The future of tendon and ligament healing

Introducing the BioBrace™ Implant

The BioBrace™ implant is an innovative bioinductive scaffold that is intended to reinforce soft tissue where weakness exists, and promote soft tissue healing. The BioBrace is cleared by the FDA in K203267

BioBrace is highly differentiated

Unlike traditional implant materials that are either synthetic or biologic, BioBrace is a biocomposite of both. The proprietary biocomposite architecture features a highly porous type 1 collagen matrix (20 μm average pore size) reinforced with bioresorbable PLLA microfilaments (15 μm diameter), which are stylized green in the cross-section SEM image below. Biorez has category-defining innovation, with 20 granted patents and 10 pending.

Innovative solution for tendon and ligament healing

The BioBrace reinforces, regenerates, and then resorbs. Its biomechanical profile enables load-sharing to reinforce ligament and tendon repair throughout the healing process, while its biologic matrix acts as a scaffold to support tissue regeneration. The BioBrace provides supplemental strength for approximately 2 years before naturally resorbing (2). 

BioBrace is available in two sizes

5mm x 250mm

23mm x 30mm

BioBrace provides Confidence in Healing™  

The BioBrace is an off-the-shelf solution for soft tissue reinforcement that is easy to use with a wide range of arthroscopic techniques. The BioBrace implant is soft and flexible, yet durable, enabling suturing and passing down a cannula. 

BioBrace demonstrated robust healing in preclinical testing 

Rapid cellular infiltration and new tissue regeneration by 6 weeks. (1,2)  

180% thicker tendon compared with non-operative control at 12 weeks. (2,3)

Rotator Cuff repair was as strong as native tendon by 12 weeks (3)

* No significant difference between 12wk and Non-Operated control (p=0.35)
** Statistically significant increase between 6 and 12 wk (p=0.01)
*** Statistically significant increase between 0 and 6 wk (p=0.01)

(1) Carter, Arnoczky et al. ORS. 2021 
(2) Kanski, Arciero et al. OSET. 2020
(3) Walsh, Arciero et al. ORS. 2021

Shortcomings of a $7B sports medicine market

The natural healing process for ligaments and tendons can be long and slow due to low cellular activity and low vascularity within these tissues. As a result, rehabilitation and recovery are long, often incomplete, and risk of re-tear or re-injury remains high.

ACL
250,000 Surgeries

Up to 29% graft failure (4)

Rotator Cuff
460,000 Surgeries

Up to 53% re-tear (5)

Other
290,000 Surgeries

Up to 16% re-tear (6)

(4) Barrett et al. Am J Sports Med. 2011
(5) Rashid et al. Acta Orthop. 2017
(6) Rettig et al. Am J Sports Med. 2005

The ability to optimize this healing process and shorten rehabilitation time would be a significant advancement.

ANNOUNCEMENT

The BioBrace Implant receives the ACE Award, for ‘Accelerating the Cutting Edge’ at the 2021 American Orthopaedic Society for Sports Medicine.

Biorez Inc.
470 James Street, #14
New Haven, CT 06513 USA

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© Biorez 2022. All rights reserved.

BioBrace FDA 510(k) Summary K203267

Indications for Use:  The BioBrace Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.

Contraindications:  The BioBrace alone is not indicated for ligament repair or reconstruction, and the BioBrace is not indicated in patients with known history of hypersensitivity to bovine-derived materials.