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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 27-Aug-15

EARNINGS
Episurf Medical reported financial results for 2Q:15. Total revenue was SEK 1.4 million ($0.2 million) in 2Q:15, beating consensus estimates and increasing from SEK 117,793 ($17,476) in 2Q:14. The company commenced a direct sales strategy in the U.K. and Germany, and its Episealer condyle Solo implant was included in the Belgian reimbursement system.

FUNDING
Providence Medical Technology secured $12 million in new financing, which consists of equity participation from existing investors Stanmore Medical Investments, Aphelion Capital and other existing private investors, and the establishment of a new debt facility with Silicon Valley Bank. The proceeds will be used to further commercialize and expand its portfolio of DTRAX cervical fusion products designed to help patients suffering from cervical degenerative disc disease (DDD).

SPR Therapeutics received a $1.6 million grant from the National Institute on Aging (an Institute of the National Institutes of Health), to advance the clinical research of their non-narcotic pain management system following knee replacement surgery. The company's the Sprint System, aims to provide a pivotal link that will enable joint replacement procedures to be performed with little to no reliance on opiates during the peri-operative and recovery period. This grant coincides with SPR's recently initiated convertible debt offering and upcoming Series B equity financing planned for 2016.

M&A
Greatbatch entered into a definitive agreement to acquire Lake Region Medical, a developer of access, delivery and retrieval medical devices for the electrophysiology, vascular access, cardiovascular, urology, oncology, orthopedics, laparoscopy, biopsy/drug delivery and arthroscopy sectors, for approximately $1.73 billion in cash and stock, or 2.1x LTM revenues of $806 million, or 11.6x LTM Adjusted EBITDA of $149 million. Under the terms of the transaction, Greatbatch will pay approximately $478 million in cash and issue an aggregate of 5.1 million shares of common stock and options to Lake Region Medical's equity holders. The transaction broadens the company's diversification, scale across product lines, proprietary technologies and high volume manufacturing capabilities, which will provide the company's OEM customers a more comprehensive portfolio of solutions and services.

REGULATORY
BIOMATLANTE received CE Mark clearance for its EZ CURE Strip and EZ CURE Plug, part of the company's range of synthetic bone graft substitutes. EZ CURE is made of a homogeneous mixture of MBCP (biphasic HA/ ß-TCP) and highly purified Type I Collagen and its micro-macroporous structure mimics that of human bone and provides an osteogenic matrix for bone regeneration.

Ortho Clinical Diagnostics received 510(k) clearance from the FDA for its ORTHO VISION Analyzer, an interactive, fully automated analyzer for transfusion medicine laboratories. Through the company's proprietary Intellicheck Technology, ORTHO VISION verifies and documents diagnostic checks throughout the immunohematology testing process and features e-Connectivity technology which provides continuous remote data tracking that monitors instrument performance.

Xtant Medical received FDA 510(k) clearance from the FDA for its OsteoSelect PLUS Demineralized Bone Matrix (DBM) Putty, the company's next-generation DBM putty with the addition of demineralized cortical chips. The system will provide a Sterile grafting solution for customers and eliminates the need to mix bone chips and DBM putty intra-operatively, saving time and reducing graft variability.

Stryker recalled 16,992 units of five various elbow replacement as the packaging, specifically, the packaging's sterile barrier, might have been compromised during transportation. The systems included are: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm's radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint (located between the two bones of the forearm); and the Radio-Capitellum to improve elbow function.

PRODUCT INTRODUCTION & UPDATE
Amedica Corporation launched its Valeo II LL interbody fusion device, made from a micro composite silicon nitride biomaterial. Valeo contains anti-infective properties and is semi-radiolucent with visible boundaries in X-rays and produce no artifacts under MRI or CT scans. Additionally, the system will include second generation instrumentation to improve patient safety and surgeon ease of use.

Conventus Orthopaedics announced first surgeries of its Conventus PH Cage, Proximal Humerus Implant Device in the U.S. and Europe. The PH cage is made of shape memory properties of nitinol and expands within the bone to create robust fixation and prevent further collapse of the fracture while eliminating the need for allograft.

MicroPort Orthopedics launched its Profemur Preserve Hip Stem, a short stem designed to support the growing market of bone and tissue preserving surgical techniques. Short stem hip systems have grown in popularity due to the more tissue-friendly approach preservation of bone.

LEGAL
The Musculoskeletal Transplant Foundation (MTF) received a favorable ruling by the Patent Trial & Appeal Board for its challenge to the EpiFix patent in a suit brought by MiMedx against MTF, Liventa Bioscience and Medline.

CLINICAL
SI-BONE announced the publication of one-year results from two separate prospective multicenter clinical trials, as well as the publication of a systematic review of 18 MIS SI joint fusion studies on its iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint. The first clinical trial publication is of INSITE (Investigation of Sacroiliac Fusion Treatment), and demonstrated that iFuse had a mean 52.0-point reduction in SI joint pain at six months on the 0-100 Visual Analog Scale (VAS) versus only a mean 12.2-point decrease in the non-surgical management (NSM) control group. The second study called SIFI (Sacroiliac Joint Fusion with iFuse Implant System), showed durable improvements in pain, disability, and quality of life with the iFuse procedure. Lastly, the third study illustrated that MIS SI joint fusion using a lateral transarticular approach provides consistent and clinically important improvements in pain and associated disability that is maintained out to five years.

RESEARCH
Researchers at Loyola University Medical Center and the Hospital for Special Surgery (HSS) have conducted a study on a new/alternative limb-lengthening technique that provides patients a less burdensome recovery period while maintaining good-to-excellent outcomes. This technique can help prevent the need for amputations in selected patients who have suffered severe fractures.

DISTIRBUTION
ECM Medical received the distribution rights in Greater China for Vertebral Technologies' Interfuse System of novel spinal implants. Interfuse is designed to provide predictable efficacy with a large, biomechanically stable footprint, while utilizing familiar, less invasive approaches. The initial launch will take place in Hong Kong and Macau in 4Q:15.

OPERATIONS
NuVasive announced its intentions to expand its manufacturing capabilities. The company is actively exploring locations to build-out a new state-of-the-art medical device facility for its spinal implant and instrument manufacturing. The planned 130,000 sq ft facility, will extend the company's existing manufacturing capabilities, support efforts to increase the amount of products it internally manufactures, enhance its focus on operational efficiency and help drive accelerated operating margin expansion. The new planned facility is expected to house approximately 100 computer numerical control (CNC) machine tools, and inspection equipment, as well as clean-room operations.

ulrich medical USA announced plans to significantly increase its U.S. workforce across multiple functional areas. The expansion is occurring in order to accommodate for the increasing demands of the company's spinal implants.


Greatbatch to Acquire Lake Region Medical for $1.7B

Greatbatch entered into a definitive agreement to acquire Lake Region Medical, a medical device developer in the cardio & vascular and advanced surgical markets, for approximately $1.73 billion in cash and stock, or 2.1x LTM revenues of $806 million, or 11.6x LTM Adjusted EBITDA of $149 million.

Lake Region Medical develops access, delivery and retrieval medical devices for the electrophysiology, vascular access, cardiovascular, urology, oncology, orthopedics, laparoscopy, biopsy/drug delivery and arthroscopy sectors.

Under the terms of the transaction, Greatbatch will pay approximately $478 million in cash and issue an aggregate of 5.1 million shares of common stock and options to Lake Region Medical's equity holders. Furthermore, Greatbatch will assume approximately $1 billion of Lake Region Medical net debt. Post-closing, the combined company will employ more than 9,000 individuals globally with LTM revenues of $1.5 billion.

Earlier this month, Greatbatch filed to divest its QiG Group, a neuromodulation medical device subsidiary, in order to better allocate resources, pursue distinct capital allocation strategies, shift focus to different growth opportunities and provide clearer investment propositions for long-term investors. The acquisition of Lake Region Medical is another step to transforming the company.

The transaction broadens the company's diversification, scale across product lines, proprietary technologies and high volume manufacturing capabilities, which will provide the company's OEM customers a more comprehensive portfolio of solutions and services. On the operational side, the deal will drive margin expansion and management expects to achieve net annual synergies at the operating profit level of $25 million in 2016 and at least $60 million in 2018.

The deal is anticipated to close in 4Q:15, in which current Greatbatch and Lake Region Medical stockholders are expected to own approximately 83.4% and 16.6% of the combined company respectively.


Researchers Conduct Study on New Limb-lengthening Technique

Researchers at Loyola University Medical Center and the Hospital for Special Surgery (HSS) have conducted a study on a new/alternative limb-lengthening technique that provides patients a less burdensome recovery period while maintaining good-to-excellent outcomes. This technique can help prevent the need for amputations in selected patients who have suffered severe fractures.

Preventing an amputation is known as "limb salvaging", and a prerequisite for salvaging an arm or a leg is the ability to regenerate missing bone. Limb lengthening procedures replace missing bone or lengthen or straighten deformed bones. Patients that undergo such procedures include children born with birth defects and patients who have suffered severe fractures or bone cancer.

In trauma patients, broken bones can become infected, necessitating surgeons to remove the infected segment. In bone cancer patients, the surgeon eliminates a segment of bone in order to remove the tumor. Limb-lengthening techniques enable patients to grow back the section of bone lost to such infection or tumor.

Conventional limb lengthening surgical procedures employ the principle known as distraction osteogenesis. A corticotomy is used to fracture the bone into two segments. A circular external fixator (a rigid frame made of stainless steel and high-grade aluminum that surrounds the limb with rings and is secured to the bone with stainless-steel pins) is then used to pull apart the two bone segments, and new bone tissue pervades the gap. Through this technique, the bone lengthens at a rate of roughly 1 millimeter (mm) a day. Once the new bone tissue is formed, it takes several more months until it fully regenerates. Bones often can be lengthened between 15-25% of their original length at a time.

In the traditional limb-lengthening approach, the patient wears the external fixator until the bone completely matures, in order to support the weight of the limb. In the new technique, the surgeon implants a titanium rod inside the bone, in order to reduce the amount of time the patient must spend in the external fixator.

The study consisted of 58 trauma patients who underwent the lengthening of their tibia (shinbone). Thirty patients were treated with the standard technique and twenty-eight patients were treated with the alternative technique. The researchers noted that the average limb lengthening was 2.1 inches for both groups, but that the alternative approach reduced the amount of time patients had to spend in the external fixator from eleven months to seven months. Additionally, the study revealed no statistically significant difference in the severity or number of complications between the groups, and good-to-excellent results were found in all patients.

Bearing an external fixator can irritate the skin and cause infections at the pin sites, and makes wearing clothes and sleeping difficult and uncomfortable. This new approach can serve as a great breakthrough for the daily lives of patients undergoing limb-lengthening procedures.


Musculoskeletal News Roundup 20-Aug-15

EARNINGS
aap Implantate AG reported financial results for 2Q:15. Total revenue was €6.5 million ($7.2 million) in 2Q:15, representing a decrease of 19% on a constant currency basis compared to €8.1 million ($11.1 million) in 2Q:14. The company's Trauma segment grew 8% from €2.9 million ($4.0 million) in 2Q:14 to €3.2 million ($3.6 million) in 2Q:15, driven by the company's LOQTEQ product family. The company's Biomaterials segment declined 34% from €4.9 million ($6.7 million) in 2Q:14 to €3.2 million ($3.6 million) in 2Q:15, driven in particular by the company's bone cement business. EBITDA was ($0.5) million in 2Q:15, decreasing from $0.3 million in 2Q:14. All growth rates are on a reported basis unless stated otherwise.

Amedica Corporation reported financial results for 2Q:15. Total revenue was $4.8 million in 2Q:15, beating consensus estimates by 2% and representing a decrease of 18% compared to $5.8 million in 2Q:14. The decrease in revenues was primarily due to decreased sales of the company's non-silicon nitride products from a decline in the level of activity for a few key surgeons. Adjusted EBITDA was ($2.0) million in 2Q:15, increasing from ($3.2) million in 2Q:14. Gross margin for 2Q:15 decreased to 71.5%, from 72.5% in 2Q:14. All growth rates are on a reported basis.

SeaSpine Holdings reported financial results for 2Q:15. Total revenue was $33.5 million in 2Q:15, missing consensus estimates by 2% and representing a decrease of 6% compared to $35.8 million in 2Q:15. Gross margin for 2Q:15 decreased to 56.6%, from 57.5% in 2Q:14. The company's segments grew by: Orthobiologics +1% and Spinal Fusion Hardware (13%) in 2Q:15 respectively. All growth rates are on a reported basis.

FUNDING
Kuros Biosurgery secured a round of financing amounting to CHF15 million ($16.6 million). The financing was led by new investors LifeCare Partners and LSP Life Sciences Partners with participation of non-disclosed German and Swiss family offices and new investor Omega Funds. The company plans to use the funds for the commercialization of its lead sealant product, KUR-023, in Europe and the U.S., and to further progress its lead orthobiologics product, KUR-111, into Phase III clinical studies. The company expects an additional investment later this year.

LDR Holding closed its public offering of 2,300,000 shares of its common stock, at a price to the public of $40.00 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 300,000 shares of common stock. The total net proceeds from the offering are estimated to be approximately $86.5 million.

M&A
Theragen entered into a definitive agreement to acquire Neurotech North America, a manufacturer of non-invasive stimulation products for orthopedics and spine indications, and subsidiary of Bio-Medical Research, Inc. The transaction accelerates Theragen's strategic initiative to develop non-invasive therapeutic solutions using electrical, mechanical and other forms of energy to provide pain relief to patients both prior to and post surgical intervention.

REGULATORY
Aurora Spine received CE Mark clearance for its full line of its TiNano sterile-packed titanium coated spinal fusion implants made of PEEK thermoplastic material, intended for the entire spine. TiNano is the company's Titanium Plasma Spray coating on PEEK Interbody implants that aim to provide surgeons with modulus and post-op imaging advantages.

Tyber Medical received 510(k) clearance from the FDA for its TyWedge Opening Osteotomy Wedge Systems, a titanium plasma sprayed PEEK wedge implant. The system features an optimized tooth profile for initial stability, allowing for angular corrections in the foot.

PRODUCT INTRODUCTION & UPDATE
OrthoPediatrics announced that its RESPONSE Spine System has been utilized in more than 130 surgical procedures, by 35 different surgeons in 32 children’s hospitals across the U.S. during its first two months on the market. RESPONSE is designed to assist the surgeon in better correcting these unique deformities in each of their patients.

OsteoMed Spine launched its PrimaLIF LLIF Lateral Interbody Fusion System. The PrimaLIF system is designed for gentle tissue distraction, minimal neuromonitoring utilization and nerve protection.

LEGAL
TLIF, LLC, entered into a settlement and license agreement with Biomet for an undisclosed amount. The TLIF portfolio consists of patents which relate to implants and prosthesis with specific claims covering placement and insertion of spinal discs into a human spinal column. The IP claims also address the components, makeup, and content of the company's spinal discs.

MARKET RESEARCH
Moody's Investors Service has raised its outlook for the U.S. medical products and devices industry from "Stable" to "Positive" due to sector mergers and acquisitions (M&A), the commercialization of new products, and an uptick in growth of hospital admissions. Moody's estimates that the projected cost synergies resulting from recent sector M&A activity, will contribute 1%-2% aggregate EBITDA growth to the sector during the 2015/2016 fiscal years. The credit agency expects that the trend of medical device companies launching and commercializing new products focused on helping hospitals reduce readmissions and improving patient outcomes, will continue to accelerate sales. In addition, the report anticipates hospital admissions and inpatient volume trends will continue to increase under the Affordable Care Act (ACA), further bolstering sales and EBITDA growth for medical device manufacturers.

DISTRIBUTION
Extremity Medical entered into an exclusive distribution agreement with Neosteo, a French orthopedic device manufacturer, for its DynafitSystem in the U.S. marketplace. DynafitSystem is an osteosynthesis solution intended for use in bone fracture and reconstruction in forefoot surgery.


Moody's Raises U.S. Medical Device Market Rating from Stable to Positive

Moody's Investors Service has raised its outlook for the U.S. medical products and devices industry from "Stable" to "Positive" due to sector mergers and acquisitions (M&A), the commercialization of new products, and an uptick in growth of hospital admissions.

In the report (subscription required), "U.S. Medical Products and Devices: Outlook Changed to Positive as M&A Synergies, New Products and Admissions Uptick Drive Profits", Moody's estimates that the projected cost synergies resulting from recent sector M&A activity, will contribute 1%-2% aggregate EBITDA growth to the sector during the 2015/2016 fiscal years.

Moody's expects that the trend of medical device companies launching and commercializing new products focused on helping hospitals reduce readmissions and improving patient outcomes, will continue to accelerate sales. In addition, the report anticipates hospital admissions and inpatient volume trends will continue to increase under the Affordable Care Act (ACA), further bolstering sales and EBITDA growth for medical device manufacturers.

Lastly, Moody's does expect U.S. medical device makers to continue expanding into emerging marketplaces, therefore currency fluctuations will remain a hindrance on growth rates over the next one to two quarters. In spite of this however, the credit agency anticipates the aforementioned drivers will contribute industry EBITDA growth of 4%-5% over the next 12 to 18 months.



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