BioEnthesis
THE FIRST-OF-ITS-KIND BIPHASIC ALLOGRAFT FOR ROTATOR CUFF REPAIR
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PUBLICATIONS
CLINICAL CHALLENGE
650,000 rotator cuff repair procedures are performed every year, yet 30-60% of them result in retears. A variety of different factors contribute to this phenomenon, including:
Sparta Biopharma has delivered a solution in BioEnthesis, a biphasic interpositional cancellous allograft by:
The native biological health of the patient,
The anatomy of the inital tear and the post operative healing paradigm,
The varying surgical approaches utilized to repair the rotator cuff.
Enhancing the health of the injured tendon and providing a porous scaffold for endogenous biological factor migration,
Directly addressing the lack of enthesis recapitulation at the bone/soft tissue junction to enable more effective healing,
Providing a solution that fits seamlessly into various surgical repair techniques.
SCIENCE
Sparta Biopharma's patented Biphasoss process is what gives BioEnthesis its unique biphasic structure. While the entire graft is constituted of highly porous human cancellous bone, the Biphassos process preserves a thin, consistent layer of fully mineralized bone. This imparts BioEnthesis with both an intact porous, collagenous matrix that allows for soft tissue ingrowth and a highly calcified layer that promotes osseointegration.

Together, the result is a biphasic structure unlike any other allograft. Take a look below at the biphasic nature of BioEnthesis:
A contiguous, interconnective porous matrix that facilitates autologous bone marrow transportation from the decorticated humeral surface to the avascular tendon and mimics the anatomical transition from soft to rigid tissue.
Scanning electron microscopy (SEM) with backscatter electrons
Purpose-Built Design
Demineralized, highly porous collagenous bone that promotes soft tissue integration at the tendon-graft interface and a mineralized cancellous contact layer that stimulates osteointegration at the bone-graft interface within a single allograft embodiment.
Radiographic image of BioEnthesis with high-magnification detail Von Kossa stained Spurr section. Mineralized matrix at red arrow. demineralized matrix at black arrow.
Biphasic structure
BIOENTHESIS
Retains the structural and tactile characteristics of a fully demineralized allograft while maintaining its biphasic nature.
Engineered for arthroscopic repair
Fits seamlessly into surgical workflow; placed interpositionally between the decorticated humeral head and torn tendon(s) in, most commonly, a transosseous equivalent double row arthroscopic rotator cuff repair
Easily implanted through a 12mm soft cannula
Highly conformable allograft enables maximal apposition to anatomical contours
Uniform pore structure provides structural integrity for tissue fixation and manipulation
Lyophilized, terminally sterilied to device grade standards, stored at room temperature, shelf stable for 2 years.
Quickly hydrated in 15 minutes in sterile water, saline, or any other desired biological fluid(s).
Click on the graft to see video
SURGICAL TECHNIQUE
INSTRUCTIONS FOR USE
BioEnthesis is indicated to provide a matrix for the repair or reconstruction of the bone of the enthesis within the rotator cuff.
Indication for Use:
BioEnthesis is contraindicated for use in any patient in whom soft and hard tissue implants are contraindicated. This includes any pathology that would limit the blood supply and compromise healing, or evidence of a current infection. BioEnthesis is contraindicated where the allograft is intended as structural support in load-bearing bone, and articular cartilage surfaces.
Contraindications:
REIMBURSEMENT INFORMATION