Sintx Announces 30-Year Spine Fusion Data With Silicon Nitride Implants

SALT LAKE CITY, Jan. 03, 2019 (GLOBE NEWSWIRE) — SINTX Technologies (NASDAQ: SINT) today reported the independent publication of 30-year clinical outcomes of lumbar fusion surgeries, performed with silicon nitride implants. The paper titled “Anterior Lumbar Interbody Fusion Using Reaction Bonded Silicon Nitride Implants” appeared in the December 2018 edition of the World Neurosurgery journal, and the findings were also featured at the 2018 Annual Scientific Meeting of the Neurosurgical Society of Australasia.

Dr. Ralph Mobbs from the University of New South Wales, Sydney, authored the study. Dr. Mobbs stated: “This work is of historical significance, being the first clinical study of silicon nitride as an implant material, the first commercial anterior lumbar interbody fusion with a synthetic material, the first design of a spinal interbody implant with endplate porosity to promote fusion, and the longest clinical follow-up of any implant material in spine surgery. This report clearly establishes the place of silicon nitride in the annals of spine surgery,” said Professor Mobbs.

“This work reflects the only known use of silicon nitride implants, outside the spine products manufactured by our company,” said Dr. Sonny Bal, Chairman of SINTX Technologies. “Despite a much earlier material composition and implant design, silicon nitride proved itself even three decades after spinal implantation. These findings are entirely consistent with the more modern data published by us, showing earlier fusion, excellent biocompatibility, ease of radiographic imaging, and other advantages of our silicon nitride spine implants. The SINTX formulation of silicon nitride is enhanced and improved even further with sintering agents that accelerate bioactivity and confer antibacterial advantages.”

“This paper is a compelling affirmation of our full confidence in silicon nitride as the ideal spine biomaterial platform, whether as an implant, surface coating, or composite formulation with other biomaterials. This report will support our sales objectives, as we prepare an official launch in the coming months in Australia – the first place to use silicon nitride in spinal fusion surgery,” said Daniel Chon, CEO of Dallas-based CTL-Amedica, the exclusive retail channel for silicon nitride spinal implants made by SINTX Technologies.

About SINTX Technologies

SINTX Technologies is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. A discussion of those risks and uncertainties can be found in Sintx’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Sintx’s other filings with the SEC. SINTX disclaims any obligation to update any forward-looking statements. Sintx undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts:
SINTX Technologies
801-839-3502
IR@sintx.com

The Hidden System That Explains How Your Doctor Makes Referrals

Dec. 27, 2018 / By Anna Wilde Mathews and Melanie Evans

Phoebe Putney Health System doesn’t want its doctors to send business to competitors. If they do, Phoebe makes sure their bosses know about it.

Doctors working for the Albany, Ga.-based hospital system’s affiliated physician group get regular reports breaking down their referrals to specialists or services. One viewed by The Wall Street Journal included cardiology, colonoscopies and speech therapy, along with the share of each referred to Phoebe health-care providers.

If the share of in-house business wasn’t viewed as adequate, administrators would press them to improve, doctors said.

“They would let you know it wasn’t high enough,” said Thomas Hilsman, a primary-care doctor recently retired from the Phoebe medical group. He said he felt referrals should be based on which health-care provider was best for patients. “They keep the Phoebe physicians busy, they see more patients, they make more money.”

Phoebe officials said they use referral policies to improve quality and reduce costs, and physicians weren’t punished for their decisions.

Patients are often in the dark about why their doctors referred them to a particular physician or facility. Increasingly, those calls are being driven by pressure to keep business within a hospital system, even if an outside referral might benefit the patient, according to documents and interviews with doctors, current and former hospital executives and lawyers.

Losing patients to competitors is known as “leakage.” Hospitals, in response, use an array of strategies to encourage “keepage” within their systems, which in recent years have expanded their array of services.

The efforts at “keepage” can mean higher costs for patients and the employers that insure them—health-care services are often more expensive when provided by a hospital. Such price pressure and lack of transparency are helping drive rising costs in the $3.5 trillion U.S. health-care industry, where per capita spending is higher than any other developed nation.

For hospital systems, doctors’ referrals are a vital source of revenue. A hospital earns an average of $1.8 million annually in revenue from an internal-medicine physician’s admissions, referrals for tests and other services, plus practice revenue for employed doctors, a 2016 survey by recruiter Merritt Hawkins, a unit of AMN Healthcare Services Inc., found. The survey didn’t include hospital revenue from referrals by internal-medicine doctors to specialists, such as orthopedic surgeons or cardiologists.

Hospitals have gained more power over doctors with a wave of acquisitions of practices and hirings in recent years, and hospitals are getting more aggressive in directing how physicians refer for things such as surgeries, specialty care and magnetic resonance imaging scans, or MRIs.

 

READ THE REST HERE

 

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

December 20, 2018 / FDA News Release

The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients. Genetech processed umbilical cord blood into unapproved human cellular products, which was distributed by Liveyon, LLC.

Additionally, as part of the FDA’s overall goal to support the responsible development of safe and effective products for patients, the agency is sending letters to reiterate the FDA’s compliance and enforcement policy to other manufacturers and health care providers who may be offering stem cell treatments.

“The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies. At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” said FDA Commissioner Scott Gottlieb, M.D. “We remain committed to supporting the development of safe and effective cell-based regenerative medicine and advancing our comprehensive regenerative medicine policy framework. These efforts include our work to encourage manufacturers to engage with the FDA early so that we can provide guidance about any applicable regulatory requirements. Even though a few sponsors have come to us, we are discouraged by the overall lack of manufacturers wanting to interact with the agency in this enforcement discretion period. The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”

As highlighted last year with the release of the FDA’s comprehensive regenerative medicine policy framework, including the FDA’s final guidance (Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use), the FDA intends to apply a risk-based approach to enforcement of cell-based regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended to be used. However, the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern to patients.

Under this policy, the agency noted that it intends to exercise enforcement discretion for certain products until November 2020 with respect to the FDA’s investigational new drug application and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns. Although the FDA has not evaluated the application of the compliance and enforcement policy to the specific manufacturers and health care providers who received the letters, or evaluated their products, the letters are intended to serve as a reminder of the enforcement discretion period and to encourage all affected manufacturers and health care providers to engage with the agency in advance of that date to determine if their products are subject to the agency’s premarket approval requirements.

The FDA offers opportunities for this type of engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. It also encourages the use of its expedited programs whenever applicable, in addition to the collaborative development of products as the FDA Commissioner and Center for Biologics Evaluation and Research director discussed in a New England Journal of Medicinedisclaimer icon perspective.

In the case of Genetech, the FDA inspected the company’s facility this past June and found the company was processing cellular products from human umbilical cord blood for administration by intra-articular (joint) injection, intravenous injection or application directly to the affected tissue to treat a variety of orthopedic conditions. These products were distributed by Liveyon in Yorba Linda, California as ReGen5, ReGen10 and ReGen30. The Genetech products are not intended for homologous use (products that are intended for the same function in the recipient as the donor), and while the products have a systemic effect, they are not intended for allogeneic (genetically similar) use in a first or second-degree blood relative. As such, the products are regulated as both drug and biological products. To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the Genetech-processed, Liveyon-distributed products.

During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products, including: deficient donor eligibility practices; unvalidated manufacturing processes; uncontrolled environment; lack of control over the components used in production and a lack of defined areas or a control system to prevent contamination and mix-ups. These deviations pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects.

The FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli), as described in a forthcoming Morbidity and Mortality Weekly Report (MMWR), titled “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.”

In September, Liveyon suspended shipment of all product pending an inquiry by the FDA into the source of the adverse reactions. Liveyon also voluntarily recalled all Genetech products it may have distributed.

“The FDA remains committed to taking action against products being unlawfully marketed and which pose a potential significant risk to patient safety at this time. However, the agency is also committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA requested a response from Genetech, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.

Health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed formcan be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Spine Surgeon Becomes First In Western Pennsylvania To Reintroduce Lumbar Artificial Disc

PITTSBURGH, PA, December 5, 2018 // — Dr. Jocelyn Idema, Orthopaedic Spine Surgeon at The Center for Disc Replacement Surgery at Advanced Orthopaedics and Rehabilitation (AOR), recently implanted Centinel Spine’s newest generation of the prodisc L lumbar artificial disc replacement.  The prodisc L® is a Total Disc Replacement (TDR) technology platform that offers a surgical alternative to spinal fusions. Patients usually suffer from a single level degenerated disc in the lower (lumbar) spine and this technology works to relieve pain while allowing the potential for motion at the diseased spinal segment. 

As lower spine treatments continue to make advancements through innovative technologies and motion preserving techniques, patients are seeking out alternatives to lumbar fusions.  The goal at The Center for Disc Replacement Surgery at AOR is to improve the motion and function of the spine while maintaining the highest quality and highest standards of care related to both surgical and non-surgical spine interventions through evidence based medicine practices.  “By using newer motion preserving techniques, spinal discs can help retain the forward-to-back, bending side-to-side, and turning left-to-right spinal motion you were intended to have.” says Dr. Idema.  “This in turn helps to reduce the wear and tear associated with your spine above and below the damaged area.”  “I can’t begin to describe how this newest generation of lumbar artificial discs will continue to be a game-changer for patients.” reports Dr. Idema after the procedure.  She further  continues  “I have been doing cervical (neck) artificial disc replacement for years with really high success rates but the lumbar artificial discs only recently are making a resurgence because of various limitations including insurance companies authorizing the procedures.”

Centinel Spine is currently the only company in the United States to offer both upper and lower spine Total Disc Replacement devices.  The prodisc I implant, the predecessor of the prodisc L implant, was first implanted in 1990. The prodisc L implant that is used today was introduced outside the United States in 1999. It was approved by the Food and Drug Administration (FDA) for use in the United States in August 2006.   A prodisc L IDE clinical study evaluated the prodisc L Total Disc Replacement surgery compared to spinal fusion surgery*. The study demonstrated that prodisc L surgery is a safe and effective alternative to fusion surgery* for qualified patients.

About Centinal Spine
From the foundation of knowledge gained from the long-term clinical success of its lumbar products, Centinel launched its cervical product in 2008. Today, Centinel Spine still embraces the pioneering culture from 1924.  In 2006, the FDA Approved the prodisc L—the 2nd U.S. Lumbar Total Disc Replacement device and in 2007, the  FDA approved the  prodisc C—the 1st Complete U.S. Cervical and Lumbar offering.

For more information, please visit www.centinelspine.com and connect on Twitter and Facebook.

Overland Park Surgical Suites First Outpatient Surgery Center In Region To Offer Robotics-Assisted Partial And Total Knee Replacement Surgery Using The NAVIO™ Surgical System

OVERLAND PARK, Kan.Dec 13, 2018 /PRNewswire/ — Overland Park Surgical Suites is a state of the art outpatient surgical center and is the first outpatient surgery center in the Midwest to offer patients a robotics-assisted alternative to traditional knee replacement surgery.

“We were eager to bring the NAVIO robotics-assisted surgery to the area,” said Scott Abraham, M.D., Orthopedic Surgeon and founder of Overland Park Surgical Suites, LLC. “This exacting technique is the preferred approach for most patients and we’ve seen dramatic surgical outcomes.”

The NAVIO Surgical System starts with an advanced computer system that gathers precise anatomic and alignment information about a damaged knee that a surgeon uses to create a specific surgical plan, according to Dr. Abraham.

“This extra layer of data collection is designed to ensure the knee procedure is performed as accurately as possible for the best long-term outcome,” he said.

Abraham has already performed more than 100 robotic-assisted partial and total knee replacements at Overland Park Surgical Suites and St. Joseph Medical Center, and draws patients to his practice from throughout KansasMissouri and Iowa. He said the NAVIO System is particularly well suited for active adults in their 40s and 50s who have developed knee problems, but have opted to put off surgery as a remedy.

“Knee replacement surgery has a controversial reputation,” Abraham added.

Unfortunately, this leads many patients to delay medical intervention because of concerns about invasive surgery, painful rehab and significant downtime. The NAVIO System helps offset these concerns with the improved accuracy and the potential for faster recovery, leading to the goal of improved surgical outcomes and increased patient satisfaction.

The first knee implant procedure was performed 50 years ago in 1968, according to the American Academy of Orthopaedic Surgeons. Now, more than 600,000 knee replacement surgeries are performed each year, making it one of the most in-demand surgical specialties in the country. Yet often, patients are dissatisfied with the outcome.

Not so for Beth Archer of Leawood, who in October was the first person in the state of Kansas to undergo a partial knee replacement using robotic surgical assistance at Overland Park Surgical Suites.

“I’d been living with knee pain for four years,” Archer said. “The quality of my life dramatically improved with my partial knee replacement done with the NAVIO Surgical System. I returned home immediately and was self-sufficient, had little pain and within a week I was walking without a cane or walker. I highly recommend this robotic surgery.”

Abraham added that the NAVIO benefits are many, yet robotic surgical-assist is still in its infancy.

“We’re proud that Overland Park Surgical Suites is the first outpatient surgery center in the region to offer this state of the art NAVIO knee replacement procedure,” Abraham said. “But we won’t be the last. In fact, we think this is the future of the surgical field. It puts the power of robotics in the skilled hand of the surgeon. And that means a better outcome for all our patients.”

For more information or to schedule a NAVIO consultation with Dr. Abraham, call APEX ORTHOPEDICS and Sports Medicine at 913-642-0200.

NOTE: Not all patients are candidates for surgery using the NAVIO Surgical System. Discuss your condition and implant options with your surgeon. Individual results of joint replacement vary. Implants may not produce the same feel or function as your original knee. There are potential risks with knee replacement surgery such as loosening, fracture, dislocation, wear and infection that may result in the need for additional surgery. NAVIO is not for everyone. Children, pregnant women, patients who have mental or neuromuscular disorders that do not allow control of the knee joint, and morbidly obese patients should not undergo a NAVIO procedure.

(www.OverlandParkSS.com
Overland Park Surgical Suites is a state-of-the-art, orthopedic outpatient surgical center in Overland Park, KS. It was established by clinical personnel to offer safe, high quality surgical care. It is one of the first surgery centers in the Kansas City area to perform outpatient total joint replacements and is licensed by the State of Kansas and accredited by The Joint Commission.

About Smith & Nephew: 
(www.RediscoverYourGo.com
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were more than $4.8 billion. Smith & Nephew is a member of the FTSE100.

TM is a Trademark of Smith & Nephew

Contact:      

Betsy Donnelly

Phone:         

913 208 5400

Email:           

Betsy@TrailheadMarketingTeam.com

SOURCE Overland Park Surgical Suites

Related Links

http://www.overlandparkss.com

In2Bones Expands Its Lead in PEEK Lower Extremity Implants with the Global Launch of the Unique PitStop® Subtalar Implant

December 11, 2018

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced the global launch of the unique, “see-through” PitStop®implant.

Manufactured from a high-performance polymer called polyether ether ketone (PEEK), the PitStop® Implant is used to help facilitate the surgical correction of progressive flat foot deformity in both pediatric and adult populations.

Flexible flatfoot is one of the most common deformities of the foot, often starting during adolescence and continuing into adulthood. The PitStop® Implant helps to restore the stability of a patient’s arch during the gait or walking process.

Several traditional metallic brands of subtalar implants are currently available today which can be limiting because of the excessive stiffness of the material compared to the adjacent bones, causing pain and biomechanical adaptation in some cases. PEEK has the benefit of being less stiff (softer) than metal and more similar to the elasticity of bone. The PEEK material in the PitStop® Implant may lead to increased and long-term patient tolerance.

Additionally, PEEK is radiolucent, meaning that it won’t show up on X-ray, something that traditional metal implants cannot do because metal absorbs X-rays and blocks the image underneath.

The Unique “see-through” PitStop® Implant demonstrates In2Bones’ commitment to expanding the extremities market by launching innovative technological advancements that improve surgical outcomes and patient care.

To support the commercial launch of the PitStop® Implant, In2Bones recently published the micro website, http://www.PitStop-Implant.com providing physicians and healthcare professionals with easy to access educational content. The materials on the site will include surgical animations and videos, surgical technique guides, case studies, patient support materials, and more.

For more information about In2Bones Global, Inc. extremity products, please visit www.In2Bones.com.

About In2Bones

Headquartered in Memphis, Tennessee, In2Bones is a global designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.in2bones.com.

Contacts

Jon Simon | Sr. Vice President of Marketing
In2Bones USA
M: 512.739.5793 • O: 901.260.7931 • F: 844-712-6637
Email: jsimon@i2b-usa.com
https://www.linkedin.com/company/22344175/

Bob Reed
Element-R Partners
630.579.1770
bob@rurelevant.com

NuVasive Grows Cervical Spinal Interbody Portfolio With PEEK Corpectomy Implant

SAN DIEGODec. 10, 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 it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith®Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.

The FDA 510(k) indications for expanded use of the Company’s Monolith Corpectomy System include procedures in the cervical spine (C3-C7 vertebral bodies) to treat a diseased or damaged vertebral body caused by fracture, tumors, osteomyelitis or to support reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders.

“Expanding the indicated use of our Monolith Corpectomy System to include cervical corpectomy procedures demonstrates the Company’s continued commitment to expanding our cervical spine interbody portfolio,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives.”

NuVasive’s Monolith Corpectomy System was initially cleared by the FDA for indicated use in thoracolumbar corpectomy procedures in 2015, offering a fully modular, imaging-friendly PEEK implant solution. The system is comprised of a monolithic core with modular endcaps that allow surgeons to customize the device to meet the patient’s specific anatomical requirements. The endcaps are available in multiple footprint and lordosis options intended to help maximize endplate coverage while addressing the surgeon’s alignment goals. The Monolith cage is constructed entirely from PEEK and includes radiographic markers, which provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures. The cage also includes large central graft apertures designed to help facilitate bony through-growth and fusion.

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

IntraFuse Granted US Patent for FlexThread™ Intramedullary Fracture Fixation System

LOGAN, UtahDec. 6, 2018 /PRNewswire/ — IntraFuse, a start-up medical device company operated by Surgical Frontiers, is focused on advanced surgical devices for improving outcomes for orthopedic extremity procedures, announced today that the United States Patent and Trademark Office has recently granted the company a key patent related to its FlexThread Intramedullary Fracture Fixation system.

US Patent 10,136,929 entitled “Flexible Bone Implant” is the first patent to issue from the intellectual property portfolio held by the company that includes additional pending US and international patent applications. The patent covers the novel combination of an intramedullary rod with cross fixation on end and a flexible bone screw on the other end. This platform technology enables percutaneous, secure fracture fixation of long bones of the extremities, especially for curved bones or where the surgical technique requires an off-axis approach to the intramedullary canal.

The simple and elegant design is easier to implant and lower cost than today’s standard-of-care fracture fixation hardware. Incorporating IntraFuse’s proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the bone, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period.

The FlexThread System is currently FDA 510(k) cleared for fibula and clavicle indications, and the FlexThread™ technology is in further development for additional indications, include fractures of the fifth metatarsal bone, also known as a Jones fracture.

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers
Surgical Frontiers develops advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Media Contact:
Mr. Wade Fallin 
CEO
205883@email4pr.com 
http://surgicalfrontiers.com/intrafuse/ 
800-230-3710

SOURCE Surgical Frontiers

Related Links

http://surgicalfrontiers.com

Jupiter Medical Center is the first hospital in the southeastern United States to use SpineJack®

Jupiter, Florida, Dec. 05, 2018 (GLOBE NEWSWIRE) — JUPITER, FLORIDA (December 5, 2018) — Jupiter Medical Center is the first hospital in the southeastern United States to use SpineJack®, an implantable system that relieves the pain of acute vertebral compression fractures (VCFs), the most common fracture in patients with osteoporosis. The innovative device stabilizes and restores damaged vertebra to their original shape and height in a minimally invasive procedure that takes about 30 minutes.

“We take pride in offering the most advanced treatment options available,” said Don McKenna, president and chief executive officer of Jupiter Medical Center. “With this new technology, we are establishing Jupiter Medical Center as a leader in spine care not just locally, but nationally.”

Approved by the U.S. Food and Drug Administration in September, SpineJack® has been commercially available in Europe since 2008, with more than 70,000 units implanted worldwide.  It is produced domestically by the Stryker medical technology company.

“This is a revolutionary advancement for treating many patients suffering from acute osteoporotic vertebral compression fractures,” said Dr. Jeffrey Miller, medical director of Neuroendovascular Surgery and co-medical director of the Stroke Program at Jupiter Medical Center. “We know from its success in Europe over the last decade that it significantly improves the patient’s quality of life almost immediately.”

“SpineJack® is part of the expanding array of treatment options available in Jupiter Medical Center’s Interventional Radiology Program,” said Dr. Lee A. Fox, medical director of Imaging at Jupiter Medical Center. “Our program offers a full scope of advanced diagnostic procedures and minimally invasive therapies, and we are delighted to bring this new treatment option to our patients.”

Dr. Miller performed Jupiter Medical Center’s first SpineJack® on Nov. 6. His patient, 75-year-old Robert Fischer of North Palm Beach, is pleased with the outcome.  “It’s only been three weeks and I feel close to perfect – I’d say 95 percent,” said Fischer, who was diagnosed with osteoporosis earlier this year after he began suffering debilitating back pain.

VCFs are the most common medical condition experienced by those with osteoporosis or low bone mass. VCFs occur when the vertebral body in the spine collapses, which can lead to severe pain, spinal deformity and loss of height. The fractures more commonly occur in the middle (thoracic) and lower (lumbar) portions of the spine. While osteoporosis is the most common cause, these fractures may also be caused by trauma or metastatic tumors. The lifetime risk of osteoporotic fracture for those older than 50 years of age is one in two for women and one in four for men.

“SpineJack® treats back pain by targeting the cause and, as a result, it reduces the need for long-term use of pain medication,” Dr. Miller said. “In addition to enhancing our patients’ quality of life, this procedure could have a significant impact in the effort to combat opioid addiction.”

For decades the only nonsurgical treatments for VCFs were bed rest, bracing (which limits mobility) and pain medication. Vertebroplasty has been used since the early 1990s and more recently kyphoplasty, which has become a mainstay in the treatment of VCFs. In vertebroplasty, bone cement is injected directly into the fractured vertebra, where it quickly hardens and acts like an internal cast. In kyphoplasty, a balloon is inserted into the fracture to expand the space before the cement is added. Neither procedure restores the vertebral body to its full height.

SpineJack® was invented by a French physician whose inspiration was a scissor jack, the diamond-shaped car jack that is commonly used to lift a vehicle when changing a flat tire. Instead of a kyphoplasty balloon, the procedure utilizes a titanium implant that resembles a tiny scissor jack, which is deployed into the fractured vertebral body. Once in place, the SpineJack® is expanded to lift the compressed vertebra and restore it to its normal height. Two implants are used in the procedure, one on each side of the vertebral body. They are locked into the desired expanded position and bone cement is then injected to stabilize the vertebra. The implant becomes encapsulated with bone cement resulting in pain relief for the patient.

Fischer proved to be the ideal patient to undergo the first SpineJack® at Jupiter Medical Center.  In August, while spending the summer in Rhode Island, he underwent a kyphoplasty procedure to treat a VCF in his upper back. While wintering in South Florida just a few months later, he suffered a second VCF during a round of golf—this time in his lower back. His primary care physician referred him to Dr. Miller, who thought he would be a good candidate for SpineJack®.

“My recovery was much quicker,” he said. “With (kyphoplasty), that recovery took about 10 weeks before I felt as good as SpineJack® feels now, just three weeks later. I would definitely recommend it.”

Performed on an outpatient basis, the procedure is appropriate for patients who have been diagnosed with a VCF within four to six months of treatment. For more information, visit https://www.jupitermed.com/spinejack or call 561-263-2200.

About Jupiter Medical Center

A not-for-profit 327-bed regional medical center consisting of 207 private acute-care hospital beds and 120 long-term care, sub-acute rehabilitation and Hospice beds, Jupiter Medical Center is reimagining how to restore the community’s health and wellness. Award-winning physicians, world-class partnerships and innovative techniques and technology enable Jupiter Medical Center to provide a broad range of services with specialty concentrations in cardiology, oncology, imaging, orthopedics & spine, digestive health, emergency and pediatric services, lung & thoracic, women’s health, weight management and men’s health.

Founded in 1979, Jupiter Medical Center has approximately 1,650 team members, 637 physicians and 640 volunteers. Jupiter Medical Center continues to perform in the top 10 percent of hospitals for patient quality and satisfaction. For more information on Jupiter Medical Center, please call (561) 263-2234 or visit www.jupitermed.com.

Attachments

Ernestine Williams
Jupiter Medical Center
5612633852
Ernestine.Williams@jupitermed.com

FX Shoulder USA, Inc. to Begin Clinical Study on Stemless Reversed Total Shoulder

DALLASDecember 5, 2018 /PRNewswire/ —

FX Shoulder USA, Inc. will begin in December 2018 the FDA approved Investigational Device Exemption (IDE) clinical study of the Easytech Reversed stemless, a shoulder prosthesis, with its first implantation scheduled for December.

Easytech Reversed Stemless is an innovative shoulder arthroplasty implant that will be under clinical study with (9) sites and (12) surgeons across the U.S. participating. Building on the current success in France (home of FX Shoulder USA’sparent company, FX Solutions), where over 800 Easytech Stemless Reversed prostheses have been successfully implanted, FX Shoulder USA is slated to enroll patients at two (2) investigational sites in December and continue enrollment with additional sites beginning in January 2019.

“The Easytech Reversed may be exactly what the U.S. market is in need of, and a reversed stemless prosthesis could potentially be the future of shoulder arthroplasty,” said Baptiste Martin, CEO of FX Shoulder USA. “We are excited to begin our clinical study and enthusiastic to see the results with each successive case throughout. There is a lot of excitement among the surgeon investigators for Easytech Reversed,” he continued. In Europe, as per the article in Med Device Online dated April 11, 2018, stemless implants are projected to surpass stemmed implants by 2025.

Founded in 2011, FX Solutions has developed a large, unique and innovative range of prosthetic shoulder products, which include the Easytech Reversed Stemless. FX Solutions is now the second largest player in the French market, with more than 3,000 prostheses sold in 2018.

FX Shoulder USA, based in Dallas, Texas, is the direct provider of FX Solutions shoulder replacement devices in the U.S. FX Shoulder USA was founded in January 2018 and focuses exclusively on shoulder arthroplasty with a growing distribution network.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements, are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; and risks related to the development of Stemless Reversed shoulder prostheses, including regulatory approvals, mandates, oversight and other requirements. In this press release, forward looking statements include those concerning the development of the Stemless Reversed shoulder prosthesis, its safety and efficacy profile, its potential to benefit patients and our ability to make it available to those patients.  We disclaim any intention or duty to update forward-looking statements made in this press release.

http://www.fxshoulder.com

info@fxshoulder.com

SOURCE FX Shoulder USA

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(Photo: https://mma.prnewswire.com/media/794131/FX_Shoulder.jpg )