Monthly Archives: October 2022

TOKYOand HENNIGSDORF, Germany, Oct. 3, 2022 /PRNewswire/ --Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pantherna Therapeutics GmbH (CEO:Klaus Giese, Ph.D., "Pantherna") today announced that the companies have entered into a new technology evaluation agreement for research to generate mRNA-based regenerative medicine programsusing direct reprogramming (transdifferentiation)*.

This agreement expands the scope of the technology evaluation agreement for research, which Astellas and Pantherna entered into in 2021, to include new target organ.

Pantherna owns a proprietary platform of state-of-the-art, unique mRNA molecules (PTXmRNAs) for enhancing the efficiency of mRNA actions in the body. Under the new agreement, Pantherna's mRNA platform and Astellas' world-class drug discovery capabilities will be combined to promote research on the generation of regenerative medicine programsfor new target organ using a direct reprogrammingapproach. Astellas will be responsible for providing drug discovery ideas, preparing candidate compounds for technology evaluation, and performing research aimed at developing this therapeutic modality, while Pantherna will be responsible for providing technical information and development support.

"We are excited about this expansion of our collaboration with Astellas," said Pantherna's Chief Executive Officer, Klaus Giese, Ph.D. "We feel honored that Astellas, as a leading pharmaceutical company, has underscored their interest in leveraging the unique aspects of our proprietary therapeutic mRNA technology."

"Through this agreement, which expands the scope of our collaboration with Pantherna, we will create innovative regenerative medicine programs for new target organ, and we expect that we will be able to thereby expand the treatment options for diseases with high unmet medical needs." said Taiji Sawamoto, Ph.D.,Executive Vice President, Applied Research & Operations, at Astellas. "The collaboration with Pantherna is an initiative which synergistically integrates Astellas' expertise with mRNA as a therapeutic modality and its capabilities cultivated in the research field of directreprogramming,and will promote the development of next-generation treatments using a new modality/technology based on the Focus Area approach strategy."

* Direct reprogramming: Direct conversion of the fate of cells without passing through the pluripotent state. https://www.astellas.com/en/science/direct-reprogramming-research-unit

About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

About PanthernaPantherna Therapeutics is a privately held biopharmaceutical company developing first-in-class therapeuticsfor vascular diseases.Pantherna's innovative technology platform is based on advanced lipid nanoparticles for thetarget-specific, selective delivery and expression of therapeutic mRNA drugs in organs and tissues such as the endothelium. Pantherna Therapeutics was recently awarded with a 2022 Pharma Trend Honor for its lead candidate PAN004 in the category "Most Innovative Product: Leap Innovations-NucleicAcid-BasedDrug Development"

(https://businesswire.com/news/home/20220916005215/en/Pharma-Trend-Honors-the-Best-Pharmaceutical-Companies-and-the-Most-Innovative-Products_2022). Pantherna is based in Hennigsdorf,Brandenburg (Innovationsforum) close to Berlin, Germany. For more information, please visit our website at https://pantherna-therapeutics.com/.

Cautionary Notes(Astellas)In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas'intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

SOURCE Astellas Pharma Inc.

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Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative...

Dr. Joseph Mejia, DO, FAAPRM&R, RMSK has been selected as a Castle Connolly Top Doctor in the field of orthopedic and regenerative medicine. Triple board certified in Physical Medicine and Rehabilitation, Interventional Pain Management and Sports Medicine, Dr. Mejia offers vast experience and expertise in nonsurgical orthopedic medicine.

Dr. Mejia serves as the medical director at Performance Rehabilitation & Regenerative Medicine in Somerset County alongside Dr. Ronald Spiaggia, the founding partner of the practice. In addition to receiving extensive training in Regenerative Medicine, Dr. Mejia is fellowship-trained in Interventional Pain/Musculoskeletal Medicine and is licensed in both New Jersey and New York. He also is certified in diagnostic musculoskeletal ultrasound and has received comprehensive training in Regenerative Medicine for advanced spine conditions. Dr. Mejia is known as a pioneer in Regenerative Medicine, having been published in multiple projects and publications, and conducting highly sought-after courses and workshops.

Dr. Mejia completed his undergraduate degree at the University of Michigan, Ann Arbor, where he received a Bachelor of Science degree in biology. He then earned a medical degree at the West Virginia School of Osteopathic Medicine. After completing his residency at New York University/Rusk Institute of Rehabilitation, he received fellowship training in Interventional Pain/Musculoskeletal Medicine at UMDNJ/Kessler Institute for Rehabilitation. He currently resides in Wayne, N.J., with his wife and four children. He is a dedicated family man with interests in traveling, photography, computers and playing basketball.

As founding partners ofPerformance Rehabilitation & Regenerative Medicine, Dr. Mejia and Dr. Spiaggia have pioneered new approaches to orthopedic treatments, sports injuries, acute and chronic spine-related disorders, herniated discs, radiculopathy, spinal cord injuries, acute and chronic joint injuries, osteoarthritis, rotator cuff tears, meniscus tears, tendinopathies, ligament tears and nerve entrapments.

AtPerformance Rehabilitation & Regenerative Medicinewe strive to get to the root cause of peoples spine and joint pain, Dr. Mejia said. Our clinic uses a proven, team-based approach that gets results. Our state-of-the-art facilities allow patients to consult with medical physicians, physical therapists, occupational therapists, acupuncturists, neurosurgeons, and orthopedic surgeons, all under one roof.

Performance Rehabilitation & Regenerative Medicine maintains offices in Watchung, Branchburg and Somerset to reach patients across New Jersey. Dr. Mejia and the Performance Rehabilitation & Regenerative Medicine team recently opened a new surgery and pain management center in Bridgewater.

I strive to reduce or eliminate pain for my patients and return them to their prior level of function so they can get back to doing what they love, Dr. Mejia commented. I utilize the latest imaging technology to diagnose and guide specific treatments for their condition with the highest level of precision. I listen to my patients and collaborate with other health care professionals, when necessary, to work toward a common goal of improving quality of life.

Performance Rehabilitation and Medicine has served more the 30,000 patients over the past 21 years. To learn more about Dr. Mejia andPerformance Rehabilitation & Regenerative Medicine or to book and appointment visitperformancerehabnj.comor call 908-754-1960.

Office Locations

Performance Rehabilitation & Regenerative Medicine of Branchburg

3150 Route 22, Branchburg, NJ 08876

Performance Rehabilitation & Regenerative Medicine of Somerset

454 Elizabeth Ave., Suite 240, Somerset, NJ 08873

Performance Rehabilitation & Regenerative Medicine of Watchung

459 Watchung Ave., Watchung, NJ 07069

Performance Surgical Associates (Surgery Center)

1081 Route 22, Bridgewater, NJ 08807

Hospital Affiliations

RWJ University Hospital Rahway

Hackensack Meridian Mountainside Medical Center

Hudson Regional Hospital

Carepoint Health-Bayonne Medical Center

The Valley Hospital

Expertise

Pain Management and Orthopedics

Physical Therapy

Occupational Therapy

Regenerative Medicine

Specialties

Non-Surgical Treatments, Physical Medicine and Rehabilitation, Interventional Pain Management, Sports Medicine,Regenerative Medicine, Stem Cell Therapy, PRP,Radiofrequency Ablation (RFA)Therapy, Ultrasound Guided Injections, Diagnostic Musculoskeletal, Nerve Conduction Studies and Electromyography, Acute and Chronic Spine Related Disorders,Herniated Discs,Spinal Stenosis,Spinal Cord Injuries,Spinal Cord Stimulation, Acute and Chronic Joint Injuries,Osteoarthritis, Rotator Cuff Tears, Meniscus Tears,Tendinopathies, Ligament Tears,Nerve Entrapments, Orthopedic Surgery, Arthroscopic Surgery, Neuro Surgery, Physical Therapy, Occupational Therapy.

Board Certification

American Board of Physical Medicine & Rehabilitation

American Board of Pain Medicine

American Board of Sports Medicine

Affiliations

American Academy of Physical Medicine & Rehabilitation

Association of Academic Physiatrists

New York Society of Physical Medicine & Rehabilitation

American Society Interventional Pain Physicians

International Spine Intervention Society

American Medical Association

American Osteopathic Association

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Performance Rehabilitation and Regenerative Medicine's Dr. Joseph Mejia honored as a Castle Connolly Top Doctor - Jersey's Best

Throughout the life of a woman, her body changes, and so does the intimate sphere. It can be subject to pregnancy, childbirth, menopause, hormonal changes, cancer problems and natural aging. All this causes internal and external changes to occur in the vaginal area, which can affect its appearance and the sensations it experiences.

Vaginal rejuvenation may be the solution to these problems, representing a breakthrough in regenerative medicine and gynecology. It is possible to restore or restore the normal functioning of female organs through various procedures.

Dr. Maria Jose Gomez, a specialist in regenerative and aesthetic gynecology, specializes in and provides innovative vaginal rejuvenation treatments to her patients. It aims to provide minimally invasive solutions and achieve progressive results by excluding the need to undergo a surgical procedure.

Who is Vaginal Rejuvenation for?

Rejuvenation refers to a set of non-surgical techniques that seeks to treat problems in the vagina. The purpose of applying these procedures is to cure problems such as urinary incontinence, vulvar lichen sclerosus, vaginal dryness, itching or atrophy of the region.

They are also used to prevent low elasticity, pain in intimate relationships, loss of tone in the walls of the vagina, genital prolapse and relaxation of the pelvic floor. Other problems in which vaginal rejuvenation is indicated are episiotomy scars that have worsened and diminished over the years.

These treatments represent a great advance, as they allow solving problems that until a few years ago were only treated with surgery in the most severe cases. For milch people, they were neither considered nor noticed, as they were thought to be a normal effect of age.

Methods by Dr. Maria Jose Gomezu

One of the methods used by Dr. Maria Jose Gomez for vaginal rejuvenation is the CO2 laser. With this state-of-the-art, non-invasive device, it achieves excellent results for the treatment of menopausal, postpartum, urinary incontinence and undesirable effects of vulvar sclerotrophic lichen.

It also applies hyaluronic acid treatment combined with platelet-rich plasma to hydrate or volumize the labia majora, improving the aesthetics of the area. But, in addition, it helps to reproduce and improves the functionality of the female genitalia, curing malformations such as atrophy and vaginal dryness.

Laser labiaplasty is one of his procedures used for vaginal rejuvenation. Through this, excess tissue of the labia minora is removed when they are enlarged, using a CO2 laser, providing faster recovery and immediate results. Its purpose is to give a harmonious look to the vulva and to treat the discomfort presented in the area.

At its centers located in Madrid and Alicante, Dr. Mara Jos Gmez Fernndez offers her patients a completely free first consultation to offer her patients the best treatment tailored to their needs.

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Company / An Advance In Vaginal Rejuvenation, Regenerative Medicine And Aesthetic Gynecology - World Nation News

Teijin Limited,Japan Tissue Engineering Co., Ltd.(J-TEC),Mitsui Fudosan Co., Ltd.and theNational Cancer Center(NCC)jointly announced today thatthey willestablish a regenerative medicine platform inKashiwanoha Smart City,a life sciencebusiness park in Kashiwa-shi, Chiba Prefecture, Japan. The platform supports the development of innovative treatments for diseases with unmet needs such as cancer. It serves a one-stop system supporting research and development, business plan formulation, and commercial production of regenerative medicine products.In particular, the four partners aim to accelerate the commercialization of regenerative medicine and innovative treatments for cancer.As part of the plan, the partners already have begun to support seed holders.

Looking at the four partners: NCC provides cutting-edge cancer treatments and produces drug discovery seeds; J-TEC has extensive experience in product development, manufacturing and marketing as a pioneer of regenerative medicines; Teijin boasts expertise in drug research, development and marketing; and Mitsui Fudosan builds spaces and communities for innovation in life sciences. Their envisioned platform, taking advantage of the physical and functional proximity of the four parties, is expected to quickly and efficiently provide solutions for manufacturing and clinical development, business planning and commercial production. The contract development and manufacturing organization (CDMO) served by Teijin and J-TEC will be located in Mitsui Link-Lab Kashiwanoha 1 operated by Mitsui Fudosan, and is adjacent to the NCC Hospital East and NCC Exploratory Oncology Research & Clinical Trial Center.

The platform will also support projects of other organizations that have seeds. NCC will provide professional consulting and collaboration with seeds holders and investigator-initiated clinical trials. Teijin and J-TEC offer practical consulting and support for contracted development and manufacturing. Mitsui Fudosan will be responsible for venue operation and providing support for individual initiatives.

In preparation to start up the CDMO facility scheduled to open in January 2024, the platform will promote the development of regenerative medicines among academic institutions,start-up companies, pharmaceutical companies and others. It also will solicit research and development and clinical collaborations with medical institutions as well as key opinion leaders (KOL) and business enterprises in the fields of cancer and regenerative medicine.

With this agreement, the four parties will strive to stimulate demand and build up their platform, aiming eventually at establishing a structure capable of supporting about 10 projects annually with the purpose of bringing regenerative medicines to market. Teijin, in collaboration with J-TEC, will invest a substantial portion of its more than JPY 3 billion CDMO-related investment budget into the project, mainly for facilities and human resource training in Mitsui Link-Lab Kashiwanoha 1 over the next two to three years, thereby helping to establish a CDMO facility mainly for supporting the development of manufacturing methods as well as actual manufacturing. Ultimately, the four parties expect to contribute to global medical care by providing new options for patients waiting for innovative treatments.

According to the NCC, some one million people are diagnosed with cancer each year in Japan. Development of innovative treatments using regenerative medicines, including genetically modified immune cell therapy, also known as chimeric antigen receptor (CAR-T) cell therapy, has been ongoing worldwide in recent years. In addition, research and development of promising treatments and their seeds are under way. Meanwhile, the practical application of regenerative medicine requires specialized knowledge and practical experience regarding matters such as pharmaceutical approval and quality control. A wide range of commercialization knowhow also is required. As a result, many academic institutions and start-up companies are unable to commercialize their research and development independently. Teijin, J-TEC, Mitsui Fudosan and NCC, based on their clear understanding of such needs, have now agreed to establish a regenerative medicine platform to provide academic institutions with professional expertise and commercialization knowhow on a collaborative basis.

Kashiwa-no-ha Smart City, which is served by Kashiwa-no-ha Campus Station about 30 minutes by express train from central Tokyo, is an area with accumulation of Japans leading academic and medical institutions for some of Japan's leading academia and medical facilities. In addition to Mitsui Garden Hotel Kashiwa-no-ha Parkside, which supports cancer patients, the smart city has become a lively community of offices and commercial facilities.Mitsui Link Lab Kashiwanoha 1, located at6-6-2 Kashiwanoha, Kashiwa-shi, ChibaPrefecture, comprises about11,000m2of total floor space and offers rentalspace ofabout 8,000 m2.

About the Teijin Group

Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the fields of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Originally established as Japan's first rayon manufacturer in 1918, Teijin has evolved into a unique enterprise encompassing three core business domains: high-performance materials including aramid, carbon fibers and composites, and also resin and plastic processing, films, polyester fibers and products converting; healthcare including pharmaceuticals and home healthcare equipment for bone/joint, respiratory and cardiovascular/metabolic diseases, nursing care and pre-symptomatic healthcare; and IT including B2B solutions for medical, corporate and public systems as well as packaged software and B2C online services for digital entertainment. Deeply committed to its stakeholders, as expressed in the brand statement Human Chemistry, Human Solutions, Teijin aims to be a company that supports the society of the future. The group comprises some 170 companies and employs some 20,000 people across 20 countries worldwide. Teijin posted consolidated sales of JPY 926.1 billion (USD 7.2 billion) and total assets of JPY 1,207.6 billion (USD 9.4 billion) in the fiscal year that ended on March 31, 2022.

Please visitwww.teijin.com

About J-TEC

J-TEC (TSE: 7774) is a maker of regenerative medical products whose corporate vision is creating a future for regenerative medicine, and has been a member of the Teijin Group since March 2021. As Japans top runner in regenerative medicine, J-TEC obtained marketing approval for autologous cultured epidermis JACE, Japans first regenerative medical product, in October of 2007, and began marketing the product in January of 2009. J-TEC then went on to obtain marketing approval for Autologous Cultured Cartilage JACC in July of 2012, for Autologous Cultured Corneal Epithelium Nepic in March of 2020, and for Autologous Cultured Oral Mucosal Epithelium Ocural in June 2021. Of the 16 regenerative medical products that have been approved in Japan, four are J-TEC products. By making the most of the experience and knowhow cultivated through these achievements, J-TEC is engaging in contract development of regenerative medical products, consulting, and contract manufacture of specific cell-processed products.

Please visitwww.jpte.co.jp/en/

About Mitsui Fudosan Co., Ltd.

(Kashiwa-no-ha Smart City:https://www.kashiwanoha-smartcity.com/en/)

Mitsui Fudosan is a comprehensive developer that creates new value by striving to resolve social issues through urban development. At Kashiwa-no-ha Smart City, Mitsui Fudosan aims to create a smart, compact city driven by data through the introduction of new technologies such as AI and IoT. It has been selected by the Ministry of Land, Infrastructure, Transport and Tourism as an advanced model project for a smart city towards realizing Society 5.0. Going forward, Mitsui Fudosan will work on developing smart medical institution services for health and medicine. In addition, the Mitsui Fudosan Group believes that it can contribute significantly to the realization of Society 5.0, which is advocated by the Japanese government, and to the achievement of the SDGs, by promoting ESG management, which means advancing businesses based on an awareness of the Environment (E), Society (S), and Governance (G).

About National Cancer Center Japan

The National Cancer Center Japan, established in 1962, is a leading medical institution in cancer treatment and research in Japan. It is actively involved in physician-led clinical trials and clinical research, and has produced a wealth of research results that have led to the development of new drugs.

Press ContactCorporate CommunicationsTeijin Limited+81 (0)3 3506 4055pr@teijin.co.jp

Corporate Communication OfficeJapan Tissue Engineering Co., Ltd.+81 (0) 533 66 2020jtec-info@jpte.co.jp

Public Relations DepartmentMitsui Fudosan Co., Ltd.+81 (0)3 32463155

Office of Public Relations, Strategic Planning BureauNational Cancer Centerncc-admin@ncc.go.jp

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Teijin, J-TEC, Mitsui Fudosan, and NCC to create a new platform for regenerative medicine innovation - The Worldfolio

Cell Regeneration Medicine Market Snapshot (2022-2032)

[250 Pages Report] According to Future Market Insights newly releasedCell Regeneration Medicine Marketanalysis report, the global market valuation stands atUS$ 30.3 Bnin 2021 and is expected to be valued atUS$ 34.3 Bnby the end of 2022. The market is expected to rise significantly at a CAGR of14.4%and the global valuation is expected to beUS$ 130.8 Bnby the end of 2032. During the forecasted period (2022-2032), the global market is anticipated to offer an absolute dollar opportunity ofUS$ 96.5 Bn.

The Therapeutics segment is predicted to be the top product segment in the Cell Regeneration Medicine Market with an expected CAGR of16.5%for the period between 2022 and 2032. This is significantly higher from the historical CAGR of14.1%owing to higher adoption of primary cell-based therapies in clinical application and their increased usage in different therapeutic indications.

Furthermore, Cell Regeneration Medicine garners highest revenue through the Oncology segment, which accounts for over a quarter share. The market revenue through Oncology segment is expected to experience the CAGR of13.1%in the therapeutic category as compared to its historical average of11.4%.The category is expected to rise due to high cancer prevalence, increasing investments in cancer research, development of advanced cell therapies and initiatives to reduce cancer burden.

Revenue of Cell Regeneration Medicine Market from 2017 to 2021 Compared to Demand Outlook for 2022 to 2032

As per the publications released by Future Market Insights market research and competitive intelligence provider, on Cell Regeneration Medicine Market, the market is currently valued atUS$ 30.3 Bnin 2021 and is expected to rise at a CAGR of14.4%during the period between 2022 and 2032. This growth has been significantly higher than the historical growth of12.4%.The market is expected to offer an absolute dollar opportunity ofUS$ 96.5 Bnbetween 2022 and 2032. By the end of 2032, the global market for Cell Regeneration Medicine is likely to hit the valuation ofUS$ 130.8 Bn.

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The market valuation is projected to grow at a significant CAGR of14.4%as compared to historical CAGR of12.4%owing to factors such as introduction of gene therapy, advancements in stem cell and tissue engineering, ongoing funding in R&D by government and commercial entities and continuous regulatory approvals for advanced therapeutic medical products.

What Factors are driving the Growth of Cell Regeneration Medicine Market?

Global Cell Regeneration Medicine Market is likely to be driven by theintroduction of gene therapy,advancements in stems cells and growth intissue engineering. Furthermore, various projects like T-Cell therapy, which comes underthe manufacturing industry of cell therapyregenerative medicinearebeing undertaken by any businesses in cooperationwith other businesses or research institutions. Furthermore, the government regulatory approvals has led to increase in the market growth.

The global pandemic has provided the global players with various chances to bring medicinal solution to fight against SARS-COV-2. Along withvarious initiatives, theongoing investments bygovernment and private sector agencies inR&D has accelerated the industrys advancement. Companies are collaboratingto expand their R&D skills to develop and sell innovative therapies to secure a position in a competitive global market.

Researchers perspectives on Cell Regeneration Medicine have been transformed by technological developments like Nanotechnology,3D bioprintingtechniques and AIin stem cell-based therapeutics. These developments aremakingdermatological grafting operations like persistent burns, bone abnormalities and skin woundsmore efficient. The market is being driven by the rising frequency of chronic medical conditions and genetic abnormalities such as congestive heart failure, myocardial infarction, Parkinsons disease andvarious kinds of bone losses. In addition, the growing elderly populationsuffering from musculoskeletal, oncologicaland cardiological problemsis driving market expansion.

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What Factors are restraining the Growth of Global Cell Regeneration Medicine Market?

The sales of Cell Regeneration Medicine is likely to be affected by the high cost of therapies. This high cost of treatment acts as a barrier in entering the new market. People in emerging economies are unable to finance organ transplantation due to socioeconomic constraints. Organ trafficking is a serious crime that is inprevalencedue to a scarcity of organs.

The developing countries pose to be a potential marketwith rising rates of chronic diseases, hereditary diseases, rising geriatricpopulation and higher demanding regionsfor organs and biomaterials. Butwithlittle awareness of Cell Regeneration Medicine, these potential markets are difficult to capture. The gene correction treatment involves nucleases that have been modified to successfully change the human genome. However, the use of gene correction treatment is limited due to someunintended consequences, such as cell manipulation, which hasimpacted the efficacyofcell formation and proliferation. However, with sufficient capital and financing, R&D is proceeding toward the cost-effective commercialization of such complex medical operations.

Country-wise Analysis

Which Country is the Driving Force for the growth of the Global Cell Regeneration Medicines Market?

In 2021, the United States Accounted for nearly 2/5th share of the global market for Cell Regeneration Medicines. The U.S. market growth is significantly higher from its historical average growth of11.9%. Between 2022 and 2032, the market is estimated to witness an absolute dollar opportunity ofUS$ 36.6 Bn.

The presence of significant playersin the United States, the availability of modern technologiesand increasing financing ofresearch institutes involved in the creation of innovative treatments can all be attributed to this expansion. In addition, the United States has the biggest revenue flow due to a large number of clinical trials, the availability of financing, and various government and private-sector efforts. For example, the US Department of Health and Human Services launched a campaign to place Cell Regeneration Medicine at the forefront of healthcare.

Which Country is expected to grow rapidly in the Global Cell Regeneration Medicines Market?

According to Future Market Insights data, the market in China is anticipated to growat the fastest rate of18.2%between 2022 and 2032. Theprojected CAGR of the U.S. is significantly higher than the historical CAGR of13.7%. In the next ten years, the Chinese market is estimated to offer an absolute dollar opportunityofUS$ 14.8 Bnto reach a valuation ofUS$ 17.8 Bn.

The rising CAGR of the Chinese market for Cell Regeneration Medicines is attributed to the rapid expansion of healthcare infrastructure and research institutes to accelerate stem cell research in a rapidly developing market. With rising government approvals forresearch projects involving human embryonic stem cells,scientists are encouragedto investigate the cellsclinical potential. Additionally, the rising prevalence of cardiovascular and musculoskeletal illnesses is driving this trend. Furthermore, the market is likely to be explored by global players targeting the untapped segments of the market.

Category-wise Insights

Which Product Type is gaining the Utmost Traction in Cell Regeneration Medicine Market?

The Therapeutics segment is the largest revenue generating segment in the Global Cell Regeneration Medicine Market, growing at a CAGR of17.8%during the period between 2022 and 2032.

Despite source diversification, this category is anticipated to maintain its leadership position in the marketplace throughout the projected period. Primary cell-based therapies are the most developed medications available from the medical sector, as they are suitable for use in both clinical applications and approved in different areas. In addition, the stem cell & progenitor cell-based therapies market is predicted to grow significantly over the forecast years, owing to increased investments in stem cell research and regulatory policy revisions.

Which Therapeutic Category is expected to drive the Growth of Global Cell Regeneration Medicines Market?

Oncology therapeutic category is expected to lead the market with the highest share in global market for Cell Regeneration Medicines. It is forecasted to grow at a CAGR of13.1%during the period.

This can be attributable to high cancer prevalence globally and the development of efficient cancer treatment options. Furthermore, huge investments by government organizations and private companies to finance cancer research is aiding the growth.

Competitive Analysis

A number of companies invested in the development of cell regenerative medicine to meet demand for clinical needs without resorting to more-invasive procedures. The market is extremely competitive, and players are making joint efforts for product development.

Some of the prominent Cell Regeneration Medicine manufacturers are AstraZeneca plc, Astellas Pharma, Inc., F. Hoffmann-La Roche Ltd., Integra Lifesciences Corp., Cook Biotech, Inc., Bayer AG, Pfizer, Inc., Merck KGaA, Abbott, Vericel Corp., Novartis AG, GlaxoSmithKline (GSK), Baxter International, Inc., Takara Bio, Inc.

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The recent developments in the Global Cell Regeneration Medicine Market are:

Cell Regeneration Medicine Market Report Scope

Details

Forecast Period

2022-2032

Historical Data

2017-2021

Quantitative Units

In US$ Mn

Key Regions Covered

North America, Latin America, Europe, APAC and MEA

Key Countries Covered

United States, China, Japan, South Korea, U.K., Canada, Brazil, Mexico, Germany, France, Spain, Italy, Russia, India, Australia, South Africa, Saudi Arabia, UAE, Israel

Key Market Segments Covered

Product Type, Therapeutic Category and Region

Market Segments Covered in Cell Regeneration Medicine Market Analysis

By Product Type:

By Therapeutic Category:

By Region:

About FMI:

Future Market Insights (ESOMAR certified market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favor the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.

Contact Us:Future Market Insights,Unit No: 1602-006,Jumeirah Bay 2,Plot No: JLT-PH2-X2A,Jumeirah Lakes Towers,Dubai,United Arab EmiratesFor Sales Enquiries:sales@futuremarketinsights.comWebsite:https://www.futuremarketinsights.comLinkedIn|Twitter|Blogs

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Cell Regeneration Medicine Market to be valued at US$ 34.3 Bn by the end of 2022 | FMI Research - PharmiWeb.com

Enlivex Therapeutics Ltd

Nes-Ziona, Israel, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the Company), a clinical-stage macrophage reprogramming immunotherapy company, today announced that company management will participate in, and present at, the 4th Macrophage-directed Therapies Summit, which is taking place in Boston, Massachusetts from October 4-6, 2022.

Enlivexs presentation will take place at 2:30 PM ET on October 06, 2022. During the presentation, company management will provide an overview of Enlviex's clinical programs in sepsis and solid cancers, and review previously presented data supporting these programs. Those interested in registering for the summit can do so here.

ABOUT THE 4th MACROPHAGE-DIRECTED THERAPIES SUMMIT

The 4th Macrophage-directed Therapies Summit will include presentations regarding approaches to target dont eat me signal, strategies to reprogram tumor-associated macrophages, and techniques to discover next-generation targeting methods to develop highly effective and controlled therapies. The program will delve into clinical translatability, novel targets beyond CD47, combination strategies vs. monotherapy approaches, and lean on the lessons learned in oncology to bridge the gap between diseases in autoimmunity, inflammation, and regenerative medicine.

ABOUT ENLIVEX

Enlivex is a clinical stage immunotherapy company developing Allocetra, a universal, off-the-shelf cell therapy designed toreprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visithttp://www.enlivex.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as expects, plans, projects, will, may, anticipates, believes, should, would, could, intends, estimates, suggests, has the potential to and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATMprograms. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivexs business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATMproduct line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivexs filings with the Securities and Exchange Commission, including in the Companys most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

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ENLIVEX CONTACTShachar Shlosberger, CFOEnlivex Therapeutics, Ltd.shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACTEric RibnerLifeSci Advisorseric@lifesciadvisors.com

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Enlivex to Present at the 4th Macrophage-Directed Therapies Summit - Yahoo Finance

BLA Includes Substantial Body of Data from Pivotal Phase 3 and Ongoing Phase 1/2 Studies

If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A

SAN RAFAEL, Calif., Sept. 29, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the Company resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. The resubmission incorporates the Company's response to the FDA Complete Response (CR) Letter for valoctocogene roxaparvovec gene therapy issued on August 18, 2020, and subsequent feedback, including two-year outcomes from the global GENEr8-1 Phase 3 study and supportive data from five years of follow-up from the ongoing Phase 1/2 dose escalation study.

BioMarin anticipates an FDA response by the end of October on whether the BLA resubmission is complete and acceptable for review. Typically, BLA resubmissions are followed by a six-month review procedure. However, the Company anticipates three additional months of review may be necessary based on the number of data read-outs that will emerge during the procedure. If approved, valoctocogene roxaparvovec would be the first commercially-available gene therapy in the U.S. for the treatment of severe hemophilia A.

The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec in March 2021. RMAT is an expedited program intended to facilitate development and review of regenerative medicine therapies, such as valoctocogene roxaparvovec, that are expected to address an unmet medical need in patients with serious conditions. The RMAT designation is complementary to Breakthrough Therapy Designation, which the Company received for valoctocogene roxaparvovec in 2017.

In addition to the RMAT Designation and Breakthrough Therapy Designation, BioMarin's valoctocogene roxaparvovec also received orphan drug designation from the EMA and FDA for the treatment of severe hemophilia A. Orphan drug designation is reserved for medicines treating rare, life-threatening or chronically debilitating diseases. The European Commission (EC) granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under the brand name ROCTAVIAN on August 24, 2022 and endorsed the recommendation from the European Medicines Agency (EMA) to maintain orphan drug designation, thereby granting a 10-year period of market exclusivity in the European Union.

"We are pleased to reach this point in the development program for valoctocogene roxaparvovec and look forward to working with the FDA with the goal of bringing a potentially transformative therapy to people with severe hemophilia A in the United States," said Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin. "This large and robust data set provided in this BLA resubmission shows an encouraging efficacy profile. We remain committed to sharing these data with the public, along with even longer-term data generated through our ongoing clinical trials and any post-approval studies, to further our understanding of AAV gene therapy in severe hemophilia A and of gene therapies more broadly."

The resubmission includes a substantial body of data from the valoctocogene roxaparvovec clinical development program, the most extensively studied gene therapy for severe hemophilia A, including two-year outcomes from the global GENEr8-1 Phase 3 study. The GENEr8-1 Phase 3 study demonstrated stable and durable bleed control, including a reduction in the mean annualized bleeding rate (ABR) and the mean annualized Factor VIII infusion rate. In addition, the data package included supportive evidence from five years of follow-up from the 6e13 vg/kg dose cohort in the ongoing Phase 1/2 dose escalation study. The resubmission alsoincludesaproposedlong-term extension studyfollowingall clinicaltrialparticipantsfor up to 15years, as well astwo post-approval registry studies.

Robust Clinical Program

BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of severe hemophilia A. In addition to the global Phase 3 study GENEr8-1 and the ongoing Phase 1/2 dose escalation study, the Company is also conducting a Phase 3, single arm, open-label study to evaluate the efficacy and safety of valoctocogene roxaparvovec at a dose of 6e13 vg/kg with prophylactic corticosteroids in people with severe hemophilia A (Study 270-303). Also ongoing are a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with pre-existing AAV5 antibodies (Study 270-203) and a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with active or prior Factor VIII inhibitors (Study 270-205).

Safety Summary

Overall, to date, a single 6e13 vg/kg dose of valoctocogene roxaparvovec has been well tolerated with no delayed-onset treatment related adverse events. The most common adverse events (AE) associated with valoctocogene roxaparvovec have occurred early and included transient infusion associated reactions and mild to moderate rise in liver enzymes with no long-lasting clinical sequelae. Alanine aminotransferase (ALT) elevation, a laboratory test of liver function, has remained the most common adverse drug reaction. Other adverse reactions have included aspartate aminotransferase (AST) elevation (101 participants, 63%), nausea (55 participants, 34%), headache (54 participants, 34%), and fatigue (44 participants, 28%). No participants have developed inhibitors to Factor VIII, thromboembolic events or malignancy associated with valoctocogene roxaparvovec.

About Hemophilia A

People living with hemophilia A lack sufficient functioning Factor VIII protein to help their blood clot and are at risk for painful and/or potentially life-threatening bleeds from even modest injuries. Additionally, people with the most severe form of hemophilia A (Factor VIII levels <1%) often experience painful, spontaneous bleeds into their muscles or joints. Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population. People with hemophilia A with moderate (Factor VIII 1-5%) or mild (Factor VIII 5-40%) disease show a much-reduced propensity to bleed. Individuals with severe hemophilia A are treated with a prophylactic regimen of intravenous Factor VIII infusions administered 2-3 times per week (100-150 infusions per year) or a bispecific monoclonal antibody that mimics the activity of Factor VIII administered 1-4 times per month (12-48 injections or shots per year). Despite these regimens, many people continue to experience breakthrough bleeds, resulting in progressive and debilitating joint damage, which can have a major impact on their quality of life.

Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. Approximately 1 in 10,000 people have hemophilia A.

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening genetic diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of eight commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases. For additional information, please visitwww.biomarin.com.

Forward-Looking Statements

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: BioMarin anticipating an FDA response by the end of October on whether the BLA resubmission is complete and acceptable for review, BioMarin's expectations regarding the duration of the review procedure, valoctocogene roxaparvovec being the first commercially-available gene therapy in the U.S. for the treatment of severe hemophilia A, if approved, BioMarin's commitment to sharing longer-term data generated through its ongoing clinical trials and any post-approval studies. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the results and timing of current and planned preclinical studies and clinical trials of valoctocogene roxaparvovec; additional data from the continuation of the clinical trials of valoctocogene roxaparvovec, any potential adverse events observed in the continuing monitoring of the participants in the clinical trials; the content and timing of decisions by the FDA and other regulatory authorities, including decisions to grant additional marketing registrations based on an EMA license; the content and timing of decisions by local and central ethics committees regarding the clinical trials; our ability to successfully manufacture valoctocogene roxaparvovec for the clinical trials and commercially; and those and those factors detailed in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

BioMarin is a registered trademark of BioMarin Pharmaceutical Inc and ROCTAVIAN is a trademark of BioMarin Pharmaceutical Inc.

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Traci McCarty

Debra Charlesworth

BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

(415) 455-7558

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SOURCE BioMarin Pharmaceutical Inc.

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BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA - PR...

October 3, 2022

When most people think of civil engineering, images of construction sites, bridges and tunnels will likely come to mind. However, a recent collaboration between Arizona State University and Mayo Clinic is placing civil engineers in a new light.

There is a huge world out there where engineers can use their skills in areas that are traditionally not associated with civil engineering, says Subramaniam Subby Rajan, a civil engineering professor in the Ira A. Fulton Schools of Engineering at ASU.

Putting that concept to the test, Rajan has spearheaded a number of projects in the School of Sustainable Engineering and the Built Environment, part of the Fulton Schools, with private companies such as Honeywell and Raytheon and government organizations such as the Federal Aviation Administration and NASA. He has aided in the materials testing of everything from jet engines to bulletproof vests efforts that have not only expanded his knowledge of civil engineering, but also that of his students and research assistants who get to participate in the studies as well.

If you ask a person on the street or even a practicing civil engineer whether civil engineering skills can be used in answering questions dealing with bone fractures, the answer will inevitably be 'no'; there is not a connection between the two. However, there are a lot of connections, Rajan says.

In his latest research project, Rajan is using his civil engineering expertise to help forensic researchers draw more accurate conclusions about the impact of trauma made on the human body.

Video by Steve Filmer/ASU Media Relations

Subramaniam Subby Rajan

With a long track record of applying civil engineering mechanics to diverse research projects, Rajan was contacted by researchers at Mayo Clinic in Arizona. The team is actively working on a project that could redefine the process for identifying trauma made to human remains. More specifically, the research could allow forensic anthropologists to determine the time at which blunt-force trauma may have occurred to a human body with greater precision and, ultimately, if the trauma played a role in a person's death.

This work is important to forensic scientists because knowing whether a fracture occurred perimortem at or around the time of death versus postmortem can give us important information about the cause and manner of death with crime scene investigations, says Natalie Langley, a consultant in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Arizona and president of the American Board of Forensic Anthropology.

The collaborative team at Mayo Clinic also includes researchers from the Center for Regenerative Medicine in Arizona, the Biomaterials and Histomorphometry Core Laboratory at Mayo Clinic Rochester, Mayo Clinic postdoctoral research fellow Jessica Skinner and ASU's Barrett, The Honors College graduate intern Yuktha Shanavas.

Langley explains that femur bones are sourced from males between the ages of 50 and 80 who donated their bodies to scientific research. Those demographic variables were chosen to control for sex- and age-related compositional differences in bone. The bones are then heated at controlled temperature and humidity for varying amounts of time to simulate the loss of elasticity that bones experience during the postmortem interval.

Bone is an elastic material, and it maintains elasticity for some time after death, Langley says. By heating the bone, we are able to replicate longer periods of time after death that commonly lead to a bone losing some elasticity, leaving different fracture patterns than if it were broken while still elastic.

A layer of spray paint is also applied to the surface of the bones so high-speed cameras can detect deformation and surface strain that occur during the impact testing.

Donated femur bones are coated in a black-and-white speckled spray paint that allows high-speed cameras to capture the deformations on the surface of the sample during fracture testing. Photo by Monica Williams/ASU

Langley says her team needed help minimizing the unknowns in their research.

I contacted ASU initially because we needed an impact tester to induce fractures in a controlled manner, she says.

Rajans team and Mayo Clinic researchers created a special apparatus to hold a fragment of femur bone to allow for an impactor to drop at a controlled and monitored rate.

These are impacts that are strong enough to break a bone, but they are not as high velocity as a gunshot wound, Langley says. We even take it one step further and use high-speed photography to measure, or track, the movement of the bone during the fracture process.

This allows her team to consider what forces are being distributed across the bone.

Once the bone is fractured, it is handed back over to Langley and her team for a thorough review and documentation of the fracture characteristics.

One of the things we look at is the pattern of the fracture, Langley says. Fractures that occur at or around the time of death have a certain appearance; and those that occur much longer after death, when the bone is not as elastic, have a different appearance.

We captured 5,000 frames per second and were able to tell where the weight struck the bone and where the cracks were propagating in the bone, says Ashutosh Maurya, a graduate research associate who volunteered to participate in the bone testing.

Maurya is completing his doctorate in civil, sustainable and environmental engineering in the Fulton Schools. Despite the bone testing research having a different focus from his dissertation work, he felt it was a great opportunity to expand his skills as he explores impact dynamics problems connected to aircraft structures.

If you look at almost any research, you will see people from different areas working together, Maurya says. This will definitely help me in my future career as I collaborate with non-engineering background professionals and manage projects across disciplines.

Ashutosh Maurya, a doctoral student of civil, sustainable and environmental engineering, volunteered to participate in the collaboration with Mayo Clinic in hopes of expanding his experience working with individuals in different research fields. Photo by Monica Williams/ASU

It is a philosophy Mauryas mentor Rajan has tried to instill in all of the students that pass through his classroom.

It's only when you start looking at the fundamental tools that are used across all these different problems, that you find there are a lot of commonalities, Rajan says. For this specific project, we are able to make an impact beyond what is commonly expected of civil engineers.

In the coming months, Langley and her team will be compiling data from the fracture testing, tracking formations and markings left in the bones at different intervals of drying. The results will then be used to create a new standard for determining when trauma was inflicted on a crime victim.

Working with Rajan and his team allowed us to think outside of the box of our own work, Langley says. Their knowledge in controlling the variables with forcefully creating fractures gives validity to our work, ultimately changing the process for solving crimes and giving closure to families.

Top photo:Natalie Langley, a consultant in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Arizona, applies fingerprint powder to a fractured bone to help see fracture surface markings left by an impact. These markings are then documented to help create a new set of criteria for determining the timing of fracture events (e.g., perimortem versus postmortem). Photo by Monica Williams/ASU

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Fracturing bones and traditional views of civil engineering - ASU News Now

ReportLinker

INTRODUCTION It is a well-known fact that almost 90% of the therapeutic interventions fail in clinical trials, resulting in significant economic losses to the pharmaceutical industry.

New York, Sept. 30, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Organ on a Chip Market - Focus on Products and Technologies - Distribution by Type of Product, Application Area, Purpose, and Key Geographical Regions : Industry Trends and Global Forecasts, 2022-2035" - https://www.reportlinker.com/p06323408/?utm_source=GNW The lack of effective preclinical prediction of drug responses in humans is one of the various reasons for drugs failure to get approved. Animal testing for preclinical evaluation of drugs sometimes fails to identify toxicity signs caused by a drug in humans. Moreover, these studies are quite expensive, time-consuming and are associated with several ethical concerns. In order to reform the drug approval process and use non-animal testing models for preclinical evaluations, the US democrats and republicans introduced the FDA Modernization Act in 2021. The U.S. Environmental Protection Agency (EPA) has also declared the termination of the funds granted for the studies on mammals by 2035. As a result, several stakeholders have opted to modernize their conventional testing methods in order to cope up with the increasing limitations associated with animal models. One such innovative technology, organ-on-chip has the potential to transform the drug discovery process by simulating the human physiological and functional environment on a microfluidic system. The use of such novel testing models in drug discovery and toxicity testing has been steadily increasing. Up till now, several pharmaceutical manufacturers and research institutions have embraced the use of these in vivo like in vitro models; however, a remarkable rise in the adoption rate of these models has been observed since the FDA changed its laws towards putting an end on the animal testing models. , The novel organ-on-chip models have various advantages over the traditional animal-based models, including fine control over microenvironment, lower cost, lesser time, easy to use and portable. , Given the inherent benefits of organ-on-chip technology, a number of players have launched their proprietary products in order to expedite preclinical studies of novel drug interventions across a wide array of disease indications. There are several organ-on-chip models, including lung-on-chip, liver-on-chip, heart-on-chip, brain-on-chip and multiple organ models, which are being offered by various players. Apart from offering efficient user-friendly organ-on-chip models, some developers also offer customization of these models as per the client requests. It is worth mentioning that various developers have made significant efforts in developing organ-on-chip technologies, paving the way for new innovations, primarily integrating artificial intelligence driven technology for early detection of pharmaceuticals and toxicity risks, along with detection of unknown mutations. Driven by promising benefits over animal testing, increasing R&D activity and financial support from investors, the organ-on-chip market is anticipated to grow at a commendable pace in the mid to long term.

SCOPE OF THE REPORTThe Organ-on-Chip Market, 2022-2035: Focus on Products and Technologies - Distribution by Type of Product (Organ(s) based Models and Disease(s) based Models), Application Area (Cancer Research, Drug Discovery and Toxicity Testing, Stem Cell Research and Tissue Engineering and Regenerative Medicine), Purpose (Research and Therapeutic Production), and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of organ-on-chip products and technologies, over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. In addition to other elements, the study includes:A general introduction of organ-on-chip, including history and development, classification, advantages and limitations and applications and future perspectives of organ-on-chip.A detailed assessment of the current market landscape of organ-on-chips based on a number of relevant parameters, such as type of offering(s) (chip, plate / system, and technology), type of model (organ(s) based and disease(s) based), status of development (commercialized, developed, and under development), type of technology / platform, number of chips in a plate, material used for construction of chip / plate (polymer, glass and silicon), type of polymer (polydimethylsiloxane, cyclic olefin polymer, cyclic olefin copolymer, elastomer, polycarbonate, polypropylene, polystyrene, polyester, tygon, and styrene TEP), compatible tissue / organ, and application area (cancer research, drug discovery and toxicity testing, stem cell research, and tissue engineering and regenerative medicine). In addition, the chapter provides details on the companies engaged in the development of organ-on-chip products and technologies, along with information on their year of establishment, company size and location of headquarters.Elaborate profiles of the key players developing organ-on-chips (which are presently commercialized), which are headquartered in North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, its financial information (if available), organ-on-chip product portfolio, recent developments, and an informed future outlook.An in-depth analysis of various patents that have been filed / granted for organ-on-chip, till 2022, based on various relevant parameters, such as type of patent, publication year, application year, issuing authorities involved, type of organizations, emerging focus area, patent age, CPC symbols, leading patent assignees (in terms of number of patents granted / filed), patent characteristics and geography. It also includes an insightful patent valuation analysis.A detailed brand positioning analysis of the key industry players, highlighting the current perceptions regarding their proprietary products by taking into consideration several relevant aspects, such as experience of the manufacturer, number of products and technologies offered, product diversity, and number of patents published.A study of the various grants that have been awarded to research institutes engaged in projects related to organ-on-chip, between 2017 and 2022, based on parameters, such as year of award, support period, amount awarded, funding institute center, grant type, emerging focus area, type of recipient organization, key regions, and leading recipient organizations.An analysis of the partnerships that have been established since 2017, covering various types of partnerships, such as research and development agreements, clinical trial agreements, product development and commercialization agreements, technology integration agreements, and product development and manufacturing agreements of the companies focused on developing organ-on-chip products and technologies.An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in start-ups / small companies (with less than 50 employees) and mid-sized companies (with 51-200 employees) that are focused on developing organ-on-chip products and technologies.A case study on scaffold-free 3D cell culture products, including hanging drop plate, 3D petri dish, and ultra-low attachment plate, featuring a list of more than 60 products that are being used for research and pharmaceutical testing, based on a number of relevant parameters, such as status of development (commercialized and developed, not commercialized), type of system (suspension system, attachment resistant and microfluidic system), type of product (ultra-low attachment plate, plate, hanging drop plate, chips and dish) and material used for fabrication (chemical / polymer based, human based and plant based).

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of organ-on-chip market. Based on multiple parameters, such as overall 3D cell culture market, and share of organ-on-chip, we have provided informed estimates of the evolution of the market for the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of type of product (organ(s) based models and disease(s) based models), application area (cancer research, drug discovery and toxicity testing, stem cell research and tissue engineering and regenerative medicine), purpose (research and therapeutic production), key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industrys growth.

The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of discussions held with the following individuals (in alphabetical order of company / organization names):Pierre Gaudriault, (Chief Business Development Officer, Cherry Biotech)Matt Dong-Heon Ha (Chief Executive Officer, EDmicBio)Michael Shuler (President, Hesperos)Jelena Vukasinovic (Chief Executive Officer, Lena Biosciences)Maurizio Aiello (Chief Executive Officer, react4life)Michele Zagnoni (Chief Executive Officer, ScreenIn3D)

RESEARCH METHODOLOGYThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This information is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:Annual reportsInvestor presentationsSEC filingsIndustry databasesPress releases from company websitesGovernment policy documentsIndustry analysts views

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWEREDWho are the leading players engaged in the development of organ-on-chip products and technologies?What are the different application areas where organ-on-chip can be used?Primarily in which geographical regions, are the organ-on-chip developers located?How has the intellectual property landscape of organ-on-chip, evolved over the years?Which partnership models are commonly adopted by stakeholders in the organ-on-chip domain?What are the investment trends and who are the key investors actively engaged in the research and development of organ-on-chip systems?How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the organ-on-chip market and its likely evolution in the short to mid-term and long term.

Chapter 3 provides a general introduction to organ-on-chip, covering details on the background of organ-on-chips along with their classification. In addition, it also provides information on various advantages and limitations of such products. It also discusses the various application areas and future perspectives of organ-on-chips market.

Chapter 4 provides a detailed analysis of the current market landscape of organ-on-chips based on a number of relevant parameters, such as type of offering(s) (chip, plate / system, and technology), type of model (organ(s) based and disease(s) based), status of development (commercialized, developed, and under development), type of technology / platform, number of chips in a plate, material used for construction (polymer, glass and silicon), type of polymer (polydimethylsiloxane, cyclo olefin polymer, cyclic olefin copolymer, elastomer, polycarbonate, polypropylene, polysterene, polyester, tygon, and styrene TEP), compatible tissue / organ, and application area (cancer research, drug discovery and toxicity testing, stem cell research, and tissue engineering and regenerative medicine). In addition, the chapter provides details on the companies engaged in the development of organ-on-chip products and technologies, along with information on their year of establishment, company size and location of headquarters.

Chapter 5 features elaborate profiles of the key players engaged in development of organ-on-chip (which are presently commercialized), which are headquartered in North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, its financial information (if available), organ-on-chip product portfolio, recent developments, and an informed future outlook.

Chapter 6 features in-depth analysis of various patents that have been filed / granted for organ-on-chip, till July 2022, highlighting key trends associated with these patents, across type of patents, publication year, application year, issuing authorities involved, type of organizations, emerging focus area, patent age, CPC symbols, leading patent assignees (in terms of number of patents granted / filed), patent characteristics and geography. It also includes an insightful patent valuation analysis.

Chapter 7 features brand positioning analysis of the key industry players, highlighting the current perceptions regarding their proprietary products by taking into consideration several relevant aspects, such as experience of the manufacturer, number of products and technologies offered, product diversity, and number of patents published.

Chapter 8 features study of the various grants that have been awarded to research institutes engaged in projects related to organ-on-chip, between 2017 and 2022, highlighting various important parameters, such as year of grant award, amount awarded, funding institute, support period, type of grant application, purpose of grant, activity code, emerging focus area, study section involved, type of recipient organization, key project leaders, key regions, and leading recipient organizations.

Chapter 9 features analysis of the partnerships that have been established since 2017, covering various parameters such as, research and development, clinical trial agreement, product development and commercialization agreement, technology integration agreement, and product development and manufacturing agreement of the companies focused on developing organ-on-chip products and technologies.

Chapter 10 features analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in start-ups / small-sized companies (with less than 50 employees) that are focused on developing organ-on-chip products and technologies.

Chapter 11 is a case study featuring scaffold-free 3D cell culture products, including hanging drop plate, 3D petri dish, and ultra-low attachment plate, featuring a list of more than 60 products that are being used for research and pharmaceutical testing, based on a number of relevant parameters, such as status of development (commercialized and developed, not commercialized), type of system (suspension system, attachment resistant and microfluidic system), type of product (ultra-low attachment plate, plate, hanging drop plate, chips and dish) and material used for fabrication (chemical / polymer based, human based and plant based).

Chapter 12 features an insightful market forecast analysis, highlighting the future potential of the market till 2035. The current and future opportunity has further been segmented on the basis of type of product (organ(s) based models and disease(s) based models), application area (cancer research, drug discovery and toxicity testing, stem cell research and tissue engineering and regenerative medicine), purpose (research and therapeutic production), key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). It is worth mentioning that we adopted a top-down approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research.

Chapter 13 is the summary of the overall report, which presents insights on the contemporary market trends and the likely evolution of the organ-on-chip market.

Chapter 14 is a collection of interview transcripts of discussions held with various key stakeholders in this market. The chapter provides a brief overview of the company and details of the interview held with Pierre Gaudriault (Chief Business Development Officer, Cherry Biotech), Matt Dong-Heon Ha (Chief Executive Officer, EdmicBio), Michael Shuler (President, Hesperos), Jelena Vukasinovic (Chief Executive Officer, Lena Biosciences), Maurizio Aiello (Chief Executive Officer, react4life) and Michele Zagnoni (Chief Executive Officer, ScreenIn3D).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which contains the list of companies and organizations mentioned in the report.Read the full report: https://www.reportlinker.com/p06323408/?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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Organ on a Chip Market - Focus on Products and Technologies - Distribution by Type of Product, Application Area, Purpose, and Key Geographical Regions...