CrannMed partners with leading Digital Research Organization, Meditrial to obtain “Breakthrough Device Designation” by the FDA for its innovative Knee Osteoarthritis Therapy
NEW YORK, May 13, 2021 (GLOBE NEWSWIRE) -- Meditrial Inc, a leading Global Digitally Driven Research Organization, is pleased to announce its successful collaboration with CrannMed Limited in supporting their objective to obtain a Breakthrough Device Designation by the U.S Food and Drug Administration for its Embosure Microspheres used to treat patients suffering from pain associated with Knee Osteoarthritis.
Knee Osteoarthritis is a degenerative disease and debilitating condition due to the progressive deterioration of joint function, resulting in diminished quality of life for the patient. CrannMed’s Embosure Microspheres are resorbable embolic particles designed to provide controlled, targeted, minimally-invasive embolization of the genicular artery as a novel treatment for blocking the tiny blood vessels that produce the swelling and restrictions in mobility.
The FDA’s Breakthrough Device Designation provides patients and healthcare providers timely access to medical devices by speeding up their development, assessment and review. For CrannMed this designation confirms the innovative and unique nature of the Embosure Microspheres and the positive impact the therapy is expected to have on patients suffering from knee ostheoarthitis. Dr. Monica Tocchi, founder and Chief Medical Officer of Meditrial Inc. stated, “The team and I are honored to be partners with CrannMed and are delighted we were able to make a meaningful contribution to their efforts on achieving the Breakthrough Device Designation. This novel device that addresses one of the most prevalent articular diseases in the western world, now has a high potential pathway for accelerated regulatory approval.” Steve Duryee, Meditrial’s Global COO added, “Its our intent to ensure CrannMed capitalizes on this opportunity to provide a solution for a leading cause of chronic disability and public health burden. With that in mind our attention has turned towards providing our regulatory insight and clinical expertise to ensure Liam and his team achieve market access and reimbursement in the shortest time frame possible.”
Liam Farrissey, CEO of CrannMed said, “We are pleased to have received the Breakthrough Designation for our Embosure Microspheres and appreciate the expertise that Meditrial provided throughout the process. Our energies are now focused on finalizing the pathway to gain market approval. Given Meditrial’s track record of success in partnering with firms like ours and the strategic contribution they have made to our organization, we are excited to continue our partnership as we tackle the next set of critical milestones.”
About CrannMed Limited:
CrannMed Limited, is focused on the development of a range of resorbable particles with resorption times ranging from hours to months. The company believes that this technology will unlock the potential of embolisation across a range of therapies. Based in Galway, Ireland, the CrannMed team has developed a strong clinical network of world leading embolization specialists and a growing portfolio of patents.
About Meditrial Inc:
Meditrial Inc headquartered in New York, with offices in Zurich, Rome, Berlin, and London, is a full-service digital research organization with a complete range of services spanning regulatory, clinical, quality and digital health solutions.
For more information, please visit: https://www.meditrial.net/
or contact Steve Duryee @ email@example.com
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