Innovative research draws more than 5000 to annual SOT conference – Environmental Factor Newsletter

Advances in neurotoxicology, research into the developmental origins of health and disease, and numerous presentations by NIEHS scientists and grant recipients were among the many highlights at this years Society of Toxicology (SOT) conference.

The 62nd Annual SOT Meeting and ToxExpo was held in Nashville, Tennessee, March 19-23. More than 90 institute scientists, trainees, and staff shared scientific innovations at the event, which drew more than 5,000 attendees from the U.S. and around the world.

The potential for new discoveries involving liquid biomarkers was the focus of this years Hot Topic Session titled Circulating Molecular and Cell-Derived Biomarkers for Translational Toxicology. Scientists may one day be able to monitor or diagnose chronic diseases such as cancer through those biomarkers, which are detectable in body fluids. Called liquid biomarkers, they can reduce reliance on hard-to-reach tissue biopsies.

Erik Tokar, Ph.D., staff scientist in the NIEHS Division of Translational Toxicology (DTT) Mechanistic Toxicology Branch, co-hosted the session, and Julie Foley, health scientist in the same branch, among others, presented research on the topic. Foley highlighted how the combination of liquid biomarker identification and other innovative scientific methods, such as multi-omics, continue to move forward efforts in translational toxicology and precision environmental health.

The NIEHS-led Hot Topic Session demonstrates that we are at the forefront of scientific research and that we are developing important applications, said SOT Vice President Dori Germolec, Ph.D. She is an immunotoxicologist in the DTT Systems Toxicology Branch.

Germolec and others in DTT are working on new approach methodologies (NAMs), which were a major topic at the conference. NAMs are strategies and technologies, such as artificial intelligence and cell-based models, that complement the use of experimental animals. They are being applied to a broad range of areas, such as prioritizing emerging chemicals of concern and understanding disease susceptibility in diverse populations.

Helena Hogberg-Durdock, Ph.D., a staff scientist in the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and an expert in developmental neurotoxicity, presented several posters and continuing education sessions where she explained the real-world application of NAMs.

NAMs can help scientists translate and understand what effects chemical exposures may have on different organs in a human-relevant situation.

We could use this approach to prioritize a class of chemicals, for example, and based on the information we get from a battery of in vitro assays, we can select which are the more concerning chemicals to investigate further, Hogberg-Durdock explained.

Other presentations included the following.

Tokar and Anna Kreutz, Ph.D., a postdoctoral fellow in the DTT Mechanistic Toxicology Branch, presented a poster describing their work on developmental neurotoxicity studies using NAMs. Specifically, they used human stem cells to identify environmental toxicants that affect the development and expression of dopamine. Another poster presentation on the topic of NAMs and developmental neurotoxicity was Tiered testing of Arsenic Developmental Neurotoxicity using Neural Organoid and 2D in vitro Models, presented by visiting fellow, Xian Wu, Ph.D., Darlene Dixon, D.V.M., Ph.D., a group leader in the Molecular Pathogenesis Group; and Tokar.

A symposium titled The Importance of the Placenta in Toxicological Studies was chaired by Thaddeus Schug, Ph.D., health scientist administrator in the NIEHS Population Health Branch. He noted that research into the placenta is key to advancing the scientific framework known as Development Origins of Health and Disease.

The placenta performs many vital roles during development and can provide critical information about the health of the baby and mom, according to Schug. For example, insights into environmental exposures, nutrition, and prenatal health and development can be gained by studying the placenta. Researchers can study the placenta to learn more about health outcomes in both mothers and children. Several NIEHS scientists and grantees presented during the session.

Schug noted that NIEHS participates in the Human Placenta Project, an effort led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The goal is to expand knowledge about placental development, function, and structure.

Neurotoxicity is always a big topic at SOT. This year, one presentation focused on the origins of neurological disease and the neural exposome, delivered by Chief of the Genes, Environment, and Health Branch Cindy Lawler, Ph.D. And a neurotoxicity battery for botanicals was discussed by Mechanistic Toxicology Branch Staff Scientist Chris McPherson, Ph.D.

A large-scale collaboration called The CIAO Project, which includes more than 80 scientists and 50 organizations worldwide, was featured during the conference. The groups latest research regarding the acute and chronic neurotoxicity effects of COVID-19 was shared with attendees.

The blood-brain barrier, for example, should be considered when examining neurological symptoms, together with the sequence of other biological events following viral exposure, explained Hogberg-Durdock. She said that doing so will help scientists understand how an exposure leads to cell damage and then to organ-level effects that result in a noticeable adverse outcome, such as loss of smell, for example. The research framework that assesses that sequence of events is referred to as an adverse outcome pathway.

We are examining what is happening at the cellular, organ, organism, and population level in COVID-19 and have developed four of these adverse outcome pathways for neurological symptoms loss of smell, encephalitis, seizures/epilepsy, and stroke. Then, we explored the modulating factors.

Those factors can include personal demographics such as age but could also be socioeconomic disadvantage or living in polluted communities.

The susceptibility piece is important because we all are different, and we each will respond differently to exposures, Hogberg-Durdock said. Some people are more vulnerable to adverse outcomes than others due to comorbidities or co-exposures.

The CIAO Project will continue to explore the key susceptibilities related to COVID exposures and various outcomes across life-stages, she noted.

Another international effort highlighted at SOT was the joint SOT and Japanese Society of Toxicology (JSOT) Symposium. Germolec hosted this years session titled Novel Insights into Mechanisms of Chemical Carcinogenesis: From Chemical Screening to Tumor Ecosystem Effects.

We hold two joint symposiums every year, Germolec said. There is one in the U.S., and then one at the JSOTs annual meeting, which this year will be in Yokohama, Japan. We take turns deciding on the topic, and two researchers from SOT and two from JSOT are invited to participate on the panel.

This years JSOT will focus on immunotoxicology, and Germolec was invited to present at the conference. The other U.S. invitee is NIEHS grantee Natalie Johnson, Ph.D., from Texas A&M University.

Also, to serve more international audiences, several editors from Environmental Health Perspectives were at the meeting to recruit editors for the soon-to-be-relaunched Journal of Health and Pollution, which will focus on research conducted in low- and middle-income countries.

NIEHS and National Toxicology Program (NTP) Director Rick Woychik, Ph.D., participated in a featured session titled Meet the Directors alongside leaders from the U.S. Environmental Protection Agency and the U.S. Food and Drug Administration.

Woychik also offered opening remarks for an exhibitor-hosted session to discuss the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Strategic Roadmap. Discussions on wrapping up the former five-year plan and receiving public comment for progressing forward were among the highlights. Efforts to advance NAMs and establish greater scientific confidence in them were also discussed.

I am excited about the robust discussion with our many stakeholders on progress ICCVAM has made in implementing the strategic roadmap and how we can tackle the many challenges that lie ahead, said Nicole Kleinstreuer, Ph.D., director ofNICEATM.

NICEATM also launched an updated version of the Integrated Chemical Environment (ICE) dashboard and held several well-attended demonstrations and tutorials for conference attendees at the NIEHS exhibit.

In addition, Woychik, U.S. Food and Drug Administration (FDA) Chief Scientist Namandje Bumpus, Ph.D., and Nigel Walker, Ph.D., chief of the DTT Systems Toxicology Branch, made remarks at an NTP exhibitor-hosted session. They discussed current efforts that are enhancing the interagency partnership and coordination of research activities.

During that session, attended by a standing-room-only crowd, NIEHS Deputy Director Trevor Archer, Ph.D., who also serves as interim DTT Scientific Director, and Bumpus responded to questions about the future of environmental justice within toxicology. They also shared how NIEHS and FDA are looking at diversity, equity, inclusion, and accessibility in the workforce and in regard to work products, including greater transparency in clinical trials and making data more available.

NIEHS program officers and grant administrators hosted several workshops and shared research funding information, and the Office of Communications and Public Liaison hosted the NIEHS booth at the ToxExpo.

We are really happy to be nearly back to pre-pandemic levels in terms of registrants and attendees, and in terms of scientific programming, said Germolec. It was very exciting to see everyone in person in Nashville.

Citation: Hogberg HT, Lam A, Ohayon E, Shahbaz MA, Clerbaux LA, Bal-Price A, Coecke S, Concha R, De Bernardi F, Edrosa E, Hargreaves AJ, Kanninen KM, Munoz A, Pistollato F, Saravanan S, Garcia-Reyero N, Wittwehr C, Sachana M. 2022. The adverse outcome pathway framework applied to neurological symptoms of COVID-19. Cells, 11(21):3411.

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Innovative research draws more than 5000 to annual SOT conference - Environmental Factor Newsletter

Diamyd Medical partners with JDRF to advance the DIAGNODE-3 … – BioSpace

STOCKHOLM, April 4, 2023 /PRNewswire/ -- Diamyd Medical and JDRF, the leading global type 1 diabetes research and advocacy organization, have entered into a four-year research and development collaboration including a non-dilutive $5 million award to Diamyd Medical to support its ongoing Phase 3 trial with the precision medicine antigen-specific immunotherapy Diamyd. The grant will be funded under JDRF's Industry Discovery & Development Partnerships program that focuses on commercialization of therapeutics and devices for the treatment, cure, and prevention of type 1 diabetes and its complications.

"We could not have a better partner than JDRF as we are focusing on rapid advancement of our antigen-specific immunotherapy towards the market," said Ulf Hannelius, CEO of Diamyd Medical. "We expect this collaboration to significantly boost patient recruitment to this international study as well as our commercial preparations."

"JDRF is committed to supporting and advancing disease modifying therapies to delay and reverse type 1 diabetes," said Sanjoy Dutta, Ph.D., chief scientific officer at JDRF. "We are excited about Diamyd Medical's groundbreaking Phase 3 trial and its potential advancements in the preservation of insulin production for people recently diagnosed with type 1 diabetes."

"JDRF has played a crucial role in many of the most novel therapeutics and devices that have been approved in the field for those with type 1 diabetes," said Mark Atkinson, Ph.D., director of the Diabetes Institute at the University of Florida and Diamyd Medical Board Member. "JDRF's commitment to this Phase 3 program is a validation of the scientific and clinical value of the antigen-specific immunotherapy Diamyd. It also emphasizes the importance of making disease modifying therapies available to everyone affected by this disease."

About Diamyd MedicalDiamyd Medical develops precision medicine therapies for Type 1 Diabetes. Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production. DIAGNODE-3, a confirmatory Phase III trial is actively recruting patients with recent-onset Type 1 Diabetes in eight European countries and is being preparedto start recruiting patients in the US this summer. Significant results have previously been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in the Company's European Phase IIb trial DIAGNODE-2, where the Diamyd was administered directly into a lymph node in children and young adults with recently diagnosed Type 1 Diabetes. A biomanufacturing facility is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the antigen-specific immunotherapy Diamyd. Diamyd Medical also develops the GABA-based investigational drug Remygen as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen trial in individuals living with Type 1 Diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB as well as in the artificial intelligence company MainlyAI AB.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.

About JDRF JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally and globally for efficiency and broader fundraising impact, and uniting on a global stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).

About Type 1 Diabetes Type 1 diabetes is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short or long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death if left untreated. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.

For further information, please contact:Ulf Hannelius, President and CEOPhone: +46 736 35 42 41E-mail: ulf.hannelius@diamyd.com

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Design and analysis of outcomes following SARS-CoV-2 infection in … – BMC Medical Research Methodology

Study design and data

We designed a retrospective cohort study of EHR-based outcomes with a non-equivalent comparator of uninfected Veterans. To facilitate measurement of patient-reported outcomes, this retrospective cohort is paired with an embedded smaller post-only survey-based prospective cohort study. In both components, comparator non-equivalence was reduced by generating matched cohorts.

As described previously [5], we assembled a cohort of VA enrollees who tested positive for SARS-CoV-2 RNA in a respiratory specimen within the VA system based on polymerase chain reaction (PCR) tests as well as those with evidence of SARS-CoV-2 infection identified outside the VA but documented in VA records as identified by the VA National Surveillance Tool between March 1, 2020 and April 30, 2021. The earliest date of a documented positive test was taken as each patients date of infection. We included only those Veterans who had an assigned VA primary care team (e.g., Patient Aligned Care Team) or at least one VA primary care clinic visit in the two-year period prior to infection to minimize missingness in EHR-based covariates that are generated from health system interaction. Cohorts were identified sequentially on a monthly basis, with assignment to a particular month for cases based on the date of the positive test or documentation in notes of non-VA evidence of infection. VA-enrolled Veterans without a positive test prior to or during the month who met the same inclusion criteria were considered uninfected potential comparators for that month. The uninfected control group members were eligible for repeated sampling and matching with replacement until they had a positive test. To avoid misclassification of first infection date based on a positive test, infected Veterans with COVID-19-related diagnostic codes (ICD-10: B97.29, U07.1, U09.9, J12.82, Z86.16) listed in fee-for-service Medicare claims 15 or more days before their VA test were excluded. In addition, Veterans from the uninfected comparator group with any such diagnostic codes were excluded from sampling for matching in the month the COVID-19-related code arose and any months thereafter.

We developed 14 separate monthly patient cohortsone for each month (March 2020-April 2021) for the purpose of defining index dates and matching covariates. For example, the March 2020 cohort included all VA enrollees with an initial positive test during March 2020 and all VA enrollees who were alive as of March 1, 2020 and had not been infected prior to April 1, 2020. SARS-CoV-2-infected patients were included as potential comparator patients in months before infection. In a given month, uninfected Veterans could be matched to multiple infected Veterans in that same month and uninfected Veterans could be included in multiple month-specific cohorts as long as they remained uninfected and continued to meet other eligibility criteria. To minimize immortal time bias, the index date was defined as the date of the earliest positive test for SARS-CoV-2- infected Veterans and as the 1st day of the relevant month for uninfected Veterans [6]. Each patients index date served as the anchor for defining matching covariates (with covariate construction starting 14 days prior to the positive test date for infected patients), based on EHR data from the prior two years.

Our goal was to conduct many-to-one matching that would maximize retention of infected patients for external validity and covariate balance for internal validity. A priori, we defined a suitable matching strategy as one that would result in <5% attrition of the infected cohort and achieve covariate balance among the selected covariates for matching based on standardized differences<0.1 [7].

Coarsened exact matching (CEM) was initially attempted. Covariates used for matching were derived iteratively at a single point in time (summer 2021) with the understanding that the evidence base about causes and consequences of COVID-19 was (and is) evolving rapidly. In collaboration with clinician-investigators (see left column, Appendix 1), we identified a broad list of demographic, clinical, and health care utilization measures hypothesized to be either risk factors for pre-specified outcomes alone (e.g., survival, depression, total VA costs, disability, healthcare-related financial strain due to high out-of-pocket costs) or confounders associated with both infection and outcomes [8].

To minimize sample loss when attempting to match on many covariates in CEM [9], the five physician principal investigators then worked together to prioritize covariates for the final matching specification (see right column, Appendix 1). Modified coarsened exact matching was then implemented using this prioritized set of covariates. However, a suitable exact match could not be identified for 53.7% of infected Veterans, so we reverted to a form of combined exact and calendar time-specific propensity score matching [10], with cohorts identified by index month.

In a two-step process, infected patients were exact matched to uninfected controls based on index month, sex, immunosuppressive medication use (binary), state of residence, and COVID-19 vaccination status (effective in January-April 2021 cohorts only) because these covariates were strong potential confounders. In the second step, a total of 39 binary, categorical, and continuous covariates were included in the propensity score model, including immunosuppressive medication use (binary), nursing home residence any time in the prior two years, vaccination status (January-April 2021 cohorts), and diagnosed CDC high-risk conditions: [11] coronary heart disease, cancer (excluding non-metastatic skin cancers), chronic kidney disease, congestive heart failure, pulmonary-associated conditions (including asthma, COPD, interstitial lung disease, and cystic fibrosis), dementia, diabetes, hypertension, liver disease, sickle cell/thalassemia, solid organ or blood stem cell transplant, stroke/cerebrovascular disorders, substance use disorder, anxiety disorder, bipolar disorder, major depression, PTSD, and schizophrenia.

Other categorical variables in the propensity score model included sex, race, ethnicity, rurality of the Veterans home ZIP code, state of residence, smoking status, and categorization of two comorbidity scores (CAN [12], Nosos [13]). Continuous covariates included age, body mass index (BMI), comorbidity score via Gagne index, distance from a Veterans home to nearest VA hospital, count of CDC high-risk conditions, count of mental health conditions, and four VA utilization measures (inpatient admissions, primary care visits, specialty care visits, mental health visits in the prior 2 years).

A caliper of 0.2 times the pooled estimate of the standard deviation of the logit of the propensity score was used to bound which uninfected patients could be matched to each infected patient [14]. To provide the survey team a sufficiently deep pool of matched controls to account for survey non-participation, the 25 matched uninfected patients closest in propensity score were retained for each infected patient. Infected patients with fewer than 25 matched uninfected patients had all their comparator patients selected as eligible matches. Matching was performed by the PSMATCH procedure from SAS/STAT 15.1 in SAS 9.4M6 via the VA Informatics and Computing Infrastructure (VINCI) platform.

The EHR-based clinical outcomes that we intend to compare between matched cohorts are mortality, depression, suicide, onset of new clinical diagnoses, exacerbation of prevalent conditions, development of COVID-19 sequelae, and health care use and VA health care costs. The survey-based outcomes to be compared between matched cohorts include disability, healthcare-related financial strain, and health-related quality of life. Our default approach to analyses will be per-protocol, such that uninfected patients who cross over to become infected will be censored at the time of infection. Future analyses will account for this potentially informative censoring via inverse probability of censoring weights [15] and/or censoring of the entire matched strata at time of censoring. The study team discussed inclusion of negative control outcomes, but an outcome expected to be null between comparators could not be identified due to the ubiquitous effects of SARS-CoV-2 infection and the conditioning of negative control outcomes on health care utilization that might be differential between comparators.

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Design and analysis of outcomes following SARS-CoV-2 infection in ... - BMC Medical Research Methodology

Hemostemix Second Round Interviews with Executive Vice President Business Development Candidates – Marketscreener.com

Alberta - Hemostemix Inc. ('Hemostemix' or the 'Company') (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) is pleased to announce it is completing a second round of interviews with candidates who may join the company as Executive Vice President, Business Development.

The EVP Business Development will be responsible for building and leading a team focused on the following: The sale of Tranch 1 - 500 ACP treatment convertible debentures at USD $35,000 each, to raise USD $17.5M, a mostly non-dilutive financing. Thereafter, the sale of tranche 2, etc., to finance production.

Commence the roll-up of USA-based Podiatry clinics.

Demonstrate to Podiatrists the impact to the clinic's revenue and margins of the addition of exempt ACP-01 treatments. For example, model the sale of up to 16 ACP, 30 minute, aseptic CLI injection procedures per day in keeping with the phase II injection protocol.

Sell and close podiatry clinicians on how they can monetize the value of their sweat equity, exchanging it for shares of Hemostemix.

Provide direction and analyses of potential Podiatry clinic acquisitions globally, analyzing market access in the EU, Mexico, Central and South America, the Middle East, India, Japan, and S. Korea.

Hire and manage articulate, multi-lingual, biotech-seasoned business development sales executives to increase the velocity of podiatry clinic acquisitions and ACP compassionate sales.

The five year survival rate of CLI amputees is < 30%. ACP-01 is a safe cell therapy for the treatment of CLI, a loss of circulation (atherosclerosis) in the limbs that leads to severe chronic pain at rest, ulcerating wounds that will not heal, gangrene and amputation.

ACP-01 has completed a Phase II clinical trial for CLI. In the 17 center Phase II clinical trial of 68 subjects randomized 2:1 to receive ACP, 93.5% of ACP-01 treated limbs were saved from amputation. An interim data point of the phase II trial published by UBC and U of T noted healing of ulcers and resolution of ischemic rest pain occurred in 10 of 12 patients, and that outcomes were maintained for up to 4.5 years.

In the ACP-01 randomized Phase I trial of 20 subjects followed for two years, there were no deaths and 70% (7/10) of treated limbs were saved from amputation. In the control group (non-treated), there were two deaths and 75% (6/8) of limbs were lost to amputation.

The annual incidence of CLI is estimated to be 220-3,500 per 1,000,000 and its prevalence is estimated to be 1% of the adult population (CLI epidemiology and clinical presentation). It is estimated there are 236 Million who suffer from peripheral arterial disease (PAD), and up to 10% of PAD patients progress to CLI (23,600,000). Hemostemix is scaling its patented automated cell therapy system ('ACTS Production) to 4,000 batches per month by the end of 2027 to optimize its costs and margins while completing its clinical trials. Thereafter, ACTS production pods may be located in centralized production plants that scale to meet demand.

ACP-01 as a treatment of heart disease (ischemic cardiomyopathy), demonstrated statistically significant improvements in 245 patients who participated in one of three phase 1 studies (171 subjects), or who were consecutively treated compassionately for ischemic cardiomyopathy (74 subjects) and studied retrospectively. In the retrospective study, left ventricle ejection fraction, a key measure of heart health, improved 27% on average at 12 months after treatment (p$9 Billion.

ABOUT HEMOSTEMIX

Hemostemix is a patient's blood-sourced stem cell therapy platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. Founded in 2003, a winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling by the end of 2027 the manufacture of 4,000 patient treatments per month in its automated cell therapy system ('ACTS') manufacturing cell. ACP-01 is created from the patient's blood. Six published studies of ACP-01, and a retrospective study of 53 consecutively treated ischemic cardiomyopathy patients, 345 study subjects in total, demonstrate ACP-01 is safe and preliminarily efficacious in the treatment of critical limb ischemia, angina, ischemic and dilated cardiomyopathy. The Company is selling ACP-01 forward on an exempt compassionate basis while it completes its clinical trials to obtain exclusive market access for certain medical indications.

Contact:

Thomas Smeenk

Email: tsmeenk@hemostemix.com

Tel: 905-580-4170

Forward-Looking Information

This news release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: the financing of the Company and its lead product ACP-01 and the commercialization of ACP-01 via the sale of compassionate treatments subject to exemption from regulatory approval. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of the litigation that Hemostemix is pursuing or defending (the 'Litigation'); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages and Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix mayface; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression;the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing.

(C) 2023 Electronic News Publishing, source ENP Newswire

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Hemostemix Second Round Interviews with Executive Vice President Business Development Candidates - Marketscreener.com

Development and application of rTMS device to murine model … – Nature.com

Coil design theory

Before designing the coil, it is important to calculate the required parameters such as coil inductance and H field intensity so we can use the minimum turns and optimal design to reach the required values. The inductance and magnetic field intensity were calculated mathematically. The HaroldWheeler formula was used to calculate the inductance13,14. This formula is applied at "low" frequencies (<30MHz) using enameled copper wire. The inductance (L) can be calculated as follows:

$$L = frac{{N^{2} A^{2} }}{{30A - 11D_{i} }}$$

(1)

where Di denotes the inner diameter of the coil set to 20mm and N and A represent the number of turns and cross-sectional area of each turn of the coil, respectively (Fig.1). Further, the area of the coil can be calculated as

$$A = frac{{D_{i} + N(W + S)}}{2}$$

(2)

where W denotes the width of the wire (considered 3 to maintain a smaller size), and S denotes the spacing between the coil's turns, which is set as 0.2mm. As we required a smaller coil, the turn of the coil (N) was kept at 7 to enable the focus most of the H field on the murine brains. Solving Eqs.(1) and (2), the calculated inductance of the coil was 2.04 H. Furthermore, the H field intensity (B) was calculated as

$$B = frac{{mu_{0} NI}}{2R}$$

(3)

where I is the input current of the coil, which is set to 1000A, and R is the total radius of the coil. Therefore, the calculated H field intensity was 0.43T.

Physical dimensions of the HaroldWheeler formula.

After calculating its parameters, we designed and analyzed the coil using an FEM simulation tool (Ansys Maxwell). The frequency of stimulation was conducted with 20Hz due to its beneficial biological effects on the Alzheimers disease model brain3. And, for thermal profile analysis, Femtet (Murata Software Co., Ltd., Tokyo, Japan) was used. The designed coil is shown in Fig.2.

Coil design and parameters.

The design parameters are summarized in Table 1.

The designed coil was simulated in Ansys Maxwell, and the inductance of the coil was analyzed (Table 2). The calculated result is almost identical to the previously calculated inductance.

Furthermore, the magnetic field intensity on the coil's surface was analyzed and matched with the calculated results shown in Fig.3. The magnetic field intensity was simulated using Finite element simulation tool with finite element method11. Therefore, the magnetic field in this study is the vector sum of the magnetic field intensity. The coil's maximum magnetic field intensity is generated at its center (0.44T), which matched our calculated value.

Magnetic field intensity of the designed coil.

To design a new rTMS coil, we optimized its design by simulating the thermal stability and focusing degree. The circular coil was adopted in this study because it demonstrates superior fine focusing ability and generates less heat compared to figure 8-shaped coil.To confirm this, we performed several simulations. In the initial stage of this study, we designed a figure 8-shaped coil with similar parameters and kept a reference plane 5mm apart to compare the magnetic field pattern with circular coil shown in Fig.4.

Simulation setup of coils for simulation of magnetic field intensity: (a) designed circular coil; (b) figure 8-shaped coil.

After running the magnetic field analysis simulations, we have observed that figure 8-shaped coil generates two focusing magnetic field patterns when placed close to the subject as shown in Fig.5b, whereas the circular coil is still producing a single focusing magnetic field pattern when placed close to the subject as shown in Fig.5a. Also, the magnetic field pattern of figure 8-shaped coil is much wider than circular coil as we are trying to focus on a smaller subject and the extra field generated by figure 8-shaped coil will be not of any use.

Comparison of magnetic field intensity on observation plane: (a) designed circular coil; (b) figure 8-shaped coil.

To examine the focus area and quantitative values of focality of two different coils, we performed 3D plot analysis of magnetic field intensity on an observing plane kept 5mm apart from coil as shown in Fig.6.

3D plot of magnetic field intensity of (a and b) Circular coil, (c and d) Figure 8-shaped coil with respect to distance.

Figure6a, b shows the 3D magnetic field distribution of circular coil across the observing plane. It is observed that the high intensity field is focused (which is displayed with red in the plot). Whereas Fig.6c, d shows 3D magnetic field distribution of figure-8 shaped coil across the observing plane where the intensity is not concentrated on a single area, rather it has two different peaks of intensity.

Further, the magnetic field distribution of two different coils is plotted on a graph for better comparison of focality as shown in Fig.7. Therefore, it is concluded that circular coil has more concentrated focusing ability than figure 8-shaped coil.

Graphical comparison of magnetic field intensity and pattern of circular coil and figure-8shaped coil.

The circular coil had a better focus than the figure 8-shaped coil. Moreover, the intensity of the circular coil was higher than that of the figure 8-shaped coil. The major drawback of the figure 8-shaped coil is that it focuses on two different places that reduce the magnetic field intensity. Therefore, a circular coil was selected for the experiment. Moreover, it is important to maintain the thermal stability of the rTMS coil. So we further studied the thermal profile of two different coils as our aim was to avoid excess heating produced by the coil. After running the temperature analysis simulations, we found out that figure 8-shaped coil is generating more heat than circular coil because of higher amount of turns as shown in Fig.6. Thermal analysis of the coil was simulated using Femtet (Fig.8). A remarkable difference in temperature was noted between the two coils. Accordingly, we concluded that circular coil is more efficient in terms of magnetic field focusing and thermal stability when the subject is small and close to the coil.

Comparison of thermal analysis of the designed: (a) circular coil; and (b) figure 8-shaped coil.

Before using the fabricated rTMS coil, it was necessary to calculate the optimal magnetic field discharge conditions. A head model was required to interpret the simulation results. There are many reports on human models but few on rodents, especially murine head models. Therefore, brain imaging images of C57BL6 mice were obtained using 7.0T MRI (Fig.9a). After the depths of the various layers constituting the head were measured, a real murine brain model was simulated (Fig.9b).

Murine head structure analysis and simulation model construction: (a) brain MRI images of C57BL/6 mice; (b) analytical model of different layers (scalp, skull, dura matter, arachnoid matter, subarachnoid space, pia matter, brain) of the murine head.

Furthermore, a circular coil was simulated using a murine brain model. The objective was to study the change in magnetic field intensity of the coil induced to the murine brain with change in distance, so the coil position was varied (0, 2, 5, 8, and 10mm away from the model) and the readings were recorded. The magnetic field simulation results are shown in Fig.10 and Table 3.

Magnetic field intensity simulation using the mice brain model. The distance between the coil and brain model varied: (a) 0mm apart; (b) 2mm apart; (c) 5mm apart; (d) 8mm apart; and (e) 10mm apart.

With increasing distance, the magnetic field induced in the brain decreased. The maximum H field was obtained when there was no gap between the coil and the mouse head. The best reading was obtained 2mm apart, and the intensity of the H field was sufficient to stimulate the brain cells.

Since the conductivity of different tissues is different, according to the MRI data, electromagnetic properties and thickness were fed in different tissues of murine brain model in the simulation tool. The thickness and electromagnetic properties of different tissue layers are summarized in the Table 4. The murine head model was modeled using 6 different tissue layers (scalp, skull, dura matter, arachnoid matter, and brain). According to measurement of the electric field strength on murine brain model, it was obtained as 136.14V/m (Fig.11).

Simulation result of electric field intensity of murine brain model.

All animal experiments were approved by the Institutional Animal Care and Use Committee of CHA University (IACUC210116). Isoflurane was administered via a VEVO COMPACT ANESTHESIA SYSTEM, and anesthesia induction was performed by positioning the nose of each mouse into a small nose cone delivering 3% isoflurane in pure medical oxygen. Anesthetized animals were fixed stereotaxically and rTMS stimulation was applied. After shaving the mouse's neck and making a minimal incision, a Tesla meter (FW Bell's model 8010) probe was inserted into the skull to measure the Tesla under the skull18. The mice were housed in four cages and maintained on a daily 12:12h lightdark cycle in a temperature-controlled room. The animals were provided standard rodent food and water ad libitum. The mice were allowed to acclimatize to the new environment inside the cage for 7days prior to the start of the study, and the ears were punctured 3days prior to confirmation.

MRI was performed using a 7.0T small animal scanner (Biospin 70/20 USR; Bruker, Fllanden, Switzerland). A quadrature birdcage coil (inner diameter, 72mm) was used for excitation, and an actively decoupled 4-channel phased array surface coil was used to receive the signal. T2-weighted images were acquired from C57BL/6N mice under isoflurane anesthesia (5% for induction, 1.5% for maintenance) using a turbo rapid acquisition with refocusing echoes (Turbo RARE) sequence with the following parameters: repetition time (TR)/echo time (TE)=3000/60ms; number of averages=4; field of view=3030mm2; image matrix=192192; and in-plane resolution=0.1560.1560.75 mm319.

Additionally, to confirm difference in output of rTMS coil for mouse form it of conventionally used for human application, the electric field intensities from those were compared by the same stimulation conditions at a place in air. As for human rTMS, a conventional clinical device, Brain-Stim-A of Remed Co. which acquired approval of Korean government was used.

Data are presented as meanstandard error. Statistical comparison between each group was performed on values calculated through simulation and magnetic field applied values by distance using one-way ANOVA using SPSS version 21.0 (IBM, Chicago, IL, USA). A value of p<0.05 was considered statistically significant as different.

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Development and application of rTMS device to murine model ... - Nature.com

Key mechanism that controls human heart development discovered – Phys.org

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Writing in Science Advances researchers of the University of Cologne describe a key mechanism that controls the decision-making process that allows human embryonic stem cells to make the heart. These discoveries enable better insights into how the human heart forms in an embryo and what can go wrong during heart formation, causing cardiac disease or, in the worst case, embryo termination.

In humans, a specialized mRNA translation circuit predetermines the competence for heart formation at an early stage of embryonic development, a research team at the Center for Molecular Medicine Cologne (CMMC) and the University of Cologne's Cluster of Excellence in Aging Research CECAD led by Junior Professor Dr. Leo Kurian has discovered.

While it is well known that cardiac development is prioritized at the early stages of embryogenesis, the regulatory program that controls the prioritization of the development of the heart remained unclear until now. Kurian and his team investigated how the prioritization of heart development is regulated at the molecular level. They found that the protein RBPMS (RNA-binding protein with multiple splicing) is responsible for the decision to make the heart by programming mRNA translation to approve future cardiac fate choice.

The study is published under the title 'mRNA translational specialization by RBPMS presets the competence for cardiac commitment' in Science Advances.

A better understanding of human cardiac development is essential not only to determine the fundamental principles of self-organization of the human heart but also to reveal molecular targets for future therapeutic interventions for congenital and adult-onset cardiac disease.

Since the heart is the first functional organ to form in a developing embryo, any anomaly in early embryonic cell fate decisions needed for the development of the heart leads to catastrophic consequences, often resulting in the termination of pregnancy or lifelong suffering due to congenital heart diseases.

In humans, approximately 30 percent of developing embryos terminate before implantation in the uterus, and about 25 percent fail during the transition from gastrulation (the early phase when the embryo begins to differentiate distinct cell lineages) to organogenesis (the phase that lasts until birth when all tissues and organs form and mature).

Often, the cause of embryo termination is impaired cardiovascular cell fate decisions and morphogenesis, the biological process by which a cell, a tissue or an organism develops its form. The failure to accurately specify cell fate and cell identity in a timely and robust manner results in developmental abnormalities and diseases. For example, 1 out of 100 children are born with congenital cardiac diseases, for the majority of which the causes are unknown.

To discover the regulatory program behind heart development, the Kurian lab used embryonic stem cell-based models that recapitulate human cardiac fate decisions in a dish under chemically defined conditions. The use of human stem cell-derived models allows the team to identify human-specific attributes, which can be drastically different from other animals. The aim of this approach is to work with the most precise models closest to human biology and to minimize animal experiments.

The team discovered that the competence for the future cardiac fate is preset in human embryonic stem cells (hESCs) by a specialized mRNA translation circuit controlled by the RNA binding protein RBPMS. RBPMS is recruited to active ribosomes, the molecular machine that produces proteins from mRNA. There, RBPMS controls the production of essential factors needed for the program that triggers the stem cells to develop into heart cells.

Mechanistically, RBPMS has two functions. On the one hand, the protein interacts with components to promote the translation of mRNA to proteins; on the other hand, RBPMS selectively regulates the production of mesoderm signaling components in hESCs by binding to a specific site on the mRNA. The mesoderm is the middle layer of the three germ layers, from which the heart develops early on in embryos.

It is believed that through early contact with cardiogenic signals, the ability of stem cells to develop into future cardiac lineages is predetermined. This study shows that the RBPMS-mediated selective mRNA translation circuit approves the cellular abundance of 'morphogen signaling infrastructure' required for cardiac mesoderm approval in hESCs. Thus, RBPMS sets up the future cardiac competence of hESCs by programming selective mRNA translation.

"In summary, we present a model whereby the state of pluripotency is primed for differentiation into future cell lineages through specialized translation of the regulators of embryonic cell fate. Our work shows that RBPMS selectively programs translation, i.e. the reading of mRNA and the production of proteins or mRNAs. This controls proteins and regulatory mRNAs that themselves code for important developmental regulators and are essential for deciding future cell fate," Dr. Deniz Bartsch, first author of the study, explained.

Based on their findings, the team proposes 'translation specialization': a regulatory mechanism that primes ribosomes to control translation in time and/or space for a set of mRNAs required for future events in response to specific stimuli or fate transitions. This allows efficient division of labor among the approximately ten million ribosomes present in each cell, which are tasked with synthesizing about two million proteins per minute, so the flow of information is streamlined and, as they show, specialized.

This study, therefore, reveals a central role for translational specialization in shaping cell identity during early lineage development and proposes that ribosomes act as a unifying hub for cellular decision-making rather than a mere protein factory.

More information: Deniz Bartsch et al, mRNA translational specialization by RBPMS presets the competence for cardiac commitment in hESCs, Science Advances (2023). DOI: 10.1126/sciadv.ade1792. http://www.science.org/doi/10.1126/sciadv.ade1792

Journal information: Science Advances

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Key mechanism that controls human heart development discovered - Phys.org

Lab-grown fat could give cultured meat real flavor and texture – EurekAlert

Researchers have successfully bulk-produced fat tissue in the lab that has a similar texture and make-up to naturally occurring fats from animals.

The results, described in a study published today in eLife, could be applied to the production of cultured meat grown entirely from cells, giving it a more realistic texture and flavour.

Cultivated meat has been making waves in the news lately, with reports from startup companies around the world developing cell-grown chicken, beef, pork and fish mostly in early stages of development, not ready for large-scale production and with a couple of exceptions, not yet approved for commercial sale. Most of those products in development are in the form of an unstructured mixture of cells like chicken nuggets rather than a slice of chicken breast. What is lacking is the texture of real meat, created by muscle fibres, connective tissue and fat and its the fat that gives meat flavour.

In fact, consumer testing with natural beef of different fat content showed that the highest scores were registered for beef containing 36% fat.

However, producing cultured fat tissue in sufficient quantities has been a major challenge because, as the fat grows into a mass, the cells in the middle become starved of oxygen and nutrients. In nature, blood vessels and capillaries deliver oxygen and nutrients throughout the tissue. Researchers still have no way to replicate that vascular network at a large scale in lab grown tissue, so they can only grow muscle or fat to a few millimetres in size.

To get around this limitation, the researchers grew fat cells from mice and pigs first in a flat, two-dimensional layer, then harvested those cells and aggregated them into a three-dimensional mass with a binder such as alginate and mTG, which are both already used in some foods.

Our goal was to develop a relatively simple method of producing bulk fat. Since fat tissue is predominantly cells with few other structural components, we thought that aggregating the cells after growth would be sufficient to reproduce the taste, nutrition and texture profile of natural animal fat, says first author John Yuen Jr, a graduate student at the Tufts University Center for Cellular Architecture (TUCCA), Massachusetts, US. This can work when creating the tissue solely for food, since theres no requirement to keep the cells alive once we gather the fat in bulk.

The aggregated fat cells immediately had the appearance of fat tissue, but to see if they truly reproduced the features of native fat from animals, the team carried out a series of further experiments.

First, they explored the texture, by compressing the fat tissue and seeing how much pressure it could withstand compared to natural animal fat. They found that cell-grown fat bound with sodium alginate was able to withstand a similar amount of pressure to fat from livestock and poultry, but the cell-grown fat that was bound with mTG behaved more like rendered fat similar to lard or tallow. This suggests it could be possible to fine-tune the texture of cultured fat, so it best resembles the real-life texture of fat within meat, using different types and amounts of binders.

Cooking releases hundreds of compounds that add flavour to the meat, and most of those compounds originate from fat, including lipids and their component fatty acids. The team therefore examined the composition of molecules from the cell-grown fat and found that the mix of fatty acids from cultured mouse fat differed from native mouse fat. However, the cultured pig fat had a much closer fatty acid profile to the native tissue. The teams preliminary research suggests it might be possible to supplement growing fat cells with the required lipids to ensure that they more closely match the composition of natural meat.

This method of aggregating cultured fat cells with binding agents can be translated to large-scale production of cultured fat tissue in bioreactors a key obstacle in the development of cultured meat, says senior author David Kaplan, Stern Family professor of Biomedical Engineering at Tufts University and director of TUCCA. We continue to look at every aspect of cultured meat production with an eye toward enabling mass production of meat that looks, tastes and feels like the real thing.

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About eLife

eLife transforms research communication to create a future where a diverse, global community of scientists and researchers produces open and trusted results for the benefit of all. Independent, not-for-profit and supported by funders, we improve the way science is practised and shared. In support of our goal, weve launched a new publishing model that ends the accept/reject decision after peer review. Instead, papers invited for review will be published as a Reviewed Preprint that contains public peer reviews and an eLife assessment. We also continue to publish research that was accepted after peer review as part of our traditional process. eLife receives financial support and strategic guidance from the Howard Hughes Medical Institute, Knut and Alice Wallenberg Foundation, the Max Planck Society and Wellcome. Learn more at https://elifesciences.org/about.

To read the latest Cell Biology research in eLife, visit https://elifesciences.org/subjects/cell-biology.

And for the latest in Stem Cells and Regenerative Medicine, see https://elifesciences.org/subjects/stem-cells-regenerative-medicine.

Aggregating in vitro-grown adipocytes to produce macroscale cell-cultured fat tissue with tunable lipid compositions for food applications

4-Apr-2023

No competing interests declared

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Lab-grown fat could give cultured meat real flavor and texture - EurekAlert

BioCardia Announces Issuance of Two Patents Related to … – InvestorsObserver

BioCardia Announces Issuance of Two Patents Related to Technology That Guides Interventional Therapies

SUNNYVALE, Calif., April 04, 2023 (GLOBE NEWSWIRE) -- BioCardia , Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the issuance of two patent grants related to enabling technologies for delivery of its investigational autologous and allogeneic cell therapies.

The United States Patent Office issued BioCardia Patent Number 11,716,859, entitled Multi-Directional Steerable Catheter, with a patent term that will expire in 2035. The patent claims a fundamental design for steerable introducer sheaths, such as those used for BioCardias autologous and allogeneic cell therapy procedures, and for transseptal procedures for the treatment of cardiac arrhythmias. The design enables the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. This design is intended to enable smooth navigation and prevent whip, when a catheter in the heart suddenly jumps from one orientation to another due to the build-up of mechanical forces in the device. This patented design is incorporated in the Companys FDA-cleared Morph DNA product, a 5 French sheath equivalent, and in the Companys FDA-cleared Avance product, an 8.5 French introducer sheath indicated for transseptal procedures.

The Indian Patent Office granted the Company Patent Number 424579, entitled Steerable Endoluminal Devices and Methods for Use, with a patent term that will expire in late 2031. The patent claims a fundamental design for steerable introducer sheaths. The design is for a coil with a braid disposed coaxially about the coil, all embedded within the wall of an introducer sheath. The coil enables a robust, kink-resistant design with enhanced column support, while the braid in the catheter shaft provides for excellent torque transmission. This patent design feature has demonstrated excellent performance in the Companys Morph Access Pro product family and has been used to treat approximately 10,000 patients to-date, ranging from a two-year-old girl to a 90-year-old man.

This positive experience with the Morph DNA, Avance, and Morph AccessPro underlies our understanding of catheter navigation that informs the delivery of our higher-value biotherapeutic interventions, where we utilize steerable guide sheaths in every procedure, said BioCardia CEO Peter Altman, PhD. The acquisitions of Baylis by Boston Scientific for $1.5 billion and the acquisition of the Acutus sheath portfolio by Medtronic for $87 million last year were focused on enabling transseptal access devices, like these, that enable ablation therapies to treat cardiac arrhythmias. These acquisitions show that these steerable catheter assets are nontrivial to develop and that the intellectual property that underlies these assets has the potential to enable large market opportunities and be quite valuable.

These new patents are anticipated to strengthen the protection of BioCardias efforts with respect to its cardiovascular therapeutic approaches and provide enhanced value for all therapies developed with the Helix biotherapeutic delivery system product family.

ABOUT BIOCARDIA BioCardia, Inc. , headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS Reimbursement. The Company's current products include the Helix Transendocardial Biotherapeutic Delivery System, which it partners selectively with other biotherapeutic companies requiring local delivery to the heart. For more information visit: http://www.BioCardia.com .

FORWARD LOOKING STATEMENTS This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to development and value of steerable access catheter products and intellectual property and statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact: Anne Laluc, Marketing Email: alaluc@BioCardia.com Phone: 650-226-0120

Investor Contact: David McClung, Chief Financial Officer Email: investors@BioCardia.com Phone: 650-226-0120

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BioCardia Announces Issuance of Two Patents Related to ... - InvestorsObserver

Middle East and Africa Stem Cell Manufacturing Market Revenue to reach USD 27,428.98 million by 2029 – openPR

Middle East and Africa Stem Cell Manufacturing Market is growing with a CAGR of 10.1% in the forecast period of 2021 to 2028 and is expected to reach USD 23,505.08 million by 2028 from USD 11,076.78 million in 2020.

Middle East and Africa Stem Cell Manufacturing Market research report provides data and information about the scenario of industry which makes it easy to be ahead of the competition in today's speedily changing business environment. This market report has been structured by applying the best and standard analytical methods which are SWOT analysis and Porter's Five Forces analysis that analyse and evaluate all the primary and secondary research data and information in this report. What is more, the credible Middle East and Africa Stem Cell Manufacturing Market report intensely analyses the potential of the market with respect to existing scenario and the future prospects by considering all industry aspects of industry.

The stem cell manufacturing market is an upcoming and trending market in which stem cells are obtained from blood cells or parts of bone marrow that have the ability to regenerate themselves into specialized cells in the human body and are used for the development of various kinds of drugs, as well as to see the chemical effects of drugs on various cells and tissues, and to see whether these drugs can repair or replace damaged cells or tissues.

This stem cell manufacturing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the stem cell manufacturing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

The stem cell manufacturing market is segmented on the basis of products, application, end user and distribution channel. On the basis of products, stem cell manufacturing market is segmented into stem cell lines, instruments, consumables & kits. On the basis of application, stem cell manufacturing market is segmented into research applications, clinical applications, cell and tissue banking and others. On the basis of end user, stem cell manufacturing market is segmented into biotechnology & pharmaceutical companies, research institutes and academic institutes, cell banks and tissue banks, hospital & surgical centers and others.

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Middle East and Africa Stem Cell Manufacturing Market Revenue to reach USD 27,428.98 million by 2029 - openPR

Global Cell Culture Market Report 2023: Government Support and … – GlobeNewswire

Dublin, April 04, 2023 (GLOBE NEWSWIRE) -- The "Global Cell Culture Market by Product (Consumables (Media, Sera, Reagent), Vessel (Roller bottle, Cell Factory), Equipment (Bioreactor, Centrifuges, Incubators)), Application (mAbs, Vaccines, Diagnostics, Tissue Engineering), End User - Forecasts to 2028" report has been added to ResearchAndMarkets.com's offering.

The global cell culture market is projected to reach USD 51.3 billion by 2028 from USD 27.9 billion in 2023, at a CAGR of 12.9% during the forecast period of 2023 to 2028. The growth of this market is majorly driven by the adoption of single-use technologies, growing focus on product development, growing popularity of monoclonal antibodies, and growth in cell and gene therapies and stem cell research. On the other hand, the high cost of cell biology research is restraining the growth of this market.

The supporting equipment sub-segment accounted for the largest share of the equipment segment during the forecast period

By product, the supporting equipment sub-segment accounted for the largest share of the equipment segment. Cell culture supporting equipment includes filtration systems, cell counters, carbon dioxide incubators, centrifuges, autoclaves, microscopes, biosafety cabinets, and other supporting equipment such as pipetting aids, pipettes, cell inserts, cell scrapers, cell lifters, cell spreaders, pH meters, shakers, flow cytometers, and water baths. These equipment play a vital role in maintaining optimum cell culture conditions. The increasing focus on cancer research, cell-based research and stem-cell research coupled with the rising need to meet the GMP standards and regulations is expected to fuel the segment market growth.

Europe: The second largest region in the cell culture market

Factors such as the increasing incidence of chronic diseases, rising government investments in life sciences, and increasing focus on stem cell research and regenerative medicine are driving the growth of the cell culture market in Europe. Moreover, several conferences, symposia, seminars, trade fairs, annual events, and workshops are being organized in Europe to create awareness of cell culture products.

Market Dynamics

Drivers

Restraints

Opportunities

Key Attributes:

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Cell Culture Market, by Product6.1 IntroductionTable 18 Market, by Product, 2020-2028 (USD Million)6.2 Consumables6.2.1 Sera, Media, and Reagents6.2.2 Vessels6.2.3 Accessories6.3 Equipment6.3.1 Supporting Equipment6.3.2 Bioreactors6.3.3 Storage Equipment

7 Cell Culture Market, by Application7.1 IntroductionTable 277 Market, by Application, 2020-2028 (USD Million)7.2 Biopharmaceutical Production7.2.1 Monoclonal Antibody Production7.2.2 Vaccine Production7.2.3 Other Therapeutic Protein Production7.3 Diagnostics7.4 Drug Screening & Development7.5 Tissue Engineering & Regenerative Medicine7.5.1 Cell & Gene Therapy7.5.2 Other Tissue Engineering & Regenerative Medicine Applications7.6 Other Applications

8 Cell Culture Market, by End-user8.1 IntroductionTable 330 Cell Culture Market, by End-user, 2020-2028 (USD Million)8.2 Pharmaceutical & Biotechnology Companies8.3 Hospitals & Diagnostic Laboratories8.4 Research & Academic Institutes8.5 Other End-users

9 Cell Culture Market, by Region

10 Competitive Landscape

11 Company Profiles

12 Appendix12.1 Discussion Guide12.2 Knowledgestore: The Subscription Portal12.3 Customization Options

Companies Mentioned

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