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Becton, Dickinson & Company (BD) entered into a definitive agreement to acquire CareFusion Corporation for $58.00 a share in cash and stock, equating to a total enterprise value of $12.2 billion, or 3.2x LTM revenues, or 13.4x LTM Adjusted EBITDA. The transaction builds upon BD's positions in medication management and patient safety solutions, and improves the company's capability to maximize outcomes in infection prevention, respiratory care, and acute care procedural effectiveness with an expanded product portfolio. The transaction is anticipated to close in 1H:15.
Bioventus entered into an agreement to acquire the OsteoAMP product line from Advanced Biologics. OsteoAMP is a tissue-based bone allograft designed to promote bone growth/regeneration and healing in spinal procedures by utilizing the bone morphogenetic proteins (BMPs) and growth factors found within human bone marrow. The acquisition of OsteoAMP, along with the 2013 agreement with Pfizer to develop a novel BMP product, constitute the foundation of Bioventus' Surgical Orthobiologics segment, a marketplace which the company has outlined as a priority.
Breg, Inc. and United Orthopedic Group, Inc. (UOG) entered into a merger agreement, creating a comprehensive suite of products and services to support orthopedic providers to prevent and rehabilitate orthopedic injuries. The combined company's product portfolio will feature four major product brands of orthopedic braces, cold therapy devices and deep vein thrombosis (DVT) prophylaxis products: Breg, Bledsoe Brace Systems, Hope Orthopedics and Cothera. Brad Lee, current President of Breg, has been appointed president of the newly combined company.
Episurf Medical secured CE Mark certification of its Episealer Trochlea product, intended to treat cartilage injury behind the patella (kneecap). Episealer is based on the company's personalized implants.
Precision Spine received 510(k) clearance from the FDA for its VAULT-C Anterior Cervical Interbody Fusion Device, intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level. VAULT-C is designed to allow for rigid screw fixation using a zero profile construct and aims to limit the risk of damage to surrounding vessels and adjacent soft tissue, while the large, open bone graft area allows for optimal graft containment.
PRODUCT INTRODUCTION & UPDATE
Globus Medical launched its SILC Fixation System (SILC), a low profile sublaminar fixation system for the correction of spinal curvatures without the need for pedicle purchase in all vertebrae. SILC consists of a polyethylene band that utilizes the strength of the laminar cortical bone as well as a top-loading clamp. It provides a solution for the full spectrum of patients ranging from pediatric to adult in order to address deformity correction, poor bone quality, and compromised anatomy.
Spine Wave launched its Lateral Access product portfolio, which consists of the previously released StaXx XDL Expandable Device and the just released StaXx IBL Expandable Interbody Device, the Abacus Lateral Spacer System, the XLR Lateral Access System and a full complement of disposable accessories, for full commercial launch. With this launch, the company now is able to offer spine surgeons multiple expandable implant options as well as a more traditional non-expandable PEEK implant.
Smith & Nephew launched its EVOS MINI Plating System for use in complex fractures of the long bones of the arms and legs. The system is designed specifically for traumatologists and includes the variety of mini, flat plates and screw sizes necessary to address both fracture reduction and short-term fixation while the final, load-bearing repair is being completed. Organized into a single tray, each EVOS MINI Plating System includes three different, color-coded, size modules that offer a variety of up to eight low-profile plate geometries.
The FDA issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal regulations. While much of the final guidance is identical to the January 2014 draft, there have been some changes made to this iteration in order to reflect comments the FDA has received.
"Custom Devices" are defined as devices not being generally available, not available in finished form, deviated for the needs of a specific patient, not advertised for commercial distribution and intended for a specific patient.
Like products developed by pharmaceutical compounders, custom medical devices are similar to already-approved devices, but are custom-made to the specifications of a single patient based on their prescribed needs as determined by a healthcare professional. They are mostly exempt from regulation, and are not required to seek premarket approval (PMA) or clearance, however, are required to meet the standards for good manufacturing practices (GMPs) under FDA's quality system regulation.
In this latest draft, the FDA has added a section to the guidance regarding its "five unit" definition, which maintains that the regulatory body will "take into account multiple considerations such as anatomical location, disease state, material, technology and indications", when examining a custom device.
The guidance now contains a new section about what to do if a patient must undergo revision surgery to replace a component that is no longer manufactured. The FDA stated that such a component would not necessarily be a custom medical device.
Lastly, the FDA incorporated a decree within the final guidance that companies should provide it with information regarding when a device is destroyed by the ordering physician. Under FDA's new "five device" policy, the agency will not count residual devices manufactured for a particular patient as long as they are either returned to the manufacturer or destroyed.
Bioventus entered into an agreement to acquire the OsteoAMP product line from Advanced Biologics. Under the terms of the agreement, Bioventus will acquire the intellectual property, commercial business, research and development (R&D) and product supply (which could lead to future innovations) associated with the OsteoAMP product line.
OsteoAMP is a tissue-based bone allograft designed to promote bone growth/regeneration and healing in spinal procedures by utilizing the bone morphogenetic proteins (BMPs) and growth factors found within human bone marrow. OsteoAMP is available in four distinctive formats: granules, compressible sponges, putty, and structural grafts, allowing surgeons to tailor delivery of the technology according to their needs in surgery. The product aims to be an alternative to recombinant growth factors and allograft-derived stem cells.
The acquisition of OsteoAMP, along with the 2013 agreement with Pfizer to develop a novel BMP product, constitute the foundation of Bioventus' Surgical Orthobiologics segment, a marketplace which the company has outlined as a priority.
Bioventus will continue to distribute OsteoAMP through the product's current network of distributors.