georgia, Augusta University (Dr. Ravindra Kolhe)Praxis Genomics (Dr. Peter L. Nagy)University of Iowa Hospitals & Clinics (Aaron Stence)H. Lee Moffitt Cancer Center (Dr. Aaron Bossler) Key Findings The peer-reviewed publication describes OGM performance metrics compared to SOC methods for challenging samples from diagnosed and undiagnosed rare diseases. The key findings are: OGM concordance for pathogenic variants in all combined samples against SOC methods was 99.5% (995 out of 1,000 samples).OGM increased the rate of finding pathogenic or likely pathogenic (P/LP) variants over that of SOC by a factor of 6% to as much as 50% depending on the patient population as outlined below: Patient PopulationNumber of SamplesNumber of Samples w P/LP findings by methodImprovement by OGM (%)SOCOGMRetrospectively collected samples from patients suspected of various genetic disorders40570 (17.3%)91 (22.5%)30%Retrospectively collected samples from patients suspected of ASD21632 (14.8%)34 (15.7%)6%Prospectively collected samples from patients suspected of a genetic disorder945 (5.3%)10 (10.6%)50% Key Takeaways The study authors reported that results demonstrate the ability of an OGM workflow to detect all classes of structural variants (SVs) with higher resolution compared to current SOC methods, including aneuploidies, triploidy, translocations, inversions, insertions, microdeletions, microduplications, nucleotide repeat expansions or contractions, and absence of heterozygosity (AOH). In contrast to variants that are detected by microarray, which are limited to gains and losses, the variants reported by OGM include all classes of SVs, several of which reside in candidate genes associated with the phenotype. The authors concluded that OGM can offer a simple and streamlined workflow that can detect relevant genomic aberrations and mitigate the need for numerous testing platforms and time-consuming wet lab work, potentially improving lab performance by reducing the associated time and costs. “Development and validation of OGM assays for postnatal analysis is an area where we believe our technology can have tremendous global impact. The performance we have seen matches our expectations. We are extremely happy with this publication demonstrating OGM’s performance across multiple sites and its potential ability to perform in a single assay what today requires multiple technologies,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano. “The process of establishing a trial program like this one is made possible by capable principal investigators and leading sites,” commented Alka Chaubey, PhD, FACMG, chief medical officer of Bionano. “We are pleased that these study authors concluded that OGM should be considered as a first-tier method of analysis for postnatal genetic disorders, and that their findings support the utility of a novel tool like OGM to help solve challenging cases in constitutional and rare diseases, including those involving pediatric intellectual disabilities and autism.” The publication is available at https://www.jmdjournal.org/article/S1525-1578(24)00004-7/fulltext#tbl1. About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis technology. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com. Unless specifically noted otherwise, Bionano’s OGM products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “can,” “may,” “potential,” “should,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances and the negatives thereof) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the ability and utility of OGM to detect all classes of SVs with higher resolution, including aneuploidies, triploidy, translocations, inversions, insertions, microdeletions, microduplications, nucleotide repeat expansions or contractions, and absence of heterozygosity (AOH); the ability and utility of OGM to identity VUSs and L/LP finding compared to SOC methods; the ability and utility of OGM to become a SOC for postnatal constitutional disorder analysis and to evaluate samples from subjects with neurodevelopmental disorders, including developmental delay, intellectual disability and autism spectrum disorder (ASD); and the ability and utility of the development and validation of OGM assays of postnatal analysis. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and future bank failures, the ongoing Ukraine-Russia conflict, related sanctions, the Israel-Hamas war, and any global pandemics, on our business and the global economy; challenges inherent in developing, manufacturing and commercializing products; our ability to further deploy new products and applications and expand the markets for our technology platforms; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; failure of future study results to support those reported and discussed in the publication referenced in this press release; future study results that contradict the results discussed and reported in the publication referenced in this press release; failure of OGM to detect all classes of SVs with higher resolution, including aneuploidies, triploidy, translocations, inversions, insertions, microdeletions, microduplications, nucleotide repeat expansions or contractions, and AOH; failure of OGM to identity VUSs and L/LP finding compared to SOC methods; failure of OGM to become a SOC for postnatal constitutional disorder analysis and to evaluate samples from subjects with neurodevelopmental disorders, including developmental delay, intellectual disability and ASD; failure of the development and validation of OGM assays of postnatal analysis; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general; our expectations and beliefs regarding future growth of the business and the markets in which we operate; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts and our ability to continue as a “going concern”; and including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We are under no duty to update any of these forward-looking statements after the date they are made to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date the statements are made. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this press release. CONTACTS Company Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com