Amedica Pulls in $30M Financing to Further Develop and Distribute Silicon Nitride Ceramic Implants in Spine

   Amedica Corporation Completes $30 MM Financing to Expand Market Share of Proprietary Silicon Nitride Ceramic (press release) Amedica Corporation, a spinal and reconstructive implant manufacturer focused on its medical grade silicon nitride ceramic material, today announced the completion of its $30 million Senior Secured Subordinated Convertible Notes financing.  This financing, which began in 2011, has [...]

17 Spine Surgeon Leaders in State Orthopedic Societies

    17 Spine Surgeon Leaders in State Orthopedic Societies (Laura Miller @ Beckers) Larry D. Cordell, MD (Midwest Spine Care, Overland Park, Kan.). Dr. Cordell is on the Board of Councilors for the Kansas Orthopaedic Society. He is a past president of the society and previously served in the United States Army. He has a professional interest [...]

Audio Interview: Spine Startup – Soteira CEO Larry Jasinski

Click to play MassDevice Podcast: Soteira CEO Larry Jasinski (MassDevice) Soteira CEO Larry Jasinski talks to MassDevice about overcoming the odds with spinal fusion devices and managing a 510(k) win even after the FDA switched things up mid-stream. Soteira CEO Larry Jasinski is no stranger to adversity. In the last 5 years the spinal fusion device maker has [...]

New President at Amedica Spine, Startup in Salt Lake City

   press release Eric Olson is the new President of Amedica Spine, succeeding Ben Shapley. Eric Olson is the President of Amedica Spine Division. Mr. Olson has in excess of 20 years’ experience in the orthopaedic and spinal device markets. Most recently, he was the Executive Vice President of Sales & Marketing for Axial Biotech, [...]

Israeli Company Wins 510(k) Clearance for TLIF Fusion Device

Award Winning Israeli Spine Company Gets 510(k) Clearance (Bilione Young @ OTW) NLT SPINE, an Israeli developer of minimally invasive spine surgery (MISS) products, has just received FDA 510(k) clearance for its PROW FUSION device. NLT SPINE is a winner of the 2011 Spine Technologies Award, given byOrthopedics This Week during the North American Spine Society conference [...]

Paradigm Spine Raises Another $8M for Its Spinal Stabilization Products

  Paradigm Spine Tingles for $8.2M (CityBizList – New York) NEW YORK — Medical device company Paradigm Spine, LLC raised $8.15 million of a targeted $14.60 million. Named in the related SEC filing were Chairman Anthony G. Viscogliosi, CEO Marc R. Viscogliosi, President and COOGuntmar Eisen, CFO Steven Amelio, and Hallett Matthews, President of VB Professional Services. Directors listed include David Robbins, Trevi Health [...]

Austen BioInnovation Spins Out Its 1st First Company – APTO Orthopaedics

   APTO’s video debut Austen BioInnovation Institute creates its first company (Crain’s Cleveland Business) The Austen BioInnovation Institute in Akron has created its first company. The company, APTO Orthopaedics, has developed a device designed to help children who need spinal implants because of spinal deformities. They typically must endure surgery once or twice a year so [...]

Eden Spine Receives FDA Clearance for New Corpectomy Device

  Eden Spine’s Giza Receives Clearance (Walter Eisner @ OTW) Eden Spine LLC has received FDA 510(k) clearance for its new corpectomy device called the Giza. The company announcement on February 2, states the device is an expandable titanium VBR (vertebral body replacement), with rotatable endplates that provide multiple angulation options by simple endplates rotation. According [...]

A Report From the ArgoSpine Symposium in Paris

     Report from the 16th Annual ArgoSpine Symposium HealthPointCapital is in Paris for the 16th annual ArgoSpine Symposium. Each year, ArgoSpine selects a theme for the event, and the latest is disorders in the junctional regions of the spine (previous topics have included the recent history of spine surgery and spine imaging).  Industry presence is much lighter than [...]

The 7 Top Concerns for Orthopedic Spine Surgeons in 2012

     7 Top Concerns for Spine Surgeons in 2012  (Laura Miller @ Beckers) Four spine surgeons discuss the topics weighing most heavily on them and their practices heading into 2012. Treating Medicare patients. Insurance company coverage for spinal procedures.  Proving spine surgery is effective in the literature.  Contracting at outpatient surgery centers.  Spine surgeons are [...]

DiFusion Technologies Lands $5.2M Funding for Antimicrobial Technology for Use in Orthopedic Implants

       website DiFusion gets $5.2M of planned $16M funding (Austin Business Journal) Medical device maker DiFusion Inc. has received $5.2 million of a planned $16 million financing. The Georgetown-based company collected the capital from 54 investors, according to a Friday filing with the SEC. DiFusion, which was founded in 2008, is working on a new [...]

Vincent GardèS Is the New CEO at Vexim, French Spine Startup

    Vincent Gardès New CEO at Vexim (Biloine Young @ OTW) Vincent Gardès, a veteran of Stryker Corporation and Medtronic, Inc., has joined Vexim, a medtech company in Toulouse, France, as Chief Executive Officer. Gardes, with over 15 years of international experience in marketing, sales and general management in the medtech industry, is fluent in [...]

KSpine Raises $2.5M to Treat Scoliosis

   Minnesota medical device company targeting scoliosis raises $2.5 million (MedCityNews) A Minnesota medical device company has raised $2.5 million in its second round of financing, according to a Form D filing with the Securities and Exchange Commission. KSpine’s spinal implant to treat scoliosis requires a less invasive surgical procedure, the company says. Ross Longhini, KSpine’s [...]

Lanx Spine Expands Its Facilities and Its Management Team

      Lanx Inc. Announces Corporate Expansion (press release) Expanded its corporate facility into a single 80,000-square-foot facility in Broomfield, CO for better surgeon training and prototyping capabilities. Various management changes: •    Wayne Chrystal is the new VP Operations. He has more than 20 years of operations experience and previously served as vice president of operations [...]

Spine Startup Soteira Enters the VCF Market in the U.S. With the Shield Kyphoplasty System

      Soteira Enters U.S. VCF Market  (Walter Eisner @ OTW) Soteira Inc. of Natick, Massachusetts, has received clearance from the Food and Drug Administration (FDA) to market the company’s Shield Kyphoplasty System in the U.S. In the December 12 press release, Larry Jasinski, Soteira’s president and CEO, said the system includes a “unilateral, steerable [...]

Spine Fusion Rates Are Increasing – Structural Allografts, Interbody Fusions, and Cervical Plates

       Researchers report increase in spine fusions, structural allografts (OrthoSuperSite) Between 1999 and 2008, orthopedic spine surgery rates increased, with more surgeons performing fusions and using structural allografts, interbody devices or anterior cervical plates, according to Boston researchers. The researchers aimed to determine the change in rates and types of procedures performed for cervical spine surgery by geographic region. [...]

Senators Ask Medtronic About Their Post-Market Device Tracking Regarding Infuse

        Senators press Medtronic for device info (Star Tribune) WASHINGTON – Three U.S. senators have asked Fridley-based Medtronic Inc. to supply detailed information about how the company keeps track of its medical devices after they go to market. In a six-page letter that strikes an investigational tone, Sens. Charles Grassley, R-Iowa, Herb Kohl, [...]

Spinal Kinetics Artificial Disc Patent Dodges Synthes Patent in Court

     ‘ Spinal Kinetics Wins in Synthes Patent Suit (press release) Spinal Kinetics, the designer and manufacturer of the innovative M6(R) Artificial Disc, today announced that a jury in the United States District Court, Northern District of California, has found that the M6 does not infringe on Synthes’ U.S. Patent No. 7,429,270. The jury found [...]

4 Former Synthes Executives Sentenced to Prison Time for Unapproved Bone Cement Study

        Sentencing… Michael Huggins (ex-COO @ Synthes) 9 months jail time currently under appeal Thomas Higgins (ex-Sr VP @ Synthes) 9 months jail time Richard Bohner (ex-VP @ Synthes) 8 months jail time John Walsh (ex-Director Clin/Reg @ Synthes)  5 months jail time Ex-Synthes Exec Bohner Sentenced To 8 Months In Prison In Bone-Cement Case (WSJ [...]

Oxford Performance Materials Is Now “Laser Printing” Patient-Specific Spinal Implants

    Oxford Performance Materials website Oxford Announces Patient-Specific Implants (Biloine Young @ OTW) Osteofab, a division of Oxford Performance Materials (OPM) of South Windsor, Connecticut, has manufactured and shipped its first patient-specific implant. According to OPM President Scott Defelice, the custom-designed implant is made by a selective laser centering machine from a polymer called polyetherketoneketone [...]

Nationwide Study to Determine if Spinal Discs Can Be Regenerated With a Stem Cell Injection

         Definitive Back-Pain Study? (Biloine Young @ OTW) Can a single injection of stem cells repair and regenerate diseased lumbar discs? That question may soon be answered by the first of its kind nationwide study that will test the safety and efficacy of the use of mesenchymal precursor cells (MPCs) to replace bone, [...]

Spotlight on Treating the SI Joint at NASS & EuroSpine – SI-BONE iFuse Implants Discussed

      Thought-leading spine surgeon presentations support increased awareness of SI joint diagnosis and iFuse® Implant System for minimally invasive SI joint fusion (press release) SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint reported today that [...]

Flexuspine, Startup With Disc Replacement, Gets $2.1M in Funding

     Flexuspine website Spine disc replacement firm Flexuspine adds $2.1M to series B round (MedCityNews) Flexuspine, which is developing a total spine disc replacement system, has added $2.1 million to a larger series B round of investment funding. CEO Vin Jannetty declined to reveal any more information about the Pittsburgh-based company’s past, present or future fundraising, but [...]

5 Spine Company Leaders Participate in Q&a Regarding the Future of Spine

  Success in the Spine Market: 5 Spine Company Leaders Discuss the Future (written by Laura Miller @ Beckers) Several medical device companies gathered at the North American Spine Society (NASS) annual conference this past month to display new innovations for a variety of spinal procedures. Even through tough economic times, companies displayed an impressive array [...]

TranS1 Launches Minimally Invasive Lateral Access Fusion System

  TranS1 Inc. Announces Launch of Minimally Invasive Lateral Access Fusion System (press release) TranS1 Inc. (Nasdaq:TSON), a pioneer in minimally invasive approaches to lumbar spine surgery, today announced the launch of its new lateral access fusion system for interbody fusions. TranS1′s minimally invasive lateral system features an innovative, two-stage retraction method that focuses on nerve [...]

Thoracic Spine Surgery: A New Technique to Avoid Operating on the Wrong Level

  Thoracic Spine Surgery: A New Technique to Avoid Operating on the Wrong Level (American Association of Neurological Surgeons (AANS)) It does not happen often, but nearly 50 percent of spine surgeons perform surgery on the wrong level of the spine sometime during their career. This is not surprising: a variety of factors make it difficult [...]

OrthoData, Spine Fusion Startup, Plans to Move From Louisville to Cleveland

      OrthoData raises $1.1 M round for spinal fusion monitor (July 2008) Spine fusion device startup eyes Cleveland move, more funding (Brandon Glenn @ MedCityNews) A Louisville company that’s developing a medical device to help surgeons monitor the progress of spinal fusion surgeries is a eyeing a relocation to the Cleveland area. OrthoData is hoping to attract some [...]

Spinal USA Launches 2 New Spine Systems

  Spinal USA Introduces New Devices (Biloine Young @ OTW) Spinal USA, headquartered in Pearl, Mississippi, introduced two of the firm’s new spinal treatment devices at the November meeting in Chicago of the North American Spine Society (NASS). The two technologies, which recently received FDA 510 (K) clearance, are the Vault Stand Alone ALIF System and [...]

The Top Ten Best New Spine Technologies for 2011

        The Top Ten Best New Spine Technologies for 2011 (Robin Young @ OTW) The winners of the 2011 Orthopedics This Week Best New Technology award for Spine are: Advanced Biologics, LLC, Aesculap, Inc., AlloSource, CoAlign Innovations, Inc., Ellipse Technologies, Inc., NeuroLogica Corporation, NLT SPINE, Nocimed, LLC, The Society for Minimally Invasive Spine [...]

30 New Spine Device Launches and Releases

       30 New Spine Device Launches and Releases (written by Laura Miller @ Beckers) Here is a list of 30 spine devices recently launched, released or introduced to the market. Many of the devices were introduced or on display at the North American Spine Society annual meeting in November or at other professional meetings [...]

DFine to Pay $2.39M Fine to DOJ After Whistleblower Reports Surgeon Kickbacks

    Whistleblower Costs DFine $2.39 Million for Kickbacks (written by Walter Eisner @ OTW) A whistleblower has struck San Jose, California-based DFine Inc. The U.S. Department of Justice (DOJ) announced on October 26 that DFine Inc. has agreed to pay $2.39 million to resolve allegations under the False Claims Act that the company paid kickbacks [...]

Medtronic Launches the New T2 Altitude Expandable Corpectomy Device

      Medtronic Announces Global Launch of the T2 Altitude™ Expandable Corpectomy Device (press release) Medtronic Announces Global Launch of the T2 Altitude™ Expandable Corpectomy Device The latest advancement in expandable cage technology for surgeons, hospitals and patients Medtronic, Inc. (NYSE:MDT) announced the global launch of the T2 ALTITUDE™ Expandable Corpectomy Device in the U.S. [...]

3 Controversies Discussed at NASS (North American Spine Society)

        Controvery # 1   The treatment of VCFs Controvery #2   The role of surgery in patients with SI pain Controvery #3   The use of BMP-2 in spine Debates Rage at Controversies Symposium (NASS Daily News) Thursday’s Current Controversies in Spine Surgery symposium featured debates on the role of vertebroplasty and [...]

100 of the Best Spine Surgeons and Specialists in America

               100 of the Best Spine Surgeons and Specialists in America (written by Molly Gamble @ Beckers) Physicians included in this list have been selected based on surveys, research and nominations.  All physicians who are placed on the list undergo a substantial review with other peers and through our own research. [...]

LDR Receives FDA Clearance for 1st ALIF Stand-Alone Spine Cage

       LDR First With Oblique ALIF Stand-Alone Cage (written by Walter Eisner @ OTW) LDR has received clearance from the FDA to market the company’s ROI-A Oblique ALIF Cage. Christophe Lavigne, president and CEO of LDR, said in the November 1 press release that the clearance makes LDR the first company to introduce an [...]

12 Spine and Neurosurgeons on the Move

      12 Spine and Neurosurgeons on the Move (written by Laura Miller @ Beckers) Here are 12 spine and neurosurgeons who recently joined a new practice or were promoted to a new position. NorthShore University HealthSystem named Julian Bailes, MD, chair of the department of neurosurgery and co-director of NorthShore Neurological Institute. He is a [...]

K2M Acquires the BLUE RIDGE Hybrid Cervical Plate System

  K2M Announces Technology Acquisition and Debut of BLUE RIDGE Hybrid Cervical Plate System at 2011 North American Spine Society Annual (press release) LEESBURG, VA … November 1, 2011 – K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, announced tomorrow’s debut of the BLUE RIDGE™ Hybrid [...]

Medtronic CEO Ishrak Nixes a Possible Spine Spinout

          Medtronic CEO Ishrak nixes spine spinout (MassDevice) Medtronic CEO Omar Ishrak puts the kaibosh on suggestions that the company ditch its spine business, saying all parts add value – except Physio-Control. Medtronic (NYSE:MDT) CEO Omar Ishrak put the kaibosh on a spinout for the company’s spine business, telling Reuters that all [...]

Milliniem Predicts the Global Spine Market Growth Through 2020

  Milliniem Research Group:   US Markets for Spinal Implants 2011

9 New Spine Products From K2M at NASS

     K2M Continues its Momentum with Nine New Products at 2011 North American Spine Society Annual Meeting (press release) K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced it will introduce five new products at the North American Spine Society (NASS) 26th Annual [...]

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February 22, 2012

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