Acron Medical Announces FDA 510(k) Clearance of its Signature PEEK TLIF Interbody System, the ACRON Interbody

Acron Medical, LLC (http://www.Acron-Medical.com), part of the spineMED Group, is a spine technology organization, dedicated to developing and commercializing globally innovative spinal implants. The company is proud to announce that it has received 510(k) clearance from the FDA for its signature new technology, the ACRON TLIF Interbody system.

“The ACRON Interbody is an exciting innovation for safe & stable thoracolumbar interbody fusion,” says Christian Schawrda, Acron Medical’s Co-Founder and CEO. “The engineering behind the development of the cage makes it the gold standard for surgeons looking for solid anchorage and optimal load distribution between the implant to protect osteoporotic patients from bone subsidence. The cage is designed to be strategically placed along the outer rim of the endplates, or ring apophysis, with superior load-bearing capacity. That approach, maximizes the strength of the fusion construct, increases fusion rates and minimizes the risk of subsidence.”

The ACRON is made of PEEK-OPTIMA, a material with a proven clinical history and a modulus of elasticity similar to bone. It also comes with a graft chamber and side windows to facilitate the formation of a robust fusion column.

The system includes a full range of implant sizes and heights that are carefully designed to accommodate different types of vertebral anatomy, and to allow surgeons to address each patient’s sagittal plane requirements.

Andreas Bernegger, Acron Medical’s Co-Founder says, “The ACRON comes to the United States after 3 years of clinical validation in Austria, Germany and Switzerland. The launch of the technology in the United States is major milestone for our group. We are currently looking for distributors and strategic partners around the country.”

Acron Medical’s management team will be attending NASS in September in Los Angeles (Sep 26-29) and is looking forward to many fruitful discussions with potential partners. For more information on Acron Medical, please visit http://www.Acron-Medical.com.

About Acron Medical, LLC. 
Acron Medical is the US subsidiary of the spineMED group, based in Austria. Acron Medical founded in 2017, has leveraged its Austrian DNA, 35 years of clinical experience and the core competencies of the spineMED Group to develop a range of clinical relevant spinal technologies. The ACRON TLIF, as well as all the technologies in the spineMED R&D pipeline, are designed to harmoniously combined the latest scientific advances with intuitive designs and instrumentation. Additional information is available online at http://www.Acron-Medical.com.

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Cartiva Announces Presentation of Long-Term Clinical Data on Treating Big Toe Arthritis with Cartiva Synthetic Cartilage Implant

July 16, 2018

ALPHARETTA, Ga.–(BUSINESS WIRE)–Cartiva, Inc., (Company) a medical device company focused on the treatment of osteoarthritis of the extremities, announced today the presentation of five-year follow up results from its pivotal MOTION Study, a prospective, randomized multi-center study which evaluated the safety and effectiveness of its Cartiva Synthetic Cartilage Implant (SCI) for the treatment of arthritis at the base of the big toe, the most common site of arthritis in the foot. The objective of the MOTION study, which involved 197 patients treated at 12 centers, was to establish non-inferiority of Cartiva SCI compared to fusion, the historical standard of care.

Judith Baumhauer, M.D., M.P.H., Professor and Associate Chair of Academic Affairs, University of Rochester Medical Center and Principal Investigator of the MOTION Study, presented the data July 14 at the annual meeting of the American Orthopaedic Foot and Ankle Society (AOFAS) in Boston, MA.

In the original MOTION Study, 135 patients received the Cartiva implant. Of these, long-term outcomes were available for 106 patients with a mean follow-up of 5.8 ± 0.7 (range: 4.4 to 8.0) years. These outcomes demonstrate that Cartiva SCI provides:

  • Durable pain relief, with patients achieving a 97% median reduction in pain.
  • Sustainable functional improvement, with patients demonstrating a 176% median improvement in sporting activities.
  • Motion preservation, with patients experiencing a 25% improvement in range of motion from baseline.
  • A high rate of satisfaction with the treatment, with 93% of patients saying they would have the procedure again.

“Cartiva SCI has now been proven to be a viable alternative to fusion for patients wanting to maintain range of motion,” said Mark Glazebrook, MD, FRCSC, MSc, PhD, Professor of Orthopaedics Surgery at Queen Elizabeth Sciences Centre in Nova Scotia, Canada and a lead enroller in the MOTION Study. “With almost six years of follow up from a rigorously conducted clinical trial, the data supports Cartiva being a game-changer in the treatment of this condition.”

Cartiva SCI gained Food and Drug Administration (FDA) premarket approval for use in arthritis at the base of the big toe in July 2016. As a condition to the approval, FDA required additional data to evaluate the long-term safety and effectiveness of Cartiva SCI, including the durability and survivorship of the implant. The primary endpoint (implant survivorship) and secondary endpoints (clinical and radiographic success for the Cartiva subjects through five years) were met and the data has been submitted to FDA.

“We were very excited to share the long-term results with the attendees of the AOFAS Annual Meeting,” said Tim Patrick, President and CEO of Cartiva. The excellent follow-up out to as long as eight years is a testament to our clinical investigators and their research staff. We believe these data support Cartiva as the standard of care for a motion-preserving alternative to fusion.”

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. is a medical device company focused on the treatment of osteoarthritis of the extremities. Cartiva’s synthetic cartilage is the only FDA-approved biomedical implant that mimics natural cartilage. The company’s venture investors include New Enterprise Associates and Windham Venture Partners. Additional information is available on the company’s website at www.cartiva.net.

Contacts

Cartiva, Inc.
Peter Pizzo, 770-754-3855
Chief Financial Officer

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Local Orthopedic Surgeon, Ritesh Shah, MD, Receives Innovation Trailblazer Award for Adoption of New Navigation System for Hip Replacement Surgery

MORTON GROVE, ILJuly 16, 2018 /PRNewswire/ – Orthopedic surgeon, Ritesh Shah, MD, was honored with the IJS Innovation Trailblazer Award of Excellence acknowledging early adoption of intellijoint HIP® into his practice at Illinois Bone & Joint Institute and in an Ambulatory Surgery Center (ASC) setting at Illinois Sports Medicine & Orthopedic Surgery Center (ISMOSC) in Morton Grove.

intellijoint HIP is a highly accurate 3D mini-optical navigation system used to assist in proper size selection and positioning of artificial implants during a hip replacement. Dr. Shah is the first orthopedic surgeon in Illinois to offer this new technology in an outpatient or ASC setting.

“Many of my patients come to me in pain looking to regain their former mobility, but are worried about the short- and long-term risks associated with total hip replacements,” explained Dr. Shah. “By utilizing the quantitative measurements that intellijoint HIP provides intraoperatively, I am able to ensure the implants have been positioned accurately resulting in a significant decrease of associated risks. Patients are back to their active lifestyles in just days, confident in their surgical outcomes.”

A total hip replacement is typically an effective surgery that can reduce hip pain and restore mobility. The risks of this procedure can include leg length discrepancy, dislocation, joint instability, reduced muscle strength, reduced hip range of motion, and long-term pain. intellijoint HIP addresses these risks by providing accurate, intraoperative measurements for cup position, leg length, and offset to assist the surgeon in placing implants in a location that best matches the patient’s native anatomy.

“Intellijoint Surgical is proud to present the Innovation Trailblazer Award to Dr. Shah today,” said Armen Bakirtzian, CEO, Intellijoint Surgical. “We want to acknowledge not only his adoption of intellijoint HIP, but his overall commitment to better surgical outcomes through exploring new advances in the field — both in technique and in technology.”

About Dr. Ritesh Shah:

Dr. Shah is a nationally recognized, board-certified, fellowship-trained orthopedic surgeon who specializes in hip and knee replacements in the outpatient setting. His mission is to return patients to their active lifestyle as quickly and as safely as possible. He travels and teaches colleagues worldwide about new advances in same day hip and knee replacement, hip arthroscopy, joint revision surgery, and the Rapid Recovery Reality approach to orthopedic care.

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 accurate positioning of orthopedic implants during Total Hip Arthroplasty. Intellijoint is committed to improving patients’ lives by providing every surgeon with effective, easy-to-use technology.

SOURCE Intellijoint Surgical Inc.

Related Links

https://www.intellijointsurgical.com/

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Aziyo Partners with SurGenTec for Minimally Invasive Bone Graft Delivery

July 13, 2018

SILVER SPRING, Md.–(BUSINESS WIRE)–Aziyo Biologics, Inc., a fully integrated regenerative medicine company, announced today it has entered into a co-marketing agreement with SurGenTec, a privately-owned medical device company based in Boca Raton, FL. The Company will supply ViBone, its proprietary bone repair product, to SurGenTec for marketing and distribution with its patented GraftGun universal graft delivery system.

“As we continue to grow our portfolio of proprietary orthopedic surgery products, innovative partnerships like this allow us to expand the reach of our product marketing and distribution in a very rapid and efficient way,” said Darryl Roberts, Ph.D., Executive Vice President and General Manager, Musculoskeletal Products. “The GraftGun system is an optimal device to deliver ViBone, enabling a next generation viable bone graft to be easily delivered and used in challenging surgeries.”

This co-marketing agreement calls for Aziyo to provide its viable bone matrix product, ViBone, to SurGenTec for use with the GraftGun System. ViBone pre-filled cartridges will be marketed through the SurGenTec distribution network.

Travis Greenhalgh, Founder and CEO of SurGenTec added, “Our Company is focused on creating intuitive solutions to improve the quality of life for patients. ViBone complements our GraftGun system by providing surgeons and patients with a bone matrix product that is as close as possible to the gold standard of autograft. This unique combination offering of ViBone and GraftGun pre-filled cartridges will significantly reduce time in the operating room.”

ViBone was launched in 2017 as a better option for bone repair procedures. The advanced science and proprietary product processing was designed for handling and clinical performance closer to that of autograft. Similarly, SurGenTec’s patented GraftGun system was also launched in 2017 with a focus on improving delivery of intraoperative bone graft materials. Both products have been used in numerous orthopedic procedures and continue to see strong market adoption.

About ViBone

ViBone is a next generation viable bone matrix that was designed to perform and handle more like high quality autograft. The proprietary manufacturing process was designed to optimally protect the tissue environment with less disruption. ViBone is based on science that brings bone grafting closer to meeting the surgeon and patient’s needs and provides a better option for bone repair. To learn more about ViBone, visit www.Aziyo.com/ViBone/.

About GraftGun

GraftGun is part of SurGenTec’s Graft Delivery System (GDS). It is designed to allow for universal, quick and accurate bone graft delivery to a surgical site without the problems of a traditional funnel. Its patented, controlled release method is designed to safely dispense bone graft with enough pressure to easily fill any bone void during bone graft surgery. The GraftGun GDS includes SurGenTec’s loading device technology, which provides surgeons the freedom to choose the bone graft that best suits their needs. To learn more about the GraftGun system, visit www.SurGenTec.com/GraftGun.php.

About Aziyo Biologics, Inc.

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the Company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular and other medical specialties. For more information, visit www.Aziyo.com.

About SurGenTec, Inc.

SurGenTec is a privately-owned medical device company based out of Boca Raton, FL that strives to bring the next level of technology to the spine and orthopedic industry. SurGenTec develops and manufactures innovative products with patient and surgeon safety at the heart of everything they do. For more information, visit www.SurGenTec.com.

Contacts

Aziyo Biologics, Inc.
Erica Elchin, 510-730-7896
PR@aziyo.com

(Graphic: Business Wire)

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NuVasive Portfolio Introduces Low-Profile Modular Implants For Posterior Fixation

SAN DIEGOJuly 16, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the launch of Reline MAS Midline (RMM), the next evolution of the Reline system that provides procedural versatility in a compact midline construct.

RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce adjacent segment transition syndrome. The system, when combined with NuVasive access and interbody technologies, is designed to provide a minimally invasive approach to bilateral decompression under complete visualization, interbody fusion and stabilization with pedicle screws. Delivering screw modularity, RMM allows for greater procedural flexibility while enhancing visibility and access. Furthermore, RMM tulip pull-off strength is comparable to preassembled pedicle screws. Enhanced fixation is achieved with NuVasive’s cortical cancellous traction thread form. The system’s 5.0mm cobalt chrome construct is low in profile and boasts fatigue strength comparable to 5.5mm titanium.

“RMM posterior fixation represents the most advanced midline cortical pedicle screw system on the market,” said minimally invasive spine surgeon Dr. Nitin Khanna, Clinical Faculty of Orthopedic Surgery at the Indiana University School of Medicine and partner at Orthopedic Specialists of Northwest Indiana. “The introduction of modular, low-profile tulip heads was designed to address concerns with adjacent segment facet joint impingement. This system furthers NuVasive’s midline portfolio as best-in-class.”

The NuVasive RMM solution utilizes adaptable, streamlined instruments to support both cortical and standard trajectory techniques. The midline approach is further simplified with the integration of access, interbody and fixation, while modular screw assembly is confirmed with visual and tactile feedback.

“Innovation is in our DNA and we are constantly looking for ways to take our existing solutions to the next level,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “RMM, a low-profile midline solution that stands out with its versatility, strength and reliability, exemplifies our commitment to innovation and provides relevant solutions to meet the diverse and evolving needs of our surgeons worldwide.”

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Digital Surgery Deploys First Surgical Artificial Intelligence System for the Operating Room

July 16, 2018

LONDON–(BUSINESS WIRE)–Digital Surgery, a health tech company shaping the future of surgery through the convergence of surgical expertise and technology, today announced it has developed and successfully demonstrated the world’s first real-time, dynamic artificial intelligence (AI) system designed for the operating room (OR). The company is building the data to power the future of surgery through its world-class and proprietary surgical procedure road maps, which aim to aid the surgical team in the OR, reducing risk and making surgery safer. Digital Surgery is the first patented AI platform bringing this scale of knowledge to the surgical community.

“This is a huge milestone for the future of surgery because it lays the foundation for how AI and computer vision will support surgical teams to deliver safer surgeries. It also enables the next generation of robotic surgery, giving these future systems the capability to function more intelligently and safely,” said Dr. Jean Nehme MD, co-founder and CEO of Digital Surgery. “We have already developed AI algorithms for multiple procedures across bariatrics and other surgical specialties like orthopedics, and our library will continue to grow. With AI, we have the unique ability to scale global surgical best practices.”

More than 5 billion people do not have access to safe surgical care, with surgical knowledge being one of the critical factors that hasn’t been able to scale globally. Addressing this problem will require emerging technologies, including AI, particularly given other technological alternatives, like robotics and telemedicine platforms, require expensive equipment or resources that limit their scalability.

Digital Surgery’s AI platform can provide road maps and act as a navigational system for every OR and surgery center, addressing the countless variables that surgical teams face — from staff turnover, language, culture, tools, resources, to the training and skill level of the surgical team. The AI recognizes what is happening during surgery through a camera view, and cross-checks and correlates the anatomy and actions against the largest library of surgical road maps. The OR team can then see in real time the platform analyzing and predicting next steps.

Quotes from leading surgeons

  • “What Digital Surgery has done with this technology feels like a comparison with the advent of laparoscopy, which was a truly disruptive and groundbreaking revolution and paradigm shift in surgery. This resulted in a huge change in approach from maximally invasive to minimally invasive surgery. In the next five years, I expect there to be a transformation from non-AI to AI supported surgery as common practice, benefiting training, patient safety, data collection and outcomes analysis. This is something my OR teams, clinical teams and I would look forward to and will truly impact patient care.” — Dr. Sanjay Purkayastha, Consultant Laparoscopic, Bariatric & Robotic Surgeon, Imperial College Healthcare NHS Trust and Clinical Senior Lecturer at Imperial College London
  • “The impact of a technology leap like this is astounding. Digital Surgery is creating the technologies that will drive the ‘integrated ORs’ and robotic systems of the future.” — Dr. Daniel Buchbinder, Mount Sinai School of Medicine

The team at Digital Surgery is best known for its leading mobile surgical training app, Touch Surgery, which is embedded in more than 160 residency programs and used by more than 2 million surgeons, healthcare professionals and others globally. Touch Surgery has more than 200 surgical simulations across 14 specialties, and it has been validated by 15 peer-reviewed publications for its approach to virtual surgical training.

About Digital Surgery

Digital Surgery, founded by surgeons for surgeons and healthcare professionals, believes safe surgical care should be accessible for all. Co-founders Dr. Jean Nehme and Dr. Andre Chow set out to shape the future of surgery by building a digital ecosystem that sits at the intersection of surgical expertise and technology. Digital Surgery is comprised of two products, Touch Surgery, the award-winning interactive training platform downloaded more than 2 million times, and GoSurgery, an operating room efficiency platform launching later this year. The company is based in London with teams around the world. For more information, please visit: http://www.digitalsurgery.com.

Contacts

For Digital Surgery
Elizabeth Soares
415-583-4433
elizabeth@brewpr.com

(Photo: Business Wire)

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J. Chris Coetzee, MD, MBChB, Installed as AOFAS® President

ROSEMONT, Ill.July 13, 2018 /PRNewswire-USNewswire/ — Foot and ankle orthopaedic surgeon, J. Chris Coetzee, MD, MBChB, has been named president of American Orthopaedic Foot & Ankle Society (AOFAS)®, the leading organization for lower extremity medicine and foot and ankle surgery. In addition to leading the Society as president, Coetzee will serve on the Board of Directors of the Orthopaedic Foot & Ankle Foundation.

As president of the 2,200-member Society, Coetzee will continue the mission of advocating for patients on local and national levels to ensure they receive the best and most appropriate orthopaedic foot and ankle care. He will also continue the AOFAS tradition of providing outreach to communities in need through the Orthopaedic Foot & Ankle Foundation. One of Coetzee’s other priorities during his one-year term is ensuring that orthopaedic residents are involved in the Society early on during their medical training.

“We still live in uncertain times. Belonging to an organization like the AOFAS helps me channel the uncertainties of today into creative solutions for tomorrow,” Coetzee said. “I am looking forward to continuing collaboration with peers from all over the world to work towards our goals of improved patient care, education, and outreach.”

Coetzee earned his medical degree from University of Pretoria School of Medicine in South Africa and performed his orthopaedic residency at University of Stellenbosch in Cape Town, South Africa. He also completed a fellowship in foot and ankle orthopaedics at the University of Washington Harborview Medical Center in Seattle in addition to a trauma fellowship in Davos, Switzerland. His current work is through Twin Cities Orthopedics in Minneapolis-St. Paul.

As an avid supporter of the educational mission of AOFAS, Coetzee served as program chair of the 2014 AOFAS Annual Meeting, and has chaired several other AOFAS committees. He is an assistant editor of the AOFAS peer-reviewed journal Foot & Ankle International and a reviewer for other orthopaedic journals.

Coetzee added, “My hope for all in the Society is to live by the words of Benjamin E. Mays: ‘The tragedy of life is often not in our failure, but rather in our complacency; not in our doing too much, but rather in our doing too little; not in our living above our ability, but rather in our living below our capacities.'”

About Foot and Ankle Orthopaedic Surgeons  

Foot and ankle orthopaedic surgeons are medical doctors (MD and DO) who specialize in the diagnosis and treatment of musculoskeletal disorders and injuries of the foot and ankle. Their education and training consists of four years of medical school, five years of postgraduate residency, and a fellowship year of specialized surgical training. These specialists care for patients of all ages, performing reconstructive surgery for deformities and arthritis, treating sports injuries, and managing foot and ankle trauma.

About the AOFAS 

The American Orthopaedic Foot & Ankle Society (AOFAS) mobilizes our dynamic community of foot and ankle orthopaedic surgeons to improve patient care through education, research, and advocacy. As the premier global organization for foot and ankle care, AOFAS delivers exceptional events and resources for continuous education, funds and promotes innovative research, and broadens patient understanding of foot and ankle conditions and treatments. By emphasizing collaboration and excellence, AOFAS inspires ever-increasing levels of professional performance leading to improved patient outcomes. For more information visit the American Orthopaedic Foot & Ankle Society online at aofas.org.

SOURCE American Orthopaedic Foot & Ankle Society

Related Links

http://www.aofas.org

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Cerapedics Announces Closing of $22 Million Financing

WESTMINSTER, Colo.July 13, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced that the company completed a $22 million financing led by KCK Group, a family investment fund that focuses on innovative medical technologies that meet significant clinical needs.

“We are pleased to announce that we have successfully completed an equity financing that will continue to accelerate the commercial release of i-FACTOR™ Peptide Enhanced Bone Graft and support the execution of a second Level I investigational device exemption (IDE) human clinical study that will broaden our market indication in the $2 billion U.S. spinal market,” said Glen A. Kashuba, chief executive officer of Cerapedics. “This year we have exceeded our own expectations regarding year over year revenue growth and have significantly expanded our user base as surgeons continue to express a high level of satisfaction with clinical results that support the safety and efficacy of our product. We also understand the value of Level I human clinical data and are committed to investing and expanding our indications. We are fortunate to be supported by KCK Group, a partner that shares in the long-term vision that differentiated products that provide safety, efficacy and economic value, supported by human clinical results, will ultimately provide the highest value to surgeons and their patients.”

Cerapedics also announced that three new members have been appointed to the company’s board of directors including Valeska Schroeder, Ph.D., managing director of the medical technologies division at KCK Group, Greg Garfield, J.D., senior managing director and head of the medical technologies division at KCK Group, and Nael Karim Kassar, investment partner at KCK Group.

“Cerapedics is well-positioned for strong growth with Level I data establishing i-FACTOR’s superiority and with a dedicated team that has deep experience in orthobiologics and spinal fusion,” said Dr. Schroeder. “This financing will allow Cerapedics to further invest to increase physician access to i-FACTOR and to build clinical evidence for new indications.”

i‑FACTOR Peptide Enhanced Bone Graft is based on proprietary biomimetic small peptide (P-15) technology that has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disc disease. This unique drug-device technology enhances the body’s natural bone healing process through cellular activity that is directional and predictable.

Cerapedics received Premarket Approval (PMA) from the U.S. Food & Drug Administration for the use of i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures, becoming the first PMA-approved bone graft with this indication. The company has also initiated an IDE clinical trial in transforaminal lumbar interbody fusion (TLIF) surgery.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary biomimetic small peptide (P-15) technology platform. i‑FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

i‑FACTOR Peptide Enhanced Bone Graft Indications for Use

USA: i‑FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i‑FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.

Media contact: 

Jenna Iacurci

Berry & Company Public Relations 

212-253-8881 

jiacurci@berrypr.com

SOURCE Cerapedics

Related Links

http://www.cerapedics.com

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Artoss Announces Completion of $1 Million Funding Round

Press Release – July 13, 2018

Artoss, Inc. is pleased to announce the successful completion of its recent funding round of Unsecured Convertible Notes. The round, which began in 2017 with a target of raising $500,000, was oversubscribed to twice that amount or a total of $1 million.

James J. Cassidy, Ph.D., Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone® Bone Graft in orthopaedic surgery, said, “We have been overwhelmed by the interest shown in our second round of angel funding. We are especially grateful to those investors who participated in our 2016 funding round and chose to increase their investment in this round as well as to our new investors for their support of Artoss.”

Paul Byerley, Managing Director of Artoss, Inc. said, “We are very pleased with our commercial success to-date and appreciate the support of our investors. Surgeon feedback on the clinical performance of NanoBone SBX Putty and QD remains extremely positive. We look forward to expanding our distribution network to put our superior bone grafting solution in the hands of more surgeons.”

Artoss, Inc. is using the proceeds of this funding to support the development of additional NanoBone Bone Graft products for the US market, for costs associated with regulatory requirements, and for commercialization activities.

 

For further information, please contact:

Artoss, Inc.

425 E Saint Germain St., Suite 106

Saint Cloud, MN 56304-0752

320-259-4321

info@artossinc.com

 

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Power T Handle Announces Completion of First Spinal Surgery Procedures Performed With Innovative Power Device

Power T Handle, LLC, a surgeon-driven, innovative company, announced today the successful completion of the first spinal surgical cases using the Power T Handle, an instrument designed to merge power and tactile feel in spinal and other surgical procedures.

The Power T Handle is the first surgical power solution that seamlessly integrates power while preserving the manual capabilities of traditional T-handles that attach to orthopedic instruments, such as screw taps and screwdrivers. This revolutionary, cordless device is the first of its kind that transforms from a manual handle to a low-speed, high-torque power driver with the press of a button. The low profile and sleek design preserves the tactile feel of traditional T-handles and is compatible with existing 1/4” square attachment instruments. This low-cost, single-use device is provided in a sterile package for immediate use.

The Power T Handle overcomes the limitations of pre-existing power tools by eliminating cumbersome surgical drills, custom instrument attachments, and power cords. This device is also cost efficient, as there is no investment in capital equipment, no reprocessing, no maintenance costs and no batteries to recharge.

Andrew Rhea, MD, Florence Neurosurgery and Spine Center, Florence, SC performed the first procedures with the Power T Handle. “I decided to use the Power T Handle in these spinal fusion procedures to allow for easier and quicker insertion of the tap and pedicle screws without loss of tactile feedback,” stated Dr. Rhea. “The Power T Handle fits my existing surgical technique. It is simple to attach, increased my surgical efficiency, and provided the natural feel of using a traditional T-handle. It also fit well in the surgical field without having to move the C-Arm or struggle with a power cable.”

Kevin Cahill, MD, PhD, President of Power T Handle LLC, said of the device, “We developed the Power T Handle to offer surgeons a better power tool. This device truly delivers power without compromise.” Dr. Cahill continued, “The Power T Handle solves many of the challenges facing surgeons and the surgical team today trying to incorporate power technologies. It offers an easy to attach and use device that increases OR efficiencies, reduces surgeon fatigue and preserves the tactile feedback of traditional instrumentation. We are eager to see what the future holds for the Power T Handle as we continue to evolve and provide better power solutions for surgeons.”

About Power T Handle, LLC 
The Power T Handle LLC was founded by Dr Cahill and a team of experienced medical device engineers with the goal of developing better power solutions for surgeons. The Power T Handle was designed to overcome the substantial limitations of existing surgical power instruments. The Power T Handle provides surgeons with the power, precision, and feedback necessary to perform surgery without the fatigue, hassle and cost of traditional instrumentation.

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