Xtant Medical Receives Approval of Compliance Plan from NYSE MKT

BELGRADE, Mont., Nov. 01, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, today announced that the NYSE MKT LLC (the “Exchange”) notified the Company that it accepted the Company’s plan to regain compliance with the continued listing requirements of the Exchange.

On August 19, 2016, the Company received notice that they are not in compliance with NYSE MKT LLC continued listing standards. Specifically, the company is not in compliance with section 1003(a)(i) and 1003(a)(ii) and section 1003(a)(iii) of the NYSE MKT Company Guide since it reported stockholder’s equity deficit of $496,000 as of June 30, 2016, and net losses in its five most recent fiscal years ended December 31, 2015.

The Company submitted its plan of compliance on September 13, 2016, and on November 1, 2016, the Exchange notified the Company that it accepted the Company’s plan of compliance and granted the Company an extension until February 15, 2018 to regain compliance with the continued listing standards. The Company will be subject to periodic review by Exchange Staff during the extension period.

About Xtant Medical Holdings

Xtant Medical Holdings, Inc. (NYSE MKT: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: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our 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.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. 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. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell 
877.889.1972
xtant@cg.capital

Company Contact 
Xtant Medical 
Molly Mason
mmason@xtantmedical.com

NuVasive Secures Magnetic Resonance (MR) FDA Conditional Clearance for MAGEC System

SAN DIEGO, CA — (Marketwired) — 10/27/16 — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced FDA clearance for magnetic resonance imaging (MRI) under certain conditions on patients treated with the innovative MAGEC® system. MAGEC is the only noninvasive solution for growth modulation in pediatric spinal deformity cleared by the FDA.

Early onset scoliosis (EOS) patients often suffer from comorbidities which makes their treatment complex and often requires them to undergo multiple MRIs. The lack of guidance on MR conditions was historically a hurdle for some surgeons in widely adopting MAGEC as a treatment option for their EOS patients.

“Having clear, defined guidance for conditional MRI compatibility with MAGEC helps alleviate uncertainty that may have limited surgeons from using the innovative MAGEC system,” said Suken A. Shah, M.D., Division Chief of the Spine and Scoliosis Center, Clinical Fellowship Director, Nemours/Alfred I. duPont Hospital for Children. “This clearance opens up the door for more patients and their families to benefit from this life changing technology.”

The clearance includes MR conditions using a 1.5 Tesla (T) Static Magnetic Field MRI machine at a maximum spatial field gradient of 3000 gauss/cm (30 T/m) with a maximum MR System reported, whole body averaged specific absorption rate (SAR) of 0.5 W/kg at 1.5T. Under the scan conditions defined, the MAGEC System is expected to produce a maximum temperature rise of no more than 3.7 degrees Celsius after 15 minutes of continuous scanning. The 1.5 T MRI machine is the global standard. The complete MRI safety information is included in the product labeling.

“As the only noninvasive growth modulation system on the market, this clearance is a key milestone in overcoming a known barrier in the treatment of children with EOS,” said Jason Hannon, NuVasive’s president and chief operating officer. “NuVasive is consistently on the cutting-edge of the latest treatment options and we work diligently to bring that innovation to as many patients as possible around the world.”

MAGEC System

MAGEC is comprised of a sterile, single use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet that is controlled by an external remote controller. Periodic lengthening of the rod is performed to follow the growth of the spine, and can be performed external to the body in an office setting. The magnetic technology helps eliminate traditional planned distraction surgeries and simplifies care for the EOS patient population.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. 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.

Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
Email contact

Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
Email contact

Source: NuVasive, Inc.

SeaSpine Announces 510(k) Clearance from the FDA of Shoreline ACS System

CARLSBAD, Calif, Oct. 27, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Shoreline™ ACS Anterior Cervical Standalone System, featuring TruProfile™ technology. TruProfile offers a low profile plate designed to minimize cephalad-caudal encroachment onto the vertebral bodies and maximize the distance from adjacent disc spaces.  The Shoreline ACS anterior plate is 1.6mm thick, providing minimal profile on the anterior spine.

The Shoreline ACS System is designed to maximize intraoperative flexibility by offering a full complement of zero and low-profile plating options, including two-, three- and four-hole variations, as well as 10 degree lordotic implants.  This complement of options provides surgeons the ability to address the variety of patient anatomical needs and surgical scenarios that may be encountered in the operating room.

“SeaSpine set out to build a product platform that reflects the critical needs of its surgeon customers, and it shows,” stated James Bruffey, MD.  “The design of this system addresses common challenges, without sacrificing ease of use and technical reliability.  I believe Shoreline ACS will provide a safe and effective option for my cervical fusion surgery patients.”

The Shoreline ACS System incorporates proprietary NanoMetalene® surface technology.  NanoMetalene interbody implants are designed to provide the benefits of a titanium surface while retaining the benefits associated with traditional PEEK devices, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.  NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO®. It is applied in a proprietary, high-energy, low-temperature process that differs from other coating applications and maximizes implant surface area with titanium nanotopography.

“We are excited about the Shoreline ACS System because it provides advantageous intraoperative flexibility, while addressing key clinical challenges often encountered by surgeons,” stated Keith Valentine, Chief Executive Officer of SeaSpine.

SeaSpine will be conducting initial cases through a limited launch over the next few months and expects a full commercial launch in the first half of 2017.

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design benefits of TruProfile technology, the Shoreline ACS System and NanoMetalene; the ability of the Shoreline ACS System to address common or key clinical challenges in spine surgery without sacrificing ease of use and technical reliability, to provide advantageous intraoperative flexibility, and to make cervical fusion surgery safer and more effective; and the timing and success of both the limited and full commercial launch of its products and systems.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that the Shoreline ACS System has not been validated clinically and may require substantial additional development activities, which could introduce unexpected expense and delay, including potentially requiring resubmission of one or more products to FDA for clearance, which clearance cannot be certain, whether on a timely basis or at all; surgeons’ willingness use the Shoreline ACS System; the risk that the Shoreline ACS System may not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support a full commercial launch; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact

Lynn Pieper

(415) 937-5402

ir@seaspine.com

SeaSpine Holdings corporation

RTI Surgical® Announces Additional 510(k) Clearance for the Streamline® OCT System

ALACHUA, Fla. (October 26, 2016) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, is pleased to announce a recent 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System. This clearance expands the indication for polyaxial screw placement to include the cervical spine, and also includes clearance for a dual diameter transition rod.

The system’s newly expanded indications span from the Occiput to T3, but additional levels of fixation can be accomplished by connecting to other RTI pedicle screw systems through the newly cleared transition rod or currently available rod-to-rod connectors.

“We are excited about the launch of the transition rod, as well as the receipt of the posterior cervical screw indication,” said Brian Hutchison, chief executive officer. “These updates to our Streamline OCT System reflect our passion to deliver surgical solutions that provide a higher standard of patient care and deliver the highest value to our customers.”

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Spineology Announces FDA Clearance of Rampart™ Duo™ Interbody Fusion System

October 25, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in anatomy-conserving surgery™, is excited to announce FDA clearance of the Rampart Duo Interbody Fusion System. The Rampart Duo Interbody Fusion Device is the first device of its kind to combine PEEK, titanium, and graft containment mesh elements.

“Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh® technology,” said John Booth, CEO of Spineology. “The 510(k) clearance of Rampart Duo opens the door to the commercialization of a family of hybrid PEEK and graft containment mesh implants designed for interbody fusion. The implant is a great addition to our anatomy-conserving product offering.”

“The implant design allows for decreased retraction requirements when compared to current interbody systems. The minimized tissue retraction may reduce the potential for nerve damage and resultant leg pain associated with the lateral approach,” said Dr. Sandeep Kunwar, San Francisco, CA.

“The device has been anatomically designed. The PEEK spacer blocks are positioned on the lateral aspects of the vertebral body, where the bone is naturally strongest, to provide solid anterior support,” adds Dr. Michael Wang, Miami, FL. “In addition, the central graft containment mesh allows for broad device deployment which increases graft footprint and facilitates conforming apposition of the graft to the endplate for fusion.”

“The small tubular retractor and streamlined instruments, including ones that allow for the placement of the device when a high iliac crest is present, may help preserve patient anatomy and limit operating room time,” said Dr. Craig Kuhns, Austin, TX.

The Rampart Duo implant design includes PEEK spacer blocks that are positioned at each end of the device and a flexible porous graft containment mesh which creates a central graft cavity. Following implantation, the porous graft containment mesh is filled with bone graft to deploy the device in the anterior-posterior direction, which allows for a wide graft footprint, and in the superior-inferior direction to provide conforming apposition with the vertebral endplates.

About Spineology

Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

FDA is working with hospitals to modernize data collection about medical devices

America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an astounding variety of ways.

From helping set a broken leg or responding to an emerging viral threat, to assisting and performing delicate heart surgeries on tiny newborns, these hospital personnel are the front line of surveillance, vigilance, and intervention.

Throughout their work day, hospital staff use a variety of medical devices: imaging machines, EKGs and in vitro tests to make diagnoses; infusion pumps, ventilators and robotics to provide treatment, and an array of implants to replace diseased joints and organs. And, as the nation’s hubs for real-time health care data, hospitals are uniquely positioned to help identify new safety problems with devices as well as changes in the frequency of already known safety problems because they use these technologies in the real-world setting of clinical practice, outside of the more controlled setting  of a clinical trial.

FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices.

Given the greater diversity and complexity of medical devices today; the rapid technological advances and iterative nature of medical device product development; the interface between the technology and the user – including the learning curve associated with adopting new technology; and, in some cases, a relatively short product life cycle that can be measured in months, not years; FDA’s evaluation of medical device safety presents unique challenges not seen with drugs and biologics. Therefore, assuring the safety of medical devices depends on many factors and should a problem arise, it could be due to a variety of causes.

At the time of premarket evaluation, however, it is not feasible to identify all possible risks or to have absolute certainty regarding a technology’s benefit-risk profile. Among other reasons, studies required to do so would likely be prohibitively large in order to capture less frequent and more unpredictable effects or consequences. In addition, such larger studies still may not reflect the true benefit-risk profile of the device. Once a device is on the market, for example, doctors may use it beyond the FDA cleared intended use. In addition, subsequent modifications to the device or changes in how the device is used in practice can result in new safety risks or greater frequency of known risks.

 

READ THE REST HERE

Medicrea Announces 2 FDA Clearances of New Specialized Components for Pediatric Deformity on PASS® and LigaPASS® Platforms for Complex Spine in Younger Patients

October 20, 2016

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, today announced that it has received two unique 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its PASS® XS posterior fixation and LigaPASS® XS band connector components designed to address pediatric spinal deformities in small stature patients.

The Company has worked with a team of leading pediatric spinal surgeons to develop low-profile implants specially tailored for the unique demands of pediatric deformity surgery. The extra-small ‘XS’ extension of the PASS® and LigaPASS® technology will enable surgeons to now effectively treat pediatric patients using around 40% less implant volume in each surgery and the lowest construct profile in-situ available on the market, while still offering the same technical innovations of the PASS LP® and LigaPASS® systems used on adults and UNiD™ Lab patient-specific, digital surgical planning and analytical services.

“By adapting our industry-leading PASS® and LigaPASS® deformity systems for the unique requirements of pediatric deformity through the ‘XS’ components, Medicrea is continuing to strengthen its position as a leader in FDA-cleared personalized analytical services and implant solutions for the treatment of complex spinal conditions,” stated Denys Sournac, President and CEO.

Medicrea is anticipated to announce the first U.S. surgery with the PASS XS and LigaPASS XS components in early November.

Upcoming Events

Medicrea will showcase the advanced corrective capabilities of the systems and attached personalized UNiD™ services at its booth (#943) during the world’s largest scientific meeting for spine specialists, held later this month, organized by the North American Spine Society (NASS) in Boston from the 26th to the 29th of October. During this event, the Company is also expected to announce a major development related to the UNiD™ services and personalized treatment modalities.

A Solution Showcase will be held during the meeting in the NASS Theater on Thursday, October 27, at 12:30pm. The symposium will feature Dr. Andrew King of New Orleans, LA, and Dr. Themistocles Protopsaltis of New York, NY. Dr. King will present on Medicrea’s complex spine solutions for pediatric patients and early results showing improved alignment and patient outcomes using patient-specific UNiD™ technology. Dr. Protopsaltis will present on the Company’s complex spine solutions for cervico-thoracic indications and discuss the early results showing improved alignment and patient outcomes using patient-specific UNiD™ Cervical Rod technology, of which the Company announced FDA clearance in April.

The Company has also previously announced that it is expecting the significant 1,000th UNiD™ surgery milestone within the next month.

About Medicrea (www.medicrea.com)

Medicrea specializes in the design, manufacture, and distribution of innovative proprietary technologies devoted exclusively to spinal surgery. Operating in a $10 billion market, Medicrea operates with 150 employees, including 50 at its Medicrea USA Corp. subsidiary based in New York City.

Medicrea is the only company to offer personalized value-based healthcare solutions to the global complex spine market. The Company has driven innovation in Spine by focusing development on market-disrupting technologies focused on patient outcomes, including the growing UNiD™ Technology Platform of Patient-Specific Implants and Analytical Services, which received the first-ever FDA clearance in November 2014 for a personalized spinal treatment modality.

Medicrea has uniquely positioned itself outside of the traditional implant manufacturer’s role in order to engage with each market player as a collaborator, offering customized implants to patients, personalized services to doctors and immediate cost-savings to providers. By leveraging its proprietary software analysis tools with big data technologies, Medicrea is well-placed to improve the efficacy of spinal care efficiency for all stakeholders in this market.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Contacts

Medicrea
Denys Sournac, Founder, Chairman and CEO
dsournac@medicrea.com
or
Fabrice Kilfiger, Chief Financial Officer
fkilfiger@medicrea.com
+33 (0)4 72 01 87 87
or
Media
The Confluence Group
Russell Ward
russell@theconfluencegroup.com
+1 310 424 8356

CollPlant Receives CE Mark for Vergenix™STR for Treatment of Tendinopathy

NESS ZIONA, Israel, October 19, 2016 /PRNewswire/ —

CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human collagen) technology for tissue repair products, today announced that it has achieved a significant milestone with the receipt of the CE Mark for Vergenix™STR, a soft tissue repair matrix for the treatment of tendinopathy. Sales in Europe are expected to commence in the coming months.

Yehiel Tal, Chief Executive Officer of CollPlant: “The CE Mark for VergenixSTR denotes an additional and key milestone achieved by CollPlant. In the past few months, we have shown that treatment with our product provides for substantially superior results when compared to published steroid treatment results, the current standard of care for tendinopathy. We are presently in dialogue with potential distributers for product marketing in Europe and expect initial sales within the coming months. Of note, this is the second CE Mark the company received this year, with the first granted at the beginning of the year, to its VergenixFG product, indicated for the treatment of chronic and surgical wounds. These accomplishments advance the company’s strategic plan to position plant-bad human collagen technology, and its medical byproducts, as the gold standard in regenerative medicine.”

VergenixSTR primarily made of cross linked rhCollagen intended to be combined with platelet-rich plasma (PRP), a concentrated blood plasma derived from the patient’s own blood, that contains high levels of platelets, which are critical to the healing process. Platelets contain growth factors are responsible for stimulating tissue generation and repair, including soft tissue repair, bone regeneration, development of new blood vessels, and stimulation of the healing process. Upon administration, CollPlant’s VergenixSTR serves as a scaffold to support cell adhesion and proliferation involved in the tendon healing while maintaining growth factor containing PRP in the vicinity of the injury. After injection into the affected area, the product forms a viscous gel matrix, holding the platelet concentrate in place. The matrix formed then has the ability to release growth factors in a controlled manner and with controlled biodegradation time, thereby enabling tissue repair.

About CollPlant:

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based rhCollagen technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary recombinant human collagen (rhCollagen), among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: VergenixSTR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; VergenixFG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and; VergenixBVF (Bone Void Filler), for use in spinal fusion procedures and trauma. CollPlant’s business strategy includes proprietary development and manufacturing of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacturing and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant
Eran Rotem
Chief Financial Officer
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC
Paula Schwartz (for US Investors)
Managing Director
Tel: 917-322-2216
Email: pschwartz@RxIR.com

SOURCE CollPlant

Feb 23, 2016, 02:33 ET

Preview: CollPlant Receives CE Mark for Vergenix™FG Wound Filler

Ohio judge dismisses hundreds of off-label Medtronic Infuse patient lawsuits

October 14, 2016

US district court judge, Timothy S Black (Southern Ohio, USA) has dismissed the accusation of several hundred plaintiffs that they have been treated off-label with Medtronic’s Infuse.

The plaintiffs were all former patients of Atiq Durrani (Cincinnati, USA), an orthopaedic surgeon indicted in 2013 for providing “medically unnecessary” spinal surgeries. Durrani’s hospital, West Chester Hospital, and its parent company, UC Health, settled allegations of violation of the False Claims Act with a payment of US$4.1 million. The hospital was accused of charging federal healthcare programmes for the “unnecessary” surgeries performed by Durrani. The surgeon now resides in Pakistan, following his indictment.

Medtronic received pre-market approval for the use of Infuse in single-level L4-S1 fusions using an anterior lumbar interbody fusion procedure in combination with the LT-cage. It was indicated as a treatment for degenerative disc disease. MedPageToday, however, reported that up to 80% of the product’s usage was likely to be off-label.

In this case, a number of plaintiffs had been treated without the use of LT-cage, while some had been treated posteriorly. Infuse had been used by Durrani in the cervical and thoracic spine, as well as across multiple levels.

In 2015, the bone morphogenetic protein received approval for three new indications; use in OLIF51 procedures with certain sizes of the Medtronic PEEK Perimeter Implant at a single level from L5-S1, use in OLIF25 procedures with certain sizes of the company’s PEEK Clydesdale Implant at a single level from L2-L5, and use in ALIF procedures with certain sizes of Medtronic’s PEEK Perimeter Implant at a single level from L2-S1.

According to Black, these off-label uses are not necessarily illegal. The plaintiffs had failed to provide sufficient evidence in court as to the harm caused by problems with the Infuse product.

The plaintiffs in this case attempted to argue both that Durrani had committed fraud, acting as an agent of Medtronic, because of his continued use of the Infuse product, in spite of his knowledge of its risks. The patients also argued, however, that Medtronic had itself committed fraud by failing to inform Durrani of the risks associated with the product, according to Black.

“Several courts throughout the country have examined this exact issue and have held that ‘the FDA established specific federal requirements for the Infuse device, even when the Infuse Protein is used alone,’” Black wrote, commenting that the FDA is not required by federal law to publish the adverse event data provided by Medtronic.

Medtronic’s Infuse product has been dogged by controversy since a number of employees failed to report over a thousand adverse events associated with use of the product to the FDA between 2006 and 2008. The adverse events—which included four deaths—were discovered in a retrospective chart review of the product. According to a Star Tribune report, staff failed to notify the FDA about the adverse events, shutting the study down in 2008. By the time news emerged of these unreported adverse events in 2013, most of the Medtronic staff involved in the scandal had left the company, causing confusion within the company itself.

Medtronic attempted to provide more adequate information regarding adverse events in a study run by Yale University, but this, too, has been the subject of some controversy.

Final MACRA Regulations Bump More Than Half of Clinicians Out of MIPS

October 14, 2016 – Robert Lowes

The federal government today issued final regulations for the Medicare Accountability and CHIP Reauthorization Act (MACRA), which now exclude or exempt between 53% and 57% of physicians and other clinicians from a possible 2019 penalty in the new reimbursement system.

The Centers for Medicare & Medicaid Services (CMS) gave roughly 200,000 more clinicians this break mostly by redefining practices that would not have to participate in the new system because their involvement with Medicare is minimal. In its proposed MACRA regulations, CMS defined such low-volume providers as having less than $10,000 in Medicare-allowable charges and fewer than 100 Medicare patients. By raising the dollar threshold to $30,000 in the final regulations, the agency bumped up the number of low-volume providers from 226,000 to 384,000.

Of these 384,000 low-volume providers, 46% work in practices with fewer than 10 physicians, according to CMS. Organized medicine had complained that many small practices lacked the time, money, and expertise to master the new payment program by the time it goes into effect in 2017. The agency has repeatedly said that it’s heard those complaints and is trying to make the new system more physician-friendly.

MACRA shifts Medicare reimbursement from fee-for-service (FFS) to pay-for-value through a new framework called the Quality Payment Program (QPP). There are two tracks in QPP. The default track, which initially will encompass the most physicians, is the Merit-Based Incentive Payment System (MIPS). It combines three existing incentive programs: meaningful use of electronic health records (EHRs), the Value-Based Payment Modifier, and the Physician Quality Reporting System (PQRS). Physicians will receive a bonus or penalty based on their composite score across the performance categories of quality of care, cost of care, clinical practice improvement, and meaningful use of EHRs, now called advancing care information.

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