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Heatstroke stresses the body years after the original heat illness – University of Florida

Posted: July 19, 2022 at 2:14 am

This summer, huge swaths of the U.S. have already faced record-breaking heat waves. Heat kills more people than any other extreme weather event, and deadly heat waves are getting longer and hotter as the climate warms.

Staying cool and informed is essential. So we spoke with Thomas Clanton, a professor of applied physiology and kinesiology at the University of Florida and an expert in the effects of heat on the body, about how to recognize heat illness and the long-term consequences of this kind of stress.

Heatstroke is a medical emergency. If you notice signs of heatstroke in a person, call 911 immediately.

It's a really broad spectrum. At the lowest end is heat exhaustion, and on the more extreme end we have heatstroke. The difference is really the presence of neurological symptoms in heatstroke. Throughout the spectrum, mild to severe injury to liver, heart, kidney and muscle can be present. So, you can have heat exhaustion and you're probably still thinking pretty well, but you know you're hot. You try to get out of the heat and you're functional. However, heatstroke victims can go unconscious, lose motor control or become delirious, so their ability to respond is limited.

Clinically, a person would be diagnosed with heatstroke if they have a temperature above 40 degrees centigrade (104 degrees Fahrenheit) and also exhibit central nervous system symptoms.

Other signs that people notice include pallor (paleness) of the skin. Whereas profuse sweating is a normal reaction to heat, at the extremes of heatstroke the sweat response doesn't work as well, and the skin can become dry. If you begin to notice these signs, get into the shade, drink plenty of water and move to a reclined position. If ice bags or wet towels are available, place them under the arms, on the neck and along the groin regions. If any unusual neurological symptoms develop, get medical assistance immediately.

A lot of times people in the heat exhaustion range may not know they are getting heat illness. I think that's one of the concepts worth emphasizing. Besides just feeling hot, an individual may feel a little woozy or just not themselves. When this occurs, and they are not well hydrated, they can move quickly to conditions of heatstroke. Heatstroke can develop rapidly and it often mistaken for just normal overheating and exhaustion, so it pays to be aware of the clinical symptoms and to act quickly.

Absolutely. A buddy can get help, call the ambulance, right? And you can help each other stay healthy. Coaches can play this role during workouts and team players up. I play golf in the summer, and my partner and I make sure each other drinks plenty of water and stays in the shade whenever possible. We bring wet towels for our shoulders. These techniques are really effective and pretty simple.

We rightfully worry about people dying from heatstroke. But the evidence in the last few years is extremely good that some people who experience heatstroke may have medical consequences that can affect them the rest of their life.

The field has documented changes in the immune system of humans and animals years after a heatstroke. Heatstroke victims also have a greater frequency of developing chronic heart disease and kidney diseases later in life.

In the animals I study,we see evidence of epigenetic changesthat likely explain some of these long-term effects. Epigenetics is kind of cellular memory. So at a cellular level, cells have their own way of remembering if they've been exposed to severe stresses in the environment, which can help them respond over time by altering their cellular responsiveness. Cells imprint this memory by using enzymes that chemically tag their DNA. This memory is often helpful and can be adaptive, but can also be maladaptive if the stress is severe.

We certainly see strong epigenetic signals in the hearts, immune cells and skeletal muscle of mice one month after heatstroke. The mice look fine, their hearts look fine, but later they begin to develop metabolic disorders and other secondary effects. We believe that many of these epigenetic changes are maladaptive and make the animals less able to withstand additional stresses in their environment or to fight off other chronic forms of disease. Once we understand this in our animal models, we hope to develop approaches in humans that will help them ward off the development of these long term consequences to severe heat exposures.

Eric Hamilton July 18, 2022

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Omega Therapeutics Announces FDA Clearance of IND Application for OTX-2002, First Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma…

Posted: July 19, 2022 at 2:14 am

CAMBRIDGE, Mass., July 14, 2022 /PRNewswire/ -- Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2, first-in-human, clinical study of OTX-2002 for the treatment of hepatocellular carcinoma (HCC). OTX-2002, an Omega Epigenomic Controller (OEC), is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

"We are thrilled to obtain clearance to advance OTX-2002 into the clinic and are excited about the prospects of what this new class of medicines may mean for patients in need," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This is an important milestone for our company, representing our first program to receive FDA clearance to enter the clinic and the first ever clinical trial to evaluate an epigenomic controller. This new class of programmable mRNA therapeutics leverages our groundbreaking science and has broad potential applicability in many therapeutic areas."

About OTX-2002

OTX-2002 is a first-in-class Omega Epigenomic Controller in development for the treatment of HCC. OTX-2002 is an mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. An IND application for OTX-2002 has been cleared by the FDA.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, 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, visit omegatherapeutics.com, or follow us on Twitter and LinkedIn

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 our product candidate pipeline, including efficacy, trial design, regulatory submissions, approvals and timing thereof, the launch of a clinical trial of OTX-2002 and timing thereof, and the filing of future IND applications and timing thereof. 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; 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 March 31, 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.

Contacts

Investor contact: Kevin MurphyArgot Partners212.600.1902[emailprotected]

Media contact: Jason BracoLifeSci Communications646.751.4361[emailprotected]

SOURCE Omega Therapeutics

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Chaotic response in Uvalde, Parkland shooter faces death penalty, mall shooting leaves 3 dead and jury selection begins in Bannon trial | Hot off the…

Posted: July 19, 2022 at 2:12 am

July 18, 2022 7:45 AM

Posted: July 18, 2022 7:45 AM

Updated: July 18, 2022 1:44 PM

A damning report and hours of body camera footage laid bare the chaotic response to a mass shooting at a Uvalde, Texas, elementary school.

Hundreds of law enforcement officers massed at the scene but then waited to confront the gunman even after a child trapped with the shooter called 911. The findings of an investigative committee were released Sunday.

The penalty trial of Florida school shooter Nikolas Cruz is about to begin. Opening statements will be made and the first witnesses called Monday. Jurors will decide whether the 23-year-old Cruz will be executed or sentenced to life without parole for the 2018 massacre of 17 people at Marjory Stoneman Douglas High School in Parkland.

Police say three people were fatally shot and two were injured at an Indiana mall after a man with a rifle opened fire in a food court and an armed civilian shot and killed him. Greenwood Police Department Chief Jim Ison says the man entered the Greenwood Park Mall on Sunday evening with a rifle and several magazines of ammunition and began firing in the food court. He says a legally armed 22-year-old from nearby Bartholomew County killed the man.

Jury selection is scheduled to begin in the trial of former Trump presidential adviser Steve Bannon. Bannon faces criminal contempt of Congress charges after refusing for months to cooperate with the House committee investigating the U.S. Capitol insurrection. A conviction on each count carries a minimum of 30 days of jail and as long as a year behind bars.

France is scrambling more water-bombing planes and hundreds more firefighters to combat spreading wildfires being fed by hot swirling winds from a searing heat wave broiling much of Europe. At least two people have been killed in blazes in Spain.

A prime-time hearing Thursday will offer the most compelling evidence yet of then-President Donald Trumps dereliction of duty on the day of the Jan. 6 insurrection. Thats according to the House committee investigating last years attack.

Police say a man fired a gun inside a comedy club in North Carolina before actor and comedian Craig Robinson was set to perform. The shot was fired Saturday night at The Comedy Zone in Charlotte. No one was injured.

In sports highlights from Sunday, the British Open produces a new Major champion, the Yankees win again, the Mariners extend their winning streak, the NL East leaders fall and sons of major league fathers go 1-2 in the MLB draft.

An Associated Press survey of state election officials across the U.S. found that the expanded use of drop boxes for mailed ballots during the 2020 election didnt lead to any widespread problems. The survey revealed no cases of fraud, vandalism or theft that could have affected the results.

Thats contrary to claims made by former President Donald Trump and his allies, who have intensely criticized their use and falsely claimed they opened the door to fraud.

Jennifer Lopez and Ben Affleck were wed in a small ceremony Saturday in Las Vegas, culminating a relationship that stretched over two decades in two separate romances and countless tabloid covers. Lopez announced their marriage Sunday in her newsletter for fans with the headline We did it.

Houses of worship are meant to be places of shelter, reflection and peace, where strangers are welcome. But after recent high-profile shootings nationwide, worshippers and leaders across faiths are facing uneasy decisions on the best ways to guard their sanctuaries.

President Joe Biden has wrapped up his four-day visit to the Middle East. Even before he stepped foot in Saudi Arabia, Biden knew there would be trouble. He was risking criticism by visiting a country he had vowed to make a pariah for human rights abuses, and there was no guarantee the visit would immediately yield higher oil production to offset rising gas prices.

The Marvel sequel Thor: Love & Thunder dropped a hefty 68% in its second weekend of release but still held the top spot at the box office. Studio estimates Sunday also show Taika Waititis Love and Thunder led all films with an estimated $46 million, bringing its two-week global total to $498 million.

The bestseller adaptation Where the Crawdads Sing debuted with a better-than-expected $17 million despite poor reviews. The Minions clung to second place. Minions: The Rise of Gru continued to hold strong with $26 million in its third weekend of release.

Scientists are shooting stem cells into space, hoping to make discoveries that help people on Earth. Some aim to overcome the difficulty of mass producing the cells on Earth that could be useful in future treatments for various diseases. Others explore how space travel impacts the body on a cellular level. And some help scientists better understand diseases such as cancer.

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

Posted: July 19, 2022 at 2:11 am

July 12, 2022

Company Name:

HEALIOS K.K.

Representative:

Hardy TS Kagimoto, Chairman & CEO

(TSE Growth Code: 4593)

Healios eNK Cells: Regenerative Medicine Product Quality Consultation

with the PMDA for Planned Clinical Trials

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

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

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

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

*1 Natural killer (NK) cells

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

1

*2 Regenerative medicine product quality consultation

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

About Pharmaceuticals and Medical Devices Agency (PMDA):

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

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

About Healios' eNK cells:

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

About Healios:

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

Contact:

Department of Corporate Communications, HEALIOS K.K.

E-mail: ir@healios.jp

2

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

Posted: July 19, 2022 at 2:11 am

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE Precise Bio

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

Posted: July 19, 2022 at 2:11 am

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

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

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

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

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

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

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

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

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

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

(Read the report in Japanese at this link.)

Author: The Sankei Shimbun

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

Posted: July 19, 2022 at 2:11 am

Treating Pain Origins with Minimally Invasive Techniques

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

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

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

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

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

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

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

About PA Pain & Spine

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

Media Contact:Kelsey Voelker215.395.8888 x104[emailprotected]

SOURCE Pennsylvania Pain and Spine Institute

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Cell Separation Technologies Market Expands with Rise in Prevalence of Chronic Diseases, States TMR Study – GlobeNewswire

Posted: July 19, 2022 at 2:11 am

Wilmington, Delaware, United States, July 18, 2022 (GLOBE NEWSWIRE) -- Transparency Market Research Inc.: The market value of the global cell separation technologies market is estimated to be over US$ 20.3 Bn by 2031, according to a research report by Transparency Market Research (TMR). Hence, the market is expected expand at a CAGR of 11.9% during the forecast period, from 2022 to 2031.

According to the TMR insights on the cell separation technologies market, the prevalence of chronic disorders including obesity, diabetes, cardiac diseases, cancer, and arthritis is being increasing around the world. Some of the key reasons for this situation include the sedentary lifestyle of people, increase in the older population, and rise in cigarette smoking and alcohol consumption across many developed and developing nations. These factors are expected to help in the expansion of the cell separation technologies market during the forecast period.

Players in the global cell separation technologies market are increasing focus on the launch of next-gen products. Hence, they are seen increasing investments in R&Ds. Moreover, companies are focusing on different strategies including acquisitions and strengthening their distribution networks in order to stay ahead of the competition.

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As per the Imperial College London, chronic diseases are expected to account for approximately 41 million deaths per year, which seven out of 10 demises worldwide. Of these deaths, approximately 17 million are considered to be premature. Hence, surge in cases of chronic diseases globally is resulting into increased need for cellular therapies in order to treat such disease conditions, which, in turn, is boosting the investments toward R&Ds, creating sales opportunities in the cell separation technologies market.

Cell Separation Technologies Market: Key Findings

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Cell Separation Technologies Market: Growth Boosters

Cell Separation Technologies Market: Regional Analysis

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Cell Separation Technologies Market: Key Players

Some of the key players profiled in the report are:

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Cell Separation Technologies Market Segmentation

Modernization of healthcare in terms of both infrastructure and services have pushed the healthcare industry to new heights, Stay Updated with Latest Healthcare Research Reports by Transparency Market Research:

Cell Culture Market: Rise in outsourcing activities and expansion of biopharmaceutical manufacturers are expected to drive the cell culture market during the forecast period

Cell Culture Media, Sera, and Reagents Market: The global cell culture media, sera, and reagents market is majorly driven by growth and expansion of biotechnology & pharmaceutical companies and academic & research institutes.

Stem Cells Market: The global stem cells market is majorly driven by rising applications of stem cells in regenerative medicines. Increase in the number of chronic diseases such as cardiac diseases, diabetes, cancer, etc.

Cell Line Authentication and Characterization Tests Market: Increase in the geriatric population and surge in incidence of chronic diseases are projected to drive the global cell line authentication and characterization tests market.

CAR T-cell Therapy Market: The CAR T-cell therapy market is expected to clock a CAGR of 30.6% during the assessment period. The CAR T-cell therapy is known as a revolutionary treatment option for cancer, owing to its remarkably effective and durable clinical responses.

Cell & Tissue Preservation Market: Rise in investments in the field of regenerative medicine research is estimated to propel the market. Human blood, tissues, cells, and organs own the capability to heal damaged tissues and organs with long-term advantages.

Placental Stem Cell Therapy Market: Placental stem cell therapy market is driven by prominence in treatment of age-related disorders/diseases and increase in awareness about stem cell therapies are projected to drive the global market in the near future.

Biotherapeutics Cell Line Development Market: The market growth will be largely driven by research and development activities due to which, new solutions and technologies have gradually entered the market.

About Transparency Market Research

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

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Contact

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Cell Separation Technologies Market Expands with Rise in Prevalence of Chronic Diseases, States TMR Study - GlobeNewswire

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Automating the Genomic Medicines of the Future – Bio-IT World

Posted: July 19, 2022 at 2:11 am

Contributed Commentary by Per Hammer, Cytiva

July 15, 2022 | Historically, the heavily regulated biopharma industry has been slow to adopt new technologies. However, a shift toward automation is vital to ensure that next-generation solutionssuch as cell and gene therapiesare produced at scale.

Less than one in five senior pharma executives strongly believe that frontier technologies, such as artificial intelligence, are widely adopted to support automation and increase the speed of specific processes. With cell therapies approved by global regulatory bodies, it is time to accelerate smart technologies and cell and gene therapy manufacturing.

Todays cell therapy treatments are often made on a small-scale, include manual preparation steps, and are produced for a clinical trial setting. Researchers spend days processing cellular material, monitoring its growth during the expansion phase, and preparing for re-administration to the patient. This process is demonstrated in administering autologous treatments so that every patient receives a unique living drug.

Though the current process is complex, it offers inspiring outcomes. For example, on April 1, 2022, the Food and Drug Administration (FDA) approved Kite Pharmas Yescarta, a chimeric antigen receptor (CAR) T-cell therapy for adult patients with large B-cell lymphoma. This kind of cancer is usually resistant to initial treatment and relapses within one year. With FDA approval, Yescarta (axicabtagene ciloleucel) is now the second-line treatment, a first for an autologous CAR T-cell therapy.

Cell Therapy Enters Mainstream

The exceptional results emerging from cell therapy clinical trials suggest we are entering a new phase of medical treatmentone where we can expect far more from our healthcare interventions than we ever imagined. Following the regulatory approval of autologous CAR T-cell therapies, the global cancer treatment landscape is changing, and the future is bright.

The success of COVID-19 vaccines signaled the arrival of the genomic medicines ageone where we hope to see cell and gene therapies deliver long-term remission and even cures for patients with some of the most complex diseases. According to the Alliance for Regenerative Medicine 2021 Annual Report, nearly 60% of the ongoing regenerative medicine clinical trials studied prevalent diseases by the end of the calendar year. But to get these powerful treatments to those who need them, we must have an automated manufacturing infrastructure that can generate cell therapies to meet increased demand in the coming years.

Saving Time Through Automation

Time is of the utmost importance, as biopharma manufacturing involves patient cells that have limited viability. Manual approaches to cell therapy production are time-consuming, and tasks such as checking cells at regular intervals during expansion are laborious. Another time-draining factor is the workflow and cleaning routines involved in maintaining a safe lab environment.

Automated solutions reduce or remove many of these challenges. After setting up a process, an operator can focus on other things while critical parameters such as temperature, pH level, gas transfer, and flow rates are monitored and controlled without human intervention.

Reducing Risks for Better Results

Manual cell processing solutions are complex, with many checkpoints across isolation, expansion, harvesting, and preservation stages. Unfortunately, each of these steps increases the risk potential. Despite the research teams expertise, there is still a chance that materials could be inadvertently contaminated during numerous open stages.

Additionally, limited process control can lead to difficulties in achieving high reproducibility. An automated modular solution minimizes these risks by bringing multiple steps within a closed, highly regulated, and controlled system.

Improving Manufacturing Efficiency

Changing a manufacturing process requires multiple manual routines and adjustments that must be checked and documented. However, documentation and protocols are less helpful when a customized process is used because they only apply to that specific setup.

Standardization would effectively improve manufacturing efficiency. This approach would ensure that what is learned in one project can be referenced in future work, with data and documentation applicable across different technology applications. A modular chain of connected systems allows for process variation with instruments running in customized configurations. Additionally, having control of an individual instrument leads to the straightforward use of built-in software and sensors.

Automated Manufacturing: The Way Forward for Cell and Gene Therapy

By using automated manufacturing to minimize human interaction, time, and resource requirements, it is possible to increase production speed and lower some risks and costs associated with commercialization.

The industry is ever-changing and adjusting its complex, yet exciting challenges will take some time. However, automation can create a significant advantage over competitors, providing the tools needed to produce cell therapies with the highest levels of safety and efficacy for patients.

Per Hammer has two decades of experience in the biopharma industry, mainly supporting customers in academics through process development and manufacturing. Per joined Cytiva in 2001, taking on several distinct roles in the company. Most recently, he progressed from Product Manager Leader for the Bioprocess Automation and Digital Team to Senior Global Product Manager for the Cell & Gene Therapy Automation and Digital Solutions. He can be reached at per.hammer@cytiva.com.

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Automating the Genomic Medicines of the Future - Bio-IT World

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Medical Nonwoven Disposables Market: Increase in Demand for Advancements in Wound Dressing Techniques to Drive the Market – BioSpace

Posted: July 19, 2022 at 2:11 am

Wilmington, Delaware, United States, Transparency Market Research Inc.: Medical nonwoven disposables are highly essential products in the healthcare field. Increase in popularity of these products has been observed as they provide better hygiene condition and reduce the contamination. Nonwoven products have many advantages over woven products.

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Nonwoven products include surgical gowns, face masks, drapes, surgeon caps, bandages, and others. Medical nonwoven disposables are made up from materials such as polypropylene, polyethylene, polyamides & polyesters, and others.

Medical nonwoven disposables products consist of high-quality fabrics for complete safety and immunity of healthcare professionals

The global medical nonwoven disposables market is driven by technological advancements in healthcare, increase in demand for advancements in wound dressing techniques, and rise in government initiatives for manufacturing nonwoven medical fabric. Moreover, demand for polyethylene is high due to low cost.

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Increase in prevalence of hospital-acquired infections among the geriatric population is expected to propel the medical nonwoven disposables market. According to the U.S. Department of Health & Human Product estimates, the U.S. is expected to have about 72.1 million geriatric population by 2030, which is more than twice the number in 2000.

As per a research paper published in the Current Opinion in Microbiology in 2018, lower respiratory tract infections which also include pneumonia, are the sixth leading cause of deaths due to hospitalizations in the U.S. and more than 90% of deaths occur in individuals who are 65 years old or more

Nonwoven medical disposables provide increased levels of protection against infectious diseases. In the past few years, nonwoven materials have shown significant reduction in post-operative infection rate compared to woven materials.

The risk of developing infection is nearly 2.5 times higher with woven products than nonwovens. Such factors help drive the medical nonwoven disposables market.

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Market Segmentation: Medical Nonwoven Disposables Market

Based on product, the global medical nonwoven disposables market has been divided into surgical products (drapes, gowns, caps, masks, and others), wound dressings (bandages, tapes, post-operative wound dressings, operative wound dressings, and dressing pads), and incontinence products (under pads and diapers)

In terms of material, the global medical nonwoven disposables market has been classified into polypropylene, polyethylene, acetate, rayon, polyamides & polyesters, acrylic, and others

In terms of end user, the global medical nonwoven disposables market has been categorized into hospitals, nursing homes, consumer & home healthcare, clinics, and ambulatory surgical centers

Each of the segments has been analyzed in detail for market trends, recent trends and developments, drivers, restraints, opportunities, and useful insights. The report provides current and future revenue (US$ Mn) for each of these segments from 2018 to 2028, considering 2019 as the base year. The compound annual growth rate (% CAGR) has been provided for each segment and market from 2020 to 2028 along with market size estimations.

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Regional Overview: Medical Nonwoven Disposables Market

In terms of region, the global medical nonwoven disposables market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The regions have been divided into major countries and sub-regions.

The current and future market value in terms of revenue (US$ Mn) of these regional markets and their major countries have been provided in the report from 2018 to 2028, with their CAGRs from 2020 to 2028.

The study also offers a list of recommendations, highlights, and useful insights of the market which would help new companies willing to enter the market and existing companies to increase market shares and help in the decision-making process.

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Major Players

The report concludes with the company profiles section that includes key information about the major players in the market

Leading players analyzed in the medical nonwoven disposables market include

Each of these players has been profiled in the report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments.

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About Us

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update - https://www.youtube.com/channel/UC8e-z-g23-TdDMuODiL8BKQ

Contact

Rohit BhiseyTransparency Market Research Inc.CORPORATE HEADQUARTER DOWNTOWN,1000 N. West Street,Suite 1200, Wilmington, Delaware 19801 USATel: +1-518-618-1030USA Canada Toll Free: 866-552-3453Website: https://www.transparencymarketresearch.comBlog: https://tmrblog.comEmail: sales@transparencymarketresearch.com

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Medical Nonwoven Disposables Market: Increase in Demand for Advancements in Wound Dressing Techniques to Drive the Market - BioSpace

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