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Meditech Spine expands its lumbar plating options by adding the CURE LP iView and QMax to its growing portfolio of spinal implants

Posted On April 30, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

ATLANTA, April 30, 2018 /PRNewswire/ — Meditech Spine, LLC, announced today it has received additional 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP iView and Cure LP QMax System clearance compliments Meditech’s recent 510(k) of the CURE Lumbar Plate System in 2017 with additional plating options. The CURE LP allows surgeons to utilize the lumbar plating system along with its novel lumbar Talos® fusion devices, which are manufactured with the PEEK-OPTIMA™ HA Enhanced polymer.

The CURE LP is a low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent screws anchored on the spine from loosening and backing out. The special 510(k) includes additional sizing options for surgeons. The CURE LP-iView is similar to the standard CURE LP anterior plate but includes a through hole with rib to nest with the Talos®-A (HA) Interbody Device. And, the CURE LP-QMax is a four hole direct lateral plate complimenting the previously cleared two hole plate. The CURE LP anterior plates, sacral plates and the new iView and Qmax plates will be combined in one tray with streamlined instruments to make it easier on hospital and surgery centers to process the system. All systems will be provided sterile packaged to aid with implant tracking while helping to reduce implant related infections. The CURE Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach.

With the introduction of the CURE Anterior Cervical Plating (ACP) last year, Meditech continues its philosophy of giving back which led to a partnership with CURE International, the namesake of the CURE ACP and CURE LP, an organization that serves children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care.

“After the introduction in late 2017 with our CURE LP system, we have continued to listen to surgeons and build upon our existing platform by providing additional plating options. Surgeons now have the flexibility of choosing from multiple plate configurations for their patients that require supplemental fixation. When coupled with our Talos®-A (HA) Interbody Fusion Device, manufactured with our next generation osteoconductive polymer, we provide a full and robust system for surgeons who utilize the anterior and anteriorlateral approaches to treat degenerative spinal conditions,” Eric Flickinger, Co-founder of Meditech Spine, noted.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a spinal device company developing innovative instrumentation for treating complex spinal issues. It partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech’s pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies.

CONTACT

Meditech Spine, LLC
(678) 974-5287
support@meditechspine.com

Caption & Copyright:

Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved.

PEEK-OPTIMA™ is a trademark of Victrex plc or its group companies. All rights reserved.

 

SOURCE Meditech Spine, LLC

Related Links

http://www.meditechspine.com

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Mobius Imaging Receives 510(k) Clearance for Airo® CT Pediatric Applications

Posted On April 27, 2018 By OrthoSpineNews In Regulatory /  

SHIRLEY, Mass., April 26, 2018 /PRNewswire/ — Mobius Imaging, LLC, announced today that it has received 510(k) clearance for its Airo® Mobile CT Imaging System for pediatric applications. The Airo Mobile CT Imaging System previously received 510(k) clearance in 2013 for non-pediatric imaging and has become a market leader in intraoperative, image guided procedures in neuro-spine surgery. Airo diagnostic images also continue to be utilized for supporting applications in brachytherapy, radiation therapy and surgical imaging.  The ability to provide Airo Mobile CT imaging for pediatrics is an important milestone in the Company’s ability to offer solutions for additional clinical segments and applications.  Pediatric patients can now receive the clinical benefits of Airo CT imaging for diagnostic and intraoperative procedures.

“There is an unmet need in being able to provide safe and reliable CT imaging for pediatric patients during various clinical procedures,” explained Gene Gregerson CEO of Mobius Imaging. “CT systems must be designed and validated for safety and efficacy using different protocols than would be appropriate for adult patients.  We are delighted to now be able to offer the benefits of Airo Mobile CT imaging to clinicians and their pediatric patients.”

About Mobius Imaging

Mobius Imaging develops, designs and manufactures advanced imaging technologies that fit seamlessly into existing medical workflows. The company’s approach to technology – Intelligent Imaging – is designed to give healthcare practitioners the crisp, clear images they want, whenever and wherever they want them, without adding time or complexity to the procedure. From the OR to the ER to clinical settings of all kinds, Intelligent Imaging expands possibilities. Founded in 2008, the company now has over 130 Airo installations in 23 countries since 2014. Mobius Imaging is a registered trademark of Mobius Imaging, LLC.

Contact:

Alan Weinberg
Director of Marketing
aweinberg@mobiusimaging.com

SOURCE Mobius Imaging, LLC

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Former Stryker Engineer Pleads Guilty To Accepting Bribe

Posted On April 25, 2018 By OrthoSpineNews In Regulatory /  

Walter Eisner • Tue, April 17th, 2018

Daniel Lawrynowicz, a former Stryker Corporation engineering director, plead guilty on April 3, 2018 to accepting a $75,000 bribe for steering business to a New York metallurgy firm.

According to the Department of Justice (DoJ), Lawrynowicz, 48, pleaded guilty before U.S. District Judge Madeline Cox Arleo in Newark federal court to an information charging him with one count of violating the Federal Travel Act.

According to DOJ documents, in 2012, while Lawrynowicz was an employee of Stryker, Eugene Ostrovsky and two other individuals at Sanova LLC, sought a contract worth $5.5 million with Stryker. Lawrynowicz was in a position to make recommendations to others at Stryker related to the goods that Sanova sought to supply under the contract.

“Ostrovsky and the other individuals made illicit bribe payments to Lawrynowicz in exchange for his assistance in helping the technology company secure the contract with the medical device company. These payments included a cash payment of approximately $75,000 to Lawrynowicz after the contract between the two companies was signed.”

Sanova VP Pleads Guilty

In February, Ostrovsky, a vice president and partner at Sanova LLC, pleaded guilty to bribing Lawrynowicz in 2012 and 2013 to win the $5.5 million contract with Stryker. He was sentenced March 9 to six months in jail, six months of home confinement and two years of supervised release. Prosecutors said Ostrovsky will also forfeit $1.1 million.

Lawrynowicz’s LinkedIn page listed him as a 15-year Stryker employee who was senior director of advanced engineering, leading “a team of 41 engineers and scientists at the Mahwah, N.J. facility dedicated to supporting the Recon Business Units.”

The U.S. Patent and Trademark Office lists at least half a dozen patents filed by Daniel Lawrynowicz, of Monroe, along with others, between 2010 and 2013, while he worked for Howmedica Osteonics Corp., of Mahwah.

Jeanine Guilfoyle, a spokeswoman for Stryker, reportedly said the company would not comment on the case or Lawrynowicz’s employment at the company.

 

READ THE REST HERE

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MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

Posted On April 24, 2018 By OrthoSpineNews In Regulatory /  

WASHINGTON, April 24, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it delivered an informational presentation on April 16th about United States Medical Device Regulations to twenty-two members of the Center for Medical Device Evaluation of the China Food and Drug Administration (CFDA) in Beijing, China.

The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process. MCRA attended along with its partner, China Med Device, LLC, a Chinese market focused integrated advisory firm. MCRA was represented by Mr. Justin Eggleton, Senior Director of Regulatory Affairs. Mr. Eggleton shared a comprehensive overview of the regulatory processes for introducing medical device technologies to the U.S. market, insights on key regulatory topics, and case studies within the neuro-musculoskeletal industry. An interactive Q&A session provided an opportunity for Chinese officials to explore the many complexities and nuances of the various regulatory pathways.

Justin Eggleton said, “MCRA is honored to be invited by the CFDA to discuss the medical device regulation process in the U.S. This discussion allowed MCRA and the CFDA to gain a deeper understanding of the challenges faced when trying to maintain an active and healthy regulatory system able to keep pace with innovation. Further, as a firm that provides integrated support for companies entering international markets, it is crucial for opportunities such as these to ensure we have direct access and knowledge of the current regulatory environment. China is the 2nd largest medical device market with double digit growth now.” MCRA general manager David Lown commented “the mutual communication and dialogues will enhance the understanding of both countries regulatory challenges and facilitate the adoption of innovation more efficiently and effectively towards the international standards in the neuromuscular sector.”

For more information on MCRA, please visit www.mcra.com 

About MCRA
Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact
David W. Lown
General Manager, MCRA, LLC
Phone: 212.583.0250 ext. 2111
Email: dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

Related Links

http://www.mcra.com

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Arthrosurface Gains FDA Clearance of OVOMotion™ Shoulder Arthroplasty System

Posted On April 23, 2018 By OrthoSpineNews In Regulatory /  

FRANKLIN, Mass., April 18, 2018 /PRNewswire/ — Arthrosurface® announced today that The Company received FDA 510(k) Clearance to market the OVOMotion™ Shoulder Arthroplasty System. This stemless total shoulder system provides the surgeon with an approach that results in increased exposure to the glenoid, minimizes bone removal, and is designed for patients with painful and/or severely disabled shoulder joints resulting from arthritis, traumatic events or AVN.

“This truly is a revolutionary stemless total shoulder, which combines the concept of anatomic restoration with an aspherical head design that more closely replicates patient anatomy but also allows improved joint access for ease of preparation of the glenoid,” said Dr. Anthony Miniaci, MD.

The OVOMotion™ Shoulder Arthroplasty System is cleared for use in conjunction with the novel Arthrosurface Inlay Glenoid System and according to a comparative study published in the Journal of Shoulder and Elbow Surgery, the inlay glenoid (socket) design was far superior to the onlay alternative with respect to the biomechanical stability.

Steve Ek, CEO said, “The OVOMotion™ Shoulder Arthroplasty System is intended to be the first of a three-element modular stemless system that will ultimately allow surgeons to intra-operatively choose between stemless, traditional and reverse options.”

About Arthrosurface
Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include joint preservation implants, instruments and orthobiologics. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 14 years. For more information, please visit our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com

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Zimmer Biomet Announces FDA Clearance and First Surgical Case of the Persona® Trabecular Metal™ Tibia

Posted On April 16, 2018 By OrthoSpineNews In Recon, Regulatory /  

WARSAW, Ind., April 16, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the completion of the first surgical case utilizing its Persona® Trabecular Metal™ (TM) Tibia by Dr. Richard Moore, Boise, Idaho on March 20, 2018. The Persona Trabecular Metal Tibia received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2018 and CE Mark approval in April 2018. The Persona TM Tibia is an integral component of the Company’s portfolio of cementless total knee arthroplasty (TKA) solutions.

“Combined with the Persona TM Femur and the TM Patella, clearance of the Persona TM Tibia allows us to provide a fully cementless total knee solution, furthering our long-standing commitment to enhancing patient experiences and outcomes,” said Dan Williamson, Zimmer Biomet’s Group President, Joint Reconstruction. “We believe this innovative product will position us to re-establish our leadership in the fully cementless primary knee market.”

Zimmer Biomet’s proprietary TM Material is a porous biomaterial made from elemental Tantalum with structural, functional and physiological properties similar to cancellous bone.1-3 With more than 20 years of clinical results, the Company’s TM Material has been used in over two million orthopaedic devices.

“The clearance of the Persona TM Tibia represents a significant step forward for those patients who can benefit from completely cementless total knee replacements that better integrate into the natural bone anatomy for durability, while possibly offering greater patient satisfaction,” said Dr. Moore.

The Persona TM Tibia features new drilling, sizing and insertion instrumentation that are unique to the Persona TM Tibia, while preserving all the anatomic benefits of the Persona Tibia design.4-8 The Persona TM Tibia is another example of how the Persona System continues to redefine personalization by combining Zimmer Biomet’s 20-year porous fixation expertise with the Persona Knee family. As the Company’s most comprehensive knee system, the Persona System offers more anatomically accurate components with finer increments to personalize patient fit and restore the unique identity of every knee.

“The TM tibial tray and pegs fit beautifully to the bone. I believe the instruments for trial prep and implant placement were a clear improvement and an advantage. I also appreciate the time efficiency of using cementless implants,” concluded Dr. Moore.

Zimmer Biomet plans a limited launch of the Persona TM Tibia in the first half of this year, followed by a full commercial launch in the second half of 2018.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

  1. Bobyn, et al., Characterization of a New Porous Tantalum Biomaterial for Reconstructive Orthopaedics. 66th Annual AAOS 1999.
  2. Zhang, et al., Interfacial Frictional Behavior: Cancellous Bone, Cortical Bone, and a Novel Porous Tantalum Biomaterial. Journal of Musculoskeletal Research. 3:4, 245-251, 1999.
  3. Karageorgiou and Kaplan. Porosity of Biomaterial Scaffolds and Osteogenesis. Biomaterials. 26: 5474-91, 2005.
  4. Dai, et al. Anatomical Tibial Component Design Can Increase Tibial Coverage and Rotational Alignment Accuracy: A Comparison of Six Contemporary Designs. Knee Surgery Sports Traumatology Arthroscopy 22:2911–2923; KSSTA 2014.
  5. Indelli, et al. Relationship between Tibial Baseplate Design and Rotational Alignment Landmarks in Primary Total Knee Arthroplasty. Hindawi Publishing Corporation Arthritis. Volume 2015, Article ID 189294.
  6. Jin, et al. How Much Does the Anatomical Tibial Component Improve the Bony Coverage in Total Knee Arthroplasty. Journal of Arthroplasty. pp. 1-5; 2017.
  7. Mizu-uchi, et al. Anatomical Shaped Tibial Baseplate Reduced Rotational Alignment Compromise in Total Knee Arthroplasty: Clinical Evaluation with Asian Knees. ORS 2017 Annual Meeting Paper No.0110. 21.Bandi, Marc, et al. Finer Femur and Insert Increments in Total Knee Arthroplasty Facilitate Accurate Balancing and Reduce the Need for Complex Techniques. Abstract number 850; ORS 2014.
  8. Stulberg and Goyal. Which Tibial Tray Design Achieves Maximum Coverage and Ideal Rotation: Anatomic, Symmetric, or Asymmetric? An MRI-based study. Journal of Arthroplasty.  30(10): 1839, 2015.

For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and www.zimmerbiomet.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

ZB-Corp

CONTACT:  Media –  Monica Kendrick, 574-372-4989, monica.kendrick@zimmerbiomet.com; Investors – Derek Davis, 574-372-4250, derek.davis@zimmerbiomet.com, or Barbara Goslee, 574-371-9449, barb.goslee@zimmerbiomet.com

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Ceterix Orthopaedics Announces FDA Clearance of the NovoStitch Pro Meniscal Repair System

Posted On April 16, 2018 By OrthoSpineNews In Regulatory /  

April 16, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced U.S. Food and Drug Administration (FDA) clearance of the company’s NovoStitch® Pro Meniscal Repair System. This next-generation meniscal repair system is a significant product evolution, offering enhanced technical features to improve the ease of use and workflow for the surgeon.

Ceterix’s NovoStitch systems enable surgeons to place stitches arthroscopically in tight joint compartments, allowing them to address complex meniscal tears that have not been amenable to repair in the past. Enhancements in the newly FDA-cleared NovoStitch Pro system include an ergonomic and intuitive handle design, the addition of well-defined visual cues for precise stitch placement, and improved control and stability from upper jaw texturing.

“The new NovoStitch Pro meniscal repair system represents a significant improvement to one of the most innovative technologies developed for arthroscopic knee repair,” said Dr. Peter Kurzweil, president of Memorial Orthopaedic Surgical Group in Long Beach, Calif. “The technological enhancements incorporated into the new system offer the potential to repair tear types that were previously considered difficult or impossible to sew, with improved control and access for the surgeon. I look forward to incorporating it into my practice.”

The meniscus is a crescent of soft cartilage resting between the femur and tibia that cushions the knee and provides stability to the joint. Meniscal tears are one of the most frequently occurring knee injuries and are most often treated by a procedure called a meniscectomy, in which a surgeon removes the torn tissue. Meniscectomy has been shown to increase a patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life. A 2015 health economics study determined that effective meniscal repair can result in long-term cost savings vs. meniscectomy due to the reduced risk of requiring costly future interventions1.

“This FDA clearance is another important milestone in our mission to reduce the number of meniscectomies and to save the meniscus,” said John McCutcheon, Ceterix’s president and CEO. “Ceterix continues to be the leader in meniscal repair by providing innovations that preserve tissue and sustain the natural biomechanics of the knee joint.”

Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats a damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually2,3.

About Ceterix® Orthopaedics

Ceterix® Orthopaedics develops surgical tools that fill unmet clinical needs for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch® Pro Meniscal Repair System has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif., and is backed by investors Versant Ventures, 5AM Ventures, and CRG. For more information, please visit www.ceterix.com and follow us at @ceterix on Twitter.

1 Feeley, B. et. al. The Cost-Effectiveness of Meniscal Repair versus Partial Meniscectomy: A Model-based Projection of Clinical Outcomes and Costs in the United States Healthcare System. ISPOR Annual Meeting 2015.
2 Brinker MR, O’Connor DP, Pierce P, Woods GW, Elliott MN. Utilization of orthopaedic services in a capitated population. J Bone Joint Surg Am. 2002 Nov; 84-A (11):1926-32.
3 New Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care System; 2006.

Contacts

for Ceterix Orthopaedics, Inc.
Krysta Pellegrino
Krysta@healthandcommerce.com

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SpinalCyte Applies with FDA to Expand Human Clinical Trial of CybroCell™ Dermal Fibroblasts as Investigational New Drug (IND)

Posted On April 12, 2018 By OrthoSpineNews In Regulatory /  

April 12, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using Human Dermal Fibroblasts, has filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to expand its study of CybroCell Human Dermal Fibroblasts to treat degenerative disc disease.“The filing of this IND is a milestone that positions SpinalCyte to lead the industry in validating a human fibroblast-based solution for disc regeneration,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “We believe this IND application can become the catalyst for further advancement in the quality of life for chronically diseased patients and address an urgent public need and impact the national opioid crisis in the U.S.”

SpinalCyte’s landmark Phase 1/Phase 2 clinical trial, which is still ongoing, currently includes 24 patients with chronic lower back pain caused by degenerative disc disease. The patients are randomly assigned to one of three groups and receive intradiscal injections in up to three discs. The first group receives placebo in the form of saline only; the second group receives 10 million HDFs and the third group receives 10 million HDFs in combination with platelet-rich plasma (PRP).

While the current treatment for degenerative disc disease is limited to surgical or palliative care, SpinalCyte is focused on a cell therapy solution to this chronic disease. According to preliminary six-month data:

  • 83 percent of CybroCell patients according to MRI imaging, demonstrated increased disc height or no change in one or more discs compared to only 66 percent of control patients.
  • More than half (52 percent) of CybroCell-treated discs on MRI showed either increased disc height or no change (a clinically relevant outcome) versus only 38 percent of control discs.
  • The administration of CybroCell appears to be safe and well tolerated with no adverse events associated with the cell product.

“The future treatment for degenerative disc disease is most assuredly cell therapy,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “SpinalCyte has demonstrated its CybroCell product shows significant promise as a long-term therapy and cure.”

Over 50 percent of patients treated with CybroCell in the trial reported significant therapeutic improvement. Preclinical animal studies demonstrated that intradiscal injection of CybroCell resulted in a significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn generate the jelly-like material (disc nucleus) that provides cushioning for the spine.

SpinalCyte’s Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts from a simple skin biopsy, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and international issued patents and has filed for an additional 48 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

SpinalCyte, LLC
Investor Contact:
281-461-6211
info@spinalcyte.com
Media Contact:
Dan Keeney, APR, 832-467-2904
dan@dpkpr.com

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CTL Wins FDA Approval for Seurat Universal Pedicle Screw

Posted On April 6, 2018 By OrthoSpineNews In Regulatory, Spine /  

DALLAS, TX / ACCESSWIRE / March 29, 2018 / CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has recently secured clearance and approval from the Food and Drug Administration to market its new SEURAT Universal Pedicle Screw System for the practice of spine fusion surgery. This is the second FDA clearance for the company in the first quarter of 2018. CTL Medical’s in-house research and development team designed the SEURAT Universal Pedicle Screw System after working closely with surgeons to determine the most comprehensive, adaptable, and advanced features for use in the surgical operative environment.

“The FDA approval of the SEURAT Universal Pedicle Screw System enables us to offer very versatile intraoperative hardware options for surgeons and the surgical spine industry as a whole,” stated Danny Chon, CEO for CTL Medical Corporation. “As the general population continues to age and the reported degenerative spine cases increase, it is inevitable that the pedicle screw market and related instrumentation challenges will continue to grow, ultimately demanding a one-stop solution. As an answer to this need, we designed the SEURAT Universal Pedicle Screw System to be a truly comprehensive pedicle screw offering unlike any other in the market today.”

The SEURAT Universal Pedicle Screws are medically classified as bone screws, designed for direct implantation into a vertebral pedicle. This system is a compilation and consolidation of the best features from each of CTL Medical’s already cleared pedicle screw systems, boasting the addition of true intraoperative versatility. The modular housing assembly option enables surgeons to intraoperatively build the most appropriate implant for the present indication, and the option to select a standard or reinforced-ring locking set screw ensures the SEURAT Universal Pedicle Screw System will accommodate a broader range of anatomical challenges and usage preferences. This comprehensive single system includes polyaxial and monoaxial; open and MIS; single and dual thread profile; solid and cannulated; and hex and hexalobe screws of all diameters and lengths.

CTL Medical expects to launch the SEURAT Universal Pedicle Screw System in the second half of 2018.

For more information on CTL Medical Corporation, visit www.ctlmed.com.

About CTL Medical Corporation

CTL Medical Corporation is a fully integrated, innovative, industry-leading, global medical device design, development and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talents, positioning it to be a leader in medical device design and manufacturing. For more information, visit www.ctlmed.com.

Media Contact:

Jeff Cheatham
TrizCom PR
O: 972-247-1369
C: 972-961-6171
jeffc@trizcom.com

SOURCE: CTL Medical Corporation

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Episurf Medical’s knee products approved for marketing and sale in Spain

Posted On April 4, 2018 By OrthoSpineNews In Regulatory /  

TUE, APR 03, 2018

Episurf Medical (NASDAQ: EPIS B) today announces that the Spanish authority AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) has approved the Episealer® knee implant for marketing and sale in Spain. The approval follows a review process and Episurf Medical will now continue the process of establishment on the Spanish market.

“We are happy for this approval which follows our strategy. Spain is a market of significant size with a large number of knee replacements annually. Knee osteoarthritis is a global disease and the global markets are homogenous when it comes to prevalence. We look forward to taking the next steps in Spain shortly”, says Pål Ryfors, CEO Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 14.00 CEST on 3 April 2018.

Tags:

Episurf Medical , EpiSurf
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