News – Page 152 – Selby Spine

BELGRADE, Mont., Sept. 12, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Irix-A interbody spacer. The clearance provides for the addition of three additional size configurations for an expanded market opportunity, and importantly, for use with allograft. This clearance is the second received during this quarter, and continues to strengthen Xtant Medical’s focus in providing a more comprehensive portfolio focused on regenerative care for the patient.

Xtant Medical’s Irix-A is a standalone interbody device used in anterior lumber interbody fusions. The current product line offers a titanium and PEEK composite implant, with the additional option of a titanium plasma coating for improved osseointegration with the spinal endplate, all with 8° or 12° of lordosis for alignment with the curvature of the spine. This new 510k clearance adds three additional degrees of lordosis, specifically 16°, 20°, and 24°, providing the surgeon with a wider variety of choices to correct the patient’s loss of lordosis and to improve sagittal balance. The FDA clearance also expands the indications of use to include use with allograft, such as Xtant Medical’s patented OsteoSponge, proprietary 3Demin, or OsteoVive viable cell allograft.

“The clearance of the additional footprints, including hyperlordotic options, further enhances our lumbar product portfolio in response to our customer’s needs,” said Gregory Juda, Chief Scientific Officer. “We continue to execute on our focus of combining our hardware and biologics technologies, strengthening our position as a comprehensive supplier for spine surgeons and their patients.”

The Irix-A Lumbar Integrated Fusion System consists of an integrated titanium ring, surrounded by an outer PEEK ring and three screws. It is intended for anterior spinal fusion procedures at one or two contiguous levels of the lumbosacral spine (L2-S1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.

Xtant Medical estimates the US market for standalone anterior lumbar interbody fusion market to be approximately $230 million and growing. The US market for Demineralized Bone Matrix (DBM) is estimated at $410M. The additional Irix-A interbody implants are intended to be available to customers later this year.

About Xtant Medical

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact

CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com

September 12, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible) (Paris:IMPL) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received FDA clearance to market the new JAZZ™ Passer.

JAZZ™ Passer comprises new passer instruments and a variation of the JAZZ™ Band braid, the JAZZ™ Passer Band. The latter is 100% compatible with all JAZZ™ platform implant connectors, and replicates the mechanical performances of the innovative JAZZ™ Band braid, highlighted in numerous scientific publications.

JAZZ™ Passer facilitates placing the band around anatomical structures, representing a breakthrough in terms of flexibility and ease of use. This simplified system should drive surgeon adoption of JAZZ™ band technologies.

This comprehensive system was designed in direct response to surgeon feedback. Implanet addresses an ever-expanding list of therapeutic indications, given the characteristics and performance of the JAZZ™ Platform. By effectively covering all degenerative, scoliosis-deformity and trauma-tumor pathologies in adolescents and adults, the Company competes in a market segment estimated at over 2 billion dollars.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “This project’s challenge lay in the need to retain our JAZZ™ technology’s proprietary performance characteristics. Our goal was also to develop simple instrumentation that provides the surgeon tactile feel when passing the braid around bony structures. Our valued surgeon advisors confirm that this twofold objective has been achieved, with the combination of the new braid and passers making it even easier to use JAZZ™, notably in the areas of degenerative and complex spine surgery, which account for most spine operations.”

Regarding this new product launch, Nicolas Marin, Implanet’s Chief Marketing Officer, adds: “The JAZZ™ Passer systems enables us to reach a new milestone in the adoption of our technology and the frequency of its use by surgeons. With 20% market share in pediatric deformity surgery in France, we feel that the use of JAZZ™ band technologies has become standard of care and will be part of the therapeutic arsenal of many surgeons in the rest of the world. JAZZ™ Passer represents the most appropriate response to the various problems encountered by spine surgeons that only our technology makes it possible to truly address, illustrated by the conversion of new user surgeons, particularly in the United States.”

Next financial press release: H1 2017 results, on September 19, 2017 after market closes

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ™ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ™ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

September 12, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Chad Kolean as the Company’s Chief Financial Officer (CFO). In his role, Kolean will oversee Titan’s Finance Team and work to build forward-looking financial preparedness as the Company continues to experience rapid growth following the launch of its nanoLOCK® surface technology.

Prior to joining Titan, Mr. Kolean served as the CFO for Cellectar Biosciences, a life sciences company, where he drove a management restructuring and raised substantial funds resulting in uplisting to the NASDAQ Capital Market. Previously, he served as the CFO at Pioneer Surgical Technologies, providing the organization with leadership strategy, development and execution, Board support, investor relations, budgeting, forecasting, operations and regulatory due diligence. Kolean is a certified public accountant and earned his B.A. in Business Administration from Hope College.

Mr. Kolean commented, “I am thrilled to join the team at Titan Spine, particularly at such an exciting time for the company. We are well-positioned for continued financial growth that capitalizes on a strong first half of 2017. Titan Spine is making substantial progress addressing the key needs for both patients and surgeons, and the company’s growth is a direct reflection of the increased demand surgeons have for the advantages of our nanoLOCK® surface technology.”

Peter Ullrich, Chief Executive Officer of Titan Spine, added, “Chad’s appointment as our CFO validates and reflects our rapid expansion as we continue to disrupt our industry and redefine the role of interbody devices in the fusion process. The growing demand for our technology and our strong sales team has led to significant growth, especially in the first half of this year, and we believe Chad will help drive our continued progress, further benefiting patients at the nano-cellular level to heal faster following spinal fusions.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

²Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

³Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate

Contacts

Company:
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media:
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

NEW YORK, Sept. 12, 2017 /PRNewswire-USNewswire/ — Two research teams at Hospital for Special Surgery (HSS) have been awarded grants by the NBA and GE Healthcare Orthopedics and Sports Medicine Collaboration. This strategic partnership between NBA and GE Healthcare was launched to collaborate with leading clinical researchers to address the prevention, diagnosis and treatment of musculoskeletal injuries affecting NBA players and everyday athletes.

A team led by Brett Toresdahl, MD, primary care sports medicine physician at HSS, received a grant of nearly $300,000that will go towards investigating the use of ultrasound imaging to monitor healing and guide readiness of return to play in athletes with bone stress injuries.

Bone stress injuries of the lower leg and foot are common among elite basketball players and can require a long period of rest in order to fully recover. Determining when a player is ready to return to play has historically been difficult as it relies primarily on a player’s symptoms since signs of healing are not reliably seen with standard imaging (such as MRI and X-ray).

“There is little known about the connection between ultrasound findings, symptoms, and readiness for return to sport for athletes with bone stress injuries,” said Dr. Toresdahl, principle investigator of the study. “Our goal is to evaluate the use of serial ultrasound to assess bony healing to optimize treatment and more accurately predict readiness for return-to-play.”

The investigators will recruit adults between 18 and 50 years of age who have a bone stress injury in the lower leg or foot as a result of sport or exercise and diagnosed by MRI.

Participants will receive standard treatment of rest and crutches, splint and/or walking boot. An ultrasound will be performed every two weeks for 12 weeks at the site of the injury. Simultaneously, patients will be tracking their pain, activity and return to activity. A radiologist will grade the amount and appearance of bony callus formation and then a repeat MRI will be performed at 12 weeks.

“Our findings could provide doctors with a new way to guide athletes to safely return to play after a bone stress injury with a minimal risk of re-injury,” added Dr. Toresdahl.

The Athlete’s Foot

The other grant received by HSS went to a team led by Martin O’Malley, MD, foot and ankle surgeon at HSS. This $100,000 grant will be used to assess risk factors and intervention strategies for fifth metatarsal stress fractures, the most common type of stress fractures for basketball players. These fractures can be difficult to treat, leading to long-term consequences for an elite basketball player.

“Currently, there is limited knowledge on how to identify athletes who are at a high risk for a fifth metatarsal stress fracture,” said Dr. O’Malley, principle investigator of this study. “Additionally, we don’t have a clinical understanding on how to intervene before such injury occurs.”

This research will utilize data from the screening of collegiate and professional basketball players to identify factors of foot structure that are common in those who sustained a fifth metatarsal injury. The investigators will employ a specialized robotic device that will stimulate walking and jumping in cadavers to find features that increase the mechanical burden on this bone.

Testing will also be done to assess the ability of intervention strategies to reduce this mechanical burden and thus, the risk of injury.

“We hope to gain objective biomechanical evidence that will rationalize intervention strategies such as orthotic devices and targeted muscle activation in order to reduce risk of injury and re-injury,” added Dr. O’Malley.

About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2017-2018), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. HSS has locations in New York, New Jersey and Connecticut.
www.hss.edu

SOURCE Hospital for Special Surgery

FRANKLIN, Mass., Sept. 12, 2017 /PRNewswire/ — Arthrosurface, Inc. announced today the publication of long-term HemiCAP® data in The Journal of Foot and Ankle Surgery, “10 Year Follow-Up of Metatarsal Head Resurfacing Implants for Treatment of Hallux Rigidus.” The study reported excellent pain relief, functional improvement, high patient satisfaction, a low reoperation rate and no serious complications.

Hallux Rigidus describes a painful condition which affects the big toe at the first metatarsal joint. Osteophytes, or bone spurs, develop on the dorsal surface of the bones involved, which limit motion and cause pain. Advanced disease may also include degenerate cartilage on the joint surfaces, which can contribute to patient pain.

Historically, arthrodesis, or joint fusion, was the standard of care to address patients’ symptoms in advanced stages, however, with eliminated joint motion, patients have shown difficulties with rising on their toes, kneeling or taking a full stride when walking. Other complications include non-union of the fusion site in about 10% of the procedures.

The proprietary HemiCAP® Implant System is designed to maximize implant stability through a strong threaded fixation component and optimizes the fit with a range of implant curvatures. As an active alternative to joint fusion, the HemiCAP® System allows physicians to provide patient specific solutions with hemiarthroplasty of the first and lesser toes, as well as total joint replacement of the big toe. The motion preserving platform provides a complete solution for primary and revision surgery, while maintaining an exit into joint fusion. To date more than 33,000 implants have been used.

“Patients today want to maintain their toe mobility to stay active, whether it is playing golf, performing yoga or being able to continue to live independently,” said Lisa Donnelly VP of Marketing. “We see tremendous traffic on our website from patients inquiring how to find a physician who is trained on our technologies. We have recently launched a new physician locator covering a nationwide network of approximately 1,000 foot and ankle surgeons to help assist them.”

“It is very satisfying to see the AOFAS score of 90.6 at the 10-year follow-up and the high degree of patient satisfaction,” said Steve Ek, President & CEO of Arthrosurface. “We hope this data continues to drive the clinical and patient communities to question the role of motion sacrificing procedures in the first MTP joint, as has happened over time in multiple other joints”.

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 devices, instruments and orthobiologics designed to preserve and restore the joints so patients can regain and maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons that can be used to treat a wide range of joint conditions. 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 13 years. For more information, please go to our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

PLANO, Texas, Sept. 11, 2017 (GLOBE NEWSWIRE) — Noel Goldthwaite, MD, senior surgeon and founding member at SpineCare Medical Group, Inc., is the first physician in northern California to implant Nuvectra’s Algovita^® Spinal Cord Stimulation System, which successfully treated a local injured veteran’s chronic pain and led to his significant reduction in opioid use. The Nuvectra Algovita SCS System is a powerful and versatile spinal cord stimulation system that includes the smallest patient controller on the market. Algovita is FDA approved as a treatment for chronic, intractable pain.

“Following injuries sustained in the line of duty, this particular patient had multiple surgeries that led to unmanaged and intense chronic back pain prior to the placement of Algovita,” Dr. Goldthwaite explains. “The smaller volume paddle lead and ability to steer it using a stylet eased the navigation of significant scar tissue during the procedure. These features allowed me to place the paddle and stimulation exactly where the patient needed it, which helped to alleviate his pain right from the start. Furthermore, after the procedure, the Algovita system differs from other SCS systems in its easy to use keychain patient controller that allows the patient, in conjunction with our medical staff, to customize the amplitude, frequency, and pulse width of the stimulation and toggle between therapy settings. The results have been outstanding! When he initially came to see me, he was severely depressed and in a wheelchair due to his pain. Now he walks into my office upright with a smile on his face and a sparkle in his eye – he’s a totally different person.”

Chronic pain affects over 100 million Americans according to the Institute of Medicine, more than diabetes, cancer, and heart disease combined. Chronic pain is difficult to treat, but one potential treatment option is spinal cord stimulation, or SCS. SCS works by masking or interrupting pain signals as they travel up the spinal cord to the brain. A small, rechargeable battery is implanted under the patient’s skin and connected to thin wires, called leads, which stimulate the nerves sending pain signals. The stimulation “overrides” the pain signals, and instead of feeling pain, patients may feel a tingling sensation known as paresthesia.

Dr. Goldthwaite also discussed the opioid dependency epidemic occurring among our veterans, stating that, “SCS is a powerful non-drug tool that can be used to control pain relief for these patients. Non-drug pain control helps them function, focus, and sleep better and more effectively deal with other related conditions, including PTSD.”

Algovita gave near immediate pain relief to this patient, enabling him to reduce his opioid usage by over 90% in the 6 months since his surgery, which he had become dependent on to keep the pain at bay. Now, he leads what he calls a life of conscious living, being able to enjoy time with his family and help other veterans who have returned from active duty.

The Algovita SCS System was designed to help physicians improve their outcomes and better manage their patients’ pain today and into the future. Algovita offers a number of unique features not available with other systems on the market. With the broadest range of capabilities and fine-tuned control, Algovita provides physicians with the tools to address the individual and changing nature of pain. In addition, Algovita’s leads cover the longest span of the spinal nerves, allowing for additional coverage options as pain moves and changes. As the only stretchable leads on the market, Algovita’s leads are designed to bend and stretch with body movement to help sustain the therapy long-term. Since pain can change throughout the day and with different activities, Algovita also features a small, wireless, key-fob patient controller so stimulation can be easily and discreetly managed.

For more information about Nuvectra and the Algovita Spinal Cord Stimulation system, visit www.nuvectramed.com.

About Dr. Goldthwaite

Dr. Noel Goldthwaite was a founding member of SpineCare Medical Group in 1988. He has performed more than 12,000 spinal operations including more than 350 spinal cord stimulator system implantations and revisions both for the lumbar spine and the cervical spine. He lectures and teaches nationally and internationally. He has a special interest in treating patients who have already had unsuccessful spine surgeries. He understands very well that inadequately treated spine problems, especially failed surgeries with chronic pain, are devastating for the patient, the patient’s family, the patient’s friends, and for society. He is prepared to address all those issues.

WESTMINSTER, Colo., Sept. 12, 2017 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced the publication of two-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of i-FACTOR™ Peptide Enhanced Bone Graft. The results published in the peer reviewed journal Neurosurgery show i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft in anterior cervical discectomy and fusion (ACDF) procedures.

i‐FACTOR Bone Graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. In November 2015, Cerapedics received Premarket Approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in ACDF procedures.

“We are pleased that the statistical superiority in overall success for i-FACTOR Bone Graft versus autograft in ACDF procedures was maintained over two years in our IDE trial,” said Jeffrey Marx, Ph.D., president and COO of Cerapedics. “The Neurosurgery publication is a testament to the hard work and dedication of the clinical investigators who continue to pursue advanced treatment options for patients with degenerative cervical disc disease.”

In the IDE clinical trial, patients received either autograft or i-FACTOR Bone Graft in a cortical ring allograft. FDA-mandated success criteria included fusion, improvement in Neck Disability Index (NDI), neurological status, and safety. At two-year follow-up, a responder analysis of combined endpoints for overall success demonstrated 70 percent success for patients receiving i-FACTOR Bone Graft versus 56 percent for patients receiving autograft. This was statistically significant for superiority (p = 0.0302).

Fusion success was confirmed radiologically for 97 percent of i-FACTOR Bone Graft patients and 94 percent of autograft patients (p = 0.2195). A more than 15-point improvement from baseline NDI was reported for 77 percent of i-FACTOR Bone Graft patients and 69 percent of autograft patients (p = 0.1804). Improvement in neurological status was similar in both patient groups (95 percent of i-FACTOR Bone Graft patients and 94 percent of autograft patients, p = 0.6944). Safety success measured by the absence of re-operation, device explantation, and device-related serious adverse events was observed in 95 percent of i-FACTOR Bone Graft patients and 91 percent of autograft patients (p = 0.1379).

“The publication of the two-year results from this Level I clinical trial further validates previous findings that i-FACTOR™ Bone Graft, with P-15 technology, is statistically superior to autograft,” said Paul Arnold, M.D., neurosurgeon at the University of Kansas Hospital Marc A. Asher, M.D. Comprehensive Spine Center and lead author of the study. “we are pleased to be able to offer a new advanced biologic bone graft with outstanding safety and efficacy to our patients.”

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic 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.

Media contact:
Adam Daley
|Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

SOURCE Cerapedics

11 Sep, 2017 – Yuval Azulai and Gali Weinreb

Medical equipment company Medtronic will be the first company to establish a development center in Israel in cooperation with the Israel Innovation Authority. In return for hiring 100 employees in spheres beyond the company’s existing activity in Israel, the company will receive a $14 million grant from the Innovation Authority. Following approval of the grant in recent days, the new deal between the state and Medtronic is a handshake away.

It is believed that the grant will be spread over three years by paying 30% of the salary of those working in the development center. The new activity will be in two locations: Jerusalem and Yokneam, and will involve brain monitoring (Jerusalem) and big data for medicine (Yokneam).

The expansion of Medtronic’s activity in Israel was agreed four months ago in the framework of a meeting between Ministry of Economy and Industry Eli Cohen, Israel Innovation Authority CEO Aharon Aharon, and Medtronic chairman and CEO Omar Ishrak. A senior source in the Ministry of Economy and Industry said today that in addition to a number of contacts at various stages taking place between the state and multinationals interested in investing in the Israeli economy, initial negotiations were also being conducted with a major pharmaceutical company.

The source said, “The background to these companies’ interest in investments in Israel involving the opening of development or manufacturing centers is the attractive tax environment in comparison with other countries and the low tax rate on intellectual property.”

Other Ministry of Economy and Industry sources said that talks were taking place today with representatives of 10 multinationals for possible investment in Israel. The sources claim that a low media profile is being maintained in these contacts in order to avoid wrecking them.

According to Innovation Authority figures, foreign investment in Israel totaled $12.6 billion in 2016, 7% more than in 2015. The Innovation Authority said that 320 multinationals were operating in Israel.

READ THE REST HERE

Written by Kristin Della Volpe

Research on whether minimally invasive surgery (MIS) for lumbar spine fusion is more advantageous than open surgery has been the topic of much debate. While studies suggest less blood loss and fewer infections with MIS, this approach may take longer and be more technically demanding.

Given the lack of consensus on which approach may be best, patient education and shared decision-making can be complex. New findings suggest that patient preference may be influenced by many factors during consent-taking, as reported in the August issue of The Spine Journal.

“Our study demonstrated that patients change their decisions between MIS and open approaches frequently during the process of consent-taking,” said lead author Hwee Weng Dennis Hey, FRCSEd (Orth), FAMS (Orth), MCI, Consultant, Orthopaedic and Spine Surgery, University Orthopaedics, Hand and Reconstructive Microsurgery Cluster, National University Health System in Singapore. “This is likely due to the different weight each patient gives to the advantages and disadvantages of MIS or open surgery.”

“The most common concerns influencing patients’ final decision are radiation and cosmesis,” Dr. Hey told SpineUniverse. “As a result, consent-taking should be conscientious such that patients are adequately informed. Radiation and cosmesis should be given more emphasis.”

Cross Sectional Study of Patients with Lumbar Spondylolisthesis
The findings are based on a cross-sectional study of 54 patients (mean age, 55.8 years) collected over a 3-month period at a single institution in Singapore. These patients were indicated for transforaminal lumbar interbody fusion (TLIF) for radiographically confirmed lumbar spondylolisthesis. All patients had chronic low back pain and radiculopathy. Patients who had undergone previous spine surgery, had concurrent spine pathologies (eg, tumors, infection, or fractures), or had high-grade spondylolisthesis were excluded from the study.

Standardized Consent-Taking Process
An independent spine specialist interviewed patients using a script that required patients to decide between MIS or open surgery at various points during the consent-taking process. Pictures of the scars from MIS and open surgery as well as information on the potential advantages and disadvantages of both approaches were also provided.

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ALBANY, New York, September 8, 2017 /PRNewswire/ —

According to the research report, the global market for Hip Reconstruction Devices stood at US$5.68 bn in 2016 and is expected to witness strong growth over the period from 2017 to 2022. Primary cemented hip replacement devices enjoy a much higher demand among all the products available in this market. With a rise to US$126.6 mn per annum in revenues, this segment is anticipated to retain its dominance over the forecast period. With an increasing patient pool, osteoarthritis and rheumatoid arthritis have emerged as the primary indication for the application of these devices. Researchers predict this trend to continue over the next few years. Hip reconstruction devices find significant application in hospitals, ambulatory surgical centers (ASCs), and orthopedic clinics.

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“With the significant increase in the geriatric population base across the world, the prevalence of osteoporosis and rheumatoid arthritis is augmenting continuously, resulting in the soaring need for hip reconstruction surgeries, which, subsequently, is boosting the demand for hip reconstruction devices,” says a TMR analyst. The rising cases of hip injuries and the growing demand for minimally invasive procedures is also propelling the global hip reconstruction devices market remarkably.

Going forward, the technological advancements in hip reconstruction devices are likely to drive the growth in this market over the next few years. The upswing in the investments for research and development of highly advanced and minimally invasive hip reconstruction procedures and devices is also projected to have a positive impact on this market in the near future.

High Cost of Devices to Act as Restraint

The worldwide hip reconstruction devices market, although, looks thriving; however, the high cost of hip reconstruction procedures and devices may restrict the market from growing steadily in the coming years. The stringent regulations required for the approval for these devices will also create hindrances in the growth trajectory of this market over the next few years.

Nonetheless, the rising awareness pertaining to the benefits of hip construction procedures in treating patients and enabling them to perform daily activities and live a normal lifestyle is expected normalize the impact of these restraints in the years to come, states the study.

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Regionally, North America has emerged as the leading market for hip reconstruction devices across the world. Analysts at TMR anticipate this regional market for remain on the top over the forecast period on the grounds of the presence of established hip reconstruction device vendors in a large number. The increasing demand for minimally invasive surgeries is also projected to boost the North America market for hip reconstruction devices in the years to come, states the research report.

With a large pool of manufacturers, the global hip reconstruction devices market is demonstrating a high competitive and fragmented business landscape, finds a new research study by Transparency Market Research (TMR). Innovation and advancements in current offerings is the key trend among the leading players in this market, such as United Orthopedic, Exactech, Corin, Braun Melsungen, DePuy Synthes, Stryker and others. However, over the forthcoming years, a shift in their focus towards strategic alliances, in the form of mergers, acquisitions, and partnerships, can be observed, notes the research study.

Hip Reconstruction Devices Market Report Is Available @ US$ 5795

About TMR

Transparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company’s exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.
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