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Dramatically improving chronic knee pain from osteoarthritis using an active steering telescopic microcatheter device in conjunction with a new ultra-low friction hydrophilic coating

Periodic Reporting for period 1 - ADDEGE (Dramatically improving chronic knee pain from osteoarthritis using an active steering telescopic microcatheter device in conjunction with a new ultra-low friction hydrophilic coating)

Reporting period: 2019-08-01 to 2019-12-31

Chronic knee pain from knee osteoarthritis (OA) is prevalent in 12% of the global population over the age of 60, 9.6% are men and 18% are women. Knee. OA results in a loss of mobility and debilitating pain in those effected. It can ultimately lead to invasive knee replacement or reconstruction surgery. Approximately 27 million US adults and more than 32 million EU adults are estimated to have clinical knee OA defined on the basis of symptoms and physical findings. Prevalence of OA increases with age; 13.9% of adults age 25 and older have clinical OA of at least one joint, while 33.6% of adults age 65 and older have OA. It is responsible for more than 6 million steroid and non-steroid based knee injections globally each year. It is among the top three reasons, globally, for both opioid and nonsteroidal anti-inflammatory drug (NSAID) prescriptions. In the US alone more than 16,000 annual NSAID-related deaths in arthritis patients have been reported whereas >100,000 people are hospitalized annually for NSAID-related GI bleeding.
Given the well documented economic benefit that comes with restored mobility in patients, the negative side effects of current drug treatments (addiction for opioids and gastrointestinal complications for NSAIDs), the expense and recovery time associated with surgery, and the high ongoing cost of drug therapy, a new treatment paradigm for osteoarthritis is clearly needed.

We, CrannMed Ltd, are developing a unique solution to revolutionise the genicular artery embolisation (GAE) treatment. Our approach involves two key innovations combined to treat chronic knee pain from osteoarthritis
1. two-stage delivery system consisting of an access and delivery catheter, and
2. a bioresorbable embolic particles which completely reabsorbs back into the body within 7 days.
During the course of project, we have conducted the following activities
1- Development of marketing and commercialisation strategy- Market segmentation and key territories of growth defined with prioritised action plan for full commercialisation strategy

2- Updating strategy and plan for operation, product development, technical development, regulatory, and reimbursement. Financial plan with 5-year projections. Establishment of key strategic relationships for business development

3- EIC project plan agreed by CrannMed leadership team including high-level Gantt, PERT and budget

4- Updated Manufacturing specification and risk register. A technical specification to facilitate the creation of commercial manufacturing plan.

5- Recruitment of partners for technical development and end user validation engaged for development and validation work

6- Updated and implemented the IP strategy
Current catheter technology for embolisation relies almost exclusively on 20-year-old technology where guidewires, microcatheter and guide sheaths are made with a fixed curve on the distal end. These curved end catheters are then manipulated through various bifurcations by turning and twisting the catheter and wire to align the catheter tip with the direction of travel. It requires a significant amount of physician skill and breaks down the further into the body the catheters are advanced. Smaller catheters also perform poorly due to their reduced torque performance and ability to maintain their preformed shapes. Interventional radiologists often struggle for 3-4hrs to manipulate catheters in difficult anatomy. As a consequence, this technology is particularly unsuited to the small distal and tortuous vessels we see in GAE (< 1mm and the smallest to be embolized in the human body).
Osteoarthritis has not seen any effective new treatments in the last 20 years and similarly embolisation catheters have not seen any new technology in the same time period. Our innovation will allow interventional radiologists to safely operate deeper in the anatomy and treat arteries significantly smaller than those currently treated. Compared to currently available treatments for OA, GAE offers dramatic pain reduction in a minimally invasive solution (preferable to the surgical state-of-the-art) with a short recovery time and significant cost savings for stakeholders.
knee osteoarthritis