RTI Surgical® Partners in New Manufacturing USA Institute

Posted On June 2, 2017 By OrthoSpineNews In Biologics, Financial, Top Stories /

June 02, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, is part of a new public-private Manufacturing USA initiative, the Advanced Regenerative Manufacturing Institute (ARMI). Headquartered in Manchester, New Hampshire, ARMI is the twelfth Manufacturing USA institute. It brings together a consortium of nearly 100 partner organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs.

Approximately $80 million from the federal government will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. As part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States, ARMI will lead the Advanced Tissue Biofabrication (ATB) Manufacturing USA Institute on behalf of the Department of Defense.

Under the umbrella of Manufacturing USA, a public-private network that invests in the development of world-leading advanced manufacturing technologies, ARMI will work to integrate and organize the fragmented collection of industry practices and domestic capabilities in tissue biofabrication technology in order to better position the US relative to global competition. ARMI will also focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.

“We need to develop twenty-first century tools for engineered tissue manufacturing that will allow these innovations to be widely available – similar to how a fifteenth century tool (the printing press) allowed knowledge to spread widely during the Renaissance,” said inventor Dean Kamen, ARMI’s chairman.

ARMI’s efforts are supported by forty-seven industrial partners, twenty-six academic and academically affiliated partners, and fourteen government and nonprofit partners. The ARMI partnership continues to grow.

“RTI Surgical is pleased to participate in the ARMI consortium,” said Todd Goede, Global Vice President of Research and Development. “We look forward to providing the regenerative manufacturing resources and knowledge that we use every day to help patients – undoubtedly, the lives of many will benefit from the innovations this initiative will create.”

About RTI Surgical Inc.

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

Forward Looking Statement

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

About ARMI

The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12^th Manufacturing USA Institute. It brings together a consortium of nearly 100 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit www.ARMIUSA.org.

Contacts

RTI Surgical
Roxane Wergin, Phone: 386-418-8888
Director, Corporate Communications
rwergin@rtix.com

CollPlant Provides Operational Update for Q1 2017

Posted On June 1, 2017 By OrthoSpineNews In Biologics, Top Stories /

NESS ZIONA, Israel, May 31, 2017 /PRNewswire/ —

CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human “rhCollagen”) technology for tissue repair products, provided an operational update for the first quarter ended March 31 2017.

During the period, the company continued to focus on product commercialization while pursuing its activities, including potential joint ventures with international companies, to develop biological ink (bioInk) for 3D printing of organs and tissues. Additionally, CollPlant has substantially reduced its operating costs, chiefly as a result of last year’s successful completion of clinical trials, and the transition to commercialization of its first products. Subsequent to the end of the first quarter, the company expanded its footprint in Europe with the signing of a distribution agreement in Turkey for its wound healing product, VergenixFG®, and is working towards the signing of additional distribution agreements in these territories.

The biological ink sector – Collagen protein is a fundamental and significant component of connective tissues in the human body, and is therefore an ideal building block for the synthesis of bioInk, which is used in the production of 3D scaffolds, together with human cells and/or therapeutic proteins. Management views this sector as a major growth opportunity and is, therefore, pleased to report during the period, that it has been actively pursing key collaborations with international companies in the field of 3D printing of organs and tissues utilizing CollPlant’s rhCollagen technology. Specifically, the Company is examining bioInk applications in the areas of orthopedics, dermatology, ophthalmology and cardiology, and others.

Yehiel Tal, Chief Executive Officer of CollPlant, stated, “CollPlant’s proprietary rhCollagen represents a potential key component of biological ink, due to a number of unique and important attributes, including its excellent biological functionality, which is reflected in its rapid cell proliferation. Our rhCollagen also has a high level of homogeneity at the molecular level, which enables the production of bioInk with controlled and supervised physical attributes such as viscosity, strength and transparency. Additionally, CollPlant’s rhCollagen has proven to be safe to use and does not cause allergic responses or lead to the transmission of diseases.”

According to the U.S. Department of Health and Human Services^[1], the number of people in the United States waiting for a transplant of a critical, life-saving organ such as a kidney, liver or pancreas, is approximately 118,000, and the organ transplant waiting list grows every year. BioInk is a significant component of the burgeoning 3D bioprinting market, which is expected to grow to approximately

————————————————–

1. U.S. Department of Health & Human Services; https://optn.transplant.hrsa.gov/

USD 1.8 billion by 2022^[2], and to increase substantially as the printing technology, and all its components, continue to mature.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix^®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix^®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

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

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2. Grand View Research; “3D Bioprinting Market Size To Be Worth $1.82 Billion By 2022,” April 2016

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

Contact at Rx Communications Group, LLC: Paula Schwartz (for US Investors)
Managing Director
Tel: +1-917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

Ortho-ACI® Included on the Australian Register of Therapeutic Goods

Posted On May 31, 2017 By OrthoSpineNews In Biologics, Regulatory, Top Stories /

May 31, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (“Orthocell or Company”) is pleased to announce it has received confirmation from the Therapeutic Goods Administration (TGA) that Ortho-ACI® has been included on the Australian Register of Therapeutic Goods (ARTG).

Orthocell’s Autologous Chondrocyte Implantation (Ortho-ACI®) for cartilage repair and regeneration has previously been approved for sale in Australia pursuant to a TGA issued manufacturing license, but in order to maintain regulatory approval in Australia for the commercial sale of Ortho-ACI® pursuant to the relevant transitional provisions, Orthocell had lodged an application for approval and inclusion on the ARTG.

Inclusion on the ARTG marks a significant milestone for the Company enabling the commencement of the process for reimbursement and also the wider sale and distribution of Ortho-ACI® for cartilage repair and regeneration within Australia and the treatment of patients in other countries such as Hong Kong, Singapore and New Zealand. This milestone also represents the first cell therapy for cartilage repair to be included on the ARTG.

Ortho-ACI® is the gold standard intervention for symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle. Damage to articular cartilage can occur through injury or normal wear and tear. When articular cartilage is damaged, it does not repair itself effectively like other tissues and cartilage defects lead to increasing joint pain and impaired mobility, which affects activities of daily living and exercise. These defects present a difficult clinical problem and if left untreated can lead to osteoarthritis.

Ortho-ACI® provides the opportunity for the body to regenerate its own cartilage and provide a functional and durable outcome. Orthocell has treated patients in Australia, Hong Kong and Singapore. Ortho-ACI® is indicated as a pre-arthritis cell therapy that is designed to treat the localized defects in the knee, patella and ankle that can lead to osteoarthritis and cartilage degeneration

Orthocell Managing Director Paul Anderson said “the inclusion by the TGA of Ortho-ACI® on the ARTG is a significant milestone for the Company and enables the continued pathway towards reimbursement.”

About Orthocell Limited

Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-licensed cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is Celgro®, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.

For more information on Orthocell, please visit www.orthocell.com.au or follow us on Twitter @Orthocellltd and Linkedin www.linkedin.com/company/orthocell-ltd

Contacts

General enquiries
Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor and Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012
bwalsh@buchanwe.com.au

Bone Therapeutics strengthens Board with the appointments of Steve Swinson and Damian Marron as Non-Executive Directors

Posted On May 30, 2017 By OrthoSpineNews In Biologics, Top Stories /

Gosselies, Belgium, 29 May 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces the appointment of Steve Swinson and Damian Marron to its Board of Directors as Non-Executive Directors.

The appointments of Steve Swinson and Damian Marron, effective 26 May 2017, complement an already strong Board of Bone Therapeutics bringing in specific public company, orthopaedic and cell therapy understanding and expertise and will provide ongoing support to the leadership team. Steve Swinson and Damian Marron will replace Jacques Reymann and Jean-Jacques Verdickt.

Steve Swinson has served in a number of senior roles in orthopaedic medical technology and electronics companies, including general management, senior strategy, sales, marketing and commercial operation positions at Medtronic International, a global leader in medical technology. At Medtronic, he led the Spine and Biologics division for Canada and Western Europe, and was Vice President and General Manager for the international spine divison with substantial revenue responsibility. In a 30 year international business career covering Asia, US, Europe and Africa, he has also held senior positions at the diagnostic and medical departments of the blue chip engineering multinationals, General Electric and Hewlett Packard. Steve has a PhD in electrical engineering from the University of Manchester and a MBA from the University of Chicago.

Damian Marron is an experienced life sciences executive with a successful track record of value creation through public and venture capital financing, portfolio planning and turnaround, M&A, licensing agreements and research and marketing collaborations. He has particular competencies in cell therapy, immuno-oncology and orphan diseases. Damian served most recently as Chief Executive Officer of Agalimmune and has also served as Chief Executive Officer of TxCell, a France-based specialist in personalised T-cell immunotherapies, where he led the Company’s IPO on Euronext Paris. As Chief Executive Officer of Trophos, France, he helped raise EUR 34 million in financing and positioned the company for a subsequent acquisition by Roche for EUR 700 million. Damian also served as Executive Vice President, Corporate Development, for NiCox, where he supported the CEO in financing rounds raising over EUR 175 million.

Michel Helbig de Balzac, Chairman of Bone Therapeutics, commented: “We are delighted to welcome Steve and Damian to the Board of Bone Therapeutics. Their collective track record in leadership and value creation in the healthcare sector and their industry knowledge and expertise in orthopaedic medical technology and cell therapy respectively will be a major asset to the Company. They will be a valuable sounding board to the leadership team as it focuses on advancing our innovative allogeneic cell therapy platform towards commercialization. We would like to thank Jacques Reymann and Jean-Jacques Verdickt for their many years of dedication to Bone Therapeutics and wish them the best in their well-deserved retirement.”

Commenting on his appointment, Steve Swinson said: “Bone Therapeutics leads the field in regenerative approaches to orthopaedics and bone diseases, and its allogeneic cell therapy platform has the potential to transform medicine in these areas. I’m delighted to have the opportunity to use my deep experience in orthopaedic medical technology to help support this Company as it advances its technology towards commercialization.”

Damian Marron added: “I am very excited to be joining Bone Therapeutics. I look forward to bringing my experience in strategic development and my expertise in cell therapy to support the Company as it approaches key value inflection points with its innovative allogeneic cell therapy platform.”

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 non-union fractures.

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.

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.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Wim Goemaere, 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

SANUWAVE Announces Appointment of LITHOMED as Distributor for Orthopedics Products in Taiwan

Posted On May 26, 2017 By OrthoSpineNews In Biologics /

SUWANEE, GA–(Marketwired – May 25, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed LITHOMED to act as distributors for SANUWAVE’s Orthopedic products in Taiwan.

Kevin Richardson II, CEO and Chairman, stated, “SANUWAVE has committed to deliver 3-5 new distribution partners in the second quarter and 7-10 by the end of the year. This is the first step in achieving or beating our target. We are also excited to be able to support our science advisor Dr. Chin-Jen Wang, Professor of Orthopedic Surgery at Chang Gung Memorial Hospital, and his newly founded Shockwave Institute in BANG DONG, Taiwan.”

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “We are very pleased with this new relationship. LITHOMED has a wealth of experience within this specific indication and will be the right fit for our needs within the orthopedic market segment in Taiwan. Their access and relationships with Key Opinion Leaders (KOL’s) will prove to be of immense value for market development and revenue growth. Taiwan is the first country where we shall have a definitive split within our distribution model. We recognize that Orthopedics and Wound Care have a different customer base and the designated distributor needs to address that. We are expecting sales from this region to be well over $500,000 within the next three years, with a maximum value of $3 million. We have more than 200 of our devices in use in Europe and we are sure the Asia market and usage will progress accordingly. Taiwan will be our second territory within Asia,” concluded André Mouton.

William Kao, Managing Director: “LITHOMED is very pleased to be the distributor for SANUWAVE’s orthopedic products in Taiwan. The orthoPACE® device, with its patented focused shock wave technology, is an important advancement in orthopedic and musculoskeletal care and offers a wide range of non-invasive treatment procedures for hospitals and doctor’s offices. I am certain it will be welcomed by Taiwanese orthopedists and their patients. These innovative products will fit perfectly within our portfolio and will be a welcomed addition to our current network of loyal customers and users. The orthoPACE device has been proven safe and effective for the treatment of chronic tendonitis and joint pain in the musculoskeletal environment. orthoPACE treatments have been especially effective in treating tendonitis and plantar fasciitis, which commonly require surgery. orthoPACE is designed to effectively treat bone conditions requiring osteogenesis, calcific joints, conditions causing painful joints, and chronic pain caused by musculoskeletal disorders. orthoPACE uses focused, shock wave treatments that are non-invasive which dramatically reduce the risk of infection. In many indications, orthoPACE has a proven success rate that is equal to or greater than that of surgery — usually with just one procedure and without the inherent risks, complications, or lengthy recovery time of invasive surgery. orthoPACE treatments require a minimal amount of treatment time. In conditions such as plantar fasciitis, patients can bear weight immediately and return to pre-treatment activity within a few days of the procedure,” concluded William Kao.

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.

About LITHOMED
Litho Med Trading Company has been established in 1994. The company specializes in distribution of medical equipment with a key focus on Shockwave Technology. It has been involved with clinical studies with OssaTron in 1998 and the company is closely working with the Key Opinion Leaders (KOL’s) within Shockwave technology within Taiwan since. The company is the sole distributor for Edaptms for UST since 2010. The orthoPACE technology and usage will be an added indication to complete the current product offering.

Litho Med Trading Co., Ltd.
TEL:06-2903269 FAX:06-2903297
3F-7, No.293 Sec 3, Dung-Men Road.
Tainan 701, Taiwan, R.O.C.

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.comSANUWAVE 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

NovaBone Announces Irrigation Resistant Products with Carriers that have Synergistic Effect in Bone Formation

Posted On May 25, 2017 By OrthoSpineNews In Biologics, Top Stories /

May 24, 2017

JACKSONVILLE, Fla.–(BUSINESS WIRE)–NovaBone Products, a leading biologics medical device company, announces the addition of NovaBone IRM and NovaBone IRM MacroPOR to its portfolio of biologically active bone graft substitutes.

NovaBone IRM, and NovaBone IRM MacroPOR are the most advanced bioactive synthetic bone graft substitutes available to the orthopedic community today. Both formulations optimize osteogenesis, uniquely signal and stimulate osteoblastic activity, and offer angiogenic potential. By design, both formulations are highly irrigation resistant with excellent cohesion and handling properties.

“NovaBone Products’ base Bioactive Glass technology has proven to out-perform traditional calcium sulfate based synthetic products and demineralized bone matrix products,” said Dennis McBride, Vice President of Sales and Marketing. “We are now advancing our science further by providing formulations with carriers that have a synergistic effect in bone formation and retain molded shapes following implantation and irrigation.”

Novabone offers the broadest portfolio of bioactive synthetic bone graft substitutes in the world, with a robust pipeline of products in development designed to expand the regenerative biologics products the company offers. Presently, products offered include minimally invasive (MIS) delivery devices, strip formulations, putty materials that are hydrated using bone marrow aspirate, and putty formulations that are ready-to-use out of the package.

“We are proud to offer products that allow a surgeon to look to one company when addressing bone grafting needs,” concluded McBride.

NovaBone Products, a privately held company based in Florida, USA since 2002 and a recognized industry leader in bioactive glass design and manufacturing, developed the first bioactive synthetic bone graft offered to the orthopaedic community.

Contacts

NovaBone Products
Arthur Wotiz, President
904-651-0607
awotiz@novabone.com

SANUWAVE Health Announces Shock Wave Scientific Program in Milan, Italy Conducted by Medical Advanced Technologies, 26 May, 2017

Posted On May 24, 2017 By OrthoSpineNews In Biologics /

SUWANEE, GA–(Marketwired – May 23, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company’s exclusive distributor in Italy, Medical Advanced Technologies S.R.L. (MATEK) is sponsoring a one day scientific program to be conducted in Milan, Italy on May 26, 2017. This program, Workshop@Rooftop, will be held at the exclusive Hotel The Square in Milan. MATEK has been one of SANUWAVE’s most active partners in promoting both dermaPACE® and orthoPACE® in Europe. Their innovative and proactive approach towards promoting dermaPACE and orthoPACE is reflected in this program which will assemble some of the most accomplished medical researchers and medical practitioners in Italy. The program will discuss the newest clinical information related to the mechanism of action for SANUWAVE’s product line and to discuss clinical case-studies and on-going research in the field of extracorporeal shock wave technology (ESWT) and in particular the use of dermaPACE for wound indications and orthoPACE for orthopedic indications. Specific topics include:

Update on mechanism of action: from mechanobiology to the clinical practice, M.C., D’Agostino
Shock Wave Therapy for Myofascial Syndrome “Trigger Point”, A. Previtera
Update about international guidelines and new therapeutic frontiers, E. Tibalt

MATEK, with headquarters in Milan, Italy, has long been SANUWAVE’s partner in Italy. With their strength, experience and knowledge of the orthopedics and the wound care market, they are well positioned to help expand SANUWAVE’s market penetration via increased clinical presence and to continue to promote the company’s core products, dermaPACE and orthoPACE. “MATEK, once again, is setting the stage for creativity in furthering the field of ESWT. They are a model, not just in Italy, but in all of Europe, for how to create excitement and discussion among clinical researchers and practitioners alike.” stated Mr. Richardson, Chief Executive Officer of SANUWAVE. “We are extremely fortunate to have MATEK as a key team member in promoting our products abroad.”

For information related to MATEK’s Scientific Program, contact Ms. Annalisa Ali by email at commerciale@mateksrl.com or by telephone at +39 02 87264725.

About SANUWAVE Health, Inc.

About MATEK

Operating since 2010 in the field of medical instruments, MATEK s.r.l. is the exclusive distributor in Italy of the products manufactured by SANUWAVE Inc., an emerging US-based regenerative medicine company. With the support of its specialized technical experts and qualified professionals, MATEK s.r.l. supplies its customers with electrohydraulic focused shock wave generators. This technique has been proven to have a high success rate in the treatment of soft tissue and bone diseases. MATEK’s mission is to provide users of medical devices, and in particular of focused shock wave generators, all-inclusive support to ensure consistently high quality levels even with intensive use. We offer training courses, assistance in promoting the presence and use of the medical device, medical/scientific support and technical/administrative information in relationships with the competent health authorities.

Forward-Looking Statements

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

General Meeting of Kuros Biosciences approves all resolutions

Posted On May 23, 2017 By OrthoSpineNews In Biologics, Financial /

23 May 17

Kuros Biosciences announced that yesterday’s General Meeting approved all resolutions proposed by the Board of Directors with a vast majority. In particular, shareholders resolved on an increase of the conditional and authorized capital. Prof. Dr. Clemens van Blitterswijk, Frank-Jan van der Velden, Giacomo Di Nepi and Dr. Ivan Cohen-Tanugi were elected as new members of the Board of Directors. A total of 36.1 % of shares were represented at the General Meeting.

The General Meeting approved the Annual Report, the Annual Financial Statements, and Consolidated Financial Statements for the year 2016 and took note of the Reports of the Auditors. Shareholders also voted in favor of the proposed appropriation of the Annual Results, discharged the members of the Board and the Executive Comittee and approved their compensation.

Dr. Christian Itin was re-elected as Chairman as were Leanna Caron, Didier Cowling, Dr. Gerhard Ries and Harry Welten as members of the Board. Shareholders also elected Prof. Dr. Clemens van Blitterswijk, Frank-Jan van der Velden, Giacomo Di Nepi und Dr. Ivan Cohen-Tanugi as new Board members. Dr. Ries and Leanna Caron were elected as members of the Compensation Committee. Finally, the current Independent Proxy as well as the Auditors were confirmed for another term.

Dr. Christian Itin, Chairman of the Board, commented on the election of Prof. Dr. van Blitterswijk, Dr. Cohen-Tanugi and Messrs van der Velden and Di Nepi: „Kuros is in transition to become a commercial-stage orthobiologics company. Ahead of the market launches of our product lines MagnetOs^TM and Neuroseal, we strengthen the commercial and scientific expertise on the Board level.” He continued: „We thank Dr. Arnd Kaltofen and Dr. Jörg Neermann who did not stand for re-election. As long-time Board members, Arnd and Jörg sustainably contributed to Kuros’ development.“

Shareholders also resolved on an increase of the authorized (to 3,224,661 registered shares) and conditional share capital for Employee Benefits (to 1,208,389 registered shares) and corresponding changes to the Articles of Incorporation.

The General Meeting took place at the Company’s headquarters in Schlieren. It was attended by 36 shareholders. 2,326,113 shares or 36.1% of a total of 6,449,323 shares were represented.

Updated company presentation

An updated corporate presentation is available under the following link: www.kuros.ch/investors/reports-presentations.html.

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel: +41 79 750 15 64

harry.welten@kuros.ch

About Kuros Biosciences Ltd

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

Forward Looking Statements

This news 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.

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BONESUPPORT™ Announces First Patient Enrolled in FORTIFY Trial with CERAMENT®|G

Posted On May 23, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 22 May 2017– BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that the first patient has been enrolled by Dr Ravi Karia at the University of Texas Health Science Center at San Antonio into the company’s pivotal Investigational Device Exemption (IDE) trial: A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (the FORTIFY trial: ClinicalTrials.gov Identifier: NCT02820363).

CERAMENT G is an injectable antibiotic-eluting bone graft substitute that has proven remodeling capabilities and provides local sustained delivery of gentamicin. The data from the trial will support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G in the US.

In spite of modern day care of open tibial fractures, bone loss coupled with wound contamination and soft tissue damage continue to impair healing and recovery, particularly if infection develops. In addition, open tibial fractures result in a general infirmity, long-term disability and reduction in quality of life for patients, and a significant clinical challenge for orthopedic surgeons.

The FORTIFY trial will assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union. The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Dr. Douglas Dirschl, the trial’s Principal Investigator, said: “I am excited to take part in the FORTIFY clinical trial. The open tibial fracture remains the most common and one of the most troublesome open fractures managed by orthopedic surgeons. Even with modern treatment protocols, patients suffering this fracture continue to be at substantial risk of infection, fracture non-union, and prolonged disability. A product that could be inserted into the fracture site at the time of definitive treatment that could promote bone formation at the same time as reducing the risk of subsequent infection, would be a major advance in the treatment of these troublesome fractures and would have the potential to provide benefit to thousands of patients each year in the United States.”

Douglas R. Dirschl, MD is the Lowell T. Coggeshall Professor of Orthopedic Surgery and Chairman, Department of Orthopedic Surgery and Rehabilitation Medicine at The University of Chicago Medicine.

“The treatment of the first patient in the FORTIFY trial is another key corporate milestone for BONESUPPORT. This clinical trial in a complex trauma indication is designed to demonstrate proof-of-concept that CERAMENT G can be used to improve and protect the healing process in open bone fractures in combination with standard procedures, minimizing the risk of deep infections which would result in the need for additional remedial procedures,” added Richard Davies, CEO of BONESUPPORT. “We plan to use the clinical data to support our planned PMA filing for CERAMENT G in the US. We also intend to generate additional clinical data with CERAMENT G to gain a broad US label for this novel, injectable antibiotic-eluting bone graft substitute, which is rapidly being adopted in Europe.”

CERAMENT G combines the bone healing and bone remodeling properties of CERAMENT with the antibiotic, gentamicin. CERAMENT G drug-eluting properties enable it to provide an initial high concentration of gentamicin to the environment of the bone fracture and then a longer sustainable dose above the minimum inhibitory concentration of many of the bacteria that could cause a bone infection at the fracture site. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.

CERAMENT G received the European CE Mark in February 2013 and is now marketed in 19 countries outside the US.

Notes to Editor

About BONESUPPORT

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENTG and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

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 based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

BONESUPPORT AB

Richard Davies

info@bonesupport.com

+46 (0)46 286 53 24

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

+44 (0)20 7638 9571

bonesupport@citigatedr.co.uk

Anika Celebrates 25th Anniversary and Inaugurates Newly Expanded Global Manufacturing Facility

Posted On May 23, 2017 By OrthoSpineNews In Biologics /

May 23, 2017 08:30 AM Eastern Daylight Time

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, is hosting a celebration today at its Bedford, Massachusetts headquarters to commemorate its 25^th anniversary and inaugurate its newly-expanded and consolidated global manufacturing facility. Previously, Anika’s manufacturing operations were split between its U.S. headquarters and a contract manufacturer in Abano Terme, Italy, but the company initiated plans to onshore manufacturing in the U.S. to maintain better control of supply chain, accelerate product development, and increase operating efficiency. By year end, our 134,000 square foot corporate headquarters and the newly expanded state-of-the-art facility will manufacture and package the totality of the company’s diverse portfolio of more than 20 products for distribution into more than 55 markets across the globe.

“We are proud and excited to consolidate our entire manufacturing operation in the United States on the 25^th anniversary of our inception,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer, Anika Therapeutics. “The new facility not only helps Anika more deftly manage global supply and inventory, but it also creates opportunities for a highly-skilled workforce, and brings sophisticated scientific capabilities and cutting-edge technologies back to the U.S. and to the state of Massachusetts, which has been a steadfast and supportive partner throughout our 25-year journey.”

Anika develops, manufactures and commercializes a diverse range of therapeutic products, the large majority of which are based on its proprietary formulation of non-animal-derived HA, a naturally occurring substance in the human body with lubricating, healing, restorative and regenerative properties. In the Bedford-based manufacturing facility, Anika utilizes proprietary processes to produce its suite of unique gel-based and textile-form products from highly-concentrated and ultra-pure HA. Anika’s Bedford-based manufacturing facility and corporate headquarters employs approximately 100 operations, engineering, clinical, assembly, warehouse, marketing, general and administrative professionals, and it is the only facility in the U.S. with the sophisticated capability to produce HA products in solid textile forms.

“We welcome Anika Therapeutics’ decision to bring its healthcare manufacturing sector back to the U.S. and to the Commonwealth as they celebrate 25 years supporting our local economy,” said Governor Charlie Baker. “Our strong and talented workforce is helping businesses large and small thrive, supporting economic growth and new jobs across Massachusetts.”

“For 25 years Anika Therapeutics has provided value and stability to not just the life sciences industry, but the Commonwealth as a whole. With this upcoming expansion, the anticipated and sustained impact on the local and state economy cannot be overstated,” Travis McCready, President & CEO of the Massachusetts Life Sciences Center said. “On behalf of the Massachusetts Life Sciences Center, I congratulate Anika on these first 25 years, and look forward to their continued success for the next quarter century and beyond, here in Massachusetts.”

“Congratulations to Anika and its leadership on celebrating 25 years of success and growth,” said Robert K. Coughlin, CEO and President of MassBio. “Their longevity and commitment to innovation is a shining example for other Massachusetts companies who are looking to follow their lead.”

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC^®, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST^®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the last sentence of the first paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s expectations regarding 2017 production capabilities. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Susan Heins, 864-286-9597