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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 23-June-16

FUNDING
Mainstay Medical completed a €30.0 million ($33.7 million) placement of 2,307,694 new ordinary shares led by KCK Ltd. and also between new and existing shareholders in Europe and North America. The shares were sold at a price of a price of €13.00 ($14.60). Mainstay will use the new capital to support European commercialization and for the U.S. PMA clinical trial for its ReActiv8 technology, an implantable neurostimulation system intended to treat disabling chronic low back pain.

OrthoPediatrics Corp. filed an S-1 to raise up to $75 million through an initial public offering (IPO) of common shares. The price range and number of shares to be sold in the offering has not yet been determined. OrthoPediatrics develops medical devices for the pediatric orthopedic market, a market the company feels has been underserved as historically, there have been a limited number of implants and instruments designed for the needs of children, leaving pediatric orthopedic surgeons to often improvise with freehand techniques and repurposed adult implant systems. The company intends to use the proceeds to pay accrued dividends on the company's Series B Preferred Stock, expand sales and marketing and research and development initiatives, pay down its revolving credit facility with Squadron, invest in implant and instrument sets for consignment for its customers, working capital and general corporate purposes, and to potentially to acquire or invest in complementary products, technologies or businesses.

SI-BONE closed a $20 million round of growth capital financing led by new investor Arboretum Ventures and included the participation of all of the company's existing major investors. The proceeds will be used primarily to fund expansion of the U.S. sales organization and incremental R&D activity to support the development and commercialization of new products.

REGULATORY
SI-BONE received coverage clearance from the FCSO the Medicare Administrative Contractor (MAC) covering the state of Florida as well as Puerto Rico and the U.S. Virgin Islands. The coverage extends to the company's iFuse Implant System, a minimally invasive device for sacroiliac (SI) joint fusion procedures. iFuse is for the treatment of chronic back pain due to SI joint dysfunction caused by degenerative sacroiliitis and SI joint disruption.

Spinal Elements received 510(k) clearance from the FDA for its line of expandable interbody fusion devices intended for posterior, anterior and lateral access to the lumbar spine. The implants are made from radiolucent polyetheretherketone (PEEK) material and the company's Ti-Bond porous titanium coating which helps allow the material to be more load sharing.

SpineGuard received 510(k) clearance from the FDA for its new PediGuard Threaded DSG device, indicated for open or minimally invasive approaches for pedicle screw insertion during spinal fusion procedures. The disposable device is available in multiple sizes to adjust to surgeons' preferences and patients' anatomy.

PRODUCT INTRODUCTION & UPDATE
Centinel Spine launched its STALIF L No-Profile system, a minimally invasive lateral lumbar Integreated Interbody device in the U.S. market and received clearance from the Therapeutic Goods Administration (TGA) in Australia to market the device in that country. STALIF features compressive lag fixation technology to assure the compression between the device and bone graft, and the company's proprietary anti-backout technology to avoid migration.

Exactech launched its Acapella One Cervical Spacer System, a cervical cage designed for disc restoration during anterior cervical spinal fusions. The system is pre-assembled with integrated anchors, which aim to simplify the procedure by allowing for a single-step deployment of both the integrated anchors simultaneously into the vertebral endplates.

Medtronic outlined other strategic initiatives within the robotics marketplace, including certain parameters on the launch of its proprietary robot-assisted surgical platform. Medtronic disclosed that the company anticipates to launch a standalone surgical robotic platform prior to its 2019 fiscal year (commences on June 1, 2018), and that the new robotics system will begin contributing material revenue (50 to 150 basis points of growth) to the company during its 2019 fiscal year. Medtronic intends to do this through its "Surgical Synergies" integrated platform initiative. With this initiative, the company will partner its various enabling technology platforms, such as its intraoperative imaging, navigation, power tools and robotics systems, with its medical device portfolio at the procedural level.

PONTiS Orthopaedics launched its PONTiS Achilles System, the company's proprietary multifilament stainless steel implant for the repair of injured Achilles tendons. The minimally invasive system aims to decrease operating time and is the first foot and ankle system developed by the company.

Spineology launched its line of Elite Expandable Interbody Fusion systems implants designed to correct the anatomical alignment of the spine. The Elite line aims to minimize neural retraction and to provide the patient with anatomy conserving procedure.

Zimmer Biomet launched new enhancements for its OSS Orthopedic Salvage System, a comprehensive set of joint reconstruction implants designed to treat patients suffering from bone loss due to tumor resection, ligamentous deficiencies, orthopedic trauma or patients who have undergone multiple knee and hip revision replacements. The company updated the system's sizes, distal femoral component, tapered Diaphyseal Segments and the Splined Stems.

CLINICAL
Life Spine completed the initial clinical cases for its LONGBOW Expandable Lateral Space System, an interbody designed to expand laterally in-situ for a direct lateral approach during minimally invasive spinal procedures. The implant aims to maximize endplate coverage with very little anterior/posterior retraction in order to reduce nerve damage and simplify bone graft insertion.

Microbion enrolled the first patient in its Phase IIA clinical study for its MBN-101 therapy, a drug designed for the treatment of orthopedic implant-related infections, including multi-drug resistant infections like methicillin-resistant staphylococcus aureus(MRSA). The randomized, placebo-controlled, dose-ranging study aims to evaluate the safety and the anti-bacterial effectiveness of MBN-101 in the treatment of a broad range of pathogens and microbial biofilms. patient outcomes associated with orthopedic infections.

INTELLECTUAL PROPERTY
Aurora Spine received a patent from the United States patent and Trademark Office (USPTO) covering the company's family of ZIP MIS ISP technologies. ZIP is the company's line of minimally invasive regenerative spinal implants intended for a dynamic and non-dynamic interspinous fusions and bone growth stimulation.

Predictive Technology received a patent from the USPTO that covers the core technology behind a number of the company's therapeutic tests and companion diagnostic products. The company’s technologies are designed to diagnose the presence of spinal deformities and syndromes.

LEGAL
The U.S. District Court for the District of Arizonainvalidated Cayenne Medical's patent infringement allegations relating to MedShape's ExoShape Femoral Soft Tissue Fastener. Cayenne claimed that ExoShape infringed on its intellectual property surrounding soft tissue fixation to the bone.

APPOINTMENTS
Wright Medical announced the resignation of Terry Rich, the President of company's Upper Extremities division. Kevin Cordell, the company's current President of its Lower Extremities & Biologics group will take over Mr. Rich's responsibilities.

Xtant Medical appointed Paul Buckman, Eric Timko, and Rudy Mazzocchi to its Board of Directors. Additionally, the company announced the resignations Jon Wickwire and David Goodman, who served on the Board, and the company's Executive Vice President and Chief Scientific Officer, Dr. David Kirschman, the latter of which will continue their role as a Board member.


Medtronic Outlines Certain Details of its Strategic Initiatives in Robotics

Along with entering into a two-stage, multi-faceted, commercial agreement with Mazor Robotics for the co-promotion, co-development of robotic-based spine systems and applications, Medtronic outlined other strategic initiatives within the robotics marketplace, including certain parameters on the launch of its proprietary robot-assisted surgical platform.

Medtronic disclosed that the company anticipates to launch a standalone surgical robotic platform prior to its 2019 fiscal year (commences on June 1, 2018), and that the new robotics system will begin contributing material revenue (50 to 150 basis points of growth) to the company during its 2019 fiscal year.

Management revealed that the platform will first be launched in India due to the less stringent regulatory restrictions, and that initially, will focus on having the capability to perform any surgical procedures historically done by other robotic systems. Key areas the platform will target include colorectal, thoracic and bariatric procedures.

Management also divulged that the company has dedicated 150 employees to the development of the platform, and that the hiring phase has long since been completed. The employees are distributed across four different locations: the robotic arms are being developed in Germany, the software in Cambridge, MA, and the instruments in North Haven, CT, and Boulder, CO.

Historically, robotic-assisted surgical procedures have experienced higher costs than open or arthroscopic procedures due to the business model. However, Medtronic is aiming to develop a more flexible robotic platform that allows for greater utilization of the system in order to drive down the various price points for robotic-assisted procedures.

Medtronic intends to do this through its "Surgical Synergies" integrated platform initiative. With this initiative, the company will partner its various enabling technology platforms, such as its intraoperative imaging, navigation, power tools and robotics systems, with its medical device portfolio at the procedural level. For example, Medtronic plans to partner its relative instruments with the proprietary robotic system, and eventually partner spinal implants with a separate robotic platform, potentially Mazor's Renaissance system. Management believes an integrated platform strategy will be able to drive a more "seamless workflow" for surgeons, therefore, decrease procedural costs.

With its proprietary robotic platform, Medtronic will be competing against the market incumbent, Intuitive Surgical's da Vinci system, and Johnson & Johnson's developing robot-assisted surgery business, Verb Surgical. Other companies developing robotic surgical systems for the same markets include TransEnterix, Titan Medical and Hansen Medical.


OrthoPediatrics Proposes $75M IPO

OrthoPediatrics Corp. filed an S-1 to raise up to $75 million through an initial public offering (IPO) of common shares. The price range and number of shares to be sold in the offering has not yet been determined.

The company intends to use the proceeds to pay accrued dividends on the company's Series B Preferred Stock, expand sales and marketing and research and development initiatives, pay down its revolving credit facility with Squadron, invest in implant and instrument sets for consignment for its customers, working capital and general corporate purposes, and to potentially to acquire or invest in complementary products, technologies or businesses.

OrthoPediatrics develops medical devices for the pediatric orthopedic market, a market the company feels has been underserved as historically, there have been a limited number of implants and instruments designed for the needs of children, leaving pediatric orthopedic surgeons to often improvise with freehand techniques and repurposed adult implant systems. The company's product portfolio presently offers 17 surgical systems indicated for pediatric trauma and deformity, complex spine and anterior cruciate ligament(ACL) reconstruction procedures. OrthoPediatrics plans to expand its offerings into the foot and ankle, hand and wrist, clavicle, pelvis and other sports-medicine marketplaces.

As of March 31, 2016, the company had 34 independent domestic sales agencies employing more than 90 sales representatives focused on pediatrics. Internationally, OrthoPediatrics' sales organization is made up of 21 independent distributors across 29 countries.

For the 2015 fiscal year, the company reported total revenue of $31.0 million, representing an increase of 31% on a reported basis compared to $23.7 in 2014. Gross margin decreased to 69.8% in 2015 from 70.1% in 2014. As of March 31, 2016, OrthoPediatric's LTM revenues were $32.9 million.

The company plans to list on the NASDAQ Global Market (NasdaqGM) exchange under the ticker symbol "KIDS". Piper Jaffray and Stifel are acting as Lead Bookrunners on the deal, while William Blair and BTIG will serve as Co-managers.


Musculoskeletal News Roundup 16-June-16

M&A
Thompson Street Capital Partners (TSCP), a private equity firm, entered into an agreement to acquire the commercial operations of ISTO Technologies (ISTO), a Missouri-based orthobiologics company that provides solutions for spine and orthopedic indications. Under the agreement, TSCP will acquire ISTO's portfolio of products including InQu, Influx and CellPoint. TSCP plans to build upon ISTO’s commercialized orthobiologics platforms with continued investment in product development, salesforce expansion, and complementary acquisitions to expand the company's presence within the spine and orthopedic marketplaces.

Zimmer Biomet completed the acquisition of Compression Therapy Concepts, Inc. (CTC), a New Jersey-based developer of medical devices and accessories for the prevention of deep vein thrombosis (DVT). The company offers its VasoPress platform, which consists of numerous pump systems, and a variety of compression garments (SCD sleeves) for the patient's calf, foot and thigh regions. Zimmer plans to operate CTC as a wholly owned subsidiary.

REGULATORY
Amedica Corporation submitted responses to the FDA regarding the company's CASCADE clinical trial, which compared the 24-month outcomes from single-level cervical fusion between Amedica's porous silicon nitride and bone autograft. The data demonstrated that the company's porous silicon nitride achieved clinical and radiographic outcomes on a comparable level to bone autograft.

KB Medical received CE Mark clearance for its AQrate Robotic Assistance system, indicated for precise positioning of surgical instruments and spinal implants during general surgical spine procedures. AQrate features hardware and software that provides the surgeon with intra-op haptic steering.

SI-BONE received 510(k) clearance from the FDA to modify the indication statement to note that use of the company's iFuse Implant System, improves pain, patient function and quality of life. The revised indication statement is based on safety and effectiveness data from retrospective studies as well as three prospective clinical trials. iFuse is a minimally invasive surgical option for sacroiliac fusion due to joint dysfunction as a result of sacroiliac joint disruption and degenerative sacroiliitis.

SpineGuard received 510(k) clearance from the FDA for its new PediGuard Threaded DSG system, which can be utilized used in open or minimally invasive approaches for pedicle screw insertion. PediGuard features a single-use DSG pin embedded with a bipolar sensor and a distal tip with an awl-like tip to facilitate redirection of the device until the tip is past the pedicle isthmus.

Tyber Medical received 510(k) clearance from the FDA for its headed and snap-off screws systems, indicated for use throughout the extremities in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair and fracture fixation of bones. The systems feature the company's proprietary BioTy technology, a nanotopography surface modification which aims to hinder the adherence of bacteria to the implants.

PRODUCT INTRODUCTION & UPDATE
AlloSource launched two new demineralized cortical fiber allografts, AlloFuse Cortical Fibers and the AlloFuse Fiber Boat, indicated for various spine and orthopedic procedures. Both products were designed with the a regenerative medicine company, TheraCell, and they consist of 100% demineralized cortical bone and are meant to offer a less costly alternative to synthetic bone void fillers.

Amendia launched its Ceres-C Stand-alone Cervical Interbody device, indicated for anterior cervical interbody fusion procedures in patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1 segments of the spine. Ceres-C is a low-profile polyetheretherketone (PEEK) interbody spacer combined with a titanium plate and screws and features a cam locking mechanism designed to minimize procedural steps and operating room (OR) time.

Mazor Robotics announced the first U.S. PROlat procedure using the company's Renaissance robotic guidance system. Mazor's PROlat solution is a lateral lumbar interbody fusion (LLIF) procedure that utilizes the company's robotic navigation system.

SeaSpine launched its Hollywood VI NanoMetalene transforaminal lumbar interbody fusion system, indicated for use in spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). The system features SeaSpine's NanoMetalene technology, a sub-micron layer of pure titanium molecularly bonded to a PEEK-OPTIMA polymer from INVIBIO. The NanoMetalene coating is designed to have a modulus of elasticity similar to bone, and good radiographic visibility for post-op imaging.

Spineart announced that more than 15,000 implantations of its BAGUERA C system in cervical disc replacement procedures. BAGUERA C features shock-absorption technology, a guided mobile nucleus and is designed to be compatible with MRIs.

Titan Spine enhanced its spinal device warranty to provide a free replacement if any of the company’s Endoskeleton interbody fusion devices delaminate or generate particulate debris during implantation. The Endoskeleton platform of devices feature the company's proprietary implant surface technology, which consists of a unique combination of roughened topographies at the macro, micro, and nano levels and are designed to create a bone response from the patient and to encourage the upregulation of osteogenic and angiogenic factors necessary for bone growth.

INTELLECTUAL PROPERTY
Bone Biologics entered into an option agreement with UCLA to exclusively license the use of the bone growth factor, Nell-1, in the treatment of osteoporosis as a bone graft substitute. Nell-1 is a recombinant human protein growth factor that induces osteoblasts to encourage the bone regeneration process in spinal fusion procedures.

LEGAL
It has been reported that court filings suggest that Biomet breached a 2012 deferred prosecution agreement (DPA) which aimed to resolve a foreign corruption investigation based upon the company's conduct in the Brazilian and Mexican marketplaces. The Department of Justice (DOJ) noted that Biomet entered the DPA to settle allegations that it paid bribes to state-employed healthcare providers in Argentina, Brazil and China in order to secure business with hospitals.

APPOINTMENTS
CTL Medical Corporation, which was created with the merger of AccelSPINE and RF Precision, announced the company's executive team. Sean Suh will be appointed as the Chief Technology Officer, Andy Choi will become the Chief Business Development Officer, and Jon Suh will serve as the Vice President of Research & Development (R&D).

curasan AG appointed Shane Ray as the President of the company's American subsidiary curasan Inc. This appointment is part of the company's expansion plan for the next two years. curasan is targeting expansion in the U.S. and China.



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