Neurodevelopmental Disorders

The innovative food-as-medicine platform will help support eligible North Carolinians with serious mental health needs transitioning from institutional care settings to independent living. STAMFORD, Conn., March 19, 2024 /PRNewswire/ -- Alliance Health, a North Carolina-based behavioral health care services managed care company, announced today that it has entered into a strategic partnership with NourishedRx, a digital health and nutrition company based in Stamford, Connecticut, to support eligible members enrolled in North Carolina's Transitions to Community Living (TCL) program. The new partnership will enable Alliance Health to better serve TCL program members transitioning from institutional care settings into community living by providing them with nutritious home-delivered food and associated nutritional support services. Continue Reading Alliance Health "Access to quality food and nutrition is an indispensable component of well-being and has a measurable impact on physical and mental health, including loneliness and depression," said Lauren Driscoll, NourishedRx Founder and CEO. "When combined with coaching, education, and social support, such services catalyze confidence in self-care and self-efficacy that is foundational to successful independent living." The TCL program supports eligible North Carolina adults living with serious mental illness who chose to live outside institutional care settings. Eligible members may have mental health disorders, substance abuse disorders, intellectual/developmental disabilities, or traumatic brain injuries. The TCL program combines affordable housing with intensive, coordinated services, including case management, peer support, and community integration support, to help program participants live and thrive in their communities. Currently, Alliance Health supports over 1,000 households through the TCL program. The partnership's goals are to positively impact tenancy and independent living, improve participants' nutrition security, support health equity, and improve self-reported health outcomes. "In NourishedRx, we've identified a partner with a proven track record of working successfully with vulnerable populations at scale, and a team and platform that can deliver the results we want to see in this innovative program," said Ann Oshel, SVP of Community Health and Well Being, of Alliance Health. "We're excited to engage with NourishedRx in our effort to improve the health and lives of North Carolinians in need of these services." About Alliance Health Alliance Health is the managed care organization for publicly funded behavioral health care services for the people of Cumberland, Durham, Johnston, Harnett, Orange, and Wake counties in central North Carolina as well as Mecklenburg County. Currently, Alliance works with a network of over 4,000 private providers to serve the needs of almost 190,000 Medicaid-eligible and state-funded individuals among a population of over 3.5M. On July 1, 2024, Alliance will begin operating as a Tailored Plan as part of North Carolina's Medicaid transformation. In that role, Alliance will manage all the health care needs – physical, behavioral, and pharmaceutical – for individuals with severe mental illnesses, substance use disorders, or long-term care needs, including intellectual/developmental disability and traumatic brain injury. About NourishedRx NourishedRx is on a mission to eradicate poor diet and nutrition insecurity as top drivers of death, disease, and disparities. Founded in 2019, NourishedRx is a digital health and nutrition company that helps people live healthier lives and supports health equity. Leveraging the connective power of food, NourishedRx partners with healthcare organizations to nourish their most vulnerable members, build health relationships, and support lasting dietary behavior change. Visit Media Contact: Cathy Giandurco [email protected] SOURCE NourishedRx

SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the publication of a study of optical genome mapping (OGM) in hereditary breast and ovarian cancer (HBOC) syndrome showing that when tumors exhibited higher overall numbers of structural variations (SVs) they tended to have more mutated genes and altered signaling pathways, which may correlate with poor prognosis, tumor progression and chemotherapy resistance. Researchers also found that OGM was able to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods. HBOC syndrome is estimated to cause 5-10% of all breast cancers and is commonly characterized by harmful germline mutations in the BRCA1 or BRCA2 genes. Due to limitations inherent in common methods of genome analysis, researchers have limited knowledge regarding the potential impact of structural abnormalities and SV heterogeneity in HBOC-related cancers. The study authors selected OGM for this analysis due to its ability to detect multiple classes of SVs with genome-wide coverage, high resolution and accuracy. Study authors categorized the HBOC-related breast cancer samples into two groups, SVhigh and SVlow, based on the number of SVs detected by OGM, high or low Ki-67 expression, and the number of mutated genes and altered signaling pathways. The authors noted that SVhigh samples were associated with higher Ki-67 expression and higher homologous recombination deficiency (HRD) scores, indicating that genetic alterations may have potential predictive and therapeutic significance. The SVhigh samples also showed higher numbers of chromothripsis events and novel gene fusions than the SVlow samples. Eight novel gene fusions were identified by OGM, including three that had not previously been detected by other methods of analysis. These gene fusions may be involved in drug resistance and tumor development. “We are pleased to see the publication of this study, which highlights OGM as a promising tool for detecting novel variants in HBOC-related breast cancer that have oncogenic potential. We believe the comprehensive assessment of the role SVs play in breast cancers with abnormal DNA repair functions might expand our current understanding of disease progression and precision medicine in breast cancer," commented Erik Holmlin, PhD, president and chief executive officer of Bionano. The paper is available at: 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 (ITP) technology. For more information, visit , or . 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,” “may,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) 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 SVs in samples suspected of HBOC syndrome; and the ability and utility of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods. 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 potential future bank failures, supply chain disruptions, global pandemics, inflation and the ongoing conflicts between Ukraine and Russia and Israel and Hamas, on our business and the global economy; general market conditions; the failure of OGM to detect SVs in samples suspected of HBOC syndrome; the failure of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods; study results that differ or contradict the results reported in the study referenced in this press release; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our need and ability to obtain sufficient financing to fund our strategic plans and commercialization efforts, our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; 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, 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, 2023 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 do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTS Company Contact: Erik Holmlin, CEO Bionano Genomics, Inc. +1 (858) 888-7610 eholmlin@bionano.com Investor Relations: David Holmes Gilmartin Group +1 (858) 888-7625 IR@bionano.com

SOLANA BEACH, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today congratulates its partner PTC Therapeutics, Inc. on completion of its BLA submission to the U.S. Food and Drug Administration (FDA) for the approval of Upstaza™ (eladocagene exuparvovec), an investigational treatment for AADC Deficiency. If approved, Upstaza™ would become the first therapy to treat AADC Deficiency in the United States. “AADC Deficiency is a devastating rare pediatric movement disorder that causes significant developmental delays and autonomic symptoms starting from birth. Patients with AADC deficiency are at a high risk of death in the first decade of life,” stated Jeremy Stigall, Chief Business Officer at ClearPoint Neuro. “The Upstaza™ BLA is the first filing for FDA approval of a treatment that addresses this devastating condition. Through our partnership with PTC, we are demonstrating our commitment to drive progress for the AADC Deficiency community.” About aromatic L-amino acid decarboxylase (AADC) deficiency AADC deficiency is a fatal, rare genetic disorder that typically causes severe disability and suffering from the first months of life, affecting every aspect of life – physical, mental and behavioral. The suffering of children with AADC deficiency may be exacerbated by episodes of distressing seizure-like oculogyric crises causing the eyes to roll up in the head, frequent vomiting, behavioral problems, and difficulty sleeping. The lives of affected children are severely impacted and shortened. Ongoing physical, occupational and speech therapy, and interventions, including surgery, also are often required to manage potentially life-threatening complications such as infections, severe feeding and breathing problems. About the SmartFlow® Cannula With over 7,000 cannulas sold to date, SmartFlow is the only co-labeled device to gain approval by a regulatory agency for delivery of an approved gene therapy to the brain. The industry-leading cannula is used by many of ClearPoint Neuro’s 50+ pharmaceutical, academic, and biotech partners to bypass the blood brain barrier and deliver therapeutics to regions of interest using Convection Enhanced Delivery (CED) under direct image guidance. The SmartFlow Cannula has 510(k) clearance from the FDA for use in the United States for the aspiration of cerebrospinal fluid or injection of the chemotherapy drug Cytarabine into the ventricles. It has also been CE marked to deliver approved fluids into the brain and for aspiration of cerebrospinal fluid, and holds regulatory clearance for clinical use in Israel and Brazil. SmartFlow is utilized in approved clinical and preclinical studies for various research and drug trials. About ClearPoint Neuro ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the context of the federal securities laws, which may include the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which has been filed with the Securities and Exchange Commission. The Company does not assume any obligation to update these forward-looking statements. A photo accompanying this announcement is available at Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (888) 287-9109 ext. 4 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.com ClearPoint Neuro ClearPoint Neuro Navigation Platform for Drug Delivery