OrthoPediatrics Corp. to Start Distributing Bioretec Devices via Private Label

WARSAW, Ind., Nov. 13, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, and Bioretec Ltd. (“Bioretec”), announced today that they have amended their existing distribution agreement in order for OrthoPediatrics to market and sell Bioretec’s unique, bioresorbable orthopaedic bone and soft-tissue fixation implants under the OrthoPediatrics brand, TorqLoc™. Bioretec’s bioresorbable implants are ideal for repairing musculoskeletal defects of children and young people. Treatment of musculoskeletal defects and trauma related bone and soft-tissue injuries are steadily increasing, as well as the need for surgeries related to treating such conditions. Bioretec’s fully bioresorbable implants have shown excellent results in repairing the growing bones of children and young people.

“We are excited to start OrthoPediatrics’ private label collaboration, whose enthusiasm towards developing and improving surgical care for children, we admire.  Our products are ideal for surgeries of children, since the bioresorption of our implants eliminates the need for secondary removal operation after the healing of musculoskeletal tissues. This is especially important with children, for whom the risks and inconveniences associated with surgical procedures are much higher,” commented Tomi Numminen, CEO of Bioretec.

OrthoPediatrics’ Vice President for Trauma & Deformity Correction, Joe Hauser, added, “This evolving strategic partnership and collaboration with Bioretec represents another area for tremendous growth within OrthoPediatrics’ portfolio.  The TorqLoc™ screw portfolio will provide a truly innovative option for many unmet pediatric orthopedic sports and tissue repair surgical needs.  In addition to OrthoPediatrics’ all epiphyseal ACL system, we now can help our surgeon partners with MPFL, foot, shoulder, and hand solutions by providing this new generation bioabsorbable implant offering.”

About Bioretec
Bioretec Ltd. is a Finnish material technology company focused on the development, manufacturing and marketing of bioabsorbable, bioactive and drug-releasing surgical implants for orthopedic, trauma and sport medicine surgeries. Bioretec implants, designed and manufactured in Finland, have been used in 33 countries, including United States, China, Russia, UK, Germany, Italy and Spain.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

Solvay helps DiFusion Technologies innovate new ZFUZE osteoconductive PEEK composite for spinal implants

Alpharetta, Ga., Nov. 9, 2017 —Solvay, a leading global supplier of specialty polymers, announced that medical device-maker DiFusion Technologies chose Zeniva® ZA-500 polyetheretherketone (PEEK) as the base polymer for its ZFUZE osteoconductive PEEK composite for spinal implants. The new compound exhibited large areas of new bone formation on all bone implant surfaces in recent testing by DiFusion, who shared its results at the recent NASS 2017 event in Orlando.

PEEK is an attractive alternative to titanium for spinal implants because it shares similar modulus to bone, and its radio transparency allows for easy visualization in X-rays. The polymer is also inert, which means it does not interact with human tissue. While this quality supports biocompatibility, it means that PEEK does not naturally lend itself to bone growth. DiFusion solved this problem by compounding negatively charged zeolites into Solvay’s Zeniva® PEEK polymer.
“It was sort of a penicillin moment,”said Derrick Johns, CEO of DiFusion Technologies. “We started out engineering anti-microbial polymers by first loading zeolite particles with silver before compounding them. But we discovered if we took the silver cations out of the zeolite, they imbued PEEK with a negative charge. Osteoblast cells are attracted to the negatively charged surface at a far higher rate than titanium, and yet we were able to preserve the polymer’s outstanding visualization, modulus and strength benefits.”
Solvay was an early collaborator in the development of DiFusion’s patented ZFUZE composite, combining industry-leading materials expertise with technical and regulatory support for medical devices. Zeniva® ZA-500 PEEK was of particular interest to DiFusion due to the polymer’s higher flow, which facilitates both the compounding process and the extrusion of osteoconductive implants.
“In addition to our materials expertise, Solvay’s open innovation business model was instrumental to the successful innovation of DiFusion’s ZFUZE osteoconductive composite,”said Jeff Hrivnak, global business manager for Healthcare at Solvay’s Specialty Polymers Business Unit. “Our uniquely collaborative approach to customer projects differentiates us from other PEEK suppliers in this industry, and it allowed us to pool our respective capabilities and resources with DiFusion to solve this demanding challenge.”
DiFusion’s ZFUZE composite technology is in the final stages of its 510K approval process with the U.S. Food and Drug Administration. It is expected to be commercially available in the U.S. early next year.
® Zeniva is a registered trademark of Solvay

Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra-high performance polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay is a multi-specialty chemical company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers in diverse global end markets. Its products and solutions are used in planes, cars, smart and medical devices, batteries, in mineral and oil extraction, among many other applications promoting sustainability. Its lightweighting materials enhance cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 58 countries. Net sales were € 10.9 billion in 2016, with 90% from activities where Solvay ranks among the world’s top 3 leaders. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Founded in 2008 in Austin, Tex., DiFusion Technologies, Inc. is a medical device company focused on reducing the rising incidence of surgical site infections in orthopedic and spine surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants. Initially focusing on the multi-billion dollar spinal implant market, the company has developed a technology with applicability across a variety of orthopedic segments using well characterized implants with benefits for the patient, surgeon, hospital and payer. For more information about DiFusion Technologies, visit www.difusiontech.com.

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Bone Therapeutics SA : Business Update for Third Quarter 2017

Gosselies, Belgium, 9 November 2017, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides a business update for the third quarter ended 30 September 2017.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “During the Third Quarter, Bone Therapeutics has delivered several key milestones that further validated our unique, minimally invasive bone cell technology, bringing us closer to potentially game-changing treatments in the large and growing orthopaedic and bone disease markets. We were delighted to report the positive interim results for our allogeneic product ALLOB® in both spinal fusion and delayed-union fracture trials. Moreover, demonstrating the international appeal and potential of our unique bone cell therapy products, we are pleased to partner with Asahi Kasei for the development and commercialization of PREOB® in Japan, with the potential to expand to other countries in Asia.

Preparations for further clinical development of ALLOB® in delayed union fractures are well under way, as well as a continued focus on process optimization and scale up to ensure a truly commercially viable product. We also look forward to announcing the completion of recruitment in our Phase IIA spinal fusion study at end of 2017 or early 2018.

Business highlights

  • In September, Bone Therapeutics reported strong interim efficacy and safety results for the Phase IIA lumbar spinal fusion study with its allogeneic cell therapy product, ALLOB®. In addition to evidence of successful fusion shown by radiological data collected over a 12-month follow-up period (absence of motion in all patients and continuous bone bridges in 9 out of 15 patients), the interim results revealed substantial clinical improvement in function (55% improvement on the Oswestry Disability Index) and a strong reduction in back and leg pain (59% and 90% respectively). From a safety perspective, treatment with ALLOB® was well tolerated in all patients. Further details are available in the press release of September 14, 2017.
  • The Company also announced positive interim efficacy data for its ALLOB® Phase I/IIA study for delayed-union fractures. At 6 months post administration, all patients treated met the primary endpoint. Radiological evaluation of fracture healing showed an improvement of, on average, 4 points on the TUS (Tomographic Union Score) scale, twice the required minimum of 2 points. The health status of patients, as measured by the Global Disease Evaluation (GDE) score, improved by, on average, 48%, compared to the predetermined minimum of 25%. Based on these interim efficacy results, the Data and Safety Monitoring Board (DSMB) has recommended stopping the trial early due to efficacy results. ALLOB® was shown to be well tolerated. Further details are available in the press release of September 20, 2017.
  • The Company signed an exclusive, royalty-bearing license agreement with one of Japan’s leading industrial companies, Asahi Kasei Corporation. The license agreement covers the development and commercialisation of Bone Therapeutics’ autologous bone cell therapy product, PREOB®, in Japan with the option to extend into additional Asian territories. Further details are available in the press release of September 22, 2017.
  • At the beginning of September, Jean-Luc Vandebroek was appointed Chief Financial Officer. With his extensive international finance experience from major public and privately-owned companies, he will oversee the Company’s financial planning needs as it continues to mature and bring its innovative cell therapy products closer to the market.

Financial highlights

  • Cash used in operating activities amounted to EUR 10.13 million for the first nine months of 2017, compared to EUR 8.95 million for the same period in 2016.
  • Operating loss amounted to EUR 8.76 million compared to EUR 8.87 million for the same period last year.
  • Net cash at the end of September 2017 amounted to EUR 9.11 million.

Outlook

  • Bone Therapeutics expects to complete recruitment of patients into the ALLOB® Phase IIA study in spinal fusion at the end of 2017 or early 2018.
  • The Company plans to initiate the Phase IIB trial with ALLOB® for delayed-union fractures in the second half of 2018.
  • Ongoing recruitment for the pivotal Phase III study in osteonecrosis for PREOB® with interim analysis expected in the second half of 2018. The interim analysis will determine whether the trial could be stopped at this stage.
  • Good cash management will remain a key priority, with a strong focus on net cash burn. Cash burn for the full year 2017 is expected to be approximately EUR 13-14 million, below the previous guidance of EUR 15 million. Based on its strategic priorities, the Company provides guidance that it has sufficient cash to carry out its strategic objectives into Q2 2018. In order to pursue the development of its promising bone-forming cell therapy platform the Company plans to raise funds with existing and new investors to strengthen its cash position.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

AlloSource Announces Bob Lay As Chief Operating Officer

CENTENNIAL, Colo.Nov. 7, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced the appointment of Bob Lay as Chief Operating Officer.

With over 20 years of experience in both finance and operations, Bob has a broad-based understanding of how each department within an organization impacts another. He has an extensive background working with businesses and medical device companies to conduct operational audits, improve processes and systems, and balance the needs of many departments to drive company growth and success.

“The Chief Operating Officer role at AlloSource is critical to creating the cellular and tissue products surgeons need to help restore mobility in more patients,” said Thomas Cycyota, AlloSource President and Chief Executive Officer. “Bob’s background, as well as his open-minded approach to driving improvements, will help us identify new opportunities to advance the work we do.”

In addition to his role as Chief Operating Officer, Bob also served AlloSource as the Director of Cost Accounting and Vice President, Operations. Prior to his time at AlloSource, he held leadership roles at both startups and large companies. Bob received his Bachelor’s and Master’s degrees in Accounting from the University of Denver.

“I am honored to lead the dedicated and passionate Operations team at AlloSource,” said Lay. “AlloSource’s commitment to donors and patients inspires me every day, and I look forward to contributing to the organization’s continued growth.”

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

 

SOURCE AlloSource

SANUWAVE Announces Exhibition at Wounds Canada 2017 Fall Conference

SUWANEE, GA–(Marketwired – Nov 3, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company will exhibit at Wounds Canada 2017 Fall Conference in Mississauga, Ontario on 16 – 19 November 2017. SANUWAVE cordially invites you to our booth number 111. Wounds Canada’s fall conference is a continuing education event designed to support healthcare 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®.

In Canada, 2.4 million people were living with diabetes in 2008-2009, a figure that is expected to rise to close to 4 million people by 2018-2019. Ulceration of the foot is one of the major health problems with diabetes, diabetic foot ulcers in acute inpatient care is a serious chronic disease, and is a major factor in the story of wounds. Wounds Canada, formerly Canadian Association of Wound Care, estimates that the average cost of treating a chronic wound in Canada is $10K and diabetes related ulcers cost the Canadian health care system $150M annually. Early treatment intervention with dermaPACE can prevent ulcers from developing complications such as infection that could lead to amputation.

“We are very excited about growing our activities in Canada in the wound care arena,” stated Mr. Richardson, Chief Executive Officer of SANUWAVE. “Our exhibition will be the springboard to establish and then grow our market presence in Canada.”

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

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

    SANUWAVE Health, Inc.
    Andre Mouton
    Vice President International Sales and Relations
    +1-615-823-9907 (Cell)
    +1-678-569-0881 (Fax)
    Skype: andre.w.mouton
    Andre.Mouton@sanuwave.com

Xtant Medical Enters into a Distribution Agreement with curasan, Inc. Bringing Matriform™ to Market

BELGRADE, Mont., Nov. 01, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced it has entered into a distribution agreement with curasan, Inc. adding a premium line of synthetic scaffolds to its biologics portfolio.

Matriform, Xtant’s brand of the curasan synthetic product portfolio for orthopedic applications, consists of a composition of pure phase Beta-Tricalcium Phosphate (β-TCP) and porcine collagen, and interconnected porosity with a variety of micro, meso, and macro pores. Distribution of Matriform will mark Xtant’s entrance into the US orthopedic Bone Graft Substitute market, the largest market globally with an annual market size of over $800 million.

“We are excited to be enhancing our biologic portfolio offering with a line of synthetic scaffolds, which will make us a comprehensive biologic supplier for our customers and their patients,” said Carl O’Connell, CEO of Xtant Medical. “Our team has been very strategic in finding a partner with a product that meets our expectations for superior handling and clinical efficacy with proven mechanisms of action.”

“It’s an important milestone for us to partner with such a forward-thinking company as Xtant Medical and expand our distribution footprint within North America. Adding additional private label distributors within the US and globally alongside our direct sales teams provide great opportunities for curasan and our distributor partners. Xtant has a great reputation for providing innovative and relevant products to orthopedic surgeons and we are pleased to expand our relationship further with Xtant.” said Michael Schlenk, CEO of curasan AG.

Matriform will be available in two formulations, and in various volumes for a multitude of orthopedic applications. The flexible strips are high density with high elasticity, making them easily adaptable to bony defects when hydrated. The moldable version is a low density bioceramic that becomes malleable when hydrated. The two formulations received 510k clearance for orthopedic applications in the US in December of 2016, and has been a synthetic of choice in Europe for a variety of orthopedic procedures for over 20 years.

About Xtant Medical

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

About curasan AG

curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, CURASAN, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan´s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.

Important Cautions Regarding Forward-looking Statements

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

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

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

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

SeaSpine Announces Limited Commercial Launch of OsteoStrand™ Demineralized Bone Fibers

CARLSBAD, Calif., Nov. 01, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch and completion of initial surgeries for its OsteoStrand™ Demineralized Bone Fibers. The first implantations were completed by Dr. Khalid Abbed, Vice Chair of Neuro Surgery and Director of Minimally Invasive Spine Surgery at Yale School of Medicine and orthopedic spine surgeon Michael W. Cluck, M.D., PhD, at the Bay Area Spine Care in San Jose, CA.

OsteoStrand fibers are the latest innovation in SeaSpine’s demineralized bone matrix (DBM) product family, which facilitate and aid in fusion.  OsteoStrand fibers provide 100% demineralized bone fibers to maximize the osteoinductive content while providing a vastly improved conductive matrix.  These fibers were developed through a disciplined R&D process that evaluated a variety of fiber geometries to deliver intraoperative handling and controlled expansion, to facilitate surgical placement, to maintain surgical position and to allow the fibers to better fill the surgical defect with the overriding goal to improve fusion potential.

“The handling properties of OsteoStrand Demineralized Bone Fibers are excellent; it is easily compressible and expands to fill the surgical defect upon implantation,” said Dr. Cluck. “The handling and 100% demineralized bone composition give me a high level of confidence for my fusion procedures.”

Dr. Khalid Abbed added, “The handling properties of OsteoStrand Demineralized Bone Fibers are excellent, and improved compared to other 100% DBM products that I have used in my practice. I believe this tissue product could lead to significant cost savings for my hospital and I look forward to evaluating the OsteoStrand Plus with Accell Bone Matrix.”

“OsteoStrand fibers will serve as a development platform for continued innovation in our orthobiologics portfolio and will further strengthen our top-three position in the U.S. DBM market while also providing operational leverage through our Irvine manufacturing facility,” said Keith Valentine, Chief Executive Officer and President of SeaSpine.  “We plan to launch the OsteoStrand Plus Demineralized Bone Fibers with our proprietary Accell™ Bone Matrix on a limited basis in early 2018.  We believe these product offerings deliver clinical value as payors and hospitals seek more cost effective orthobiologic solutions.”

About SeaSpine
SeaSpine (www.seaspine.com) 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 implants 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 implant 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 potential benefits of the OsteoStrand Demineralized Bone Fibers product, including to improve fusion; the ability of the OsteoStrand Demineralized Bone Fibers to strengthen SeaSpine’s top-three position in the U.S. DBM market and provide operational leverage; the timing of launch of the OsteoStrand Plus Demineralized Bone Fibers product in early 2018; and the potential for new product offerings to clinical value to payors and hospitals.  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 ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; 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

MiMedx Agrees To Lawsuit Settlement With Halo Wound Solutions

MARIETTA, Ga., Nov. 1, 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 Company has agreed to a confidential settlement of the lawsuit the Company filed against BioResolutions LLC d/b/a Halo Wound Solutions (Halo) and one of the Halo executives.

MiMedx filed its lawsuit against Halo and its executive, Tracy Lucas, in January 2017. In its suit, MiMedx alleged that Lucas used MiMedx trade secrets and other confidential, proprietary business information to unlawfully solicit the sales of Halo’s medical products with the assistance of MiMedx employees, and tortiously interfered with MiMedx’s contracts with its employees. Mr. Lucas is a former employee of MiMedx. MiMedx alleged that during and after Mr. Lucas’ employment with MiMedx, Halo and Mr. Lucas engaged in wrongful conduct with MiMedx employees, knowing they were actively employed by MiMedx and knowing that MiMedx employees have contractual and legal obligations to the Company.

In addition to an undisclosed monetary settlement, other settlement terms were reached. Certain of these additional settlement terms include: for a period of two years Halo will not sell amniotic tissue products, human tissue/skin substitute products to MiMedx’ existing customers; and  for a two-year period, Halo will not solicit MiMedx employees to work for Halo in any fashion or to leave MiMedx’s employment. Luke Esslinger, President and CEO of Halo, stated, “I apologize that this situation arose. To our knowledge, MiMedx was not aware that its employees were selling third party products or services, including Halo products. We realize now that MiMedx firmly disapproves of its employees selling our products and that such a situation had the potential to create a conflict with the rightful obligations these employees had with their employer, MiMedx.”

Parker H. “Pete” Petit, MiMedx Chairman and CEO, said, “We are pleased to have another one of these lawsuits behind us. We have reached an amicable and favorable settlement with Halo. I applaud Halo for dealing with this in a professional manner and treating it as a learning experience for their future business activities.”

“We have been very effective in continuing our growth trajectory and sustaining our operational excellence, in spite of these corporate distractions. Our constant focus has been on growing our business for the benefit of our customers and their patients, employees and shareholders. I could not be more proud and complementary of our organization for its continued concentration on our business while these distractions are being resolved,” added Bill Taylor, MiMedx President and COO.

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 1,000,000 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 potential outcomes of legal actions.  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 the risk that different or additional facts may be discovered that change conclusions, and the risks of litigation.  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.

Related Links

http://www.mimedx.com

Global Spine Orthopaedic Devices Market 2017-2023 – Increase Usage of Orthopedic Biomaterials in Spine Surgery

DUBLINNovember 1, 2017 /PRNewswire/ —

The “Global Spine Orthopaedic Devices Market: Drivers, Restraints, Opportunities; Trends and Opportunities to 2023”report has been added to Research and Markets’ offering.

The “Global Spine Orthopedic Devices Market” is Estimated to Witness a CAGR of 6.23% During 2017-2023

The market is dominated by the Spine Implants segment with the presence of advanced fusion and non-fusion procedures performed with orthobiologics and the availability of clinical data regarding the safety and efficacy of the devices. This enables surgeons to adopt devices for treatment of various spine-related disorders as these surgeries contribute 60% of the total orthopedic procedures.

Therefore, opportunities for growth in the emerging countries of LATAM and APAC remain vast. The increasing adoption of MI surgeries in treating orthopedic disorders, particularly in the elderly, and the growing availability of devices in the market also contribute to the growth of the market.

Europe accounted for the second largest market with chronic pain being one of the major complications with the rising burden of spine chronic cases (lower back). In 2015, the public spending on healthcare in Europe amounted to 18% of the overall government expenditure. The expenditure on chronic pain care with orthopedic devices is directly reimbursed to hospitals within the NHS. Clinical evidence of spine orthopedic devices compared to other treatments, such as drug therapy, are expected to increase during the forecast period.

Factors, such as high prevalence of orthopedic diseases, presence of large pool of patients, and rise in awareness about treatment for complex orthopedic disorders, drive the market growth in the emerging economies, especially APAC. Further, the increase in government spending in healthcare, infrastructure, research centers, and establishing of manufacturing facilities by major vendors in the market are influencing the high growth of the market.

Market Dynamics

Drivers

  • Rise in the prevalence of spinal disorders
  • Growing popularity of minimally invasive surgeries
  • Rise in elderly population
  • Increase in number of outpatient procedure

Opportunities

  • Adoption of spinal navigation technology
  • Increase usage of orthopedic biomaterials in spine surgery
  • Increase healthcare spending
  • Increase in mergers & acquisitions

Restraints

  • High cost of spine surgery procedures
  • Complications and risk associated with spine surgeries
  • Stringent regulatory framework and labeling requirement
  • Poor reimbursement policies
  • Intense competition among vendors

Key Topics Covered:

1 Industry Outlook

2 Report Outline

3 Market Snapshot

4 Market Outlook

5 Market Characteristics

6 Types: Market Size and Analysis

7 End User: Market Size and Analysis

8 Regions: Market Size and Analysis

9 Competitive Landscape

10 Vendor Profiles

11 Companies to Watch For

12 Other Prominent Vendors

Companies Mentioned 

  • Alphatec Spine
  • Johnson & Johnson (DePuy Synthes, Inc)
  • K2M
  • Medtronic PLC
  • NuVasive, Inc.
  • OMNIlife Science
  • Orthofix International N.V.
  • SeaSpine Holdings Corp.
  • Stryker Corp.
  • Zimmer Biomet Holdings, Inc

For more information about this report visit https://www.researchandmarkets.com/research/6vvbbw/global_spine

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
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For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

Related Links

http://www.researchandmarkets.com

Arthrosurface acquires an acellular dermal technology from WASAS, LLC

FRANKLIN, Mass.Oct. 30, 2017 /PRNewswire/ — Arthrosurface, Inc. announced today that it has completed the acquisition of an acellular dermal stabilization device technology, including the intellectual property rights to and associated with this technology, from WASAS, LLC based in Fort Lauderdale, Florida. Arthrosurface plans to use this technology to develop and market a platform of novel methods to be used to correct orthopedic challenges in multiple therapeutic areas.

Acellular dermis is derived from a human source, a process is used to remove cells and retain portions of the extracellular matrix (ECM). Dermal allografts have a history of human use in a wide range of clinical indications.

“The availability of this allograft to Arthrosurface will allow us to execute on a pipeline of clinical applications that we have identified with our surgeon partners over the past several years,” said Steve Ek, CEO of Arthrosurface.

About Arthrosurface

Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include devices, instruments and orthobiologics designed to preserve and restore the joints so patients can regain and maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons that can be used to treat a wide range of joint conditions. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 13 years. For more information, please go to our website at www.arthrosurface.com

 

SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com