ABOUTMOIRAI ORTHOPAEDICS
Moirai Orthopaedics has developed an advanced, minimally-invasive surgical Pyrocarbon Implant Replacement (PIR) System for the treatment of degenerative and arthritic knee disorders.

The PIR is specifically intended to treat symptomatic cartilage defects of the anterior or central medial femoral condyle and the patello-femoral joint. The pyrocarbon articular resurfacing implant is a single component that consists of an anatomic articular surface cap with bone-contacting surfaces coated with hydroxylapatite (HA) for fixation.





CLINICALCHALLENGES
Osteochondral and chondral defects occur frequently – not only in young athletes, but also in older and more sedentary individuals. Articular cartilage defects of the knee are common, painful, and predispose patients to debilitating osteoarthritis. Making matters worse, avascular cartilage tissue has an extremely low capacity for repair.

The current treatment options, including regenerative and replacement treatments, are suitable for only a range of individuals. Active, middle-aged patients are left to opt for procedures that may not be suitable for their defects, often leading to poor outcomes.




PRODUCTOVERVIEW
The PIR is intended for the treatment of symptomatic cartilage defects of the anterior or central medial femoral condyle (MFC) in patients who have had an inadequate response to prior conservative treatment or previous arthroscopic debridement and lavage, have failed or are not candidates for cartilage regeneration techniques.

The PIR implant is a single component that consists of an articular surface cap on a tapered and grooved stem. The symmetric or oval articular cap restores the articular surface of a chondral or osteochondral defect of the anterior or central medial femoral condyle. The stem supports the articular surface cap and is press fit into the prepared subchondral and cancellous bone to provide stability and fixation to bone.






The PIR is designed to restore the articular surface of a chondral or osteochondral lesion of the medial femoral condyle (MFC) or patellofemoral joint (PFG) in order to relieve pain and restore function, while preserving as much host bone and intact cartilage as possible. The implantation procedure can be performed in an out-patient setting and utilizes a complete instrument kit, which includes alignment guides, cutters, and trials to ensure optimal implant size, orientation, and placement.



SURGICALTECHNIQUE
The PIR Medial Femoral Condyle (PIR-MFC) implants are designed to treat articular cartilage defects (1 – 5 cm2) of the anterior or central medial femoral condyle. The PIR-MFC consists of 11 implants and treats over 95% of expected defect sizes. It is implanted using a simple surgical technique in four (symmetric implant) or eight steps (oval implant).

The PIR Patellofemoral Groove (PIR-PFG) implants are designed to treat articular cartilage defects of the patellofemoral groove. The system includes 10 implants with either a 20mm or 25mm cap diameter, a 1mm or 3mm offset, and a trochlear groove angle of 125°, 135°, or 145° and contains an optional polyethylene patellar component. The system is implanted using a simple 5-step surgical technique.


 

Size Catalog No.
10 100-IMP-1000
12.5 100-IMP-1250
15 100-IMP-1500
17.5 100-IMP-1750
20 100-IMP-2000

 
 





 

Size Catalog No.
15x20 150-IMP-1520
15x25 150-IMP-1525
17x22 150-IMP-1722
17x27 150-IMP-1727
20x25 150-IMP-2025
20x30 150-IMP-2030

 
 









 

Size Catalog No.
20.125.1 300-IMP-20.125.1
20.125.3 300-IMP-20.125.3
20.135.1 300-IMP-20.135.1
20.135.3 300-IMP-20.135.3
20.145.1 300-IMP-20.145.1
20.145.3 300-IMP-20.145.3
25.135.1 300-IMP-25.135.1
25.135.3 300-IMP-25.135.3
25.145.1 300-IMP-25.145.1
25.145.3 300-IMP-25.145.3

 
 






 
 
 




PRESSRELEASES
PIR Knee System Receives FDA Approval to Initiate Clinical Study
Metairie, LA – April 5, 2015 – Moirai Orthopaedics, LLC, an orthopaedic implant development company based in Metairie, Louisiana, is pleased to announce it has received approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to initiate clinical study of the company’s multi-patented Pyrocarbon Implant Replacement (PIR) System. The PIR System previously received CE mark approval in August 2013. The PIR System was developed in conjunction with the Fellowship of Orthopaedic Researchers.

The purpose of the clinical study is to evaluate the safety and effectiveness of the PIR System in the treatment of articular cartilage defects (Outerbridge Grade III or IV) of the medial femoral condyle compared to control treatment. The targeted indication is for the treatment of symptomatic cartilage defects of the anterior or central medial femoral condyle in patients who have had an inadequate response to prior conservative treatment or previous arthroscopic debridement and lavage.

Over four million knee arthroscopies are performed annually worldwide, with approximately 60% demonstrating the presence of focal cartilage defects located primarily on the medial femoral condyle. The PIR System is designed for patients too young for a total knee replacement (TKR) who are either poor candidates for or those unable or unwilling to devote the necessary rehabilitation time for cartilage regenerative procedures.

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Moirai Orthopaedics expects to begin a clinical trial of the PIR System in the summer of 2015, with the first implantations performed by Dr. Deryk G. Jones, Section Head of Sports Medicine at the Ochsner Sports Medicine Institute in New Orleans. Dr. Jones commented: “The PIR System addresses an important unmet clinical need and we have been anxiously awaiting the start of the study.” The early interventional cartilage replacement PIR device is expected to compete in both the $4 billion arthroscopy market and the $7 billion TKR market. Samantha L. Salkeld, M.S., Director of Business Development at Moirai, indicated that the company has the ability to fund the clinical study on its own but is also currently in discussions with parties regarding acquisition of the PIR technology, and would seriously consider this, should an appropriate opportunity arise.

The PIR System is a single-component implant, fabricated from On-X pyrolytic carbon (On-X Life Technologies, Inc., Austin, Texas), with hydroxyapatite coating on all bone interfacing surfaces. The implant is placed as a hemi-arthroplasty through a minimally invasive surgical approach and articulates with the native tibia cartilage. The unique wear properties of the PIR System’s pyrolytic carbon material are expected to extend the functional life of the implant, making it appealing to both surgeons and patients. In addition, unlike conventional knee replacement procedures, the tissue-sparing PIR System replaces only the damaged cartilage, while retaining healthy tissue.

“Pyrocarbon is the ideal biomaterial for this clinical application,” stated Stephen D. Cook, Ph.D., Chief Scientist at the Fellowship of Orthopaedic Researchers and developer of the PIR System. “In addition to its exceptional mechanical characteristics, including stiffness similar to bone, it has superior wear properties when articulating with native cartilage compared to other orthopaedic biomaterials in preclinical studies.”



Unique New PIR Knee System Receives CE Mark
Metairie, LA – August 23, 2013 – Moirai Orthopaedics, LLC, is pleased to announce it has received CE mark approval for its new Pyrocarbon Implant Replacement (PIR) System.

The PIR System, developed in conjunction with the not-for-profit Fellowship of Orthopaedic Researchers, is intended to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee. Greater than one million knee arthroscopies are performed annually in the United States, and at least an equal number worldwide, with over 60% demonstrating the presence of focal cartilage defects.

Moirai Orthopaedics expects to launch the product in the fourth quarter of 2013, with initial implantations in Australia and England. The company is currently pursuing clearance of its IDE application through the FDA, and expects to initiate a clinical trial of the PIR System in the United States in the near term. This early interventional cartilage replacement device will compete in both the $4 billion arthroscopy market and the $7 billion TKR market. Samantha L. Salkeld, M.S., Director of Business Development at Moirai, indicated that the company has had preliminary discussions with interested parties regarding acquisition of the PIR technology, and would consider this, should an appropriate opportunity arise.

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The PIR System is a one-piece implant, fabricated from On-X pyrolytic carbon (On-X Life Technologies, Inc., Austin, Texas), with hydroxyapatite coating on all bone interfacing surfaces. The unique wear properties of the System’s pyrolitic carbon material can extend the functional life of the implant, making it appealing to both surgeons and patients. And, unlike conventional knee replacement procedures, the tissue sparing PIR System replaces only the damaged cartilage, while retaining healthy tissue. The implant is placed as a hemi-arthroplasty, through a minimally invasive surgical approach, and articulates with the native tibia cartilage.

“Pyrocarbon is the ideal biomaterial for this clinical application,” stated Stephen D. Cook, Ph.D., former Tulane University Professor and current Chief Scientist at the Fellowship of Orthopaedic Researchers, the developers of the PIR technology. “In addition to its exceptional mechanical characteristics, including a stiffness similar to bone, it has superior wear properties when articulating with native cartilage compared to the Cobalt Chromium alloy material utilized in competitive products,” Dr. Cook added.




CONTACT Moirai Orthopaedics

Moirai Orthopaedics, LLC, is a privately-held company with research and development facilities in Metairie, Louisiana. Our company is dedicated to developing innovative, quality solutions designed to treat serious orthopaedic medical conditions, with improved patient outcomes.

(+1) 504.309.9845
info@moiraiortho.com

320 Hammond Highway, Suite 406
Metairie, LA 70005