Category Archives: Regenerative Medicine

Abstract: Organoids bearing human stem cell-derived progenitors enable basic and applied investigation of organogenesis in a wide range of epithelial tissues. During liver organogenesis (LO), E9.5 collectively migrating hepatoblasts (MHs) arise from the E9.0 liver diverticulum (LD) and directly penetrate the surrounding mesoderm (MES) tissue, forming cell strands that link migration, differentiation, and growth. Currently, human pluripotent stem cell (hPSC) organoid protocols model the E10.5 liver bud and forward differentiation, but not the LD or the LD-derived MHs, in spite of their significance. In fact, the transcriptome underlying MHs, the niche that drives their migration, and methods to induce them from hPSC remain key questions. We performed bioinformatics analysis of single cell RNA-seq data, in vivo transplantation, and in vitro hPSC differentiation with organoid formation, microscopy, gene and protein expression, small molecule inhibitor screening of growth, and organoid culture in bioengineered devices to assess tissue tension. Our in depth bioinformatic analysis of early murine LO demonstrates pathway up-regulation of an unexpected wide array of soluble signaling factors, as well as cell cycle, chromatin modification, and metabolic reprogramming, in addition to a widespread cell stress-response. These findings led us hypothesize that the LD and MES tissue form a tissue complex (LD-MESC) that drives MH induction. Using this LD-MESC concept, we designed an in vivo transplant system, as well as a three-step in vitro protocol for inducing hPSC-derived MHs, both of which recapitulate liver growth, morphogenesis, differentiation. We show that Hippo signaling pathway, in agreement with murine MH data, mediates migration and growth of hPSC-MH in vitro. These data substantiate the LD-MESC model developed here, and directly address key challenges facing liver regenerative medicine. Our bioinformatics, in vitro, and in vivo data all support the concept that the LD-MESC initiates LO. This concept can be used to change protocols to emphasize linking of migration, growth, with differentiation. Modeling epithelial collective migration for LO bolsters not only organogenesis studies of alternate endodermal organs, but also in vivo transplantation efforts, and facilitates employing migrating organoids to therapeutically target human tumor migration/metastasis.

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Dynamic changes in the niche and transcription trigger early murine and human pluripotent stem cell-derived liver organogenesis - Newswise

Ms. DuRossbrings more than 25 years' experience to her new position. Prior to joining CSafe, she was the co-founder and CEO of Vineti, an enterprise software platform used to digitize chain of identity and chain of custody requirements for CGT products. Earlier in her career, DuRoss held several prestigious positions including, Chief Business Officer at Navigenics, Chief of Staff for the California Institute for Regenerative Medicine (CIRM), and Co-Founder, Co-Author, and Executive Director of California's $3B stem cell research ballot initiative.

"We are delighted to have Amy leading our CGT team. Her diverse experience in both corporate development, patient advocacy and entrepreneurship is exactly the right mix to drive innovation and superior solutions in this deeply complex supply chain," said CSafeCEO, Patrick Schafer. "We expect to see significant strides forward in this portfolio under Amy's strategic guidance."

"I'm honored to have the opportunity to collaborate with the world-class team at CSafe Global in bringing a new standard of high-quality, high-value supply chain transport to the most exciting innovation area in personalized medicine, cell and gene therapies," Ms. DuRoss said, "CSafe Global's outstanding worldwide service network and proven expertise in robust and actionable analytics to drive supply chain efficiencies will hasten the industrialization of an emergent market that offers critical hope for an increasing number of patients in need."

Ms. DuRossearned her bachelor'sand two master'sdegrees, including her MBA, from Stanford University. She serves on the boards of Biolife Solutions (BLFS), MJH, Americans for Cures, and the ARM Foundation and is a member of the Aspen Institute Global Network.

Media Contact:Lori ConawayGlobal Marketing Communications+1 405.633.2344[emailprotected]

About CSafe Global

CSafe Global provides end-to-end thermal shipping solutions to the pharmaceutical and life science industries worldwide. An industry innovator, CSafe provides AI-enabled lease forecasting to ensure active container availability and real-time shipment visibility for customers to monitor shipments and intervene to preserve a payload when needed. CSafe offers industry-leading maintenance and reuse programs for active and passive containers providing superior product performance and alignment with customer sustainability objectives. With a presence in 150 countries, 24/7 support and 100% container availability, CSafe is well-positioned to be the partner of choice in the cold chain. csafeglobal.com

SOURCE CSafe Global

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CSafe Global Continues Investment in Cell and Gene Therapy Solutions with Addition of New Portfolio President - PR Newswire

The National Institutes of Healths All of Us Research Program aims to recruit 1 million participants to advance biomedical research to benefit all

SAN ANTONIO, July 25, 2022 (GLOBE NEWSWIRE) -- South Texas Blood & Tissue has partnered with the National Institutes of Healths All of Us Research Program, to recruit and engage participants in one of the nations largest and most diverse health information databases.

All of Us aims to enroll at least 1 million participants who reflect the rich diversity of the U.S. Participants can choose to share information about their health history, their environment and they can contribute a blood or saliva sample. This information will help researchers learn how biology, lifestyle and our environment affect our health.

One of the biggest goals of this program is to increase diversity in medical research. Many populations have been left out of research in the past, which means less is known about the health of those groups.

South Texans can join the program by visiting JoinAllofUs.org/SouthTexasBlood. After completing an online portion (including study consents and health history surveys), participants may be asked to visit South Texas Blood & Tissue in San Antonio to have physical measurements taken and give blood and urine samples for the program.

Biological information, health surveys and physical measurements all can help researchers in the new field of precision medicine, which aims to create tailored treatments that are not one-size-fits-all. With this resource, researchers will be able to conduct thousands of studies on health and disease.

All information collected for All of Us will be stored on protected computers, and the NIH will remove participants names and other direct identifiers like Social Security numbers.

Participants may be compensated for their time and travel with a $25 gift card after giving their samples at South Texas Blood & Tissue. Through participating in the program, participants also can receive specific information about their DNA that could help them learn about their unique traits and genetic ancestry, if they want to receive genetic health-related information.

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Anyone 18 years or older living in the United States may participate in this program, regardless of health condition or prior blood donation eligibility.

Joining All of Us is another way for generous donors to improve the health of communities and future generations.

To learn more about All of Us, please call 210-731-5589 or email Research@SouthTexasBlood.org.

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About South Texas Blood & Tissue: South Texas Blood & Tissue (STB&T) is a nonprofit community blood center that provides blood, plasma, platelets, and other blood components to 100 hospitals in 48 South Texas counties. It is the largest blood supplier in our region. In addition, STB&T supports the development of advanced therapies, including those derived from donated human cells and tissues used in research and in new therapies and cures for cancers and degenerative diseases. Through the generous life-legacy gifts of human tissue, STB&T also supports development of tissue allografts for patients in need of reconstructive surgery, repair, or tissue regeneration. STB&T has a 47-year history serving the South Texas community and is part of the BioBridge Global family of nonprofit organizations, which offers services in regenerative medicine and research including blood banking and resource management; cellular therapy; umbilical cord blood collection and storage; donated human tissue recovery and distribution for transplant; and testing of blood and plasma products to help patients in the United States and worldwide. STB&T has seven donor centers in South Texas and conducts hundreds of mobile blood drives each year. STB&T is online at SouthTexasBlood.org.

About BioBridge Global: BioBridge Global (BBG) is a San Antonio-based 501(c)(3) nonprofit regenerative medicine enterprise that offers diverse services through its subsidiaries South Texas Blood & Tissue, QualTex Laboratories, GenCure and The Blood & Tissue Center Foundation. BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue, as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. BBG is committed to saving and enhancing lives through the healing power of human cells and tissue. It enables advances in the field of regenerative medicine by providing access to human cells and tissue, testing services and biomanufacturing and clinical trials support. Learn more at BioBridgeGlobal.org.

All of Us is a registered service mark of the U.S. Department of Health & Human Services (HHS).

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South Texans can participate in massive, national health program to change the future of healthcare - Yahoo Finance

Genome writing company Replay haslaunchedoperations with $55 million in seed financing, mainly from OMX Ventures and KKR.

Replay features next-generation genomic medicine technologies in its portfolio to address the needs of diseases that have large unmet needs. It also aims to create solutions to increase payload capacity and off-the-shelf cell therapies that will improve production volume, speed and consistency, reduce costs and expand opportunities for genome engineering.

Some of the genomic medicine platforms that Replay is working onincludeuCell, a universal, renewable, genomically rewritten iPSC-derived cell source for regenerative medicine and cell therapy; synHSV, a high-payload-capacity HSV vector that can deliver as much as 30 times the AAV payload; and DropSynth, a genome writing platform that enables the low-cost and rapid synthesis of big DNA and libraries of synthetic genes. Its fourth platform, LASR, offers an inference algorithm that can rewrite proteins to achieve optimal functionality.

Replay takes pride in its unique corporate structure, which keeps the therapeutic product development and technology development units separate. The company has set up four synHSV companies to bring key DNA treatments to monogenic disorders affecting the brain, muscle, eye and skin.

"Genomic medicine has the potential to transform the future of clinical therapeutics. Over my three decades of experience working in clinical medicine, academia, and the biopharmaceutical industry, it has become clear that we require a more robust and comprehensive toolkit of molecular genetic platform technologies to solve biology's most complex problems and realize its full therapeutic potential," Adrian Woolfson, B.M., B.Ch., Ph.D., the executive chairman, president and co-founder of Replay, commented in a statement.

Replay was co-founded by Woolfson, Lachlan MacKinnon, and Ron Weiss, Ph.D. MacKinnon is a founding team member at Oxford Science Enterprises and a founding investor in ONI, OMass Therapeutics and Base Genomics, while Weiss is a professor of biological engineering at the Massachusetts Institute of Technology. Before Replay, Woolfson was the executive vice president, head of research and development at Sangamo Therapeutics, and chief medical officer at Nouscom.

"Replay's mission is to create a world-leading company that develops and owns the tools to reprogram biology by writing and delivering big DNA; we believe these capabilities will unlock the largest untapped opportunity in medicine. Replay has tremendous entrepreneurial experience within the Company, as well as a team of seasoned industry players to guide the development of the platform technologies and product companies to bring new treatments to patients," Kugan Sathiyanandarajah, the managing director at KKR who also had a board seat at Replay said.

The other companies that invested in the seed funding are ARTIS Ventures, Lansdowne Partners, SALT, Axial and DeciBio Ventures. KKR is investing through the KKR Health Care Strategic Growth Fund II, which focuses on high-growth health care firms. Replay's headquarters are San Diego, California and London, United Kingdom.

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Replay Launches with $55M In Seed Funding To Author Genomic Medicine - BioSpace

New York, July 21, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Amniotic Products Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type, Application, End User, and Geography" - https://www.reportlinker.com/p06295644/?utm_source=GNW The amniotic membrane and suspension are two products that can be used for treatment.

The amniotic membrane is the innermost layer of the placenta that nourishes and maintains an unborn child. Amniotic fluid is the liquid that surrounds the baby until delivery.Due to the high prevalence of burn wounds, demand for wound care biologics, such as amniotic membranes, has increased significantly.According to the WHO, many burn cases occur in low- and middle-income countries, with over 2-3rd occurring in the WHO African and Southeast Asian areas.

Every year, one million people in India suffer from mild to severe burns (Source: WHO).Other Southeast Asian countries, such as Bangladesh and Nepal, have a high rate of burn cases.

An estimated 173,000 children in Bangladesh yearly suffer from moderate to severe burns. Burn is Nepals second most prevalent injury, accounting for 5% of disability cases.Based on type, the amniotic products market has been bifurcated into amniotic membranes and amniotic suspensions.The amniotic membranes segment is likely to hold the largest share of the market in 2022.

The amniotic membrane segment growth is growing due to increasing research in stem cell and regenerative medicine, high R&D investments, and an increase in the number of surgeries conducted globally.Further, they are commonly employed in the treatment of bacterial keratitis, corneal ulcers, cataract, glaucoma, bullous keratopathy, corneal degeneration, ocular dystrophy, eyelid reconstruction, and other eye surface problems.

The expansion in the worlds senior population increases the number of ophthalmology surgeries, , resulting in a growing need for tissue-based products.Further, PalinGen, Fl?Graft, AmbioDisk, and AmnioFix are examples of commercially available dehydrated amniotic membranes.

In addition, these membranes are widely used in the treatment and management of surgical wounds and incisions, owing to properties such as their ability to maintain a watertight seal, inhibit inflammatory responses, and prevent disease transmissions. Hence, these factors are driving the segment growth.In December 2016, the US passed the 21st Century Cures Act.This new law was passed with the goal of advancing regenerative medicine research and medical innovation.

The Act contains a number of provisions that could impact the development and approval of many products in the coming years.A new "Regenerative Medicine Advanced Therapy" classification and a fast-track approval procedure for innovative regenerative medicine products and therapies have been developed due to this Act.

The passage of this Act could lead to the approval of new regenerative medicine products and therapies in the US and a boost in regenerative medicine research and development.It was designed to promote patient access to electronic health information, advance innovation, and address information blocking practices.

The 21st Century Cures Act was created to help speed up medication development and approval processes, allowing for faster and more efficient delivery of new medical advancements to patients. These requirements are expected to improve interoperability and facilitate electronic health information access, exchange, and use.A few key primary and secondary sources referred to while preparing the report on the prostate cancer nuclear medicine diagnostics market are the World Health Organization (WHO), the Centers for Disease Control and Prevention, and the National Programme for Prevention, Management and Rehabilitation of Burn Injuries.Read the full report: https://www.reportlinker.com/p06295644/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The amniotic products market is expected to grow from US$ - GlobeNewswire

SIRIUS MANAGEMENT CONSULTING

The biopharmaceutical industry is rapidly growing with most pharma companies shifting their focus on increasing the efficacy and safety of biopharmaceutical drugs, thereby allowing them to command high prices for innovative drugs.

Chicago, July 25, 2022 (GLOBE NEWSWIRE) -- According to Ariztons latest research report, the global biopharmaceutical excipients market to grow at a CAGR of 7.56% from 2022 to 2027. The rising demand for biopharmaceuticals is the major factor driving the demand for excipients used in the manufacturing of various biologic drugs. The need for diverse biological treatments is rising as the burden of cancer increases. Both large and small biopharmaceutical businesses continue to look for the molecular causes of cancer and create medications to stop malignant cells. As a result, the biopharma sector is playing a key role in determining many facets of the oncology market.

Cell-based therapy is the fastest-growing segment of regenerative medicine, a field that promises to cure diseases that are not treated by other small molecules or biological drugs. Vaccines are commonly used biologics that are witnessing high demand, especially since the COVID-19 outbreak. Due to the increased production of vaccines, the demand for vaccine-based excipients has increased drastically. In addition, new cell & gene therapies for the treatment of various diseases are also growing. Thus, the need for excipients used in their formulation is likely to grow.

Biopharmaceuticals Excipients Market Report Scope

Report Attributes

Details

MARKET SIZE (2027)

$3.23 Billion

MARKET SIZE (2021)

$2.08 Billion

CAGR (2022-2027)

7.56%

BASE YEAR

2021

FORECAST YEAR

2022-2027

MARKET SEGMENTS

Excipient, Biologics, Scale of Operation

GEOGRAPHIC ANALYSIS

North America, APAC, Europe, Latin America, and MEA

KEY VENDORS

Merck KGAA, BASF SE, Avantor, Evonik Industries, and Roquette

Click Here to Download the Free Sample Report

Emerging Demand for Novel Excipients in Drug Product Development

Novel excipients are playing a crucial role in developing new, improved, and safe drugs for the biopharmaceutical market. Several companies prefer to bring sophisticated and innovative formulations that involve novel excipients. To modernize drug formulation and biopharmaceutical development processes, the FDA launches a testing program to check the safety and suitability of novel inactive ingredients in new drugs and biologics applications. The aim is to encourage sponsors of clinical trials to formulate innovative therapies with those new excipients that the FDA finds acceptable for use under this program.

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Moreover, excipient makers acknowledge that they will be more willing to invest in the production and the characterization of novel excipients if it is possible to gain the FDA review on the benefits of the product outside clinical testing for a new molecular entity. The initiative and ongoing efforts to set international standards for excipient use have the potential to enhance the drug formulation and support modern manufacturing and quality control efforts.

Increasing Need for Outsourcing Biopharmaceutical Excipient Manufacturing

Outsourcing is a common way for pharmaceutical companies to increase their operational efficiencies, expand their geographic footprints, and expand their therapeutic expertise and on-demand services. Outsourcing helps companies to save on resource costs, infrastructure costs, and other overheads. Cost savings remain the main reason for outsourcing multiple features across the industry, but some major pharmaceutical companies have radically changed their outsourcing motives. In the current market, pharmaceutical companies cite improved quality and faster time to market as the main reasons for outsourcing business functions to CROs and CDMOs.

Over the last decade, more and more pharmaceutical and biotechnology companies have turned to complementary metal-oxide semiconductor (CMOs) and contract development and manufacturing company (CDMOs) to help them perform, develop, and manufacture the latest innovations. Outsourcing is a multi-billion-dollar industry today. Most spending is focused on early development, and about two-thirds of annual spending is outsourced.

Key Highlights

In 2021, the monoclonal antibodies segment accounted for the largest share of 45% in the global biopharmaceutical excipients market

The commercial segment dominated the market by contribution largest share of over 73% in 2021.

In 2021, the pharma & biotech companies segment accounted for the larger share of 57.63% in the global biopharmaceutical excipients market.

Key Offerings:

Market Size & Forecast by Volume | 20212027

Market Size & Forecast by Value | 20212027

Market Dynamics Leading trends, growth drivers, restraints, and investment

OpportunitiesMarket Segmentation A detailed analysis by excipient, biologics, scale of operation, end-user, and geography

Competitive Landscape 6 key vendors and 27 other vendors

Market Segmentation

Excipient

Biologics

Monoclonal Antibodies

Vaccines

Others

Scale Of Operation

End-User

Geography

North America

Europe

Germany

France

UK

Switzerland

Italy

Spain

APAC

China

Japan

South Korea

India

Australia

Latin America

Middle East & Africa

Turkey

Saudi Arabia

UAE

South Africa

Competitive Analysis

The global biopharmaceutical excipients market is fragmented, with revenue generated by vendors ranging from emerging mid-sized to established players. Major players are concentrating on strategic licensing, acquisitions, and collaboration agreements with growing players to enter the biopharmaceutical excipients market and to quickly access commercially launched products. Companies are also launching advanced and novel excipient solutions to support pharma drug development. They are focusing more on distribution chains and are providing the required demand for the biopharmaceutical excipients. Players are also focusing on market expansion in existing and newer markets to cater to the needs of an increasing customer base, widening their product portfolios, and boosting their production capabilities that can help in gaining traction from end-users.

Vendors

Merck KGAA

BASF SE

Avantor

Evonik Industries

Roquette Freres

Other Prominent Vendors

Aceto

Angus Chemical

Apothecon

Ashland Global

BioSpectra

BOC Sciences

C.G. Group

Clariant

Colorcon

DFE Pharma

DOW

Eastman Chemical

IMCD N.V.

Innophos

Invitria

JRS Pharma

Kirsch Pharma

Meggle

Novo Nordisk

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Biopharmaceutical Excipients Market to Reach $3.2 Billion by 2027. Rising Demand for Vaccines and Cell & Gene Therapy-based Excipients are the...

July 12, 2022

Company Name:

HEALIOS K.K.

Representative:

Hardy TS Kagimoto, Chairman & CEO

(TSE Growth Code: 4593)

Healios eNK Cells: Regenerative Medicine Product Quality Consultation

with the PMDA for Planned Clinical Trials

HEALIOS K.K. ("Healios") is developing next-generation cancer immunotherapies for solid tumors using NK cells*1 derived from allogeneic iPSCs (Development Code: HLCN061 "eNK cells") whose specific functions have been enhanced with gene editing technology. In preparation for the start of clinical trials using eNK cells, we have conducted a regenerative medicine product quality consultation*2 (face-to-face advice) with the Pharmaceuticals and Medical Devices Agency (PMDA).

Healios has succeeded in developing eNK cells through its own research and has confirmed that eNK cells have anti-tumor effects in mice engrafted with human lung cancer cells and human liver cancer cells. We are conducting joint research with the National Cancer Center Japan, Hiroshima University, and the Hyogo Medical University, to evaluate the effect of eNK cells in various human solid cancers. Furthermore, we have established an automated, 3D perfusion bioreactor based manufacturing system that enables efficient and stable mass production of eNK cells for the manufacture of investigational product. Healios initiated the operations of its Cell Processing Center (CPC), a GMP manufacturing facility based on these technologies, and is advancing preparations for eNK clinical trials.

As part of these preparations, we have begun consultations with the PMDA through a formal regenerative medicine product quality consultation process. In an initial face-to-face consultation meeting, we have discussed with the authorities genome analysis and evaluation of transgenic iPS cells for the purpose of assessing the quality of HLCN061, among other matters. We will continue with consultations with the PMDA as we work towards the submission of an investigational new drug application and the start a clinical trial in FY2024.

Even though the advent of molecular targeted drugs and cancer immunotherapy has improved treatment outcomes for some cancer patients, the efficacy of existing treatments for solid tumors remains poor. Healios is committed to its continued research and development of effective treatments for solid cancer patients.

*1 Natural killer (NK) cells

Natural killer (NK) cells are a subset of lymphocytes, a type of white blood cell. NK cells play a central role in a cell mediated defense system that human bodies naturally have, and attack cancer cells and virus-infected cells. The expected efficacy of treatments using NK cells includes life- extension, promotion of healing, relief of symptoms, and improvement of quality of life.

1

*2 Regenerative medicine product quality consultation

Guidance and advice are provided as a specialized consultation on matters related to the quality of processed cells, etc. and regenerative medicine products, such as specifications, test methods, stability, and manufacturing methods.

About Pharmaceuticals and Medical Devices Agency (PMDA):

PMDA is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. It conducts scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety. It is also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.

In response to applications from sponsors, etc., we provide guidance and advice on clinical trials for pharmaceuticals, medical devices, regenerative medicine products, etc., as well as on clinical trials for reevaluation and reassessment. https://www.pmda.go.jp/english/review-services/consultations/0002.html

About Healios' eNK cells:

Healios eNK cells are a gene edited iPSC-NK cell therapy with several functional enhancements achieved through gene-editing including enhanced cytotoxicity towards cancer, improved capability to migrate and infiltrate solid tumors, and the ability to recruit host immune cells. Healios has succeeded in developing eNK cells through its own research and has confirmed that eNK cells have anti-tumor effects in mice engrafted with human lung cancer cells and human liver cancer cells. In joint research with the National Cancer Center Japan("the NCCJ") we are evaluating the antitumor effects of eNK cells in a PDX mouse disease model created using the NCCJ's JPDX samples. Furthermore, Healios is conducting joint research on cancer immunotherapies using eNK cells for hepatocellular carcinoma with Hiroshima Universityand for mesothelioma with Hyogo Medical University. Healios is continuing with in vitro and animal testing of its eNK cell therapy in preparation for its first clinical trials.

About Healios:

Healios is Japan's leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative medicine. It aims to offer new therapies for patients suffering from diseases without effective treatment options. Healios is a pioneer in the development of regenerative medicines in Japan, where it has established a proprietary, gene-edited "universal donor" induced pluripotent stem cell (iPSC) line to develop next generation regenerative treatments in immuno- oncology, ophthalmology, liver diseases, and other areas of severe unmet medical need. Healios' lead iPSC-derived cell therapy candidate, HLCN061, is a next generation NK cell treatment for solid tumors that has been functionally enhanced through gene editing. Its near-term pipeline includes the somatic stem cell product HLCM051, which has been evaluated in Japan in Phase 2/3 and Phase 2 trials in ischemic stroke and acute respiratory distress syndrome (ARDS), respectively. Healios was established in 2011 and has been listed on the Tokyo Stock Exchange since 2015 (TSE Growth: 4593). https://www.healios.co.jp/en

Contact:

Department of Corporate Communications, HEALIOS K.K.

E-mail: ir@healios.jp

2

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Healios eNK Cells: Regenerative Medicine Product Quality Consultation with the PMDA for Planned Clinical Trials - Marketscreener.com

The companies will jointly develop 4D bio-fabricated corneal transplants for diseases that require endothelial keratoplasty and natural lenticule transplants

Carl Zeiss Meditec will invest in Precise Bio and fund the further development of Precise Bio's two cornea transplant products and has exclusive worldwide commercialization rights for these products

JENA, Germany and WINSTON SALEM, N.C., July 18, 2022 /PRNewswire/ -- Carl Zeiss Meditec and Precise Bio, a regenerative medicine company advancing the use of bio-printed tissues and organs, announced today that the companies have entered into a partnership to develop and commercialize fabricated corneal tissue for transplants in patients that require endothelial keratoplasty and natural lenticule transplants for treating keratoconus and vision correction.

Under the terms of the agreement, Carl Zeiss Meditec will invest in Precise Bio and fund the further development of Precise Bio's two cornea transplant products and has exclusive worldwide commercialization rights for these products. Financial terms were not disclosed.

"This investment in Precise Bio is expected to complement our leading portfolio of cataract and corneal refractive workflow solutions," said Euan S. Thomson, PhD, President of Ophthalmic Devices and Head of the Digital Business Unit for Carl Zeiss Meditec. "The technology has the potential to advance treatment options for corneal disease, as well as for elective procedures furthering enabling optimization of patient care."

"We are very excited with this partnership that builds on our successful, ongoing collaboration with ZEISS for the development of corneal tissues to address unmet needs in the field of ophthalmology," stated Aryeh Batt, Co- Founder and CEO of Precise Bio. "This strategic agreement leverages ZEISS' global leadership in ophthalmology and Precise' innovative and unique 4D bio-fabrication platform technology. We are confident that the synergy between the two companies will allow us to develop breakthrough solutions for recovering patients' eyesight, bringing hope to hundreds of millions of patients worldwide."

Precise Bio combines engineering, biomaterials, cell technology, bioengineering, and 3D printing into an unparalleled 4D bio-fabrication platform for transplantable organs and tissues. The Company's proprietary platform technology allows to fabricate tissues by 'printing' cells in a single-cell resolution and spatial accuracy, enabling complex organoid constructs with both structural integrity and long-term cell viability. Overcoming multiple technology challenges, Precise Bio's 4D bio-fabrication technology allows to reliably scale up tissue engineering for clinical use, and produce large quantities in a reproducible, quality controlled and cost-effective process. Precise Bio's ophthalmological pipeline consists of three products, the two cornea products that are the subject of the collaboration with Carl Zeiss Meditec and a retinal implant for age-related macular degeneration, all of which demonstrated successful results in animal models. The Company's ophthalmological products address global markets exceeding $10 billion annually.

Bio-fabricated tissues comprised of human cells and natural materials, mimicking the anatomical structure and natural tissue components, can replace damaged or diseased tissue, substitute for donor tissue in cases where there is lack of tissue or solve unmet therapeutic needs.

About ZEISSCarl Zeiss Meditec AG (ISIN: DE 0005313704), which is listed on the MDAX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With approximately 3,531 employees worldwide, the Group generated revenue of 1,646.8m in fiscal year 2020/21 (to 30 September).

The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 41 percent of Carl Zeiss Meditec AG's shares are in free float. The remaining approx. 59 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries.

For further information visit:www.zeiss.com/med

About Precise BioPrecise Bio develops regenerative medicine therapies that can transform patient care across a wide range of medical indications. Precise Bio's proprietary, break-through 4D bio-fabricating platform overcomes limitations of existing extrusion and ink-jet printers and paves the way for fabricating clinically viable tissues and organs. The Company's initial product pipeline is focused on ophthalmology and includes fabricated functional corneal grafts, intrastromal lenticules for treating keratoconus and vision correction,and a retinal implant for age-related macular degeneration. The Company also has earlier R&D programs to address unmet needs in additional medical indications, which are limited by the number of available donor tissues and organs, or where today's critical health problems can be solved using Precise Bio's naturally-based, hyper-accurate technology.

Precise Bio was founded in 2016 by Prof. Anthony Atala, MD, Director of the Wake Forest Institute of Regenerative Medicine (WFIRM), Prof. Shay Soker, PhD, from WFIRM and Mr. Aryeh Batt, who developed the Company's transformative laser printing technology. The Company operates out of two centers, in Winston Salem, NC and Modi'in, Israel.For more information, please visit http://www.precise-bio.com.

Photo - https://mma.prnewswire.com/media/1860898/Precise_Bio_Cornea.jpg

Precise Bio contact for investors:Eyal ArieliCFO/COOPrecise BioPhone: +972 76 539 1001[emailprotected]

Precise Biocontact for press / media:Tsipi HaitovskyGlobal Media LiaisonPrecise BioPhone: +972 52 598 9892[emailprotected]

ZEISS contact for investors:Sebastian FrericksDirector Investor RelationsCarl Zeiss Meditec AGPhone: +49 3641 220-116[emailprotected]

ZEISS contact for the press / media:Laurie FergusonHead of Global Communications Ophthalmic DevicesCarl Zeiss MeditecPhone: +1 925 719 7825[emailprotected]

SOURCE Precise Bio

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Carl Zeiss Meditec and Precise Bio Announce Partnership in the Development and Commercialization of Tissue-Based Implants for Ophthalmology USA -...

A Tokyo Medical and Dental University (TMDU) team announced on July 7 that it has conducted the worlds first clinical transplant of a mini organ into a patient with ulcerative colitis, an intractable disease. Part of a clinical study, the mini organ is made from cells obtained from the patient, and functions like a large intestine.

Researchers hope that the therapeutic method can possibly repair the ulcerated area of the intestine, which is difficult to treat with drugs. Its practical use as a new therapy in regenerative medicine is anticipated.

The surgery was conducted on an ulcerative colitis patient with refractory ulcers at the Tokyo Medical Dental University Hospital on July 5. Stem cells, which are tissue-building cells, were collected from the vicinity of a healthy colonic mucosa and cultured. Many spherical mini organs measuring at 0.1 ~ 1.2 millimeters were produced. These were then transplanted into the ulcerated area with an endoscope.

The surgery was successful and the patient was discharged from the hospital the following day. The team will monitor the patients condition over the next year to confirm safety and efficacy of the treatment.

At the press conference, Professor Ryuichi Okamoto stated, We were able to reach the starting line of a new medical therapy. We hope to continue a steady progression in our research and deliver the results to patients.

Mini organs are a collection of cells that bear the function and three-dimensional structure of actual organs. Also called organoids, their utilization in applied research in regenerative medicine is gaining momentum with various organs.

The surgery on July 5 is said to be the first ever full-scale organoid transplant to be conducted.

Ulcerative colitis is an intractable disease brought on for unknown reasons. It causes inflammation and ulcers along the mucosa of the colon, triggering symptoms such as abdominal pain and bloody diarrhea.

The number of patients is rapidly increasing, with an estimated 220,000 people affected in Japan. Symptoms can improve with anti-inflammatory drugs. However, if the disease becomes severe it could be difficult to repair or regenerate the ulcerated area using only symptomatic treatments available up to now.

Organoids bear a resemblance to the conditions of actual human tissues. Therefore, they are able to regenerate the ulcerated area because of their ability to attach to the affected area. Combined with the use of medication, a complete recovery is said to be possible.

(Read the report in Japanese at this link.)

Author: The Sankei Shimbun

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Tokyo Medical and Dental University Team Succeeds with First Mini Organ Transplant - JAPAN Forward

Treating Pain Origins with Minimally Invasive Techniques

CHALFONT, Pa., July 18, 2022 /PRNewswire/ -- Local Pain Medicine & Rehabilitation Practice, Pennsylvania Pain and Spine Institute (PA Pain and Spine) changes the way pain is treated with access to premier technologies and treatments unavailable elsewhere for patients in the region.

PA Pain and Spine is a professional medical center providing diagnostic and treatment services for various pain-related conditions in the Philadelphia region of Pennsylvania and beyond. With a team of highly qualified and trained providers, the Harvard-trained founders H. David Qu, MD and Robert Kelly, DO have led the practice to serve 800+ patients a week in both diagnosing and treating their chronic, pain-related conditions.

"Typically, when people hear the term 'Pain Management' they think of medication and a spiraling path of depression. When we started out and saw the available pain 'treatments' in the area, we realized there was a need for less medication and surgery and instead more true treatments. We wanted to be different. We wanted to learn everything we could to provide people in our community with the absolute best options available to treat any type of pain and related conditions at the source and allow them to get back to doing the things they love in life." states Founding Physician H. David Qu, MD.

The practice continues to grow to see more patients in need, beyond the Montgomery and Bucks counties in Pennsylvania, and offers access to various minimally invasive injection therapies, regenerative medicine therapies, medical acupuncture, cutting edge minimally invasive out-patient procedures and more all over the region.

With a strong focus on community support and helping people get their lives back, it comes as no surprise that the practice has hundreds of patient testimonials expressing how their lives have changed after working with this team.

"There is no limit for the future. We are constantly evolving and learning new treatment methodologies to better serve our community as the world changes. We want to be the team where people feel heard, and leave better than when they came in. The amount of dedication and passion our team has for helping others is limitless and we want to continue spreading this care across the state and beyond," states President and Founding Physician Robert Kelly, DO.

Patients and local community can learn more about the practice and the team of providers by visiting https://www.pennpain.com, or by calling the office at (215) 395-8888.

About PA Pain & Spine

Pennsylvania Pain and Spine Institute was founded in 2013 by Ivy League trained physicians Dr. David Qu, MD and Dr. Robert Kelly, DO. The practice is a pain management and rehabilitation privately-owned clinic with a focus on utilizing minimally invasive techniques and pain generator diagnostics in order to heal patients at the source. The practice currently has two offices located in Chalfont, Pennsylvania and Quakertown, Pennsylvania and treats patients with any type of pain.

Media Contact:Kelsey Voelker215.395.8888 x104[emailprotected]

SOURCE Pennsylvania Pain and Spine Institute

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Local Pain Medicine Practice Changes the Way Pain is Treated - PR Newswire