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November 2-4 - American Congress of Rehabilitation Medicine Annual Conference 2016
November 8-11 - SOFCOTComplete Calendar »
Oct 31 @ 8:00 AM ET - Zimmer Biomet
Nov 2 @ 5:00 PM ET - K2MComplete Calendar »
Orthofix received coverage recommendations from NASS for its electrical bone growth stimulators, supporting the use of pulsed electromagnetic field (PEMF) stimulation devices as an alternative to spinal fusion surgery in the cervical and lumbar regions. The company's devices, CervicalStim and SpinalStim, use a low-level pulsed electomagnetic field that aims to help activate and augment the body's natural healing process.
NuVasive received clearance from the FDA for its use of magnetic resonance imaging (MRI) under certain conditions on patients treated with its MAGEC system, a noninvasive solution for growth modulation in pediatric spinal deformity. During an MRI, the MAGEC system is expected to produce a maximum temperature rise of 3.7 degrees Celsius after 15 minutes of continuous scanning. MAGEC is comprised of a sterile, single use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet that is controlled by an external remote controller. The system is periodically lengthened to follow the growth of the spine.
RTI Surgical received 510(k) clearance from the FDA for its Streamline OCT Occipito-Cervico-Thoracic System, including an indication for polyaxial screw placement to include the cervical spine, and also includes clearance for a dual diameter transition rod. The new indication allows additional levels of fixation to be accomplished by connecting to other RTI pedicle screw systems through the transition rod or rod-to-rod connectors.
SeaSpine received 510(k) clearance from the FDA for its Shoreline ACS Anterior Cervical Standalone System, featuring TruProfile technology, a low-profile plate designed to minimize cephaladcaudal encroachment onto the vertebral bodies and maximize the distance from adjacent disc spaces. Shoreline is designed to offer a full complement of zero and low-profile plating options, such as 10 degree lordotic implants and incorporates the company's NanoMetalene surface technology, comprised of titanium molecularly bonded to INVIBIO's PEEK-OPTIMA polymer.
SIGNUS received 510(k) clearance from the FDA for its DIPLOMAT pedicle screw system, a low-profile, modular two-piece implant with a 14.9mm tulip that can be removed and replace in situ during surgery. The system utilizes a self-tapping double thread that aims to provide fixation and close anchoring in the bone.
Spineology received clearance from the FDA for its Rampart Duo Interbody Fusion System that combines PEEK, titanium and graft containment mesh elements. The devices design utilizes PEEK spacer blocks at each end of the device and each end of the device and a flexible porous graft containment mesh.
TheraCell received a patent from the United States Patent and Trademark Office (USPTO) for its demineralized bone fiber (DBF) technology, part of AlloSource's AlloFuse Cortical Fibers and AlloFuse Fiber Boats. The products are made demineralized cortical bone and be used in a variety of spine and orthopedic procedures.
PRODUCT INTRODUCTION & UPDATE
DePuy Synthes Spine launched its KICK System with FluoroExpress Software Module, a portable spine imaging system designed to provide access to affordable advanced imaging technology with real-time navigation for pedicle screw placement. The system utilizes a small, portable infrared camera with a computer and monitor displaying up to four different X-ray images at once to move between operation rooms and work with existing X-ray equipment to support surgical workflow. The system is compatible with company's VIPER and EXPEDIUM Spine system implants, enhancing visualization during minimally invasion and open procedures for the treatment of a variety of spinal disorders.
DePuy Synthes Spine launched its SYNFIX Evolution System, a stand-alone Anterior Lumbar Interbody Fusion (ALIF) designed to deliver biomechanical stability to promote fusion and restore function in the spine. Multiple studies have shown that the SYNFIX provides superior biomechanical stability compared to traditional stand-alone ALIF implants and equivalent biomechanical stability relative to lumbar fusion performed through the back. The system is comprised of a PEEK spacer, a titanium zero-profile plate and four divergent locking screws and a thread lock sleeve to prevent disengaging during procedures.
Globus Medical launched its QUARTEX OCT Stabilization System and the INDEPENDENCE MIS integrated ALIF plate/spacer system. QUARTEX is a threaded screw and rod platform offering thoracic pedicle screws with diameters up to 5.5 mm, allowing surgeons to take of varying spinal anatomy. INDEPENDENCE is an integrated ALIF plate-spacer system designed to simplify implantation and fixation by offering fewer procedural steps and a less invasive surgical corridor than traditional integrated spacers.
K2M launched its CASCADIA Interbody Systems, featuring the company's Lamellar 3D Titanium Technology in the United States. The CASCADIA product portfolio includes the CASCADIA TL, AN, Lateral, AN Lordotic Oblique, and Cervical Interbody Systems indicated for the treatment of patients suffering from degenerative disc disease, degenerative scoliosis and other spinal deformities. The implants are 70% porous with an increased bone graft volume and are of similar stiffness when compared to equivalent K2M PEEK designs.
Life Spine launched its two new Transforaminal Lumbar Interbody Fusion (TLIF) products, the TLIF Retractor and the PLATEAU-LO. The Retractor is designed with independent angulating blades and modular taps, which anchor to the pedicles and allow disc space distraction, furthermore, reducing tissue disruption and maximizing the exposure for better visualization. The PLATEAU-LO is a oblique, lordotic interbody cafe indicated to address sagitall alignment.
Mazor Robotics launched its MAZOR X system, a surgical assurance and assistance platform. The company entered into a strategic partnership with Medtronic earlier this year for the co-marketing and promotion agreement of MAZOR X and since then have gained support from capital and clinical specialists.
MEDICREA launched a lifetime warranty on its patient-specific UNiD technology. The warranty covers all UNIF Throacolumbar Rods, UNiD Cervical Rods and all associated MEDICREA components implanted in the US from November 1, 2016.
Pinnacle Spine launched its InFill V2 Lateral Interbody Device, a bone graft deliver system featuring a larger, single graft chamber and a large load-bearing surface area, which aims to restore and maintain disc height and facilitate the formation of a fusion column. The company's line of InFill interbody devices utilize an access port that secures the implant to the inserted which allows for controlled device placement and in situ graft delivery.
Styker introducted Ascential, an implant and delivery solution for lower acuity spinal procedures in the ambulatory surgery center (ASC) and hospital settings. The Ascential portfolio includes the ACP 1 Anterior Cervical Spacer System, the IBD PEEK Anterior Cervical Spacer System and VBA Vitoss Foam Pack, all of which are sterile-packaged implants manufactured by Stryker. The distribution model is designed to provide competitive pricing, operational efficiencies and reduced operating costs to allow staff to spend more time and resources on patient care.
Synaptive Medical announced that the company will be showcasing its BrightMatter technology at NASS in Boston. BrightMatter utilizes a camera mounted on a robotic arm to automatically follow the surgeon's instruments and projects it onto a large monitor for the entire team to view, simplifying the surgical workflow and addressing the complexities of the operation room setup.
Tyber Medical launched its TyPEEK, a titanium plasma sprayed PEEk, composite interbody fusion device with a lateral plating system that provides three points of fixation in each vertebral body with two screws. The system aims to eliminate some instrumentation required by other systems on the market which minimizing surgical steps.
Zimmer Biomet announced that its Mobi-C Cervical Disc Prosthesis is now the most widely covered device for one- and two-level cervical disc replacement by commercial health insurers in the United States. The device is a cobalt chromium alloy and polyethylene mobile-bearing prothesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels.
AMNIOX published the results of a clinical study of its CLARIX Regenerative Matrix, a cryopreserved Amniotic Membrane (AM), as an adjunct to lumbar discectomy. The 80 patient study treated half of the patients with CLARIX 100 in the disc space following removal of the disc herniation, while the other half received traditional care which involved removal of the herniation alone. The results indicate that patients treated with CLARIX showed significant improvement in lowering back pain and enhanced mental well-being. The study also reports that at the 2-year follow-up period, no recurrent herniations occurred in the group treated with CLARIX.
Spinal Elements announced the first procedures with its MIS Katana Lateral System were successfully completed. The system is a muscle-splitting system that is gently created in the plane of the muscle,that aims to prevent muscle entrapment and nerve compression problems.
Spineology completed 100 cases using its Palisade Pedicular Fixation System, an addition to the company's Anatomy-Conserving Technology (ACT) produce platform. The system is comprised of an articulating rod passing capability and low-profile implant components to maximize conservation of anatomy and speed up posteroperative recovery for the patient. The Palisade screw utilizes a quick-starting thread design, integrated reduction threads, and break-off extensions to enhance surgical efficiency and reduce intraoperative imaging requirements.
Vertera Spine announced the clinical results using its COHERE Cervical Interbody Fusion Device, utilizing the company's porous PEEK (polyetherether ketone) Scoria biomaterial technology. The company has implanted the device successful more than 400 COHERE since its soft launch in May, 2016. Scoria's porous design aims to provide an environment for bony tissue ingrowth while retaining the mechanical and imaging properties of traditional PEEK implants. The company will display the device as NASS in Boston.
HealthpointCapital Invests in ProSomnus Sleep Technologies and Completes Sale of MicroDental Laboratories
HealthpointCapital is pleased to announce that it has sold MicroDental Laboratories, a leading network of dental laboratories across North America, to Modern Dental Group Limited (SEHK: 3600), a global dental prosthetic device provider. The transaction closed on October 21, 2016.
ProSomnus Sleep Technologies, a former division of MicroDental, which develops and manufactures Oral Appliances for the treatment of Obstructive Sleep Apnea (OSA) was retained by HealthpointCapital due to its compelling investment opportunity.
More than 25 million people suffer from OSA in the U.S. and 100 million globally. The Oral Appliance Therapy (OAT) market represents a new and large patient demographic for dentists and allows them to offer an alternative to Continuous Positive Airway Pressure (CPAP) therapy. The global OSA market for therapeutic devices was estimated to be $4 billion at the end of 2015. The market is anticipated to grow to $6 billion by 2020, implying a five-year compound annual growth rate (CAGR) of 9%. With this profile, the OSA market is one of the fastest growing segments in the entire medical device industry.
Len Liptak has been named CEO and is an experienced dental industry leader with expertise operating and developing businesses driven by product innovation. He is surrounded by a strong leadership team including Mark. Murphy, DDS, FAGD as Lead Faculty, Jerry Vogel as Vice President of Sales, Dave Kuhns, PhD as Vice President of Technology, Sung Kim as Vice President of Engineering and Bob Starr as Chief Administration Officer all of whom have experience developing high quality products and driving growth in dental and medical device businesses.
“With an innovative product portfolio and a differentiated manufacturing approach, ProSomnus has a unique opportunity to partner with dentists to treat the more than 25 million adults suffering from Obstructive Sleep Apnea,” commented Len Liptak, CEO of ProSomnus Sleep Technologies. “Our strategic partnership with HealthpointCapital enables us to accelerate plans to reduce the undiagnosed population and provide a less invasive treatment option for the population who have abandoned CPAP therapy.”
ProSomnus is focused on commercializing device designs that are clinically relevant, creating treatment experiences that exceed the needs of the practicing sleep dentist, and supporting scientific research that further establishes dental sleep medicine as a viable therapy for OSA.
ConforMIS appointed Mark Augusti as company President & Chief Executive Officer, effective November 14, 2016.
Mr. Augusti succeeds Dr. Philipp Lang as President & CEO, who will continue to serve on the company's Board of Directors. It is expected that Mr. Augusti will be appointed to the company’s Board of Directors after the commencement of his employment.
Prior to ConforMIS, Mr. Augusti served as Corporate Vice President and President of Orthopedics and Tissue Technologies at Integra LifeSciences, CEO of Bioventus LLC, and as President of Smith & Nephew's Biologic and Orthopedic Trauma & Clinical Therapies Global divisions.
Cerapedics secured $11 million from a Series D financing. The proceeds will be used for commercialization of the i-FACTOR Peptide Enhanced Bone Graft, as well as for further development of the company's synthetic small peptide technology for lumbar spine fusions.
Checkpoint Surgical and Neuros Medical secured an undisclosed amount of capital from JumpStart. Checkpoint Surgical develops handheld intra-operative nerve and muscle stimulators that help surgeons locate, identify and evaluate nerve and muscle function during surgical procedures, and Neuros is developing an implantable nerve blocking therapy focused on the elimination of chronic pain caused by neuroma/residual limb, post-surgical, and migraine conditions.
Emerging Implant Technologies (EIT) secured an undisclosed amount of new capital from SHS Gesellschaft für Beteiligungsmanagement. EIT develops 3D-printed spinal fusion cages and patient-specific implants. The company plans to use the investment to expand its manufacturing capabilities internationally, including in the United States.
Harbor MedTech secured $5 million in equity from three undisclosed investors in a round of financing the company is targeting at $8.5 million. The company develops tissue regeneration products from collagen protein, biologic substrates and xenografts, and are intended for chronic wounds and hernia, and joint repair.
Histogenics closed a $30.0 million private placement of common stock, Series A Convertible Preferred Stock and warrants. The private placement was led by new healthcare dedicated institutional investors, with participation by certain existing investors. The company expects to use the proceeds to support the development of its NeoCart product, a cartilage repair therapy, the completion of the ongoing Phase 3 clinical trial, and for general corporate and working capital purposes.
Nasseo, Inc., was awarded a Small Business Innovation Research Grant from the National Science Foundation (NSF). The proceeds will be used for research & development and feasibility studies for the company's spinal implants.
Relievant Medsystems secured $36 million in equity financing led by New Enterprise Associates (NEA) with Canaan Partners, Emergent Medical Partners and Morgenthaler Ventures also participating. The proceeds will be used to advance additional clinical studies, expand and enhance the company's product portfolio, and accelerate commercial activities.
Rivanna Medical received a $1.5 million grant from the National Institutes of Health through the Small Business Innovation Research program. The proceeds will fund the development of the company's BoneEnhance system, an ultrasound-based 3-D imaging device meant to detect bone fractures in patients who present at an emergency department. BoneEnhance is part of Rivanna's Accuro handheld image-guidance platform, which is used to aid providers in applying spinal and epidural anesthesia. Additionally, the company raised $3.5 million in capital financing from a small group of existing and new individual investors. The capital from this new equity raise will be utilized to increase global sales and marketing efforts for Accuro.
Spineart secured €30 million from an equity investment from GIMV NV. The proceeds will be used to reinforce the company’s sales organization and processes, geographical expansion in select markets such as the United States, as well as for product development.
Titan Spine secured $7.5 million in a Series D round led by Southlake Equity Group with five other undisclosed investors participating. With its investment, Southlake Equity received a minority ownership stake in the company.
Valeris Medical raised $1.5 million in a new round of debt financing from 18 undisclosed investors. The company developed its BoneCam Suture Anchors, which are intended to be utilized for suture fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip.
VertiFlex raised $15 million in a new round of debt financing from six undisclosed investors. The company offers the Superion device, designed to be implanted in the spine with a minimally invasive procedure to relieve spinal stenosis, a narrowing of the spine, which can put pressure on spinal nerves. VertiFlex also offers the Totalis direct decompression system.
Mallinckrodt PLC completed the acquisition of Stratatech Corp., a company that develops regenerative skin tissue and technology to treat severe burns. Stratatech is presently in Phase 3 development of its StrataGraft product, a regenerative skin tissue and technology platform, designed to mimic human skin and promote tissue regeneration, and intended for the treatment of severe burns. If approved, StrataGraft would be the first biological “off-the-shelf” skin substitute product for the indication.
Richard Wolf GmbH, Knittlingen, Germany-based medical equipment manufacturer for minimally invasive and endoscopic surgery, and extracorporeal shock wave therapy, founded its new subsidiary company RIWOspine GmbH. The subsidiary will manage the ongoing development, marketing and sales for the company.
PRODUCT INTRODUCTION & UPDATE
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced that it will introduce several new products, as well as its current comprehensive portfolio at the upcoming North American Spine Society (NASS) meeting at the Boston Convention and Exhibition Center in Boston, Massachusetts, which will be held from October 26th — 29th, 2016. Alphatec Spine will be located in booth number 1523. In addition, today the Company announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Battalion™ Lateral Spacer System featuring the Alphatec Squadron™ Lateral Retractor.
Spineology launched a limited release of its Elite Expandable Interbody Fusion System for the treatment of patients with spinal disorders. The implant is inserted into the disc space in a contracted minimal height to minimize dissection and neural retraction, and is incrementally expanded to restore the anatomical height of the space and aims to provide indirect neural decompression.
Zyga Technology announced the 12-month fusion and clinical results for patients receiving its SImmetry Sacroiliac (SI) Joint Fusion system with decortication. The system is a minimally invasive procedure intended for the treatment of spinal conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The study results indicate decreased back pain and fusion in the area of decortication.
Isto Holdings entered into an agreement to acquire Arteriocyte Medical Systems Inc., a developer of point-of-care technology to assist patients in the healing process after surgery.
Established in 2007, Arteriocyte offers the MAGELLAN Autologous Platelet Separator System, an automated platelet separator device designed to help patients heal faster from cardiac, orthopedic and vascular surgical procedures. MAGELLAN separates the peripheral blood or a combination of peripheral blood and bone marrow of a patient to create Platelet Rich Plasma (PRP) as well as Platelet Poor Plasma (PPP), biologic concentrator materials that are applied to the surgical site to try and make it heal faster. Such materials can be mixed with autograft and/or allograft bone prior to application as well. The company also provides sterile disposables.
Post transaction-close, the companies will integrate themselves under the name "Isto Biologics" and become a pure-play provider focused on solutions for the spine, orthopedics, and functional-medicine markets. Isto's present-day portfolio includes bone-growth and cell-therapy products.
The combined company will be headquartered in St. Louis, MO and maintain Arteriocyte's operations in Hopkinton, MA. George Dunbar, the current CEO of Isto Technologies, will serve as CEO of Isto Biologics.