Category: Knee deformation

  • Biogennix launches OsteoSPAN fiber matrix

    Biogennix launches OsteoSPAN fiber matrix

    IRVINE, California, October 24, 2023 / OrthoSpineNews / – Irvine-based Biogennix, an osteobiology company that develops, manufactures and distributes proprietary bone graft products used for bone fusion procedures, today announced the launch of its new OsteoSPAN fiber matrix.

    OsteoSPAN Fiber Matrix consists of 100% demineralized cortical fibers and is designed for optimized handling, while providing verified osteoinductive potential and an osteoconductive scaffold that supports cellular bone formation and stimulates fusion. OsteoSPAN Fiber Matrix is ​​also processed to provide fast, consistent hydration and fluid retention while resisting irrigation.

    The OsteoSPAN fiber matrix is ​​malleable and cohesive when hydrated with blood or bone marrow, and expands to conform to irregular bone voids. The product is available in volumes of 1cc, 2.5cc, 5cc and 10cc.

    “OsteoSPAN Fiber Matrix is ​​Biogennix’s first allograft product,” said Mark Borden, CTO of Biogennix. “We are excited to expand our portfolio with allografts that will complement our extensive synthetic offering and give us access to a new segment of the bone graft market.”

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    Biogennix® is a fully integrated osteobiology company headquartered in Irvine that develops, manufactures and distributes proprietary bone graft products used in bone fusion procedures. Biogennix is ​​committed to advancing the technology behind natural bone grafting solutions, delivering outstanding quality with exceptional value and customer-focused excellence. More information can be found at biogennix.com.

    Media contact:
    Paul Williams
    310-569-0023
    paul@medialinecommunications.com

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  • Centinel Spine® PMA application for first-of-its-kind 2-level prodisc® C Vivo and prodisc C SK Match-the-Disc™ Cervical Total Disc Replacement System submitted and followed up with substantive review

    Centinel Spine® PMA application for first-of-its-kind 2-level prodisc® C Vivo and prodisc C SK Match-the-Disc™ Cervical Total Disc Replacement System submitted and followed up with substantive review

    • The clinical trial evaluated the safety and effectiveness of prodrive C Vivo and prodisc C SK system by comparing it to an approved total disc replacement (TDR) product as a check for 2-level indications.
    • This is the first IDE study to allow surgeons to choose from two different TDR devices to treat each surgical level separately.
    • The IDE trial involved 431 subjects at 29 locations in the United States.

    WEST CHESTER, Pa., Oct. 26, 2023 /PRNewswire/ — Centinel Spine®LLC, (“the Company”), the leading global medical device company addressing cervical and lumbar spine diseases with the world’s most clinically proven total disc replacement (TDR) technology platform (prodisk®), today announced that the Food and Drug Administration (FDA) has accepted the submission of its Premarket Approval (PMA) application submitted for the Investigational Device Exemption (IDE) study evaluating the company’s benefitsdrive C I’m alive and prodisk C SK cervical TDR system. The filing date for the company’s PMA application was September 27, 2023, and the submission is now under substantive review by the FDA.

    The prospective, randomized clinical trial was designed to evaluate the safety and effectiveness of the prodrive C I’m alive and prodisk C SK system by comparing it to an approved TDR product as a control for 2-level indications, making it the first and only trial of its kind with two investigational devices and a TDR control. The study completed enrollment in June 2023 and included 431 subjects at 29 US sites and allowed surgeons to select the study device: the prodrive C I’m alive and/or prodisk C S.K—based on patient anatomy, as well as other surgical factors. The ability to individually treat each level of disease at two levels provides surgeons with both more options and opportunities to tailor the intervertebral disc to the patient’s anatomical needs.

    One of the lead investigators in the study, orthopedic spine surgeon Dr. Brian Perri of DOCS Health in Los Angeles, CA, commented on this important milestone: “Centinel Spine is once again working to demonstrate innovation, safety and effectiveness in their line of cervical disc replacements through this unique study. I hope for FDA approval soon, which will make Centinel Spine the first company to offer multiple disc designs for two-level procedures and allow the surgeon to select the best cervical total disc replacement for each level treated.

    “The proffesionaldisk C Alive and prodisk C SK The 2-level cervical disc clinical trial was unique in two respects,” said Steve Murray, CEO of Centinel Spine. “It is the first cervical study to use total disc replacement devices in both study arms, and it is the only study to offer disc options in the study arm according to surgeon preference based on patient anatomy. This trial is in line with Centinel Spine’s strategy to be the only company providing both cervical and lumbar intraoperative prostate products.disk options for one- and two-level total drive replacement procedures. We look forward to the FDA’s careful review of the PMA submission.”

    The proffesionaldrive C I’m alive system has been in clinical use internationally since 2009 and is currently one of the most implanted TDR devices in the world. The device has a keelless fixation and combines a unique anatomically designed superior endplate with lateral spikes to optimize fit and provide immediate fixation. The proffesionaldisk C SK The device features a flat end plate designed for optimized implant positioning, allowing surgeons to explore the individual patient’s anatomy – with a low-profile central keel that provides immediate fixation and allows for a streamlined keel preparation technique.

    More information about the clinical trial can be found at www.clinicaltrials.gov using the identifier NCT04012996.

    About Centinel Spine, LLC
    Centinel spine®LLC is the leading global medical device company addressing cervical and lumbar spine diseases with the world’s most clinically proven total disc replacement (TDR) technology platform (prodisk®). The company’s prodisk technology is the most studied and clinically proven TDR system in the world, validated by more than 540 published articles and more than 250,000 implantations worldwide.

    Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst for change in the spine industry and change the way spine surgery is experienced. The proffesionaldisk platform remains the only technology with multiple motion preservation solutions for both cervical and lumbar anterior column reconstruction.

    For more information, please visit the company’s website at www.CentinelSpine.com or contact:

    Varun Gandhi
    Finance Director
    900 Airport Road, Suite 3B
    West Chester, PA 19380
    Phone: 484-887-8871
    Email: v.gandhi@centinelspine.com

    SOURCE Centinel Spine, LLC

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  • Global Scoliosis Management Market Report 2023: Market to Grow by $1 Billion by 2030 – Spinal Fusion Surgery Offers Major Opportunities

    Global Scoliosis Management Market Report 2023: Market to Grow by $1 Billion by 2030 – Spinal Fusion Surgery Offers Major Opportunities

    Dublin, October 26, 2023 (GLOBE NEWSWIRE) – The report “Scoliosis Management – ​​​​Global Strategic Business Report” has been added to ResearchAndMarkets.com’s to offer.

    The global scoliosis treatment market will reach $3.8 billion by 2030

    The global scoliosis treatment market, estimated at USD 2.8 billion in the year 2022, is expected to reach a revised size of USD 3.8 billion by 2030, with a CAGR of 4.1% over the analysis period 2022-2030.

    This data includes an analysis of the Thoracolumbosacral Orthosis (TLSO) and related orthosis markets worldwide. It includes current, historical, and future annual sales figures in thousands of dollars for the years 2022 through 2030, along with percentage compound annual growth rates (%CAGR).

    The analysis is segmented into different product types, including TLSO, Cervical Thoracic Lumbar Sacral Orthosis (CTLSO), Lumbosacral Orthosis (LSO), and Other Product Types. Furthermore, within these product types a distinction is made between the Pediatric and Adult segments.

    Thoracolumbosacral orthosis (TLSO), one of the segments analyzed in the report, is expected to register a CAGR of 4.4% and reach $2.9 billion by the end of the analysis period. Growth in the Cervical Thoracic Lumbar Sacral Orthosis (CTLSO) segment is estimated at 3.7% CAGR over the next eight years.

    The US market is estimated at $987.6 million, while China is expected to grow at a CAGR of 5%

    The US scoliosis treatment market is estimated to reach USD 987.6 million by the year 2022. China, the second largest economy in the world, is expected to reach a projected market size of USD 422.1 million by 2030, at a CAGR of 5% over recent years. analysis period 2022 to 2030.

    The data provides a 16-year perspective, breaking down the percentage of value sales for different geographic regions, including the US, Canada, Japan, China, Europe, Asia Pacific and the rest of the world, for the years 2014, 2023 and 2030 Finally, it provides a comprehensive analysis of the scoliosis treatment market, including annual sales figures from 2014 through 2030, and segmented analyzes for different geographic regions.

    Other notable geographic markets include Japan and Canada, each expected to grow by 3.1% and 3.4%, respectively, over the 2022-2030 period. Within Europe, Germany is expected to grow at a CAGR of approximately 4.1%.

    This comprehensive report also provides detail on the approaches that leading market competitors such as Aspen Medical Products, Bauerfeind AG and Boston Orthotics & Prosthetics are taking, providing invaluable insights that you as an executive can leverage.

    What’s new?

    • Special discussions on the global economic environment and market sentiment
    • Coverage on global competitiveness and key market shares of competitors
    • Multi-region market presence analysis – Strong/active/niche/trivial
    • Online interactive peer-to-peer collaborative custom updates
    • Access to digital archives and a trademarked research platform
    • Free updates for a year
    • Access curated YouTube video transcripts of market sentiments shared by CEOs, domain experts and market influencers through interviews, podcasts, press statements and event keynotes

    MARKET OVERVIEW

    • Scoliosis: An abnormal lateral curvature of the spine
    • Scoliosis Management/Treatment Options
    • COVID-19 is casting a shadow on the scoliosis treatment market
    • Competition
    • Scoliosis Management – ​​Percentage Market Share of Key Competitors Globally in 2023 (E)
    • Competitive Market Presence – Strong/Active/Niche/Trivial for Global Players in 2023 (E)
    • Great startup ecosystem
    • Global market analysis and prospects
    • The global scoliosis management market will demonstrate steady growth driven by innovations and advancements
    • North America holds a leading position in the global scoliosis management market
    • ThoracoLumboSacral Orthosis (TLSO) dominates the market
    • AIS remains the primary disease type segment
    • Pediatric/adolescent as an important age group segment
    • Hospitals and ASCs claim leading share
    • Technological advancements as pulsating trends drive the scoliosis treatment market forward
    • Increase R&D activity to drive market expansion
    • Market restrictions
    • Market challenges
    • Recent market activity
    • GLOBAL BRANDS

    MARKET TRENDS & DRIVERS

    • Rising prevalence of idiopathic and congenital scoliosis drives market growth
    • Spinal fusion surgery offers great opportunities
    • The demand for fusionless scoliosis surgery is increasing
    • Tying the vertebral body provides traction
    • Schroth therapy – a useful approach to treat scoliosis
    • Strong focus on minimally invasive spine surgery and increasing use of navigation and robotics in scoliosis surgery to increase prospects
    • Increasing cases of scoliosis in adults and a growing aging population to propel the adult segment
    • Increase healthcare spending to stimulate growth
    • Recent technological advances/innovations in the scoliosis treatment market
    • New Satellite Rod-Based Sequential Correction for Severe Rigid Spinal Deformities to Reduce Surgical Risks and Other Complications
    • ApiFix system for correcting moderate scoliosis with single curves
    • Shriners Hospitals for Children’s The Tether, a device for treating scoliosis, receives FDA approval
    • Minimally invasive spine surgeries are becoming commonplace, but long-term research into results is essential for wider adoption
    • Disruptive technologies in the spine space – a review
    • 3D printed braces have potential to improve the treatment of scoliosis

    FOCUS ON SELECTED PLAYERS(Total 91 recommended)

    • Aspen Medical Products, LLC
    • Bauerfeind AG
    • Boston Orthoses and prosthetics
    • Chaneco
    • Enovis
    • Fitted, Inc.
    • Horton’s Orthotics and Prosthetics
    • Lawall Prosthetics and Orthotics
    • Optec USA, Inc.
    • Orthotec
    • Ottobock SE & Co. KGaA
    • Spinal Technology Inc.
    • Real

    For more information about this report, visit https://www.researchandmarkets.com/r/ozemky

    About ResearchAndMarkets.com
    ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, top companies, new products and the latest trends.

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  • Exactech announces approval for its new 3D printed Vantage® ankle-tibial implants

    Exactech announces approval for its new 3D printed Vantage® ankle-tibial implants

    GAINESVILLE, Fla., October 26, 2023–(BUSINESS WIRE)–Exactech, a developer and manufacturer of innovative implants, instrumentation and smart technologies for joint replacement surgery, today announced the 510(k) clearance of its new 3D printed tibial implants, the Vantage® Only 3D and 3D+. This is the second recent approval for the broader Vantage Total Ankle System, following Activit-E™, a new advanced vitamin E polyethylene, which received approval from the Food and Drug Administration last month.

    The new implants provide orthopedic surgeons with additional tibial height options for total ankle replacement patients. Both implants are 3D printed and designed with a porous surface that mimics subchondral bone to aid in biological fixation. They are fitted with pointed pegs and a central bone cage, of varying lengths, to achieve initial fixation. The Vantage Ankle 3D builds on the design philosophy of the system’s current tibial offering and is available in a 10mm height. The Vantage Ankle 3D+ is a stem implant with options of 15, 20, 25 and 30 mm.

    “As an original member of the Vantage Ankle design team, I am excited about the next generation, state-of-the-art Vantage Ankle 3D and 3D+ tibial components,” said Mark Easley, MD, of Duke Health. “Developed through the collaborative efforts of our extensive team of expert consultant surgeons and experienced engineers, the redesigned tibial implants feature innovative, intuitive surgical technique and surgeon-friendly instrumentation.”

    The Vantage Ankle 3D and 3D+ are compatible with Exactech’s patient-specific instruments, the Vantage Ankle PSI cutting guides. 3D Systems (NYSE:DDD), manufacturer of the Vantage Ankle PSI, previously received 510(k) clearance for four additional cutting guides, two of which are specifically made for use with these new tibial implants.

    “We are laser-focused on delivering innovative solutions that our surgeons and patients need,” said Devan Carter, Exactech’s foot and ankle marketing director. “With these new additions, the Vantage Ankle now offers solutions from pre-operative planning to complex deformities, bringing us one step closer to providing a complete continuum of care.”

    Full market availability for the Vantage Ankle 3D and 3D+ is expected before the end of 2024. For more information, please contact your local Exactech representative.

    About Exactech

    Exactech is a global medical device company that develops and markets orthopedic implant devices, related surgical instruments and Active Intelligence® platform of smart technologies for hospitals and doctors. Headquartered in Gainesville, Florida, Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Tweet and Instagram. With Exactech by your side you have EXACTLY what you need.

    Contacts

    Samantha DiVirgilio
    Senior Manager Marketing Communications
    media@exac.com



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  • Aclarion Announces Signing of Commercial Agreement with Porter Hospital, an AdventHealth Facility, to Bring Nociscan Technology to Denver

    Aclarion Announces Signing of Commercial Agreement with Porter Hospital, an AdventHealth Facility, to Bring Nociscan Technology to Denver

    Porter Hospital becomes first facility in Denver to give patients with chronic low back pain access to revolutionary Nociscan technology that measures biomarkers to pinpoint the source of pain

    George Frey, MD becomes the first Aclarion KOL surgeon to use in-hospital MRI to add Nociscan data to his treatment decision process for patients with chronic low back pain

    Published clinical data shows that patient outcomes improve and costs decrease when surgical treatment is consistent with disc levels that Nociscan identifies as painful

    BROOMFIELD, CO, October 25, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that uses biomarkers and proprietary enhanced intelligence algorithms to help physicians identify the location of chronic low back pain, today announced their expanded presence in Colorado with AdventHealth Porter. From their Denver location, AdventHealth Porter provides exceptional medical care to patients throughout Colorado’s frontline region.

    George Frey MD, orthopedic surgeon and founder of the Colorado Comprehensive Spine Institute said, “Treating patients effectively starts with an informed understanding of where their pain comes from. In my experience with Nociscan, objectively measuring the biomarker content associated with pain in an intervertebral disc that may look healthy on an MRI adds to my knowledge of how to treat that patient. At AdventHealth Porter, we strive to provide cost-effective care of the highest quality. The published evidence makes it clear to me that adding Nociscan to our diagnostic evaluation can help us do just that.”

    Brent Ness, CEO of Aclarion, said: “In line with our strategy to bring Nociscan to a standard of care through KOL advocacy, we applaud AdventHealth Porter for bringing Nociscan technology to Denver in support of Dr. Frey to use our technology to improve results. while reducing costs. The support of pioneering leaders like Dr. Frey and AdventHealth is exactly the leadership we need to unequivocally demonstrate the superior clinical outcomes for patients that will drive payers’ coverage decisions and provide all patients with access to Nociscan technology. We thank Dr. Frey and AdventHealth look forward to the positive impact that increasing Nociscan volumes will have on the surgical outcomes of chronic low back patients in and around the Denver community.”

    “Providing exceptional care with cutting-edge treatments is a core value of our multidisciplinary care team here at AdventHealth Porter,” said Carol Bermingham, Imaging Manager at AdventHealth Porter. “We are excited about adding Nociscan to our MRI capabilities and believe that providing personalized biomarker data to treating physicians is one more investment in our commitment to providing an environment where our physicians can do their very best for their patients . Our radiology service line always strives to stay at the forefront of the technical advancement curve.”

    Chronic low back pain (cLBP) is a global healthcare problem, with approximately 266 million people worldwide suffering from degenerative spine disorders and low back pain. It is estimated that low back pain affects approximately 30 million adults in the U.S. population annually, leading to millions of doctor consultations each year.

    Aclarion’s proprietary decision support tool, Nociscan, is the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies.

    About Aclarion, Inc.

    Aclarion is a healthcare technology company that uses magnetic resonance spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers and enhanced intelligence algorithms to optimize clinical treatments. The company is entering the chronic low back pain market for the first time with Nociscan, the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies. For more information, please visit www.aclarion.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These forward-looking statements are based on management’s current plans and expectations and are subject to a number of uncertainties and risks that could materially affect the company’s current plans and expectations, as well as its future results of operations and financial condition. These and other risks and uncertainties are discussed in more detail in our filings with the Securities and Exchange Commission. Readers are encouraged to read the section entitled “Risk Factors” in the Company’s April 21, 2022 Prospectus as filed with the Securities and Exchange Commission on April 25, 2022 under Rule 424(b)(4), as well as other disclosures. included in the Prospectus and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor contacts:
    Kirin M. Smith
    PCG Advice, Inc.
    646.823.8656
    ksmith@pcgadvisory.com

    Media contacts:
    Jodi Lamberti
    SPRIG advice
    612.812.7477
    jodi@sprigconsulting.com

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  • Dr.  Abbasi from Inspired Spine brings OLLIF’s expertise to Orlando, where he meets Dr.  Jose Jimenez-Almonte trains

    Dr. Abbasi from Inspired Spine brings OLLIF’s expertise to Orlando, where he meets Dr. Jose Jimenez-Almonte trains

    Inspired Spine CMO Dr. Hamid Abbasi performs one of more than 1,500 OLLIF procedures

    BURNSVILLE, Minn., Oct. 25, 2023 /PRNewswire/ — Inspired Spine, a leader in innovative minimally invasive spine surgery, is pleased to announce that Dr. Abbasi, a renowned pioneer in the field of orthopedic and neurosurgery, will travel to Orlando, Florida to share his expertise in the revolutionary Oblique Lateral. Lumbar Interbody Fusion (OLLIF) Procedure for Dr. Jose Jimenez-Almonte.

    Dr. A leading figure in the world of minimally invasive spine surgery, Abbasi is known for his groundbreaking contributions in the field. His OLLIF procedure has not only improved patient outcomes, but also dramatically shortened recovery times, making it a preferred choice for patients seeking relief from debilitating back pain.

    The OLLIF procedure offers a minimally invasive alternative to traditional open spinal fusion, allowing patients to regain their quality of life faster with less pain and less scarring. Dr. Abbasi’s commitment to advancing this field has made him a sought-after teacher and mentor to many surgeons in the United States.

    Inspired Spine is pleased to facilitate this unique opportunity for Dr. Jose Jimenez-Almonte, an esteemed spine surgeon in Central Florida. The dedication of Dr. Jimenez-Almonte’s commitment to offering its patients advanced spine surgery options aligns perfectly with Inspired Spine’s mission to advance minimally invasive spine surgery techniques.

    The Proctorship offers Dr. Jimenez-Almonte an exclusive opportunity to hear directly from Dr. Abbasi, who will share his insights, techniques and 10 years of experience in the OLLIF procedure. The collaboration reflects Inspired Spine’s commitment to advancing excellence in minimally invasive spine surgery, further expanding access to innovative treatments for patients in Orlando and beyond.

    “We are thrilled to bring together two exceptional medical professionals for this event,” said Amanda Armagost, a representative of Inspired Spine. “Dr. Abbasi’s mastery of the OLLIF procedure, coupled with the expertise and dedication of Dr. Jimenez-Almonte, holds great promise for the advancement of minimally invasive spine surgery in the Orlando area.”

    This collaboration is an example of Inspired Spine’s commitment to advancing the field of minimally invasive spine surgery and making advanced treatment options more widely available, ultimately benefiting patients with debilitating spine conditions.

    For media inquiries or for more information about Inspired Spine and this exciting event, please contact Amanda Armagost at aarmagost@islife.us

    Inspired Spine is a leader in the development and promotion of minimally invasive techniques for spine surgery, with a strong focus on the OLLIF procedure. Their commitment to innovation and collaboration with leading surgeons such as Dr. Abbasi allows them to provide patients with advanced treatments that provide faster recovery and a better quality of life. Inspired Spine continues to lead the way in advancing minimally invasive spine surgery.

    SOURCE Inspired Spine

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  • Aspen Medical Products launches the first off-the-shelf cervical to sacrum spine system

    Aspen Medical Products launches the first off-the-shelf cervical to sacrum spine system

    VRTX CTLSO

    IRVINE, Calif., Oct. 25, 2023 /PRNewswire/ — Aspen Medical Products (Aspen), a leader in spine solutions for pain and mobility management, has launched the VRTX System – the first fully integrated spine support system in the post-operative and trauma care market.

    According to the American Academy of Orthopedic Surgeons, millions of spine-related injuries occur annually in the United States. Patients with traumatic injuries to the spine at multiple levels typically require a custom-made Cervical Thoracic Lumbar Sacral Orthosis (CTLSO) that stabilizes the spine before or after surgery. These patients may wait up to three days to receive their CTLSO after being measured and fit, increasing the risk of deep vein thrombosis, pressure sores, breathing problems and other complications.

    The VRTX System is the first-ever cervical to sacral system designed to redefine spine care in acute care settings. The prefabricated design with intuitively adjustable sizing helps doctors fit patients and immediately stabilize the spine. This turnkey solution can help reduce length of stay and the risk of complications, while optimizing operational efficiency in hospitals by improving time and inventory management.

    “Aspen is once again leading the way in innovation and clinical solutions with the VRTX system,” said Jim Cloar, Chief Executive Officer of Aspen. “We understand the need for an improved experience for patients and physicians, and we designed the VRTX system to add value to the healthcare system as a whole. Our ultimate goal was to create a family of products that all interact with each other, simplify the fitting process through an intuitive design and ensure ease of use at home. We are proud to bring the first total spine solution to market.”

    A pioneer in advancing spine care, the VRTX System is built on a foundation of results and innovation. The modular, low-profile design comfortably supports a wide range of patient anatomies and improves patient outcomes by helping them become ambulatory faster. An integrated QR code scans patient instructions, so you always have the correct application instructions at hand and can ensure compliance.

    Each component of the VRTX system consists of a prefabricated CTO, TLSO, LSO and CTLSO and provides optimal movement restriction and can be lowered or increased depending on the patient’s needs. This modular solution enables standardization of products and services across the hospital to maximize staff efficiency and patient care.

    Building on the success of the Vista Cervical Collar, Aspen has included enhanced features in the new VRTX Collar. A symmetrical back panel ensures accurate and consistent application every time, and clinicians now have the convenience of writing directly on the surface of the collar to indicate pad replacement time. Additionally, more finite height adjustments are suitable for a wider range of patients, and the VRTX collar can be adjusted to a lower setting.

    “From day one, Aspen has been committed to understanding the complex needs and challenges of both patients and healthcare providers. Years of patient and physician feedback and industry insights have been our guiding forces in creating the VRTX system. This innovation is more than just a product; it is a testament to our commitment to improving the healthcare landscape and ultimately increasing the well-being of everyone we serve,” said Albert Romo, Aspen’s Director of Research and Development.

    More information about the VRTX system is available at vrtx.aspenmp.com.

    About Aspen medical products

    Founded in 1994, Aspen Medical Products, LLC is an industry leader in the development and manufacturing of spinal orthopedics and pain therapy solutions. Designed to restore function and relieve pain, Aspen products address a variety of patient needs across the care continuum to help them resume activities of daily living. Aspen is headquartered in Irvine, California and has local sales representations in the US and internationally. www.aspenmp.com

    SOURCE Aspen Medical Products

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  • International sales gain for PUR Biologics

    International sales gain for PUR Biologics

    PUR Biologics’ robust distribution channels appear to be expanding sales worldwide

    October 24, 2023, Irvine, CA., / OrthoSpineNews / – Following a successful participation at the North American Spine Society (NASS) conference, healthcare technology company HippoFi, Inc. (OTC: ORHB) announced that its wholly owned subsidiary, PUR Biologics, has expanded its sales to include several notable global healthcare institutions.

    Ryan Fernan, Head of PUR Biologics, said: “Our recent collaborations with ZIMMER BIOMET and Italian company BPB Medica have attracted wider international attention. It is encouraging to see our spinal biologics expertise and innovation gaining global recognition.”

    CJ Wiggins, Executive Chairman and CEO of HippoFi, added: “The strength of our distribution channels is a core component of our company design and provides us with deep coverage and a source of revenue opportunities for our spinal biologics.”

    With PUR Biologics’ clear leadership trajectory in the biotech sector, there is incredible momentum building.

    For more information about PUR Biologics’ full line of biological products, visit www.PURbiologics.com.

    __________

    About PUR Biologics
    PUR Biologics, a wholly owned subsidiary of HippoFi, Inc. (OTC PINK: ORHB), is a leading biologics company committed to supporting surgeons and hospitals in providing the best care to their patients. PUR Biologics’ full line of biological products currently includes: advanced allografts and demineralized extracellular matrices (d-ECM), innovative synthetic solutions, cellular-derived tissues, and a future of next-generation regenerative stem cell and growth factor-driven therapies for the treatment of osteoarthritis and cartilage. regeneration.

    About HippoFi, Inc.
    HippoFi, Inc. delivers its breakthrough healthcare innovations through an extensive sales channel network while deploying first-to-market solutions in the multi-billion dollar biotech, fintech and artificial intelligence (AI) markets. HippoFi consists of three segments: Regenerative Therapeutics, Digital Payments and AI, which use the same customer channels to commercialize solutions, increase revenue and improve patient outcomes.

    HippoFi, Inc. is publicly traded under the symbol: ORHB and is headquartered in Irvine, California. For more information, please visit: www.HippoFi.com and www.PURbiologics.com.

    Contact
    HippoFi, Inc.
    949-323-2330
    info@hippofi.com

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  • ATEC announces a proposed public offering of common stock

    ATEC announces a proposed public offering of common stock

    CARLSBAD, California, October 24, 2023–(BUSINESS WIRE)–Alphatec Holdings, Inc. (“ATEC”) (NASDAQ: ATEC), a provider of innovative solutions aimed at revolutionizing the approach to spine surgery, today announced that it has commenced a proposed underwritten public offering of $150 million of common stock. In connection with the proposed offering, ATEC intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of common stock sold in the offering. All shares in the offering will be sold by ATEC. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Morgan Stanley, TD Cowen, Barclays and Stifel are acting as joint book-running managers on the offering.

    The shares of common stock are being offered pursuant to a registration statement on Form S-3 (File No. 333-271336) previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a written prospectus and a prospectus supplement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

    When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Morgan Stanley, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; Cowen and Company, LLC, 599 Lexington Avenue, New York, New York 10022, by telephone at (833) 297-2926 or by email at prospectus_ecm@cowen.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 1-888-603-5847 or by email at barclaysprospectus@broadridge.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. The offering may only be made by means of a prospectus supplement and a related base prospectus.

    About ATEC

    ATEC, through its wholly owned subsidiaries, Alphatec Spine, Inc., EOS imaging SAS and SafeOp Surgical, Inc., is a medical device company committed to revolutionizing the approach to spine surgery through clinical differentiation. ATEC’s Organic Innovation Machine™ is focused on developing new approaches that integrate seamlessly with the company’s growing AlphaInformatiX Platform to better inform surgery and achieve the goals of spine surgery more safely and reproducibly. ATEC’s vision is to be the standard bearer in the spine field.

    Forward-Looking Statements

    This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risk 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. ATEC cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those anticipated or implied in such forward-looking statements as a result of various factors. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate,” “look forward” 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. Forward-looking statements include, but are not limited to, the Company’s expectations regarding the completion, timing and size of the proposed public offering. Important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, risks and uncertainties associated with market and other conditions and the fulfillment of the usual closing conditions relating to the proposed audience. to offer. A further list and description of these and other factors, risks and uncertainties can be found in ATEC’s most recent annual report, any subsequent quarterly and current reports, and certain other documents filed with the SEC. ATEC disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Company contact:
    J. Todd King
    Finance Director
    investorrelations@atecspine.com

    Investor/media contact:
    Tina Jacobsen
    Investor Relations
    (760) 494-6790
    investorrelations@atecspine.com

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  • Five-year study results of the NuVasive Simplify Cervical Disc were presented at the 38th Annual Meeting of the North American Spine Society

    Five-year study results of the NuVasive Simplify Cervical Disc were presented at the 38th Annual Meeting of the North American Spine Society

    AUDUBON, PA, October 24, 2023 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, presented the five-year results of the NuVasive Simplify Cervical Disc study at the North American Spine Society (NASS) 38e Annual meeting. The study demonstrates positive long-term clinical outcomes, high overall composite success at 60 months, and statistical superiority over the procedural results of anterior cervical discectomy fusion (ACDF).

    “Having clinically sound, long-term data for the Simplify Cervical Disc validates the promising clinical data we saw Simplify have after two years,” said Kyle Malone, senior vice president, Scientific Affairs, Globus Medical. “We will continue to innovate within the cervical spine segment and provide industry-leading procedural solutions that are clinically designed to deliver better patient outcomes.”

    The five-year Simplify Cervical Disc study* found:

    • Simplify Cervical Disc was statistically superior to the ACDF Control in terms of overall composite success at five years,
    • Statistically significant postoperative improvements in the Neck Disability Index (NDI) and visual analogue scale (VAS) (combined neck and arm pain) found at two years were maintained over five years, with the Simplify Cervical Disc group experiencing significantly lower NDI and had VAS scores at five years. years compared to the ACDF control,
    • Mean disc height and flexion/extension range of motion increased postoperatively in the Simplify Disc group and remained above preoperative levels throughout follow-up, and
    • No device errors were reported in the Simplify Disc group.

    Dr. Pierce Nunley of the Spine Institute of Louisiana expressed enthusiasm about the durability of the positive results seen after 24 months. He stated: “I am eager to see the continued success of these results after 60 months. This study further reinforces that Simplify is an excellent motion-saving solution with lasting clinical benefits over ACDF.”

    *Data on file.

    Simplify Cervical Disc is not yet available in all countries. Please refer to the Simplify Disc directions for use and patient labeling for important product information, including but not limited to indications, contraindications, warnings, precautions, risks and possible side effects. The instructions for use and patient labeling can be found here.

    About Globus Medical, Inc.
    Globus Medical is committed to delivering innovative technologies and leading clinical support to help surgeons and healthcare providers deliver better care around the world. The company offers one of the most comprehensive offerings of musculoskeletal solutions and assistive technologies to impact the continuum of care, now including NuVasive’s procedurally integrated portfolio. The company’s employees are relentlessly focused on advancing patient care. For more information, visit www.globusmedical.com/uniting.

    Safe Harbor Statements
    All statements in this press release, other than statements of historical fact, are forward-looking statements and can be identified by the use of words such as “believe,” “may,” “could,” “could,” “will.” aim”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that could affect our business and operations and could cause actual results to differ materially from those projected. These risks and uncertainties include, but are not limited to, the risks and costs associated with the integration of, and the ability of Globus Medical and NuVasive to successfully integrate their businesses and realize expected synergies, health epidemics, pandemics and similar outbreaks . including the COVID-19 pandemic, factors affecting our quarterly results, our ability to manage our growth, our ability to maintain our profitability, demand for our products, our ability to compete successfully (including but not limited to our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and implement successful business strategies our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to protect our intellectual property, our success in defending legal proceedings against us, trends in the medical device industry , general economic conditions and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, please refer to the disclosure in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in a changing environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business, or the extent to which any factor, or combination of factors , could cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors that arise or come to our attention after the date hereof.

    Contact person for investors:
    Brian Kears
    610-930-1800
    investors@globusmedical.com

    Media contact:
    Melanie Ordoñez
    858-722-3899
    media@globusmedical.com

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