BELGRADE, Mont., Nov. 23, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Xsert Lumbar Expandable Interbody System.

The Xsert System is an all titanium expandable interbody device that expands in-situ. It is available in various sizes and lordotic angulations to fit the most complex anatomical needs of patients. These spacers are designed to simplify surgeon insertion technique[s] while offering implant height adjustability. Osteointegration will be encouraged through nanotextured endplate surfaces as well as central and lateral implant graft windows. The system is intended for use at one or two contiguous levels (L2-S1 inclusive).

Xsert is also cleared to be packed with autograft or allograft bone graft. Xtant Medical’s 3Demin and patented OsteoSponge technology are excellent allografts to use with Xsert due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion.

“We are very pleased to have received clearance for Xsert. This system allows the surgeon to implant the cage in a tighter corridor and then expand the device according to the patient’s anatomy,” stated Dr. David Kirschman, developer of Xsert and current member of the Xtant Medical Board of Directors. “With the clearance of allograft use with Xsert, Xtant Medical further expands combined device and biologic solutions for surgeons and their patients.”

Xtant Medical estimates the U.S market for lumbar interbody devices at $1.3M and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. Xsert will be available in an initial product release in mid 2017.

About Xtant Medical Holdings

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

Posted in Regulatory and Compliance by MDDI staff on November 21, 2016

The FDA has released a final guidance on Medical Device Reporting for Manufacturers. This follows the corresponding draft guidance of July 2013 and replaces the guidance of March 1977, which is no longer available on FDA’s website. That guidance was ambiguous with regard to the reporting of non-injurious malfunctions caused by user error. Among various revisions from the 2013 draft is the treatment of user error, which the guidance also calls “use error.”

To many, these terms are not interchangeable since user error seems to denote clear fault (the user) while use error identifies what happened but leaves the cause open. For instance, the error might have been caused or facilitated by inadequate labeling or bad design. The term “use error” was introduced in MD+DI in 1995 and has since been widely adopted.

FDA notes with regard to use errors that “such errors often reflect problems with device labeling, the user interface, or other aspects of device design.” Further, FDA states that it “believes that these events should be reported in the same way as other adverse events which are caused or contributed to by the device.” It then goes on to say that such errors related to deaths and serious injuries are to be reported, as has been the case. However, use errors associated with malfunctions that did not result in death or serious injury no longer have to be reported, according to the new guidance.

This is a change from the draft and may reflect feedback from industry participants who did not want to have to report use errors that weren’t associated with deaths or serious injuries. It may also be that FDA decided they didn’t want to deal with such reports. Unlike the preamble to rules and regulations, which are sometimes cited as agency policy and give a—more or less—detailed analysis of why an agency made the decisions it did, guidance documents are issued without such analysis being publicly reported.

So much for transparency. In contrast, the 1995 MDR Final Rule included 20 pages of notes and comments in the three-column Federal Register format.

READ THE REST HERE

Elizabeth Hofheinz, M.P.H., M.Ed. • Mon, November 21st, 2016

Move over cell phone…there is another portable device that may want to share that space—the world’s first pocket-sized diagnostic device for osteoporosis. Bone Index Ltd., a company based in Finland, has been granted a U.S. patent for its unique product, known as Bindex.

Bone Index’s CEO, Dr. Ossi Riekkinen said in the November 11, 2016 news release, “Bindex is unique technology. Now we have a total of 19 patents globally including the U.S., China, Japan and large European countries. The United States is a very significant market and we are actively seeking a partner who has the capabilities to take advantage of this unique opportunity. The overall aim is to prevent osteoporotic fractures and improve the quality of life of families in the U.S.”

Dr. Riekkinen told OTW, “Bindex is the first reliable, fast and easy to use point-of-care instrument for osteoporosis diagnostics. We have received 510(k) clearance from FDA for the Bindex to help in osteoporosis diagnosis.”

“Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA [dual-energy X-ray absorptiometry]. Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.”

READ THE REST HERE

November 16, 2016

EOS imaging has received FDA 510(k) clearance for its knee EOS 3D surgical planning software for total knee arthroplasty, which means the company can now market the software in the United States.

Leveraging weight-bearing 3D images and data from the EOS system, the online 3D planning software can provide an optimized surgical plan for total knee arthroplasty. The software facilitates surgical preparation and alignment in 3D while illustrating relevant clinical parameters in real time, and that generates an initial proposal for the size selection and position of the implant components.

“The knee EOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market,” says Marie Meynadier, EOS imaging’s CEO. Explaining further, she says the solution will support the growing adoption of EOS images, 3D models, and patient-specific datasets throughout the care continuum.

For patients, this means personalized treatments, absent the high dose and cost associated with CT imaging.

For more information about this software, visit EOS imaging.

By Kelcee Griffis

Law360, New York (November 14, 2016, 8:58 PM EST) — Medtronic Inc. must pay $20.3 million in damages to a doctor who sued the medical device company for patent infringement, a Texas jury decided Friday.

The jury found Medtronic “actively induced” infringement on both of the patents in question held by Mark A. Barry, a doctor who sued the company in 2014 for allegedly infringing on his devices that align vertebrae in patients with conditions such as scoliosis.

The patents cover hardware such as specialized screws and a method of implanting them by surgeons to correct certain spinal deformities.

Barry said Medtronic reproduced and sold implants that compete with his own across the U.S. and internationally. In a motion for judgment as a matter of law filed toward the end of the trial Thursday, the company fired back, saying that there was no way to prove surgeons relied on that highly specific set of screws and tools to complete the surgery.

The jury disagreed, awarding $17.6 million for infringement that occurred within the U.S. and the rest for infringement that took place outside the country.

The trial began Nov. 3 and wrapped up Nov. 11, said Sean P. DeBruine of Kilpatrick Townsend & Stockton LLP, the lead attorney representing Barry. The 10 jurors deliberated for about five hours before coming to a unanimous verdict, he said.

DeBruine said the jury was admirable for spending the Veteran’s Day holiday deciding on the verdict.

READ THE REST HERE

Posted in Regulatory and Compliance by MDDI Staff on November 15, 2016

On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely used to treat medical conditions ranging from minor cuts and burns, to diabetic foot ulcers and historically have been cleared by FDA through the 510(k) process. While this is not the first time FDA has looked to experts to help evaluate the classification of wound dressings containing drugs, this panel meeting was prompted in part by evolutions in technology, the breadth of cleared indications for use, the extensive list of ingredients (many with known or potential chemical activity), and the public health implications associated with antimicrobial resistance (as evidenced by FDA’s recent ban of 19 antibacterial agents in soaps).

The panel’s main focus was on dressings containing antimicrobial drugs, but certain single entity dressings containing materials that are not antimicrobial drugs or preservatives, but that act solely within the dressing to enhance its barrier properties, were also discussed. The panel discussion was largely consistent with FDA’s historical regulatory approach for devices containing drugs, but also highlighted that these products present unique regulatory challenges and public health concerns.

A critical point of discussion involved the differentiation of these products based on the purpose of the drug and how such differences could lead to different regulatory pathways. The use of antimicrobial agents that could lead to increased antimicrobial resistance or toxicity also was a focal point of the discussion and was of particular interest to the panel members. The panel believed that increased scrutiny and regulation may be necessary for some of these products to prevent or limit future increases in antimicrobial resistance.

FDA’s Regulatory Framework and Antimicrobial Resistance Concerns

Antimicrobial agents, which are commonly used to treat, manage, and prevent infectious diseases, come in many forms, all of which are expected to kill or inhibit the growth of microorganisms including bacteria, viruses, fungi, and parasites. Antimicrobials have been added to a variety of medical devices to reduce the risk of infections, including through the prevention of microbial growth on the device itself.

FDA frequently views the addition of an antimicrobial agent to increase the risks associated with a medical device. Many Class I, 510(k)-exempt devices, including hydrogel wound dressings and mattress covers for medical purposes, for example, require 510(k) clearance when an antimicrobial agent is added. FDA generally considers the addition of these agents to change the fundamental scientific technology of the device, thus exceeding the limitations of their 510(k) exemptions.

READ THE REST HERE