Uppsala, August 17, 2023 – OssDsign AB (publ.) right now publicizes that the corporate has enrolled 200 sufferers within the multi-center, potential spinal fusion registry, PROPEL. The registry was initiated in March 2022, to assemble real-world information from sufferers who’ve been handled with OssDsign Catalyst.
“This necessary milestone displays our means to gather clinically related information and is a direct results of the excessive degree of curiosity from surgeons to proceed utilizing OssDsign Catalyst, leading to a rising variety of sufferers being included in PROPEL. The gathering of sturdy medical proof is a strategic precedence for us, with the intention to show OssDsign Catalyst’s effectiveness in real-world medical follow,” commented Morten Henneveld, CEO of OssDsign.
PROPEL is bridging the hole between the gadget’s efficiency in pre-market medical trials and its use in routine follow over time. The registry is an important step in OssDsign’s technique to gather medical proof of its nanosynthetic bone graft OssDsign Catalyst. Because the initiation of the PROPEL registry in 2022, clinics have progressively enrolled sufferers, with the target of evaluating the use and consequence of OssDsign Catalyst in real-world medical follow. The first endpoint of the research is measuring the speed of spinal fusion, utilizing pc tomography (CT) or radiography, 12 months postoperatively. Moreover, sufferers’ high quality of life, neurological operate, and the medical security profile of the spinal implant are recorded.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of wholesome bone tissue in spinal fusion surgical procedures. The graft consists of a proprietary nanocrystalline construction which is resorbed and changed by new and wholesome bone tissue. The product was launched within the U.S. in August 2021. The market clearance within the U.S. is predicated on preclinical outcomes that surpass what is often seen with different artificial bone grafts in probably the most demanding preclinical mannequin for spinal fusion – the Boden mannequin.
OssDsign continues to speed up a sturdy program of gathering medical proof anchored by PROPEL and the medical research TOP FUSION, by which affected person enrolment was accomplished in April 2022.
For additional data, please contact:
Morten Henneveld, CEO, OssDsign AB
Tel: +46 73 382 43 90, e mail: firstname.lastname@example.org
Erik Penser Financial institution AB is the corporate’s Licensed Adviser. Contact data: Erik Penser Financial institution AB, Field 7405, 103 91 Stockholm, Sweden, cellphone: +46 (0)8-463 80 00, e mail: email@example.com
OssDsign is a developer and international supplier of subsequent technology bone alternative merchandise. Primarily based on leading edge materials science, the corporate develops and markets merchandise that assist the physique’s personal therapeutic capabilities and thereby enhance the medical consequence in a variety of orthopedic areas with excessive medical wants. With a product portfolio consisting of patient-specific implants for cranial surgical procedures and an off-the-shelf artificial bone graft for spine surgical procedures, OssDsign give sufferers again the life they deserve. The corporate has a powerful business presence within the U.S., Europe and chosen Asian international locations. OssDsign’s share is traded on Nasdaq First North Development Market in Stockholm, Sweden.