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April 23-25 - Arthroscopy Association of North America Annual Meeting
May 6-9 - American Academy of Cosmetic DentistryComplete Calendar »
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Johnson & Johnson reported financial results for 1Q:15. Total revenue was $17.4 billion in 1Q:15, in-line with consensus estimates and representing an increase of 6% compared to $18.1 billion in 1Q:14. Gross margin for 1Q:15 decreased to 69.6%, from 69.9% in 1Q:14. Domestic sales increased 9%, while international sales increased 3% in 1Q:15. Total Orthopedic sales were $2.32 billion in 1Q:15 increasing 2% compared to $2.42 billion in 1Q:14 with domestic and international orthopedic sales growing 1% and 3% respectively. Hips increased 3% worldwide on an operational basis driven by strong volume growth in primary hip stem platform sales. U.S. Hip sales grew 3%. Knee sales worldwide increased 1% on an operational basis, with U.S. sales growing 2% and international sales decreasing 1%. Knee growth was driven by sales of the ATTUNE fixed bearing knee platform and was offset by pricing pressures. Trauma grew 3% on an operational basis due to market growth.
Medicrea reported financial results for 2014. Total revenue was €24.2 million ($27.8 million) in 2014, increasing 6% from €22.9 million ($31.5 million) in 2013. Gross margin for 2014 increased to 81.0%, from 80.0% in 2013. Import difficulties encountered by the company's leading distributor in Brazil contributed to a globally mediocre performance over 1H:14. All growth rates are on a reported basis.
Ortho Kinematics raised $9.6 million in equity of a targeted $10.7 offering. The capital will be utilized to further develop its Vertebral Motion Analysis diagnostic technology. Participating investors include Medtronic, MB Venture Partners and TEXO Ventures.
Zimmer Holdings announced the "outside date" for completing its proposed $13.4 billion acquisition of Biomet has been extended from April 24, 2015 to July 23, 2015. The deal has received approval from the European and Japan Fair Trade Commissions, but remains subject to clearance by the U.S. Federal Trade Commission (FTC) and other customary closing conditions. Zimmer expects to receive clearance for the proposed transaction from the FTC by the end of April or shortly thereafter.
PRODUCT INTRODUCTION & UPDATE
Lima Corporate launched its new Physica total knee replacement system, which includes three different types of total knee implants. The first is Physica KR, a kinematic and posterior cruciate ligament (PCL) retaining design. The second is Physica PS, a Posterior Stabilised solution (PCL sacrificing) with an asymmetric cam that aims to optimize the patient's knee kinematic profile and enhance load transmission. The third Physica system includes a cruciate retaining implant which is PCL retaining and designed to conserve bone to help improve load transfer and enable more anatomical patellar tracking.
IlluminOss Medical announced the publication of an efficacy data in the Journal of Biomedical Materials Research Part B: Applied Biomaterials. The study demonstrates that percutaneous intramedullary fixation can provide for stabilization of bone fractures while avoiding the need for large tissue-dissections. The results validate the intramedullary application of a light-curable photodynamic bone stabilization system from IlluminOss as a biocompatible, feasible method for fracture fixation in load-bearing bones. The system utlizes proven medical polymers and traditional balloon catheter technology to provide a novel technology for patient-specific, percutaneous orthopedic implants.
Moirai Orthopaedics received approval from the FDA for its Investigational Device Exemption (IDE) application to initiate clinical study of its Pyrocarbon Implant Replacement (PIR) System. The study will evaluate the safety and effectiveness of the PIR System in the treatment of articular cartilage defects (Outerbridge Grade III or IV) of the medial femoral condyle compared to control treatment.
RepliCel Life Sciences received approval from the University of British Columbia (UBC) Clinical Research Ethics Board (CREB) to conduct a phase 1/2 clinical trial at the UBC Hospital. The trial, entitled, "A randomized, double-blind, placebo-controlled, single-center study to evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis" (also known as the "ReaCT study"), will investigate the potential of RepliCel's tendon repair product, RCT-01, to treat chronic tendon injury.
Lima Corporate entered into an agreement to acquire Zimmer's Unicompartmental High Flex Knee (ZUK) and Biomet's Discovery Elbow systems within the European Economic Area (EEA) and Switzerland, as well as Biomet's Vanguard Complete Knee System in Denmark and Sweden.
This transaction is a result of the European Commission's (EC) conditional clearance of Zimmer's proposed acquisition of Biomet, which requires Zimmer to divest a knee-implant business in the EEA, and Biomet to sell an elbow-implant unit in the EAA, and a knee-implant business in Denmark and Sweden.
The EC approved Lima Corporate as a suitable buyer and the transaction will become effective after the merger between Zimmer and Biomet has been closed.
The deal provides Lima entry into the unicompartmental knee and elbow replacement segments and helps expand the company's proprietary Physica total knee system.
Straumann entered into an agreement to acquire the remaining 51% ownership of Neodent for BRL 680 million ($218.3 million) in cash, which values the total equity of the company at $432 million, or 5.2x Neodent's TTM (trailing twelve month) revenues of $83 million.
In June 2012, Straumann acquired 49% of the company for BRL 549 million ($259.3 million), which at the time, valued the total equity of the company at $566 million, or 6.6x TTM revenues. The rationale for the initial transaction was to expand Straumann's product suite into the value implant segment.
Neodent was founded in Brazil in 1993 as JJGC Indústria e Comércio de Materiais Dentários S/A. In 1998, the company moved its headquarters and manufacturing to Curitiba, Brazil where it develops dental implants and related prosthetic components.
This deal augments Straumann's presence in the tooth replacement sector in the Latin American region and Brazil, which is the second largest market for implant dentistry.
SpineGuard reported financial results for 1Q:15. Total revenue was €1.5 million ($1.6 million) in 1Q:15, representing an increase of 27% compared to €1.0 million ($1.4 million) in 1Q:14. US revenue was €1.1 million ($1.2 million), increasing 30% compared with €0.7 million ($1.0 million) in 1Q:14, and represented 74% of the company's global revenue. In the rest of the world, total revenue was €0.4 million ($0.4 million), increasing 20% compared with €0.3 million ($0.5 million) in 1Q:14, and represented 26% of global revenue. All growth rates are on a constant currency basis.
PRODUCT INTRODUCTION & UPDATE
Anika Therapeutics filed an Investigational Device Exemption (IDE) with the U.S. FDA to conduct a pivotal Phase III clinical trial for its Hyalofast product, a biodegradable, 3D, HA-based scaffold with autologous bone marrow aspirate concentrate (BMAC). The prospective, randomized, active treatment-controlled, evaluator-blinded, and multi-center study will compare Hyalofast’s treatment of articular knee cartilage defect lesions to that of a control microfracture treatment. Anika expects to enroll 200 patients at up to 30 sites in the U.S. and Europe beginning 4Q:15. Hyalofast is CE Marked in Europe for the entrapment of mesenchymal stem cells in connection with the treatment of chondral and osteochondral lesions.
Mesoblast Limited announced the company intends to expand its Phase 3 clinical program of its product candidate MPC-06-ID in the treatment of chronic low back pain due to degenerative disc disease to include sites in the European Union (EU). Mesoblast's Phase 3 program for this product candidate is currently enrolling patients in the United States under an Investigational New Drug (IND) application filed with the US FDA. Discussions with the European Medicines Agency (EMA) occurred as part of combined scientific and reimbursement advice under an EU pilot program known as Shaping European Early Dialogues (SEED), which may result in a final comprehensive EU development and commercialization program in order to increase the likelihood of producing data that will be acceptable for both registration and reimbursement review in multiple European countries.
Titan Spine announced the publication of a study comparing its proprietary surface technology to polyetheretherketone (PEEK) in the peer-reviewed journal Spine. The study demonstrates Titan’s line of Endoskeleton Interbody Devices promote osteoblastic differentiation and enhanced bone-forming environment compared to devices made from PEEK. Furthermore, the data indicates that Titan’s surface technology reduces production of inflammatory mediators and increases production of anti-inflammatory mediators compared to PEEK, thus creating an enhanced environment for bone growth and fusion. Fibrous tissue formation around PEEK spinal implants is due to several factors including increased inflammatory cytokines and decreased cell viability.
Product Introduction & Update
Straumann announced the appointment of Petra Rumpf as the company's Head of Instradent & Strategic Alliances and Member of the Executive Management Board, starting March 30, 2015. Instradent is the company's international value implant platform which is currently marketed in Germany, Iberia, Italy and the U.S. Prior to Struamann, Ms. Rumpf previously seved as a member of the Executive committee with responsibility for corporate development, M&A and expansion of the company's value brand at Nobel Biocare.
Align Technology appointed Joseph Hogan as company President, Chief Executive Officer and Director, effective June 1, 2015. Mr. Hogan will replace Thomas Prescott, who announced his retirement the same day.
Mr. Hogan most recently served as CEO of ABB Ltd., a $40 billion global power and automation company with 140,000 employees. Prior to ABB, Mr. Hogan spent more than 25 years at General Electric (GE) including eight years as the CEO of GE Healthcare.
Mr. Prescott will continue to serve on Align's Board of Directors.