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Press Kit

Press Release


 

Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence

 


“‘It is our belief that data science and analytics are critical components of improved patient outcomes and efficiencies. For that reason, Medicrea has stepped into a space unoccupied by traditional device manufacturers: Software development and Artificial Intelligence,’ stated Denys Sournac, President and CEO of Medicrea. ‘The UNiD™ HUB represents Medicrea’s ability to lead the Spine industry with breakthrough innovations by offering a unique forward-thinking and holistic approach to personalized spinal surgery.’”

 

Lyon and New York–(BUSINESS WIRE) The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received 510(k) Clearance from the Food & Drug Administration for UNiD™ HUB, a data-driven digital portal for the Company’s Adaptive Spine Intelligence.


“It is our belief that data science and analytics are critical components of improved patient outcomes and efficiencies. For that reason, Medicrea has stepped into a space unoccupied by traditional device manufacturers: Software development and Artificial Intelligence,” stated Denys Sournac, President and CEO of Medicrea. “The UNiD™ HUB represents Medicrea’s ability to lead the Spine industry with breakthrough innovations by offering a unique forward-thinking and holistic approach to personalized spinal surgery.”

 

The UNiD™ HUB is designed to support the surgeon workflow, identify tendencies and correlations and build predictive modeling to drive intelligent strategic decisions and create personalized implant solutions for surgery. The UNiD™ HUB software also serves to enhance the existing proprietary IT utilized by Medicrea’s UNiD™ ASI platform for digital surgical planning to create a seamless communication channel between the Company’s UNiD™ LAB biomedical engineers and Surgeon users to deliver UNiD™ TEK, patient-specific spinal implants manufactured by Medicrea through proprietary rod bending and 3D printing techniques.

 

The digital communication portal opened with the introduction of UNiD™ HUB instantly creates a sticky, user-friendly environment for surgeons to track and manage their open cases in both snapshot and detailed views, access their complete history with post-operative analyses and dialogue with a dedicated biomedical engineer in real time. Future functionalities will become available alongside the software’s wide release planned in October of 2017, for Eurospine in Dublin, Ireland on the 11-13 October and at the annual meeting of the North American Spine Society, held 25-28 October in Orlando, Florida.

 

Mr. Sournac continued, “As a media tool for surgeons, we have received very positive feedback from our UNiD™ ASI customers who have seen beta versions of the software and we are now ready to make the UNiD™ HUB digital portal immediately available to them. The software integrates well with their clinical habits and enhances their experience with UNiD™ ASI technology.” Mr. Sournac added, “This new generation of software will be more than a communication tool for surgeons – It will grant surgeons access to the same data analytics and machine learning technology that is curated by our data scientists to use the UNiD™ HUB as an unparalleled research engine and networking platform.”

 

UNiD™ HUB has been developed in desktop and mobile applications and is accessible from medical offices as well as on the go. For a first look at the UNiD™ HUB, a video preview is available for viewing here.

 

About Medicrea (www.medicrea.com)

 

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 175 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

 

By leveraging its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

 

For further information, please visit: medicrea.com.


Connect With Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Denys Sournac
Founder, Chairman and CEO
dsournac@medicrea.com

Fabrice Kilfiger
Chief Financial Officer
fkilfiger@medicrea.com
Tel: +33 (0)4 72 01 87 87

 

MEDICREA is listed on EURONEXT  Growth Paris
ISIN: FR 0004178572 – Ticker: ALMED
###

 

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Lifetime Warranty


 

Medicrea Launches LIFETIME WARRANTY for its Patient-Specific UNiD™ Constructs at the 2016 Annual Meeting of the North American Spine Society (NASS)

 


“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.'”

 

Lyon and New York–(BUSINESS WIRE)– The Medicrea® Group (Euronext Growth 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.”

 

rod-select

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)

 

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“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.

 

References:
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)

 

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 175 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

 

By leveraging its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

 

For further information, please visit: medicrea.com.

 

Connect With Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Denys Sournac
Founder, Chairman and CEO
dsournac@medicrea.com

Fabrice Kilfiger
Chief Financial Officer
fkilfiger@medicrea.com
Tel: +33 (0)4 72 01 87 87

 

MEDICREA is listed on EURONEXT  Growth Paris
ISIN: FR 0004178572 – Ticker: ALMED
###

 

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