First UK Clinical Trial Site Open for Recruitment of Diabetic Patients with Chronic Limb-Threatening Ischemia Using Novel Patient-Specific…

London, UK, 4 December 2019:The first UK clinical trial site for the treatment of diabetic patients with chronic limb-threatening ischemia (CLI) using a novel patient-specific regenerative therapy has opened for patient recruitment at the University Hospital of Wales in Cardiff. The site will be evaluating Rexgeneros REX-001 in two Phase III trials, codenamed the SALAMANDER trials. The trials are being led by Mr Ian Williams, a Consultant Vascular Surgeon and the Principal Investigator at the site.

The University Hospital of Wales is participating in the trials through a consortium, the Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC), part of the Advanced Therapy Treatment Centre Network (ATTC) which aims to bring pioneering advanced therapy medicinal products (ATMPs) to patients. THE MW-ATTC has been working in collaboration with the Cardiff & Vale University Health Board to progress the initiation of the two SALAMANDER trials and is planning to activate new clinical trial sites in the Midlands in England shortly.

CLI is a chronic disease and the most serious form of peripheral arterial disease (PAD), a common condition in which a build-up of fatty deposits in the arteries reduces the blood flow to the legs and feet. CLI is characterized by chronic ischemic at-rest pain, ulcers or gangrene in one or both legs. CLI is a common condition in Europe and the United States affecting 1-1.5% of the population aged over 401. It represents an area of high unmet medical need as there are currently no approved therapies that successfully treat the CLI patient population. Patients with CLI have a very negative prognosis. A year after initial diagnosis, around 12% of patients have had an amputation. Five years after diagnosis the situation is even worse with mortality at 50%, rising to 70% after ten years2.

REX-001 represents a new class of regenerative medicines. It is an autologous cell therapy manufactured using the patients own bone marrow and consists of immune cells (lymphocytes, monocytes and granulocytes) and progenitor cells involved in immune modulation and tissue regeneration. It is administered as a single dose within 4 days after collection of bone marrow cells.

Ian Williams, Consultant Vascular Surgeon and Principal Investigator commented,Chronic limb-threatening ischemia is a serious disease with severe consequences and limited treatment options. There is a high unmet need for novel and innovative therapiessuch as REX-001that have the potential to be a highly effective treatment and to reduce amputation and mortality rates amongst the patient population.

Chris Fegan, Consultant Haematologist, Cardiff and Vale University Health Board said, We have brought together many highly specialized teams from diabetes, surgery, radiology and stem cell transplantation to participate in the pioneering SALAMANDER study here at Cardiff and Vale, which we hope will revolutionize treatment options for patients with chronic limb-threatening ischemia.

Rexgenero, the company pioneering the development of REX-001, says that the experimental product has already demonstrated efficacy in Phase I/II studies. In the Phase II clinical trial, 82% of patients with non-healing ischemic ulcers were healed within the first 12 months after a single administration dose of REX-001.

Joe Dupere, CEO of Rexgenero added, Treating our first patient with REX-001 in the UK will be an important milestone for our Phase III program in diabetic patients with chronic-limb threatening ischemia, a severe condition with high unmet need. With clinical trial sites and manufacturing bases now open across multiple countries in Europe, we are one step closer to completion of the Phase III studies and potential regulatory and market approval for an innovative and much-needed product.

Rexgenero is planning to treat a total of 60 patients with CLI and rest pain and 78 patients with CLI and non-healing ischemic ulcers in two independent Phase III SALAMANDER trials in approximately 25 hospitals across Europe.In addition to the trial sites in the UK, Rexgenero is also recruiting patients for both trials at sites inSpain, Austria, Portugal, Poland, Hungary, the Netherlands and the Czech Republic.

For more information about the REX-001 Phase III SALAMANDER trials, and how to participate, please visit theclinical trial website.

References

ENDS

For further information, please contact:

At Rexgenero

For media enquiries (Rexgenero)

Joe Dupere, CEO+44 (0)20 3700 7480info@rexgenero.com

Instinctif PartnersAshley Tapp+44 (0)20 7866 7923Rexgenero@instinctif.com

At the University Hospital of Wales

Cardiff and University Health BoardCommunications Team+44 (0)29 2074 6381news@wales.nhs.uk

About Rexgenero

Rexgenero is a clinical-stage regenerative medicine company developing innovative cell-based therapies targeting serious diseases with unmet medical needs.

The Companys lead candidate, REX-001, is a highly innovative autologous cell therapy that is being studied in a Phase III clinical programme in patients with chronic limb-threatening ischemia (CLI) with diabetes, a poorly treated disease with a high risk of amputation and death. REX-001 has been shown to be effective in Phase I/II and Phase II trials, alleviating CLI in the majority of patients, offering the potential to increase the quality of life of CLI patients by reducing pain, alleviating ulcers, increasing mobility, improving sleep and reducing the need for amputation. Rexgenero is developing REX-001 in a range of indications and, pending approval, intends to launch and market this specialty product in major territories.

Rexgenero is a privately-owned company, which draws on an exceptional understanding of the fundamental science of cell therapies developed by the Andalusian Health Authority (Servicio Andaluz de Salud) and Andalusian Initiative of Advanced Therapies.

The Company was founded in 2015 and is headquartered in London (UK) with R&D and manufacturing operations in Seville (Spain) and Frankfurt (Germany).

For more information, please visit:www.rexgenero.com

Connect with us: Twitter:@_Rexgenero; LinkedIn:https://www.linkedin.com/company/rexgenero-limited/

About the REX-001 Phase III SALAMANDER Trials

REX-001 has shown efficacy in 70% of patients in Phase I and I/II studies and is currently progressing through two Phase III SALAMANDER trials in Europe being conducted at approximately 30 sites, with plans to enrol a total of 138 patients. The trials are given the name SALAMANDER in reference to the amphibians ability to regenerate its tail and limbs.

ThePhase III studyin patients with Rutherford stage 4 CLI will assess the efficacy and safety of REX-001 with a primary endpoint of complete relief of ischemic rest pain.

ThePhase III studyin patients with Rutherford stage 5 CLI will assess the efficacy and safety with a primary endpoint of complete ulcer healing.

Amputation-free survival is included as a secondary endpoint in both studies. The trials are expected to produce interim analysis in early 2021 with full results expected later that year; all dependent on the speed of patient recruitment.

For more information about the REX-001 Phase III SALAMANDER trials, please visit:https://www.cli-treatment.com

About the Midlands and Wales Advanced Therapy Treatment Centre (MW-ATTC)

The Midlands and Wales Advanced Therapy Treatment Centre (MW-ATTC) consists of a large regional network with the necessary commercial and NHS infrastructure required to facilitate the delivery of advanced therapy treatments to patients. The centre includes a wide range of specialists in advanced therapy manufacturing including academic and commercial partners, logistics companies, specialists in clinical trial delivery and teams focussed on IT solutions and health economics.

For more information, please visit:https://www.theattcnetwork.co.uk/centres/midlands-wales

The ATTC Network Programme is a world-first, UK system of Advanced Therapy Treatment Centres (ATTC) operating within the NHS framework and coordinated by the Cell and Gene Therapy Catapult to address the unique and complex challenges of bringing pioneering advanced therapy medicinal products (ATMPs) to patients. The centres include Innovate Manchester Advanced Therapy Centre Hub (iMATCH), Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC, comprising Birmingham, Wales and Nottingham) and Northern Alliance Advanced Therapies Treatment Centre (NA-ATTC, comprising Scotland, Newcastle and Leeds).

The network is initially supported by the Industrial Challenge Strategy Fund with the aim to develop first-of-a-kind technologies for the manufacture of innovative medicines across areas including blindness, cancer, heart failure, liver disease, neurological conditions and rare paediatric diseases.

For more information, please visit:https://www.theattcnetwork.co.uk/

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First UK Clinical Trial Site Open for Recruitment of Diabetic Patients with Chronic Limb-Threatening Ischemia Using Novel Patient-Specific...

Medicine Against Bone Disease Found in the Leaves of Saussurea – Global Health News Wire

Bacterial bone infections are quite resistant to antibiotics and require new therapeutic approaches. A team of researchers from Kant Baltic Federal University discovered the ability of an extract from the leaves of Saussurea controversa to considerably reduce inflammatory processes and increase immune response in cases of osteomyelitis. The results of the study werepublishedin theMoleculesjournal.

Saussurea controversa is a perennial herbaceous plant that has been traditionally used by the people of the Far East, Siberia, Tibet, and Mongolia to treat liver, kidney, digestive tract, and locomotive diseases. Its dried leaves are sold in pharmacies because their decoction is widely used as a medicine against cold and bronchitis. To understand what substances this plant owes its medicinal properties to, a team of scientists from Siberian State Medical University and Tomsk Polytechnic University extracted individual components from the plant and determined their composition. To do so, they passed the substances in gas form through a special station. As the substances were of different size, it took them different time to pass through it. The useful components of the decoction included flavonoids and polysaccharides. These groups of substances are known for their antimicrobial properties and the ability to speed up bone tissue regeneration. Flavonoids are small aromatic molecules, while polysaccharides are high molecular weight hydrocarbons. However, both have a positive effect on bone tissue regeneration.

Infectious locomotive diseases are considered one of the most difficult to treat. The microorganisms that attack bone tissue are often resistant to antibiotics. The restoration of the bone also plays an important role in the healing process. Medics from BFU suggested using Saussurea extract to treat bone tissue infections and tested its ability to affect stem cells. To do so, the extract of Saussurea leaves was added to the substrate with such cells. The growth of the cell culture slowed down under the influence of plant polysaccharides. It turned out that Saussurea did not stimulate the division of stem cells, but made them turn into bone tissue. This was confirmed by specific colouring.

To test the antibacterial properties of Saussurea, the team from BFU added the extract of its leaves into substrate with Staphylococcus aureus. These bacteria cause such deadly diseases as osteomyelitis, endocarditis, pneumonia, and sepsis. Moreover, they are highly resistant to a wide range of antibiotics making the therapy long and complicated. The experiment showed the decrease of S. aureus growth in the substrate with Saussurea compared to a control group.

The isolated components have antimicrobial and regenerative properties. Our plan is to participate in the development of a medicinal drug for comprehensive treatment of bone diseases and injuries associated with the risk of infectious complications. Plant materials are less toxic. They can be administered as regular pills making the treatment much easier, concluded Larisa Litvinova, MD, a head of the Basic Laboratory for Immunology and Cell Biotechnologies, Professor of the Department of Fundamental Medicine, Institute of Medicine, Kant Baltic Federal University.

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Medicine Against Bone Disease Found in the Leaves of Saussurea - Global Health News Wire

Will We Live to Age 120? International Expert Weighs in at Danbury Event – HamletHub

Emerging medical research and cutting-edge technology will dramatically increase human life expectancy and quality of life in the near future, according to a recent fireside chat titled How Do We Make 100 Years Old Our New 60? hosted by Bob Reby, Ambassador of the Fairfield- Westchester Chapter of Singularity University and CEO of Reby Advisors, with special guest Sam Gandy, MD, Ph.D., a prominent internationally recognized expert in neurology and psychology.

Anyone interested in learning more about these medical breakthroughs may watch a video of the event for free on the Reby Advisors website: http://www.rebyadvisors.com/live-events-videos

Dr. Gandy, Chairman Emeritus of the National Medical and Scientific Advisory Council of the Alzheimer's

Association shared new research on human stem cells, genetic codes and the complex hereditary nature of Alzheimers Disease, among other topics.

With regard to stem cell research, Dr. Gandy explained, Its possible now to restore sight and hearing in certain conditions. This was not possible before. These are people who were deaf and blind, doomed to being deaf and blind lifelong.

He continued, Stem cells are the primordial type of cell that can ultimately be differentiated or specialized to form any type of cell in the body. If you have a stem cell from someone, you can then recreate the heart cells or lung cells or brain cells that a particular person has. It can really [lead to] person-based medicine.

Reby also brought up the topic of CRYSPR Genome Editing, and the potential of this research to be used for both good and harm.

CRYSPR is basically gene editing, which means that you can go into the DNA and make changes, edits. If you want to eradicate genetic diseases, it's possible to use this technology to go into an egg, or a sperm, and correct the mutation. So, you could edit out a hereditary disease.

As futuristic as these advancements in medical technology and genetic engineering may be, finding the cure for some complex diseases, like Alzheimers, remains a major challenge.

Most people with Alzheimer's Disease, it's not that simple. The challenge is to find an intervention that we can use beginning in midlife that is safe and will prevent Alzheimer's. Some of the ways that we have of intervening now are not perfectly safe and would not be things that you'd want to give people for 50 years.

The fireside chat was the first event for the Fairfield-Westchester Chapter of Singularity University, a global learning and innovation community using exponential technologies to tack the worlds biggest challenges and build a better future for all.

According to Reby, future events will focus on artificial intelligence, robotics and other exponential technologies. He explained, The reason I like [Singularity University] is their faculty is made up of a lot of business owners, so theyre not just talking about it. Theyre doing it as well.

Community leaders, business owners and technology enthusiasts are encouraged to contact Reby

Advisors if they would like to participate in the Fairfield-Westchester Chapter of Singularity University.

To watch the video of this first event, go to: http://www.rebyadvisors.com/live-events-videos

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Will We Live to Age 120? International Expert Weighs in at Danbury Event - HamletHub

Study highlights the need to adhere to more uniform diagnostic criteria for rare lymphoma – News-Medical.net

In what is believed to be one of the largest studies of a rare disorder known as primary cutaneous gamma delta T-cell lymphoma (PCGDTCL), Rutgers Cancer Institute of New Jersey investigators and other collaborators examined characteristics, treatment patterns and outcomes of the disease, and determined accurate diagnosis of the disease requires ongoing analysis. Results of the work are being shared as part of a poster presentation at the American Society of Hematology Annual Meeting in Orlando later this week by lead investigator Kevin David, MD, hematologist/oncologist at Rutgers Cancer Institute. Dr. David, who is also an assistant professor of medicine at Rutgers Robert Wood Johnson Medical School, shares more about the work.

Q: Why is this topic important to explore?

A: Primary cutaneous gamma delta T-cell lymphoma is a rare disorder, and in comparison to other more common subtypes of non-Hodgkin lymphomas, relatively little is known about prognostic factors and optimal treatments. Although it is a rare condition, it can in many instances behave quite aggressively and profoundly impact patients. Therefore, learning more about how this disease behaves, which disease characteristics affect outcomes, and which treatments may improve outcomes are all important to understand more fully.

Q: Tell us about the work and what you and your colleagues found.

A: Given the rarity of this particular lymphoma, collaboration with lymphoma researchers across the country was key in this study. We identified cases of PCGDTCL at 10 U.S. medical centers that occurred between 2000 and 2017, and collected information about patient characteristics, pathology characteristics, treatments administered, and outcomes, including remission rates and the length of time the disease was controlled. Although it is ideal for lymphomas to be diagnosed with uniform standards across the country, we found important nuances in the manner in which pathologists at different medical centers diagnose this rare lymphoma. Identifying these differences will be key to better streamline diagnoses in the future. We also found that patients in better overall health, as measured by the ECOG Performance Status scale, and with normal, as opposed to increased, levels of a tumor marker (lactate dehydrogenase) had better outcomes.

There is no one standard treatment regimen for this lymphoma, and a wide variety of treatments were used for newly diagnosed patients, ranging from ultraviolet light treatment to multi-agent chemotherapy. While no single treatment regimen resulted in the best outcomes, our results suggest that incorporating allogeneic stem cell transplant in treatment planning can improve results.

Q: Why are these results significant?

A: Our findings demonstrate the importance of trying to create and adhere to more uniform diagnostic criteria for this rare lymphoma. Additionally, we have much work to do in identifying better treatment regimens to improve outcomes for PCGDTCL, and continued multi-center collaborations will be crucial.

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Study highlights the need to adhere to more uniform diagnostic criteria for rare lymphoma - News-Medical.net

100 hospitals and health systems with great orthopedic programs | 2019 – Becker’s Hospital Review

Laura Dyrda and Angie Stewart - Wednesday, December 4th, 2019Print|Email

The hospitals featured on Becker's Hospital Review's 100 hospitals and health systems with great orthopedic programs list for 2019 have earned recognition for quality of care and patient satisfaction for orthopedic and spine surgery.

Many are high-volume centers where surgeons annually perform hundreds, and in some cases thousands, of total joint replacements, in addition to less complex musculoskeletal surgeries. Theseprograms highlighted have rich histories of innovation and have won grants to research musculoskeletal treatments. The centers also include robust nonoperative services and provide care to professional and elite athletes in their communities.

Our editorial team accepted nominations for this list and took several rankings and awards into consideration, includingU.S. News & World Reportrankings for adult and pediatric orthopedics. The team also considered CareChex rankings, Healthgrades awards, Leapfrog, Blue Cross Blue Shield Blue Distinction Center designation, The Joint Commission Gold Seal of Approval and hospitals' reputations for innovation in orthopedic care.

Note: Hospitals and health systems cannot pay for inclusion on this list, and organizations are listed in alphabetical order.

For questions or comments about this list, contact Laura Dyrda atldyrda@beckershealthcare.com.You can nominate a hospital or health system for the 2020 list here.

Abbott Northwestern Hospital (Minneapolis). The Orthopaedic Institute at Abbott Northwestern Hospital includes specialists in joint replacement, spine surgery and sports medicine. The hospital's joint replacement center has a 90 percent patient satisfaction rating of good to excellent care and has earned the Blue Distinction Center for Knee and Hip Replacement designation from Blue Cross Blue Shield Association. The hospital, a member of Allina Health, ranks among U.S. News & World Report's top 50 hospitals for orthopedic surgery in 2019-20. The hospital's surgeons perform around 4,000 orthopedic procedures annually.

Atrium Health (Charlotte, N.C.). The Atrium Health Musculoskeletal Institute has 10 locations systemwide and an orthopedic residency top ranked by Doximity. It is a collaboration with more than 200 physicians involved in more than 20 externally funded research trials. It is also part of the Major Extremity Trauma and Rehabilitation Consortium, with more than 7,000 patients enrolled across 18 projects. The health system, which includes 40 hospitals and 900 care sites, has had hospitals ranked among the top orthopedic programs in the nation by U.S. News & World Report and supports research and clinical trials for new orthopedic treatments.

Banner Health (Phoenix). Banner Health's orthopedic program spans hospitals in Phoenix, Tucson and Northern Colorado. The health system partners with Phoenix-based The CORE Institute and the Banner CORE Center for Orthopedics to streamline the continuum of care. The center includes orthopedic surgeons as well as integrated services such as inpatient and outpatient therapy. The two groups have a history together, partnering on co-management agreements and joint ventures on outpatient clinic locations.

Baptist Health Care / Andrews Institute (Pensacola, Fla.). The Gulf Breeze, Fla.-based Andrews Institute, an affiliate of Baptist Health Care, was founded by renowned orthopedic surgeon James Andrews, MD, who treats elite athletes. The institute has 34 physicians on staff and provides care at nine locations. The Andrews Institute is also designated a Blue Distinction Center+ for knee and hip replacement surgery from Blue Cross Blue Shield Association and received an 'excellent' rating in the third year of participating in Medicare's Comprehensive Care for Joint Replacement quality performance category. Many of the physicians also participate in the Andrews Research and Education Foundation, which received a $1 million grant from the state for two consecutive years to support its research into regenerative medicine.

Barnes-Jewish Hospital (St. Louis). The orthopedic department at Barnes-Jewish Hospital includes team physicians for the St. Louis Blues and Washington University athletics, in addition to other local teams. It supports joint replacement and preservation, spine and sports medicine as well as orthopedic concierge services. The National Institutes of Health has granted the orthopedic surgery departments research funding for its projects, which include basic science and clinical research. The hospital has earned the Joint Commission's Gold Seal of Approval for hip and knee joint replacement and its surgeons perform more than 1,100 procedures annually.

Baystate Medical Center (Springfield, Mass.). Baystate Medical Center's orthopedic services include the Baystate Orthopedic Surgery Center and services from New England Orthopedic Surgeons. The practice includes 18 physicians and 180 employees who focus on spine, sports medicine and joint replacements. The hospital has computer-assisted technology for orthopedic procedures.

Beaumont Hospital (Royal Oak, Mich.). Beaumont Hospital's orthopedic surgeons perform around 8,500 joints per year, typically using minimally invasive techniques. It also serves as a learning institution, and surgeons come from around the nation to its Applebaum Simulation Learning Institute for training in new techniques. U.S. News & World Report ranked Beaumont Hospital among the top 30 orthopedic hospitals in the nation. The hospital's clinicians also focus on research, including basic science studies and FDA clinical trials. Areas of interest for research include biomechanics, tissue engineering, regenerative medicine and joint wear simulation.

Bethesda North Hospital (Cincinnati). Bethesda North Hospital Orthopedics, part of TriHealth, has had the Anthem Blue Distinction Centers for Knee and Hip Replacement recognition and Aenta's Institute for Quality Orthopedic Care for Total Joint Replacement honor since 2010. TriHealth's Orthopedics & Sports Institute, which has locations at multiple system hospitals, earned the first Joint Commission Gold Seal Award for advanced hip and knee certification and its physicians serve professional athletes for the Cincinnati Reds and Bengals.

Boston Children's Hospital. Surgeons and clinicians at Boston Children's Hospital attend to more than 100,000 patient visits and perform 6,000 surgeries annually. The hospital's orthopedics department dates to 1903 and has now grown to include 13 specialty clinics and urgent care facilities throughout Massachusetts. The hospital also supports the Orthopedic Center's Research & Innovations Department, which includes a focus on spine surgery and joint preservations. The hospital is a leader in hip preservation surgery, having performed more than 1,200 periacetabular osteotomies. Its sports medicine injury clinic also includes 40,000 patient visits per year. For 2019-20, U.S. News & World Report ranked the hospital No. 1 for pediatric orthopedic care.

Boston Medical Center. Boston Medical Center's department of orthopedic surgery is affiliated with Boston University School of Medicine and works with the specialists to provide orthopedic care and support research in the orthopedic space. The department includes 11 orthopedic and trauma surgeons that focus on joint replacements, spine and fracture care.

Brigham and Women's Hospital (Boston). The department of orthopedic surgery at Brigham and Women's Hospital traces its roots to 1980 and has since grown to include around 40 orthopedic surgeons who specialize in joint reconstruction, sports medicine and spine, among other subspecialties. The department is also dedicated to education and trains around 60 orthopedic residents per year. The hospital's surgeons also engage in research through the Musculoskeletal Research Center within the Brigham Research Institute for cross-collaborative projects.

Carilion Roanoke (Va.) Memorial Hospital. Carilion Clinic supports the orthopedic services at multiple locations of the Institute for Orthopaedics and Neurosciences, including at Carilion Roanoke Memorial Hospital. The academic orthopedic practice has more than 50 trained providers and pioneers minimally invasive techniques. Carilion Clinic surgeons perform more than 1,500 hip and knee replacements annually and have maintained The Joint Commission's Gold Seal of Approval for quality care award since 2007. The organization also has a robust sports medicine team that performs more than 12,000 surgical procedures per year and cares for athletes at six colleges and universities.

Cedars-Sinai Medical Center (Los Angeles). Cedars-Sinai supports the Cedars-Sinai Kerlan-Jobe Institute, which includes team physicians for the Los Angeles Clippers and Rams. NRC Health voted Cedars-Sinai No. 1 for quality medicine in Los Angeles and U.S. News & World Report ranked the hospital No. 3 in the nation for orthopedics in 2019-20. Cedars-Sinai also focuses on medical training, and more than 600 medical students apply for its orthopedic residency program each year.

Children's Hospital Los Angeles. The Children's Orthopaedic Center at CHLA has programs in spine, hip preservation and sports medicine. The sports medicine specialists are also physicians for the L.A. Galaxy professional soccer team and have access to the John C. Wilson, Jr. Motion and Sports Analysis Laboratory. The center includes surgical and non-surgical specialists at the main hospital as well as five outpatient locations. U.S. News & World Report ranked Children's Hospital Los Angeles among the top five hospitals in the nation for pediatric orthopedics in 2019-20.

Children's Hospital of Philadelphia. The division of orthopedics at Children's Hospital of Philadelphia includes 31 orthopedic surgeons focused on specialties from spine to sports medicine and joint pain. The program has served pediatric patients into adulthood for more than 120 years and its specialists also engage in research about treating pediatric orthopedic conditions. U.S. News & World Report ranked Children's Hospital of Philadelphia among the top five hospitals in the nation for pediatric orthopedics.

Children's Medical Center Dallas - Texas Scottish Rite Hospital for Children. Texas Scottish Rite Hospital for Children is dedicated to pediatric orthopedic cases as well as children with neurological disorders. The hospital includes six centers of excellence known for providing innovative solutions to spine care, limb lengthening and other disorders. The hospital is also committed to research to develop new solutions for scoliosis treatment, concussion management and other conditions. U.S. News & World Report ranked the hospital among the top five in the nation for pediatric orthopedics in 2019-20.

Christ Hospital (Cincinnati). The Christ Hospital Health Network Joint & Spine Center provides care for patients with simple and complex orthopedic conditions. It has 87 private inpatient rooms, 12 outpatient rooms and space for physical and occupational therapy. The health system also offers bundled services for select spine and joint replacement procedures through its centers of excellence program. Individuals and employers can pay one fixed cost for procedures that include the episode of care as well as postoperative therapy. The health system also has three outpatient surgery centers focused on orthopedic and spine procedures, with the most recent having opened in January 2018.

Cincinnati Children's Hospital Medical Center. The division of orthopedics at Cincinnati Children's Hospital focuses on patients with fractures, scoliosis, neuromuscular conditions and more. The division has 14 orthopedic surgeons who are also involved in research as a core tenet of their professional mission. The research includes microbiology and biomechanics as well as improvements to clinical care. U.S. News & World Report named Cincinnati Children's Hospital among the top five hospitals in the nation for pediatric orthopedics in 2019-20.

Cleveland Clinic. Cleveland Clinic's orthopedic surgeons focus on simple and complex joint procedures. They perform more than 7,000 hip, knee, shoulder, ankle, elbow, wrist and finger replacements per year. Cleveland Clinic also has among the highest volume of patients in the nation for severe osteoarthritis and rheumatoid arthritis as well as trauma. Cleveland Clinic's Orthopaedic & Rheumatologic Institute has around 168 clinicians, including physicians. U.S. News & World Report ranked two Cleveland Clinic hospitals among the top 50 hospitals in the nation for orthopedics in 2019-20.

Duke University Hospital (Durham, N.C.). Duke University Hospital's department of orthopedic surgery includes 83 orthopedic faculty and 40 orthopedic residents. The academic medical center also has 17 orthopedic clinical fellows and 29 research trainees. The orthopedic department treated 175,824 patients in 2017, the last data available, and performed 16,440 procedures. U.S. News & World Report ranked Duke University Hospital among the top 25 hospitals in the nation for orthopedic surgery in 2019-20.

Emory University Hospital (Atlanta). Emory Orthopaedics & Spine Center is the official sports medicine provider for the Atlanta Hawks, Braves, Falcons and Harlem Globetrotters. The hospital broke ground in October on the new Emory Musculoskeletal Institute in Brookhaven, Ga., a 180,000-square-foot, LEED-certified building designed for orthopedic and spine cases. The new building is expected to open in 2021 and provide more environmentally friendly care.

Erlanger Health System (Chattanooga, Tenn.). Erlanger Orthopaedic Institute's surgeons are on the faculty of the University of Tennessee College of Medicine and participate in clinical trials for joint replacement and fracture care. The health system also has a Bone Health Clinic and Ortho Symposium. The Joint Commission granted Erlanger Orthopaedic Institute its Gold Seal of Approval as a Certified Center of Excellence for Primary Hip and Knee Replacements.

Hackensack (N.J.) University Medical Center. The Orthopedic Institute at Hackensack University Medical Center has more than 50 physicians and healthcare professionals on staff. The institute's Center for Joint Replacement offers tailored care plans for patients, and 96 percent of patients are able to stand or walk on the same night as their procedure. The health system boasts a 1.9 percent 30-day readmission rates for orthopedic patients, and 80 percent of them are discharged home. U.S. News & World Report named Hackensack University Hospital among the high performing hospitals for knee and hip replacement in 2019-20. Healthgrades also rated it among America's 100 Best Hospitals for Orthopedic Surgery and Joint Replacement.

Hoag Orthopedic Institute (Irvine, Calif.). Hoag Orthopedic Institute was developed through a partnership between Orange County physicians and Hoag Memorial Hospital Presbyterian. The hospital has 70 beds and nine operating rooms dedicated to orthopedics. HOI also has more than 300 specialty physicians, including 93 orthopedic surgeons. In 2018, the hospital reported 5,509 orthopedic surgeries while HOI's ASC performed 12,454. The hospital participates in bundled payments for orthopedics and reports a 1.4 percent complication rate for total hip and knee replacements, well below the 2.5 percent national average.

Hospital for Special Surgery (New York City). Hospital for Special Surgery has been ranked the top hospital in the nation for orthopedic surgery by U.S. News & World Report for the past 10 years, most recently in 2019-20. Founded in 1863, the hospital focuses on orthopedics and rheumatology, and its surgeons perform more than 32,000 procedures per year. It is also the highest volume hip and knee replacement hospital in the nation. The hospital also focuses on innovation, opening the HSS Research Institute, which comprises 20 laboratories and 300 staff members dedicated to musculoskeletal health. HSS physicians hold faculty appointments at Weill Cornell Medical College in New York City, instructing residents in musculoskeletal health.

Houston Methodist Hospital. Surgeons at Houston Methodist Orthopedics & Sports Medicine perform more than 20,000 orthopedic procedures per year. The staff have more than 100 years of experience in orthopedics, including minimally invasive techniques. The health system's sports medicine physicians are the official healthcare providers for the Houston Texans and Houston Astros. U.S. News & World Report named Houston Methodist Hospital among the top 15 hospitals in the nation for orthopedic surgery in 2019-20.

Huntington Hospital (Pasadena, Calif.). Huntington Orthopedics Institute participates in the Comprehensive Care for Joint Replacement Model from CMS. It has been recognized by Blue Cross Blue Shield Association as a Blue Distinction Center for Knee and Hip Replacement. U.S. News & World Report also recognized the hospital in 2019-20 for musculoskeletal care, ranking it among the top 50 hospitals in the nation for orthopedics.

Indiana University Medical Center (Indianapolis). The IU School of Medicine's department of orthopedic surgery was established in 1948 and has grown into a full academic department with a research arm that receives $5.4 million in funding, with another $3.5 million pending. NIH recently provided a $1.8 million grant to the department to study mobile compression devices that would prevent deep vein thrombosis after knee replacement surgery. The orthopedic department includes 32 full-time faculty as well as 29 graduate students and 50 supporting staff.

Inova Mount Vernon Hospital (Alexandria, Va.). Patients from across the U.S. travel to Inova Mount Vernon Hospital for orthopedic care. The hospital's surgeons perform more than 2,000 hip, knee, shoulder and ankle replacements annually. The Inova Joint Replacement Center earned The Joint Commission's Gold Seal of Approval for outstanding care in joint replacement and is a UnitedHealthcare Center of Excellence for Joint Replacement.

Johns Hopkins Hospital (Baltimore). Founded in 1900, the Johns Hopkins department of orthopedic surgery has evolved to include joint replacements, spine, trauma and sports medicine. The specialists are also focused on research and participate in clinical trials as well as basic and translational research. U.S. News & World Report named Johns Hopkins Hospital among the top 50 hospitals in the nation for orthopedic surgery in 2019-20.

John Muir Health (Walnut Creek, Calif.). Quality and transparency are important aspects of the orthopedics program at John Muir Health. It participates in the Comprehensive Care for Joint Replacement program, a five-year bundled payment program making it responsible for the quality and cost of care. It also offers voluntary participation in the California Joint Replacement Registry, which tracks results for total hip and knee surgeries to provide better care to patients in the future. The health system is designated as Blue Distinction Center for Knee and Hip Replacement by Blue Cross Blue Shield Association and its Walnut Creek (Calif.) Medical Center is ranked among the top 50 hospitals in the nation for orthopedics by U.S. News & World Report for 2019-20.

Keck Hospital of USC (Los Angeles). The department of orthopedic surgery at Keck Hospital of USC has a mission to provide quality care and educate the next generation of orthopedic surgeons. Its orthopedic surgeons are also focused on research, including investigations into stem cell therapy for cartilage repair and biomechanical research. The Epstein Family Foundation also donated $10 million to name the USC Epstein Family Center for Sports Medicine in 2018; the center serves athletes in the community and physicians at the center serve as official doctors for USC Trojan athletes.

Lahey Hospital and Medical Center (Burlington, Mass.). Lahey Hospital and Medical Center has collected data on total joint replacement patients since 1988 and conducts academic reviews of the data to improve the care delivery process. Blue Cross Blue Shield Association has designated the hospital a Blue Distinction Center for Knee and Hip Replacement and serves as the teaching hospital for Boston University's Orthopaedic Surgery Resident Training Program. Orthopedic surgeons from its sports medicine center treat professional and amateur athletes.

Lehigh Valley Health Network (Allentown, Pa.). The Centers for Orthopedic Medicine at Lehigh Valley Health Network includes fellowship-trained joint replacement and sports medicine surgeons. The physicians lead a team of 400 experts across specialties and sports performance. It has earned the Blue Cross Blue Shield Association Blue Distinction Center+ for hip and knee replacements and Aetna's Institute of Quality in orthopedics. U.S. News & World Report also ranked Lehigh Valley Hospital in Allentown among the top 50 hospitals in the nation for orthopedics in 2019-20.

Loyola Medicine (Maywood, Ill.). Loyola Medicine takes a multidisciplinary approach to orthopedic care. The health system reports around 85 percent to 90 percent of knee replacement surgeries performed there are successful for 10 years or more. The system also has a robust sports medicine department with team consultants for major associations, including the U.S. Soccer Federation and U.S.A. Hockey.

Massachusetts General Hospital (Boston). Surgeons in the department of orthopedic surgery at Massachusetts General Hospital treat the full spectrum of musculoskeletal conditions, seeing more than 80,000 patients each year. Spine, trauma and joint replacement specialists treat patients at Massachusetts General, which also has a robust sports medicine department that is home to the team physicians for the Boston Red Sox, New England Patriots and Boston Bruins. U.S. News & World Report ranked Massachusetts General Hospital among the top 10 hospitals in the nation for orthopedic surgery in 2019-20.

Mayo Clinic Health System (Rochester, Minn.). Mayo Clinic is a national leader in orthopedics, with more than 80 orthopedic surgeons spanning its locations in Rochester, Phoenix, and Jacksonville, Fla. The W. Hall Wendel Jr. Musculoskeletal Center at Mayo Clinic's flagship campus in Rochester opened in 2007 and includes 57 exam rooms as well as an outpatient surgical center and ancillary services. Its surgeons also have a mission for education, traveling internationally to train surgeons as well as working with residents and fellows. U.S. News & World Report ranked Mayo's locations in Rochester and Phoenix among the top 50 hospitals in the nation for orthopedic surgery in 2019-20.

MedStar (Columbia, Md.). MedStar Orthopaedic Institute has more than 80 physicians and 20 locations across the health system's coverage area. Its specialists focus on minimally invasive treatments and have earned The Joint commission's advanced certification in hip, knee and spine surgery. U.S. News & World Report also ranks two MedStar hospitals as high performing in knee replacement. The health system has a robust sports medicine program and serves as the official medical providers for the Baltimore Ravens, Washington Capitals, Washington Wizards and Baltimore Orioles.

Memorial Hermann (Houston). Memorial Hermann's orthopedic services include the Memorial Hermann Joint Centers, offered at eight locations across the system, as well as the Ironman Sport Medicine Institute at four locations focusing on athletic training, biomechanics and sports injuries. The Joint Center physicians perform around 3,000 hip and knee replacements annually. Blue Cross Blue Shield Association has also designated Memorial Hermann Southwest a Blue Distinction Center for Knee and Hip Replacement. The health system also includes the Memorial Hermann Orthopedic & Spine Hospital, which has 64 patient rooms and 10 surgical suites. The Center for Advanced Orthopedics at Memorial Hermann Memorial City Medical Center is a 90,000-square-foot facility where surgeons perform more than 4,100 orthopedic surgeries per year.

MemorialCare (Laguna Hills, Calif.). MemorialCare has a broad orthopedic program across its health system, with the Saddleback Medical Center earning a spot on the U.S. News & World Report's top 50 hospitals for orthopedics in the U.S. for 2019-20. Saddleback reports a 98 percent success rate for orthopedics and earned the Blue Cross Blue Shield Association designation for joint replacements. Beyond offering innovative clinical care, the health system offers research and clinical trials for orthopedic patients and earned the Aetna Institutes of Quality for total Joint Replacement distinction.

Miami Orthopedics & Sports Medicine Institute at Baptist Hospital of Miami. Baptist Health South Florida's Miami Orthopedics & Sports Medicine Institute cares for the Miami Heat and Miami Dolphins and Florida Panthers. Established at Doctors Hospital, Miami Orthopedics & Sports Medicine Institute is a 281-bed acute care facility that also sees adult and pediatric trauma patients. U.S. News & World Report ranked the hospital among the top 50 hospitals in the nation for orthopedic surgery in 2019-20.

Morristown (N.J.) Medical Center. Atlantic Health System's Morrison Medical Center is known for innovative orthopedic procedures and equipment. The hospital's surgeons perform more than 4,000 joint replacements each year at the Atlantic Orthopedic Institute, using robotics and gender-specific technology. The system also partners with Atlantic Health System Children's Health and Goryeb Children's Hospital to provide pediatric orthopedic care. The health system is also the official healthcare partner of the New York Jets. In 2019-20, U.S. News & World Report named Morristown Medical Center among the top 50 hospitals in the nation for orthopedic surgery.

Mount Sinai Hospital (New York City). Mount Sinai Health System's orthopedic services are spread across locations throughout the metropolitan New York City area. U.S. News & World Report ranked the hospital among the top 20 hospitals for orthopedics in 2019-20. It also earned The Joint Commission's Advanced Certification in total hip and knee replacement. Mount Sinai is also recognized for its sports medicine expertise, having served as the official medical service provider for the U.S. Open for seven consecutive years. Mount Sinai is home to a center dedicated to serving former NFL players and providing joint replacement to the players.

MUSC Health University Medical Center (Charleston, S.C.). MUSC Health Sports Medicine offers medical coverage or consultation services to several elite athletes and athletic teams including the Charleston Battery, a Class A affiliate of the New York Yankees, and the Women's Tennis Association Volvo Car Open. The hospital is also designated a Blue Cross Blue Shield Association Blue Distinction Center for Spine Surgery and Hip and Knee Replacement. In 2019-20, U.S. News & World Report named MUSC Children's Hospital among the top hospitals in the nation for orthopedic surgery.

New England Baptist Hospital (Boston). New England Baptist Hospital has spent the past 30 years as the official hospital of the Boston Celtics, providing orthopedic care and other services for the players and their families. It also has a history of innovation, as one of the first hospitals in the country for surgeons to perform total joint replacement. NEBH has earned The Joint Commission's Gold Seal of Approval for Advanced Certification for total hip and total knee replacement.

NewYork-Presbyterian (New York City). NewYork-Presbyterian Orthopedics provides a full range of surgical services as well as pioneering spinal procedures at The Spine Hospital. The orthopedics department has more than 150 years of history and has grown to include a surgical volume of 10,900 procedures as of 2016, including 3,475 hip and knee procedures and 3,509 spine procedures. It is also a level 1 adult advanced trauma center and serves as the official hospital and orthopedic physicians for the New York Yankees and New York City FC. The health system's orthopedics department is also busy with research; the National Institutes of Health provided grants to Columbia Orthopedics, a partner of NewYork-Presbyterian, totaling more than $3.3 million.

NorthShore University Hospitals (Evanston, Ill.). The Orthopaedic & Spine Institute at NorthShore University Hospitals includes more than 100 specialty trained physicians who are dedicated to practicing innovative care. The health system includes computer-aided technology for surgical procedures and utilizes regenerative medicine in the NorthShore Orthopaedic & Spine Institute to treat patients. U.S. News & World Report ranked the hospital among the top 15 hospitals in the nation for orthopedic surgery in 2019-20.

Northwell Health (New Hyde Park, N.Y.). Northwell Health Orthopaedic Institute focuses on minimally invasive techniques for procedures, including joint replacements and has robotic technology for knee and hip procedures. Several of its hospitals have earned The Joint Commission's disease-specific certification for joint replacements and U.S. News & World Report recognition. In 2017, the health system partnered with Philadelphia-based Rothman Institute to provide additional orthopedic coverage, and 10 Rothman surgeons currently practice at Phelps Hospital Northwell Health.

Northwestern Medicine (Chicago). Northwestern Medicine has a robust orthopedics program that includes joint replacement, spine surgery and sports medicine. U.S. News & World Report ranked two of the system's hospitals Northwestern Memorial Hospital and Northwestern Medicine Central DuPage Hospital among the top 50 hospitals in the nation for orthopedic surgery in 2019-20. At the system's flagship hospital, Northwestern Memorial Hospital, physicians perform more than 7,000 orthopedic surgeries per year.

NYU Langone Health (New York City). The NYU Langone Orthopedic Hospital provides both inpatient and outpatient surgery for adult and pediatric patients. The hospital's surgeons have provided more than 1,500 outpatient total joint replacements and earned a spot on the U.S. News & World Report top 10 hospitals for orthopedics and rheumatology in 2019-20. NYU Health's Winthrop Hospital was also ranked in the top 50 hospitals for orthopedics by U.S. News for the past year. The health system's department of orthopedic surgery is also focused on research and innovation, offering physicians and scientists to opportunity to collaborate on improving outcomes for the more than 20,000 orthopedic procedures performed by the system's specialists each year.

Ohio State University Wexner Medical Center (Columbus). The Ohio State University Wexner Medical Center is on the forefront of minimally invasive orthopedic procedures and provides comprehensive care for patients. Its specialists are involved in clinical trials examining injury outcomes, ACL tear treatment and bone tumors. The hospital is a level 1 trauma center and includes robotic technology for knee and hip surgery procedures.

OHSU (Portland, Ore.). OHSU orthopedic specialists focus on minimally invasive procedures and rely on innovative research and technology to differentiate from other joint replacement programs in the region. The health system includes three joint replacement surgeons as well as sports medicine, spine and trauma physicians. OHSU's Orthopedics and Rehabilitation department also focuses on research into topics such as stem cells, tissue engineering and spinal fusion enhancements. OHSU is a level 1 trauma center and is ranked as high performing in orthopedics by U.S. News & World Report in 2019-20.

OrthoIndy Hospital (Indianapolis). OrthoIndy Hospital is a physician-owned hospital with three locations focused on orthopedic surgery. The hospital has earned five-star recognition from Healthgrades for joint replacement excellence, spinal fusion surgery and total hip and knee replacement in 2020. Press Ganey Associates also honored the hospital as a Guardian of Excellence Award winner for achieving the 95th percentile of performance from 2009 to 2019. OrthoIndy serves as the official orthopedics providers for the Indiana Pacers as well as Butler University and other local athletic teams.

OrthoNebraska Hospital (Omaha). OrthoNebraska Hospital is a physician-owned hospital with 21 physician owners. The hospital has created raving fans among those it treats; in a survey of Medicare patients, 92 percent said they would recommend OrthoNebraska Hospital, compared with 72 percent at the national average. The hospital takes a customized approach to joint replacements and earned recognition as a Nebraska Center of Excellence for knee and hip replacements by Blue Cross Blue Shield of Nebraska. The hospital's physicians and specialists also cover athletic events throughout the state.

Orthopaedic Hospital of Wisconsin (Glendale). Orthopaedic Hospital of Wisconsin is a member of Ascension Wisconsin and serves patients from across the state. Since being established in 2001 as a joint venture between a group of orthopedic surgeons and Columbia St. Mary's Ascension, the hospital has added services and expanded into a larger location. More recently, it ranked in the top 1 percent of hospitals for overall patient satisfaction, as measured by Press Ganey, and earned the Top 100 Workplaces award from the Milwaukee Journal Sentinel from 2013 to 2019. The physician-owned hospital participates in Medicare's value-based purchasing program and provides physical therapy and athletic training for UW Milwaukee.

Penn Medicine (Philadelphia). Penn Medicine's orthopedic department is devoted to research, innovation and patient care. The department's surgeons have access to the McKay Orthopaedic Research Laboratory to collaborate on projects; it has more than 100 research personnel and six principle investigators focusing on musculoskeletal tissue engineering, bone metabolism and cancer-associated bone disease and mesenchymal stem cell maintenance. The health system is also home to the current president of the American Academy of Orthopaedic Surgeons, Kristy Weber, MD, who serves as the chief of the system's sarcoma program. In 2019-20, U.S. News & World Report ranked Penn Medicine Lancaster (Pa.) General Hospital among the top 50 hospitals in the nation for orthopedics.

Penn State Health Milton S. Hershey Medical Center (Hershey, Pa.). Penn State Health Milton S. Hershey Medical Center includes the Center for Orthopaedic Research and Translational Science as well as the Bone and Joint Institute and Spine Center. The hospital has 40 orthopedic surgeons focused on a variety of specialties and dedicated to research that advances the field. The faculty's research spans the bone and cartilage cell biology, computational biomechanics and orthopedic implant function and failure. In 2019-20, the hospital earned a spot among U.S. News & World Report's top 50 hospitals for orthopedic surgery.

Porter Adventist Hospital (Denver). Surgeons at The Porter Center for Joint Replacement perform around 2,000 knee and hip replacements each year and recorded a 99 percent patient satisfaction rating from an independent study. The hospital's specialists have published more than 700 journal articles and chapters and earned recognition for hip and knee replacement clinical quality by Blue Cross Blue Shield Association and United Healthcare. The hospital remodeled its six dedicated orthopedic operating suites in 2007 for joint replacements and now hosts international fellowship training in hip, knee and shoulder surgery techniques.

Rothman Orthopaedic Specialty Hospital (Bensalem, Pa.). Rothman Orthopaedic Specialty Hospital is a 65,000-square-foot facility with six operating rooms equipped for joint replacement and other orthopedic procedures. More than 30 physicians and surgeons bring operative and non-operative cases to the hospital. The hospital's team of orthopedic and spine surgeons perform more than 3,000 spine surgeries and nonoperative treatments per year. The hospital earned the Outstanding Patient Excellence Award, Patient Safety Excellence Award and Excellence Awards for total knee, hip and joint replacement from Healthgrades.

Rush University Medical Center (Chicago). Rush University Medical Center orthopedic surgeons perform around 3,800 hip and knee replacements per year. They serve as the team physicians for the Chicago Bulls, White Sox, and Fire soccer team as well as other local athletic organizations. Rush publishes its own annual journal focused on orthopedics and was ranked No. 7 in the nation for orthopedic surgery by U.S. News & World Report in 2019-20. Rush also conducts research, with physicians and scientists participating in clinical trials about conservative treatment for arthritic knee pain and stem cell treatments for rotator cuff conditions.

Saint Francis Hospital Memphis (Tenn.). The Saint Francis Joint and Spine Center includes 23 specialty orthopedic and spine beds within the 479-bed Saint Francis Hospital Memphis. Surgeons performed around 921 spine and joint replacements at the hospital for the first half of 2019, and more than 1,900 in 2018. It was also the first hospital in Memphis to offer robotic total knee replacements, and now its surgeons have completed more than 1,000 partial and total knee replacements with the technology. The Saint Francis Joint and Spine Center is home to a spine surgical robot, which the team has used for more than 500 procedures. The hospital has earned The Joint Commission Gold Seal of Approval as a certified hip and knee replacement program.

Santa Monica (Calif.)-UCLA Medical Center and Orthopaedic Hospital. The UCLA Health and Orthopedic Hospital has built a comprehensive orthopedic program joining surgical and non-surgical specialists, academic medicine and scientific research. The health system's location in Santa Monica has earned the Blue Distinction Center for Knee and Hip Replacement designation from Blue Cross Blue Shield Association and ranked among the top 50 hospitals in the nation by U.S. News & World Report in 2019-20. In terms of research, the health system's orthopedic program is connected to The J. Vernon Luck, Sr., M.D. Orthopaedic Research Center on the UCLA campus, and its faculty ranks among the top 10 in the nation for National Institutes of Health medical-research funding.

Scripps La Jolla (Calif.) Hospitals. The orthopedic surgeons at Scripps perform more than 3,000 hip and knee replacements per year, and the hospital includes robotic technology for increased precision in orthopedic procedures. The system's hospitals have received the Blue Distinction Center designation for orthopedic care from Blue Cross Blue Shield Association and Scripps La Jolla Hospitals was rated in the top 50 hospitals in the nation for orthopedics by U.S. News & World Report. The health system also has a robust research program through the Scripps Shiley Center for Orthopaedic Research and Education with ongoing projects focused on areas such as allograft transplantations for cartilage repair, joint implant design, joint implant wear testing and orthopedic stem cell research and genomics.

Sentara Leigh Hospital (Norfolk, Va.). The Orthopedic Hospital at Sentara Leigh is an orthopedic specialty hospital offering the full continuum of care. The hospital's joint replacement program includes robotic technology for partial knee replacements, and was home to the 1,000th surgery performed on the Navio robotic system. The 48-bed hospital also includes the Sentara OrthoJoint Center Express Track, which allows patients to leave the hospital one day after joint replacement surgery.

Spectrum Health (Grand Rapids, Mich.). Spectrum Health has a robust orthopedic surgery and joint replacement program, with as many as 95 percent of joint replacement patients reporting high or very high satisfaction ratings after surgery. In 2019, the hospital also earned recognition among America's 100 Best Joint Replacement hospitals from Healthgrades. The health system has around 56 orthopedic surgeons and more than 100 dedicated orthopedic beds. In addition to providing patient care, the orthopedic department also focuses on research and has received around $600,000 in external funding.

St. Luke's Regional Medical Center (Boise, Idaho). In 2018, St. Luke's Health System opened a new 230,000 square-foot orthopedic specialty facility in Boise with 12 operating rooms and 30 beds. The facility can accommodate 20,000 visits and 7,000 surgeries per year. The health system opened a separate orthopedics location after realizing that its community was expanding, with a 10 percent projected increase in demand for orthopedic services from 2017 to 2020. The health system also has a sports medicine and training program with affiliations that span the U.S. Ski and Snowboard Association, U.S. Soccer Federation and Ultimate Fighting Championship.

St. Peter's Health Partners (Albany, N.Y.). St. Peter's Hospital Joint Replacement Center surgeons perform 2,500 total hip and knee replacements per year, ranking it among the highest volume hospitals in New York. The hospital also aims to discharge patients to their home, reporting 94 percent of joint replacement patients were discharged home between January 2017 and March 2018, exceeding the national average of 85 percent to 88 percent. The average length of stay for joint replacement patients is also around a half-day shorter at St. Peter's Hospital. In 2018, Women's Choice Award honored the hospital among America's Best Hospitals for Orthopedics and it also earned high performance designation in hip and knee replacement from U.S. News & World Report.

Stanford (Calif.) Health Care-Stanford Hospital. Stanford Hospital's orthopedic team includes around 55 physicians who span joint replacement, spine, sports medicine and extremities care. The hospital includes both inpatient care and an outpatient center in Redwood City, Calif., focused on orthopedics and sports medicine. The hospital's orthopedics department is also focused on research and is currently participating in 17 clinical trials, including studies on pediatric bone tumors and treatment for chronic back pain. U.S. News & World Report ranked Stanford Hospital among the top 50 hospitals in the nation for 2019-20.

Stony Brook (N.Y.) University Hospital. The clinical practice of Stony Brook Medicine includes Stony Brook Orthopaedic Associates, which reports more than 68,000 annual office visits. The hospital's orthopedics team also performs more than 5,600 surgeries each year across both routine and complex specialties. Stony Brook is the only level 1 trauma center in Suffolk County, and has the specialists available to treat orthopedic traumatic injuries. U.S. News & World Report ranked Stony Brook among the top 50 hospitals in the nation for orthopedics in 2019-20.

Tampa (Fla.) General Hospital. Tampa General Hospital has a skilled, high-volume orthopedic team, reporting low readmission rates, postoperative complications and revision procedures. The hospital reported 600 knee replacement procedures in 2018 and includes robotic technology for more precise, minimally invasive procedures. Tampa General also participates in the CMS Comprehensive Care for Joint Replacement Model. Newsweek honored the hospital in 2019 as one of the World's Best Hospitals for orthopedics based on patient satisfaction, clinician recommendations and key performance indicators. U.S. News & World Report also ranked Tampa General among the top 50 hospitals in the nation for orthopedics in 2019-20.

Texas Health Presbyterian Plano. As Texas Health Presbyterian Plano aims to grow its orthopedics program, the hospital recently completed a $25.4 million expansion project that added five designated orthopedic operating rooms to its campus. The new rooms include advanced technology for complex joint and spine procedures. The hospital also has a robust sports medicine program, which includes physical therapy, concussion management, athletic training and sports nutrition. U.S. News & World Report distinguished Texas Health Presbyterian Plano as high performing in orthopedics in 2019-20.

Texas Orthopedic Hospital (Houston). Texas Orthopedic Hospital opened in 1995 and is a joint venture between physicians and Fondren Orthopedic Group. It is affiliated with HCA Houston Healthcare and earlier this year earned a spot on the Top Workplaces 2019 list by the Houston Chronicle. The hospital has also ranked consistently in the top 5 percent nationwide by HCAHPS and earned Healthgrades' 5-star recognition for total knee and hip replacements for the past 12 years. In May, Texas Orthopedic affiliated with Texas Southern University and became the official sponsor of its athletic programs.

Thomas Jefferson University Hospitals (Philadelphia). Jefferson Health's department of orthopaedic surgery includes specialists from Rothman Orthopaedics at Jefferson Health, 3B Orthopaedics and Abington Orthopedic & Spine Institute - Jefferson Health. The system's team performs more than 61,000 surgical orthopedic procedures per year and ranked among the top 50 hospitals in the nation for orthopedics by U.S. News & World Report in 2019-20. More than 60 board-certified physicians make up the department, focused on clinical care and research focused on vertebral disc disease and osteoarthritis.

Torrance (Calif.) Memorial Medical Center. The Lundquist Orthopedic Institute at Torrance Memorial Medical Center has earned recognition as a Blue Cross Blue Shield Blue Distinction Center for knee and hip replacement surgery as well as spine surgery. It is the fifth largest private orthopedic hospital in Los Angeles County and earned recognition from U.S. News & World Report as one of the top hospitals for orthopedic surgery in 2019-20. Its specialists take a team approach to treating orthopedic patients and support more than 2,100 orthopedic procedures each year.

UC Davis Medical Center (Sacramento). UC Davis Health launched its orthopedics department in 1969, and it has grown into an internationally known orthopedics program. The health system includes the UC Davis Trauma Center, among the three busiest level 1 trauma centers in the country, as well as an adult reconstruction center and sports medicine program. The health system's flagship hospital, UC Davis Medical Center, earned recognition as one of the top 50 hospitals in the nation for orthopedics by U.S. News & World Report in 2019-20. U.S. News also ranked the health system's Shriner's Hospitals for Children - Northern California among the top hospitals for pediatric orthopedics in the nation this year.

UC San Diego Health-Jacobs Medical Center (La Jolla, Calif.). More than 20 orthopedists make up the team at UC San Diego Health's orthopedic center. The system is the official healthcare provider for the San Diego Padres as well as UC San Diego Athletics. In addition to providing orthopedic care, the health system's specialists participate in clinical trials and have research interest in biologic treatments for injured and diseased tissue, intraoperative tools to assist surgeons during procedures and outcomes for experimental interventions.

UCHealth University of Colorado Hospital (Aurora). The orthopedics team at UCHealth University of Colorado Hospital performs more than 4,000 orthopedic surgeries per year. The orthopedics department specializes in joint replacement and preservation, spine and sports medicine, taking an interdisciplinary approach to patient care. U.S. News & World Report ranked the hospital among the top 50 hospitals in the nation for orthopedics in 2019-20. Beyond practicing medicine, the hospital's physicians collaborate with researchers to investigate new techniques and treatments.

UChicago Medicine. The orthopedic surgeons at UChicago Medicine focus on innovating in orthopedic and spine care for more personalized treatments. The health system established the nation's first full-time orthopedic surgery faculty in 1930 and that has grown to include 31 surgical and non-surgical physician specialists. The orthopedics team is also focused on clinical research for musculoskeletal diseases, cartilage regeneration, orthotic techniques and more. U.S. News & World Report distinguished University of Chicago Medical Center as high performing in orthopedics in 2019-20.

UCSF Health (San Francisco). The specialists at the UCSF Arthritis and Joint Replacement Center perform more than 800 hip and knee procedures per year. The health system also has a robust sports medicine program, which includes a sports concussion program and the Sports Medicine Center for Young Athletes, which supports more than 13,000 patient visits and performs around 1,000 surgeries per year for young athletes at all levels, including U.S. Olympians. Finally, the health system treats around 10,000 spine patients per year. U.S. News & World Report ranked UCSF Medical Center among the top 50 hospitals in the nation for orthopedics in 2019-20.

UMass Memorial Medical Center (Worcester, Mass.). More than 100 experts in orthopedics and rheumatology provide care at UMass Memorial Medical Center. The hospital's joint replacement program earned Blue Distinction Center+ for Knee and Hip surgery from Blue Cross Blue Shield Association and earned the five-star rating from Healthgrades for total knee replacements for three consecutive years, most recently in 2018. The hospital's researches have received $19 million in funding from the National Institutes of Health as well as $1.7 million from the National Institute of Arthritis and Musculoskeletal Skin Disease to improve outcomes after total knee replacement surgery.

University Hospital (Augusta, Ga.). To deliver specialized patient care, University Hospital has devoted its ninth floor to a $9 million Orthopaedic & Spine Center with 45 private patient rooms, a dedicated rehabilitation gym and expansive workspace for physicians and nurses. Anchoring University Health Care System, the 812-bed University Hospital is the only facility in its region to receive designation from Blue Cross Blue Shield as a Blue Distinction Center+ for knee and hip replacement and spine surgery. It is also the region's only facility recognized as an Aetna Institute of Quality for joint replacement and spine surgery.

University Hospitals (Cleveland). With nine specialty divisions, University Hospitals' orthopedics department takes pride in its multidisciplinary, collaborative approach to care. Physicians at the 1,032-bed hospital are also enlisted as full-time faculty members at Case Western Reserve University School of Medicine, a Cleveland institution known for heavy investment in research over the past two decades. Through its sports medicine division, UH serves as the official medical provider for the Cleveland Ballet and the Cleveland Browns.

University of Iowa Hospitals and Clinics (Iowa City). The orthopedics and rehabilitation department at the University of Iowa Hospitals and Clinics has 48 beds across its system, which includes 10 outpatient clinics and a specialty radiology unit. The department's physicians see around 280 patients per day and around 70,000 patients per year. The orthopedic surgical team performs 7,000 procedures annually. In addition to clinical care, University of Iowa's orthopedic specialists are involved in research for the prevention of osteoarthritis after joint injuries, concussion treatment, sports-related treatment protocol and other innovative projects. U.S. News & World Report ranked the hospital among the top 50 hospitals in the nation for orthopedics in 2019-20.

University of Kansas Hospital (Kansas City, Kan.). The University of Kansas Hospital is home to The University of Kansas Health System's orthopedics department, which includes more than 30 providers. The system is the official healthcare provider for The Kansas City Chiefs and The Kansas City Royals and provides athletic training and sports medicine services at multiple school districts. For 2019-20, University of Kansas Hospital was ranked in the top 10 percent of hospitals for orthopedics by U.S. News & World Report.

University of Kentucky Albert B. Chandler Hospital (Lexington). As a university-affiliated program, the orthopedics department at Albert B. Chandler Hospital strives to provide cutting-edge care. The 569-bed hospital opened in 1962 and employs fellowship-trained orthopedic trauma surgeons at its level 1 trauma center, which is the only one in central and eastern Kentucky. UK Chandler Hospital features multiple hospital-based clinics, including one entirely devoted to orthopedic surgery.

University of Maryland St. Joseph Medical Center (Towson). Each year, more than 25,000 patients come to the University of Maryland St. Joseph Medical Center to see specialists at The Orthopaedic Institute, which is known for excellence in pain management and rapid rehabilitation after joint replacement. The 218-bed hospital partners with Towson Orthopaedic Associates to deliver 1,600 joint replacements a year and offers comprehensive rehabilitation services in conjunction with Towson Sports Medicine. St. Joseph Medical Center's 50-bed orthopedic unit features 32 private patient rooms and a rehabilitation facility.

University of Minnesota Medical Center (Minneapolis). University of Minnesota Medical Center's 50-plus orthopedic providers are nationally and internationally recognized for expertise in sports medicine, physical medicine, family medicine and rheumatology, among other fields. With a physical medicine and rehabilitation program that has been around for more than 50 years and a walk-in clinic for orthopedic and sports medicine services, University of Minnesota Medical Center operates under the belief that muscle, bone and joint pain shouldn't prevent patients from doing the things they enjoy. This approach has helped the hospital obtain Blue Cross Blue Shield's Blue Distinction Centers+ designation for efficiency and expertise in knee and hip surgery.

University of Tennessee Medical Center (Knoxville). With a team of eight orthopedic trauma surgeons, the 685-bed University of Tennessee Medical Center operates East Tennessee's only level 1 trauma center verified by the American College of Surgeons. In October, the hospital unveiled plans to open a freestanding orthopedic surgery center in partnership with Knoxville-based OrthoTennessee and University Orthopedic Surgeons. University of Tennessee Medical Center was the first in the state to receive The Joint Commission's Gold Seal of Approval for Advanced Certification for total hip and total knee replacement.

University of Virginia Medical Center (Charlottesville). With more than 84,000 patients visiting its clinics, UVA Orthopedics recorded 1,189 hip and knee surgeries from mid-2018 to mid-2019, while beating the national average length of stay for hip fracture patients. University of Virginia Medical Center also beat the national average on surgical infection rates for hip replacement for 2018. University of Virginia Medical Center was also the state's first hospital to receive premier certification from the International Geriatric Fracture Society and earned recognition from Blue Cross Blue Shield as a Blue Distinction Center for knee and hip replacement.

University Hospital-Michigan Medicine (Ann Arbor). Under the leadership of former chair James E. Carpenter, MD, who stepped down in May, Michigan Medicine's orthopedic surgery department has grown to include several dozen faculty members and nearly 400 staff members. In addition, the system accommodates over 300,000 outpatient visits annually at its Comprehensive Musculoskeletal Center. The center now employs 250-plus physicians across 22 facilities, including the 550-bed University Hospital which earned recognition among the top 50 hospitals in the nation for orthopedic surgery by U.S. News & World Report for 2019-20.

University of Utah Hospital (Salt Lake City). University of Utah Hospital's Center for Hip & Knee Reconstruction leverages resources from the University Orthopaedic Center and University of Utah Health to diagnose and treat patients. The system's orthopedic surgery department received $12.4 million in funding from the National Institutes of Health in 2018, earning a No. 1 ranking from The Blue Ridge Institute for Medical Research. Designated as a Blue Distinction Center for knee and hip replacement, University of Utah Hospital is home to the Center for Hip & Knee Reconstruction, a charter member of the American Joint Replacement Registry.

UPMC (Pittsburgh). Encompassing 13 research laboratories with funding from the National Institutes of Health and other institutions, UPMC's orthopedic surgery department helps shape the field's future through evidence-based studies and clinical trials. The organization's sports medicine division is the official medical provider of the Pittsburgh Steelers and over 60 high school, college and regional teams and events, providing specialized treatment for athletes at two full-service sports complexes. With high marks in advanced technologies, patient services, nurse staffing and patient volumes, UPMC Presbyterian Shadyside was ranked among the top 50 hospitals in the nation for orthopedics by U.S. News & World Report for 2019-20.

UR Medicine (Rochester, N.Y.). UR Medicine supports robust orthopedic services across its seven hospitals. The Evarts Joint Center at Highland Hospital earned the Joint Commission's Gold Seal of Approval for knee and hip replacements, and the Aetna Institutes of Quality also distinguished the center for excellence in orthopedics. UR Medicine's orthopedic surgeons are also involved in research and are among the top in the nation for National Institutes of Health orthopedics research funding. The system's Center for Musculoskeletal Research includes 75 scientists that work alongside principal investigators and researchers to improve bone health.

UT Southwestern Medical Center (Dallas). With a team of 28 orthopedic specialists, UT Southwestern Medical Center offers a multidisciplinary approach to care across six locations. Surgeons at the academic medical center pioneered minimally invasive percutaneous surgery and were the first in North Texas to use a female-specific prosthetic for knee replacement. Led by professor and chair Dane Wukich, MD, the hospital's orthopedic surgery department has researchers currently involved in more than four dozen clinical studies.

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100 hospitals and health systems with great orthopedic programs | 2019 - Becker's Hospital Review

Investigating the Human Intestinal Mucus Barrier Up-close and Personal – Technology Networks

We have a mutualistic but complicated relationship with the collection of microbes in our gut, known as the intestinal microbiome. This complex community of bacteria breaks down different food components, and releases nutrients such as vitamins and a plethora of other factors that control functions in tissues way beyond the intestinal tract. However, the sheer numbers of microbes also present a threat as they can trigger inflammation, which is thought to be at the root of many intestinal diseases, including inflammatory bowel disease, radiation-induced intestinal injury, and some cancers.

To allow the uptake of beneficial substances from the gut lumen, and at the same time prevent gut microbes from contacting the intestinal epithelial tissue surface, specialized cells called goblet cells continuously produce mucus, the slimy goo-like substance that coats the entire intestinal surface. Mucus thus far has been notoriously difficult to study: its structure quickly disintegrates in surgically removed sections of the gut, the system most often used to study mucus, and no in vitro culture system has been able to reconstitute an in vivo-like mucus layer with the natural structure seen in living intestine outside the human body. Adding to these difficulties, mucus also differs between humans and other species, different sections of the intestinal tract, and even different individuals.

Now, focusing on the large intestine or colon which houses the greatest number of commensal microbes and has the thickest mucus layer, a team of tissue engineers at Harvards Wyss Institute for Biologically Inspired Engineering has developed a colon-on-a-chip (Colon Chip) microfluidic culture device lined by patient-derived colon cells that spontaneously accumulates a mucus layer with the thickness, bi-layered structure, and barrier functions typically found in normal human colon. The mucosal surface in their model also responds to the inflammatory mediator prostaglandin E2 (PGE2) by mounting a rapid swelling response. Their findings are published in Cellular and Molecular Gastroenterology and Hepatology.

Our approach provides researchers with the opportunity to find answers to questions about normal and disease-associated mucus biology, such as its contributions to intestinal inflammatory diseases and cancers, and complex host-microbiome interactions, said Founding Director Donald Ingber, M.D., Ph.D., who is the senior investigator on the study. Importantly, we use patient-derived cells to line these devices and so this represents an entirely new approach for personalized medicine where it can be possible to study how mucus functions or dysfunctions in a particular patient, and to tailor therapy accordingly.

Ingber is also the Judah Folkman Professor of Vascular Biology at Harvard Medical School and the Vascular Biology Program at Boston Childrens Hospital, as well as Professor of Bioengineering at Harvards John A. Paulson School of Engineering and Applied Sciences. His team is part of a multi-institutional collaboration supported by a Cancer Research UK Grand Challenge grant in which his Wyss team investigates how inflammation-related changes contribute to formation of cancers, including colon cancers. The Grand Challenge is an ambitious international cancer research initiative, supporting world-leading teams of scientists to take on some of the toughest challenges in cancer, and giving them the freedom to try novel approaches at scale.

The teams approach starts out with patient-derived colon cells from colon resections and endoscopic biopsies that are first grown as organoids, tiny organized balls of colon tissue that contain mainly epithelial stem cells. After fragmenting the organoids, their cells are used to populate the upper of a two parallel channels of a microfluidic chip that are separated by a porous membrane. Simply by perfusing the channels continuously with nutrient medium, the colon stem cells grow into a continuous sheet and form highly functional goblet cells that secrete mucus.

Growing the cells on-chip under flow results in about 15% of epithelial cells spontaneously differentiating into goblet cells. Distributed throughout the epithelium, these produce an in vivo-like mucus layer, said first-author Alexandra Sontheimer-Phelps, a graduate student from the University of Freiburg, Germany, working in Ingbers group. At the same time, other epithelial cells that keep dividing also replenish the goblet cell population just like in living colon, which means that the chip can be maintained in steady-state conditions for more than two weeks, which makes it highly useful for longer-term studies.

The Wyss team showed that the colon epithelium in the chip is fully polarized with distinct markers restricted to its lumen-exposed, mucus-secreting side and its opposite membrane-binding side. Its goblet cells secrete the major mucus protein mucin 2 (MUC2), which when linked to complex chains of sugar molecules, assembles into multi-molecular network or gel that takes up water. Our approach actually produces the bi-layered structure of normal colon mucus with an inner dense layer that we show is impenetrable to bacteria-mimicking particles flowed through the intestinal channel, and a more loose outer layer that allows particles to enter. This has never been accomplished before in vitro, said Sontheimer-Phelps.

To investigate the functionality of the mucus, she and her co-workers exposed the chip to the inflammatory mediator PGE2. The mucus underwent rapid swelling within minutes and independent of any new mucus secretion, and this process of mucus accumulation can be visualized in living cultures by viewing the chips from the side with dark field illumination. This dynamic response could be blocked by inhibiting one particular ion channel, which pumps ions into the colon epithelium and passively allow water molecules to follow and apparently, this drives mucus swelling when stimulated by signals such as PGE2.

Mucus has long been thought to be a passive, host barrier, but it is becoming increasingly clear that microbial species affect its structure and function in addition to feeding on its carbohydrates as an energy source. Our in vitro system brings us one step closer to figuring out how individual bacterial species and more complex microbial communities can affect mucus and vice versa, as well as how this complex interplay impacts development of intestinal diseases. We also now have a testbed to discover new therapeutic drug and probiotic strategies that might prevent or reverse these diseases said Ingber.

Reference:Sontheimer-Phelps, A., Chou, D. B., Tovaglieri, A., Ferrante, T. C., Duckworth, T., Fadel, C., Ingber, D. E. (2019). Human colon-on-a-chip enables continuous in vitro analysis of colon mucus layer accumulation and physiology. Cellular and Molecular Gastroenterology and Hepatology. https://doi.org/10.1016/j.jcmgh.2019.11.008

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Investigating the Human Intestinal Mucus Barrier Up-close and Personal - Technology Networks

Omeros Reports Positive Data Across Primary and Secondary Endpoints in Pivotal Trial of Hematopoietic Stem Cell Transplant-Associated Thrombotic…

SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced positive data from its pivotal clinical trial of the companys novel investigational complement inhibitor narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a frequently lethal complication of HSCT. These preliminary data were recently provided to FDA as part of the companys ongoing interactions with the Agency on the narsoplimab Biologics License Application (BLA). All safety and efficacy endpoints including the composite primary endpoint and the secondary endpoints are agreed with FDA. The reported data support a strongly positive benefit-risk balance.

The primary efficacy endpoint in this single-arm open-label trial of HSCT-TMA patients is the proportion of patients who achieve a highly rigorous set of response criteria that requires both improvement in HSCT-TMA laboratory markers and improvement in clinical status (organ function and transfusions). Patients who did not fully meet these criteria were considered non-responders. The secondary endpoints include survival rates and change from baseline in HSCT-TMA laboratory markers. Consistent with the pre-specified statistical analysis plan for the trial, the primary and secondary endpoints are assessed for (1) all patients who received at least one dose of narsoplimab and (2) patients who received at least 4 weeks of narsoplimab dosing. Patients enrolled in this trial had a high expected mortality rate. In severe cases of HSCT-TMA, mortality can exceed 90 percent.

Primary Efficacy Endpoint:

Secondary Endpoints:

Safety:

The HSCT-TMA patient population enrolled in this trial had multiple high-risk features that portend a poor outcome. These include persistence of HSCT-TMA despite modification of immunosuppression (which was a criterion for entry into the trial), graft-versus-host disease, significant infections, non-infectious pulmonary complications and neurological findings. Patients in the trial had a high expected death rate, with 93 percent of them having multiple risk factors.

Patient enrollment in the pivotal trial has been completed. The details of the endpoints, including the response criteria agreed with FDA, and the number of patients in the trial remain confidential for competitive business reasons.

Last year the company reported data on 19 HSCT-TMA patients treated with narsoplimab on which FDA granted breakthrough therapy designation. The results reported today are even stronger. The response rate remains equally high at 56 percent, while the 100-day survival has improved from 53 percent to 65 percent.

The response rate in this high-risk population would be expected to be 10 to 15 percent with a 100-day survival rate of less than 20 percent. The response rate and 100-day survival achieved with narsoplimab in this trial demonstrate an unprecedented effect in this condition, said Rafael Duarte M.D., Ph.D., F.R.C.P., Associate Professor, Head of Hematology Department and Hematopoietic Transplantation Program, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain, and Secretary of the European Society for Blood and Marrow Transplantation. The other secondary endpoints are equally impressive. The data are consistent with my personal experience with narsoplimab. Patients with severe forms of HSCT-TMA have a dismal prognosis with no treatment currently available. I expect a treatment with this profile would be widely adopted for use in these patients and even lead to increased physician recognition of the disorder.

Omeros reported the initiation of its rolling BLA in October. Narsoplimab, also referred to as OMS721, is Omeros lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) and has breakthrough therapy designation from FDA for this indication.

The striking results seen in our pivotal trial are tremendously gratifying, said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. Our rolling BLA is underway the nonclinical sections have been submitted and the data from this trial form the efficacy basis of the application. We continue to compile the remaining sections of the BLA and look forward to continued partnership with regulators to make narsoplimab widely available for the treatment of this devastating condition.

Data from this pivotal trial will also support the narsoplimab marketing authorization application for HSCT-TMA in Europe. The data are planned for publication and for presentation at international congresses in the first part of 2020.

In addition to breakthrough therapy designation from FDA, narsoplimab has orphan drug designation in both the U.S. and Europe for HSCT-TMA. Narsoplimab also has been awarded breakthrough therapy designation for immunoglobulin A nephropathy (IgAN), and Omeros has Phase 3 programs for narsoplimab ongoing in IgAN and in atypical hemolytic uremic syndrome (aHUS).

Conference Call and Webcast Details

Omeros management will host a webcast and conference call to present data from its pivotal trial of narsoplimab in HSCT-TMA. The call will be held today at 8:30 a.m. Eastern Time; 5:30 a.m. Pacific Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3774209. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3774209.

To access the live or subsequently archived webcast and presentation materials on the internet, go to the companys website at http://www.omeros.com and select Events under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. In addition, the company has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

About HSCT-TMA

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplants. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, GvHD, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an HSCT-TMA incidence of approximately 40 percent, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae are common. There is no approved therapy or standard of care for HSCT-TMA.

About Narsoplimab

Narsoplimab, also known as OMS721, is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

Phase 3 clinical programs are in progress for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), in immunoglobulin A (IgA) nephropathy, and in atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the safe harbor created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, likely, look forward to, may, on track, plan, potential, predict, project, prospects, scheduled, should, slated, targeting, will, would and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, expectations regarding regulatory exclusivities, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros investigational product, are based on managements beliefs and assumptions and on information available to management only as of the date of this press release. Omeros actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, availability and timing of data from clinical trials and the results of such trials, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading Risk Factors in the companys Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2019. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of any new information, future events or otherwise, except as required by applicable law.

Source: Omeros Corporation

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Omeros Reports Positive Data Across Primary and Secondary Endpoints in Pivotal Trial of Hematopoietic Stem Cell Transplant-Associated Thrombotic...

Stem cells may trigger immune repair to mend hearts – BioNews

2 December 2019

Stem cell therapies may become redundant in repairing cardiac function after a heart attack, suggests a new study in mice.

It showed how stem cell treatments can heal hearts by triggering an immune response which can be achieved by using a chemical instead.

'This work is paradigm-shifting because it demonstrates a mechanism to explain a perplexing phenomenon that has intrigued cardiologists as a result of decades of cardiac stem cell trials,' Dr Jonathan Epstein at the University of Pennsylvania's Perelman School of Medicine in Philadelphia told The Scientist.

Stem cell therapies to repair damaged heart tissue are currently being tested in human clinical trials. In these treatments, human stem cells are injected into the heart and this leads to an improvement in heart function. However, how this works is not fully understood.

One possibility is that the injected stem cells are incorporated into the heart tissue and repair the damage. However, the latest study, published in the journal Nature, suggests that this may not be the case. Instead, the study indicated that the repair is actually a result of triggering the innate immune response.

Researchers injected different types of stem cell or a chemical inducer (zymosan) of the innate immune response into an experimental mouse model of heart disease. They saw improvement in heart function that was similar in all cases, and showed that this repair occurs via activation of macrophage cells of the innate immune system.

'The innate immune response acutely altered cellular activity around the injured area of the heart so that it healed with a more optimised scar and improved contractile properties,' said Dr Jeffery Molkentin at the University of Cincinnati and Cincinnati Children's Hospital Medical Centre, Ohio, who led the study. 'The implications of our study are very straightforward and present important new evidence about an unsettled debate in the field of cardiovascular medicine.'

The work could open up new possibilities for optimising the treatments currently in development, as well as alternative new therapies.

'If there is a chemical off-the-shelf, it would be a much more feasible therapy [than stem cell transplants],'Dr Kory Lavine at Washington University in St Louis, Missouri, told Nature News.

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Stem cells may trigger immune repair to mend hearts - BioNews

Hunter Syndrome Treatment Market Size, Share & Trend Analysis By Treatment, By Region And Segment Forecasts, 2019 – 2026 – P&T Community

NEW YORK, Dec. 4, 2019 /PRNewswire/ --

Hunter Syndrome Treatment Market Size, Share & Trend Analysis By Treatment (Enzyme Replacement Therapy, Hematopoietic Stem Cell Transplant), By Region, And Segment Forecasts, 2019 - 2026

Read the full report: https://www.reportlinker.com/p05830601/?utm_source=PRN

The global hunter syndrome treatment market size is expected to reach a value of USD 1.52 billion by 2026, expanding at a CAGR of 7.1%. High unmet needs, robust pipeline, increasing awareness about this rare disease and growing R&D activities for the development of novel therapies are expected to drive market growth over the forecast period.

Hunter syndrome, also referred as mucopolysaccharidosis type II (MPS II), is a rare genetic disorder caused by the missing or malfunctioning iduronate-2-sulfatase enzyme. According to the data published by the National Institute of Neurological Disorders and Stroke, MPS II syndrome occurs in around 1 in every 100,000 to 150,000 male births.

Presently, there are no approved curative therapies for the treatment of Hunter syndrome.The available treatment options such as enzyme replacement therapy (ERT) and hematopoietic stem cell transplant (HSCT) are focused on providing symptomatic relief and management of complications associated with disease progression.

Shire plc's Elaprase (idursulfase) is the only key drug available for the treatment of Hunter syndrome worldwide, with GC Pharma's Hunterase (idursulfase beta) being approved only in South Korea.

Key players are focused on extensive R&D activities for product development and gaining approval as novel therapies.Launch of such novel therapies in the near future is expected to significantly fuel the Hunter syndrome treatment market growth.

For instance, in May 2018, REGENXBIO Inc. received the U.S. FDA's Fast Track designation for its novel drug candidate RGX-121, indicated for the disease treatment.

Further Key Findings from the Study Suggest: The enzyme replacement therapy segment has acquired the largest share in 2018, owing to the increased adoption of Elaprase and the potential approval of Hunterase worldwide The absence of curative therapies for MPS II creates lucrative opportunities for the key players in the market for developing new therapies The launch of late-stage pipeline therapies is expected to drive the market growth during the forecast period Currently, Shire Plc. is one of the leading players, supported by strong sales of their marketed drug ELAPRASE for the disease treatment Major players in the market are adopting inorganic growth strategies such as partnerships and collaborations for the development and commercialization of novel therapies In 2018, North America held a dominant position in the global market, owing to favorable reimbursement scenario, high awareness regarding rare disorders, and presence of major players Some of the key companies in hunter syndrome treatment market include GC Pharma, Sangamo Therapeutics, Inc.; JCR Pharmaceuticals Co Ltd.; RegenxBio Inc.; and Shire Plc. (Takeda Pharmaceutical Company)

Read the full report: https://www.reportlinker.com/p05830601/?utm_source=PRN

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Hunter Syndrome Treatment Market Size, Share & Trend Analysis By Treatment, By Region And Segment Forecasts, 2019 - 2026 - P&T Community

Cell-Easy Leads the Way Towards Tomorrow’s Healthcare With Accessible Stem Cell Therapy – StreetInsider.com

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