FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix

Collagen Matrix

Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures.

The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites.

The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said.

“We continue to expand our product portfolio for the Spine market with the development of this unique line of Bioactive bone graft matrices that combines a carefully-selected ratio of three powerful components. This innovative moldable version offers surgeons options for better ensuring predictable outcomes,” CEO Bart Doedens said in a press release.

Intrinsic Therapeutics raises $52m for Barricaid annulus seal

Intrinsic Therapeutics

Intrinsic Therapeutics said today that it raised $52 million in a new round of equity financing to support the U.S. commercialization of its Barricaid annulus seal.

The Boston-based company’s Barricaid implant is a polymeric mesh that is designed to sit at the posterior intervertebral disc space and is connected to a metal anchor that is attached to the vertebral body. The device is intended as an adjunct for lumbar limited discectomy to replace missing or damaged parts of the annulus to prevent re-herniation, disc collapse, the return of sciatica and potentially to help stave off low back pain.

Intrinsic Therapeutics won FDA approval for the Barricaid in February despite the fact that the prosthesis received a 5-8 advisory panel against recommending approval in December 2017.

“Recurrent lumbar disc herniations have been shown to cause significant disability for patients and expense for our healthcare systems. The Barricaid clinical trial highlights a technology that can reduce the burden from this spinal condition which deserves close evaluation from all who manage this complication,” Dr. Wellington Hsu of Northwestern University said in prepared remarks.

The Series Growth equity round was led by Questa Capital and joined by existing investors New Enterprise Associates, Greenspring Associates, Quadrille and Delos Capital.

“Questa invests in healthcare innovations that deliver value by providing improved clinical outcomes at an acceptable cost.  By cutting reoperation rates in half, Barricaid can help prevent chronic disability, improve quality of life, and prevent a degenerative spiral. The odds of a patient not returning to work are nearly three times higher after a revision surgery, therefore preventing reherniation is critical,” Questa Capital founder & managing director Ryan Drant, who will join the company’s board of directors in connection with the financing, said in a prepared statement.

“We are extremely pleased that Questa led this financing to support our U.S. commercialization efforts for the Barricaid device. Meaningful clinical data demonstrate that treatment with Barricaid can reduce reherniations and repeat surgeries for patients, and we’re excited to welcome Questa to our fantastic group of investors as we execute a strategic market release in the United States,” Intrinsic Therapeutics CEO Cary Hagan said in a press release.

The 10 largest orthopedic device companies in the world

skeleton bones orthopedic device companies orthopedics ortho

[Image courtesy of Unsplash]

Robot-assisted surgery continues to generate headlines in the orthopedics space. But there is so much more going on among the world’s largest orthopedic device companies.

Go to our sister site Medical Design & Outsourcing and discover what’s new among the 10 largest companies in the medical device industry’s ortho sector.



Note: Medical Design & Outsourcing drew on research for its annual Big 100 list of largest medical device companies to create the 10 largest orthopedic device companies list.


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Medtronic seeks another bite at the apple in $24m patent loss to spine doc inventor

Medtronic logo updated

Medtronic (NYSE:MDT) asked a federal appeals court for a full-bench review of its nearly $24 million loss in a patent infringement lawsuit brought by a physician inventor.

In February 2014, Dr. Mark Berry alleged that Fridley, Minn.-based Medtronic infringed on three patents covering a “system and method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions.”

In November 2016, a jury in the U.S. District Court for Eastern Texas sided with Barry, awarding $15.1 million for infringement of one patent, more than $2.6 million for infringement on the second and $2.6 million for overseas infringement. In January 2017 a judge reduced the $20.3 million verdict by $2.6 million, ruling that Barry did not present sufficient evidence on the overseas violation but upholding the U.S. infringement claims. Later that year, the court awarded total damages of nearly $24 million.

In January the U.S. Court of Appeals for the Federal Circuit issued a split 2-1 opinion affirming the lower court’s decision. In a March 27 filing, Medtronic asked the appeals court to seat its full complement of judges for a review of the case, arguing that the dissenting judge’s argument on one of the patents should carry the day.

“In Dr. Barry’s case, all of the foregoing considerations – the lack of records indicating experimentation, the normal fee charged, the control exercised, and the failure to inform customers of experimental purpose – would look the same if the surgeries were for commercial purposes. The only thing that affirmatively suggests these surgeries were experimental is that Dr. Barry said they were – after the fact, during litigation. As a matter of law, that is insufficient to show experimental purpose,” Judge Sharon Prost wrote in the dissent. “The record in this case shows that Dr. Barry waited too long to file for the ‘358 patent and that the on-sale bar applies.”

“Rehearing is warranted to reaffirm that such post hoc testimony, unsupported by contemporaneous objective evidence, cannotsave otherwise-invalid patent claims from operation of the statutory on-sale and public use bars,” Medtronic wrote in its rehearing petition.

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Sterilization plant closures: Here’s why you need to care

(Image by Jose Fontano on Unsplash)

The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant.

Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. With a Viant sterilization plant in Grand Rapids, Mich. slated to close later this year, the FDA is warning of spot shortages, and smaller medtech companies may be the hardest hit.

Get the full story on our sister site, Medical Design & Outsourcing.

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Zimmer Biomet wins FDA nod for robotic Rosa One Spine platform

Zimmer Biomet logo

Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its robotic Rosa One Spine System intended for use in robotically assisted minimally invasive complex spine procedures.

The Warsaw, Ind.-based company touted that the Rosa One Spine combines robotics and navigation alongside real-time patient dynamic tracking capabilities.

The system also features 3D intraoperative planning software and a suite of navigation technologies intended to improve implants, instrument placement accuracy and predictability, Zimmer Biomet said.

“Rosa One Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures. We are extremely excited about the addition of Rosa One Spine to our already released Rosa One Brain and Rosa Knee systems,” spine, CMF and thoracic surgery assisting tech group prez Aure Bruneau said in a press release.

Zimmer Biomet said that the Rosa One Spine system is available on the same platform as its Rosa One Brain and Rosa One Knee system, making Zimmer Biomet the only company with a robotic platform intended for neurosurgical, spinal and knee pathologies. Both the Rosa One Brain and Rosa One Knee system have already received FDA 510(k) clearance.

Last month, Zimmer Biomet saw shares rise after the medical device maker beat expectations on Wall Street with its fourth quarter and full year 2018 earnings results.

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Medtronic launches Grafton DBM in Japan

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it launched its Grafton demineralized bone matrix bone grafting product in Japan.

The Fridley, Minn.-based company touted the Grafton DBM as the first and only demineralized bone matrix product available in Japan, having won clearance from the country’s PMDA last August.

The newly launched Grafton DBM is a bone graft extender, bone graft substitute and bone void filler intended for use in bony voids or gaps in the skeletal system. The company added that the Grafton DBM has consistently high osteoconductivity scores and that it is the “most utilized and scientifically-studied DBM on the market.”

“Our unmatched combination of biologic therapies, services and expertise help surgeons meet the needs of each unique patient. Grafton is an important option within our comprehensive, market-leading biologics portfolio, and we’re excited that surgeons in Japan now have access to this clinically-proven osteoinductive bone graft product,” spine division prez Jacob Paul said in a prepared statement.

Medtronic said that the Grafton DBM is comprised of multiple forms, and that it is launching the Grafton Putty, Grafton Matrix and Grafton Strip in Japan.

Yesterday, Medtronic said that it won 510(k) clearance from the FDA for its Accurian radiofrequency nerve ablation device for treating chronic pain.

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Innovasive rebrands as Amplify Surgical

Amplify Surgical

Spinal device manufacturer Innovasive said yesterday that it is rebranding under the moniker Amplify Surgical.

The Mission Viejo, Calif.-based company began the name change in January and said that it expects the rebranding process to continue through the end of the first quarter.

“The Amplify Surgical name better emphasizes our commitment to delivering new, cutting-edge, surgical solutions that reestablish the standard of care for our surgeon customers and their patients. In addition, the new name and brand better represents the Company’s inventive culture and product pipeline,” CEO Andy Choi said in a press release.

Amplify Surgical’s first product is the DualX dual expanding interbody fusion system, which won FDA clearance last October.

The system is comprised of titanium expandable interbody devices intended for use in transforaminal lumbar interbody fusion, posterior lumbar interbody fusion and lateral lumbar interbody fusion procedures, the company said.

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Orthofix wins FDA PMA nod for M6-C artificial cervical disc


Orthofix (NSDQ:OFIX) said yesterday that it won FDA approval for its M6-C artificial cervical disc, intended for treating patients suffering from cervical disc degeneration.

The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April.

The newly cleared M6-C is a next-gen artificial disc intended to replace an intervertebral disc damaged by cervical disc degeneration. The system is designed to restore physiological motion to the spine and is indicated as an alternative to cervical fusion, Orthofix said.

Pre-market approval of the device came based on results from an FDA investigational device exemption study of the system which evaluated the safety and effectiveness of the M6-C as compared to anterior cervical discectomy and fusion for treating symptomatic cervical radiculopathy with or without cord compression, the company said.

Two-year results from the trial indicated that 90.5% of patients who received the disc showed a meaningful clinical improvement on the Neck Disability Index versus only 79.9% in the ACDF cohort, as well as improvements in arm pain in 91.2% of M6-C patients, higher than the 77.9% reported in ACDF patients.

Data from the trial indicated that patients who received the M6-C disc showed a preserved range of motion in flexion-extension and lateral bending.

A total 80.6% of M6-C disc patients and 85.7% of ACDF patients reported taking pain medications for their cervical spine condition, Orthofix said. At 24 months, 14% of M6-C patients reported still taking pain medications, compared to 38.2% of the ACDF cohort.

Additional surgeries at the treated level was required in only 1.9% of M6-C patients, lower than the 4.8% rate for ACDF patients, the company said.

“Cervical disc degeneration is a common condition that can cause pain in the neck, shoulders, arms and hands and lead to numbness and weakness in the arm or hands. Often this condition is the result of a vertebral disc that has deteriorated or been damaged due to the natural aging process or an injury. For many of these patients, the M6-C artificial cervical disc will give us the ability to replace the patient’s damaged disc with one that closely mimics their natural disc, enabling them to regain motion and return to their normal activities,” M6-C artificial cervical disc IDE study investigator Dr. Rick Sasso of Indianapolis’ Indiana University School of Medicine said in a prepared statement.

Orthofix said it plans to launch the M6-C artificial cervical disc this year through a controlled, limited market launch in the U.S. with an extensive training and education program. The device already has CE Mark approval in the European Union.

“With the approval of the M6-C artificial cervical disc, Orthofix now has the industry’s most comprehensive portfolio of cervical spine products to best serve our surgeon customers and patients. In addition to a full line of anterior, posterior and interbody fusion cervical implants, we offer the CervicalStim device, the only FDA-approved cervical bone growth stimulation therapy, and the Trinity Elite allograft, a market-leading allograft developed in partnership with MTF Biologics. The launch of the M6-C artificial cervical disc in the U.S. will complement this existing spine portfolio and represents a significant milestone in the execution of our strategy to accelerate topline growth,” Orthofix prez & CEO Brad Mason said in a press release.

Earlier this week, Orthofix said that it acquired Florida-based medical device distributor Options Medical for an undisclosed amount.

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Relievant back-pain device study stopped for positive results

Relievant Medsystems said it has halted enrollment in a clinical trial of its Intracept lower-back pain device due to the device’s superiority over non-surgical management.

The Level I Intracept study found a “highly significant reduction” in the Oswestry Disability Index (ODI) score in patients treated with the Intracept procedure over patients in the non-surgical management arm. The trial’s independent data management committee recommended that investigators stop enrollment and offer Intracept treatment to control-arm patients, according to the Minneapolis, Minn.-based company.

The interim analysis of the primary endpoint 104-participant trial demonstrated a 20.9 point difference in mean ODI reduction at three months between the Intracept arm and the non-surgical management arm. The Intracept-treated patients reported a 25.3 point reduction in ODI from baseline at three months. One-year results from a prior study released in February 2018 showed a statistically significant difference between patients treated with Intracept and a sham treatment cohort.

“This is the second Level I study that has demonstrated clinically significant improvement in pain and function for patients with modic changes on MRI and solidifies the Intracept procedure as a compelling early treatment option for patients with (chronic lower back pain),” said principal investigator Steven Garfin, M.D., interim dean, University of California San Diego School of Medicine, in a prepared statement.

“Stopping a Level I trial early for superiority is an extremely rare event and we are thrilled with this result,” said Relievant Medsystems CEO Kevin Hykes. “The Intracept procedure has demonstrated compelling and consistent clinical results in both sham-controlled and real-world Level I studies. The combined strength of these studies provides convincing evidence of the outcomes that patients and physicians can expect from the Intracept procedure.”

The full results of the Intraceptstudy are expected to be presented and published later in 2019.

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