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September 2-4 - EuroSpine 2015
September 9-12 - Annual Meeting of the American Association for the Surgery of TraumaComplete Calendar »
Sep 3 @ 6:15 AM ET - MedtronicComplete Calendar »
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.
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
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.
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 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 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.
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.
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.
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
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.
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.