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ZKR Orthopedics Receives IDE Approval for Clinical Trial

Retrieved on: 
Wednesday, February 14, 2024

SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.

Key Points: 
  • SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.
  • We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use," commented David Cash, CEO of ZKR Orthopedics.
  • The IDE approval announcement was made as part of the ZKR Orthopedics activities at the 2024 American Academy of Orthopedic Surgeons annual meeting in San Francisco.
  • In addition to reporting IDE trial approval, the Company participated in the Canaccord Genuity Musculoskeletal Conference earlier this week.

Orthopedic Surgeon Tomas Pevny, MD, of Valley View, Is the First in the Roaring Fork Valley to Offer iovera°, a New Option to Manage Knee Pain

Retrieved on: 
Tuesday, February 13, 2024

GLENWOOD SPRINGS, Colo., Feb. 13, 2024 /PRNewswire/ -- Valley View, the Roaring Fork Valley leader in healthcare technology, is pleased to announce that Orthopedic Surgeon Tomas Pevny, MD, is first in the region to offer iovera°, an FDA-approved, non-surgical, non-opioid osteoarthritis knee pain treatment that uses extreme cold to temporarily stop nerves from sending pain signals.

Key Points: 
  • Osteoarthritis is the most common form of arthritis, affecting 32.5 million United States adults, according to the Centers for Disease Control (CDC).
  • Osteoarthritis is caused by damage or breakdown of joint cartilage between bones, which may cause pain, stiffness, decreased range of motion and swelling.
  • Part of Valley View, ValleyOrtho is committed to being the trusted leader in innovative, quality-focused, comprehensive musculoskeletal care in Aspen, the Roaring Fork Valley and beyond.
  • ValleyOrtho also provides world-class orthopedic surgery at Valley View Hospital in Glenwood Springs and the Valley View Surgery Center in Basalt.

Herbal medicinal product: Lecithinum ex soyaArray, D: Draft under discussion

Retrieved on: 
Saturday, February 10, 2024

Overview

Key Points: 
  • Overview
    This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of soya-bean lecithin.
  • Herbal medicines containing soya-bean lecithin are usually available in solid or liquid forms to be taken by mouth.
  • Soya-bean lecithin may also be found in combination with other herbal substances in some herbal medicines.
  • Key facts
    - Latin name
    - Lecithinum ex soya
    - English common name
    - Soya-bean lecithin
    - Botanical name
    Glycine max (L.) Merr.

Trinity Biotech Announces Application for Early Sjogrens Syndrome Test Panel PLA Code

Retrieved on: 
Wednesday, February 7, 2024

(Nasdaq: TRIB) (the “Company”) today announced that its New York based reference laboratory, Immco Diagnostics, has applied for a Proprietary Laboratory Analyses (PLA) code for its Early Sjögrens Syndrome Test Panel, to allow for an optimised market access strategy to deliver broader patient access and improved profitability.

Key Points: 
  • (Nasdaq: TRIB) (the “Company”) today announced that its New York based reference laboratory, Immco Diagnostics, has applied for a Proprietary Laboratory Analyses (PLA) code for its Early Sjögrens Syndrome Test Panel, to allow for an optimised market access strategy to deliver broader patient access and improved profitability.
  • It is estimated that up to approximately 3 million people in the US have Sjögrens Syndrome, making it one of the most prevalent autoimmune syndromes.
  • The Early Sjögrens Syndrome Test Panel is a valuable immunological tool for clinicians to both identify patients earlier, when therapeutic intervention is most effective, and to also identify patient cohorts most at risk of progression to Sjögren’s Syndrome.
  • A PLA code is a distinct, specific code assigned to a particular test and approved by the American Medical Association’s (AMA) Current Procedural Terminology (CPT) Editorial Panel.

New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Retrieved on: 
Thursday, February 1, 2024

In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.

Key Points: 
  • In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.
  • Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.
  • In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.
  • “The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at Université Paris Cité in Paris and president of EURETINA, who is presenting the data at Angiogenesis.

2024 OREF Clinical Research Award Celebrates Study of Local Gene Therapy to Treat Osteoarthritis

Retrieved on: 
Friday, February 2, 2024

ROSEMONT, Ill. , Feb. 2, 2024 /PRNewswire/ -- The 2024 Orthopaedic Research and Education Foundation (OREF) Clinical Research Award was presented to Christopher H. Evans, PhD (Mayo Clinic), Steven C. Ghivizzani, PhD (University of Florida), and Paul D. Robbins, PhD (University of Minnesota), for their research on local gene therapy for osteoarthritis (OA).

Key Points: 
  • ROSEMONT, Ill. , Feb. 2, 2024 /PRNewswire/ -- The 2024 Orthopaedic Research and Education Foundation (OREF) Clinical Research Award was presented to Christopher H. Evans, PhD (Mayo Clinic), Steven C. Ghivizzani, PhD (University of Florida), and Paul D. Robbins, PhD (University of Minnesota), for their research on local gene therapy for osteoarthritis (OA).
  • Together, the team spearheaded the research from a laboratory concept to human clinical trials over the course of 30 years.
  • The OREF Award recognizes outstanding clinical research related to musculoskeletal disease or injury.
  • Evans, Ghivizzani and Robbins co-founded an arthritis gene therapy startup company, Genascence Corporation, which will help fund future clinical trials.

Eating leafy greens could be better for oral health than using mouthwash

Retrieved on: 
Tuesday, January 30, 2024

These treatments have side effects, such as dry mouth, the development of antimicrobial resistance and increased blood pressure.

Key Points: 
  • These treatments have side effects, such as dry mouth, the development of antimicrobial resistance and increased blood pressure.
  • But research has indicated that a molecule called nitrate, which is found in leafy green vegetables, has fewer side effects and offers greater benefits for oral health.
  • Periodontitis is a more advanced form of gum disease, causing damage to the soft tissues and bones supporting the teeth.

Leafy greens may be the secret

  • Leafy greens and root vegetables are bursting with vitamins, minerals, and antioxidants – and it’s no secret that a diet consisting of these vegetables is crucial for maintaining a healthy weight, boosting the immune system, and preventing heart disease, cancer and diabetes.
  • The multiple health benefits of leafy greens are partly because spinach, lettuce and beetroots are brimming with nitrate, which can be reduced to nitric oxide by nitrate-reducing bacteria inside the mouth.
  • However, in the mouth, it helps to prevent the overgrowth of bad bacteria and reduces oral acidity, both of which can cause gum disease and tooth decay.
  • Antimicrobial resistance is a global health concern, predicted to cause 10 million deaths yearly by the year 2050.


In contrast, dietary nitrate is more targeted. Nitrate eliminates disease-associated bacteria, reduces oral acidity and creates a balanced oral microbiome. The oral microbiome refers to all the microorganisms in the mouth. Nitrate offers exciting potential as an oral health prebiotic, which can be used to prevent disease onset or limit disease progression.

How many leafy greens for pearly whites?

  • As a rule of thumb, a generous helping of spinach, kale or beetroot at mealtimes contains about 6-10 mmol of nitrate and offers immediate health benefits.
  • For example, consuming lettuce juice for two weeks reduced gum inflammation and increased healthy bacteria levels in patients with gum disease.


Mia Cousins Burleigh has previously received funding from The Royal Society of Edinburgh. Siobhan Paula Moran does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

AIRSUPRA® (albuterol/budesonide) now available as the first and only FDA-approved anti-inflammatory rescue option for asthma

Retrieved on: 
Monday, January 22, 2024

In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma.

Key Points: 
  • In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma.
  • In DENALI, AIRSUPRA had a similar onset of bronchodilation compared to albuterol in patients with mild to moderate asthma.2
    The approach to treating asthma symptoms with rescue has changed.
  • The 2023 Global Initiative for Asthma (GINA) report supports a rescue approach that treats both symptoms and inflammation together.
  • Now, with AIRSUPRA available we can provide patients, especially those on maintenance therapy, another rescue option for managing their breakthrough symptoms.

Inflammasome Therapeutics Announces First Patient Dosed in Phase I Diabetic Macular Edema Study of the Dual Inflammasome Inhibitor K8

Retrieved on: 
Thursday, January 18, 2024

Inflammasome Therapeutics ( https://www.inflam.com ), a clinical-stage, private company developing a new class of inflammasome inhibitor drugs, Kamuvudines, as therapies for prevalent, degenerative diseases, announced the first patient has been dosed in a Phase 1 study of one of the company’s novel compounds in the treatment of diabetic macular edema (DME).

Key Points: 
  • Inflammasome Therapeutics ( https://www.inflam.com ), a clinical-stage, private company developing a new class of inflammasome inhibitor drugs, Kamuvudines, as therapies for prevalent, degenerative diseases, announced the first patient has been dosed in a Phase 1 study of one of the company’s novel compounds in the treatment of diabetic macular edema (DME).
  • The 24-week study (ClinicalTrials.gov ID NCT05699759) is designed to assess safety and initial evidence of efficacy.
  • This investigator-sponsored study, led by Dr. Michelle Abou-Jaoude of the University of Kentucky, is expected to be completed this year and will enroll five patients.
  • We initially are targeting a time period of three months,” said Dr. Paul Ashton, CEO of Inflammasome Therapeutics.

Dermavant Announces Positive Data from the ADORING Phase 3 Development Program in Atopic Dermatitis with VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

Retrieved on: 
Thursday, January 11, 2024

The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.

Key Points: 
  • The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.
  • In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application.
  • “Atopic dermatitis is a burdensome disease, especially for pediatric patients, the most frequently affected patient population.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.