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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 11-Feb-16

EARNINGS
CONMED Corporation reported financial results for 4Q:15. Total revenue was $191.0 million in 4Q:14, beating consensus estimates by 1% and representing an increase of 1% compared to $195.0 million in 4Q:14. Adjusted EBITDA margin increased to 18.5% in 4Q:15 from 18.1% in 4Q:14. Gross margin for 4Q:15 increased to 53.6% from 53.3% in 4Q:13. The company's segments grew by: Orthopedic Surgery +6%, General Surgery (5%) and Surgical Visualization (9%) respectively in 4Q:15. All growth rates are on a constant currency basis.

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.

FUNDING
JustRight Surgical closed $4.2 million in a Series B financing and also secured $7 million in debt financing in conjunction to the equity round. The capital will be utilized to continue to advance sales, marketing, and other commercialization efforts for the company's core 3mm JustRight Sealer and its JustRight 5mm Stapler in both U.S. and European marketplaces.

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.

M&A
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 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.

PRODUCT INTRODUCTION & UPDATE
MX Orthopedics (MXO) received 510(k) clearance from the FDA for its dynaMX Compression Staple, a superelastic nitinol-based device. The system does not require post insertion tamping and aims to provide rudimentary intraoperative removal.

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.

CLINICAL
Cerapedics published the clinical results of its Pivotal IDE Clinical Trial of its i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF). The research showed that i-FACTOR bone graft demonstrated safety and efficacy while meeting FDA mandated non-inferiority success criteria when compared to local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy.

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.

RESEARCH
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. 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.

DISTRIBUTION
OrthAlign entered into a multi-country distribution agreement with Smith & Nephew (SNN) for its KneeAlign Total Knee Arthroplasty (TKA) component alignment technology. Under the agreement, SNN will distribute KneeAlign technology in 21 countries across Asia, Africa, the Middle East, Australia and New Zealand, supporting the company's JOURNEY II, LEGION and GENESIS II knee systems.

APPOINTMENTS
Implanet appointed Brian Ennis as President of Implanet America. Prior to Implanet, Mr. Ennis served as President and CEO of Etex Corporation, President of Empi, a provider of electrotherapeutic and pain management solutions, and President of International for Wright Medical. He has also served as an Independent Board of Director and Special Advisor for Implanet for the past two years.



Stryker to Acquire Synergetics USA's Neurology Product Portfolio

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.


Musculoskeletal News Roundup 4-Feb-16

M&A
CLT Medical Corporation entered into a definitive agreement to acquire AccelSPINE, a spinal implant manufacturer based in Dallas, TX. The AccelSPINE brand will remain intact until the integration is complete and appropriate regulatory measures have been met. CTL will retain all of AceelSPINE's employees and executives.

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
Amendia launched its OmegaLIF system, an expandable lumbar interbody device designed to treat degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The device features a self-locking expansion mechanism that is adjustable, with a cannulated bullet nose design for minimal impaction and easier insertion.

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.

CLINICAL
Active Implants initiated SUN (Safety Using NUsurface), the second clinical trial evaluating its NUsurface meniscus implant as a treatment option to help patients delay or avoid total knee replacement (TKR). The prospective, single-arm, open-label, non-randomized observational trial will enroll 120 patients with persistent knee pain caused by injured or deteriorating meniscus cartilage.

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.

RESEARCH
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. 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.To date, the team has filed patents for the technology in Australia, Europe, China and the United States.

REIMBURSEMENT
Medovex received approval for its DenerveX Facet Joint Syndrome treatment from the reimbursement authority in Germany. DenerveX is designed to provide a minimally invasive treatment from pain associated with facet joint syndrome.

COLLABORATIONS
BONE THERAPEUTICS extended its collaboration with Kasios, a synthetic bone substitute specialist, to develop next generation spinal fusion integrated products. The companies aim to combine BONE THERAPEUTICS' ALLOB allogenics osteoblastic cell therapy with Kasios’ spinal fusion cage containing a 3D-bioprinted synthetic matrix.

LEGAL
Predictive Therapeutics received a favorable ruling from the United States Patent and Trademark Office's (USPTO) Patent Trial and Appeal Board (PTAB) on its spinal deformity molecular diagnostic tests and companion therapeutics. The board completely reversed the examiner and approved all 20 of the company's pending patent claims.

APPOINTMENTS
TranS1 appointed Chris Groppa as the company's Chief Marketing Officer and Director of Reimbursement. Prior to TranS1, Mr. Groppa worked in product development at Blue Cross Blue Shield, and brand marketing for IBM.


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.



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