Category Archives: Regenerative Medicine

Wilmington, Delaware, United States, Transparency Market Research Inc.: 3D cell culture is a controlled simulated environment outside of a living organism, wherein cells are allowed to grow and migrate by interacting within their habitat. 3D cell culture nurtures levels of cell differentiation and tissue organization which is not viable in traditional 2D culture systems. 3D cell culture has more tissue divergence and cell cohesion properties.

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3D cell structures are gaining popularity and have shown increased applications, especially in the early drug discovery and other research and development. This technique is used by researchers to fabricate physiologically similar cell culture stereotypes that aid drug discovery and development. Persistent need to refine efficiency in pharmaceutical research and development is also encouraging the use of 3D cell cultures.

3D cell culture is one of the rapidly growing segments in the health care space due to considerable range of applications in cancer research, in vitro environment, and regenerative medicine. The ability of 3D cell culture to strengthen the understanding of tissue maturation and organization, organogenesis, and cell differentiation has increased its utility.

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It has also replaced animal prototypes in clinical testing and experiments, as these look similar to cells in vivo. Increase in adoption of 3D cell culture in diagnostic centers, hospitals, and pharmaceutical and biotech companies, and rise in demand in organ transplantation, tissue regeneration, and regenerative medicine. The major drivers of the 3D cell culture market.

Researchers are conducting experiments to advance and develop better options for culturing cells, and 3D cell culturing presents various benefits such as gaining better information and helping to conduct better research. 3D cell structures are relatively thicker. Hence, these could experience some potential barriers. Cells could react and emerge differently in 3D cell culture environment. This would require changes in experiments.

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The global 3D cell culture market can be segmented based on product type, application, end-user, and region. In terms of product type, the market can be divided into scaffold-based 3D cell culture (hydrogels /ECM analogs, micro patterned surfaces, and solid scaffolds), scaffold-free 3D cell culture (low adhesion micro plates, 3D petri dishes, 3D bioreactors, and hanging drop plates), microfluidics-based 3D cell culture, magnetic levitation, and 3D bio printing. Based on application, the global 3D cell culture market can be classified into drug discovery and toxicology, cancer and stem cell research, and tissue engineering & regenerative medicine. In terms of end-user, the market can be categorized into pharmaceutical & biotechnology companies and research laboratories and institutes.

Geographically, the global 3D cell culture market can be segmented into North America, Latin America, Europe, Asia Pacific, and Rest of the world. North America and Europe dominate the market. High market share of these regions is attributed to rise in prevalence of cancer and increase in investment in R&D and health care. Moreover, governments in these regions support advancement in the field of 3D cell culture through grants and funds. The market in Asia Pacific is expected to expand at a high CAGR due to increase in demand for 3D cell culture in developing nations.

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Major players in the global 3D cell culture market are Merck, InSphero, Lonza, Thermo Fisher Scientific, Inc., ReproCELL, Inc., Nano3D Biosciences, Inc., Corning Technologies, Synthecon Incorporated, Global Cell Solutions, 3D Boitek, Kuraray Co. Ltd., Hamilton Company, Mimetas, and QGel.

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3D Cell Culture Market: Rise in Demand in Organ Transplantation, Tissue regeneration, and Regenerative Medicine to Drive the Market - BioSpace

The concept of synthesizing small-scale human organs in lab dishes has matured from pure science fiction to legitimate bioscientific reality in recent years. However, the usefulness of organoids as a research tool for studying the digestive system quickly ran into a roadblock, due to the fact that these in-demand tissues remain difficult to create.

Organoids are stem cell-derived three-dimensional tissue cultures that are designed to exhibit detailed characteristics of organs or act as model organs to produce a specific cell type in laboratory conditions. However, when growing organoids, the yield from each batch of starting material can vary massively and can even fail to produce any viable organoids at all. This of course results in severe delays in their production and utilization in pre-clinical experiments that test the efficacy and safety of drugs.

In a recently published paper from Stem Cell Reports, researchers from Cincinnati childrens (OH, USA) have developed a new practice that overcomes the organoid production hurdle. This novel procedure is already being utilized within the medical facility to boost organoid studies. However, because the materials utilized can be frozen and thawed while still producing high-quality organoids, this discovery allows for the shipment of starter materials to other labs anywhere in the world, foreseeably leading to a dramatic increase in the utilization of human gastrointestinal organoids in medical research.

This method can make organoids a more accessible tool, explains the first author Amy Pitstick, manager of the Pluripotent Stem Cell Facility at Cincinnati Childrens. We show that the aggregation approach consistently produces high yields and we have proven that precursor cells can be thawed from cryogenic storage to produce organoids of the small intestine.

Using this approach will make it possible for many research labs to use organoids in their experiments without the time and expense of learning how to grow induced pluripotent stem cells (iPSCs), states corresponding author Chris Mayhew, director of the Pluripotent Stem Cell Facility. The ability to freeze the precursor cells also will allow labs to easily make organoids without having to start each new experiment with complicated and highly variable iPSC differentiation.

Generally, organoid creation begins with the collection of skin or blood cells, which are then transformed in the lab to become induced pluripotent stem cells. To create intestinal organoids, highly skilled lab professionals produce a flat layer of organ precursor cells known as the mid-hindgut endoderm.

Under the correct conditions, early-stage organoids, termed spheroids, autonomously develop into a three-dimensional ball of cells. These are then collected and placed into a growth medium, which supplies the required signals for the cells to develop into the specialized cell types of a human organ.

However, the quantity of spheroids produced in this manner has been unpredictable. The Cincinnati Childrens researchers discovered that they could harvest the unused precursor cell layer and employ a centrifuge to transport cells into hundreds of tiny wells housed on small plastic plates. This causes the creation of 3D cell aggregates, which may then be collected and utilized to produce organoids.

The experiment described in the research paper demonstrates that the spheroids created in this manner had no discernible differences from those that formed naturally. The scientists then stored samples of the progenitor cells in freezers. These cells generated viable spheroids after being frozen and aggregated.

The paper goes on to verify that these spheroids can be consistently grown into mature organoids, which can simulate organ function. In the case of this research, the mature organoids went on to mimic the function of the small intestine, large intestine and the antrum, the portion of the stomach that links to the intestine.

Although this development is a welcome and promising advance in organoid fabrication, years of research will be required to create organoids large enough and complex enough to be utilized as replacement tissue in transplant surgery. However, having access to a large number of readily manufactured organoids offers up numerous possibilities for medical study.

More labs will be able to create patient-specific organoids in order to evaluate drugcombination therapiesfor precision treatment of complex or rare disease states that necessitate personalized care. Scientists also conducting basic research to understand more about the genetic factors and molecular pathways at play in digestive tract diseases will be able to incorporate organoids in their experiments by procuring frozen spheroid precursors.

In his current effort to generate transplantable intestinal tissues, Michael Helmrath, Director of Clinical Translation for the Center for Stem Cell & Organoid Medicine (CuSTOM) at Cincinnati Childrens, has already begun employing materials made from this new method.

This is a great step forward for the field on many fronts, Helmrath says. To be able to reduce the complexity of the process and provide higher yields is beneficial to our work. And to be able to translate the methods to other labs will help move regenerative medicine forward.

Source: https://linkinghub.elsevier.com/retrieve/pii/S2213671122003599

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New milestone organoid synthesis will boost disease and drug development research - RegMedNet

CAMBRIDGE, Mass., Aug. 4, 2022 /PRNewswire/ --Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, today announced financial results for the second quarter ended June 30, 2022, and highlighted recent Company progress.

"This has been an exciting second quarter for Omega, in which we were thrilled to receive FDA clearance of our first IND application for OTX-2002, representing the first ever Omega Epigenomic ControllerTM, a new class of programmable mRNA therapeutics. This is a critical milestone for Omega as we enter our next phase of growth and reflects our pioneering work to realizethe potential ofepigenomic programming," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "Additionally, we were also pleased to share exciting, new supportive preclinical data, both from our lead program OTX-2002 in hepatocellular carcinoma, as well as from another program in our pipeline focused on non-small cell lung cancer, a potential future indication. We look forward to continuing this momentum as we enter the clinic in the second half of this year and further exploring the broad ranging capabilities of our novel platform in additional therapeutic areas."

Recent Business Highlights

Development Pipeline and Platform

Corporate

Second Quarter 2022 Financial Results

As of June 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $173.7 million.

Research and development (R&D) expenses for the second quarter of 2022 were $19.4 million, compared to $11.2 million for the second quarter of 2021. The $8.2 million increase in R&D expense was primarily driven by an increase in personnel-related expenses, external manufacturing costs, and study costs in support of the advancement of our programs

General and administrative (G&A) expenses for the second quarter of 2022 were $6.2 million, compared to $3.6 million for the second quarter of 2021. The $2.6 million increase in G&A expense was primarily driven by an increase in personnel-related expenses to support business growth.

Net loss for the second quarter of 2022 was $25.9 million, compared to $15.4 million for the second quarter of 2021, driven predominantly by increased R&D and G&A expenses to support the Company's growth and operations as a public company.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, is a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA medicines, Omega Epigenomic Controllers, are designed to target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases, including alopecia.

For more information, visitomegatherapeutics.com, or follow us onTwitterandLinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing and design of our Phase 1/2 MYCHELANGELOTM clinical trial; the potential of the OMEGA platform to engineer programmable epigenetic mRNA therapeutics that successfully regulate gene expression by targeting insulated genomic domains; expectations surrounding the potential of our product candidates, including our lead OEC candidate OTX-2002; and expectations regarding our pipeline, including trial design, initiation of preclinical studies and advancement of multiple preclinical development programs in oncology, immunology, regenerative medicine, and select monogenic diseases. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controller machines due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; potential delays in and unforeseen costs arising from our clinical trials; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; the impact of increased demand for the manufacture of mRNA and LNP based vaccines to treat COVID-19 on our development plans; difficulties manufacturing the novel technology on which our OEC candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Investor contact: Kevin MurphyArgot Partners212.600.1902[emailprotected]

Media contact: Jason Braco, Ph.D.LifeSci Communications646.751.4361[emailprotected]

Omega Therapeutics, Inc.

Condensed consolidated statements of operations and comprehensive loss

(thousands, except share and per share amounts)

Three Months Ended June30,

Six Months Ended June30,

2022

2021

2022

2021

Collaboration revenue from related party

$

476

$

$

743

$

Operating expenses:

Research and development

19,387

11,184

33,659

20,933

General and administrative

6,202

3,637

11,336

6,452

Related party expense, net

741

384

1,562

763

Total operating expenses

26,330

15,205

46,557

28,148

Loss from operations

(25,854)

(15,205)

(45,814)

(28,148)

Other expense, net:

Interest expense, net

(55)

(190)

(210)

(402)

Change in fair value of warrant liability

(11)

(340)

Other expense, net

(3)

(4)

(52)

(8)

Total other expense, net

(58)

(205)

(262)

(750)

Net loss

$

(25,912)

$

(15,410)

$

(46,076)

$

(28,898)

Net loss per common stock attributable to common

stockholders, basic and diluted

$

(0.54)

$

(3.36)

$

(0.96)

$

Continue reading here:
Omega Therapeutics Reports Second Quarter 2022 Financial Results and Highlights Recent Company Progress - PR Newswire

Record revenue of $64.2 million for the quarter, up 14% as reported and 18% at constant currency (year-over-year)

Supporting a record 626 global clinical trials; a net of 17 new trials added during the quarter

Opened first two Global Supply Chain Centers, which include BioServices, in June 2022

Expanded global footprint into Spain and Ireland

NASHVILLE, Tenn., Aug. 4, 2022 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced financial results for the three- and six-month periods ended June 30,2022.

Cryoport, Inc.

Jerrell Shelton, CEO of Cryoport, commented, "We delivered a strong performance for the second quarter of 2022 highlighted by overall top-line growth of 14%, or 18% on a constant currency basis. Each of our end markets, Biopharma/Pharma, Reproductive Medicine and Animal Health, grew in the double digits during the quarter driven by strong continued demand for all of our products and services.

"Our Biopharma/Pharma revenue was $51.7 million for the second quarter of 2022 compared to $45.5 million for the second quarter of 2021. We are now supporting a record 626 global clinical trials in regenerative medicine, up by 17 trials sequentially compared to our previous quarter end. Importantly our clinical trial pipeline continues to mature with 285 trials now in Phase 2 and 81 in Phase 3. Overall revenue growth in the Biopharma/Pharma market was driven by our support of global clinical trials and commercially launched therapies.

"Demand for our Animal Health products and services, which is driven primarily by protein production, increased by 14% to $9.6 million for the second quarter of 2022.

"Reproductive Medicine revenue increased by 24% to $2.9 million for the second quarter of 2022. This growth was driven by CryoStork logistics solutions and cryogenic shipper products. We continued to grow in the Reproductive Medicine market as the number of fertility clinics we support increases and as IVF technologies continue to stimulate increased interest on a global basis.

Story continues

"Our strategic expansion continued to progress during the second quarter and included the grand openings of Cryoport's two new Global Supply Chain Centers in Texas and New Jersey. These world-class facilities form the foundation of our Global Supply Chain Center Network and include the important addition of GMP (Good Manufacturing Practices) BioServices to our portfolio of premier, comprehensive supply chain solutions. During the quarter, we further strengthened our presence in the EMEA region with the acquisition of Cell&Co BioServices in Clermont-Ferrand, France. We anticipate that Cell&Co BioServices will play a significant role in the further development of our Global Supply Chain Center Network as we expand into the Paris, France region.

"We also continued our development in EMEA subsequent to quarter end with CRYOPDP opening a logistics center in Ireland and acquiring Polar Expres, based in Spain, which adds logistics centers in Madrid and Barcelona. Additionally, Cryoport Systems just completed the acquisition of Cell Matters, based in Belgium, specializing in cryo-process optimization, cryo-processing, and cryopreservation. These developments are important steps in further building out our leadership position as a provider of global temperature-controlled supply chain solutions to the life sciences industry and are expected to also positively impact our operations in the Americas and APAC in the future.

Mr. Shelton concluded, "We continue to have robust product and services development projects underway as well as an accretive acquisition pipeline. We remain confident in our outlook for the remainder of the year and reiterate our previous full year 2022 revenue guidance to be between $260 million and $265 million, representing a 17% to 19% increase over 2021 revenue."

In tabular form, revenue by market for the three- and six-month periods ended June 30, 2022, as compared to the same period in 2021 was asfollows:

Cryoport, Inc. and Subsidiaries

Total revenues by market

(unaudited)

Three Months Ended June 30,

Six Months Ended June 30,

(in thousands)

2022

2021

% Change

2022

2021

% Change

Biopharma/Pharma

$ 51,728

$ 45,489

14%

$ 94,739

$ 87,877

8%

Animal Health

9,562

8,394

14%

16,356

17,394

-6%

Reproductive Medicine

2,863

2,308

24%

5,360

4,204

28%

Total revenues

$ 64,153

$ 56,191

14%

$ 116,455

$ 109,475

6%

As of June 30, 2022, the Company supportednine (9) commercial therapies and anettotalof 626 global clinical trials, a net increase of 65 clinical trials over second quarter 2021 and an increase of 24 clinical trials from year-end 2021. The number of trials in Phase 3 was 81 as of the end of the second quarter. The number of trials by phase and region are as follows:

Cryoport Supported Clinical Trials by Phase

Clinical Trials

June 30,

2020

2021

2022

Phase 1

198

227

260

Phase 2

227

265

285

Phase 3

66

69

81

Total

491

561

626

Cryoport Supported Clinical Trials by Region

Clinical Trials

June 30,

2020

2021

2022

Americas

400

444

488

EMEA

72

88

104

APAC

19

29

34

Total

491

561

626

Continue reading here:
Cryoport Reports Results for the Second Quarter 2022 - Yahoo Finance

CAMBRIDGE, Mass., Aug. 3, 2022 /PRNewswire/ --Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing platform, today announced that Thomas McCauley, Chief Scientific Officer, will participate in a fireside chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10, 2022, at 8 a.m. ET.

A live webcast of the fireside chat will be available on the Investors & Media section of the Company's website at http://www.omegatherapeutics.com. An archived replay of the fireside chat will be available on the same website for approximately 90 days.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, is a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA medicines, Omega Epigenomic Controllers, target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases, including alopecia.

For more information, visitomegatherapeutics.com, or follow us onTwitterandLinkedIn.

Contacts

Media contact:Jason BracoLifeSci Communications646.751.4361jbraco@lifescicomms.com

Investor contact:Kevin MurphyArgot Partners212.600.1902ArgotOmega@argotpartners.com

(PRNewsfoto/Omega Therapeutics)

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SOURCE Omega Therapeutics

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Omega Therapeutics to Participate in the 2022 Wedbush PacGrow Healthcare Conference - Yahoo Finance

VIKEN, Sweden, Aug. 3, 2022 /PRNewswire/ -- A new study with TikoMed's lead drug candidate, ILB, addressing underlying causes of neurodegeneration in acute and chronic diseases, was published in the International Journal of Molecular Sciences today. The data from the rodent model studying severe traumatic brain injury (sTBI), demonstrated that ILB administration 30 minutes after sTBI prevents glutamate excitotoxicity and normalizes levels of amino acids involved in crucial brain metabolic functions.

"The study shows the beneficial effect of ILB on post-impact brain metabolism using a single dose of the drug administered in a window of time corresponding with situations as seen with TBI patients in clinical settings. It is clear that the results of this study appear of great relevance for future applications in the treatment of TBI patients," said Professor Giuseppe Lazzarino", Principal Investigator and Professor at the Department of Biomedical and Biotechnological Sciences, University of Catania.

This study provides evidence that the therapeutic administration of ILB uses a unique mechanism to activate growth factors that protect nerve cells in the brain from damage by significantly improving mitochondrial functions and energy metabolism, as well as decreasing oxidative/nitrosative stress of rats exposed to severe traumatic brain injury.

"TBI is a silent epidemic with limited treatment options currently available, so this research demonstrates the development of a drug candidate activating natural molecules to protect and repair damaged brain tissues. Significantly improved neurocognitive functions, as demonstrated in this study, reinforce the potential of ILB as a completely new therapy for the treatment of sTBI, as well as other neurodegenerative conditions", added Ann Logan, Co-Author and Scientific Director at Axolotl Consulting Ltd-, and Professor of Regenerative Medicine at the University of Warwick.

Traumatic brain injuries result in both short and long-term effects on individuals, their families, and society and the economic costs are enormous. To date, there are no satisfactory pharmacological treatments capable of decreasing mortality/morbidity and improving the recovery of sTBI patients.1,2.

"These results are a significant milestone for TikoMed as they demonstrate ILB's potential as a disease modifying treatment, enabling neurons to regain lost functions even in an acute neurodegenerative disease such as TBI. We remain confident in our ongoing clinical development program with ILB in acute and chronic degenerative neurological diseases and will shortly be presenting additional study results validating ILB's unique effects and mechanism of action," said Anders Kristensson, CEO of TikoMed.

Contact: info@tikomed.com or +46 42 23 84 40

Media:International: Richard Hayhurst, richard@rhapr.eu or +44 7711 821527Nordics: Ola Bjorkman, ola.bjorkman@letemknow.se or +46 70 245 7497

About TBI

Traumatic brain injury (TBI) is one of the most common acute neurodegenerative diseases and represents the leading cause of death for those under 45 years of age in Western countries. Depending on the severity of the symptoms, evaluated by the Glasgow Coma Scale, TBI is classified as mild (mTBI) and moderate or severe (sTBI). Severe TBI is characterized by a high mortality rate and those who survive often suffer from profound disabilities with permanent impairment of cognitive, physical and psychosocial functions, associated with a diminished or altered state of consciousness and inability to be independent, work correctly and maintain social relationships.1

About TikoMed AB

TikoMed is committed to improve human life by exploring and harnessing the medical potential of the body's ability to self-repair and regenerate. With an adaptive, multi-modal mechanism of action, TikoMed's drug platform rebalances the body's inflammatory, immune and fibrotic responses to acute and chronic inflammation in order to enhance self-repair and regeneration. Currently applied as a therapy in neurodegeneration and an enabling technology for advanced therapies, the initial development programs include Amyothrophic Lateral Sclerosis (ALS), Traumatic Brain Injury (TBI) and islet cell transplantation. Broader use of the drug platform will be considered for a wider range of diseases using a creative business and financing model. TikoMed's highly scalable proprietary technology aims to provide safe, qualitative and affordable medicine to as many patients as possible across the globe. TikoMed is privately-owned and based in Viken, Sweden. To learn more, visit http://www.tikomed.com

The International Journal of Molecular Sciences is a peer-reviewed, fully open access international journal. For full study details on "ILB, a Low Molecular Weight Dextran Sulphate, Restores Glutamate Homeostasis, Amino Acid Metabolism and Neurocognitive Functions in a Rat Model of Severe Traumatic Brain Injury", please access the publication here: https://www.mdpi.com/1422-0067/23/15/8460

References

1. Abdelmalik, P.A.; Draghic, N.; Ling, G.S.F. Management of moderate and severe traumatic brain injury. Transfusion 2019, 59(S2):1529-1538.

2. Scerrati, A.; De Rosa, S.; Mongardi, L.; Cavallo, M.A.; Trapella, G.; De Bonis, P. Standard of care, controversies, and innovations in the medical treatment of severe traumatic brain injury. J Neurosurg Sci 2018, 62, 574-583.

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TikoMed's ILB activates the body's natural repair signals to restore glutamate homeostasis, amino acid metabolism and neurocognitive functions in a...

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The AVITA Medical Inc(ASX: AVH) share price has shot well into the green in lunchtime trade on Wednesday.

At the time of writing, the companys shares are 19.88% higher at $2.05 apiece on no news.

In broader market moves, the S&P/ASX 200 Health Care Index (ASX: XHJ) is 0.35% lower so far today.

Lets check what may be going on.

Its been a quiet few months from the regenerative medicine company, although not so much on the charts.

Avita shares have eroded more than 40% this year to date, after gliding from a high of $5.61 on 2 September 2021.

They found a bottom almost a year later at $1.32 on 17 June.

However, the healthcare share has caught a bid since then and now trades more than 42% higher on the month, and up 27% in the past five days of trade.

While theres been no news from Avitas end, two things stand out. First, the company is set to report earnings next week on 11 August.

Second is that healthcare shares have been strengthening ever since we rolled into the new financial year.

As seen on the chart below, both the healthcare benchmark index and the Avita share price bounced from lows in late June and have curled up since.

In the absence of any company-specific updates, it stands to reason the share might be attracting buyers on the back of this sector strength.

With Avita due to post earnings next week, investors may also be expecting a strong report from the company.

Either way, it looks a little early to tell if the Avita share price has completely turned the corner. In the last 12 months, it is down 61% and has some catching up to do.

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Why is the Avita Medical share price tracking 20% higher today? - The Motley Fool Australia

The Healthcare Technology Report is pleased to announce The Top 100 Healthcare Technology Companies of 2022. The awardees on this years list represent the absolute best in the healthcare technology space. From companies like Novartis with more than 100,000 team members around the globe, to numerous smaller startups with just a few dozen employees in a single office, these companies are changing the face of the industry. They are leveraging their considerable talent to find innovative solutions to the most pressing issues in healthcare, and they are saving countless lives and extending healthspans in the process.

Some of this years awardees include Hologic, whose growth across breast and skeletal health, diagnostic solutions, and GYN surgical solutions is driven by the clinically proven ability of its products to detect, diagnose, and treat illnesses and other health conditions earlier and better; Integra LifeSciences, which offers a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management, and neuro-critical care; and Axtria, whose best-in-class cloud-based analytics platforms have leveraged AI and machine learning to help life sciences operators make the most of their data for the benefit of their clients.

The top 100 companies this year represent a range of specialties, from genomics to pharmaceuticals, lab testing, therapeutics, data analysis, and much more. What they have in common is the impact they are having on patients lives, whether through direct treatment or by providing advanced, game-changing products and services to treatment providers. They are driving the industry forward and creating an environment in which better care for all is possible. Please join us in celebrating The Top 100 Healthcare Technology Companies of 2022.

1. NovartisCategory: Biotech

As one of the largest pharmaceutical companies in the world, Novartis has continued to break new ground in delivering innovative medical solutions to almost 1 billion people around the world. It employs approximately 125,000 individuals in its international offices and production facilities, most notably from its headquarters in Basel, Switzerland and Cambridge, Massachusetts.

Novartis was born out of the 1996 merger of Ciba-Geigy and Sandoz, and the new company quickly grew to push the boundaries of achievement in cancer-fighting drugs and other essential pharmaceutical products. The company has attracted a great deal of praise from industry and civil organizations for the benefits of its generic drugs, which have been praised by the Access to Medicine Index for widening access to medicine among underserved populations. Amid a difficult period for multinationals, Novartis has shown impressive growth in its major brands, and its continued developments in multiple sclerosis treatments have been met with international acclaim.

2. StrykerCategory: Medical Devices

Michigan-based medtech company Stryker is recognized as an industry leader in the field, designing and manufacturing devices used in hospitals and care facilities in more than 100 countries. Strykers main offerings are divided into the segments Orthopedics, MedSurg, and Neurotechnology and Spine, the latter of which has seen groundbreaking advances in recent years. Boasting more than 46,000 employees around the world, the company has posted a remarkable four decades of consistent growth over its lifetime, reporting over $17 billion in sales in 2021.

Founded as the Orthopedic Frame Company by Kalamazoo orthopedist Dr. Homer Stryker in 1941, the company has made a name for itself in its production of medical devices that quickly become indispensable for modern health care. Stryker has frequently been hailed as a forward-thinking workplace, having been named to Fortunes list of the worlds best workplaces five years in a row. Most recently, it has made waves with the launch of its new Global Technology Center, a unique 150,000-square-foot R&D facility in New Delhi designed to supercharge the companys capacity to develop new life-saving innovations.

3. Edwards LifesciencesCategory: Medical Devices

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease and critical care monitoring. Driven by a passion to help patients, the company collaborates with the worlds leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. As the pioneer of many products considered industry standard, including the transcatheter aortic valve replacement, Edwards products are sold in approximately 100 countries around the world. Founded by engineer Miles Lowell Edwards in 1958, the company has 16,000 employees around the world with manufacturing operations in North America, Europe, Singapore, and the Caribbean.

The Edwards Lifesciences Foundation supported more than 250 global charities in 2021 and continued its work with Every Heartbeat Matters, the Foundations primary philanthropic initiative, to improve the lives of 2.5 million additional underserved structural heart and critical care patients by the end of 2025.

To advance social equity, Edwards established a Social Impact Investment Fund with $100 million to support economic development in predominantly Black and underserved communities in the U.S. When Edwards was established as a separate company from Baxter in 2000, the company was formed around a credo which serves as a reminder to always put patients first, and that as a company Edwards will remain committed to making a positive impact on the quality of life for patients around the world.

4. Centura HealthCategory: Consumer HealthTech

Faith-based health care nonprofit Centura Health is known as a leader in high-quality health care services throughout Colorado and western Kansas. Its network of 17 hospitals and 6,000 physicians are responsible for delivering the best possible medical outcomes to traditionally underserved communities across the region. Centura traces its roots to a dedicated, compassionate order of Catholic sisters in 1882, and has pushed since its founding 25 years ago to deliver on that mission of building healthy people and communities.

As befits an organization that was founded on the value of altruistic service, Centura has developed a reputation as an invaluable supporter of local communities, launching initiatives to promote food security, mental and behavioral health, and rural community care. It has contributed a great deal of resources and attention to supporting community hospitals and rural communities in seven different countries, and recently issued a $5 million health equity and advancement grant to help regional organizations enhance health outcomes across the board.

5. HologicCategory: Medical Devices

Headquartered in Marlborough, Massachusetts, Hologic and its team of more than 6,700 have created an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While Hologic discovers and develops groundbreaking products and services that benefit everyone, they are especially passionate about those that advance womens health and well-being, allowing the company to prosper and grow while empowering women to experience healthier lives.

None of this would be possible without the talent, skills, and aspirations of Hologics employees. Since its founding in 1985, the company has expanded to more than 100 countries and territories and holds more than 3,000 patents. Its employees expertise and dedication to developing and sharing more robust, science-based certainty drives Hologics increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families, and communities.

Hologics growth across breast and skeletal health, diagnostic solutions, and GYN surgical solutions is driven by the exceptional and clinically proven ability of its products to detect, diagnose, and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which the team at Hologic fulfills by always challenging itself to improve health through better technology, education, and market access. The companys goal is to minimize doubt and maximize the confidence its customers and their patients have in their decisions and diagnoses. By focusing on womens health while still delivering health benefits to everyone, Hologic is setting a new standard of excellence that is strengthened by purpose, driven by passion, and brought to life by its promise of more certain early detection and better health outcomes.

6. Access HealthcareCategory: Software & Data

Access Healthcare provides business process outsourcing, applications services, and robotic process automation tools to hospitals, health systems, providers, payers, and related service providers. The company operates from 19 global delivery centers in the U.S., India, and the Philippines. Their 25,000+ staff is committed to bringing revenue cycle excellence to clients by leveraging technology, emerging best practices, and global delivery. Based in Dallas, Texas, the company supports more than 400,000 healthcare providers through 85+ clients, serving 80+ specialties, processing more than $70 billion in accounts receivable annually, and ascribing medical codes to more than 30 million charts annually.

With more than 3,500 virtual bots in operation, Access Healthcare's proprietary robotic process automation platform helps its clients improve efficiency. Access Healthcare is HITRUST, PCI DSS, SOC, ISO 27001, and ISO 9001 certified, providing security, availability, and confidentiality of sensitive health information.

7. CitiusTechCategory: Software & Data

CitiusTech is a partner of choice to the worlds largest healthcare and life sciences organizations to accelerate digital innovation, drive business transformation, and enable industry-wide convergence. With more than 7,000+ healthcare technology professionals, CitiusTech provide strategic consulting, digital engineering, data, analytics & AI, specialized platforms, and end-to-end solutions to more than 130 organizations across the payer, provider, medtech, and life sciences industries.

CitiusTechs cutting-edge technology expertise, deep healthcare domain expertise, and a strong focus on digital transformation enable organizations to deliver better outcomes, accelerate growth, drive efficiencies, and make a meaningful impact to patients, caregivers, and consumers. CitiusTechs deep commitment to world-class quality and unwavering focus on delivery excellence and client satisfaction is evident in their customer satisfaction score of 4.5/5 and a Net Promoter Score (NPS) of over 70.

8. Integra LifeSciencesCategory: MedTech

Integra LifeSciences is a global leader in neurosurgery and regenerative medicine. The company offers a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management, and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, nerve, and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 3,000 employees worldwide as well as offices, manufacturing, and research facilities in Asia, Australia, Europe, the Middle East, and the Americas. Integra products are ubiquitous in many hospital intensive care units and operating rooms around the world. And some of its leading brands include AmnioExcel, Bactiseal, CerebroFlo, Certas Plus, Codman, CUSA, DuraGen, and DuraSeal. In March, the company launched its newest product: NeuraGen 3D Nerve Guide Matrix , a resorbable implant for the repair of peripheral nerve discontinuities.

9. Jazz PharmaceuticalsCategory: Biotech

Global biotech company Jazz Pharmaceuticals is a tireless pioneer in innovating medical treatments for serious ailments once thought uncurable, such as narcolepsy and schizophrenia. Among the companys best-known productsall of which have provided relief to thousands around the worldare Vyxeos, Xywav, and Jazzs crown jewel, narcolepsy medication Xyrem. For its efforts in the development of these innovative treatments, Jazzs neuroscience and oncology divisions together posted revenues of $814 million in the first quarter of 2022, up more than a third from last year.

First launched in 2003 from Dublin, Ireland, Jazz has grown to expand its corporate presence and manufacturing to multiple sites in Europe and the Americas, and now employs more than 3,100 biotech experts to deliver on its promise of reimagining what is possible in medicine. Following its successful 2021 acquisition of GW Pharmaceuticals, it has pushed to expand its offerings in international markets while continuing to develop daring new treatments for multiple sclerosis and lymphoma.

10. AxtriaCategory: Software & Data

Life sciences technology pioneer Axtria was built to harness the best in cutting-edge data science and cloud technology and use it to improve health outcomes around the world. The company is best known for its best-in-class cloud-based analytics platforms, DataMAx, SalesIQ, InsightsMAx, and CustomerIQ, which have leveraged AI and machine learning to help life sciences operators make the most of their data for the benefit of their clients.

The company was launched by data scientist and onetime Entrepreneur of the Year Jassi Chadha in 2010, and has since expanded to bring new products and services to healthcare providers in 75 countries and counting. In addition to its perpetual placement on Deloittes Fast 500 and Inc. 5000, Axtria has repeatedly been certified a Great Place to Work in both its Indian locations and its U.S. headquarters in Berkeley Heights, New Jersey. Reflective of the high esteem in which the company is held in the life sciences world, Axtria was recently invited to deliver the keynote address on the future of the pharmaceutical world at Reuters Pharma USA 2022 event.

11. Horizon TherapeuticsCategory: Biotech

There may be no grander figure when it comes to the development of medicines for rare and rheumatic diseases than Irish biotech research company Horizon. Leading products such as Krystexxa, Duexis, and Rayos have brought comfort to and improved the lives of millions of individuals around the world who suffer from rare diseases such as gout, thyroid eye disease, and a variety of other inflammatory diseases. Horizons team of more than 2,000 strive to achieve the companys mission from their headquarters in Dublin as well as its U.S. office in Lake Forest, Illinois.

In addition to its already significant work improving the health outcomes of rare disease patients, Horizon supports an impressive array of community outreach initiatives, working to advance STEAM education and environmental sustainability in partner sites around the world. For its labors in these noble fields, the CSR World Leader company was named one of Peoples Companies That Care in 2021, and has received praise from the IBIO Institute and the Communitas Awards.

12. Leica BiosystemsCategory: Biotech

A German cancer diagnostics company that has as its motto Advancing Cancer Diagnostics, Improving Lives, Leica Biosystems provides the world a unique comprehensive diagnostic portfolio built to help identify and beat cancer using the latest technology. Leica is a proud partner of the Mayo Clinics Department of Laboratory Medicine and Pathology, and it works to improve patient outcomes there with the development of new cytogenic imaging software products.

Founded in 1989, Leica has expanded out of its headquarters in Wetzlar, Germany to establish offices across the Americas, Europe, and Asia Pacific. Today, its products are used in more than 100 countries around the globe. Among the companys latest developments in biotechnology are the exploration of innovative applications of artificial intelligence and machine learning in pathology. Further, with the introduction this year of Leicas new advanced, fully automated staining platform BOND-PRIME, it has managed to improve user experience while achieving major revenue growth despite a difficult climate.

13. ModereCategory: Consumer HealthTech

First founded as an all-natural shampoo that delivered on the natural ingredients promise made and broken by so many competitors, Modere has grown to become a household name for science-backed clean label health and beauty products. Its omnichannel consumer products have been featured as standout offerings in personal care and nutrition among its more than 3 million customers, and have been shared on national platforms including Good Morning America, NPR, and Forbes.

Modere has accomplished a great deal since its founding 30 years ago. Led by Chief Executive Officer Asma Ishaq, the company was named the top woman-led company of the year in 2021 by the JPMorgan-backed Women Presidents Organization. Modere was also ranked the #1 fastest growing woman-led company by Forbes, and its state-of-the-art collagen sciences offerings have been hailed by industry voices for raising the bar for consumer applications of the latest health sciences.

14. Penumbra, Inc.Category: Medical Devices

Penumbra, Inc. is a global healthcare company which designs, develops, manufactures, and markets innovative therapies to address complicated medical conditions in a novel way, supporting healthcare providers, hospitals, and clinics in more than 100 countries. Penumbra has redefined care across conditions that impact millions of Americans, including ischemic stroke, peripheral blood clots (clots throughout the body, such as pulmonary embolisms), and aneurysms with first-to-market minimally invasive interventional medical devices that have improved clinical outcomes. Penumbra recently expanded into immersive healthcare using virtual reality to inspire and empower potentially millions of patients to engage and challenge themselves more fully in their physical and cognitive rehabilitation and mental wellness.

As a global market leader that continues to experience double-digit revenue growth year-over-year, Penumbra is committed to advancing innovations that address unmet needs and help as many people as it can with its technologies.

15. PractoCategory: Software & Data

Practo is an Indian healthcare platform renowned for breaking down the barriers between patients and doctors with its signature all-in-one consumer healthcare software. By using Practos video conferencing platform, the company empowers more than one billion Indian people to take charge of their health and make more informed care decisions for their loved ones. Other Practo services include Ray, a practice management software used by thousands of clinics in the country, and Insta, a standout full-stack HIMS solution trusted in more than twenty markets around the world.

Founded in Bangalore and still headquartered there, Practo has a longstanding commitment to privacy and equity that has connected patients and doctors since its establishment in 2008. In remarkable expansions of this mission to traditionally underserved populations, the company added online consultation functionality in 15 vernacular languages at the height of the COVID-19 pandemic, and the launch of a digital veterinary consult option in 2021 has brought Practos game-changing technology into yet another critical market segment.

16. TempusCategory: Biotech

With a stated mission of bringing the frontiers of technology to the world of medicine, Chicago-based biotech research company Tempus is leveraging an incredible data library to apply AI to the establishment of a new era of precision medicine. Tempus offerings empower healthcare partners to more efficiently diagnose patients and model the effectiveness of treatments, and its clinical trial matching capabilities have helped more than 10,000 patients since its founding in 2015.

Tempus is empowered to make use of its greater than 50 petabytes of data thanks to its partnerships with prominent figures across the biotech research world, including 120 biopharma companies and more than half of all academic medical centers in the U.S. As a recognized innovation driver in the industry, the company has announced recent advances in machine learning-based genomic testing, and has presented dozens of papers at this years meetings of the American Association for Cancer Research and the American Society of Clinical Oncology.

17. VerilyCategory: Biotech

Alphabets life science research organization, Verily is dedicated to using the power of data to change how healthcare is managed and delivered. Among the solutions provided by Verily are its evidence generation services, care delivery, and care management, as well as its joint ventures in precision risk management, addiction recovery, and other cutting-edge areas. With new partnerships announced with Lumea and Highmark Health, it is continuing to play an active role in some of the latest developments in health tech.

Verily began as a division of Google X until its transition to an independent subsidiary in 2015. Since then, the company has engaged in a series of expansions that have vastly boosted its profile in the health science research industry, including a remarkable $1 billion fundraise in 2019 and the sale of its robot-assisted surgery venture Verb Surgical. In 2020, the company announced its entry into the insurance market with the launch of a Re Group-backed insurance subsidiary called Coefficient Insurance Company.

18. Carbon HealthCategory: Consumer HealthTech

In a world in which accessing healthcare seems to become more and more difficult and time-consuming for the average consumer, Carbon Health strives to use smart tech to provide a seamless relationship between patient and provider. From its home base in San Francisco, Carbon Healths platform enables individuals across the country to make virtual or in-person appointments with their primary care provider, urgent care provider, or mental or behavioral health specialist. It has also risen to the challenge of the pandemic era by offering expanded services for diabetes care, LGBTQ and womens health, and COVID care programs for employers.

Carbon Health was started in 2015 by immigrant entrepreneurs Eren Bali and Caesar Djavaherian, who saw a gap in the U.S. healthcare system and devised a means to use technology to remove boundaries to care. Having perfected the telemedicine niche at a critical moment of need, the Co-Founders and Chief Executive Officers have steered their company to a $3 billion valuation in just six years, and have continued to change the game in how doctors and patients alike use technology for the care they need.

19. Global Healthcare Exchange (GHX)Category: Software & Data

Founded in 2000 in Louisville, Colorado, GHX is a software-as-a-service company that is reducing the cost of doing business in healthcare by automating supply chain processes and improving visibility into the products used in patient care. The GHX Global Network, the worlds largest community of healthcare trading partners, connects supply chain, finance, and clinical professionals with their suppliers, and the cloud-based technology makes it easier for customers to drive costs out of the healthcare supply chain. Since 2010, GHX has saved the healthcare industry more than $5 billion. Today, the company is expanding its solutions to further enhance data management and allow integration of clinical and business systems.

The focus of GHX is on the healthcare supply chain, through which hospitals and their suppliers buy and deliver the thousands of medical-surgical supplies that clinicians need to effectively care for patients. At the heart of GHX is the GHX Exchange, a platform that connects healthcare providers and suppliers so they can work together electronically. This helps lower costs and simplifies supply chain management by eliminating error-prone, manual order processes. GHX is known for operating the largest healthcare trading network in the U.S., representing more than 80% of licensed beds in the country, with more than 85% of med-surg products flowing through the platform.

20. TELUS HealthCategory: Software & Data

Digital health technology and services provider TELUS Health is the power behind the digital health ecosystem used by 130,000 physicians to treat millions of patients across Canada. From its headquarters in Montreal and its offices throughout the nation, it electronically processes 130 million health insurance claims annually. The company also works to help employers optimize their health insurance packages for their workforces, and its round-the-clock Virtual Care platform directly links people who need healthcare to the appropriate providers.

TELUS Health is a division of Canadian multinational Telus Corporation, a company that has grown over three decades to lead the charge in telecommunications, agriculture, security, and health sciences. TELUS Health has long worked to achieve considerable social good with its corporate activities, recently helping two million Canadians gain access to their own digital health records and opening a mental health clinic in Montreal to better support the community.

21. Tandem Diabetes CareCategory: Medical Devices

Tandem Diabetes Care is a medical device company that has become synonymous with quality, reliable care for diabetes sufferers the world over. Tandem is responsible for the development and production of the t:slim X2 insulin pump with Control-IQ technology, one of the most trusted names in user-friendly digitally enabled insulin pumps for individuals with Type I diabetes.

From its head office in San Diego, Tandem has long characterized itself as a positively different pump manufacturer, working with users to make sure their products are perfectly configured to meet their unique needs. The company has continued to push the envelope when it comes to insulin management, developing new and better device software while leveraging user data to drive new insights into diabetes treatment. Ongoing research has confirmed optimal health outcomes among t:slim X2 users the world over, and with the recent acquisition of insulin set developer Capillary Biomedical, Tandem is preparing to carry their tradition of innovation and service into the future.

22. Cue HealthCategory: Biotech

Out of the many hero companies that arose to help the world meet the challenge of the COVID-19 pandemic, one of the inarguable standouts was California biotech research company Cue Health. In a move that transformed Cue into a household name virtually overnight, the companys interdisciplinary team of 1,200 medical professionals was the first to produce an at-home molecular diagnostic test for COVID, and its approval by the FDA for over-the-counter use brought the benefits of Cues remarkable achievement to millions of beleaguered Americans.

Cue Health has expanded well beyond its 2010 origins, growing to encompass five state-of-the-art buildings at its San Diego headquarters, where its tests and other products are designed, tested, and manufactured. Among the organizations that have come to rely on their partnership with Cue are ConocoPhillips, Johnson & Johnson, and a variety of national sports leagues. The fruits of the companys mammoth achievement included a striking $3 billion valuation last year.

23. CertaraCategory: Software & Data

Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. As a global leader in biosimulation, Certara serves more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Seventeen global regulatory agencies, including the U.S. FDA, Japans Pharmaceuticals and Medical Devices Agency, and Chinas National Medical Products Administration, have adopted Certaras Phoenix PK/PD software and/or Simcyp PBPK Simulator. The Companys COVID-19 Vaccine Model received both an R&D 100 Award and Edison Award in the past year. In October 2021, Certara acquired Pinnacle 21, a leading provider of SaaS solutions for clinical data fitness, regulatory compliance, and submission readiness.

With its software and global team of nearly 1,200 employees, Certara advances confident decision-making throughout the biopharma R&D lifecycle to help reduce time, lower cost, and improve outcomes for patients. The companys customers who use its software and services have received over 90% of new drug approvals by the FDA since 2014, excluding diagnostics.

24. Thrive GlobalCategory: Enterprise HealthTech

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The Top 100 Healthcare Technology Companies of 2022 - The Healthcare Technology Report.

Wilmington, Delaware, United States, Transparency Market Research Inc.: According to the report, the global urinary catheters market was valued at US$ 3.5 Bn in 2020 and is projected to expand at a CAGR of 4.5% from 2021 to 2028. Urinary catheters are used to drain and/or collect urine from the bladder. Urinary catheters are available in different shapes, sizes, materials (latex, silicon, Teflon, etc.) and types (Foley, coude tip, straight, etc.).

Urinary catheters have been categorized into three major segments: Foley (indwelling) catheters, intermittent (temporary) catheters, and male external (condom) catheters. Urinary catheterization is often recommended when an individual is suffering from disorders such as urinary incontinence, urinary retention disorder, post prostrate or genital surgery or multiple sclerosis, or neurological disorders such as Parkinsons disease or dementia.

People suffering from such disorders often show symptoms such as lack of efficient control over urination and a few face difficulties in urine discharge. Hence, urinary catheters help these patients with proper urine drainage and/or collection, thereby maintaining sanitary conditions and helping patients recover faster.

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Presently, physicians prefer intermittent catheters due to several applications and advantages. Urinary catheters are used in hospitals, specialty clinics, ambulatory surgery centers, etc. These devices are designed with several properties, such as the degree of hydrophilic coating, softness, track ability, and stability.

COVID-19 Impact on Urinary Catheters Market

COVID-19 has hampered businesses and economic activities globally, and is expected to have a short-term negative effect on the urinary catheters market. Urinary catheters are used for surgical applications and be affected to some extent due to the temporary postponement of various elective surgeries, as government authorities seek to ensure the availability of resources for COVID-19 patients. Various governments have provided guidelines on elective surgeries in an effort to minimize the strain on the healthcare system, decrease disease transmission, and conserve personal protective equipment (PPE).

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As on March 18, 2020, the U.S. CMS announced that all elective surgeries, as well as non-essential medical, surgical, and dental procedures, would be delayed. Other areas that are negatively affected include the supply of products meant for hospitals (including ICUs, neurological care centers, emergency rooms, and trauma patients), owing to lockdowns and mobility restrictions in various countries across the globe. However, businesses are likely to revive and resume normalcy once restrictions on elective surgeries and movement are lifted.

Increase in Number of Urinary Bladder Disorders

Rise in the number of diseases related to bladder dysfunction such as urinary incontinence and neurovascular diseases, technological innovations, surge in the geriatric population, favorable insurance & reimbursement policies, and increase in per capita healthcare expenditure are projected to drive the global urinary catheters market.

Increase in demand for urinary catheters and rise in the number of surgical procedures are other drivers of the global urinary catheters market. Increase in the incidence of chronic disorders has resulted in the rise in demand for urinary catheters globally. According to a report published by the WHO, around 200 million people suffer from one or the other urological problems, which essentially require urinary catheterization.

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Intermittent Catheters Segment to Dominate Global Market

In terms of product type, the global urinary catheters market has been classified into intermittent catheters, Foley Catheters, and male external catheters. The intermittent catheters segment held the largest share of the global urinary catheters market in 2020. The segment's dominance can be attributed to short-term or temporary catheterization. This feature has helped reduce the ever-increasing incidence of CAUTIs, which is one of the major forms of healthcare-associated infections (HCAIs) in developed countries.

Indwelling or Foley catheters have been primarily associated with CAUTIs due to the catheterization of hospitalized patients for considerably longer duration. Other factors fueling the expansion of the segment are driving the demand and acceptability among healthcare professionals as well as patients and fewer side effects associated with these urinary catheters.

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North America to Dominate Global Market

In terms of region, the global urinary catheters market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global urinary catheters market in 2020, followed by Europe.

North America is projected to lead the global urinary catheters market during the forecast period, followed by Europe. The U.S. is anticipated to dominate the market in North America largely due to larger population and well-established healthcare infrastructure. Well-established pharmaceutical and biotechnology industry, increase in research activity, rise in prevalence of neurological disorders are factors driving the market in the region.

Competition Landscape

The global urinary catheters market is fragmented in terms of number of players. Key players in the global market include Teleflex Incorporated, Hollister Incorporated, ConvaTec, Inc., Medtronic plc, Cook Medical, Boston Scientific Corporation, Coloplast, C. R. Bard, Inc., B. Braun Melsungen AG, TE Connectivity Corporation, and other prominent players.

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Urinary Catheters Market Insights by Leading Companies and Emerging Growth till 2028 - BioSpace

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced Precision-T, its pivotal Phase 3 study, is open, enrolling and treating patients at clinical trial sites including Stanford Health Care, City of Hope, Winship Cancer Institute of Emory University, Sarah Cannon Research Institute, Ronald Reagan UCLA Medical Center and Oregon Health & Science University. Precision-T is expected to enroll approximately 174 patients at more than 20 transplant centers across the U.S.

Precision-T (NCT05316701) is a randomized, open-label multi-center study that is evaluating the safety and efficacy of Orca Bios lead investigational high-precision cell therapy, Orca-T, compared to standard of care allogeneic hematopoietic stem cell transplant (standard allo-HSCT). Orca Bio received guidance from the Food and Drug Administration on the design of Precision-T, which will evaluate Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

By precision engineering the donor graft, we aim to create a cell therapy that retains the benefits of transplant without serious complications like graft versus host disease and disease relapse, said Robert Negrin, M.D., professor of medicine at the Stanford School of Medicine. This has been demonstrated by the recent results of the Phase 1b/2 single-arm trials with Orca-T, and we are pleased to be evaluating this novel cell therapy in a randomized Phase 3 clinical trial.

The primary endpoint of the Precision-T study is the rate of moderate-to-severe chronic GvHD-free survival. The secondary endpoints are graft-versus-host-disease and relapse-free survival (GRFS), moderate-to-severe chronic GvHD and relapse-free survival. The randomized Phase 3 trial is being conducted concurrently with Orca Bio's ongoing single-arm Phase 1b trial of Orca-T.

The Precision-T study is an important step forward for patients battling deadly blood cancers like AML and ALL, which are often aggressive and for which standard allo-HSCT treatment carries significant risks, said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. We are pleased to collaborate with these clinical trial centers and the broader blood cancer community to advance this study with the ultimate goal of delivering a safe and effective therapy to the patients who need it.

Orca-T is a first-in-class high-precision cell therapy that combines purified cells from a matched donor. It is designed to replace a patient's diseased blood and immune system with a healthy one while lowering the risk of developing GvHD and other life-threatening transplant-related side effects. Almost 200 patients have been treated to date with Orca-T in single-arm trials with extremely encouraging results, which were recently presented at the European Hematology Association (EHA) 2022 Congress, the 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings and the American Society of Hematology (ASH) Annual Meeting.

More information about the Precision-T study can be found at http://www.precisiontstudy.com or http://www.clinicaltrials.gov.

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit http://www.orcabio.com and follow Orca Bio on Twitter: @orcabio.

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Orca Bio Announces the Precision-T Phase 3 Study is Open and Enrolling Patients at Transplant Centers Across the U.S. - Business Wire