001_main-1-2bto.jpg

OrthoPediatrics Announces Expanded Indication for FIREFLY® Pedicle Screw Navigation Guides

Posted On July 31, 2018 By OrthoSpineNews In Spine, Top Stories /  

WARSAW, Ind., July 31, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce that FIREFLY® Pedicle Screw Navigation Guides (“FIREFLY”) received additional FDA 510(k) clearance for an expanded indication to include S2AI [screw] trajectory for sacral-iliac fixation in complex spinal reconstruction surgeries, including scoliosis. When applied to the challenging S2AI trajectory, the precise and personalized mechanical guidance enabled by FIREFLY minimizes complexities associated with crossing the sacral-iliac joint while eliminating the need for excessive radiation/fluoroscopy.

OrthoPediatrics is the exclusive distributor of FIREFLY technology in children’s hospitals in the US. FIREFLY is FDA-cleared for use in adult and pediatric populations and is manufactured by Mighty Oak Medical.

The patient-specific, 3D printed FIREFLY Pedicle Screw Navigation Guides are a novel solution to complex and costly navigation systems. This patented navigation technology is designed to increase OR efficiency and eliminate the need for intraoperative radiation, making it the optimal choice in more complicated spinal construct cases, such as those involving the S2AI trajectory.

David Bailey, Executive Vice President of OrthoPediatrics, commented, “We are pleased our partners at Mighty Oak Medical have received additional FDA clearance for this enhancement of the FIREFLY technology. This signifies another pediatric patient segment that surgeons now can treat efficiently and effectively. Ensuring our customers and their patients have access to this novel technology is one more way we continue leading innovation in pediatric orthopedics.”

About Mighty Oak Medical
Mighty Oak Medical is an independent incubator focused on developing and marketing spinal technologies that improve operating room efficiencies, surgical outcomes, and the overall patient experience, by leveraging the talents of experienced surgeons and biomedical engineers. They are located in Englewood, Colorado. For more information, call 720-398-9703 or send an inquiry to info@mightyoakmedical.com.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

Read More
download.jpeg

Medicare Reconsiders Paying For Seniors’ Spine Operations At Surgery Centers

Posted On July 30, 2018 By OrthoSpineNews In Regulatory, Spine /  

By Christina Jewett / July 30, 2018

Medicare is reviewing whether seniors should undergo spine surgeries at same-day surgery centers, the government-run health program announced Wednesday, five months after a USA Today Network-Kaiser Health News investigation revealed a spate of patient deaths following the procedures.

The proposal states that Medicare officials will examine whether these procedures “pose a significant safety risk” to patients and continue to “meet the criteria” for Medicare payment.

The news investigation found that in 2015 and in 2017 Medicare approved same-day spine operations for seniors even though at least 14 patients had died since 2008 after such procedures.

Some suffocated from a well-known complication of upper-spine surgery that can generally be reversed if caught immediately and treated properly.

The investigation also found that some medical professionals urging Medicare to pay surgery centers to operate on seniors’ spines failed to mention recent incidents of death at their own or an affiliated facility.

Dr. Nancy Epstein, a chief of neurosurgical and spine education at New York University Winthrop Hospital, lauded the proposal, saying patients face extensive risks after spine surgery.

“It’s about time,” Epstein said of the review proposal, which she expects to rankle some doctors who have a financial stake in a spine surgery center.

Bill Prentice, executive director of the Ambulatory Surgery Center Association, which represents the centers in policymaking discussions, said he supports Medicare stepping up its efforts to perform an internal and external review of the procedures it pays for at surgery centers.

“The more resources they use, the better,” Prentice said. “I think that the more data points they have, the more likely they are to make the right decision. … We believe these procedures can be performed very safely in the ambulatory surgery center space.”

Medicare announced the plan to re-evaluate its decision to pay for seniors’ spine procedures in an annual rule-making document released Wednesday. The agency is accepting comments on the proposed changes through Sept. 24 and is expected to release a final decision late in the year.

 

READ THE REST HERE

 

Read More
1d2c76e445c828347fdd9adb97f29181-1-1.jpg

Implanet Opens German Subsidiary

Posted On July 27, 2018 By OrthoSpineNews In Spine /  

July 26, 2018

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

Implanet (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its establishment in Germany.

Following the opening of the Implanet UK sales branch in June 2018, Implanet continues direct operational expansion in the European market at a rapid pace with the opening of Implanet GmbH, in Frankfurt am Main. Implanet targets the German degenerative spine disease market, the largest in Europe, estimated at 300 million dollars1, with approximately 1,000 potential surgeon customers. Like Implanet UK, this new German branch will capitalize on the success of Implanet’s strategy in France and the United States by setting up a mixed network of direct sales representatives and exclusive sales agents.

Implanet GmbH is headed by Jana Heuer, with 10 years of experience as a sales leader in the spinal surgery market, most recently at Paradigm Spine for four years and K2M for six years.

Ludovic Lastennet, Chief Executive Officer of Implanet, said: “After announcing Implanet UK in June, the opening of Implanet GmbH in Germany represents a new milestone in the implementation of our 2018-2019 strategic plan: this consists in promoting Implanet’s product range directly in key European markets and preparing to integrate the products of our partner L&K Biomed.”

Next press release: first-half 2018 results, Wednesday 19 September 2018

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 46 staff and recorded 2017 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. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 Company estimates

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

Read More
download-12bto-3.jpg

CarboFix’s CarboClear®, Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA

Posted On July 27, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

HERZELIYA, Israel, July 26, 2018 /PRNewswire/ — CarboFix Orthopedics LTD., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United States. The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear system provides unique clinical advantages to spine cancer patients and their physicians. Among those advantages are: no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue, minimal attenuation of External Beam Radiation (EBRT), allowing radiation to pass through the implant with almost zero reduction in the radiation dose level; and no artifact in CT, for optimal radiation CT planning. CarboClear spinal implants also offers superior fatigue strength, beneficial for a patient population known for extended delays in healing.  Additionally, the CarboClear Pedicle Screw System offers enhanced follow up abilities due to minimal CT/MRI artifact.

Dr. Stefano Boriani, head of oncological spine surgery of GSpine4 at the Galeazzi Institute Milano, said of his clinical experience with the CarboClear® system: “This unique material provide us with additional treatment options that we didn’t have in the past, and in our experience provides better clinical outcomes for the treated patients.”

About CarboFix Orthopedics LTD.

CarboFix Orthopedic Ltd, is recognized as the world’s leading company in developing, manufacturing and marketing innovative carbon fiber orthopedic solutions. CarboFix Orthopedics’ headquarters and manufacturing are located in Herzeliya, Israel, with additional manufacturing for the Asia market in Guangzhou, China. CarboFix is working in the United States through its subsidiary CarboFix Inc. and in the rest of the world through a network of distributors. The company’s products are approved by the FDA, CE and other regulatory bodies.

For more information, please visit www.Carbo-fix.com, or reach out directly to 

Ron Szekely

Int’l V.P., Sales & Marketing

Ron@carbo-fix.com

SOURCE CarboFix Orthopedics LTD.

Related Links

http://www.carbo-fix.com

Read More
NuVasive-Headquarters.jpg

NuVasive Unveils Spine’s First Integrated Surgical Automation Platform

Posted On July 27, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

SAN DIEGO, July 27, 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 Pulse™ surgical automation platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the foundation for Surgical Intelligence™, the Company’s ecosystem enabling better surgery. Pulse introduces 2D- and 3D-navigation and smart imaging capabilities while integrating the Company’s leading neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies. This single platform addresses a broad range of clinical challenges, with enhanced utility and intuitive workflow. The fusion of these technologies supports reproducible spine surgery at facilities ranging from major health systems to ambulatory surgery centers.

“Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room,” said Dr. Stephen Ryu, neurosurgeon at the Palo Alto Medical Foundation in Palo Alto, Calif. “Unlike other newer surgical technologies, Pulse enhances the surgeon’s ability and can positively affect outcomes by providing a modular platform of useful intraoperative tools that do not disrupt familiar workflow. Additionally, Pulse provides enhanced support throughout each case be it a simple decompression all the way to complex deformity cases.”

Pulse’s FDA clearance marks a major milestone in the Company’s commitment to introduce 2D- and 3D-navigation technology built on a platform of the Company’s NVM5® nerve monitoring system, LessRay®, Bendini® and Integrated Global Alignment® (iGA®) systems. The Pulse platform provides an intuitive surgeon experience by anticipating user needs and fusing these technologies to create a seamless, optimized workflow for operating rooms (OR). Through Wi-Fi connectivity and independent device access, case participants can simultaneously view the technologies’ imaging and insights in real time, allowing them to utilize various modules in parallel and further drive OR efficiencies.

“With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customized applications,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “Through the aggregation of clinical data and intelligent design, Pulse intuitively delivers the necessary technological intervention to drive improvements in procedural workflow and support the clinical needs for each OR, surgeon and case.”

To help surgeons overcome frequent visualization challenges during spine surgery, Pulse integrates multiple high-resolution cameras combined with low-profile, 360-degree arrays to drive uninterrupted line-of-sight and optimized procedural workflow. Additionally, Pulse introduces advanced artificial intelligence (AI) by automating several technologies utilized throughout a procedure.

NuVasive will showcase the Pulse platform at the North American Spine Society 2018 Annual Meeting held September 26-29, 2018 in Los Angeles, Calif.

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

Read More
1.jpeg

DePuy Synthes Launches CONCORDE LIFT Expandable Interbody Implant as Part of a New Procedural Solution for Minimally Invasive Spine Surgery (MIS)

Posted On July 26, 2018 By OrthoSpineNews In Spine, Top Stories /  

RAYNHAM, Mass., July 26, 2018 /PRNewswire/ — Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes** is launching the CONCORDE LIFT Expandable Interbody Device in the U.S. The CONCORDE LIFT Implant is designed to treat patients suffering from degenerative disc disease as part of the new offering called UNLEASH MIS TLIF (Transforaminal Lumbar Interbody Fusion) Procedural Solution. The complete system includes a comprehensive set of solutions to help simplify key stages of this surgery by enhancing surgical efficiency.

During spinal fusion surgery, the degenerated disc is removed and the CONCORDE LIFT Expandable Interbody Device is implanted in its place to help restore the disc height between the two vertebrae in the spine.

“I’ve had the privilege of performing one of the first cases of spinal fusion surgery using the CONCORDE LIFT Implant in the United States and have been very happy with what I have been able to achieve using this device,” said John Hall, M.D., Spine and Orthopaedic Trauma Surgeon***. “I believe that being able to access the disc through a small space and then controllably expanding the cage to fill the disc space allowed me to achieve a reliable fusion.”

By 2020, it is estimated that half of all spinal fusion procedures will be performed using a minimally invasive approach.1While it has a steep learning curve, minimally invasive spine surgery has been associated with reducing complications, blood loss, muscular damage and pain, with a faster recovery for patients compared to conventional open spine surgery.2,3

This MIS TLIF Procedural Solution was developed by DePuy Synthes Spine to simplify key stages of the MIS TLIF surgery and additionally includes the CONCORDE Clear MIS Discectomy Device and the VIPER PRIME System for percutaneous pedicle screw insertion.  Here are the steps involved in the procedure:

  • The single-use CONCORDE Clear MIS Discectomy Device allows the degenerated disc-clearing process to occur with fewer instrument passes while increasing the amount of disc material removed compared to standard discectomy tools.4
  • The CONCORDE LIFT Expandable Interbody Device is inserted once the disc has been cleared. With this implant, the surgeon can expand the cage to specifically fit the cage to an individual patient’s anatomy without being confined to pre-set intervals. The streamlined instrumentation provides tactile feedback during the expansion maneuver and the system offers surgeons the option to back-fill the space with bone graft even after the cage has been fully expanded.
  • The VIPER PRIME System, aimed at efficiency, combines multiple instruments into one screw inserter tool enabling the surgeon to perform percutaneous pedicle screw insertion in a single instrument pass.

This new offering exemplifies the company’s commitment to innovative platforms that are designed to reduce surgical complexity, improve patient outcomes and decrease costs. In an anatomic lab study, this MIS TLIF Solution suggested a potential reduction in instrument passes and showed a reduction in procedure time during disc removal, cage implantation and screw placement compared to a control group of current product offerings****. Based on the early indications of this promising cadaveric study, DePuy Synthes is investing in a health economic study in addition to a clinical study to evaluate the potential benefits of the UNLEASH MIS TLIF Procedural Solution as compared to traditional MIS TLIF procedures.

“This UNLEASH Solution delivers a new offering to help reduce the complexity associated with minimally invasive spine surgery while reducing costs and OR footprint,” said Nadav Tomer, Worldwide President, DePuy Synthes Spine. “DePuy Synthes is committed to innovating the tools and technology required to serve more patients globally in a range of care settings by delivering disruptive procedural solutions that improve outcomes supported by real world clinical and economic evidence.”

About the Johnson & Johnson Medical Devices Companies

As the world’s most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of healthcare. With unparalleled breadth, depth and reach in surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. Learn more about our latest innovations by visiting: https://www.jnjmedicaldevices.com.

About DePuy Synthes 

DePuy Synthes provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

**DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

***Consultant to DePuy Synthes Spine

****Comparing CONCORDE Clear MIS Discectomy Tool to traditional discectomy tools, CONCORDE LIFT Expandable Interbody Device to the CONCORDE Bullet Lumbar Interbody System, and VIPER PRIME System to the VIPER 2 MIS Spine System. Results based on non-clinical study (n=3). Cadaveric test results may not necessarily be indicative of clinical performance.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding CONCORDE LIFT Expandable Interbody Implant as part of a new procedural solution for minimally invasive spine surgery that enhances surgical efficiency. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, Inc., any of the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

©DePuy Synthes 2018. All rights reserved. 

095402-180719

1 Huang, Tsung-Jen. The State of the Art in Minimally Invasive Spine Surgery. Biomed Res Int. 2017. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350391/.

2 Peng, CW et al. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9.

3  Phan, K et al. Minimally invasive versus open transforaminal lumbar interbody fusion for treatment of degenerative lumbar disease: systematic review and meta analysis. Eur Spine J 24:1017-1030. 2015.

4 Lavelle, W et al. An In Vitro Study Examining a Novel Suction Curette Device for Lumbar Discectomy Compared with Standard Manual Discectomy. J Neurosurg Spine 26:454-458. 2017.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

Read More
about-12bto.jpg

BioRestorative Therapies Appoints Jason M. Lipetz, M.D. to its Scientific Advisory Board

Posted On July 25, 2018 By OrthoSpineNews In Spine /  

MELVILLE, N.Y., July 25, 2018 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (OTC:BRTX), a life sciences company focused on stem cell-based therapies, today announced that Jason M. Lipetz, M.D. has been appointed to the Company’s Scientific Advisory Board.

Dr. Lipetz is the founder of Long Island Spine Rehabilitation Medicine, a prominent spine and musculoskeletal care center specializing in the non-surgical treatment of the spine and orthopedic rehabilitation.

In 2014, Dr. Lipetz was appointed Chief of Spine Medicine for the Northwell Health Spine Center and previously served as the Director of the Center for Spine Rehabilitation for the North Shore Long Island Jewish healthcare system from 1999-2006. In his current capacity, Dr. Lipetz is responsible for the development of non-surgical spine care services for the Northwell Health System.

Dr. Lipetz has served as a representative to national medical organizations since his residency years, including Chair of the Education Committee of the Physiatric Association of Spine, Sports, and Occupational Rehabilitation (PASSOR). Dr. Lipetz has most recently served as a member of the research committee of the International Spine Intervention Society. He served as the Residency Training Program Director for the Division of Physical Medicine and Rehabilitation at Long Island Jewish Medical Center from 2003 to 2005, and is an Assistant Professor of Rehabilitation Medicine at Hofstra University School of Medicine. Dr. Lipetz is uniquely triple board certified in Physical Medicine & Rehabilitation, Pain Management, and Electrodiagnostic Medicine.

Dr. Lipetz has authored over thirty original articles and abstracts in peer reviewed journals and several textbook chapters, including chapters within the leading texts in both the Interventional Spine Care and Physical Medicine and Rehabilitation literature.  He has lectured nationally and has been featured in both regional and national TV and newspaper segments.

Dr. Lipetz received his specialized and interventional spine medicine training during a fellowship year at the Penn Spine Center of the Hospital of the University of Pennsylvania. After receiving his medical degree with Alpha Omega Alpha honors from Columbia University’s College of Physicians and Surgeons, Dr. Lipetz completed his residency in Physical Medicine and Rehabilitation at the Kessler Institute for Rehabilitation and the University of Medicine and Dentistry of New Jersey. He was elected and served as Academic Chief Resident during his senior year of residency. Dr. Lipetz received his bachelor’s degree in biology with summa cum laude honors through the Presidential Honors Program of the State University of New York at Buffalo.

Mark Weinreb, Chief Executive Officer of BioRestorative Therapies, said, “We are pleased to welcome Dr. Lipetz to our Scientific Advisory Board, as he brings a wealth of medical knowledge, relationships, and expertise that will be invaluable as we advance our spine program through clinical trials.”

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells.  Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

  • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells.  In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery.  We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.
  • Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company’s Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Email: ir@biorestorative.com

Read More
sitemgr_photo_5250-12bto.png

FBC Device ApS Receives First FDA Clearance For Spinal Interbody Implant Providing Lordosis Adjustment from 9 to 21 Degrees to Aid Surgeons & Patients

Posted On July 24, 2018 By OrthoSpineNews In Regulatory, Spine /  

July 24, 2018

AARHUS, Denmark–(BUSINESS WIRE)–FBC Device ApS, a medical device company focused on restoring natural alignment of the spine through innovative interbody implants, has received its first US FDA clearance for its technology, enabling access to the US market.

Professor Finn Christensen, MD, PhD and founder and CEO of FBC Device says: “There is overwhelming evidence that poor spinal alignment is associated with back pain and disability. When we started the company, our goal was to commercialize a series of implants to help surgeons easily restore alignment when performing spinal fusions, so that more of their patients would achieve good or even great results. We have now accomplished three elements crucial to reaching our goal:

  • Regulatory approval, now in the US along with a second implant that has been CE marked since 2013.
  • Patents granted around the world to protect these two implant designs as well as others to follow.
  • Documented clinical evidence demonstrating that the technology enables surgeons to restore normal alignment and that patients receiving the technology have excellent results in patient-based outcome measures.”

The FDA clearance brings FBC Device one step closer to its goal. To fully commercialize its products, the Company will immediately engage interested parties capable of bringing the technology to large markets across the world.

For more information, visit www.fbcdevice.com

About the FBC Technology

Each individual has different alignment requirements – it is not one size fits all. The FBC technology is a two-piece interbody fusion device that allows for in-situ adjustment from 9-21 degrees, enabling surgeons to simply adjust alignment for each patient’s need and then lock the two pieces relative to each other.

Contacts

FBC Device ApS
Prof. FB Christensen
Email – finn@fbcdevice.com

Read More
TitanSpine_Endoskeleton_WEB-A-123-1.jpg

Titan Spine Appoints Peter Wehrly to Board of Directors

Posted On July 23, 2018 By OrthoSpineNews In Spine /  

July 23, 2018

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, Inc., a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Peter Wehrly to its Board of Directors. Mr. Wehrly’s appointment, effective July 9, 2018, provides the Company with extensive medtech market knowledge and experience as it continues to drive improved patient outcomes1 through the deployment of its nanoLOCK® surface technology.

nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.2

Mr. Wehrly commented, “Titan Spine has done a remarkable job forging the surface technology category in spine over the past several years and has the opportunity to continue its leadership position with the company’s unique nanoLOCK® offering. I see a clear opportunity for the Company to further carve out a substantial share of the orthopedic market and look forward to contributing to Titan Spine’s growth and success.”

Mr. Wehrly is currently CEO of Synaptive Medical, a privately-held, Toronto-based company that combines proprietary surgical planning and robotic navigation platforms targeted initially for cranial and spinal applications. Prior to his appointment as CEO of Synaptive in October 2017, Mr. Wehrly was Chairman of the Board of Directors and an advisor to Synaptive from 2015 to 2017. From April 2016 to August 2017, Mr. Wehrly served as the CEO of PQ Bypass, a company based in Sunnyvale, California focused on breakthrough technology for the treatment of peripheral arterial disease. Previously, he was the Group President of Developed Markets at Covidien, a medical device manufacturer with annual sales of over $10.7 billion that was acquired by Medtronic, Inc. in 2015. In this position, Peter held profit and loss responsibility for the marketing and sale of products to all developed markets outside the U.S. between 2013 and 2015. Preceding this role, Peter was the Group President of Respiratory and Monitoring Solutions, Vascular Therapies, and for all of Covidien’s Japanese, Australian-New Zealand, and Canadian businesses. Prior to Covidien, Mr. Wehrly held the position of President and CEO at Medingo Youqneam, an Israel-based team that developed a novel insulin pump for diabetic patients. He also presided over Medtronic’s Spinal, Biologics, and Navigation businesses from 2004 to 2008. Peter started his career with DePuy, a Johnson & Johnson company.

Peter Ullrich, MD, Chief Executive Officer of Titan Spine, stated, “We recognize the importance of adding exceptional talent, guidance and expertise to our Board to help us continue driving Titan’s growth. Peter is a strategic leader who consistently delivers top-line growth and operational efficiencies across a wide range of global cultures. He has excelled in both public and private organizations, in both start-ups and multi-billion-dollar businesses, and in both developed and emerging markets. We are confident that Peter’s addition will advance our near and long-term goals for further building Titan Spine as the leader in surface technology medical devices.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched 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, Inc. 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, headquartered in Mequon, Wisconsin, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S., Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

1 Data on file.

2 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.

3 Olivares-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.

4 Matteson JL, Greenspan DC, Tighe TB, et al. Assessing the hierarchical structure of titanium implant surfaces. Journal of Biomedical Materials Research Part B Applied Biomaterials 104(6). May 2015. DOI:10.1002/jbm.b.33462.

Contacts

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

Read More
PEEK_20HA_75P_press_release_04-3.jpg

cultivate(MD) Funds Announce Investments Into Happe Spine

Posted On July 19, 2018 By OrthoSpineNews In Spine /  

HOLLAND, Mich., July 19, 2018 /PRNewswire/ — Genesis Innovation Group, LLC, announces the formation of HAPPE Spine LLC as well as investments by cultivate(MD) Capital Fund I, LLC and cultivate(MD) Capital Fund II, LP into HAPPE Spine.

Based on the work of Ryan K. Roeder, Ph.D. and researchers from the University of Notre Dame, HAPPE Spine has developed and will commercialize a material technology that allows for the construction of partial or fully porous hydroxyapatite reinforced polyetheretherketone (PEEK) implants.

Hydroxyapatite (HA) has been shown to encourage osteointegration of implants due to the unique nature of this material providing a very bone-friendly surface.  HA whisker reinforced PEEK with variable porosity allows HAPPE to create advanced spinal interbody implants.

Dr. Roeder explained, “More than a decade ago, we envisioned that modifying PEEK to be both porous and bioactive would provide an ideal implant material solution for interbody spinal fusion.  At that time, the market was not yet prepared for this innovation.  As surgeons are now recognizing the advantages of utilizing bioactive hydroxyapatite enhanced PEEK or surface-porous PEEK, we are excited to combine both innovations into the same device.”

Dave Blue, Managing Director of cultivate(MD) said, “We believe the technology has the potential to provide significant differentiation in the spinal interbody market.  But there are numerous other potential applications throughout the body and HAPPE will evaluate additional device applications as part of the product strategy.”

Rob Ball, Chairman and CEO, Genesis Innovation Group said, “Genesis is excited to have the opportunity to partner with Dr. Roeder and engage this exciting technology. The experienced talent at Genesis Innovation Group combined with financial capital at cultivate(MD) make for a powerful combination when envisioning the future of these types of innovations. Many orthopedic indications would benefit from a strong, bioactive, osteointegrative, and radiolucent material. We are making fast progress and continuing the development of this technology and products.”

Genesis Innovation Group and cultivate(MD) Capital Funds look forward to partnering with the developers of the material technology, all who will continue to be engaged with the Company as owners, investors, and advisors.

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies.  cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness.

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities.  There will not be any sale of any securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Contact:

Matt Ahearn

Vice President of Finance and Operations

https://genesisinnovationgroup.com/contact-us/

Forwarding-Looking Statements 

Certain Statements in this press release constitute forward-looking statements. When used in this press release, the words “will,” “anticipate,” and similar expressions or the negatives thereof are generally intended to identify forward-looking statements. Such forward-looking statements, including the intended actions and performance objectives of fund, its general partner, cultivate(MD) or any cultivate(MD) portfolio company referenced herein, involve known and unknown risks, uncertainties, and other important factors that could cause the actual results, performance, or achievements of the general partner, or any cultivate(MD) fund or portfolio company to differ materially from any future results, performance, or achievements expressed or implied by such forward-looking statements. No representation or warranty is made as to future performance or such forward-looking statements. All forward-looking statements in this press release speak only as of the date hereof.  The fund, its general partner and cultivate(MD) expressly disclaim any obligation or undertaking to disseminate any updates  or revisions to any forward-looking statement contained herein to reflect any change in its expectation with regard thereto or any change in events, conditions, or circumstances on which any such statement is based.

SOURCE cultivate(MD)

Read More