Repair. Reconstruct.

introduCing

BioEnthesis

the first-of-its-kind
biphasic interpositional
allograFt FOR 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 ovine BioEnthesis allograft
No evidence of inflammatory response or gap formation
Rapid allograft resorption and integration into both bone and tendon
Evidence of Sharpey fiber formation
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
Images 3 and 6 show two locations of new bone formation and enthesis regeneration at different maturity stages (1.25X magnification).

Images 1, 2, 4, and 5 are enthesis sections that demonstrate the progression of Sharpey Fiber formation. As the fibers form, they progress from disorganized and randomly aligned to organized and uniformly aligned (10X magnification).
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 sterilized 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)

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