Musculoskeletal News Roundup 28-April-17

April 28, 2017 | Blake Mossy

EARNINGS

Johnson & Johnson reported financial results for 1Q:17. Total revenue was $17.77 billion in 1Q:17, missed consensus estimates by 1% and representing an increase of 2% compared to $17.48 billion in 1Q:16. Gross margin for 1Q:17 decreased to 69.7%, from 69.5% in 1Q:16. Domestic sales increased 1%, while international sales increased 4% in 1Q:17. Total Orthopedic sales were $2.33 billion in 1Q:17 decreasing 0.2% compared to $2.34 billion in 1Q:16 with domestic and international orthopedic sales growing (1%) and 1% respectively. Hips increased 4% worldwide, with U.S. Hip sales up 3% and international up 5%. Knee sales worldwide increased 3%, with U.S. sales growing 1% and international sales increasing 7%. Trauma sales increased 0.3% worldwide, U.S. sales growing 3% and international sales decreasing 3%. Spine & Other sales decreased 3% worldwide, decreasing 6% domestically and increasing 0.3% internationally. All growth rates are on a constant currency (operational) basis.

NuVasive reported financial results for 1Q:17. Total revenue was $249.9 million in 1Q:17, missing consensus estimates by 0.3% and representing an increase of 16% compared to $215.1 million in 1Q:16. Adjusted EBITDA was $60.2 million and the company exhibited an adjusted EBITDA margin of 24.1% in 1Q:17. Gross margin for 1Q:17 increased to 75.3%, from 74.8% in 1Q:16. All growth rates are on a constant currency basis.

Stryker reported financial results for 1Q:17. Total revenue was $2.96 billion in 1Q:17, beating consensus estimates by 2% and representing an increase of 18% compared to $2.49 billion in 1Q:16. Gross margin for 1Q:17 decreased to 66.4%, from 67.9% in 1Q:16. The company's segments grew by: Knees +9%, Hips +2%, Trauma & Extremities +8%, Other Orthopedics +34%, Instruments +8%, Endoscopy +14%, Medical +132%, Sustainability +8%, Spine +4% and Neurotechnology +10% respectively in 1Q:17. International revenues increased by 19% and represented 36% of total revenue in 1Q:17. All growth rates are on a constant currency basis.

ulrich Medical reported financial results for 2016. Total revenue grew 15%, and EBITDA increased 20% for the 2016 fiscal year. The annual U.S. case numbers increased by 247% and more than 50% of the company’s revenue is now done outside the corpectomy sector.

REGULATORY

Amedica received regulatory clearance for its Valeo interbody fusion device in Australia. The device is comprised of the company’s proprietary medical grade silicon nitride ceramic, which utilizes a nanostructured surface, and osteoconductivity, osteoinductivity, and anti-microbial properties.

Ziptek received 510(k) clearance from the FDA for its ZipE knotless tissue repair system and attachment device. The system is an absorbable button that moves down a suture, locking itself from moving backward with each forward movement, for use in minimally-invasive and open surgeries to accomplish tissue-to-tissue and tissue-to-bone repair.

PRODUCT INTRODUCTION & UPDATE

Arthrosurface launched its OsteoMATE, an arthrodesis implant for the treatment of OA. The sterilized, pre-drilled, implant is comprised of allograft bone which is translucent under x-ray allowing the surgeon to visualize and monitor bone ingrowth post-operatively. OsteoMATE’s design utilizes Four Corner Fusion of the hang and Lisfranc of the foot, and its allograft composition aims to mitigate non-union of the fusion area.

Nexxt Spine launched its INERTIA CORTI-FIXX Cortical-Cancellous Pedical Screw System. The system’s screws are designed to achieve cortical bone purchase with a smaller midline incision when utilized in a medial to lateral pedicle approach. Corti-Fixx’s dual to quad lead threads double the screw/bone contact points within the pedicle to support increased resistance to pull-out.

Titan Spine announced the 1,000 implantation of its Endoskeleton titanium interbody fusion devices utilizing the company’s nanoLOCK surface technology. Reportedly, nanoLOCK has been used by 74 surgeons in 51 hospitals across 26 states in the U.S., and the systems’ sales volume has increased by 270% since December 2016.

CLINICAL

BioPoly published two-year clinical results from a study evaluating its RS Partial Resurfacing Knee system. The study demonstrated statistically significant and clinically meaningful improvement in knee pain and function with the use of the system.

Cartiva announced the enrollment and treatment of 50 patients in a multi-center study evaluating its Synthetic Cartilage Implant (SCI) for first carpometacarpal joint osteoarthritis (OA) at the base of the thumb. The device is comprised of a proprietary biocompatible polymer and aims to mimic natural cartilage.

 ProSomnus Sleep Technologies, the leader in precision oral appliance manufacturing for obstructive sleep apnea, has announced the beginning of the EFFECTS study. It is estimated that up to 20% of the population has OSA and only 10-15% have been identified and diagnosed. According to the RAND study, the comorbidities, accidents and other deleterious sequelae to OSA and poor sleep are estimated to cost the US economy upwards of 411 Billion Dollars or 2.28% of the GDP. One problem with treatment is, many patients abandon CPAP, or avoid this alternative completely. Oral appliances are an emerging therapy that offer a better patient experience and therapeutic outcomes. This study is designed to confirm this.

SI-BONE announced the publication of a 6-year study comparing its iFuse Implant to both conservative management and radiofrequency (RF) denervation. The study suggested that patients treated with conservative management or RF denervation worsened in outcome measures of pain and function, while patients with the company’s iFuse Implant demonstrated superior improvements.