Conference Calendar

September 10-13 - The American Academy of Periodontology Annual Meeting 2016

September 14-16 - ISCoS Annual Scientific Meeting

Complete Calendar »

Earnings Calendar

No Upcoming Events Scheduled
Complete Calendar »

Read our research via:
email art

Weekly Email

rss art

RSS



app icon

iPhone

app store icon

Kindle



Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 22-Sept-16

M&A
GE entered into agreements to acquire Arcam AB and SLM Solutions Group, two suppliers of additive manufacturing equipment, for approximately $1.4 billion in aggregate. Additive manufacturing, also known as 3-D printing involves taking digital models from computer aided design (CAD) software and laying horizontal cross-sections to manufacture a part. Arcam provides additive manufacturing solutions for the production of metal components for the aerospace sector, metal implant systems for the orthopedics market, and produces advanced metal powders for the software industry. SLM Solutions produces laser machines for metal-based additive manufacturing solutions for customers in the aerospace, energy, healthcare and automotive industries. GE will retain management teams and employees and will maintain the headquarter locations and key operating locations of each company.

REGULATORY
Life Spine received 510(k) clearance from the FDA for its PRO-LINK Ti Standalone Cervical Spacer, low-profile, stand-alone cervical utilizing the company's proprietary Osseo-Loc technology for the treatment of spinal disorders. The titanium surface with 500-600 microns of porosity, fosters an environment for potential bone growth.

K2M received 510(k) clearance for components of its MESA Spinal System. The clearance allows the system's screw and connector components to be used in the growing rod construct in patients under 10 years old. The growing rod is surgically lengthened periodically in order to obtain and maintain correction of severe, progressive life threatening spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.

NuVasive received 510(k) approval from the FDA for its MAGEC System, a magnetically controlled growing rod system to be surgically implanted using the company's Reline posterior fixation system for the treatment of severe spinal deformity conditions in pediatric patients. MAGEC is a single-use rod is periodically lengthened externally by the surgeon as the patient grows.

RTI received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its nanOss Bioactive Bone Void Filler System. nanOss Bioactive is a synthetic-based bone graft composed of nano-structured hydroxyapatite granules which is similar to bone, increasing its potential to regrow new bone. The system is designed to fill bony voids and gaps that are not intrinsic to the stability of the structure.

PRODUCT INTRODUCTION & UPDATE
Bioventus launched its EXOGEN Ultrasound Bone Healing System in Saudi Arabia. The system is designed to apply low-intensity ultrasound pulses to help stimulate the body's natural healing process. Study results show that EXOGEN provides a 86% heal rate for fracturesthat do not heal on their own and an 38% faster healing rate for fresh fractures.

Zimmer Biomet launched its Vanguard Individualized Design (ID), a patient-specific total knee arthroplasty (TKA) that aims to provide simplified soft tissue preservation and balance. The system incorporates two individual polyethylene bearings between metal portions of an implant with articulations on the medial and lateral sides, unlike traditional TKA implants. The system allows surgeons to produce more personalized implants with differing thickness and geometry for the implant bearings.

CLINICAL
Band-LOK announced the first surgery using its Band-LOK, a pedicle-sparing polyester band technology designed for the treatment of complex spinal and pathologies. The company was granted patent approval from the United States Patent and Trademark Office (USPTO) in November 2015.

Inspired Spine published clinical results from its study on minimally invasive direct thoracic interbody fusion (MIS-DTIF), a spinal fusion surgery that is designed to alleviate back pain in patients with degenerative disk disease (DDD). The four participant study measured patient-reported pain, procedure time and complications. The study results show that patients experienced significantly reduced back pain after receiving MIS-DTIF.

Integra LifeSciences completed the first successful clinical cases for its Cadence Total Ankle System, a two-component implant indicated for total ankle replacement procedures. Cadence has incorporated multiple anatomical considerations to maintain more bone stock and correctly align the ankle to its original location.

RESEARCH
Researchers at Duke University published results of a clinical study in which they restored partial sensation and muscle control in the lower limbs of eight people who had been paralyzed from spinal cord injuries by utilizing brain-controlled robotics. In this virtual reality program, the patients controlled a 3-D avatar on a screen by imagining motion in their arms or legs. The study concluded that a mixture of robotic and traditional movement therapy could significantly improve patients’ recovery, sensation and muscle control. The data from the study demonstrated that patients who used this neuromechanical interface for an extended period of time exhibited improvement in motor behavior, sensation and involuntary function below the spinal cord injury.


Researchers Demonstrate that Brain-machine Interfaces Utilized with Robotic Limbs Can Help Paraplegics Regain Partial Sensation and Muscle Control, and Therefore Walk Again

Researchers at Duke University published results of a clinical study in which they restored partial sensation and muscle control in the lower limbs of eight people who had been paralyzed from spinal cord injuries by utilizing brain-controlled robotics.

The participants wore caps lined with electrodes to record signals from the neurons of their brain by EEG. To translate these signals into movement, the research team developed a virtual reality system that provided a direct communication interface between the participants' cognitive activity and the robotic limbs. The participants were able to simulate movement of their legs by controlling a digital likeness of themself in this virtual environment.

In this virtual reality program, the patients controlled a 3-D avatar on a screen by imagining moving their arms or legs. After this step, the participants would use a robotic gait trainer in a similar way by imagining taking steps. The brain-controlled robotic exoskeleton that they were hooked up to would then respond to those thoughts and act accordingly. The study concluded that a mixture of robotic and traditional movement therapy could significantly improve patients’ recovery, sensation and muscle control.

The data from the study demonstrated that patients who used this brain-machine interface for an extended period of time exhibited improvement in motor behavior, sensations and involuntary function below the spinal cord injury. Furthermore, the majority of the participants displayed improved bladder control and bowel function, which help reduce their risk of infections as they subsequently required less laxatives and catheters.


GE to Acquire Both Arcam AB and SLM Solutions for an Aggregate $1.4B

GE entered into agreements to acquire Arcam AB and SLM Solutions Group, two suppliers of additive manufacturing equipment, for approximately $1.4 billion in aggregate.

Both transactions will be structured as a public tender offer for all of the outstanding shares of stock of each company. Under the terms of the two deals, GE will acquire Arcam for an enterprise value of $648.1 million, or 8.8x LTM revenues of $73.4 million, and SLM for an enterprise value of $740.3 million, or 7.6x LTM revenues of $96.7 million.

Additive manufacturing, also known as 3-D printing involves taking digital designs from computer aided design (CAD) software, and laying horizontal cross-sections to manufacture the part. As additive components require less welding and machining, they are normally lighter and more durable than traditionally-manufactured components, and generate sufficiently less scrap material.

Arcam provides additive manufacturing solutions for the production of metal components for the aerospace sector, metal implant systems for the orthopedics market, and produces advanced metal powders for the software industry. The company invented the electron beam melting machine for metal-based additive manufacturing. The company is based in Mölndal, Sweden, and employs 285 people.

SLM Solutions produces laser machines for metal-based additive manufacturing solutions for customers in the aerospace, energy, healthcare and automotive industries. The company operates in two segments, Machine Sales and After Sales. The Machine Sales segment develops machines for selective laser melting (SLM) additive manufacturing. The After Sales segment provides machine-related services and offers replacement parts, accessories, and merchandise. SLM is based in Lübeck, Germany and employs 260 people.

Both Arcam and SLM will spearhead GE's evolution into a digital industrial company and provides the company with complementary additive technology modalities to serve as the foundation for GE's new additive equipment business. Arcam and SLM each provide GE with technologies that will extend the company's line of additive manufacturing equipment and products and give GE an opportunity to reduce product cost and improve new product innovation (NPI) spend. It will also transition GE's growing additive manufacturing platforms into more of a service business for its customers. Management anticipates to grow the new additive platform to $1 billion by 2020.

GE will retain both Arcam's and SLM's management teams and employees and will maintain the headquarter locations and key operating locations of each company. These facilities will collaborate with the broader GE additive network including the manufacturing and materials research center in Niskayuna, Japan, and New York, NY, and the additive design and production lab in Pittsburgh, PA. Arcam and SLM will be incorporated under GE's Aviation division and the executive teams will report to David Joyce, the President & CEO of GE Aviation.


Musculoskeletal News Roundup 15-Sept-16

M&A
Ferring Pharmaceuticals entered into an agreement to acquire the worldwide rights (excluding Japan) to Seikagaku Corporation's SI-6603 (condoliase) product, a chemonucleolytic injection therapy for the treatment of radicular leg pain caused by lumbar disc herniation. Under the terms of the transaction, Ferring will pay Seikagaku an upfront licensing fee, development and regulatory milestones and royalties. Seikagaku will be held responsible for completing the development of the product and obtaining U.S. regulatory approval. Following FDA clearance, Ferring will commercialize the product in the U.S. and will have further rights to develop, register and commercialize condoliase worldwide, excluding Japan.

StemCells, Inc. and Microbot Medical Ltd.entered into a definitive merger agreement, in order to pursue the development of robotics based medical devices for the treatment of cerebrospinal fluid and gastrointestinal disorders, as well as other conditions. The merger provides Microbot access and greater exposure to the U.S. capital markets and concludes StemCells' extensive search for strategic alternatives since the company was unable to demonstrate robust clinical data in its Phase II clinical trial of its human neural stem cells platform in the treatment of chronic spinal cord injury.

Stryker entered into a definitive agreement to acquire the assets of Instratek, a company specializing in staple and hammertoe implants and minimally invasive soft tissue recession instrumentation for foot, ankle and upper extremity procedures. The transaction is believed to close in the fourth quarter of 2016.

Zimmer Biomet acquired Clinical Graphics, a novel imaging company specializing in 3-D range-of-motion simulation technology that informs early treatment decisions for common hip conditions such as femoroacetabular impingement and dsyplasia. The company plans to integrate Clinical Graphics' technologies with their resources to facilitate the next generation of 3-D imaging for the treatment of joint pain.

REGULATORY
Meditech Spine received 510(k) clearance from the FDA for its CURE Anterior Cervical Plates (ACP), a titanium plate made from Invibio Biomaterial Solutions' PEEK-OPTIMA HA Enhanced material. The implant is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine in skeletally mature patients with Degenerative Disc Disease (DDD). The system is named in honor of CURE International, a non-profit focused on providing medical care to children suffering primarily from orthopedic and neurological conditions, and a portion of proceeds from the sale of every system will go to treat patients in need of surgical care in underserved areas.

INTELLECTUAL PROPERTY
Progenerative Medical (PGM) entered into a technology licensing agreement with Kinetic Concepts (KCI). Under the terms of the agreement, PGM obtained exclusive rights to KCI's intellectual property and preclinical product development portfolio enabling effective delivery of negative pressure therapy for spine and orthopedic indications.

CLINICAL
Implanet announced clinical results from the first surgical procedures using its Jazz Lock implant, intended for degenerative spine disorder procedures. The clinical results indicate positive results in over 25 cases in France, Italy and the United States. The implant is based on the company's polyester sublaminar braid platform and is designed to simplify procedures by replacing the locking screw and connecting rod with its locking system.

OrthoFix enrolled its first patient in the company's clinical trials, evaluating the use of pulsed electromagnetic field (PEMF) technology for osteoarthritis (OA) of the knee. The study will assess the company's Physio-Stim system, which aims to reduce inflammation and cartilage breakdown, restore extracellular matrix homeostasis and provide pain relief and new cartilage formation. The prospective, ramdomized, double-blind trial will enroll 150 patients at three U.S. sites, if successful, this system will be the first disease-modifying treatment for osteoarthritis.

DISTRIBUTION
Medovex entered into an agreement with M.Fast Technologies for the of Medovex's DenerveX System in Israel. The system combines a single-use device and power generator to provide a minimally invasive treatment for pain associated with facet joint syndrome.

Vertebral Technologies (VTI) announced its agreement with Bio Med for the distribution of VTI's InterFuse S and InterFuse T spinal fusion devices in Mexico. The system is utilized in over 20 countries and employs a large footprint through an intra-body modular assembly technique using a minimally invasive posterior and transformational approach.

VEXIM entered into a distribution agreement with Creatori Health for the distribution of its SpineJack in South Africa. SpineJack is an intravertebral implant for the anatomical restoration of vertebral compression fractures caused by excessive craniocaudal unidirectional compression force. VEXIM's portfolio has received reimbursement from a medical health insurance company in South Africa.


StemCells and Microbot Medical Announce Merger

StemCells, Inc. and Microbot Medical Ltd. entered into a definitive merger agreement, in order to pursue the development of robotics based medical devices for the treatment of cerebrospinal fluid and gastrointestinal disorders, as well as other conditions.

StemCells is in the clinical development of its proprietary HuCNS-SC product, a purified human neural stem cells platform technology intended to treat the degregation of the three components of the human central nervous system (CNS), the brain, spinal cord and eye. The company also markets stem cell research products, including media and reagents, under its SC Proven brand. StemCells went public on the NASDAQ on March 25, 1992, and is based in Newark, CA.

Microbot Medical develops micro-robotics assisted medical technologies. The company's product portfolio consists of its ViRob device, an autonomous crawling micro-robot that is controlled by electromagnetic fields, TipCAT, a semi-disposable, self-propelled endoscope, Self-Cleaning Shunt, a robotic system that intends to prevent occlusions in the proximal cerebrospinal fluid shunt system, and TipCAT colonoscope, a self-propelled semi-disposable colonoscope. The company is based in Yokneam, Israel, and was co-founded in 2010 by Moshe Shoham, a co-founder of Mazor Robotics.

The merger provides Microbot access and greater exposure to the U.S. capital markets and concludes StemCells' extensive search for strategic alternatives since the company was unable to demonstrate robust clinical data in its Phase II clinical trial of its human neural stem cells platform in the treatment of chronic spinal cord injury.



Complete Archive