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March 14-18 - American Association of Orthopaedic Medicine Annual Meeting 2017
March 14-December 31 - Canaccord Genuity Musculoskeletal ConferenceComplete Calendar »
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SeaSpine Holdings reported financial results for 4Q:16. Total revenue was $32.5 million in 4Q:16, representing a decrease of 6% compared to $34.7 million in 4Q:15. Gross margin for 4Q:16 increased to 58.6%, from 52.0% in 4Q:15. The decline in the company's Orthobiologics portfolio was mostly driven by fewer year-end stocking orders, pricing pressures, and product mix-shift to lower cost DBM products. The decline in the company's Spinal Hardware portfolio was driven primarily by lower demand for older products, tepid demand from European markets, and pricing pressures. The company's U.S. segments decreased by: Orthobiologics (6%) and Spinal Fusion Hardware (6%) in 4Q:16 respectively. Overall, U.S. revenue decreased 5% to $29.8 million 4Q:16. All growth rates are on a reported basis.
Shoulder Options is preparing to divest its proximal humerus plate portfolio, designed for the treatment of proximal humerus fractures, and for rotator cuff repair. The company intends to divest three products: its AFT Proximal Humerus Fracture Plate, AFT Greater Tuberosity Fracture Plate, and CRP Cuff Repair. With this divestiture, Shoulder Options wants to achieve large scale distribution of these products in order to make them more accessible to a greater number of patients and healthcare providers, and to help fund the commercialization of the company's non-FDA approved, Proteus Shoulder Arthroplasty platform.
PRODUCT INTRODUCTION & UPDATE
OrthAlign launched its UniAlign system, a handheld navigation device for unicompartmental knee arthroplasty (UKA). The technology is designed to offer surgeons with a minimally invasive approach that provides real-time data, precise bone cuts and minimal pin site morbidity.
Vertebral Technologies (VTI) appointed three distributors in Germany, Finland and Sweden for the distribution of its InterFuse modular interbody fusion implants. The distributors include Joline GmbH & Co KG, based in Hechingen, Germany, Articular, based in Helsinki, Finland and Anatomica, headquartered in Gothenburg, Sweden. This transaction aims to allow VTI a strengthened global portfolio.
Shoulder Options is preparing to divest its proximal humerus plate portfolio, designed for the treatment of proximal humerus fractures, and for rotator cuff repair.
Shoulder Options, founded in 2007 and based in Waxhaw, NC, develops surgical shoulder implants for rotator cuff repair, humerus fractures, humeral head replacement, and joint surface repair. The company intends to divest three products: its AFT Proximal Humerus Fracture Plate, AFT Greater Tuberosity Fracture Plate, and CRP Cuff Repair.
The AFT Proximal Humerus Fracture Plate, is an anatomically shaped implant that utilizes multiple suture tying points, and is indicated for the treatment of fractures and fracture dislocations of the proximal humerus. The device incorporates 20 degrees of retroversion between its head and shaft in order to help facilitate the restoration of normal anatomy. It received 510(k) clearance from the FDA in 2012 and has been under a limited release in the U.S. market.
The AFT Greater Tuberosity Fracture Plate is a minimally invasive system for the treatment of fractures of the greater tuberosity and cuff avulsions.
The CRP Cuff Repair Plate is a fixable suture anchor plate intended for the augmentation of transosseous rotator cuff repair, specifically in massive tears and re-ruptures in proximity to osteopenic bone. According to the company, it is the first fixable suture plate on the U.S. market and is designed with multiple suture tying points that aim to improve anchorage-to-bone strength during rotator cuff repair. The system received 510(k) clearance from the FDA in 2011 and has been fully launched in the U.S. marketplace.
In addition to FDA approval, the aforementioned assets have utility and design patents from the U.S. Patent and Trademark Office (USPTO).
With this divestiture, Shoulder Options wants to achieve large scale distribution of these products in order to make them more accessible to a greater number of patients and healthcare providers, and to help fund the commercialization of the company's non-FDA approved, Proteus Shoulder Arthroplasty platform.
K2M entered into an agreement to acquire e-Fellow, a mobile software platform that aims to streamline the patient billing and care process.
e-Fellow offers service-based technology that provides real-time automated solutions that gathers and secures patient data, insurance preauthorization documentation, and operative results. The company's platform intends to provide surgeons and healthcare facilities with easier access to relevant data that evaluates patient care and outcomes and reduces provider preauthorization denials.
This transaction is in conjunction with, and augments, K2M's launch of its Balance ACS (BACS), a comprehensive diagnostic and treatment platform that utilizes 3D solutions to help deliver quality outcomes for spine patients across the whole clinical care continuum.
BACS employs predictive analytics to balance the spine by addressing each of the patients anatomical vertebral segments with a 360-degree approach of the axial, coronal and sagittal planes. Along with 3D printed implants, the platform also incorporates the BACS System, service-based technology that provides preauthorization tools and preoperative planning, 3D anatomical modeling and postoperative reporting solutions to support the intraoperative process and drive better outcomes.
Additionally, K2M entered into a partnership with 3D Systems Corporation, a provider of 3D printers, print materials, on-demand manufacturing and software technology to develop exclusive software for the BACS System.
With the launch of the Balance ACS platform, partnership with 3D Systems, and the acquisition of e-Fellow, K2M is aiming to supplement its surgical implant portfolio with data driven solutions that provide clinical services and engagement tools to evaluate, analyze and improve patient care and outcomes. With these actions, K2M joins Johnson & Johnson, Medtronic and Zimmer Biomet in this trend.
joinmax received full product registration from the Thai Food & Drug Administration (FDA) for its systems and training methods for endoscopic minimally invasive spinal surgery. The company also has approvals in South Korea, China, Singapore, Indonesia, Hong Kong and Vietnam. joinmax systems for endoscopic minimally invasive spinal surgery include TESSYs transforaminal, iLESSYS interlaminar and CESSYS cervical for decompression procedures, MultiXZYTE SI for SI joint therapy and EndoLIF and Percusys for endoscopic minimally-invasive assisted stabilization.
Synergy Biomedical received CE Mark clearance in the European Union for its BIOSPHERE PUTTY synthetic bone graft product. The system utilizes a form of bioactive glass in combination with a moldable phospholipid carrier to fill bony voids or gaps in the skeletal system. The product including an application in interbody and posterolateral fusion and general bone defect filling in the extremities and pelvis. BIOSPHERE may be used alone or in combination with autograft or allograft.
Research Shows that A Permanent Repeal of the Medical Device Tax Could Recover 28,000 Jobs for the Industry
The American Action Forum (AAF) estimates that the medtech industry could recover the 28,000 jobs that were terminated during the implementation of the the Affordable Care Act's 2.3% medical device excise tax by 2021 if Congress permanently repeals the tax this year.
The tax went into effect in January 2013 and pertained to domestic medical device sales. In December 2015, Congress passed the Omnibus Appropriations Act, a $1.1 trillion funding bill that negated another government "shut down" and kept the U.S. federal government functioning until September 30, 2016. Within this legislation was a provision to suspend the medical device excise tax for 2016 and 2017.
According to AdvaMed, the leading lobbyist/trade group for the medical device industry, from 2012 to 2015, the number of U.S. medtech jobs declined 7.2% from 401,472 to 372,638, a loss of 28,834 jobs for the period.
The AAF also noted that if the tax was to be reinstated as opposed to being permanently repealed, such an action could result in a loss of an incremental 25,000 jobs within the industry by 2021. AAF based its findings on employment data from the Department of Commerce and tax-revenue collection projections from the White House Office of Management and Budget.