BOSTON and COPENHAGEN, Denmark, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that senior healthcare executive Jayson Dallas has joined its Board of Directors, effective November 19.

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Galecto Appoints Experienced Healthcare Executive Jayson Dallas to Board of Directors

Global News Feed Comments Off on Galecto Appoints Experienced Healthcare Executive Jayson Dallas to Board of Directors | November 23rd, 2020

NEW YORK, Nov. 23, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to transform the lives of patients with unmet medical needs, today announced that management will provide a corporate overview at the 2020 Evercore ISI HealthCONx Conference on December 2, 2020.

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BeyondSpring to Participate in Upcoming Evercore ISI 2020 Conference

Global News Feed Comments Off on BeyondSpring to Participate in Upcoming Evercore ISI 2020 Conference | November 23rd, 2020

TouchStar theta burst protocol leverages NeuroStar® Advanced Therapy’s patented Contact Sensing technology to help ensure the optimum prescribed treatment dose to patients TouchStar theta burst protocol leverages NeuroStar® Advanced Therapy’s patented Contact Sensing technology to help ensure the optimum prescribed treatment dose to patients

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Neuronetics® Receives FDA Clearance for Three-Minute TouchStar™ Treatment Protocol

Global News Feed Comments Off on Neuronetics® Receives FDA Clearance for Three-Minute TouchStar™ Treatment Protocol | November 23rd, 2020

BELTSVILLE, Md., Nov. 23, 2020 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced that it will participate in a fireside chat at the Piper Sandler Virtual 32nd Annual Healthcare Conference on December 1st.

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NextCure to Present at Piper Sandler Virtual 32nd Annual Healthcare Conference

Global News Feed Comments Off on NextCure to Present at Piper Sandler Virtual 32nd Annual Healthcare Conference | November 23rd, 2020

EWING, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer has participated in a fireside chat presentation and will host investor meetings at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held on December 1-3, 2020.

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Antares Pharma to Participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference

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Disclosure of trading in own shares from November 17, 2020 to November 20, 2020

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Sanofi: Disclosure of trading in own shares

Global News Feed Comments Off on Sanofi: Disclosure of trading in own shares | November 23rd, 2020

-Strengthening Selvita’s position as one of the largest preclinical contract research organizations in Europe -

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Selvita to acquire Fidelta from Galapagos

Global News Feed Comments Off on Selvita to acquire Fidelta from Galapagos | November 23rd, 2020

MELBOURNE, Australia, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Molecular diagnostics company Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE, “Company”) is pleased to announce an interview with its interim-CEO, Dr. Jerzy Muchnicki aired on The RedChip Money Report television program. The RedChip Money Report airs in 100 million homes on Sundays at 6 p.m. local time in every country in Europe on Bloomberg International.

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Genetic Technologies Interview Aired on Bloomberg International on the RedChip Money Report

Global News Feed Comments Off on Genetic Technologies Interview Aired on Bloomberg International on the RedChip Money Report | November 23rd, 2020

AUSTIN, Texas, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced that the company will present and host one-on-one meetings at the following virtual investor conferences to be held in December:

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Lumos Pharma to Participate in December Investor Conferences

Global News Feed Comments Off on Lumos Pharma to Participate in December Investor Conferences | November 23rd, 2020

Stem cell-derived cells are ready-made human induced pluripotent stem cells (iPS) and iPS-derived cell lines that are extracted ethically and have been characterized as per highest industry standards. Stem cell-derived cells iPS cells are derived from the skin fibroblasts from variety of healthy human donors of varying age and gender. These stem cell-derived cells are then commercialized for use with the consent obtained from cell donors. These stem cell-derived cells are then developed using a complete culture system that is an easy-to-use system used for defined iPS-derived cell expansion. Majority of the key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

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The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

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North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

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To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

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The Stem Cell-Derived Cells Market to witness explicit growth from 2019 and 2029 - The Haitian-Caribbean News Network

IPS Cell Therapy Comments Off on The Stem Cell-Derived Cells Market to witness explicit growth from 2019 and 2029 – The Haitian-Caribbean News Network | November 23rd, 2020

Stem Cells Market Overview:

Reports and Data has recently published a new research study titled Global Stem Cells Market that offers accurate insights for the Stem Cells market formulated with extensive research. The report explores the shifting focus observed in the market to offer the readers data and enable them to capitalize on market development. The report explores the essential industry data and generates a comprehensive document covering key geographies, technology developments, product types, applications, business verticals, sales network and distribution channels, and other key segments.

The global Stem Cells market is forecasted to grow at a rate of 8.4% from USD 9.35 billion in 2019 to USD 17.78 billion in 2027.

The report is further furnished with the latest market changes and trends owing to the global COVID-19 crisis. The report explores the impact of the crisis on the market and offers a comprehensive overview of the segments and sub-segments affected by the crisis. The study covers the present and future impact of the pandemic on the overall growth of the industry.

Get a sample of the report @ https://www.reportsanddata.com/sample-enquiry-form/2981

Competitive Landscape:

The global Stem Cells market is consolidated owing to the existence of domestic and international manufacturers and vendors in the market. The prominent players of the key geographies are undertaking several business initiatives to gain a robust footing in the industry. These strategies include mergers and acquisitions, product launches, joint ventures, collaborations, partnerships, agreements, and government deals. These strategies assist them in carrying out product developments and technological advancements.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Thermo Fisher Scientific, Agilent Technologies, Illumina, Inc., Qiagen, Oxford Nanopore Technologies, Eurofins Scientific, F. Hoffmann-La Roche, Danaher Corporation, Bio-Rad Laboratories, and GE Healthcare.

An extensive analysis of the market dynamics, including a study of drivers, constraints, opportunities, risks, limitations, and threats have been studied in the report. The report offers region-centric data and analysis of the micro and macro-economic factors affecting the growth of the overall Stem Cells market. The report offers a comprehensive assessment of the growth prospects, market trends, revenue generation, product launches, and other strategic business initiatives to assist the readers in formulating smart investment and business strategies.

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Product Outlook (Revenue, USD Billion; 2017-2027)

Technology Outlook (Revenue, USD Billion; 2017-2027)

Therapy Outlook (Revenue, USD Billion; 2017-2027)

Application Outlook (Revenue, USD Billion; 2017-2027)

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Key Coverage in the Stem Cells Market Report:

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Stem Cells Market Research Provides an In-Depth Analysis on the Future Growth Prospects and Industry Trends Adopted by the Competitors | (2020-2027),...

IPS Cell Therapy Comments Off on Stem Cells Market Research Provides an In-Depth Analysis on the Future Growth Prospects and Industry Trends Adopted by the Competitors | (2020-2027),… | November 23rd, 2020

By Adam Owens, WRAL anchor/reporter

A 74-year-old Raleigh man spends an average of two weeks a month traveling around the world delivering stem cells or bone marrow to patients as part of Be The Match, a volunteer-based donor program.

According to Troy "Davis" Moore, Be The Match uses a database of 135 countries to find life-saving bone marrow or stem cells for patients with leukemia and other blood diseases. The stem cells are delivered from donors to patients around the world by volunteers like Moore.

Moore said, when he retired 17 years ago, gardening and working around the house just wasn't enough. His friend, who was already a volunteer courier with Be The Match, told him about the opportunity.

To date, Moore has logged more than 5,000 hours as a volunteer courier. He has traveled as far as London, Barcelona, Croatia, Portugal, Singapore and Taiwan.

On Thanksgiving week, Moore will travel to South America to pick up blood stem cells and deliver them to a patient in the United States. He had to get a rapid COVID-19 test before his trip.

"It's been a lot more challenging during COVID-19 because the rules have changed so much in these countries," said Moore, explaining he recently ran into some trouble in Croatia when he hadn't had a coronavirus test in 72 hours.

Moore said, although he doesn't get to meet the families he helps due to confidentiality, the job is incredibly special. In an interview with WRAL's Adam Owens, Moore described a trip he made on Christmas Day, 10 years ago, to deliver bone marrow from the United Kingdom to a hospital in Columbus, Ohio.

Moore said a nurse was walking him through the hospital hallways when she tapped on his shoulder and pointed to a patient room. Inside, he saw the parents of a child waiting for a transplant. "I have children and I could only imagine," Moore said. "They were just pacing down the room, waiting for it."

Moore said he plans to keep traveling until he can't anymore. Volunteering works well for him, he said, especially now that his children are grown.

Some people might get caught up in the adventure of travel, Moore said, but he's usually only in another country for one day.

"At some point, you realize that's not what it's all about," he said. "It's about getting [a cure] to someone."

Link:
Raleigh man delivers stem cells to patients around the world - WRAL.com

Bone Marrow Stem Cells Comments Off on Raleigh man delivers stem cells to patients around the world – WRAL.com | November 23rd, 2020

Since losing her cousin to leukemia during childhood, Heather Lynn made it her mission to ensure others battling blood cancers get a second chance at life. Earlier this year, the St. Louis native fulfilled that life purpose: saving a stranger by donating her stem cells.

Five years ago, Lynn became the director of global special events for DKMS, the worlds largest bone marrow and blood stem cell donor center, and registered as a potential donor with the hope that someday she could give a blood cancer patient what her cousin didnt have a second chance at life and more time with the patients family.

Amid this years coronaviral pandemic, Lynn received the life-changing call from a colleague that she was a match for a 58-year-old man battling acute myeloid leukemia. I screamed with joy, Lynn recalls. I was a match for someone with blood cancer and was about to be the first employee at DKMS to donate and ultimately save someones life. After the call, Lynn realized she would be giving more than stem cells: I was giving something much bigger: hope.

Despite the uncertainty surrounding COVID-19, Lynn felt a strong sense of purpose to help this man and donated her stem cells to save his life. I have seen how much someones life can change with a blood cancer diagnosis, Lynn says. The fear, the pain, the loss it can be devastating. I have spent the past five years working to elevate the message about donating and how easy it is to sign up and give back it simply requires swabbing the inside of each cheek for 60 seconds.

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St. Louis Native Heather Lynn Discusses Motivation for Donating Stem Cells - Ladue News

Bone Marrow Stem Cells Comments Off on St. Louis Native Heather Lynn Discusses Motivation for Donating Stem Cells – Ladue News | November 23rd, 2020

NEW YORK, Nov. 23, 2020 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today highlighted its intellectual property portfolio for apamistamab, a CD45 targeting antibody, and the Antibody Radiation Conjugate (ARC) comprised of apamistamab and the radioisotope iodine-131 used in the Company's lead Phase 3 candidate, Iomab-B, and its Iomab-ACT programs. Actinium owns issued or pending patents within the United States and globally covering composition of matter, formulation, methods of use, and methods of administration with potential coverage for 19 years or longer. Importantly, Actinium owns an issued patent in the US covering composition of matter, for which the Company expects validity until 2037.In addition, the Company owns a second issued US patent that further covers composition of matter, methods of use, and methods of administration for Iomab-B. The company has also received a notice of allowance in Europe for this second patent and expects it to be in force until 2036.

Iomab-B is currently being investigated in the ongoing pivotal Phase 3 SIERRA trial, which is over 75% enrolled, for targeted conditioning prior to potentially curative bone marrow transplant (BMT) for patients with relapsed or refractory Acute Myeloid Leukemia ("R/R AML"). In addition, Actinium is utilizing apamistamab with lower doses of iodine-131, known as Iomab-ACT, for targeted conditioning prior to gene therapy and adoptive cell therapy ("ACT"), namely CAR-T, including in its recently announced collaboration with Memorial Sloan Kettering Cancer Center that is supported by NIH STTR Fast Track grant funding.

"The continued protection of our lead asset Iomab-B, our Iomab-ACT program and apamistamab by a strong patent position is an important component of our development efforts, particularly as we approach the conclusion of our pivotal Phase 3 SIERRA trial for BMT conditioning in R/R AML The growth of BMT, ACT and Gene Therapy has highlighted the importance of conditioning and the need to move beyond non-targeted chemotherapy to increase the number of patients that could benefit from these potentially curative therapies.CD45 is an ideal target for conditioning applications given its unique expression on blood cancer cells and blood forming stem and immune cells and with no expression outside the hematopoietic or blood system," said Dr. Dale Ludwig, Actinium's Chief Scientific Officer. "Apamistamab is well characterized and its use in conditioning is supported by extensive clinical data across multiple clinical trials and indications. Our robust data shows that apamistamab has a favorable biodistribution profile that, together with our ARC technology, has significant advantages over other approaches such antibody drug conjugates that require payload internalization, making them impractical for targeting CD45.Further, our ARC approach allows us to use varying intensities of targeted radiation to achieve our desired conditioning outcome.With these important patents in place, and continued expansion of our patent portfolio in the US, EU and other select countries, we look forward to continuing to build out our targeted conditioning strategic business unit."

About Iomab-B

Iomab-B is Actinium's lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, apamistamab (formerly BC8), labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient's cancer and marrow cells. In a Phase 1/2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced enabled 100% of patients to proceed to transplant with all patients achieving transplant engraftment by day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, Hodgkin's disease, Non-Hodgkin lymphomas and multiple myeloma. Actinium obtained the worldwide, exclusive rights to apamistamab (BC8) and Iomab-B from the Fred Hutchinson Cancer Research Center. Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

About Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation.Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities.With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently.Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning.The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings.More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform.This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes.Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Clayton Robertson Actinium Pharmaceuticals, Inc. [emailprotected]

Hans VitzthumLifeSci Advisors, LLC[emailprotected](617) 430-7578

SOURCE Actinium Pharmaceuticals, Inc.

http://www.actiniumpharma.com

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Actinium Highlights Foundational Patents Covering the Composition of Apamistamab Antibody and Iomab-B Antibody Radiation Conjugate for Targeted...

Bone Marrow Stem Cells Comments Off on Actinium Highlights Foundational Patents Covering the Composition of Apamistamab Antibody and Iomab-B Antibody Radiation Conjugate for Targeted… | November 23rd, 2020

SEATTLE, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, together with its collaborators will present data from more than 35 abstracts studying the use of Adaptives clonoSEQ Assay for minimal residual disease (MRD) assessment at the American Society of Hematology (ASH) virtual 62nd Annual Meeting and Exposition, December 5-8. clonoSEQ is the first and only U.S. Food and Drug Administration (FDA)-cleared assay for MRD assessment in chronic lymphocytic leukemia (CLL), multiple myeloma and B-cell acute lymphoblastic leukemia (B-ALL) and is widely available to clinicians and patients across the U.S.

We are thrilled to see so many investigators presenting clonoSEQ data at ASH this year, among the more than 300 ASH studies highlighting MRD data, significantly growing the body of evidence validating this tool as a critical measure of patient outcomes, said Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies. As innovation continues for the treatment of blood cancers with novel and highly targeted therapies that create deep and durable responses for patients, we see clinicians increasingly utilizing clonoSEQ to help guide day-to-day patient care.

Assessment of MRD is a way to directly detect and quantify remaining disease, even in the absence of symptoms, across a spectrum of blood cancers. A patients MRD status gives clinicians timely information about how a patient may be responding to treatment, so patients and providers can be in control when it comes to managing their disease and treatment decisions.

clonoSEQ, the first clinical application of Adaptives immune medicine platform, will be featured in 14 oral presentations and 23 posters at ASH. Data on clinical and research utility from studies, as well as findings based on real-world experience, will be presented across a range of cancers including multiple myeloma, ALL, CLL and non-Hodgkins lymphoma (NHL). These new data show a correlation between clonoSEQ MRD results and improved blood cancer patient outcomes, enhanced clinical decision-making, and potential savings to the healthcare system.

Additional data at ASH this year will highlight Adaptives immune profiling research tool, immunoSEQ, to quantitatively assess the immune response to novel therapies in development.

Key presentations include:

AbouttheclonoSEQ AssayThe clonoSEQ Assay is the first and only FDA-cleared assay for MRD in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD) refers to the small number of cancer cells that can stay in the body during and after treatment. clonoSEQ was initially granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with MM and B-ALL using DNA from bone marrow samples.InAugust 2020, clonoSEQ received additional clearance from theFDA to detect and monitor MRD in blood or bone marrow from patients with CLL.

The clonoSEQ Assay leverages Adaptives proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and predict potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with CLL, MM and ALL.

The clonoSEQ Assay is a single-site test performed at Adaptive Biotechnologies.In addition to its FDA-cleared uses, clonoSEQ is also available as a CLIA-validated laboratory developed test (LDT) service for use in other lymphoid cancers and sample types. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visitwww.clonoSEQ.com/technical-summary.

About immunoSEQ Assay Adaptives immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and B-cell receptors from a single sample in exquisite detail. Offered as a Service or Kit, the immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures.

About AdaptiveAdaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is natures most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics and drug discovery. We have two commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.

For more information, please visit adaptivebiotech.com and follow us on http://www.twitter.com/adaptivebiotech.

Forward Looking Statements This press release contains forward-looking statements that are based on managements beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words may, will, could, would, should, expect, intend, plan, anticipate, believe, estimate, predict, project, potential, continue, ongoing or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with theSecurities and Exchange Commissionfrom time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

MEDIA CONTACT:Beth Keshishian917-912-7195media@adaptivebiotech.com

ADAPTIVE INVESTORS:Karina Calzadilla201-396-1687

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Adaptive Biotechnologies and Collaborators to Present Data from More Than 35 Abstracts at ASH 2020 Highlighting Clinical Relevance of MRD Testing with...

Bone Marrow Stem Cells Comments Off on Adaptive Biotechnologies and Collaborators to Present Data from More Than 35 Abstracts at ASH 2020 Highlighting Clinical Relevance of MRD Testing with… | November 23rd, 2020

SEATTLE--(BUSINESS WIRE)--The cells of the body are made up of the same basic components, namely: Blood, Muscle, Nerve, Brain, Gut, Respiratory, Skin, Cardiovascular, Urine, and Stem Cells. Each of these cells is unique in its characteristics but all of them play an important role in how healthy your body is and how well it functions.

Blood cells are made up of red blood cells (erythrocytes), platelets (platelet-activating factor) and neutrophils (killer T cells). Unlike blood cells in other organs of the body, white blood cells (white blood cells) do not multiply: they only act as a defense mechanism for the body in the fight against infection and in keeping your immune system active. Blood cells can also be converted to other cells such as platelets and plasma by the action of the protein platelet-activating factor (PAF). When a platelet or plasma cell reproduces, it becomes another cell: a daughter cell. The daughter cell then either becomes a blood cell or goes on to differentiate into a different type of cell such as a red blood cell or a platelet.

The global stem cells market is expected to account for US$ 9941.2 Mn in 2020 in terms of value and is expected to grow at a CAGR of 9.1% during forecast 2020-2027.

Market Drivers:

High prevalence of cancer is expected to propel growth of the global stem cells market over the forecast period. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S.

Moreover, developments towards boosting the availability and use of induced pluripotent stem cell technology is also expected to aid in growth of the market. For instance, in November 2020, FUJIFILM Cellular Dynamics, Inc. partnered with Lonza Walkersville, Inc. to enable drug developers to leverage both companies expertise and technologies for the generation of human induced pluripotent stem cells through licensing agreements.

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Market Opportunities

Potential of stem cell therapy in the treatment of Covid-19 is expected to offer lucrative growth opportunities for players in the global stem cells market. For instance, in November 2020, the randomised, controlled Phase III trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection has been advised to continue by the independent Data Safety Monitoring Board (DSMB).

Moreover, increasing funding for R&D in stem cell therapy is also expected to aid in growth of the market. For instance, in November 2020, Californias stem cell agency will receive an infusion of US$ 5.5 billion in new research funding after voters approved Proposition 14. Similarly, in November 2020, California Institute for Regenerative Medicine awarded a US$ 9 million grant to Diana Farmer and Aijun Wang to help launch the worlds first human clinical trial using stem cells to treat spina bifida, a birth defect that occurs when the spine and spinal cord dont form properly.

Market Trends

Major players operating in the global stem cells market are focused on R&D to expand their product portfolio. For instance, in November 2020, IMAC Holdings, Inc. announced that the company is opening enrollment in its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual slowing and loss of spontaneous body movement, due to Parkinsons disease.

Competitive Landscape:

Major players operating in the global stem cells market include, Advanced Cell Technology, Inc., FUJIFILM Cellular Dynamics, Inc., Angel Biotechnology Holdings PLC, Bioheart Inc., Lineage Cell Therapeutics., BrainStorm Cell Therapeutics, Inc., IMAC Holdings, Inc., California Stem Cell Inc., Celgene Corporation, Takara Bio Europe AB, Cellular Engineering Technologies, Cytori Therapeutics Inc., Osiris Therapeutics, and STEMCELL Technologies Inc.

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Market segmentation:

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Global Stem Cells Market is estimated to account for US$ 18289.9 Mn by end of 2027, Says Coherent Market Insights (CMI) - Business Wire

Spinal Cord Stem Cells Comments Off on Global Stem Cells Market is estimated to account for US$ 18289.9 Mn by end of 2027, Says Coherent Market Insights (CMI) – Business Wire | November 23rd, 2020

This persuasive Exosome Therapeutic Market report makes to focus on the more important aspects of the market like what the market recent trends are. The company profiles of all the key players and brands that are dominating the Exosome Therapeutic Market have been taken into consideration here. The market analysis and competitor analysis helps the firm in determining the range in terms of sizes, colors, designs, and prices, etc within which its products are to be offered to the consumers. Important industry trends, market size, market share estimates are analyzed and mentioned in the Exosome Therapeutic Market business report.

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Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in theExosome Therapeutic Marketreport areevox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global.Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

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Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

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Exosome Therapeutic Market to Record Escalated Growth in Revenue During the Forecast Period || Major Gaints Jazz Pharmaceuticals, Inc., Boehringer...

Cardiac Stem Cells Comments Off on Exosome Therapeutic Market to Record Escalated Growth in Revenue During the Forecast Period || Major Gaints Jazz Pharmaceuticals, Inc., Boehringer… | November 23rd, 2020

Global 3D Cardiac Mapping Systems Market: Overview

Cardiac mapping is a special type of technique which helps in gathering and displaying the information from cardiac electrograms. Such technique is mainly used in the diagnosis of heart rhythms. Therefore, cardiac mapping technique has gained immense popularity in case of arrhythmia. The cardiac mapping procedure involves the percutaneous insertion of catheter into the heart chamber and recording the cardiac electrograms sequentially. Such procedure helps in correlating the cardiac anatomy with the electrograms. The latest 3D cardiac mapping systems provide the three dimensional model of hearts chamber, which further helps in tracking the exact location of the catheter. Such advantages are majorly driving the global 3D cardiac mapping systems market.

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From the perspective of technology, the global 3D cardiac mapping systems market is segmented into basket catheter mapping, electroanatomical mapping, and real-time positional management (Cardiac pathways) EP system. Among these segments, electroanatomical mapping segment accounts for the maximum share in the global 3D cardiac mapping systems market. This mapping are extensively used in several healthcare industry due to its potential in increasing the safety, accuracy, and efficiency of catheter. A research report by TMR Research (TMR) thoroughly explains the new growth opportunities in the global 3D cardiac mapping systems market. Additionally, the report also provides a comprehensive analysis of the markets competitive landscape.

Global 3D Cardiac Mapping Systems Market: Notable Developments

Some of the recent developments are contouring the shape of the global 3D cardiac mapping systems market in a big way:

Key players operating in the global 3D cardiac mapping systems market include BioScience Webster, Boston Scientific Corporation, and Abbott.

Global 3D Cardiac Mapping Systems Market: Key Growth Drivers

Rising Number of Patients with Cardiac Disorders and Arrhythmia Fillips Market

The global 3D cardiac mapping systems market has grown steadily over the years, owing to the convenience it provides to the patients with heart problem. Growing number of people with cardiovascular diseases and rising cases of arrhythmia are the major factors fueling growth in the global 3D cardiac mapping systems market. Along with this, increasing pressure for reducing diagnosis errors and rapidly rising healthcare expenditure are also responsible for boosting the global 3D cardiac mapping systems market. However, above all such factors, the global 3D cardiac mapping systems market is majorly fueled by the accuracy and patient safety provided through real-time monitoring. Such 3D cardiac mapping systems are mainly designed to improve the resolution. This system also helps in gaining prompt of cardiac activation maps. All such advantages are also providing impetus to the growth of the global 3D cardiac mapping systems market.

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Furthermore, rising ageing population who are prone to heart-attack and several chronic heart disorders and increasing diagnosis rate of cardiac illness are the factors stoking demand in the global 3D cardiac mapping systems market. Moreover, this 3D cardiac mapping helps in reducing the diagnosis time. Such factor is also contributing to the growth of the global 3D cardiac mapping systems market.

Global 3D Cardiac Mapping Systems Market: Regional Outlook

On the regional front, North America is leading the global 3D cardiac mapping systems market as the region has seen rapid growth in healthcare industry. Along with this, increasing prevalence of heart attacks, rising healthcare expenditure, and burgeoning population is also responsible for fueling growth in the 3D cardiac mapping systems market in this region.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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3D Cardiac Mapping Systems Market Competitive Landscape Analysis with Forecast by 2028 - The Haitian-Caribbean News Network

Cardiac Stem Cells Comments Off on 3D Cardiac Mapping Systems Market Competitive Landscape Analysis with Forecast by 2028 – The Haitian-Caribbean News Network | November 23rd, 2020

In the intro to the HBO sci-fi series Westworld, a 3D printer churns out humanoid robots, delicately assembling the incredible complexities of the human form so that those robots can go on tospoiler alertdo naughty things. It takes a lot of biomechanical coordination, after all, to murder a whole lot of flesh-and-blood people.

Speaking of: Researchers just made a scientific leap toward making 3D-printed flesh and blood a reality. Writing recently in the journal ACS Biomaterials Science & Engineering, a team described how they repurposed a low-cost 3D printer into one capable of turning an MRI scan of a human heart into a deformable full-size analog you can actually hold in your hand. Squeeze it, and itll give like the real thing. Slice it open, and youll find chambers. The idea isnt to one day realize the homicidal humanoids of Westworld, but to give surgeons a better way to practice on a patients heart before an operation. The advance might eventually lead to fully-functioning 3D-printed hearts, and give medical device developers an unprecedented platform for testing their wares.

The researchers call their technique the Freeform Reversible Embedding of Suspended Hydrogels, or FRESH. They begin with a scan of a real heart and translate the data into something a 3D printer can read. Because the device works by depositing layers of material one on top of another, they run the 3D image through a slicer program. For every layer, it basically defines the path that the material is going to be extruded, and then feeds that to the printer, says Adam Feinberg, a biomedical engineer at Carnegie Mellon University who coauthored the new paper.

That printer churns out alginatea squishy material derived from seaweedthat the researchers chose both for its low cost and likeness to the material properties of human heart tissue. But instead of it extruding it into air, as a normal 3D printer might do when building something out of plastic, this extrudes the ersatz heart into a container of support gel, specifically gelatin.

The analogy I have is: Imagine you were printing inside of hair gel, says Feinberg. Think of the little bubbles suspended in that bottle of gelthe material is providing enough support for them to float indefinitely, or at least until you squeeze the gel out of the bottle. In this case, the gelatin offers enough give for the needle of the 3D printer to slide through. Whatever you extrude stays embedded in place, kind of like those air bubbles in hair gel, Feinberg says.

Printing in the gelatin bath

And now for something completely different when it comes to the art of artificial hearts: jello shots. After the organ is done printing, the researchers need a way to dissolve the gel lattice thats surrounding it, and they use a familiar method. I think a lot of people have experienced this from using gelatin in baking or making jello shots, says Feinberg. It's actually a liquid when you warm it up, but it becomes a solid gel when you cool it down. And so we take advantage of that. When theyre ready to extract the heart, all Feinberg has to do is raise the bath to body temperature, melting away the support gel and leaving behind the 3D-printed structure.

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This Squishy 3D-Printed Human Heart Feels Like the Real Thing - WIRED

Cardiac Stem Cells Comments Off on This Squishy 3D-Printed Human Heart Feels Like the Real Thing – WIRED | November 23rd, 2020

Novartis has licensed a new stem cell therapy from Mesoblast, just weeks after the FDA rejected the Australian biotechs pitch for an approval on a separate indication.

The Swiss pharma announced Thursday afternoon it is partnering with Mesoblast $MESO to develop remestemcel-L for the treatment of acute respiratory distress syndrome, including ARDS related to Covid-19. As part of the deal, Novartis will shell out $25 million in upfront cash and take a $25 million stake in the biotech, while offering up to $1.255 billion in potential milestone payments.

Mesoblast investors embraced the news, sending shares up 11% on the Australian stock exchange Friday. The companys stock was also up roughly 17% on the Nasdaq before Fridays opening bell.

The milestone payments are split as such, per Mesoblast: $505 million will be available pre-commercialization, with an additional $750 million set aside for hitting certain sales targets and double-digit royalties.

Remestemcel-L, or Ryoncil, acts as an anti-inflammatory and consists of culture-expanded mesenchymal stem cells derived from a bone marrow donor. Currently, the drug is being evaluated in a Phase III study for Covid-19-related ARDS with 300 patients, and the first cut of data is expected in early 2021.

Should that outcome prove successful, Novartis will launch a Phase III in non-Covid ARDS after the deal closes. The companies highlighted Novartis ability to rapidly scale up cell-based therapies from the clinic to the commercial phase as a motivator for the collaboration.

The drug had been examined in a small compassionate use program for Covid-19 ARDS back in March, which included 12 patients requiring ventilators. Remestemcel-L treatment demonstrated an 83% survival rate in that program and was the basis for the ongoing Phase III.

Thursdays deal comes less than two months after the FDA issued a CRL for remestemcel-L in Mesoblasts pediatric acute graft-versus-host disease program. The rejection, which denied the company an accelerated approval, came after an ODAC adcomm in August voted 9 to 1 in favor of approval as panel members struggled to envision what a pivotal trial might look like.

During both the adcomm and in their CRL, regulators took issue with Mesoblasts study design given that the company submitted its application on the basis of one, single-arm and open-label trial. In the study, Remestemcel-L demonstrated a statistically significant benefit in its primary endpoint against the historical control rate.

But because many parents and pediatricians are reluctant to risk putting children into the placebo arm of a randomized study, Mesoblast argued that key opinion leaders said an additional study was not feasible. The veto came despite the FDA approving a similar drug Incyte and Novartis Jakafi based on one single-arm trial, something for which ODAC members chastised the FDA.

Earlier this week, Mesoblast met with the agency for its Type A meeting, and the company reported in its third quarter earnings that it does not expect the FDA to reverse its decision for accelerated approval. Mesoblast is still waiting to receive final meeting minutes to know whether thats indeed the case. The CRL set back potential approval in GvHD from 2021 to 2024, per analysts.

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Novartis bags Mesoblast's stem cell therapy for ARDS, including in Covid-19, in a deal worth up to $1.2B+ - Endpoints News

Bone Marrow Stem Cells Comments Off on Novartis bags Mesoblast’s stem cell therapy for ARDS, including in Covid-19, in a deal worth up to $1.2B+ – Endpoints News | November 21st, 2020