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Orthopedic and Dental Industry News Complete Archive »

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Amendia Acquired Custom Spine

Amendia announced that it acquired of Custom Spine, Inc., a developer of spinal implants and instruments for the treatment of spinal disorders.

One of Custom Spine's core technologies is its Pathway articulating vertebral interbody device (AVID), which features three intra-linked PEEK cages that are inserted using a standard transforaminal approach. The product aims to offer better placement control with a large footprint to increase structural support.

This transaction provides Amendia with a comprehensive product portfolio that incorporates a vertically-integrated business model designed to maximize efficiencies, cost savings and customer service, positioning Amendia for scalable and sustainable growth. For example, management anticipates Pathway will have an immediate positive impact on Amendia's distribution network. Furthermore, Custom Spine holds the rights to 40 patents in its IP portfolio which is expected to instantaneously increase the breadth and depth of Amendia's R&D pipeline.

Custom Spine was founded in 2003 and is based in Parsippany, New Jersey.


Bacterin to Acquire X-spine Systems for $86M

Bacterin International entered into an definitive agreement to acquire X-spine Systems, Inc., a manufacturer for surgical spinal procedure devices, for an approximate enterprise value of $85.9 million, or 2.0x 2014 revenues of $42.2 million, or 11.7x 2014 EBITDA of $7.3 million.

Under the terms of the agreement, the total consideration Bacterin will pay for the outstanding capital stock of X-spine is comprised of $60 million in cash and the issuance of 4.24 million shares of Bacterin common stock at an issue price of $4.00 a share. Additionally, concurrent with the deal's closing, the combined company will change its name to Xtant Medical Holdings.

The transaction positions Xtant as a comprehensive supplier for spine surgery procedures that offers both hardware and biologics with pro forma revenues and EBITDA for 2014 of approximately $77.5 million and $3.9 million respectively. X-spine offers numerous products for the treatment of spinal disease, with an emphasis on less-invasive treatments for the degenerative spine. X-spine's implants and instrumentation are highly complementary to Bacterin's orthobiologics portfolio, and expands Bacterin's breadth of product offerings and distribution capabilities, and strengthens the company's overall customer relationships.

The deal will be funded by an amended and restated $42 million senior secured debt facility with OrbiMed at an annual interest rate of 14% plus LIBOR (minimum 1%) and $65 million in convertible senior notes with a maturity July 2021.


Musculoskeletal News Roundup 23-July-15

EARNINGS
CONMED Corporation reported financial results for 2Q:15. Total revenue was $181.0 million in 2Q:15, missing consensus estimates by 1% and representing an decrease of 0.4% compared to $188.2 million in 2Q:14. Adjusted EBITDA was $28.8 million in 2Q:15, decreasing from $32.8 million in 2Q:14. Adjusted EBITDA margin decreased to 15.9% in 2Q:15 from 17.4% in 2Q:14. Gross margin for 2Q:15 decreased to 51.6% from 53.7% in 2Q:14. The company's segments grew by: Orthopedic Surgery (1%), General Surgery +2% and Surgical Visualization (9%) respectively in 2Q:15. International sales represented 50.8% or total revenue in 2Q:15 and decreased 3% compared to 2Q:14. All growth rates are on a constant currency basis.

GS Medical reported financial results for 2Q:15. Total revenue increased 10% in 2Q:15 compared to 2Q:14 as a result of expansion of the company's distribution network. The company stated that it has several products in development and under FDA review.

FUNDING
Vertiflex secured $4.8 million in debt financing through a $5 million convertible corporate debt and warrant offering.

M&A
The private equity firm, Arlington Capital Partners, acquired Avalign Technologies, an OEM manufacturer of implants and instruments, specialty instrumentation, cutting tools, and cases and trays to the orthopedic medical device and specialty surgical markets. Arlington acquired Avalign from RoundTable Healthcare Partners, another private equity firm.

Integra LifeSciences completed its previously announced acquisition of TEI BioSciences and TEI Medical (TEI). TEI is a biomedical company that offers regenerative technology-based products for soft tissue repair and regeneration applications including dura, hernia, tendon and abdominal wall repair and plastic and reconstructive surgery.

Mindray Medical competed its previously announced acquisition of Wuhan Dragonbio for RMB 435 million ($70.2 million). Mindray now holds 100% of Dragonbio, a Chinese manufacturer of trauma, spine and joint medical devices and other surgical products.

REGULATORY
Captiva Spine received 510(k) clearance from the FDA for its SmartLox enhanced cervical plate system and proprietary Nitinol self-locking screw mechanism. The system has been engineered for ease of use, enhanced control, and predictable performance. SmartLOX features large graft/endplate windows for clear visualization, flush/smooth screw head profile, and options for self-tapping, self-drilling, fixed and variable angled screws.

ChoiceSpine received ISO Certification for its quality management system. This certification from the International Organization Standardization facilitates compliance to the requirements of customers and various global regulators.

St. Jude Medical received FDA clearance for its Invisible Trial System, intended to help manage chronic pain originating at the patent's spinal cord. The therapy relies on a small implanted device and leads to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain, which reduces the sensation of pain. Since this connection is wireless, and the EPG can be worn under the clothing, the system looks invisible to the wearer.

PRODUCT INTRODUCTION & UPDATE
4WEB Medical completed the development of its first 3-D printed, patient specific implant in Australia. The company uses 3-D software reconstructions of the patient's anatomy acquired from a CT scan, enabling the surgeon to plan the bone resections. 4WEB then produces the patient specific truss implants using an additive manufacturing process leverging 3-D printing technology. The resections utilize a open architecture truss design, similarly engineered in bridges and buildings, providing a scaffolding for structural support and osseous incorporation.

Silver Bullet Therapeutics announced its plans for the European launch of its OrthoFuzion Antimicrobial Bone Screw System in 3Q:15. The system utilizes silver ion technology that encourages ionization of the silver and creation of an antimicrobial zone around the screw.

Xenco Medical announced the first spine surgery utilizing its Argus Cervical Interbody system, constructed from disposable, plastic surgical rasps and implant inserter. The instruments are engineered from a durable combination of nylon plastic and fiberglass and are disposed of at the end of the surgery. As the instruments are disposable, the chance of infection due to reused, improperly sterilized instruments is eliminated. Argus is intended for cervical spinal fusion procedures at one level in patients with degenerative disc disease.

INTELLECTUAL PROPERTY
Silver Bullet Therapeutics received two new patients from the U.S. Patent & Trademark Office (USPTO) for "coatings for the controllable release of antimicrobial metal ions" and for "bone implant and systems that controllably release silver." The expansion of their IP portfolio allows the company to apply its antimicrobial technology on a range of medical devices and implants, including orthopedic screws, hip and knee prostheses.

CLINICAL
Cartiva announced it has successfully met the primary endpoint of its pivotal (Phase III) randomized controlled trial evaluating the safety and effectiveness of its Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis of the first metatarsophalangeal (MTP) joint. The 192-patent randomized, prospective study was conducted at 12 sites in Canada and the United Kingdom and compared Cartiva to arthrodesis (the current standard of care). At the 95% confidence interval, 79% of the Cartiva met the definition of success compared to 62% of the arthrodesis control patients.

Researchers at the University of Sheffield demonstrated that the application of small quantities of antibiotics to the surface between the polymer layers of orthopedic and dental implants can help prevent bacteria and other harmful microorganisms from attaching, and subsequently growing onto the implant, which can result in deadly diseases like sepsis.

Safe Orthopaedics announced the results of a retrospective clinical study, examining the advantages of its sterile single use instrumentation intended for lumbar fusion of degenerative spine disease. The 45 patient study completed lumbar fusion using Safe's Sterispine kits, and demonstrated no cases of infection.

OPERATIONS
Episurf Medical established a UK subsidiary and sales team to market its minimally invasive, personalized treatment for knee and cartilage damage. Management believes that Episurf's treatments improved outcome and reduced cost profile fits the UK's National Health Service (NHS) guidelines.

RESEARCH
U.S. News & World Report released their annual list of the best orthopedic hospitals in the country this week, and New York City's Hospital for Special Surgery (HSS) topped the list once again in 2015. The only change in the top five from last year's list was Boston's Massachusetts General Hospital edged out New York City's Hospital for Joint Diseases for the #4 spot.

APPOINTMENTS
IlluminOss Medical appointed Clive Ridgewell as Vice President of Sales. Mr. Ridgewell previously served 21 years at Zimmer holding a number of senior exective roles within its European, Middle Eastern and African operations, most recently as Vice President of the Trauma.

NuVasive appointed Jason Hannon as Executive Vice President, International. Mr. Hannon has spent the last 10 years at NuVasive serving as General Council. He will continue serving as NuVasive's General Counsel as well until a successor is identified.

Titan Spine appointed Jim Sevey as Senior Nanotechnology Specialist. Mr. Sevey previously served in several positions at Synthes/Depuy Biomaterials, including most recently, Manager, Biomaterials Technical Specialist.


Researchers Utilize Nanotechnology to Develop an Antibiotic Delivery Approach to Protect Orthopedic and Dental Implants from Infection

Researchers at the University of Sheffield demonstrated that the application of small quantities of antibiotics to the surface between the polymer layers of orthopedic and dental implants can help prevent bacteria and other harmful microorganisms from attaching, and subsequently growing onto the implant, which can result in deadly diseases like sepsis.

Such bacteria are known to attach to implants during surgical procedures and are notoriously difficult to treat once they are on a non-living surface. Only two-thirds of patients suffering prosthetic joint infections are alive after five years, which is a lower survival rate than some types of cancer. However, the researchers revealed that by making the actual surface of the surgical implant inhospitable to such microorganisms, the risk of deep bone infection is substantially reduced.

The UK-based research team utilized nanotechnology to modify the many small polymer layers inside implants, which measure between 1 and 100 nanometers (to put in perspective, a human hair is approximately 100,000 nm wide), by adhering antibiotics to the layers. In the study, the team revealed that such technology can not only inhibit the initial infection, but the secondary infection as well.

The researchers believe this new application for nanotechnology can improve the quality of life for patients, as well as save health providers, such as the UK's National Health Service (NHS), millions of pounds a year.



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