Lyon and New York, October 25, 2016 - The MEDICREA Group (Alternext Paris: FR0004178572 - ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, announced today that the Company will implement a LIFETIME WARRANTY on its patient-specific UNiD™ technology. The warranty will cover all UNiD™ Thoracolumbar Rods, UNiD™ Cervical Rods and all associated MEDICREA components implanted in the United States from November 1, 2016.
Denys Sournac, President and CEO, stated, “Because of the overwhelmingly positive results obtained in all of the 950 plus UNiD™ patient-specific cases performed to date and our confidence in the science behind UNiD™ technology, MEDICREA is taking the extra step to warranty each patient-specific implanted construct for the duration of the patient’s life. This is a true testament to our belief that, by offering surgical planning services with a patient-specific device, MEDICREA is eliminating the inherent risks and associated costs to the healthcare system that are created by manually bending a rod during surgery.”
Mr Sournac continued, “While we know scientifically that sagittal alignment is linked to patient outcomes, our experience with UNiD™ has shown that applying the correct alignment to the rod, using proprietary digital analysis organization that we have developed, may also be directly linked to a reduction in surgical complications such as mechanical failures and revision rate – something that was previously only theorized.”
Currently, MEDICREA is the only company to propose a warranty on spinal implants used in posterior spinal fusions, a procedure that more than 409,000 patients suffering from back pain undergo each year in the US alone.(1) In complex spinal indications such as adult deformity, research shows that nearly 1 in 10 patients who have undergone spinal fusion experience symptomatic rod fracture.(2) This poses a significant cost to the patient and the healthcare system with the associated costs of readmission with reoperation totaling an average of $80,000, a 70% cost increase from initial treatment.(3) Further, these patients often require more than one revision surgery, with each subsequent intervention becoming more and more complex leading to a reported complication rate as high as 59%.(4)
The UNiD™ LIFETIME WARRANTY Program is offered as an affiliated benefit of the UNiD™ Lab Premier Service, which includes a real-time support team of biomechanical engineers supporting all pre-operative planning and post-operative analytical services. MEDICREA will extend this LIFETIME WARRANTY to all countries using UNiD™ technology, in order for patients and healthcare providers to receive the maximum benefit of the Company’s personalized services for complex spinal indications all over the world. The LIFETIME WARRANTY proposed will fully cover UNiD™ Lab services, patient-specific UNiD™ Rod replacement and all associated MEDICREA implant components required to treat any patient undergoing a revision surgery.
This announcement is released for the commencement of the North American Spine Society (NASS) Annual Meeting in Boston. The scientific event held from the 26th to the 29th of October is the largest of its kind bringing together the global community of spinal surgeons, industry and healthcare experts to present and exchange on the latest spinal research. MEDICREA will host a Solution Showcase in the NASS Theater on Thursday, October 27 at 12:30pm to present the early results showing improved alignment and patient outcomes using UNiD™ patient-specific planning and implant technology. The symposium is led by Dr. Andrew King of New Orleans, LA and Dr. Themistocles Protopsaltis of New York, NY and will feature MEDICREA’s innovative and growing portfolio of solutions for complex spine, including PASS OCT®, PASS LP® and LigaPASS®.
Interested parties are encouraged to visit MEDICREA at NASS booth #943 or contact the company for more details about the UNiD™ Lab Premier Service and UNiD™ LIFETIME WARRANTY Program.
(1) 2015 Thoracolumbar Procedures annually (409k). Millennium Research Group, Inc., “Traditional Thoracolumbar Implant Market, by Indication.”
(2) Smith JS, Shaffrey CI, Klineberg E, et al. Prospective multicenter assessment of risk factors for rod fracture following surgery for adult spinal deformity. J Neurosurg Spine 21:994–1003, 2014.
(3) McCarthy IM, Hostin RA, Ames CP, et al. Total hospital costs of surgical treatment for adult spinal deformity: an extended follow-up study. Spine J. 2014
(4) Cho SK, Bridwell KH, Lenke LG, et al. Comparative analysis of clinical outcome and complications in primary versus revision adult scoliosis surgery. Spine (Phila. Pa. 1976). 2012
About MEDICREA (www.medicrea.com)
MEDICREA specializes in the design, manufacture, and distribution of innovative proprietary technologies devoted exclusively to spinal surgery. Operating in a $10 billion market, MEDICREA operates with 150 employees, including 45 at its MEDICREA USA Corp. subsidiary based in New York City.
MEDICREA is the only company to offer personalized value-based healthcare solutions to the global complex spine market. The Company has driven innovation in Spine by focusing development on market-disrupting technologies focused on patient outcomes, including the growing UNiD™ Technology Platform of PatientSpecific Implants and Analytical Services, which received the first-ever FDA Clearance in November 2014 for a personalized spinal treatment modality.
MEDICREA has uniquely positioned itself outside of the traditional implant manufacturer’s role in order to engage with each market player as a collaborator, offering customized implants to patients, personalized services to doctors and immediate cost-savings to providers. By leveraging its proprietary software analysis tools with big data technologies, MEDICREA is well-placed to improve the efficacy of spinal care efficiency for all stakeholders in this market.
Connect with MEDICREA:
Denys Sournac, Founder, Chairman and CEO
Russell Ward for MEDICREA
Tel: +1 310 424 8356
Chief Financial Officer
Tel: +33 (0)4 72 01 87 87