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 [...]

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May 18, 2012

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