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Devices Surgery FDA

 News Release - September 26, 2023

Abyrx Receives FDA Clearance for MONTAGE(R) Settable Bone Putty for Use in Cardiothoracic Surgery

First-Ever FDA Clearance for Use of a Settable Bone Putty on the Sternum Delivers Long-awaited Innovation for Enhancing Sternal Repair in Cardiothoracic Surgeries

STAMFORD, Conn., Sept. 26, 2023 -- (Healthcare Sales & Marketing Network) -- Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for use during surgical procedures, today announced that the United States Food and Drug Administration (FDA) has provided regulatory clearance for the company's MONTAGE® Settable Bone Putty for use in cardiothoracic surgery following sternotomy. This represents the first time that the FDA has granted clearance for the use of a settable bone putty on the sternum, and it follows previous FDA clearances for MONTAGE as a bone void filler, cranial cement, and hemostatic bone putty.

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.1 Surgeons have preferred MONTAGE over other bone putties due to its unmatched breadth of FDA-cleared claims, history of safe and reproducible performance, and intraoperative handling benefits. MONTAGE is unique as a moldable putty that adheres to bleeding bone and rapidly hardens to achieve bone-like properties after application.

"This clearance marks a new frontier for cardiothoracic surgery and addresses a longstanding clinical gap where important technological innovation has been stagnant for more than 60 years," said Dr. Paul Fedak, MD PhD, cardiac surgeon, translational scientist and director of the Libin Cardiovascular Institute, University of Calgary. "Standard sternal (breastbone) closure techniques use simple mechanical fixation devices such as wires and plates to provide mechanical support until the bone heals naturally over 8-12 weeks. The broken breastbone causes pain and delays recovery. MONTAGE is a breakthrough product that has potential to enable heart surgeons to enhance sternal closure and repair and accelerate patient recovery after surgery. The product is applied to the separated sternum in a putty-like consistency. Upon application, MONTAGE controls bleeding and eliminates the need for topical agents known to prevent bone healing, such as bone wax. Following closure, MONTAGE hardens and has been shown in a pilot clinical study to potentially accelerate patient recovery and reduce pain. I predict that sternal closure using MONTAGE settable bone putty will become a standard of care for patients undergoing heart surgery through the breastbone and will significantly improve recovery and meaningful clinical outcomes."

For over a decade, Dr. Fedak has championed enhanced sternal closure using settable biomaterials to accelerate patient recovery after open heart surgery. In a single-center pilot randomized trial, conducted in partnership with Abyrx, he recently evaluated MONTAGE's feasibility, safety, and efficacy for sternal repair in over 60 patients (NCT #03365843). The results, which were published in the world's highest impact cardiothoracic peer-reviewed publication, The Journal of Thoracic and Cardiovascular Surgery, showed that patients who received MONTAGE with wire cerclage had improved physical functional recovery, reduced pain, and shortened hospital stays.2 Long-term outcomes and sternal integrity were also assessed post-surgery using rigorous patient follow-up and radiographic imaging. The use of MONTAGE in cardiac surgery will be further validated by Abyrx in a planned multi-center randomized trial in collaboration with Dr. Fedak.

John J. Pacifico, founder and chief executive officer of Abyrx, commented, "When we initially set a course to develop the MONTAGE technology platform, we believed its polymer backbone had unique capabilities that could ultimately support the use of the product as a new standard of care for treating bone defects during surgical procedures. Today, we see the product's impressive breadth of indications enabling widespread, on-label use of MONTAGE across surgical specialties that represent millions of procedures each year. We believe MONTAGE has the potential to eliminate the need or desire for all other settable and non-settable biomaterials used on bone as it is easy to use, can be molded and shaped to conform to varying anatomy, hardens with bone like properties even in the presence of irrigation and bleeding, and has been shown to resist brittle fracture and disintegration over time as it is replaced by bone during the remodeling process."

In addition to this latest regulatory milestone, Abyrx recently received FDA clearances for its MONTAGE FastSet™ and MONTAGE Flowable® products for use as a bone void filler. MONTAGE FastSet reduces the product's hardening time by approximately 50%. MONTAGE Flowable is offered pre-loaded in a hand-held delivery system to enhance its ease of use and deliverability to bone. With these clearances, both the FastSet and Flowable products may augment provisional hardware and help stabilize bone fragments during the surgical procedure. The products can also be drilled and tapped, and hardware can be placed through them anytime during the setting process.

The company continues to evaluate and pursue additional regulatory clearances for the MONTAGE family of products, including tissue fixation, intra-operative shaping of patient-specific implant devices, and site-specific delivery of Growth Factors, anti-infective agents, and local anesthetic drugs.

About Abyrx

Founded in 2013, Abyrx develops, manufactures, and provides therapeutic devices for surgical procedures. The company's products are FDA-cleared for use in the United States and approved in Europe and Canada. Abyrx's product portfolio is approaching 450,000 uses at more than 1,000 hospitals in the United States, with cumulative revenues of over $100 million. Privately held Abyrx has over 50 issued and pending patents and operates a manufacturing and distribution facility in Stamford, CT.

For more information, please visit www.abyrx.com.

Forward-Looking Statement

This press release contains forward-looking statements based on management's beliefs, assumptions and expectations and information currently available to management. All statements that address events or developments that we expect or anticipate will occur in the future are forward-looking statements, including, without limitation, our expectations concerning the timing and progress of research and development activities. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Abyrx does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

1 Please see individual product Instructions for Use for full labeling

2 Vasanthan V, Hassanabad AF, Kang S, Dundas J, Ramadan D, Holloway D, Adams C, Ahsan M, Fedak PWM. Novel hardening bone putty enhances sternal closure and accelerates postoperative recovery. J Thorac Cardiovasc Surg. 2022 Sep 17:S0022-5223(22)00999-0. doi: 10.1016/j.jtcvs.2022.09.016., PMID: 36272766.


Source: Abyrx

Issuer of this News Release is solely responsible for its content.
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