LDR filed to raise up to $150 million in new capital through a "shelf” registration process utilizing any combination of offerings of common and preferred stock, debt securities or warrants. As the registration is valid for up to three years, the company may determine not to begin to raise capital at this particular time. The company raised $75 million in proceeds through its initial public offering (IPO) process in 3Q:13.
OrthogenRx raised $575,000 in financing from Ben Franklin Technology Partners. The orthopedic device company plans to use the funds on the development of new products and to finance applications for FDA product approval. OrthogenRx expects approvals in 2014 and sales in 2015.
Sonoma Orthopedic Products secured a $12 million investment from First Analysis, intended to enable the company to receive FDA clearance on its new ankle implant, to launch the product, and to scale commercially. Sonoma develops surgical orthopedic implants for wrist, ankle, collarbone, or smaller bone fractures that are difficult to access with standard surgical nails.
Zyga Technology raised $2 million in an equity-and-options round from four undisclosed investors. The company plans to eventually raise a total of $5 million through this round.
AxioMed Spine entered into an agreement to be acquired by KICVentures, after the company was put up for sale by its senior secured lender. The company's product portfolio is commercialized in Europe, but not yet in the United States. AxioMed has finished enrolling 400 patients in a pivotal U.S. study designed to test its Freedom Lumbar Disc. It is anticipated that AxioMed will work closely with another one of KICVentures investments, SpineFrontier, which focuses on less exposure surgery technologies for outpatient spine surgery.
A plan by New Zealand and Australia to create a single agency called the Australia New Zealand Therapeutic Goods Agency (ANZTPA), to regulate the medical device sector in both countries, has been dropped after a comprehensive review of the costs and progress of the plan. Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (MedSafe) will continue to oversee their respective marketplaces separately.
EOS imaging received 510(k) clearance from the FDA for its hipEOS, 3D hip arthroplasty planning software based on the company's stereo-radiographic 2D/3D imaging. The software enables surgeons to perform, using EOS unique stereo-radiographic 2D/3D low dose images, pre-surgical planning including hip implant selection and virtual positioning in a functional, weight-bearing 3D image.
Karmed Saglik received CE Mark approval for its Superfusion interbody cages, made from Invibio's PEEK-OPTIMA HA Enhanced polymer, for the treatment of degenerative cervical and lumbar conditions. The polymer is offered by Invibio Biomaterial Solutions.
Kaiser Permanente, Weill Cornell Medical College, and worldwide registries collaborated to demonstrate the significance of tracking medical devices' effectiveness and safety, specifically of hip and knee implants, after implantation. Public health and regulatory agencies in the U.S. and internationally acknowledge that there are gaps both in the ability to track these devices and to provide the public the accurate, evidence-based information consumers need to improve their health and make informed care decisions. Researchers analyzed data from seven national and regional registries to examine the performance and safety of hip and knee implants. The registries are part of the International Consortium of Orthopedic Registries, an initiative that aims to address major gaps in evidence related to implants, as well as demonstrate the importance of registries and international collaboration for the evaluation of performance and patient safety worldwide.
Expanding Orthopedics (EOI) entered a multi-million dollar agreement with Trout Medical, to distribute its FLXfit 3D expandable cage in the state of Texas. FLXfit offers patients an "all in one" fusion solution that incorporates an MIS capability, great footprint, large bone graft chamber, smoother insertion and placement, and a lordotic expansion designed to correct sagittal balance.
SDRI entered into a five-year agreement with JOIMAX GmbH for exclusive rights to market and distribute the company's SYNERGY family of products in Germany, Austria and Switzerland. SYNERGY Disc is a cervical disc replacement designed to correct pre-operative deformity, prevent post-operative misalignment and provide optimal stability for multi-level procedures. The system incorporates multiple alignment corrections to help provide surgeons with control of lordosis and sagittal balance. Joimax is a leading medical device distributor for minimally invasive spinal surgery.
Baxano Surgical's bankruptcy auction has been set for January 22, 2015. The company's assets include $6.4 million in net implant and instrument inventory, consisting of $2.5 million in VEO Lateral Interbody, $2.1 million in AxiaLIF and $1.45 million in iO-Flex/iO-Tome. The company has $7 million in secured creditor claims payable to Hercules Technology Growth Capital, an additional $28 million in unsecured claims payable to former employees, distributors, vendors, and other investors, as well as a $4 million settlement payable to the federal government.
K2M Group plans to relocate its global headquarters and research and development operations to a new 146,000-square-foot facility in Leesburg, VA. The approximately $28 million project is expected to create 97 new jobs and retain 268 jobs.
Sirona reported financial results for its 4Q:14. Total revenue was $290.0 million in 4Q:14, increasing 4% compared to $278.6 million in 4Q:13. Gross margin increased in 4Q:14 to 55.1% from 51.4% in 4Q:13. The company's segments grew at: Instruments +13%, CAD/CAM (5%), Imaging Systems (0%), and Treatment Centers +28% in 4Q:14. All growth rates are on a constant currency basis.
Patterson Companies entered into an agreement to acquire Holt Dental Supply, a regional dental supply company that serves dental practices in Wisconsin, Illinois, Minnesota, Missouri, Michigan and Indiana. The transaction helps accelerate Patterson's local reach and deepens its Midwest influence. Total sales for Holt Dental in 2013 were approximately $15 million. Patterson anticipates the deal to be modestly accretive in its first year.
Product Introduction & Update
Align Technology launched first premolar innovations for its Invisalign G6 clinical extraction, designed to improve clinical outcomes for orthodontic treatment of severe crowding and bimaxillary protrusion. The new premolar extraction solution provides vertical control and root parallelism by utilizing the company's new SmartStage technology and SmartForce features which aim to optimize the progression of tooth movements for first premolar extraction treatment planned for maximum anchorage. Additionally, the company expanded its chairside CAD/CAM workflow options for its iTero intraoral scanner by announcing connectivity to IOS Technologies. These new workflow options provide a broader spectrum of available CAD/CAM options to clinicians who wish to offer in-office same-day crowns, inlays, onlays and veneers.
Henry Schein appointed Dr. Lawrence Bacow to its Board of Directors, increasing the size of the Board to 15 Directors. Prior to Henry Schein, Dr. Bacow served as President of Tufts University for ten years, where he oversaw all seven of the University's schools, including its School of Dental Medicine, School of Medicine and the Cummings School of Veterinary Medicine. He also served on the Board of Trustees and as a member of the executive committee of Tufts Medical Center.
LDR filed to raise up to $150 million in new capital through a "shelf” registration process utilizing any combination of offerings of common and preferred stock, debt securities or warrants.
As the registration is valid for up to three years, the company may determine not to begin to raise capital at this time.
The company plans to use the potential proceeds for general corporate purposes, which may consist of working capital, capital expenditures, repayment or refinancing of indebtedness, acquisitions, repurchases and redemptions of securities, other corporate expenses and acquisitions of products, technologies or businesses.
LDR develops surgical implants, devices, and instrumentation for the treatment spinal disorders. The company's primary products are its VerteBRIDGE fusion and Mobi non-fusion platforms, both designed for applications in the cervical and lumbar spine. The company raised $75 million in proceeds through its initial public offering (IPO) process in 3Q:13.
Aurora Spine reported 3Q:14 financial results. Total revenue was 543.4 thousand in 3Q:14, representing an increase of 635% compared to $73.9 thousand in 3Q:13. Gross margin for 3Q:14 decreased to 46.4%, from 50.0% in 3Q:13. During 3Q:14, the company expanded operations in the United Kingdom, Germany, Italy and other European countries and Israel. Sales outside of the U.S. represent 25% of revenues for 2014. The company is comprised of three segments: Spinal Implants, Discovery PEEK Cervical Implants and Biologics. Furthermore, the company launched its TiNano Interbody systems, a Titanium Plasma Spray coating on Invibio PEEK Interbody implants and conducted the first U.S. surgery utilizing its ZIP Graft pre-packaged sterile bone dowel.
Flower Orthopedics raised $2.2 million in a private stock sale. According to its Form D filing, the company is seeking to raise a total of $4.5 million. The company is the developer of FlowerCube, a surgical kit containing implants and disposable instruments needed for bone-fixation procedures.
Symmetry Surgical completed its separation from Symmetry Medical, which was sold to Tecomet for $450 million in cash or 1.4x LTM revenues. Symmetry Surgical will focus on the reusable general surgical instrument market and begin trading on the NASDAQ under the symbol "SSRG".
The FDA has postponed its Orthopaedic and Rehabilitation Devices Panel meeting on the Premarket Approval application (PMA) for Vertiflex's Superion InterSpinous Spacer (ISS) to February 20, 2015 in order additional time required by the FDA to review the presented data of the sponsor. The spacer is a motion-preserving, indirect decompression spinal implant system for the treatment of moderate lumbar spinal stenosis.
Aurora Spine received the Health Canada Medical Device License for its ZIP MIS Interspinous Fusion System, a fixation implant for spinal fusion. The system consists of a ONE-STEP locking mechanism, articulating spikes and various sizes to accommodate variations in patient anatomy. The Screwless-Procedure has been developed to increase the possibility of significant benefits to patients, hospitals, and surgeons, including reduced surgery time, shorter hospital stays, and faster recovery time.
DePuy Synthes received 510(k) clearance from the FDA for its VEPTR/VEPTR II Vertical Expandable Prosthetic Titanium Rib Devices for the treatment of Thoracic Insufficiency Syndrome (TIS), a rare congenital condition where severe deformities of the chest, spine or ribs impair breathing and lung growth in children. VEPTR/VEPTR II Devices include a system of curved titanium rods that are surgically attached to the ribs, spine or pelvis to stabilize and straighten the spine, and to create a separation between ribs to potentially improve breathing and enable normal lung growth and development. After an initial procedure, the VEPTR/VEPTR II Devices are lengthened as a child grows using minimally invasive techniques.
THINK Surgical received 510(k) clearance from the FDA for its TSolution One, an active robotic system for total hip arthroplasty (THA). The system consists of the company's TPLAN 3-D planning workstation, which assists surgeons with preoperative planning by creating a 3-D model of the patient's anatomy based on CT images, and the TCAT computer-assisted tool, which creates a preoperative plan of the patient's anatomy to prepare their bone cavity and joint surface.
SpineGuard received certification from the Brazilian governmental regulatory authority, (Agência Nacional de Vigilância Sanitária (ANVISA), allowing the company to initiate the registration process for the company's Curved, Cannulated and XS versions of its PediGuard handheld device for pedicle screw-based stabilization.
VEXIM received 510(k) clearance from the FDA of its Masterflow Injection System for mixing and injecting orthopedic cement. The system targets the vertebral augmentation (back trauma) market and aims improve simplicity, accuracy and control of the injection of ultra-high-viscosity cement to treat vertebral fractures.
PRODUCT INTRODUCTION & UPDATE
Hunter Medical launched its ElbowLOC Arm Positioning System, a surgical assist device that aims to improve procedural and anesthetic times in the operating room (OR). The system intends to simplify patent positioning while enhancing humeral stability and for quicker arm positioning/preparation.
Lima Corporate announced that 100,000 of its C2 Hip Stem have been implanted to date since initial launch. For 2014, the company is on track to exceed 40,000 implants of its entire Hip Femoral Prosthesis line.
Minimus Spine announced the first patient surgical cases utilizing its Triojection System, intended to treat patients suffering from leg pain associated with a lumbar disc herniation. Triojection is a percutaneous procedure involving the controlled delivery of ozone gas to a herniated disc.
IlluminOss Medical received two patents from the U.S. Patent and Trademark Office (USPTO) regarding the company's internal bone fixation system. The patents provide coverage for the company's internal bone fixation devices and kits for repairing a weakened or fractured bone, as well as internal bone fixation devices and systems for internal fixation of a fractured bone, and methods for internal fixation of a fractured bone.
Stryker Corporation entered into a settlement with the U.S. Department of Justice (DOJ) in connection with the DOJ's civil and criminal investigations into the sales and marketing of the OtisKnee prior to Stryker's acquisition of OtisMed in November 2009. Stryker and OtisMed will pay $79.6 million plus interest.
Intrinsic Therapeutics completed patient enrollment for the company's randomized superiority clinical trial of its Barricaid anular closure device. The 550 patient controlled trial investigates reherniation, reoperation, economic impact, and risk-factors associated with clinical outcomes following lumbar discectomy and includes radiographic, economic, and clinical components.
A team of researchers at Columbia University Medical Center describe a newly developed methodology in a paper published in Science Translational Medicine, to replace the human meniscus utilizing a personalized 3-D printed implant (scaffold) infused with human growth factors. In the study, the method was tested in 11 sheep (whose knee closely resembles that of humans), whose menisci regenerated in about four to six weeks. In the postmortem analysis, the researchers noted that the regenerated menisci in the treatment group had structural and mechanical properties very similar to those of natural meniscus.
BONESUPPORT entered into a partnership agreement with Orthocell to co-develop, Celgro, a collagen scaffold facilitate bone repair and growth. The partnership will utilize BONESUPPORT's CERAMENT, an injectable synthetic bone substitute used for orthopaedic trauma, bone infection and instrumentation augmentation, for the platform's delivery.
A team of researchers at Columbia University Medical Center describe a newly developed methodology in a paper published in Science Translational Medicine, to replace the human meniscus utilizing a personalized 3-D printed implant (scaffold) infused with human growth factors.
Damaged menisci are rather difficult to repair due to the limited bloodflow the tissue receives. Small tears can be sewn back in place, but larger tears have to be surgically removed. While removal helps reduce pain and swelling, it leaves the knee without a shock absorber between the femur and tibia, greatly amplifying the risk of arthritis. The tissue can be replaced with a meniscal transplant, which utilizes tissue from other parts of the body or from cadavers. However, this procedure has a low success rate and carries significant risks.
The researchers' method begin with MRI scans of the intact meniscus in the undamaged knee, which are then converted into a 3-D image. Data collected from the image are then used to direct a 3-D printer, which produces a scaffold in the exact shape of the meniscus. The scaffold is then printed from polycaprolactone, a biodegradable polymer surgical sutures are made of.
The scaffold is then permeated with two recombinant human proteins. The first being a connective growth factor (CTGF) and the second, a transforming growth factor β3 (TGFβ3). The team noted that sequential delivery of these two proteins attracts existing stem cells from the body and encourages them to form meniscal tissue.
For a meniscus to properly form though, the proteins must be released in specific areas of the scaffold in a certain order. The team achieved this by encapsulating the proteins in two types of slow-dissolving polymeric microspheres, first releasing CTGF and then TGFβ3, which stimulates the production of the outer and inner meniscus respectively. Once the implant is inserted in the knee, it eventually dissolves and is eliminated by the body.
In the study, the method was tested in 11 sheep (whose knee closely resembles that of humans), whose menisci regenerated in about four to six weeks. In the postmortem analysis, the researchers noted that the regenerated menisci in the treatment group had structural and mechanical properties very similar to those of natural meniscus.
The research team is now conducting studies to determine whether the regenerated tissue is long-lasting. Once the team has received the necessary funding, they are planning to begin the clinical trials.
Symmetry Surgical Inc. completed its separation from Symmetry Medical Inc., which was sold to Tecomet for $450 million in cash or 1.4x LTM revenues.
Symmetry Surgical will focus on the reusable general surgical instrument market and begin trading on the NASDAQ under the symbol "SSRG".
The separation allows Symmetry Surgical to focus on the reusable general surgical instrument market, which management believes will help optimize the company's sales channels and cost structure, and provides capital to evaluate a wider scope of strategic opportunities and acquisitions in orthopedic implants and adjacent medical device marketplaces. Furthermore, the divestiture frees the new company from the financial limitations associated with its current capital structure and potential conflicts with, or volatility of capital spending of, OEM customers.
Symmetry Medical is the Original Equipment Manufacturer (OEM) Solutions division of the business. The segment focuses on manufacturing:
- Forged, cast and machined medical implants
- Instruments used in the placement and removal of orthopedic implants and in other surgical procedures
- Plastic, metal and hybrid cases used for orthopedic, endoscopy, dental and other surgical procedures
- Specialized products for the aerospace market.