21 February 2018
Positive Eight-Year Results of ChondroMimetic® Cartilage Repair Clinical Study
Study confirms sustained long-term repair of knee cartilage and improved clinical symptoms
Collagen Solutions Plc (AIM: COS), the developer and manufacturer of medical grade collagen and tissue components for use in regenerative medicine, including orthopaedic, dental, wound care, and cardiovascular applications, announces successful results from an eight-year extension clinical study of 15 patients who received ChondroMimetic® implants as an osteochondral scaffold for the repair of cartilage defects in the knee. These positive results have now allowed Collagen Solutions to submit an initial submission for CE Mark.
- Quantitative 3D MRI analysis in the long-term study concluded that cartilage regeneration in the treated defects had reached a level and structural quality nearly identical to native cartilage.
- Improvement in patient clinical symptoms, including pain, function and activity level after treatment sustained over the eight-year period.
- The 'Knee Injury and Osteoarthritis Outcome Score' (KOOS), a well-known and validated patient reported outcome measure, showed outcomes following the ChondroMimetic® procedure were equal to or better than KOOS scores reported in the literature for substantially more expensive two-stage cartilage repair technologies.
Backed by these results ChondroMimetic® is positioned as the only minimally invasive, cost-effective, single-stage treatment that fits within surgeons' current surgical techniques for smaller cartilage defects with eight-year clinical effectiveness and repair quality data.
There are over 1 million surgical procedures in the U.S. and Europe performed each year to treat cartilage defects of the knee1, yet current treatments have not demonstrated sustainable efficacy beyond five years post-treatment and/or have limited adoption due to cost and complexity. The current indication target for ChondroMimetic® is positioned to address at least 30%-40% of these surgeries once adopted world -wide.
The results of the ChondroMimetic® eight-year follow-up study demonstrated favorable improvement for clinical outcomes of pain, function and activity level. Specifically, patient reported scores from the "Modified Cincinnati Rating System" improved from 64.4 pre-operatively to 80.9, which was a highly statistically significant change (p=0.0065) and represented an 8-year overall grading of 'excellent'. Further the study reported KOOS scores for 5 subscales that were equal to or better than KOOS values reported in the literature for more expensive two-stage cartilage repair technologies (Saris AJSM 2008 and Saris AJSM 2014 respectively).
Advanced quantitative, 3D MRI analysis examined the tissue within the ChondroMimetic®-treated defects and found improved cartilage volume and tissue quality that was sustained through the 8-year follow-up. The extent of total defect filling was reported as an average of 95.1%, and repair tissue mean T2 relaxation time (a relative measure of tissue structure) was 52.5 ms, compared to 52.3 ms for the surrounding native cartilage in the same knees. These results demonstrate near complete filling of defects and regeneration of high-quality cartilage nearly indistinguishable from native cartilage.
Commenting on these clinical study results, Dr. László Hangody, orthopedic surgeon and the Principal Investigator for the study said: "Based on our first-hand clinical experience with ChondroMimetic® and these new results confirming the sustainability of both cartilage regeneration and the improvement in patient outcomes, it is my firm belief that this scaffold has an important place in the treatment of focal chondral lesions as an alternative to microfracture." Dr. Alan Getgood, orthopedic surgeon involved with ChondroMimetic's® early development, also commented: "The long term quantitative MRI data of cartilage repair volume and tissue quality in patients who were treated with ChondroMimetic® are extremely attractive. This is consistent with the previously performed animal studies which showed a 25% improvement in cartilage repair over controls."
The Company has made a presentation available regarding this study with further details on its website:
In December 2017, Collagen Solutions announced that it signed a license and distribution agreement with a South Korean industrial partner. The Company is in active discussions with potential multi-national partners and distributors, in anticipation of a European launch following CE Mark approval.
European regulatory clearance next steps
Collagen Solutions has started the submission process to re-establish the CE Mark for ChondroMimetic®. Following finalisation of the clinical study report, supplemental data will be submitted to complete the submission and support CE Mark approval, targeted for the second half of 2018.
Commenting on these positive results, Jamal Rushdy, CEO said: "This compelling data is a significant achievement in the decades-long effort by clinicians and scientists to develop a cost-effective and clinically effective treatment for these types of cartilage defects. We have illustrated the commercial opportunities with the announcement of an agreement with our South Korean partner in December last year. We look forward to announcing further key milestones including the granting of the CE Mark over the next few months. We are excited by ChondroMimetic's® progress and believe that Collagen Solutions is now in a period of solid progression which will provide future sustainable revenue generation."
Investor evening on 26 February 2018
As recently announced, on Monday 26 February Jamal Rushdy, CEO, will give an update to investors on ChondroMimetic® and in particular the significance of the most recent clinical data compared to current competitive procedures. Jamal will also summarise the key milestones expected this year for both ChondroMimetric® and the Company's core business activities. This event will also allow investors to meet Collagen Solutions' new CFO, Hilary Spence. The presentation will be filmed and the video will be available on the Company's website shortly afterwards at: http://ir.collagensolutions.com/content/investors/presentations.asp. For more information on the event please contact email@example.com or firstname.lastname@example.org.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014
|Collagen Solutions Plc||Tel: 07721 413 496 or email@example.com|
|Jamal Rushdy, Chief Executive Officer|
|Hilary Spence, Chief Financial Officer|
|Lisa Baderoon (Head of Investor Relations)|
|Cenkos Securities plc (Nominated Adviser and Broker)||Tel: 0207 397 8900|
|Walbrook PR||Tel: 020 7933 8780 or firstname.lastname@example.org|
|Anna Dunphy||Mob: 07900 608 002|
About Collagen Solutions:
Collagen Solutions Plc is a global supplier, developer, and manufacturer of medical grade collagen, tissues, and related medical devices and components for use in regenerative medicine, medical devices and in-vitro diagnostics and research. The Company is also expanding its range of biomaterials-based finished medical devices based on its internal and acquired intellectual property for commercialisation with partners via licensing and distribution arrangements, including ChondroMimetic®. The Company's products are used in a wide variety of applications including orthopaedics, cardiovascular, dental, plastic surgery, wound healing, neurology and urology.
For more information go to: www.collagensolutions.com