News – Page 227 – Selby Spine

SACRAMENTO, CA (PRWEB) MARCH 08, 2017

El Dorado Hills, CA, March 8th, 2017: Consensus Orthopedics, a joint reconstruction manufacturer, proudly announces its entry into the orthopedic wearable devices market. TracPatch is a groundbreaking wearable device that remotely monitors a patient’s post-surgical activities by continuously sending activity data, including range of motion (ROM), ambulation, exercise compliance, and wound site temperature trends. Healthcare Providers will now have insight 24/7 into how a patient is recovering from total joint surgery, thus improving outcomes and reducing costs. The TracPatch wearable device system will be debuted at next week’s American Academy of Orthopedic Surgeons Annual Meeting in San Diego, CA, March 14th-17th, 2017, Booth #1233.

The first six weeks of at-home recovery after total joint surgery are critical for a positive outcome. Visibility into the patient’s at-home activity is nonexistent. This limited insight along with the emergence of value-based medicine, including programs such as Comprehensive Care for Joint Replacement (CJR), signifies a new paradigm shift in cost control and responsibility for hospitals and surgeons. The Centers for Medicare & Medicaid Services, CMS, is sending a clear message with CJR: they want hospitals and post-acute providers to partner and coordinate for a patient’s entire 90-day episode of care. Through an IoT (Internet of Things) approach, TracPatch helps both the patient and healthcare provider coordinate care and accountability.

The TracPatch device is placed on the lower leg just below the joint line, using non-allergenic adhesive disposable pad. TracPatch is designed to enable any healthcare provider to collectively and continuously monitor their TracPatch patients’ progress. TracPatch will record patient’s range of motion (ROM), ambulation, exercise compliance, and temperature trends regardless of what implant system is used.

This machine learning device optimizes the patient’s entire episode of care by enabling a proactive approach. Whether the recovery is going well or needs immediate attention, the healthcare provider can adjust the patient’s post-surgical activities and goals anytime, anywhere to better facilitate and improve the patient’s recovery. The device transmits key post-surgical data points directly to a secure cloud-based platform, where healthcare providers can track patient progress on the TracPatch mobile app or web dashboard. The TracPatch app features an intuitive interface for easy operation on any smart phone or tablet with Bluetooth technology.

Dr. Shervin Oskouei, MD, Dept. of Orthopedic Surgery, Emory University School of Medicine, said “TracPatch can add tremendous value to the entire episode of care. This technology allows a healthcare provider insight into never-before-seen data for post-surgical rehabilitation. Being able to monitor your patient’s range of motion progress and exercise compliance daily is a game changer. TracPatch is making proactive care easy, so every patient has an excellent outcome.”

Curt Wiedenhoefer, President of Consensus Orthopedics, says, “In this new value-based healthcare environment, to be able to combine the exploding adoption of wearable technology and apply it to the total joint industry is going to revolutionize the way we deliver care. For the first time in the history of joint surgery, we are using microelectronics to passively capture valuable post-surgical recovery information. Now, healthcare providers have objective data for every patient, especially during those critical six weeks of post-acute care.”

With the launch of TracPatch, Consensus Orthopedics is ideally positioned to partner with all healthcare providers looking to improve outcomes, reduce costs and enhance patient satisfaction. With CJR bundled payments rolling out nationwide, TracPatch is a truly innovative product for the value-based healthcare market as well as any provider looking to redefine their episode of care.

Explore TracPatch by visiting Consensus Orthopedics Booth #1233 at the American Academy of Orthopedic Surgeons Annual Meeting in San Diego, March 15-17. See for yourself how this device can revolutionize the way you deliver care.

To learn more about the TracPatch wearable device system, visit tracpatch.com, call 916-355-7131, and visit Booth #1233 at AAOS.

About Consensus® Orthopedics, Inc.
Consensus Orthopedics was founded in 1992 as a medical device consulting company. In 1996, Consensus Orthopedics acquired US Medical Products, becoming a global manufacturer of reliable large joint orthopedic devices. In 2016, Consensus Orthopedics launched its innovative TracPatch division focused on creating transformative wearable technology designed for real time continuous post-surgical patient monitoring. With a focus on patient care, Consensus is dedicated to creating one team and providing exceptional outcomes. Learn more at http://www.consensusortho.com.

LEESBURG, Va., March 08, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it will debut the Balance ACS™ (or BACS™) platform at the Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS) and the American Academy of Orthopaedic Surgeons Annual Meeting (AAOS). The Company will also participate in the British Association of Spine Surgeons (BASS) annual meeting, marking the international introduction of the Balance ACS platform.

Balance ACS is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

During the meetings, K2M will demo the BACS System, which provides the necessary services to facilitate quality surgical outcomes and support the intraoperative process. The Company will also unveil a BACS app, which serves as a convenient portal for surgeons to access the BACS System, including:

BACS Preauthorization: An easy-to-follow insurance documentation tool that displays payer- and patient-specific requirements.
BACS Surgical Planner: A surgical image measuring technology to assist in planning and preoperative implant selection.
BACS Anatomical Modeling: 3D-printed anatomical models to aid in visualization of patient anatomy for surgical planning and intraoperative use.
BACS Data Management: A data collection and operative reporting system to track patient quality metrics achieved with spinal balance.

“K2M is excited to introduce the Balance ACS platform of three-dimensional solutions and host educational workshops at leading spine conferences in the United States and internationally,” said K2M President and CEO Eric Major. “Our experience developing complex spine innovations and advancements in 3D solutions has led us to a comprehensive, next-generation BACS platform to help surgeons achieve quality outcomes and Total Body Balance for their patients.”

K2M Meeting Participation Details

K2M will showcase the Balance ACS platform and demo the BACS System and the BACS app. The Company will also host physician workshops featuring prominent spine surgeons presenting on the latest research and clinical applications of the platform.

Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves: March 8–10, Las Vegas, NV
- BACS Platform Exhibition and BACS App Demo: Booth #901
- Workshop: Techniques to Optimize Spinal Balance
  - Friday, March 10, 2017; Noon–1 p.m. (PST); Marquis 6
  - Faculty: Andrew Dailey, MD
American Academy of Orthopaedic Surgeons Annual Meeting: March 14–18, San Diego, CA
- BACS Platform Exhibition and BACS App Demo: Booth #425
British Association of Spine Surgeons: March 15–17, Manchester, UK
- BACS Platform Exhibition and BACS App Demo: Compass Room, Stand #C9
- Workshop: Techniques to Optimize Spinal Balance
  - Wednesday, March 15, 2017; 12:30–13:15; Aldridge Studio
  - Faculty: Robert Lee, BSc, MBBS, FRCS

For more information about Balance ACS and K2M, visit www.BACS.com and www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan. In some cases, you can identify these forward-looking statements by the use of words such as ““outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com 

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

WOBURN, Mass., March 8, 2017 /PRNewswire/ — Bio2 Technologies will present a poster at the Annual Meeting of the Orthopaedic Research Society (http://www.ors.org) in San Diego, CA on March 22, 2017 reporting the results from an ovine interbody fusion study conducted at Colorado State University comparing Bio2’s Vitrium device to an implant of similar design constructed from PEEK polymer. Autograft bone was placed in the central lumen of both devices.

Vitrium is an advanced orthobiomaterial with structural properties similar to cortical bone. It is composed of bioactive glass, a material with well-established osteostimulative properties. Bio2 has developed a proprietary manufacturing process to produce a strong, three-dimensional structure featuring interconnected pores facilitating the propagation of new bone.

The biomechanical tests (performed by mdevdev, San Francisco, CA) evaluated Vitrium’s ability to exhibit the ideal characteristics of a spinal fusion product, prospectively defined as: a) an effective, safe resorption/bone formation profile, b) stimulation of new bone formation to increase fusion rates, and c) sufficient strength to bear/share physiologic loads. Janet Krevolin, Ph.D., Bio2’s Chief Technical Officer and co-author of the poster, stated “the test results clearly demonstrated that Vitrium achieved these objectives. All subjects demonstrated a reduction in motion at 26 weeks indicating a fusion taking place for both the Vitrium and PEEK implants. Of note, in axial compressive load to failure testing the Vitrium fusion exhibited strength in excess of the adjoining vertebral bodies, whereas the PEEK fusion failed at the fusion site. The test data show the Vitrium devices exhibited the ideal characteristics of an interbody fusion product.”

Additional information on Vitrium and the ovine spinal fusion study may be found at: http://www.bio2tech.com

SOURCE Bio2 Technologies, Inc.

CARLSBAD, Calif., March 06, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc. (Nasdaq:ATEC), a provider of spinal fusion technologies, announced today that it continues its investment in new executive talent with the hiring of Jeffrey G. Black as Executive Vice President and Chief Financial Officer.

Mr. Black is a seasoned executive with over 25 years of experience in financial and operations management, including senior-level finance roles for six publicly-traded companies. As the CFO at Alphatec, Mr. Black will lead the finance, investor relations and accounting organizations, architecting the appropriate capital structure for the Company to execute its strategy and build a sustainable financial foundation for future growth.

“Jeff’s financial insight, capital restructuring and financing experience, as well as his open leadership style will be great enhancements to the Alphatec team,” said Terry Rich, Chief Executive Officer of Alphatec Spine. “His history of successfully leading growing organizations, his Wall Street relationships in the healthcare sector, and his strong discipline in cost and cash control make him an ideal fit for Alphatec. I look forward to partnering with Jeff as we continue to build a high-growth U.S. spine company and improve surgeons’ experiences and patient outcomes through our differentiated product offerings. We also thank Dennis Nelson, Vice President, Finance, for serving as Alphatec’s Principal Accounting Officer, and offering strong leadership of our finance and accounting organizations while we engaged in the CFO search.”

Mr. Black, 48, previously served as the Chief Financial Officer of Applied Proteomics, Inc., a company that develops novel, non-invasive diagnostics using a proteomics-based platform. Before joining Applied Proteomics, Mr. Black served as the Chief Financial Officer of AltheaDx, Inc., a molecular diagnostics company specializing in pharmacogenetic testing. Prior to AltheaDx, Mr. Black served as Chief Financial Officer of Verenium Corporation (formerly Diversa Corporation), a Nasdaq-listed pioneer in the development and commercialization of high-performance enzymes for use in industrial processes. During his nine-year tenure at Verenium/Diversa, Mr. Black played a leadership role in more than $500 million of strategic, equity, and debt financing transactions, culminating in the sale of the company to BASF in 2013. Mr. Black is a certified public accountant (inactive) and began his career with Ernst & Young LLP. He currently serves on the Board of Directors of Cellana, Inc., a privately-held algae bioproducts company.

“I am pleased to be joining Terry and his high-caliber leadership team, with a proven record of success in the spine market,” said Mr. Black. “With this new team in place, a robust product portfolio, and a rich pipeline of new products, Alphatec is well-positioned to continue on an accelerated path to improve patient lives. I am excited to be a part of the company’s transformation, with an eye toward building value for shareholders.”

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on February 21, 2017, the Compensation Committee of the Board of Directors approved the following inducement awards to Mr. Black: 75,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 75,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan. Collectively, the RSUs and options were granted as inducements material to Mr. Black entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of Mr. Black’s first date of employment, assuming in each case that he remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (March 6, 2017). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case Mr. Black remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

The Board approved an amendment to the Plan to increase the shares reserved for issuance thereunder by 600,000 shares, effective February 21, 2017.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

Further information regarding the Company’s appointment of Jeffrey G. Black as Executive Vice President Finance and Chief Financial Officer is set forth in a Current Report on Form 8-K that was filed with the U.S. Securities and Exchange Commission (SEC) on March 6, 2017 and is available on both the SEC’s website at www.sec.gov and the Company’s website at www.alphatecspine.com.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the Company’s ability to build a high-growth U.S. spine company; ability to strengthen its position in the U.S. spine market; ability to improve surgeon’s experiences, patient outcomes and patient lives; ability to build value for shareholders; ability to architect the appropriate capital structure; ability to build a sustainable financial foundation for future growth; the potential of the Company’s pipeline of products; and the Company’s ability to achieve its strategic goals. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; the failure to obtain FDA clearance or approval for new products or prolonged delays in the process; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; claims related to the Company’s intellectual property; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations 
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

ALISO VIEJO, Calif., March 7, 2017 /PRNewswire/ — Vertos Medical, a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has received national coverage for its mild^® Procedure through a recently approved study under the Centers for Medicare & Medicaid Services’ (CMS) Coverage with Evidence Development (CED) Program. A clinically proven outpatient procedure performed through a portal the size of a baby aspirin, mild requires no stitches, no general anesthesia, no implants, and no overnight hospital stay.

Broad access to the mild procedure has been granted for Medicare patients via a CMS-approved claims-analysis study that will passively collect and analyze real-world data to demonstrate the role of the therapy in the continuum of care for LSS. CMS’s recent decision to expand access follows the successful completion of the company’s CMS-approved randomized controlled study, MiDAS ENCORE.¹

“Patient and physician demand for the mild procedure has grown a great deal, and I’m excited to hear that my patients and fellow practitioners will now have access to this effective, proven method for relieving pain and getting people back to doing the things that make life enjoyable,” said Nagy Mekhail, M.D., Ph.D., Director of Evidence Based Pain Medicine Research and Education at Cleveland Clinic, who is an investigator of previous clinical studies of mild and has been performing the procedure since 2010. “Neurogenic claudication related to lumbar spinal stenosis can be extremely life limiting; this first-line treatment stands to benefit the many patients currently being treated for LSS in the United States, who have no viable treatment options.”

It is estimated that roughly 10% of Americans have lumbar spinal stenosis, and that by 2021 some 2.4 million will be experiencing considerable pain as a result of the condition.

“This is great news for the thousands of people who suffer from the debilitating symptoms related to their lumbar spinal stenosis with neurogenic claudication, who have struggled to find a safe, effective, low-cost solution,” said Eric Wichems, President and CEO of Vertos Medical.

The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials, and has been performed on more than 20,000 patients. Peer-reviewed clinical data has demonstrated that mild helps patients suffering from LSS stand longer and walk further with less pain.²

¹Benyamin, R., et al. (2016). mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician, 19: 229-242. ISSN 1533-3159.

² Mekhail, Nagy, et al. (2012). Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x.

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild^®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild^®treats this condition by restoring space in the spinal canal using specialized mild^® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that mild^® can help LSS patients stand longer and walk farther with less pain¹, and no major device-related complications have been reported in any clinical trial.² Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how mild^® treats LSS click here.

SOURCE Vertos Medical

WATERLOO, ON, March 7, 2017 /PRNewswire/ – Intellijoint Surgical^® Inc., a privately-held Canadian medical technology company, announces FDA clearance of intellijoint HIP^® Anterior, the newest application to the intellijoint HIP suite. intellijoint HIP Anterior is a 3D mini-optical navigation solution that provides quantifiable, intraoperative measurements for cup position, leg length, and offset to orthopaedic surgeons performing Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA).

“intellijoint HIP Anterior has been developed by a group of brilliant engineers with deep understanding of the steps involved in direct anterior hip replacement, which allows surgeons to integrate the device easily into their workflow,” said Dr. Javad Parvizi, member of Intellijoint Surgical’s Scientific Advisory Board and DAA orthopaedic specialist at Thomas Jefferson University Hospital’s Department of Orthopedic Surgery. “intellijoint HIP Anterior provides quantifiable, intraoperative measurements that allows surgeons to optimally position the components, restore limb length and offset. intellijoint HIP Anterior stands to eliminate fluoroscopy verification for cup position, leg length and offset that is often used by surgeons.”

Per bench top validation testing cleared by the FDA, 20 separate simulations were performed with intellijoint HIP Anterior accurately measuring anteversion to within 0.47°and inclination to within 0.65° when compared to radiographic scans. intellijoint HIP Anterior was intuitively designed to provide cup position measurements in relation to the supine coronal plane or Anterior Pelvic Plane, depending on surgeon’s preference.

“The low-cost fee-per-case pricing model of intellijoint HIP Anterior allows me to utilize navigation for all of my total hip replacements with the Direct Anterior Approach.” commented Dr. Michael Bradley, President/CEO of Orthopedics Rhode Island. “My DAA patients have peace of mind knowing that their hip implants are positioned exactly how I planned pre-operatively, thanks to intraoperative measurements from intellijoint HIP Anterior.”

Intellijoint Surgical will be showcasing the full intellijoint HIP suite including intellijoint HIP Anterior at AAOS 2017 Annual Meeting – Booth #5551 from March 15 – 18, 2017 in San Diego, California, USA. intellijoint HIP Anterior is currently in Limited Market Release and will be available in New York, Illinois, Rhode Island and Houston, Texas in early summer 2017.

About Intellijoint Surgical:

Intellijoint Surgical^® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP^® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Guided by a scientific advisory board comprised of Dr. Allan Gross, an orthopaedic surgeon at Mount Sinai Hospital, and members, Dr. Javad Parvizi at Thomas Jefferson University Hospital, Dr. Michael Cross at Hospital for Special Surgery, Dr. Wayne Paprosky at Rush University Medical Center, and Dr. Ran Schwarzkopf at NYU School of Medicine, Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

SOURCE Intellijoint Surgical Inc.

(March 7, 2017) VTI – Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has strengthened its distribution in Northern Europe to better serve its international customers. During this process VTI has appointed three new distributors with a strong focus on the spine market. This improved territory coverage will help increase awareness and give surgeons access to VTI’s InterFuse® modular spinal implants.

The three new distribution channels VTI will be partnering with are: Joline GmbH & Co KG, based in Hechingen, Germany: Articular, based in Helsinki, Finland and Anatomica, headquartered in Gothenburg, Sweden. All three distributors have a strong presence in all major hospitals within their respective countries.

Vice President of International Sales Ben Wasscher states “We believe that we have significantly upgraded the quality of our distribution network in Northern Europe, enabling VTI to better serve its existing surgeon customers as well as significantly expanding on this existing user base. This will bring the benefits of the InterFuse® modular interbodies to a larger patient population.”

“Anatomica’s sales force is very enthusiastic about the InterFuse® system!” says CEO Sverker Stomberg of Anatomica.

When asked about how surgeons react when seeing the InterFuse® product, Peter Kohlbecher Director of Sales & Marketing at Joline GmbH & Co KG said, “They like the fact that a large surface implant can be inserted from posterior; no need to flip the patient; no need to work with general surgeons to get access to the spine from the anterior”.

ABOUT VERTEBRAL TECHNOLOGIES, INC.

Vertebral Technologies, Inc. (VTI) is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells InterFuse® modular interbody fusion devices worldwide.

For more information visit, http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or +1.877-912-5401

Allendale, N.J.—March 8, 2017—Stryker’s Spine division will feature its 3D-printed Tritanium Posterior Lumbar (PL) Cage and introduce a variety of new cage sizes at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 15-18, 2017, in San Diego (booth No. 3133).

Stryker’s Tritanium PL Cage launch initially included four footprint options, eight height options, and two lordosis options. The company now offers several additional sizes based on surgeon needs and requests, including a hyper-lordotic (12°) cage option, as well as two new footprints—9 x 32 mm and 11 x 32 mm.

During the conference, Stryker’s proprietary Tritanium In-Growth Technology will be featured in a virtual reality “tour,” providing surgeons with a unique perspective on how 3D printing, also known as additive manufacturing, allows the company to produce highly porous implants that would be difficult or impossible to create using traditional manufacturing techniques.

Tritanium Technology allows for the creation of porous structures designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.¹This “precise randomization”¹ of fully interconnected pores differs from other technologies featuring longitudinal channels and traverse windows that result in a uniform lattice structure, as well as cages offering porosity that is only present on the surface.

“Stryker is a pioneer in 3D additive manufacturing, investing nearly 15 years in research and development,” said Stryker’s Spine division President Bradley Paddock. “Unlike traditional manufacturing techniques, the flexibility of our 3D additive manufacturing capabilities allows us to precisely engineer and produce porous Tritanium devices. We are excited to continue growing our unique suite of Tritanium spinal products.”

Also at AAOS, results will be presented from a pre-clinical animal study that evaluated the biomechanical performance and bone in-growth potential of various lumbar interbody fusion implants utilizing different materials, including the Tritanium PL Cage. Preliminary results of the study were presented at the North American Spine Society conference in October 2016. (Click here to access the Tritanium pre-clinical study summary.)

The Tritanium PL Cage features fully interconnected pores that span endplate to endplate. Its large lateral windows and open architecture allow visualization of fusion on CT and X-ray,² and its solid-tipped, precisely angled serrations are designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage. Additional spinal implants based on Stryker’s Tritanium Technology are in development.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. For more information, visit www.stryker.com or www.stryker.com/builttofuse.

Media Contact
Barbara Sullivan, Sullivan & Associates
bsullivan@sullivanpr.com, 714/374-6174

Editor’s note: For images, video footage, or animation of the Tritanium PL Cage and Stryker’s 3D additive manufacturing process, contact Barbara Sullivan at bsullivan@sullivanpr.com or 714/374-6174. A backgrounder is available at www.stryker.com/builttofuse.

References

Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
Abbushi A, Cabraja M, Ulrich-Wilhelm T, Woiciechowsky C, Kroppenstedt S. The influence of cage positioning and cage type on cage migration and fusion rates in patients with monosegmental posterior lumbar interbody fusion and posterior fixation. Eur Spine J. 2009;18: 1621–1628.

Content ID: TRITA-PR-6_13360

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: AMagine, Stryker, Tritanium. All other trademarks are trademarks of their respective owners or holders.

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Rockaway, NJ — March 7, 2017 — LinkSPINE, a medical device company focused on the development of less invasive techniques for spine surgery, has named Tom McLeer Vice President of Sales and Marketing.

McLeer is an established medical device executive leader who has made a name in the industry by exponentially boosting sales for existing companies and leading startups through clinical approval and into full commercialization. He most recently served as Senior Vice President of US Commercial Operations for Alphatec Spine. Previously, he was CMO and General Manager of Spinal Operations for Pioneer Surgical Technology and VP of Sales and Marketing for Archus Orthopedics. Earlier in his career, McLeer was VP of Marketing and Business Development for Spinal Concepts and VP of Marketing for Interpore Cross International.

“We are excited to welcome Tom McLeer to the LinkSPINE team to lead our Sales and Marketing efforts,” sad LinkSPINE President, Dennis Farrell. “Tom’s deep leadership experience in spine and familiarity with novel technologies will be invaluable to us as we as we continue to expand our less invasive Midline Choice product portfolio.”

Farrell added that LinkSPINE remains committed to developing innovative solutions which reduce surgical morbidity and which are designed for placement with minimal fluoro and shorter learning curves than tubular MIS techniques; and that McLeer is ideally suited to help bring those solutions to the surgical community.

‘Midline Choice’ is LinkSPINE’s comprehensive midline fusion portfolio, which includes CorticaLINK and FacetLINK. A single kit houses a complete array of screws and devices, offering the surgeon the ability to intra-operatively create a less invasive fusion construct based upon each patient.

“I’m excited to be part of such a great team and I look forward to working with my existing contacts to help advance this minimally invasive procedure to a wide patient population,” said McLeer. “I was drawn to LinkSPINE’s dedicated focus on improving patient outcomes — and it’s innovative portfolio of powerful, yet simple solutions for less invasive surgery. The devices are novel, elegant and intuitive and fulfill a desire for a simple, less invasive approach to lumbar surgery, adding true value for surgeons who are tiring of long learning curves. It will be rewarding to be part of the company’s growth and success.”

McLeer and his new LINKSpine colleagues will be exhibiting the company’s technology in Booth 907 at the Spine Summit 2017 AANS/CNS Meeting in Las Vegas, from March 8-11, 2017.

LinkSPINE is a privately held medical device company focused on the development of less invasive techniques for spine surgery. LinkSPINE is a sister company of Waldemar Link GmbH of Hamburg Germany, a worldwide leader in Reconstructive Orthopedics.

Media: Interviews and photos are available upon request. Please contact Paul Williams at 310/569-0023 or via paul@medialinecommunications.com.

Paul Williams

President

MediaLine Communications

310/569-0023

Kalamazoo, Michigan, USA – March 7, 2017 – Stryker announced today that its AVAflex Balloon System has received FDA 510(k) clearance and is, for the first time, available with Stryker’s market-leading bone cements and implants and the AutoPlex Mixing and Delivery System.

“Doctors who perform vertebral augmentations are committed to the health and wellness of their patients, and Stryker is committed to empowering those doctors to provide the best possible care,” said Chad Ludwig, marketing director at Stryker Instruments. “The AVAflex Balloon System enables doctors to achieve bipedicular results with a unipedicular approach to vertebral augmentation.”

The AVAflex and AutoPlex systems are used in the treatment of vertebral compression fractures (VCF), which affect an estimated 750,000 Americans each year. VCF patients can suffer from extreme pain and are at an increased risk for serious health problems. Vertebral augmentation, including the use of a balloon system, has been shown to provide patients with significant pain relief and dramatically reduce mortality rates.^,

The AVAflex curved balloon system’s new 11-gauge size allows surgeons to achieve with one insertion and a smaller needle what had previously required two insertions, making procedures less invasive and potentially reducing the risk of patient trauma. Using a minimally invasive technique, physicians can successfully create a midline cavity for targeted cement placement by accessing one pedicle.

AVAflex is now available with Stryker’s bone cements and implants and the AutoPlex Mixer and Delivery System, an easy-to-use bone cement mixing and delivery system. The AutoPlex system provides consistent and thorough blending of components, helping eliminate human error and variability.

Stryker has furthered its mission of making health care better for physicians, hospital staff and patients with the addition of the AVAflex portfolio, which it acquired from Becton Dickinson in 2016. Stryker provides the most complete and least invasive portfolio of vertebral compression fracture treatment options.

With an unrivaled collection of balloon catheters and augmentation options, cements, automated mixers and directional delivery systems, Stryker enables care providers to tailor their approach for the treatment of vertebral compression fractures. Stryker is now the exclusive provider of automatic mixing and delivery systems and 11-gauge curved balloons.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

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