LYON & NEW YORK--(BUSINESS WIRE)--The MEDICREA® Group (Euronext Growth Paris: FR0004178572 – ALMED; OTCQX Best Market – MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD ASI™ (Adaptive Spine Intelligence) proprietary software platform, services and technologies, announced today that it has extended the FDA 510(k) clearance of its proprietary surgical planning software, UNiD HUB™, to integrate a complete database of the Company’s implant portfolio to directly simulate and select implants during surgical planning provided for surgery, enabling significant improvements in surgical efficiency.
Denys SOURNAC, President and Chief Executive Officer, stated, “In addition to supporting the clinical workflow, assisting surgeons in building their surgical plan and providing patient specific implants, the UNiD ASI™ service platform provides radically improved implant logistics in the operating room as every implant can be planned before the surgery allowing the hospital and surgical staff to focus on the interoperative care rather than excess of inventory. Currently, manufacturers are providing a standard kit with up to 450 screws when only 2 are used per instrumented vertebrae. By receiving FDA-clearance to integrate Medicrea’s complete implant database within our software, we are uniquely positioned to reform this antiquated delivery model by optimizing the implants provided for each surgery, with novel device selection services to deliver patient-specific implants, including the only FDA-cleared patient-specific cage on the market.”
Healthcare reform is built upon the premise that costs can be reduced while improving clinical outcomes. The cost of reprocessing and sterilization of a spine system increases as the number of trays which comprise that set increases. Similarly, the time and effort required to complete reprocessing and sterilization can impact the turnaround between cases. The minimization of a system footprint provides hospitals with an opportunity to reduce costs associated with inventory and sterilization. Adding implant selection to the growing number of services associated with MEDICREA®’s UNiD™ technology enables the Company to optimize the implants provided for each surgery, meeting the market needs.
Denys SOURNAC continues “In the situation of a set being loaned for a specific surgery, less than 10% of the inventory shipped is implanted in the patient. By pre-operatively measuring the patient’s pedicles diameter and length, we were able to reduce by 70% the amount of inventory being shipped during the beta phase. Similarly, in hospitals where inventory is consigned, we were able to optimize the number of implants and observed a reduction of inventory of 80% during the beta phase. These results are very promising, and MEDICREA® anticipates even greater reductions by the end of the beta phase.”
This recent FDA clearance makes MEDICREA® the only manufacturer able to streamline inventory required to operate as well as provide patient-specific devices, through intelligent pre-operative surgical planning. It also enables MEDICREA®’s UNiD LAB™ team of biomedical engineers to more efficiently generate comprehensive surgical plans, using outcome-centered predictive modeling algorithms to optimize surgical strategy. These documented UNID™ surgical plans also allow the operating room staff to clearly anticipate when each implant will be needed by the surgeon. This is a critical combination as it streamlines the OR workflow with precise pre-selected implants and alignment of staff to the patient specific surgical plan and as it makes the surgery safer for the patient by reducing the chances for errors.
The integration of an implant database with MEDICREA®’s UNiD HUB™ enables the Company to perform a comprehensive patient-specific preoperative planning that will more completely link implant selection with post-operative analyses and increase the robustness and efficiency of MEDICREA®’s proprietary predictive model. By substantially increasing the clinical and logistical data integrated into UNiD ASI™ (Adaptive Spine Intelligence), MEDICREA® continues to disrupt spine industry norms and extends its leadership of the digital revolution in spine care.
Denys SOURNAC to conclude: “The entire spine industry is facing a major and structural problem with a working capital requirement reaching 20% and 25% of turnover due to the very high inventory weight in their activity, between kits consigned in hospitals, products loaned to distributors and agents, and implants in logistic centers to ensure replenishment. This model is no longer sustainable as it generates high costs and immobilizes incredible levels of cash.”
About MEDICREA® (www.medicrea.com)
Through the lens of predictive medicine, MEDICREA® leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.
Operating in a $10 billion marketplace, MEDICREA® is a Small and Medium sized Enterprise (SME) with 200 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D- printed titanium patient-specific implants.
For further information, please visit: medicrea.com.
MEDICREA® is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
MEDICREA® is traded on
OTCQX Best Market