CS MEDICA A/S: Update on Clinical trials
CS MEDICA A/S (”CS MEDICA” or the ”Company”) announces that additional three clinical trials and several in-vitro tests have been initiated, and the Company hereby provides an update on the Company’s clinical trials and in-vitro test.
With CS MEDICA’s continual focus on regulatory compliance, further clinical trials and in-vitro test have been initiated to comply with the new stricter legislation MDR, which was set in force in 2017 and currently is in the transition phase from MDD to MDR.
Furthermore, the Company, our stakeholders, and current as future customers are relying on successfully performed clinical trials by the Company in order to be a trustful Company providing proven products with high efficacy and few-to-none adverse events (no side effects and no harm to the body of the patient).
Following clinical trials have been approved by the SRAMCH Institutional Ethics Committee, the recruitment has been initiated and the clinical trials are expected to be finalized during H1 2023:
CANNASEN® Pain Patch – An open Label single Arm Clinical Study to Evaluate the efficacy of CANNASEN Pain Patch for muscular or joint pain - Number of Subjects: 80, No. of Sites: 1 or 2
Primary objective is to study the efficacy of CANNASEN® Pain Patch by:
Subject Global Assessment (SGA)
Visual Analog Scale (VAS)
Duration of Pain relief -up to 24 hours
Secondary objectives are to check the ease of use of Pain Patch for not causing any problems in usual activities, physical, social, and emotional conditions by:
•WOMAC
•EQ-5D-5L QOL
•ROM
•Cooling effect (Check skin temperature on 1st and 2nd day)
CANNASEN® Nasal Spray Night against placebo: A double-blinded, randomized, placebo-controlled Clinical Study to Evaluate the efficacy of CANNASEN® Nasal Spray Night in patients with Insomnia. Number of Subjects: 120, No. of Sites: 1 or 2
The primary objective is to study the efficacy of CANNASEN® Nasal Sleep Spray in Insomnia
The secondary objectives are to evaluate the Quality-of-life changes with CANNASEN® Nasal Sleep Spray. To study the efficacy of free breathing, ensuring a clean nasal pathway.
Additional test: Lab based Sleep study (Test v/s Melatonin)
CANNASEN® Protective Nasal Gel: A single arm Study on 60 subjects in a high-risk zone of pollens and other particles in the environment.
The primary objective is to study the efficacy of CANNASEN® Protective Nasal Gel in Pollen and other particles in the environment.
The secondary objectives are to evaluate the Quality-of-life changes with CANNASEN® Protective Nasal Gel.
Initiated In-vitro test
The Company’s CANNASEN® Wound Gel has been developed for acute wounds and up to 2nd deep-degree burns. To perform a clinical trial on CANNASEN® Wound Gel the clinical trial institute needs to recruit 60 people with similar acute wounds or 2nd degree burns to perform a clinical trial, this is very difficult.
Therefore, the Company and the Clinical trial institute have evaluated the possibility to perform a clinical trial on chronic wounds, where it is easier to recruit people for the trial. The result of this evaluation was primarily to perform an in-vitro test to show that the CANNASEN® Wound Gel has accelerated healing ability on both burns and rashes, anti-inflammatory effect, and antimicrobial effect, together with no harm to the body.
Chronic wound
A chronic wound often remains in the inflammatory phase for an extended period (a chronic wound is defined as a wound that takes longer than usual to heal, often due to underlying medical conditions or external factors such as pressure or trauma). Therefore, the Company has initiated the in-vitro test with a focus on antiinflammation, accelerated healing, and no harm to the body.
The CANNASEN® Wound Gel has been designed to perform the in-vitro test on the following parameters:
- Cytotoxicity - Wound gel (2 samples)
- Skin Sensitization - Wound gel (2 samples)
- Skin Irritation - Wound gel (2 samples)
- Anti-Inflammatory – Wound gel (2 samples)
- Anti-Microbial/ Bacterial – Wound gel (2 samples)
- Healing Activity (Burn UV rays)- Wound gel (2 samples)
- Rash Wound healing- Wound gel (2 samples)
before a clinical trial on chronic wounds can and will be performed.
The following clinical trials have been successfully completed:
CANNASEN® Arthritis Gel versus Placebo – the conclusion of the study:
On the 23th of June 2022 we released the conclusion of the study as follows; the WOMAC Index and VAS score have significantly reduced in the NGA-01 arm (CANNASEN® Arthritis Gel). All the major attributes like pain, swelling, stiffness, tenderness, crepitus, and pain during flexion have shown improvement during the treatment. Both Subject’s and Physician’s Global Assessments have shown a reduction in the disease intensity on one hand, and EQ-5D has shown betterment in the overall life quality of the subjects. The Treatment was found well tolerable, and no adverse events were reported during the study. The Pain indices, assessments, and life quality questionnaires together confirm that NGA-01 (CANNASEN® Arthritis Gel) is effective in the treatment of osteoarthritis with joint pain, along with improving the overall quality of life.
CANNASEN® Arthritis Gel & CANNASEN® ARTH Supplement in combination against placebo:
On the 12th of July 2022 we released the conclusion of the study:
The WOMAC Index and VAS score has significantly reduced in the Test arm (active product test) with a combination of CANNASEN® Arthritis Gel & CANNASEN® ARTH Supplement (NGA-01 gel and NSA- 01 capsule). All the major attributes like pain, stiffness, tenderness, crepitus, and pain during flexion have shown improvement during the treatment. Both Subject’s and Physician’s Global Assessments (SGA) have shown a reduction in the disease intensity on one hand, and EQ-5D has shown betterment in the overall life quality of the subjects. There was a reduction observed in the Hs-CRP & ESR values and the change was significant for ESR values. The Treatment was found well tolerable, and no AE (Adverse Events) were reported during the study. The Pain indices, assessments, and life quality questionnaires together confirm that the combination of CANNASEN® Arthritis Gel & CANNASEN® ARTH Supplement (NGA-01 gel and NSA-01 capsule) is effective in the treatment of Osteoarthritis with joint pain, along with improving the overall quality of life.
CANNASEN® Psoriasis Gel against placebo – the conclusion of the study:
On the 29th of August 2022 we released the final efficacy analysis in the clinical trial of CANNASEN® Psoriasis Gel (NGP-01) which met all the trial’s primary and secondary efficacy endpoints. Analysis of the data confirms that CANNASEN® Psoriasis Gel (NGP-01) has efficacy in reducing skin pain, Itch, redness, scaling, and the reduction of psoriasis attack in participants with mild-to-moderate psoriasis.
The clinical trial data show that the CANNASEN® Psoriasis Gel (NGP-01) shows no adverse effects and is well tolerated and safe. No negative issues have been reported by the participants and all the vital signs were found normal at all the visits.
For more information about CS MEDICA, please contact:
Lone Henriksen, CEO
Phone: + (45) 71 20 30 47
Email: lh@cs-medica.com
Website: https://www.cs-medica.com/
CS MEDICA A/S is a Danish-based MedTech company committed to improving people's lives with products that make a difference. We combine science, nature, and passion to deliver innovative alternatives with high efficacy and bioavailability to patients. From autoimmune to stress therapies, we aim to transform healthcare with more effective treatments.
We research, develop, manufacture, commercialize and brand over-the-counter (OTC) products under pharmaceutical legislation. Currently, 21 products with cannabidiol aimed at autoimmune and stress-related diseases have been developed. The first products reached Danish stores in 2020, and now 9 products are available on the European market at more than 500 points of sale. Another 12 products will be launched before the end of 2024, with 11 patent-pending products. The product line surpasses competing products on the market by being located at the intersection of natural products, science, and cannabinoid technology while being registered under pharmaceutical legislation.
CS MEDICA was recognized earlier this year as a company of Europe's top 10 MedTech companies at European Lifestars Awards as the company both Research & Develop, Manufacture, Distribute and Brand life-supporting medical technologies. The additional research and innovation to develop cutting-edge CBD technologies allow us to lead in CBD medical advancements.
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