Musculoskeletal News Roundup 21-April-17

April 21, 2017 | Blake Mossy

EARNINGS
IMPLANET reported financial results for 1Q:17. Total revenue was €2.1 million ($2.2 million) in 1Q:17, increasing 3% compared to €1.9 million ($2.0 million) in 1Q:16. The company's Spine revenue was €1.1 million ($1.2 million) in 1Q:17, increasing 27% compared to €0.8 million ($0.9 million) in 1Q:16. The company's Knee & Arthroscopy segment decreased by (15%) 1Q:17. All growth rates are on a reported basis.

FUNDING

BioDirection secured $2 million in an interim financing led by Provident Healthcare Capital, MedScience Ventures, and others in the medical technology investment sector. The new capital will be used to support BioDirection’s Tbit blood-based test system, indicated for use in the diagnosis of concussions and other traumatic brain injuries.

Cerapedics secured a $20 million senior term loan from Oxford Finance. The company intends the use the new capital for the ongoing commercialization of its i-FACTOR ‘s use in cervical spine procedures and to initiate an FDA trial on its application in Transforaminal Lumbar Interbody Fusion (TLIF).

Integra LifeSciences increased its outstanding credit facility from $1.5 billion to $2.2 billion. The facility consists of an expanded term loan of $1.2 billion with no charge to the existing revolving line of credit of $1.0 billion. Integra plans to use $700 million from its existing revolving facility to finance its acquisition of Codman Neurosurgery from Johnson & Johnson. The incremental loan will be made available upon the closing of the acquisition.

Organogenesis entered into a $25 million revolving credit line agreement with Silicon Valley Bank. Organogensis, a regenerative medicine firm, recently acquired NuTech Medical and intends to develop a portfolio of wound care products and surgical biologics which compliments its PurAPly AM device for acute and chronic wound managements.

 M&A

Amendia announced its acquisition of Spinal Elements, a provider of spinal fusion and motion preservation systems, and orthobiologics. Spinal Elements’ portfolio includes its Ti-Bond porous titanium coating, Hero allograft and its Lucent XP expandable cage and the Clutch interspinous process device, which will complement Amendia’s Overwatch pedicle screw, Syzygy reduction screw and Ceres cervical product lines.

DePuy Synthes acquired 3D printing technology from Tissue Regeneration Systems (TRS). The 3D printing methods created by TRS will support Depuy’s efforts to develop patient-specific, bioresorbable implants with a mineral coating intended to support bone healing in patients with orthopedic and craniomaxillofacial deformities and injuries.

Medtronic entered into an agreement with to divest a portion of its patient monitoring, deep-vein thrombosis (DVT), nutritional insufficiency and recovery businesses for $6.1 billion, or 2.5xltm revenues of $2.4 billion, to Cardinal Health. The divested products include dental/animal health, chart paper, wound care, incontinence, electrodes, SharpSafety, thermometry, perinatal protection, blood collection, compression and enteral feeding, some of which that Cardinal Health already distributes, and also includes 17 dedicated manufacturing plants. For Medtronic, this transaction enables the company to better focus on a portfolio that supports its strategic initiatives, like minimally invasive devices. Through this deal, Cardinal Health gains a complimentary product portfolio that significantly expands its medical device footprint. The acquisition is expected to be financed with a combination of $4.5 billion in new senior unsecured notes and existing cash. 

REGULATORY

Life Spine received 510(k) clearance from the FDA for its PLATEAU-C Ti Cervical Spacer System. The devices utilizes the company’s proprietary OSSEO-LOC titanium surface technology and additional graft windows for increased visibility in situ.

PRODUCT INTRODUCTION & UPDATE

NuVasive launched its RELINE Trauma, designed for intra-operative customization for the treatment of spinal fractures. The system allows for controlled fracture correction throughout the procedure, with or without a rod present during the construct. Additionally, RELINE is integrated with the company’s Computer Assisted Technologies such as NVM5, NuvaLine, NuvaMap and NuvaMap O.R., all with the Integrated Global Alignment (iGA) platform.

Vexim launched its Masterflow Plus, a treatment designed for low-energy osteoporotic fractures, in Germany. The system allows surgeons to treat multiple vertebral levels in a single surgery when used with the company’s Masterflow Injection System.

CLINICAL

Bonutti Research received two patents from the United States Patent and Trademark Office (USPTO) covering its robotic unicompartmental, bicompartmental, total knee, and its robotic arthroplasty implantation. The company currently holds 15 patents in robotics, knee arthroplasty and computer navigation.

Zyga Technology enrolled the 100th patient in its EVoluSIon study. The prospective, 40-site, 250-patient trial aims to evaluate long-term fusion and pain reduction implanted with the company’s SImmerty Sacroiliac Joint Fusion system, a minimally invasive device that uses joint decortication, bone graft delivery and fixation to achieve arthrodesis.

COLLABORATION

7D Surgical entered into a partnership with Surgical One and DB Surgical for the U.S. distribution of its Machine-Vision Image Guided Surgery platform for spinal procedures. Surgical One will cover the Midwest to the Gulf Coast, and DB Surgical will cover the southeast U.S., assisting 7D’s direct salesforce. 7D develops optical technologies and machine vision-based registration algorithms for the improvement of surgical workflow and patient care.

APPOINTMENTS

The Advanced Medical Technology Association (AdvaMed) appointed Nadim Yared as the organization’s Chairman of the Board of Directors. Yared has served on AdvaMed’s board since 2011, and has been on the Board of AdvaMed Accel since 2012. Mr. Yared succeeds Chairman, CEO and President Vincent  Forlenza.