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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 9-March-17

EARNINGS
K2M Group reported 4Q:16 financial results. Total revenue was $61.8 million in 4Q:16, representing an increase of 14% compared to $54.2 million in 4Q:15. Adjusted EBITDA was $0.8 million in 4Q:16, decreasing from $1.3 million in 4Q:15. Gross margin for 4Q:16 decreased to 62.1% compared to 66.3% in 4Q:15. The company's U.S.-based segments grew by: Complex Spine +18%, Minimally Invasive +7% and Degenerative +21% in 4Q:16. The company's U.S. and International segments grew 21% and decreased (3%) respectfully in 4Q:16. International revenues represented 23% of the company's total revenue in 4Q:16. All growth rates are on a constant currency basis.

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.

FUNDING
Vertiflex secured $40 million in a round of financing led by Endeavour Vision and H.I.G BioHealth Patners, with participation from existing investors, New Enterprise Associates, Thomas, McNerney & Partners and Alta Partners. The new capital will be used to support Vertiflex's Superion Indirect Decompression System, a minimally invasive spinal implant designed for the treatment of moderate lumbar spinal stenosis.

M&A
K2M entered into an agreement to acquire e-Fellow, a mobile software platform that aims to streamline the patient billing and care process. his 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. 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.

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.

REGULATORY
Intellijoint Surgical received 510(k) clearance from the FDA for its intellijoint HIP Anterior application, a 3D mini-optical navigational tool. The device aims to provide quantifiable, intraoperative measurements for cup position, leg length, and offset for a direct anterior approach for Total Hip Arthroplasty (THA).

PRODUCT INTRODUCTION & UPDATE
Consensus Orthopedics launched its TracPatch, a wearable monitoring device, offering real-time data, including range of motion, ambulation, exercise compliance, and wound site temperature trends, continuously post-operation. The device is placed on the lower leg just below the joint line and is designed to allow any healthcare provide access to the patient's data. The healthcare provider can monitor the patient's progress and adjust post-surgical activities and rehabilitation goals.

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.

DISTRIBUTION
Misonix entered into a distribution agreement with Weigao Orthopedic, a medical device company in China specializing in research and development, production and sale of spine, trauma and joint orthopedic implant devices. Under the terms of the agreement, Weigao Orthopedic will sell, market and distribute Misonix's Bone Scalpel in China, Hong Kong, and Macau for five years.

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.

CLINICAL
Bio2 Technologies announced the results of ovine interbody fusion study comparing its Vitrium bioactive glass device's capability to support interbody fusion to an implant of similar design constructed from PEEK polymer. The biomechanical tests evaluated each device's effective, safe resorption/bone formation profile, stimulation of new bone formation to increase fusion rates, and its strength to bear physiologic loads. All subjects demonstrated a reduction in motion at 26 weeks indicating a fusion taking place, however Vitrium fusion exhibited a superior adjoining of vertebral bodies. The results indicate Vitrium devices exhibit ideal characteristics of an interbody fusion product.

REIMBURSEMENT
Vertos Medical received national coverage from the Centers for Medicare & Medicare Services' (CMS) for its mild Procedure designed for the treatment of lumbar spinal stenosis (LSS). The outpatient procedure is minimally invasive, fluroscopically guided through a small portal and requires no general anesthesia, implants or stitches. The system received coverage through a claims-analysis study under CMS and Evidence Development Program.

INTELLECTUAL PROPERTY
TheraCell received a patent from the United States Patent and Trademark Office (USPTO) covering its demineralized bone fiber (DBF). The technology incorporates two demineralized cortical fiber allografts, AlloFuse Coritcal FIbers and AlloFuse Fiber Boat, commercialized by AlloSource, for use in surgical procedures.

APPOINTMENTS
Alphatec Spine appointed Jeffrey G. Black as Executive Vice President and Chief Financial Officer (CFO). Prior to Alphatec, Mr. Black served as CFO of Applied Proteomics, AltheaDx, and Verenium Corporation. Mr. Black has over 25 years of experience in financial and operations management and will lead the finance, investor relations and account organizations, and architecting the capital structure of the company.




Shoulder Options Plans to Divest its Proximal Humerus Plate 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 to Acquire e-Fellow and Launches Implant and Services Platform, Balance ACS

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.


Musculoskeletal News Roundup 3-March-17

FINANCIALS
Anika Therapeutics reported financial results for 4Q:16. Total revenue was $28.3 million in 4Q:16, beating consensus estimates by 3% and representing an increase of 11% compared to $25.6 million in 4Q:15. Product gross margin increased to 73.4% in 4Q:16 from 75.4% in 4Q:15. The company's segments grew by: Orthobiologics +13%, Surgical +17%, Dermal (2%) and Other (23%) in 4Q:16 respectively. The company grew geographically: Domestic +12%, European +10% and ROW +3% in 4Q:16. All growth rates are on a reported basis.

M&A
Shoulder Options sought out a divestiture of its proximal humerus plate devices. The plating systems are designed for the treatment of proximal humerous fractures and for rotator cuff repair, are 510(k) approved by the FDA, and have been granted patents by the USPTO. The devices include the AFT Proximal Humerus Fracture Plate, the AFT Greater Tuberosity Fracture Plate, and the CRP Cuff Repair Plate.

REGULATORY
Amend Surgical received 510(k) clearance from the FDA for its NanoFUSE BA, a bone graft extender for spine and orthopedic applications. Bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogensis, creating a favorable environment for bone fusion as it remodels into the recipient's skeletal system.

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.

PRODUCT INTRODUCTION & UPDATE
Alphatec Spine launched its Arsenal Deformity Adolescent Idiopathic Scoliosis (AIS) System and has successfully completed initial patient cases. The system is designed to give surgeons a sloution to address complex deformity pathologies, including unique uniplanar screws, which enable easier screw positioning and rod placement, while restricting motion in the medial/lateral plane for derotation correction.

CLINICAL
Centric Medical completed initial cases with its Hammertoe Correction System, designed with dual treading, the system is inserted between the proximal and middle phalanges so that opposing threads fixate on the phalangeal canal of the toe and compress the joint.

INTELLECTUAL PROPERTY
IMPLANET received a patent from the French patent office for its JAZZ Lock implant in France. The implant is designed from the treatment of degenerative spine disorders and aims to allow surgeons to shorten and simplify the surgical procedure by removing multiple steps and implants used in traditional systems.

APPOINTMENTS
OrthAlign appointed Eric Timko company its Chief Executive Officer (CEO) and Chairman of the Board. Mr. Timko will succeed William Maya. Prior to OrthAlign, Mr. Timko served as president and CEO of Blue Belt Technologies. Before Blue Belt Technologies, he served as president and CEO of NeuroVasx, president of Carl Zeiss Surgical and as vice president of Siemens Medical Systems. Mr. Timko has over 25 years of experience in the healthcare industry and has served on OrthoAlign's Board of Directors since July 2016.

RESEARCH
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. 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.



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.



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