Kuros Biosciences May Secure Equity Financing of up to CHF 30 million

Posted On November 26, 2017 By OrthoSpineNews In Financial /

Schlieren (Zurich), Switzerland, November 22, 2017

Kuros (SIX: KURN) announced today it has entered into a Standby Equity Distribution Agreement (“SEDA”) with a fund managed by Yorkville Advisors Global, LLC (“Yorkville”). Under the terms of the agreement, Yorkville has committed to provide up to CHF 30 million in equity financing over a 36-month period in individual tranches of up to CHF 1,000,000 each. In exchange for the funds to be provided, Yorkville will receive Kuros shares at a price, which will be determined anew each time a SEDA tranche is called. The shares will be placed at a 5% discount to the market price – which is in line with Swiss market practice for private placements.

The SEDA has been established as part of the medium-term funding of Kuros’ operations. If Kuros were to utilize the SEDA in full, the cash runway would be extended by roughly two years. It remains at the sole discretion of Kuros to determine if and when to draw from the facility. In return for the 3-year investment commitment provided by Yorkville, Kuros will pay an initial upfront fee of CHF 300,000 in shares or cash at the full discretion of the Company. An additional installment of CHF 300,000 (in shares or cash at the full discretion of the Company) will be due when the amount drawn from the facility crosses CHF 10 million and an additional installment of CHF 200’000 (in shares or cash at the full discretion of the Company) will be due when the amount drawn from the facility crosses CHF 20 million.

For share to be delivered to Yorkville under the SEDA agreement, Kuros is contemplating to create treasury shares out of existing and to be approved authorized capital. At the current share price (CHF 13.35), the total commitment of CHF 30 million represents a maximum of approximately 2.3 million shares. At the date of this release, the number of Kuros shares issued is 8.2 million.

The pricing of the shares will be determined as 95% of the lowest daily volume-weighted average share price of the five trading days following the date on which Kuros shall have sent to Yorkville the relevant advance notice. Further, should the daily volume-weighted average share price on any of the five trading days following the date of advance notice fall below a certain minimum price, the number of shares pursuant to the relevant advance notice may be reduced, and such price shall not count in the corresponding determination.

Yorkville can at no point in time hold more than 9.9% of the number of outstanding shares. Yorkville is committed not to short sell or enter into any hedging transactions related to Kuros stock.

Harry Welten, Chief Financial Officer of Kuros, commented, “This type of equity financing is customary for biotech companies and has been used successfully in the past to provide the companies with financial flexibility, a key success factor. Further, it has a reasonable pricing, limiting dilution for our current shareholders.”

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel +41 79 750 15 64

harry.welten@kurosbio.com

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

News release (pdf)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

MiMedx Provides Update On Its Reimbursement Coverage

Posted On November 21, 2017 By OrthoSpineNews In Biologics /

MARIETTA, Ga., Nov. 21, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, provided a reimbursement update today.

Parker H. “Pete” Petit, Chairman and Chief Executive Officer, said “With the publication of the Venous Leg Ulcer (VLU) study earlier this quarter, one of the nation’s largest not-for-profit health plans serving more than 3 million people recently decided to add EpiFix® coverage for Diabetic Foot Ulcers (DFUs), VLUs and burns. We also added another state Medicaid with nearly 2 million lives adding EpiFix coverage for DFUs, VLUs and burns. We expect many more health plans to follow suit with this type of decision in the future.”

The Company also provided a reimbursement update in light of the recently issued Food and Drug Administration (FDA) Final and Draft Guidance documents related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use” (the “HCT/P Guidance”).

Over the years, the Centers for Medicare and Medicaid Services (CMS), through its sub-committee, the Healthcare Common Procedure Coding System (HCPCS) Committee, has assigned Q Codes for numerous products. These Q codes are assigned based on the Committee’s review and are maintained by the HCPCS national panel, composed of representatives from Blue Cross/Blue Shield Association, the Health Insurance Association of America and CMS. Once assigned, payers typically then determine whether to reimburse those Q Codes. The payers further develop coding decisions based on the product’s efficacy. Since MiMedx’s EpiFix was introduced to the market in 2011, this is the process that payers have followed regarding EpiFix payment policy. Based on the clearly demonstrated efficacy of EpiFix in the numerous Randomized Controlled Trials (RCTs) in which EpiFix was the focus, the reimbursement coverage of EpiFix for the treatment of wounds has continued to grow over the years.

Petit added, “With the issuance of the final HCT/P Guidance document by the FDA, we believe the payer coverage for EpiFix will further improve. The only changes we anticipate from the final HCT/P Guidance are the addition of more payers covering EpiFix. Our recently published landmark multicenter VLU clinical trial and completed DFU study, along with the rest of our compendium of clinical data including an EpiFix comparative RCT, should further solidify MiMedx’s leadership position in the wound care market. Payers have long stated they want products that help to close wounds faster thereby reducing reduce hospital days and other expenses. It is important to note that the HCPCS Committee has assigned Q codes for product indications as a ‘cover’ as well as ‘wound healing’ with similar reimbursement rates. Based on product efficacy, the payers have traditionally utilized both ‘cover’ and ‘wound healing’ codes for their coverage decisions. We expect this traditional practice will be fully continued by the payers with the issuance of the final HCT/P guidance.”

Bill Taylor, President and Chief Operating Officer, commented, “With the recent publication of the VLU study, which is the first large scale successful VLU study completed in nearly 20 years, and the first large RCT of this quality on an amniotic membrane, we announce that we anticipate a robust increase in the level of reimbursement coverage for VLU procedures from commercial payers. Please recall that we have Medicare reimbursement coverage for both VLUs and DFUs; however, the breadth of our reimbursement coverage with commercial payers is primarily for DFUs. With the publication of the VLU study and the outstanding results in VLU healing rates, we are expecting a significant revenue opportunity to develop as commercial payers add EpiFix coverage for treatment of VLUs. On a very conservative basis, we have communicated that we could obtain VLU coverage for approximately 133 million additional commercial lives.”

“We view the impact of the final HCT/P Guidance as having a very positive effect on not only sustaining our current levels of EpiFix reimbursement coverage, but also being highly complementary to our on-going initiative with commercial payers in the adoption of coverage for the treatment of VLUs. The body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of DFUs and VLUs is overwhelming,” concluded Petit.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s belief that EpiFix RCTs are responsible for the growth in reimbursement coverage over the years and that this coverage will continue to improve, that the final HCT/P Guidance will have a positive effect on the Company and the only change anticipated is the addition of more payers covering EpiFix for DFU’s and VLUs, that the combination of the VLU and DFU studies and the Company’s compendium of clinical data should solidify the Company’s position in the wound care market, and the Company’s belief that it could obtain VLU coverage for approximately 133 million more commercial lives. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the guidance documents may not be implemented as expected; payers may decide not to add reimbursement coverage notwithstanding the clinical data and the guidance documents available; unexpected results or concerns may arise from data or analysis from our clinical trials; EpiFix RCTs may not have been responsible for the growth in reimbursement coverage over the years and therefore this coverage may not continue to improve with further clinical data; additional reimbursement coverage may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; and the Company’s clinical trial successes may not translate to commercial advantages. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

BONESUPPORT™ Signs Commercialization Agreement for the Italian Market

Posted On November 21, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 08.00 CET, 20 November 2017 – BONESUPPORT™, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces it has signed a second distribution agreement for Italy with Citieffe Srl to strengthen its access to trauma and orthopaedic surgeons in this market.Citieffe is a trauma implant manufacturer based in Bologna. It is part of the Medistream Group, owned by ArchiMed an independent French Healthcare Investment Firm. Citieffe, which has a direct sales force in Italy with national coverage, views BONESUPPORT’s CERAMENT® products as a very synergistic addition to its current implant offering to trauma surgeons in particular.

This new commercialization agreement in Italy will improve coverage for BONESUPPORT’s products in a key European market. BONESUPPORT markets its products directly in five European countries: the UK, Germany, Switzerland, Sweden and Denmark. BONESUPPORT has a commercial team of 20 people in Europe focused on driving the sales of its antibiotic-eluting injectable bio-ceramic bone substitute products, CERAMENT® G and CERAMENT® V.

Richard Davies, CEO of BONESUPPORT, commented: “I am pleased that we have signed this agreement with Citieffe, a commercial partner that will give us access to a portfolio of new trauma customers in the Italian market. We see Italy as a particularly important sales opportunity for CERAMENT® G and CERAMENT® V given the size of the market and the clear clinical and economic benefits that our antibiotic-eluting products deliver. I look forward to a mutually beneficial relationship with Citieffe.”

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

About Us

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G* and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent.The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies.BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152).Further information is available at ww.bonesupport.com*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United StatesBONESUPPORT™ is a registered trademark.

EOS imaging to Present at the 29th Annual Piper Jaffray Healthcare Conference

Posted On November 20, 2017 By OrthoSpineNews In Extremities, Spine /

November 20, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of 2D/3D orthopedic medical imaging, today announced that Marie Meynadier, Chief Executive Officer, is scheduled to present at the 29^th Annual Piper Jaffray Healthcare Conference in New York, NY.


Event:			29^th Annual Piper Jaffray Healthcare Conference
Date:			Wednesday, November 29, 2017
Time:			10:30 am ET / 4:30 pm CET

Investors attending the conference who would like to schedule a one-on-one meeting with EOS imaging management may do so by contacting their Piper Jaffray representative, or Emma Poalillo of The Ruth Group at epoalillo@theruthgroup.com.

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging service dedicated to osteo-articular pathologies and orthopaedics, as well as the associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan, China and the European Union (EC). It posted revenues of €30.8 million in 2016 and employed 132 people at December 2016, including an R&D team of 43 engineers. The group is based in Paris and has five subsidiaries: in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

EOS imaging has been selected to integrate the EnterNext © PEA – SME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
CFO
Pierre Schwich, +33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent, +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

dermapace-029-1200xx4992-2808-0-260-1-e1511197578982.jpg

SANUWAVE Health to Hold Third Quarter 2017 Financial Results and Business Update Call on Tuesday, November 21, 2017

Posted On November 20, 2017 By OrthoSpineNews In Financial /

SUWANEE, GA–(Marketwired – Nov 13, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) announced today that the Company will release financial results for the third quarter ended September 30, 2017 on November 14, 2017.

The Company will host a conference call on Tuesday, November 21, 2017, beginning at 10:00AM Eastern Time to discuss the third quarter financial results, provide a business update and answer questions.

Shareholders and other interested parties can participate in the conference call by dialing 888-567-1602 (U.S.) or 404-267-0372 (international) or via webcast at http://www.investorcalendar.com/event/22346.

A replay of the conference call will be available beginning two hours after its completion through December 5, 2017, by dialing 877-481-4010 (U.S.) or 919-882-2331 (international) and entering Conference ID 22346.

SANUWAVE will exhibit, in conjunction with Georgia Department of Economic Development, at MEDICA in Dusseldorf, Germany on 13 -16 November 2017. SANUWAVE cordially invites you to visit our booth in section 16D10-8 of Hall 16. MEDICA is the world’s leading trade fair for the medical industry. SANUWAVE is using this occasion to further educate on our lead wound care product, dermaPACE® and our industry leading device for the treatment of various orthopedic conditions, orthoPACE®. Kevin Richardson, Acting CEO, Iulian Cioanta, Vice President of Research and Development, and André Mouton, Vice President of International Sales and Relations, will be in attendance at this conference.

SANUWAVE will exhibit at Wounds Canada 2017 Fall Conference in Mississauga, Ontario on 16 -19 November 2017. SANUWAVE cordially invites you to visit our booth number 111. Wounds Canada’s fall conference is a continuing education event designed to support health-care professionals who work with patients with wounds or who are at risk for developing wounds. SANUWAVE is using this occasion to introduce and educate on our lead wound care product, dermaPACE. Lisa Sundstrom, Chief Financial Advisor, will be in attendance at this conference.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

Contact:
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com

Paradigm Spine, LLC Announces-Highmark, Inc. Is 1st Private Payor To Issue Exclusive Positive Coverage Policy For coflex® Interlaminar Stabilization®

Posted On November 20, 2017 By OrthoSpineNews In Spine, Top Stories /

NEW YORK, Nov. 20, 2017 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis announces issuance of a Highmark, Inc. Medical Policy, entitled “Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)” dated November 6, 2017. The coverage policy may be found here https://www.highmarkbcbswv.com/west-virginia-commercial-medical-policy/S-191-016.html

Importantly, the Medical Policy specifically excludes any other interspinous distraction or interlaminar stabilization devices, other than the coflex^® device, from coverage. Highmark, Inc. is the first commercial insurance carrier to provide exclusive coverage for the coflex^® device, due to the more than 85 peer-reviewed published articles supporting the safety and effectiveness of the coflex^® technology.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 yrs) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine. The coflex^® device is a non-fusion, motion preserving stabilization implant, that is FDA PMA approved for the treatment of Lumbar Spinal Stenosis, and can be used in conjunction with a decompression or used in lieu of a spinal fusion.

To learn more about coflex^® Interlaminar Stabilization^®, please visit www.coflexsolution.com.

J. Rush Fisher, MD, Chief of Spine Section, Christiana Care Health Services – “Over the last four years, I’ve treated 67 patients with coflex^® and have been very satisfied with the outcomes. Coflex^® offers stability to the spine while maintaining physiologic function to the motion segment. The coflex^® procedure is often an outpatient, non-fusion procedure that allows for fast recovery, and a high quality functionally active lifestyle for my patients. I’m understandably pleased that insurance coverage will now be available to more of my patients.”

Marc Viscogliosi, Chairman & CEO – “With over 85 peer-review published articles, including landmark 5 year follow-up studies, medical society guidelines, and now with commercial insurance coverage, it is wonderful to be able to expand patient access to the coflex^® technology. We are particularly gratified by the recognition of Highmark to exclusively cover coflex^® as the only interlaminar/interspinous device treatment option for LSS.”

About Paradigm Spine, LLC

Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex^® Interlaminar Stabilization^®device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

SOURCE Paradigm Spine, LLC

Invibio Investing to Accelerate Innovation for Medical Device Companies

Posted On November 17, 2017 By OrthoSpineNews In Biologics, Top Stories /

THORNTON CLEVELEYS, UNITED KINGDOM (PRWEB) NOVEMBER 16, 2017

Invibio Biomaterial Solutions has implemented a series of investments to help achieve the best possible clinical outcomes and lower total healthcare costs, a challenge faced by both the medical profession and industry, including medical device companies, globally. By assisting medical device companies to change the way they develop new products Invibio is focused on accelerating the time-to-market of new innovations. To deliver on this and provide greater clinical efficacies, the company has invested in clinical-study expertise, component manufacturing facilities and component testing. The innovator of implantable PEEK-OPTIMA™ polymer is also launching a new website that efficiently provides information on materials and applications to OEMs and Health Care Professionals (HCPs), and a comprehensive journal with further scientific information and clinical evidence.

John Devine, Medical Business Director at Invibio Biomaterial Solutions explains the quandary of innovative medical device makers: “When faced with delivering a consistent quality of healthcare at the lowest cost, the market has yet to create an environment that encourages more ambitious solutions than simply preserving the status quo at a fractionally reduced price.”

Redefining the total cost of care

Defining “best clinical outcomes” while delivering healthcare at the lowest possible cost is challenging, because clinical outcomes are typically obtained through clinical studies, which are expensive and time-consuming. In addition, there could be variations in the level of clinical evidence by region and different types of stakeholders and their needs, which can, for example, depend on where they sit on the curve of the diffusion of innovation. As a consequence, the medical device industry faces a difficult task, when seeking to demonstrate that new product innovations are addressing these issues and, ultimately, improving patient care.

John Devine sums it up: “The majority of current cost metrics focus on up-front purchasing costs rather than the total cost of care. For example, no standards exist for accurately assessing complication rates, or measuring the cost of revision surgeries, and reflecting these in purchasing decisions.”

As a leading pioneer in the use of PEEK-OPTIMA polymer solutions in medical applications, Invibio is convinced it can deliver the greatest clinical and economic benefits in four key areas, Dental, Spine, Orthopedics, and Trauma.

Establish and maintain clinical efficacy

To help raise its own bar for patient care and provide even greater clinical efficacy, Invibio recently recruited a clinical study manager and is working with Health Care Professionals (HCPs), medical device manufacturers and other stakeholders to determine the clinical and economic impact of its solutions. The company has also brought in clinical relations expertise to interact with HCPs, hospitals and payers. Martin Court, Executive Director at Victrex, emphasizes: “Doing so ensures that the clinical evidence we develop is not only shared in the marketplace, but accurately supports the benefits our materials can offer patients and the entire healthcare community.” As a result of these enhanced research and clinical data capturing efforts, Invibio has become more certain of the effectiveness of its solutions.

Investments in component manufacturing and testing

In addition, the company´s investments have made it easier for medical device companies to innovate and change the way they develop new products. Court continues: ”Our investment in component manufacturing facilities and component testing, for example, gives us a greater role in the design, development and commercialization of trauma fracture plates made of PEEK-OPTIMA™ Ultra Reinforced, a carbon-fiber-reinforced polymer. We have also pledged more support for our customers’ new product development programs. In addition, we are continuing to help customers worldwide navigate the challenging, regulatory pathway toward product safety and efficacy. It’s a win-win for Invibio, our customers, and patients alike.”

“Invibio Insider” journal and a new website for additional insights

Invibio is also launching a new comprehensive annual journal, the “Invibio Insider”, the first edition of which offers a detailed insight into key topics that will help to pioneer progress in the medical arena. Focused topics are intended to provide a greater understanding of the levels of clinical evidence, and what that may mean in combination with the company´s strategic drive to improve patient and clinical outcomes. It also explores approaches for treating challenging patients, taking into account the HCP’s perspective, and showcases recent clinical evidence while also discussing its potential economic impact.

The company´s new website will serve as a hub for OEMs and Health Care Professionals (HCPs) alike. For OEMs, it is a go-to practical and educational resource for implantable PEEK related knowledge and clinical data, including product offerings, manufacturing, quality and partnering for custom-design and regulatory services. For HCPs, it aims to facilitate the clinical adoption of new medical devices made of the company´s high-performance polymer, by providing implantable PEEK-related knowledge, clinical data and information concerning the potential benefits of Invibio´s solutions for HCPs and ultimately their patients. With a new emphasis on clinical evidence and an easy to navigate online academy, Invibio is not only addressing the needs of different target groups, but also hoping to contribute to achieving the best possible clinical outcomes and lowering the total costs of care.

Further information is available on Invibio´s new website: https://invibio.com.

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

About Victrex plc
Victrex is an innovative world leader in high performance polymer solutions, focused on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications, which contain our materials – from smart phones, aeroplanes and cars to oil and gas operations and medical devices. With over 35 years’ experience, we develop world leading solutions in PEEK and PAEK-based polymers, and selected semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at http://www.victrex.com

MiMedx Market Leadership Well Positioned In Light Of FDA New Guidance Document

Posted On November 17, 2017 By OrthoSpineNews In Biologics, Regulatory /

MARIETTA, Ga., Nov. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Food and Drug Administration (FDA) issued numerous Final and Draft Guidance documents. Among them was the final Guidance document related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use” (the “HCT/P Guidance”). Additionally, “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies,” Draft Guidance for Industry was published (the “RMAT Guidance”).

In the final HCT/P Guidance document, FDA updated and clarified its previous draft Guidance documents regarding HCT/Ps. In summary, MiMedx views the final HCT/P Guidance document as generally beneficial to the Company, physicians and patients. Bill Taylor, President and Chief Operating Officer, commented, “While there are a few items that are not consistent with the regulations, in general, we believe it should be viewed as a positive development in the industry. MiMedx is by far the leader in clinical and scientific studies and related publications on placental tissue. This places the Company years ahead of its competition. Note that the Final Guidance is largely in line with the MiMedx expectations for both micronized and sheet products as discussed on the Company’s September 2016 conference call. As expected, MiMedx’s sheet products are largely unaffected, but may require slight changes to the Company’s labeling and marketing documents. MiMedx micronized products are the subject of our four ongoing IND/BLA clinical studies.”

In FDA’s news release announcing the final HCT/P Guidance document, the Agency also stated that it would “apply a risk-based approach to enforcement,” and “for the first 36 months following issuance of the final guidance document, the FDA intends to exercise enforcement discretion for certain products.” In contrast, “the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern,” noting that “this risk-based approach allows product manufacturers time to engage with the FDA, and to determine if they need to submit a marketing authorization application.” MiMedx has a proven track record of safety based on its experience in distributing over 1 million allografts. The Company’s products have been allowed to proceed to Phase 3 with its plantar fasciitis and Achilles tendonitis Investigational New Drug/Biologic License Application (IND/BLA) studies.

The HCT/P Guidance document addresses many aspects of HCT/Ps, with the two most relevant items to MiMedx being Minimal Manipulation and Homologous Use. Minimal Manipulation relates to the way the tissue is processed and Homologous Use refers to the “intended use” as reflected by labeling, advertising, etc.

Taylor commented, “The HCT/P Guidance document clearly reiterates that products such as the MiMedx amniotic tissue in sheet form are considered to be minimally manipulated. This is consistent with the previous FDA positioning and what has been communicated to MiMedx by FDA.”

The final HCT/P Guidance document also maintains FDA’s position that micronized amnion is more than minimally manipulated. Parker H. “Pete” Petit, Chairman and Chief Executive Officer, said, “Although MiMedx still believes this is a flawed position and is not consistent with the HCT/P preamble and regulations, MiMedx has been following the IND/BLA pathway since 2014. At present, MiMedx has four IND clinical trials under way for our micronized amniotic tissue, AmnioFix® Injectable. Two of the studies are for plantar fasciitis (Phase 2B and 3), one for Achilles tendonitis (Phase 3), and the fourth is for osteoarthritis of the knee (Phase 2B). Based on the work we have done over the past four years and the finalization of this guidance document, MiMedx believes that we are years ahead of our competition relative to our micronized product platform.”

Taylor stated, “With respect to Homologous Use, FDA was largely consistent between the draft and final guidance issued as they relate to amniotic tissue. The Agency’s position remains that homologous use of amniotic tissue would include its use as a cover or to offer protection in repair and reconstruction procedures. MiMedx will review this Guidance Document and our marketing materials regarding our sheet products and determine what adjustments, if any, will be required. As stated in our September 6, 2016 shareholder call, with the completion of our multicenter Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) trials, when combined with the rest of our compendium of clinical data including an EpiFix® comparative RCT, MiMedx is well-positioned to file for IND/BLAs for specific indications for EpiFix, if we find it desirable to do so. Recall that both of these studies were designed as adequate and well controlled trials able to support a BLA by adhering to FDA’s Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment.”

In a statement on the RMAT Guidance release, FDA Commissioner Scott Gottlieb, M.D. stated, “The suite of four guidance documents we are making public today also delivers on important provisions of the 21st Century Cures Act, including our continued promise to fully implement the Regenerative Medicine Advanced Therapy (RMAT) designation program, which is designed to expedite the development and review of regenerative medicine advanced therapies.”

The RMAT designation as laid out in the 21^st Century Cures Act offers companies with regenerative medicine products such as MiMedx a pathway for conditional and expedited approvals. In Dr. Gottlieb’s statement, he clearly signals the FDA’s commitment to fully implement the RMAT program.

Petit commented, “Related to our IND/BLA studies, MiMedx reminds shareholders that it issued a press release announcing that we were allowed to proceed with our Phase 2B IND for osteoarthritis. Supporting osteoarthritis as a serious condition, the FDA guidance included hypothetical examples of regenerative medicine therapies, one of which is severe osteoarthritis. The MiMedx IND/BLA for osteoarthritis protocol inclusion criteria addresses severity levels 2 and 3 which clearly aligns with severe osteoarthritis. We plan to explore every pathway afforded by the FDA. We are in the process of evaluating the steps needed in order to file for the RMAT designation for AmnioFix injectable and will update shareholders once we determine our pathway.”

“In summary, the finalization of this HCT/P Guidance document is generally in a form that MiMedx anticipated, and it should facilitate our continued progression with our IND/BLA studies. We expect to have completed the prerequisites and be in a position to file our first BLA within the next two years or earlier if we get the RMAT designation. Importantly, we do not expect our forecasted revenue to change. Reimbursement for our sheet allografts is established for wound care and studies are completed. With micronized and RMAT guidance, we believe this could be a pathway to reducing timelines and accelerate our five-year revenue growth. MiMedx is clearly the leader in our market sector; this reinforces and enhances our position in relation to the rest of the market,” concluded Petit.

MiMedx also reiterates its revenue guidance for the fourth quarter and full year 2017:

Fourth quarter of 2017 revenue forecasted to be in the range of $87 to $88 million
2017 revenue guidance increased to the range of $320.6 to $321.6 million
Gross profit margins for 2017 expected to be in the range of 89% to 90%
GAAP EPS (FD) for 2017 projected to be in the range of $0.31 to $0.32
Adjusted EPS(FD)* for 2017 projected to be in the range of $0.31 to $0.32

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding expectations for fourth quarter and full year 2017 revenue, full year 2017 gross profit margin, EPS and Adjusted EPS for 2017, statements regarding the significance of the draft guidance documents for MiMedx, the Company’s belief that it is years ahead of competitors in terms of its clinical study progress, and statements regarding the Company’s belief that it might qualify for RMAT designation for certain applications and that this could accelerate associated product revenues. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that actual fourth quarter and full year 2017 financials may not materialize as expected; the draft guidance documents may not be implemented as expected; unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; advantages in clinical studies progress may not translate into market advantage; and the Company may not qualify for RMAT designation for certain applications, or even if the Company obtains RMAT designation for certain applications, this may not translate into accelerated revenues. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Fellowship Trained Orthopedic Spine Surgeon, Dr. Mark McFarland, Completes Successful Outpatient Surgery Using SpineFrontier’s (LES®) Technology

Posted On November 17, 2017 By OrthoSpineNews In Spine /

NEWPORT NEWS, VA. (PRWEB) NOVEMBER 17, 2017

Orthopedic Surgeon Dr. Mark McFarland utilized SpineFrontier’s newly updated angled driver design – in accordance with A-CIFT SoloFuse-P technology – in a successful C4-6 anterior cervical discectomy and fusion on Tuesday, Nov. 14, at Mary Immaculate Hospital in Newport News, Va. The patient was discharged and on her way home within two hours of surgery, currently recovering with arm and shoulder pain resolution.

Dr. McFarland performed the surgery on a 68 year old female patient – who was experiencing radiating pain in both her shoulders and upper arms, along with neck pain and discomfort. She noticed the pain was much worse in the mornings and often radiated past her elbows, especially on the right side. MRI revealed a central broad based disc protrusion at C4-5, which resulted in moderate to severe central stenosis. Additionally, the MRI revealed a moderate posterolateral bone disc complex combined with an annular bulge at C5-6, which resulted in right foraminal narrowing and moderate central stenosis. Prior to undergoing surgery, the patient had failed conservative treatments, including epidural steroid injections, anti-inflammatory medications and home exercise programs.

Dr. McFarland remarked on the advantages of the A-CIFT SoloFuse-P and angled driver, crediting the “zero profile implant design” in providing “a great option for outpatient surgery.” “The newly updated angled driver further enhances the ease-of-use and simplicity of the system,” he said.

SpineFrontier’s A-CIFT SoloFuse-P is a Less Exposure Surgery (LES) technology designed with both patients and surgeons at the forefront. The A-CIFT SoloFuse-P standalone vertebral body fusion device is an LES system – featuring a simple, dual screw construct, a large graft window, large diameter screws and slim, agile instrumentation. Its zero-profile and all PEEK-OPTIMA® Natural design minimize tissue disruption.

Dr. McFarland currently practices at the Orthopaedic & Spine Center in Newport News, Va., where he focuses primarily on the care and treatment of injuries and disorders of the spine. Dr. McFarland graduated from Oklahoma State University Medical School in 1999. He completed his residency in orthopedic surgery at Ohio University and went on to complete an Orthopedic Spine Surgery Fellowship at the Florida Spine Institute in Clearwater, Fla. Dr. McFarland is a member of the American Academy of Orthopedic Surgeons and the American College of Osteopathic Surgeons. He received the “Graduating Physician Academic Excellence Award” and his research includes studies on vertebral compression fracture outcomes. Dr. McFarland has also been recognized as a “Hampton Roads Top Doc” for the past five years in a survey of physicians conducted by Coastal Virginia Magazine, among other honors.

About SpineFrontier Inc.
SpineFrontier is a growing medical technology company that designs, develops and markets both implants and instruments for spine surgery based on the Less Exposure Surgery (LES®) Philosophy. These technologies are designed to allow for outpatient surgery due to minimal disruption of normal tissues. SpineFrontier believes LESS is more: LESS time in treatment and recovery is more time in action for patients and surgeons. SpineFrontier is headquartered in Malden, Mass. and was founded in 2006. SpineFrontier is a KICVentures portfolio company and the leader in LES technologies and instruments.

NuVasive To Participate In The 29th Annual Piper Jaffray Healthcare Conference

Posted On November 16, 2017 By OrthoSpineNews In Spine /

SAN DIEGO, Nov. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that NuVasive management will be presenting at the Piper Jaffray 29th Annual Healthcare Conference at the Lotte New York Palace in New York City on Wednesday, November 29 at 8:30 a.m. ET / 5:30 a.m. PT.

A live webcast of the presentations will be available online from the Investor Relations page of the Company’s website at nuvasive.com. A replay of the presentations will remain available on the website for 30 days after the applicable live webcast.

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 $962 million in revenues (2016), NuVasive has an approximate 2,300 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.

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