Get Our Free Research Email
February 11-13 - Joint Interventional Meeting 2016
February 11-14 - American College of Foot and Ankle Surgeons Annual MeetingComplete Calendar »
Feb 11 @ 4:30 PM ET - NuVasive
Feb 11 @ 4:30 PM ET - ConforMISComplete Calendar »
Johnson & Johnson reported financial results for 4Q:15. Total revenue was $17.8 billion in 4Q:15, in-line with consensus estimates and representing an increase of 4% compared to $18.3 billion in 4Q:14. Gross margin for 4Q:15 increased to 68.1%, from 67.9% in 4Q:14. Domestic sales decreased 8%, while international sales increased 1% in 4Q:15. Total Orthopedic sales were $2.42 billion in 4Q:15 increasing 5% compared to $2.44 billion in 4Q:14 with domestic and international orthopedic sales growing 7% and 1% respectively. Hips increased 6% worldwide, with U.S. Hip sales up 10% and international up 2%. Knee sales worldwide increased 6%, with U.S. sales growing 8% and international sales increasing 2%. Trauma sales increased 6% worldwide, U.S. sales growing 8% and international sales increasing 5%. Spine & Other sales increased 2% worldwide, increasing 6% domestically and decreasing 2% internationally. All growth rates are on a constant currency (operational) basis.
Osseon reported financial results for 2015. Total revenue increased 42% in 2015 compared to 2014. The company added 21 new Distributors and 78 new treating physicians including neurosurgeons, pain management physicians, interventional radiologists and orthopedic surgeons. The company is projecting that 2016 sales will continue on double-digit growth trend.
Seikagaku Corporation reported financial results for the first three months of 2015. Net sales YTD were ¥23.4 billion ($194.5 million), representing an increase of 6% from ¥22.1 billion ($184.0 million) for the same period. Sales of the company's single-injection injectable treatment for osteoarthritis pain of the knee, Gel-One, in the U.S. and internationally both increased, in part by the expansion of the local sales structure through an acquisition made by a sales partner. Operating income YTD increased 21% from ¥2.7 billion ($22.8 million) to ¥2.3 billion ($19.0 million) for the same time period. All growth rates are on a reported basis.
Smith & Nephew reported financial results for 4Q:15. Total revenue was $1,257million in 4Q:15, beating consensus estimates by 1% and representing an increase of 5% compared to $1,249 million in 4Q:14. The company's segments grew at: Knee +6%, Hip 1%, Sports Medicine / Joint Repair +9%, Arthroscopic Enabling Technologies 3%, Trauma & Extremities 0% and Other Surgical +13% respectively in 4Q:15. All growth rates are on a constant currency basis.
Regentis Biomaterials closed its $15 million investment Series D investment round led by Haisco Pharmaceutical Group and by existing investors including Medica Partners, SCP Vitalife Partners, Generali Financial and both the Technion Research & Development Foundation and the Technion Innovation Opportunities Fund. The capital will be used primarily for conducting a U.S. pivotal clinical trial on the company's GelrinC, a proprietary hydrogel.
PRODUCT INTRODUCTION & UPDATE
Tyber Medical launched its TyWedge Osteotomy Wedge Systems, a titanium plasma-sprayed PEEK wedge implant. The system features the proprietary TyPEEK PEEK coating and includes an optimized tooth profile for initial stability and angular corrections in the foot.
VGI Medical announced its first implementation of its VerteLP Lateral Lumber Cage, a lateral lumbar fusion device system that features bi-cortical plating technology to facilitate a more simplified cage insertion. VerteLP provides integrated fixation through a direct, minimally invasive approach.
Wenzel Spine received 510(k) clearance from the FDA for its VariLift-LX lumbar interbody fusion (IBF) implant. The zero-profile, stand-alone, expandable interbody fusion device is indicated to be implanted in a unilateral or bilateral capacity through a posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) approach and may be used without supplemental fixation.
LDR announced the publication of five-year results of cost utility analysis of its Mobi-C Cervical Disc, a two-level cervical Total Disc Replacement (cTDR). The study evaluated the cost-effectiveness of Mobi-C Cervical Disc as compared to ACDF. Based on the outcomes, the study suggested that cTDR may become more cost-effective overtime.
Stryker entered into a definitive agreement to acquire all of the assets associated with the neurology product portfolio of Synergetics USA.
Under the terms of the all-cash transaction, the acquired portfolio includes the Malis Electrosurgical Generator, Spetzler Malis disposable forceps, and the intellectual property for Stryker's existing Sonopet tips and MultiGen radiofrequency (RF) generator. This portfolio of products achieved OEM sales of approximately $31 million in 2015.
The Malis electrosurgical generator is for endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels. The Spetzler Malis forceps are single-use devices intended for coagulation of tissue during electrosurgery. The MultiGen RF generator is intended for the coagulation of soft tissue in orthopedic, spinal and neurosurgical applications. The Sonopet tips are used in the Sonopet Ultrasonic Aspirator system for fine bone dissection. The last two devices are already owned by Stryker, but were sponsored by Synergetics during the regulatory process.
The transaction provides a product portfolio that is highly complementary to Stryker Instruments' Neuro Spine & ENT (NSE) business and is aligned with the division's strategy of expanding its neurosurgical offerings. Furthermore, the deal gives Stryker access to two electrosurgical devices that are currently distributed by its competitor, Johnson & Johnson.
The transaction is expected to close in 1Q:16.
Researchers Develop a Superelastic Adaptive Titanium Alloy That Could Improve the Success Rate of Early-onset Scoliosis Treatments
Researchers at Texas A&M University have developed a new titanium shape memory alloy that could improve the success rates and significantly reduce the complications of conventional treatments utilizing spinal screw and rod systems for early-onset scoliosis.
Scoliosis is defined as a sideways curvature of the spine that occurs most often during a person's growth spurt just prior to puberty. Such a condition can eventually lead to severe physical deformity in addition to pulmonary and cardiac problems. Early-onset scoliosis refers to spine deformity that is present before a person is of 10 years of age.
Children diagnosed with early-onset scoliosis often spend their childhood undergoing multiple surgical procedures to amend the unnatural curve in their spine. In conventional surgical procedures, spine surgeons implant metallic growing rods in the spine and expand them in bi-annual surgeries to keep pace with the child's growth. However, as the child's body grows/moves, a deviation between the mechanical properties of the implants and the bone becomes apparent. This deviation frequently results in complications like implant loosening, bone atrophy from stress shielding, and bone disease near implant extremities. These complications increase the likelihood that the child will need to undergo further complicated surgical procedures to correct or repair the damage such complications can create.
Using a series of thermo-mechanical processing steps, the researchers developed a superelastic adaptive titanium alloy that preserves the strength and adds flexibility to the implants without compromising the mechanical properties. The new implant allows the natural movement of the body to occur as it can self-adjust depending on the stress applied by the growing spine.
The alloy permits its rods to bend at the ends and stay stiff in the middle as it is 5x more flexible than any other currently available rod system and possesses stress-dependent elastic properties that gradually decrease as the stress on it is increased. This reduces the friction and stress on the patient's spine allotting them more natural movement.
Furthermore, the research team has designed the adaptive alloy to have bio-inert constituents, less sensitivity to impurities and inclusions, better corrosion resistance, more stable fatigue response and predictable fatigue life.
Exactech (EXAC) entered into an agreement to acquire Exactech Australia, an independent importer and distributor of Exactech’s orthopaedic implants, instrumentation and surgical technology based in Sydney, Australia. The transaction gives Exactech a direct sales platform that will help the company establish a greater presence in the Asia-Pacific marketplace.
Stryker entered into a definitive agreement to acquire Sage Products, LLC, a developer of disposable health and personal care products targeted at reducing hospital acquired infections (HAIs) primarily in the intensive care unit and MedSurg hospital unit setting, from Madison Dearborn Partners in an all cash transaction for $2.8 billion, or 6.5x FY2015 revenues of $430 million. The transaction provides Stryker with a product portfolio that is complementary to its current disposable and capital equipment offerings and aligns with Stryker's strategic initiative to focus on offering products and services that support prevention.
PRODUCT INTRODUCTION & UPDATE
Implanet announced the completion of the first idiopathic scoliosis surgical procedure in Brazil utilizing its JAZZ platform. JAZZ aims to be an alternative to pedicle screw systems for the correction of major spinal deformities.
CollPlant announced the publication of the final clinical trial results of its Vergenix STR product, intended for the treatment of tendinopathy. The objective of the prospective, open label, single arm trial was to demonstrate the safety and performance of VergenixSTR in 20 patients suffering from the inflammation of the patient's elbow tendon (tennis elbow). The study's results demonstrated a favorable performance of Vergenix compared to standard of care therapeutics.
Histogenics Corporation announced that it has enrolled 123 out of 245 patients for its ongoing NeoCart Phase 3 clinical trial. The device is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells. The study is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults and show superiority of NeoCart against the current standard of care, microfracture.
Eminent Spine published clinical results of its King Cobra anterior cervical plate and Copperhead cervical cage. To date, none of the patients who received this instrumentation have required reoperation, or have experienced screw or plate breakage or migration of the cervical cage.
Researchers Develop a New Spinal Fusion Implant that Does Not Require Bone Graft and is Less Invasive
Researchers at The University of New South Wales, Australia, have developed a new experimental spinal fusion medical device called "Thru-Fuze", which is less invasive, requires no bone graft to support fusion and affords the patient little to no radiation exposure. Human trials have not yet begun and the device has not received FDA approval in the United States.
Chronic back pain from spinal disorders or degenerative disc disease (DDD) is the most common reason for pain and disability in people aged under 50. Spinal fusion procedures are conducted when conservative therapies such as physical therapy, medication and injections have failed to treat the problem.
Conventional methods of spinal fusion utilize rod and/or cage systems that require screws to be drilled into the spine and bone graft, the material employed to create the bridge and obtain the fusion between the vertebrae in the spine, generally harvested (painfully) from the patient's iliac crest. Such procedures rely on the bone to make its way right across the vertebrae, which can take up to one year to find out if the surgery has been a success. Furthermore, existing methodologies are costly, time consuming to install, difficult to perform and have experienced relatively variable rates of success, some with non-union, or fusion failure rates of over 50%.
The Thru-Fuze device is positioned between the spine's transverse processes to stabilize and hold the spine in place to prevent extraneous movement which can cause back pain. The ends of the implant are porous, therefore fusion occurs as a result of the bone growing through and on the implant, enabling it to form a bridge. Over time, the device allows for additional bone to grow between and across the adjacent vertebrae, fusing the vertebrae together, bone to bone.
The research team believes Thru-Fuze will be more effective and provide better patient outcomes than existing technologies as it less invasive, employs a faster and more rudimentary procedure, does not require bone graft and only results in minimal radiation exposure for the patient. So far, pre-clinical and laboratory testing of Thru-Fuze in animal models has demonstrated fusion of bone on and through the device after it has been placed between the vertebrae, resulting in "rapid biomechanical" fixation.
The researchers plan to conduct human trials beginning in late 2016 at the Prince of Wales Hospital, Sydney. Funding is to be provided to the research team by the NSW Government’s Medical Device Fund in the amount of $1.6 million. The new NSW Government funding is incremental to the $2.3 million that has already been invested in the development of Thru-Fuze by the private equity firm, Intellectual Ventures. To date, the team has filed patents for the technology in Australia, Europe, China and the United States.