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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 25-Sep-14

EARNINGS
Orthofix expects further delay of its restatement amendments and 2Q:14 Form 10-Q after the company determined that further data is required regarding certain inventory reserve amounts related to the company’s Spine Fixation devices that are held as consignment inventory.

FUNDING
Andiamo, a British-based developer 3D-printed, custom orthotics for disabled children, is in the process of a crowdfunding (the practice of funding a project or venture by raising monetary contributions from a large number of people, typically through the internet) to raise £60,000 ($98,000). The company plans to reduce wait times from six months to just a few days for back braces, hand splints and ankle-foot orthotics by utilizing 3-D scanning and printing.

Baxano Surgical completed a subordinated convertible note financing of approximately $1.5 million to extend its cash runway. Additionally, the company has also streamlined its business to reduce its operating expenses while maintaining its commercial operations. Last week, Baxano announced it was exploring potential strategic alternatives for business.

Intrinsic Therapeutics has raised $17.3 million of a proposed $20.9 million round from more than 28 investors including New Enterprise Associates, New Leaf Venture Partners and Spray Venture Partners. The company is developing the Barricaid Anular Prosthesis, an implant designed to treat large anular ruptures in patients experiencing lumber discectomy.

ReWalk Robotics priced its initial public offering (IPO) of 3.0 million shares of common stock at a price of $12.00 per share, raising total proceeds of $36 million. This equates to an enterprise value of approximately $155 million. The final terms came in lower than the initial proposed price range of $14 to $16 and number of shares to be offered of 3.4 million. ReWalk Robotics is medical device company that develops exoskeletons, devices that provide wheelchair-bound individuals with mobility impairments or other medical conditions, the ability to stand and walk once again.

Zyga Technology completed a $10 million round of financing, consisting of $8 million in debt supplemented with $2 million in equity. Silicon Valley Bank was the sole debt provider and the equity financing will be supported by all existing major investors. Zyga intends to use the proceeds to fund the expansion of its U.S. sales and marketing organization as it prepares for the implementation of a Category 1 CPT code for SI joint fusion procedures in January 2015, and to support three clinical studies.

M&A
Integra LifeSciences entered into an agreement with Medtronic to acquire Medtronic's MicroFrance and Xomed manual Ear, Nose & Throat (ENT) and laparoscopy instrumentation lines for approximately $60 million in cash. Under the terms of the agreement, Integra acquires a portfolio of approximately 4,000 MicroFrance and Xomed manual ENT and laparoscopic surgical instruments, as well as Medtronic's St. Aubin le Monial, France manufacturing facility.

The Blackstone Group entered into an agreement to acquire an unspecified stake in Xinrong Best Medical Instrument Co., a Chinese-based developer of orthopedic implants with Trauma, Spine and Joint applications, for a reported $100 million. Xinrong is planning to target hospitals and other care organizations in tier-2 and tier-3 Chinese cities and is aiming to be more competitive on implant pricing than multinational medical device manufacturers operating in the country.

REGULATORY
The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will meet to make recommendations on the Premarket Approval (PMA) application for Vertiflex's Superion InterSpinous Spacer in December.

Life Spine received 510(k) clearance from the FDA for its LONG BOW Expandable Lateral Interbody System, which expands laterally in-situ specifically for a direct lateral approach. The system aims to help surgeons decrease the amount of tissue retraction and potential nerve damage associated with the lateral access approach.

Nanovis Spine received 510(k) clearance from the FDA for its sterile packed FortiCore interbody fusion devices. FortiCore implants integrate BioSync highly porous titanium scaffold technology, licensed from SMed-TA/TD, with a PEEK core.

SI-BONE announced that the American Medical Association's (AMA) Current Procedural Terminology (CPT) Editorial Panel has published its CPT 2015 Professional Edition Manual, which includes a newly created Category I CPT code for minimally invasive surgical (MIS) sacroiliac (SI) joint fusion. The procedure is now recognized as an accepted standard of care for patients requiring sacroiliac joint fusion for certain conditions.

PRODUCT INTRODUCTION & UPDATE
4WEB Medical launched its Osteotomy Truss System, its largest offering of 3D-printed foot and ankle osteotomy implants. The system is indicated for internal bone fixation and osteotomies in the foot and ankle, such as Evans lengthening osteotomies, opening wedge osteotomies of Hallux Valgus, and Cotton opening wedge osteotomies, and offers 74 sizing options, helping to tailor to patient-specific needs.

Dallen Medical announced the first human use of its Compressyn Staple, a rigid compression fixation technology designed to deliver continual, dynamic compression for small bone fixation. The device is cleared for a range of foot, ankle and hand fixation procedures. The first procedure was a treatment for an arthritic foot, where the device was used to perform the calcaneal cuboid fusion of a triple arthrodesis.

DePuy Synthes launched its two new variable angle VA Locking and VA LCP plating systems, for calcaneal fractures and fusion procedures respectively. The low-profile, pre-contoured plates are designed to treat both simple and complex fractures, with multiple fixation points targeting key areas of hard cortical bone in the calcaneus. Surgeons are able to adapt the screw trajectory to match patient anatomy and fracture pattern and angulate screws towards specific fragments of bone.

Materialise NV announced that the first total knee surgery, preplanned by means of the company's X-ray knee guide solution, was performed. Materialise's technology allows for the preplanning of knee replacement surgeries as well as the 3-D printing of related surgical guides, solely on the basis of 2D X-ray images.

Paragon 28, Inc. launched its GORILLA R3CON Plating System, a foot plating system that supplants the Normed product line previously distributed by Paragon 28. R3CON is comprised of 10 interchangeable subsystems and is indicated for many common foot procedures including MTP fusions, Lisfranc stabilizations, Lapidus procedures and various opening wedge osteotomies.

SafeWire launched its Tiger Pedicle Access Needle product portfolio, designed to increase the accuracy and ease of MIS pedicle access by providing surgeons with control of pedicle access needle advancement, measured and adjustable guide wire deployment, streamlined pedicle preparation, and atraumatic mechanical access needle removal.

Spine Wave launched its Annex Adjacent Level System, intended to treat patients with currently instrumented segments from a minimally invasive approach. The system allows the surgeon to treat multiple adjacent levels at a time through a percutaneous or mini open approach.

INTELLECTUAL PROPERTY
DiFusion Technologies received (subscription required) two patents from the U.S. Patent & Trademark Office (USPTO). Both patents protect DiFusion's method of manufacturing polyetheretherketone (PEEK) implants exhibiting antimicrobial properties. Such antimicrobial effects are produced by incorporating ceramic particles containing antimicrobial metal cations into molten PEEK resin, which is subsequently allowed to cool and set in its final shape achieved by injection molding, cutting and machining or other techniques.

SI-BONE received a patent from the U.S. Patent and Trademark Office (USPTO) relating to the systems and methods for the fixation and fusion of bone. The patent broadly covers a threaded, fenestrated implant with a tapered distal end that may be placed from one bone across a joint into another bone and further strengthens the company's existing patent portfolio covering rectilinear shaped implants for use in the fixation or fusion of any joint in the body.

LEGAL
NuVasive's trademark registrations for the word “neurovision” was canceled by a federal court after the company was determined to have infringed Neurovision Medical's trademarks. A $30 million verdict had been awarded to Neurovision Medical for the alleged infringement.

CLINICAL
BONESUPPORT announced new twelve-month follow-up data from an on-going clinical trial investigating the safety and efficacy of its CERAMENT|G in chronic bone infection and the completeness of bone healing after surgery. The study's results demonstrated complete wound healing in all patients treated with CERAMENT|G, and full bone remodeling of the void in 75% of patients at 6-months with evidence of ongoing bone remodeling in 80% of the remaining patients. CERAMENT|G is an injectable antibiotic eluting bone substitute indicated to promote and protect bone healing being jeopardized by infection.

Diaxonhit announced the completion of patient enrollment for the validation study of its BJI InoPlex, a non-invasive blood test for the diagnosis of prosthetic bone and joint infections in hip and knee replacements. The study has enrolled 470 patients, including 200 patients whose prostheses were infected. The results of the study are currently being analyzed, and the final performance of BJI InoPlex is expected for 4Q:14. CE marking for the test is scheduled for December 2014.

Rotation Medical launched a postmarket trial to test the use of its rotator cuff device in treating patients with supraspinatus rotator cuff tendon tears. The multicenter study will measure shoulder function as well as assess postoperative changes in tendon thickness, tendon quality and tear size, after implantation of the bioinductive implant in patients implanted with the device.

DISTRIBUTION
MiMedx Group entered into a distribution agreement with Zimmer. Under the terms of the agreement, MiMedx will provide its dehydrated human amnion/chorion membrane (dHACM) allograft products to Zimmer to be marketed non- exclusively on a private label basis. MiMedx's dHACM allografts are processed utilizing the company's proprietary PURION process. The distribution agreement encompasses a range of musculoskeletal applications to include reconstructive, sports medicine, trauma, extremities and spinal applications.


Blackstone to Acquire Stake in Xinrong Best Medical Instrument for a Reported $100M

The Blackstone Group entered into an agreement to acquire an unspecified stake in Xinrong Best Medical Instrument Co., a Chinese-based developer of orthopedic implants with Trauma, Spine and Joint applications, for a reported $100 million.

Xinrong is planning to target hospitals and other care organizations in tier-2 and tier-3 Chinese cities. Furthermore, the company is aiming to be more competitive on implant pricing than multinational medical device manufacturers operating in the country.

Regarding the transaction, Blackstone reportedly was not the only interested buyer, nor did Blackstone have the highest bid. Xinrong ended up choosing Blackstone due the private equity firm's ability to attract experienced managers.

Blackstone will acquire their stake from Xinrong's three founders, who own 100% of the company. Moreover, the investment will reportedly give Blackstone influence over the decision-making at the company (board seats).


Integra to Acquire Medtronic ENT and Laparoscopy Instrumentation Lines for $60M

Integra LifeSciences entered into an agreement with Medtronic to acquire Medtronic's MicroFrance and Xomed manual Ear, Nose & Throat (ENT) and laparoscopy instrumentation lines for approximately $60 million in cash.

Under the terms of the agreement, Integra acquires a portfolio of approximately 4,000 MicroFrance and Xomed manual ENT and laparoscopic surgical instruments, as well as Medtronic's St. Aubin le Monial, France manufacturing facility. Integra plans to fund this transaction with cash held outside the United States.

The transaction provides Integra with a product portfolio that aligns well with the company's current sales channels and adjacent divisions, particularly its Neurosurgery business. Furthermore, the deal provides Integra with access to R&D, service & repair and other infrastructure in France, expanding the company's Instruments presence outside the United States, and improving its ability to service its current portfolio and development new products.

Integra expects the transaction to close in 4Q:14 and for integration to be completed by 2H:15.


ReWalk Robotics Prices IPO

ReWalk Robotics priced its initial public offering (IPO) of 3.0 million shares of common stock at a price of $12.00 per share, raising total proceeds of $36 million. This equates to an enterprise value of approximately $155 million.

The final terms came in lower than the initial proposed price range of $14 to $16 and number of shares to be offered of 3.4 million.

ReWalk Robotics is medical device company that develops exoskeletons, devices that provide wheelchair-bound individuals with mobility impairments or other medical conditions, the ability to stand and walk once again. The company's two flagship devices are ReWalk Personal and ReWalk Rehabilitation, which are exoskeletons intended for people with paraplegia, a spinal cord injury resulting in complete or incomplete paralysis of the legs, who have the use of their upper bodies and arms. Both ReWalk systems utilize the company's tilt-sensor technology and an on-board computer and motion sensors to drive motorized legs that power movement.

For the 2013 fiscal year, ReWalk reported total revenue of $1.6 million, representing an increase of 63% on a reported basis compared to $1.0 million in 2012. Sales outside the U.S. accounted for 41% of the company's total revenue in 2013.

The company listed on the NASDAQ Global Market (NasdaqGM) under the ticker symbol "RWLK". Barclays and Jefferies served as Joint-lead Bookrunners on the deal, while Canaccord served as a Co-manager.


Musculoskeletal News Roundup 18-Sep-14

FUNDING
Nimbic Systems received a $1.5 million grant from the National Institutes of Health to further study its Air Barrier System (ABS) device in a pivotal, multi-center clinical trial. ABS is a portable, inexpensive device that helps shields surgical sites from bacteria present in the operating room by creating a localized clean-air field over the surgery site that prevents airborne microorganisms from entering the incision. The device is FDA-cleared for use in hip arthroplasty and posterior spine surgery.

Spine Pain Management secured a $2 million revolving credit facility (revolver) from Wells Fargo to help accelerate its legacy PI case growth and launch its Quad Video HALO.

Tissue Regeneration Systems secured $2 million in a round of financing from existing investors: Venture Investors, the University of Michigan, the Michigan Economic Development Corporation and Wisconsin Alumni Research Foundation. The new capital will help the company progress its 3-D printed bioresorbable scaffolds that can promote natural bone tissue growth and reduce the need for bone grafts.

M&A
Baxano Surgical has engaged Houlihan Lokey as its financial advisor to advise it on potential strategic alternatives for business. Management believes the company is an attractive asset as it has made encouraging progress on its major milestones in 2014, including new product launches, economic based clinical data and the building of a hybrid sales organization.

REGULATORY
ChoiceSpine received 510(k) clearance from the FDA for its THUNDERBOLT Minimally Invasive Pedicle Screw System. The system is designed for a small incision procedure with sleek and streamlined instrumentation.

EOS imaging received 510(k) clearance from the FDA for its sterEOS 1.6, the company's next-generation sterEOS 3D imaging software. sterEOS software provides 3-D modeling of the spine and lower limbs based on scans taken with the EOS System, and automatically calculates more than 100 clinical parameters relevant to diagnosis and surgical planning. The new sterEOS 1.6 software integrates a postural assessment feature dedicated to spine pathologies and associated surgeries that allows a fast analysis of a patient’s skeletal balance and helps the surgeon plan adequate spinal surgery to maintain or restore this balance, which is often modified or lost with ageing or scoliotic deformity.

PRODUCT INTRODUCTION & UPDATE
Amedica Corporation launched its second generation silicon nitride transforaminal lumbar (TL) interbody fusion device, the Valeo II TL. The device is made of a micro composite silicon nitride biomaterial, contains anti-infective properties, is semi-radiolucent with clearly visible boundaries in x-rays, and produces no artifacts under MRI or CT scans.

Aurora Spine launched its ECHO MIS Interbody (PLIF) and ECHO XL MIS Interbody (OLIF) systems which feature the company's new TiNano titanium spray coating technology. The TiNano surface is created by thermal spray technology of Titanium particles to support osseointegration and will be available on all of Aurora interbody cages, including Cervical, PLIF, OLIF, TLIF, ALIF and LLIF.

Integra LifeSciences announced the full commercial release of its Integra Freedom Wrist Arthroplasty System, indicated for the treatment of wrist arthritis, in the United States. The comprehensive system features a more anatomic and advanced implant design, and enhanced instrumentation to aid in efficient and potentially more reproducible surgical results.

K2M Group launched its EVEREST Minimally Invasive Spinal System, a cannulated top-loading polyaxial pedicle screw system featuring the company's flexible polymer SERENGETI Minimally Invasive Retractor System to assist with placement and direct visualization. EVEREST features a screw-based method of retraction to provide a fixed position to the anatomy, allowing for one-step, percutaneous placement of the screw and retractor, with direct visualization and improved access for rod introduction.

Medtronic launched its KYPHON Express II Balloon Kyphoplasty Platform, which includes the KYPHON Cement Delivery System, for the treatment of vertebral compression fractures. The platform features a maximum pressure rating of 700 psi and offers physicians the option of using the cement resistant technique, which allows one balloon to remain inflated during contralateral cement fill, helping to maintain the goal of fracture reduction. The new cement delivery system (CDS) includes new features designed to increase the efficiency and precision of delivering bone cement into a vertebral body and continues to allow the physician to deliver highly viscous bone cement to the patient from up to 4 feet away from the radiation source while maintaining tactile feel.

NovaBone launched MacroFORM Packable Graft and MacroFORM Composite, two new bioactive packable and moldable composite devices. MacroFORM Packable Graft combines 85% bioactive ingredient with collagen in a mixing cup and is engineered to have an open porous structure to enhance the absorption of bone marrow aspirate and facilitate bone growth. MacroFORM Composite combines 90% bioactive ingredient with collagen in a preformed strip. Both products can be manipulated into a putty format after mixing.

OMNIlife science announced surgeons have completed over 4,000 total knee replacements (TKRs) in the U.S. utilizing the company's OMNIPlasty technique, a TKR procedure that uses robotics to help optimize implant placement. Surgeons are able to plan and execute a patient specific procedure utilizing the system's intra-operative 3-D modeling technique that is not dependent on pre-operative CT scans or x-rays.

Smith & Nephew launched its D-RAD SMART PACK System for treating distal radius fractures. The system aims to improve workflow efficiency and reduce downtime for instrument sets by consisting of four, complete, single-use, sterile instrument kits containing implants, and a tray of sterile packaged fasteners and templates. This allows the hospital operating room (OR) staff to reduce the typical process used for reprocessing traditional plate and screw systems from eight-steps down to two.

Spineology Inc. launched its VIA Spinous Process Fixation System, which features independently compressible superior and inferior plates that are contoured to maximize the fit between the implant and the spinous processes and associated laminae. VIA is the latest addition to Spineology’s Anatomy Conserving Technology (ACT) product platform and aims to maximize teeth engagement.

INTELLECTUAL PROPERTY
Orthocell received an Australian patent further protecting its Ortho-ATI autologous tenocyte implantation technology for tendon regeneration. The patent relates to the use of bio-scaffolds and tendon stem cells to treat tendon degeneration and the company's method to treat rotator cuff tears.

CLINICAL
Rotation Medical initiated a multi-center post-market clinical study evaluating the use of its rotator cuff system in treating supraspinatus rotator cuff tendon tears. The study will evaluate tendon healing and growth of new tendinous tissue after the implantation of a Rotation's bioinductive implant that is utilized as either a standalone treatment for tendon tears or as an adjunct to surgical repair. Patients will undergo magnetic resonance imaging (MRI) to assess post-operative changes in tendon thickness, tendon quality, and tear size.

COLLABORATION
DePuy Synthes, the world's largest provider of orthopaedic and neurological solutions, announced today a worldwide commercial agreement with Blue Belt Technologies, a global medical technology company specializing in enabling technologies for orthopaedic surgery. The agreement will enable orthopaedic surgeons to use the SIGMA HP Partial Knee System with Blue Belt's Navio surgical system. SIGMA HP, combined with Navio surgical system for orthopaedic surgery, has the potential to help minimize surgical disruption of healthy tissue while enabling more precise implant placement through minimally invasive incisions. The Navio System combines CT-free navigation software with a hand-held computer controlled bone shaping tool that is designed to bring a high degree of implant placement accuracy along with soft tissue balancing benefits.

Ortho Kinematics entered into an agreement with Medtronic, giving Medtronic the ability to promote Ortho Kinematics' VMA (Vertebral Motion Analysis) test to spine surgeons. The VMA is Ortho Kinematics' flagship spine diagnostic test and can be prescribed as an alternative to flexion/extension x-ray tests for the assessment of spinal motion and instability in the cervical and lumbar spine.


Baxano Surgical Announces it is Exploring Potential Strategic Alternatives

Baxano Surgical has engaged Houlihan Lokey as its financial advisor to advise it on potential strategic alternatives for business.

Management believes the company is an attractive asset as it has made encouraging progress on its major milestones in 2014, including new product launches, economic based clinical data and the building of a hybrid sales organization.

Baxano develops minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region. The company presently markets the AxiaLIF pre-sacral access and interbody fusion system for single and two level lower lumbar fusion, the VEO lateral access and interbody fusion system, the iO-Flex set of flexible instruments used by surgeons during spinal decompression procedures, and the iO-Tome instrument for rapid and precise removal of bone, specifically the facet joints, a technique which is commonly performed in spinal fusion procedures.

Baxano Surgical was formed in March 2013 by the merger of TranS1 Inc. and Baxano, Inc. For the 2013 fiscal year, the company reported pro forma total revenue of $23.3 million, representing a decrease of 3% on a reported basis compared to $24.0 million in 2012.



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