Repair. Reconstruct.

introduCing

BioEnthesis

the first-of-its-kind
biphasic interpositional
allographt rot rotator cuff repair

Clinical Challenge

650,000 rotator cuffs are repaired every year. 30-60% of them result in retears.

FACTORS IMPACTING RCR SUCCESS RATES

BIOENTHESIS:

Patient health

Provides scaffold for endogenous
biologic migration

Tear anatomy

Directly addresses enthesis
recapitulation

Surgical technique

Fits seamlessly into any surgical technique

Science

Purpose-Built Design

Scanning electron microscopy (SEM) with backscatter electrons

An 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.

Biphasic structure

Radiographic image of BioEnthesis with high-magnification detail Von Kossa stained Spurr section. Mineralized matrix at red arrow. demineralized matrix at black arrow.

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.

BioEnthesis chronic RCR sheep study at CSU

CONTROL

6 WEEKS, 1.25X MAG

TREATMENT (BIOENTHESIS)

12 WEEKS, 10X MAG

1 - Neovascularized tendon
2 - Early-stage enthesis

Confirmed safety of ovineBioEnthesis allograft

No evidence of inflammatory response or gap formation

Rapid allograft resorption andintegration into both bone and tendon

Evidence of Sharpey fiberformation

3- Enthesophytes
4 - Enthesis-penetrative tendon
5 - Newly formed bone

Sharpey Fiber Formation and Enthesis Restoration

IMAGES WERE CAPTURED FROM A TREATMENT ANIMAL AT 12 WEEKS POST-OP

Low magnification images 1.25X, images 3, 6 show two locations of new bone formation and enthesis regeneration at slightly different maturity stages.

High magnification images 10X, images 1, 2, 4, 5 were taken from two locations within the regenerating enthesis that show the progression of Sharpey Fiber formation from randomly aligned and disorganized to uniformly aligned and highly organized.

BRIGHT FIELD (10X)

POLARIZED LIGHT (10X)

1.25X

BRIGHT FIELD (10X)

POLARIZED LIGHT (10X)

1.25X

*Animal study outcomes are not necessarily predictive of human outcomes.

Engineered for arthroscopic repair

Easily implanted through standard arthroscopic 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)

surgucal technique

Instruction for Use

Indication for Use:

BioEnthesis is indicated to provide a matrix for the repair or reconstruction of the bone of the enthesis within the rotator cuff.

Contraindications:

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.

Full IFU

Reimbursement Information

For reimbursement guide, please click here

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Product Demo Lab