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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 17-Apr-15

EARNINGS
aap Implantate AG reported financial results for 1Q:15. Total revenue was €7.1 million ($7.7 million) in 1Q:15, representing an increase of 16% compared to €6.1 million ($8.4 million) in 1Q:15. The company's Trauma segment grew 15% from €2.2 million ($3.0 million) in 1Q:14 to €2.5 million ($2.4 million) in 1Q:15, driven by the company's LOQTEQ product family. The company's Biomaterials segment grew 23% from €3.6 million ($5.0 million) in 1Q:14 to €4.4 million ($4.8 million) in 1Q:15, driven in particular by the company's bone cement business.

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.

FUNDING
BONESUPPORT closed a $14 million round of funding led by a new investment from a major Scandinavian Pension Fund, with additional participation from existing investors. The new capital will be used to grow global sales and marketing efforts and accelerate the expansion of the company's CERAMENT synthetic bone substitute platform.

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.

M&A
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.

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.

REGULATORY
Conventus Orthopaedics received 510(k) clearance from the FDA for its PH (proximal humerus) Cage, an expandable fracture cage for the surgical repair of shoulder fractures. The cage is comprised of nitinol, a nickel titanium alloy and expands within the bone to help create robust fixation and prevent further collapse of the fracture.

PRODUCT INTRODUCTION & UPDATE
BioPoly announced the performance of the 100th surgery utilizing its BioPoly partial resurfacing knee implants. The technology incorporates a proprietary material that utilizes the patient’s own joint lubricating fluid.

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.

LEGAL
Wright Medical entered into definitive agreements settling a patent infringement suit filed by ConforMIS alleging that Wright's PROPHECY knee and ankle systems infringe four ConforMIS patents. Under the settlement, Wright will enter into a license agreement with ConforMIS for its InBone and Infinity total ankle replacement systems.

CLINICAL
Vertos Medical's announced full enrollment of its 27-site study, "MiDAS ENCORE", comparing two conservative treatments for back pain resulting from lumbar spinal stenosis in patients with neurogenic claudication. All patients have been treated. The randomized controlled study will examine the long-term benefits for approximately 300 patients who received either minimally invasive lumbar decompression (MILD) or epidural steroid injections (ESIs).

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.

OPERATIONS
BONE THERAPEUTICS established a US based subsidiary called "Bone Therapeutics USA Inc.", in Boston, MA. The company aims to lead to the initiation of Bone Therapeutics’ clinical trials for fracture repair and osteonecrosis in the U.S. and this is the first step to moving the company's strategy forward.

COLLABORATION
Johnson & Johnson entered into a partnership with IBM to co-develop a mobile wellness coaching solutions centered on pre- and post-op patient care for joint replacement and surgical spine procedures. The partnership is intended to provide healthcare systems with holistic virtual coaching and rehabilitation solutions striving to transform the patient experience and healthcare delivery model by creating an integrated view of patient care. The solution will utilize advanced data analysis and insights to help develop personalized patient engagement and coaching solutions that span consumer wellness and chronic condition management.


Lima Corporate to Acquire Zimmer and Biomet Reconstruction Lines

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 Acquires Residual 51% Ownership in Neodent

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.

Last year, the company changed its name to Instradent and launched its implants in the U.S. marketplace.

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.


Musculoskeletal News Roundup 9-Apr-15

EARNINGS
Biomet reported financial results for its 3Q:15. Total net sales were $800.9 million in 3Q:15, representing an increase of 1% compared to $822.5 million in 3Q:14. Adjusted EBITDA was $298.4 million in 3Q:15, increasing 10% from $271.5 million in 3Q:14 on a reported basis. Adjusted EBITDA margin increased to 37.3% in 3Q:15 from 33.0% in 3Q:14. Gross margin for 3Q:15 increased to 75.0%, from 60.3% in 3Q:14. The company's segments grew at: Knees +1%, Hips +4%, Sports, Extremities & Trauma (S.E.T.) +0%, Spine, Bone Healing & Microfixation +3%, Dental (1%), and Cement, Biologics & Other (0%) respectively in 3Q:15. All growth rates unless stated otherwise, are on a constant currency basis.

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.

FUNDING
Atlas Spine announced plan to raise a $5 million Series B preferred round in order to expand its existing business and monetize, through a licensing and royalty model, their patented portfolio of spinal implant product systems. The company holds seven patented products and has 28 patents in development.

M&A
Elos entered into an agreement to acquire Onyx Medical Corporation, a US-based supplier of Trauma and Extremities products. The transaction gives Elos a wider presence in Europe, Asia and the US and fulfills Elos’s strategy to focus on strengthening its market positions in target growth segments within orthopedics such as trauma, spine and extremities. Onyx generated sales of $16 million in 2014 and employs 120 people. The deal is expected to close in April 2015.

PRODUCT INTRODUCTION & UPDATE
TeDan Surgical Innovations launched its Phantom AL Retractor System intended to provide superior visualization with minimal tissue trauma during MIS Anterior Lumbar Interbody Fusion (ALIF) procedures. The system utilizes two angled attachment arms to provide a one point connection to the circular retractor ring increasing stability and minimizing the frame profile. Unlike other systems, Phantom includes a lighting system that directly illuminates the surgical site using a flexible arm and low heat LED light.

INTELLECTUAL PROPERTY
Bacterin received a patent from the United States Patent and Trademark Office (USPTO) which covers certain demineralized bone matrixes containing minimum levels of bone morphogenetic protein-2 (BMP-2), which include products in Bacterin's OsteoSponge product line. The patent is entitled "Process for Demineralization of Bone Matrix with Preservation of Natural Growth Factors. OsteoSponge's demineralized bone matrix (DBM) technology allows for the allograft comprised of human bone to become compressible, while maintaining the spectrum of native growth factors inherent to bone.

CLINICAL
The American Academy of Orthopaedic Surgeons (AAOS) presented its 2015 William W. Tipton, Jr., MD, Leadership Award, AAOS' highest leadership honor, to HealthpointCapital Scientific Board of Advisors (SBA) member, Dr. Andrew "Andy" Weiland. The Tipton Leadership Award recognizes academy members who have demonstrated outstanding leadership qualities that have benefitted the orthopedic community, patients, and/or the public. Dr. Weiland is recognized for his pioneering work and knowledge in microvascular surgery of the hand.

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.


Dental News Roundup - March 2015

Product Introduction & Update
Natural Dental Implants (NDI) launched its minimally invasive, same day REPLICATE Immediate Tooth Replacement System. Replicate acts as an alternative to traditional dental implants and three-unit bridges. Prior to extraction, the practitioner scans and takes dental impressions to create an anatomical copy of the patient's natural, extracted tooth. After extraction, the Replicate tooth, a super-hydrophilic titanium root fused to a zirconia abutment, is placed in the extraction socket and a temporary crown used until osseointegration completes.

Legal
Align Technology and ClearCorrect reached an agreement to resolve the pending Remanded Enforcement Proceeding that is before the International Trade Commission. The companies expect the U.S. Federal Circuit to hear oral arguments in the infringement case in July 2015 and present a decision six to nine months later. In order to avoid the cost of further proceedings and additional uncertainty, the companies have agreed to resolution terms based on the Federal Circuit's decision.

Appointments
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 effective the same day.

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 Appoints New CEO

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.



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