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Biologics

Tissue Regenix Announces Proposed Acquisition of CellRight Technologies

July 21, 2017 OrthoSpineNews

July 21, 2017

SAN ANTONIO–(BUSINESS WIRE)–Tissue Regenix, the UK-based regenerative medical devices company, today announced the proposed acquisition of CellRight Technologies, a U.S. regenerative medicine company based in San Antonio, TX. This acquisition would bring together two highly complementary technology and product platforms focused on soft-tissue regeneration and regenerative bone matrices, respectively.

The deal accelerates both companies’ vision to becoming a global leader in regenerative medicine by accelerating growth and penetration into key U.S. markets. The combined group will have a highly complementary product offering with CellRight Technologies’ existing orthopedic portfolio, based on human-derived bone graft products, and Tissue Regenix’s soft tissue products based on its patented decellularisation dCELL® Technology (dCELL®), a multi-tissue regenerative medical platform.

The combined group provides CellRight Technologies with the infrastructure of a larger, multi-national organization and a platform to enter new geographies. CellRight Technologies’ human tissue-based products, including Matrix OI, will expand the current Tissue Regenix portfolio, which includes DermaPure® for wound care applications. Additionally, CellRight Technologies’ existing tissue bank in San Antonio, TX, provides Tissue Regenix with a purpose built U.S. base to self-manufacture products utilizing its patented dCELL® process.

Combined with the capabilities of CellRight Technologies’ osteobiologics, this acquisition positions Tissue Regenix to launch into the U.S. orthopedics market in early 2018 with a focus on ligament reconstruction, initially addressing anterior cruciate ligament repair, through OrthoPure® HT, a decellularised human tendon.

“We are excited by the huge potential that this acquisition brings for the advancement of regenerative medicine to our patients globally,” said Antony Odell, CEO of Tissue Regenix. “We are combining two highly complementary companies that are committed to developing a robust portfolio of products and we are poised for rapid growth through our existing product offering with plans for multiple U.S. launches over the next two years.”

CellRight Technologies has seen tremendous success in the U.S., including leveraging strong relationships with orthopedics and sports medicine companies. Founder and CEO Jesus Hernandez has been at the heart of research and development for the CellRight Technologies product line.

“Becoming part of the Tissue Regenix family is an exciting and important milestone for our company,” said Jesus Hernandez, founder and CEO of CellRight Technologies. “With the combined talent and expertise in biologics, we look forward to continuing to lead regenerative medicine, bringing our patients and healthcare partners the products and innovation which enhance their lives. We are all excited at the potential of what we will be able to accomplish together.”

For more information about Tissue Regenix, please visit http://www.tissueregenix.com/.

Important notice

The information contained herein is not for release, directly or indirectly, in or into Australia, Canada, Japan or the Republic of South Africa. This document (and the information contained herein) does not contain or constitute an offer of securities for sale, or solicitation of an offer to purchase securities, in the United States, Australia, Canada, Japan or the Republic of South Africa or any other jurisdiction where such an offer or solicitation would be unlawful. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States unless the securities are registered under the Securities Act, or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. No public offering of the securities will be made in the United States.

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularisation (‘dCELL®’) Technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

About CellRight Technologies

CellRight Technologies is the industry leader of osteoinductive matrices and is committed to providing clinicians and their patients with verified osteoinductive implants known to positively impact patient and fusion outcomes. In-vivo and in-vitro testing to verify osteoinductivity is performed post-sterilization by an independent testing laboratory using validated osteoinductivity test methods.

Contacts

Racepoint Global
Jeff Stoecker, +1-617-624-3424
jstoecker@racepointglobal.com

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BiologicsTop Stories

Singapore launches $13M 3D printing center with focus on medical research

July 21, 2017 OrthoSpineNews

Jul 21, 2017 | By Tess

A new 3D printing center with a focus on healthcare research was inaugurated in Singapore this morning. Called the National University of Singapore Centre for Additive Manufacturing (AM.NUS), the new facility is initially being funded by a grant of S$18 million (around $13,208,102) provided by NUS, the National Additive Manufacturing Innovation Cluster (NAMIC), and the Singapore Economic Development Board (EDB).

Researchers at AM.NUS, which was launched earlier today by Mr. Amrin Amin, a Parliamentary Secretary at the Ministry of Home Affairs and Ministry of Health, will reportedly work alongside the NUS’ Yong Loo Lin School of Medicine, as well as its Faculties of Engineering, Science, and Dentistry, and its School of Design and Environment.

The goal of establishing the new additive manufacturing center is to advance 3D printing technologies in the fields of biomedicine and healthcare and to “boost” NUS’ standing in the field of biomedical additive manufacturing.

“The NUS Centre for Additive Manufacturing will play a critical role in supporting Singapore’s vision of becoming a leading AM hub,” commented Professor Jerry Fuh Ying-Hsi, Co-Director of AM.NUS and the Thrust Lead of Restorative Repair & Implants from the Department of Mechanical Engineering at the NUS Faculty of Engineering.

“Through this inter-faculty pooling of expertise, we hope to boost technology capabilities as well as advance intellectual property development and commercialization of AM-enabled biomedical technologies.”

The new AM center will focus its research on a number of specific areas, including the development of customized 3D printed surgical instruments, simulators, and functional prosthetics; 3D printing-enabled customized medicine (i.e. personalized drug formulations, dosages, and drug release); advancing tissue repair using 3D printed scaffolds and tissue engineering; developing restorative repairs and implants with ceramic and metal 3D printing; and oral health and craniofacial applicaitons, which will be conducted with the NUS Faculty of Dentistry.

 

READ THE REST HERE

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Biologics

Collagen Matrix Celebrates 20 Years of Science, Technology and Innovation

July 20, 2017 OrthoSpineNews

OAKLAND, N.J., July 18, 2017 /PRNewswire/ — It started with an idea that transformed into a success story, 20 years in the making. Today, Collagen Matrix, celebrating its 20th anniversary, has developed collagen and mineral based medical devices that have helped patients worldwide with over 7.5 million products sold. The Company has grown from a start-up business with a handful of employees to nearly 200 team members located in two state-of-the-art facilities totaling 73,000 sq. ft. and now distributes products worldwide.

Advancing the Science
The Company’s passion for advancing the science of tissue repair and regeneration has helped the healthcare industry by designing, developing and manufacturing innovative medical devices that support the body’s natural ability to regenerate. Collagen Matrix has built two decades of science, technology and innovation into its robust product portfolio in five key therapeutic areas – Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair.

Teamwork, Leadership & Evolution
Collagen Matrix is very proud of its evolution and advancement, which shows how determination, perseverance and teamwork can provide significant success. “To see what has transpired here in just 20 years is an incredible achievement for this organization,” said Bart J. Doedens, Chief Executive Officer. “We continue to build on our capabilities to help our customers provide products that solve clinical challenges, and we confidently look forward to what the next 20 years will bring.”

“The past two decades have been an extraordinary journey,” said Shu-Tung Li, Ph.D., Founder and Chief Scientific Officer, “Our focused commitment to R&D continues to position us as the expert in producing collagen based products and has facilitated the Company’s success. We wouldn’t be here without the dedication and commitment of our employees and support of our customers.”

New Branding, Website & Celebration
To celebrate, the Company has launched new branding for its five Business Units and developed a technologically savvy new website, www.CollagenMatrix.com, with interactive product videos, downloadable marketing and sales literature and numerous valuable resources for its users. A formal event is planned for the fall where the Collagen Matrix team members will celebrate the Company’s success.

About Collagen Matrix
Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate. The Company currently manufactures finished medical devices in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery. The evolution of the Company’s leadership, proprietary technologies, manufacturing expertise and product portfolio has established a solid foundation for continued growth. Opportunities continue to exist for collaboration through Product Distribution, Product Development and Contract Manufacturing. More information about Collagen Matrix can be found at www.CollagenMatrix.com.

Contact: Margo Lane
201-405-1477
mlane@collagenmatrix.com

SOURCE Collagen Matrix, Inc.

Related Links

http://www.collagenmatrix.com

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BiologicsTop Stories

SANUWAVE Appoints Alat Medika Indonesia as Distributor for dermaPACE and Liaison to Clinical Trials Participation for Company’s Wound Care Product(s) in Indonesia

July 20, 2017 OrthoSpineNews

SUWANEE, GA–(Marketwired – Jul 20, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the Company has appointed Alat Medika Indonesia as distributor for dermaPACE® and liaison for clinical trials participation for Company’s wound care product in Indonesia. The expected revenue from this agreement will be north of $1 million over the next three years.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage Alat Medika Indonesia was made to increase our focus and visibility within Indonesia for the wound care market. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Indonesian market. It is well known that diabetes and related concerns need to be addressed within Indonesia and having access to outstanding technology such as SANUWAVE’s within the country is a positive step. We will need speedy access to potential clinical trials to ensure we add value with our product offering as well as clinical proven outcome. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOLs),” concluded André Mouton.

Christian Hainsch, Chief Product Officer of Alat Medika International Group, declared, “Setting the ‘PACE®‘ in wound healing in Indonesia! A technical milestone in professional wound healing is coming to Indonesia. With dermaPACE, SANUWAVE developed an innovative medical device for patients suffering from diabetic wounds, ulcer or burn injuries. One of the major indications for the use of dermaPACE, and most important for Indonesia, is the treatment of diabetic ulcers. With dermaPACE the regeneration process of tissue from chronic wounds is increased and can be an alternative to amputation or medication based treatment. Diabetes and other patients benefit from a simple, painless and side-effect free treatment for faster healing and quicker recovery to improve quality of life,” concluded Mr. Hainsch.

SANUWAVE is using this occasion to further educate on our lead wound care product dermaPACE. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www.sanuwave.com.

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 Alat Medika Indonesia
Being a reliable partner for hospitals, doctors and health care facilities, Alat Medika Group Indonesia brings the best medical devices to Indonesia. Serving the health care market with dedication, passion and highest quality technology standards the expert team of Alat Medika provides local medical practitioners, clinics and hospitals with a full range of medical devices ranging from laboratory equipment to radiology, sonography, laser technology for diagnostics, therapy and health care. Our team of technical and medical experts helps customers all over Indonesia to identify their needs, supply best in class medical devices and maintain and service the health care infrastructure.

Contact:
PT. Alat Medika Indonesia
Graha Mustika Ratu Bldg. 10th Floor
Jl. Jend. Gatot Subroto Kav. 74-75
Jakarta 12870 – Indonesia
sales@almed-indonesia.com
Phone: +62 21 83708874

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

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

CONTACT INFORMATION

  • Contact:

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

    SANUWAVE Health, Inc.
    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

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Biologics

Bioventus Expands EXOGEN® Performance Program in Canada to Include All Fracture Types

July 17, 2017 OrthoSpineNews

July 17, 2017

MISSISSAUGA, Ontario–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced it has expanded the Performance Program* for its EXOGEN Ultrasound Bone Healing System to include delayed union and acute fractures. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.1

Since 2014, the Performance Program has been in place to refund patients their out-of-pocket payment for EXOGEN if progression of fracture healing for nonunion was not shown. The company is now expanding this program in Canada to include delayed union and acute (fresh) fractures, excluding the skull and vertebrae.

“Physicians and patients have enjoyed positive outcomes from EXOGEN and the expansion of the Performance Program to include all fracture types underscores our belief in the device,” said Tony Bihl, CEO, Bioventus. “If progression of healing is not shown, we will take the device back and refund the patient associated out-of-pocket costs for it.”

Absence of healing (progression to bony union) is determined by the prescribing physician by comparing the patient’s X-rays taken prior to using EXOGEN to one taken at 120 days or later. Patients must treat their fracture with EXOGEN per product instructions, for a minimum of 120 days and achieve maximum adherence of 90%. The device contains an internal patient usage monitor that records the date, time and duration of each treatment session.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.

*Certain restrictions apply, visit our website for full details.

1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001; 16(4):671-680.

Summary of Indications for Use: In Canada, the EU, Australia and New Zealand

EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:

• Treatment of delayed union and non-unions†

• Accelerating the time to heal of fresh fractures

• Treatment of stress fractures

• Accelerating repair following osteotomy

• Accelerating repair in bone transport procedures

• Accelerating repair in distraction osteogenesis procedures

• Treatment of joint fusion

† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling at www.exogen.com.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

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BiologicsExtremities

PuraPly™ Antimicrobial Named One of Top 10 Innovations in Podiatry

July 13, 2017 OrthoSpineNews

CANTON, Mass., July 13, 2017 /PRNewswire/ — PuraPlyTM Antimicrobial (PuraPlyTM AM), an FDA 510(k)-cleared wound management product from Organogenesis Inc., has been named one of the “Top 10 Innovations in Podiatry” by Podiatry Today, an award-winning publication that covers the latest developments in podiatric medicine.

PuraPly AM was selected as a top innovation for 2017 for its impact on reducing bioburden in wounds.

It is estimated that the majority of wounds possess biofilm, which can negatively impact tissue repair and delay healing if not addressed. With PuraPly AM, clinicians have a product solution to specifically address this challenge.

“A lot of times, debridement alone isn’t enough to prevent the reformation of biofilm,” said Ryan Fitzgerald, DPM, FACFAS, Associate Professor of Surgery at the University of South Carolina School of Medicine, in the article from Podiatry Today. “As part of a comprehensive biofilm-based wound management approach including sharp debridement, PuraPly AM provides a barrier that helps prevent biofilm re-formation and supports healing.”

PuraPly AM is an FDA 510(k)-cleared Class II medical device that is intended for management of a variety of acute and chronic wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers. PuraPly AM is unique in that it combines purified native collagen with PHMB, which provides broad antimicrobial coverage and protects against a wide range of bacteria that colonize wounds and can progress to biofilm formation and infection.

“Developing and manufacturing innovative products that serve our customers’ needs is at the heart of what we do, so it’s an honor for PuraPly AM to receive this distinction,” said Gary S. Gillheeney, Sr., President & CEO of Organogenesis Inc. “We’re pleased about the extremely positive reception this product has received since its 2015 launch and look forward to helping more wound care clinicians utilize PuraPly AM in the fight against bioburden and infection.”

For more information on PuraPly AM, click here.

About Organogenesis Inc.
Headquartered in Canton, Massachusetts, Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’ versatile portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

Media Contact:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com/

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BiologicsTop Stories

FIDIA PHARMA USA Inc. Continues to Expand U.S. Presence as Fidia Farmaceutici S.p.A. Leads European Orthopedic Biomaterials Market

July 12, 2017 OrthoSpineNews

July 11, 2017

PARSIPPANY, N.J.–(BUSINESS WIRE)–Fidia Farmaceutici S.p.A., a world leader in the research, development and manufacturing of hyaluronan (HA)-based products, and its wholly owned subsidiary, FIDIA PHARMA USA Inc., are projecting continued growth in 2017. The global viscosupplementation market is anticipated to increase to over $2.64 billion by 2021, according to a research study by RnR Market Research1.

Fidia Farmaceutici S.p.A. now leads the orthopedic biomaterials market in Europe after increasing its market share over the past few years. The largest segment of the biomaterials market internationally is HA viscosupplementation, to inject lubricating fluid into a joint. The company’s strong presence in the HA viscosupplementation market, with its product HYALGAN®, and Fidia’s entrance into the German market have contributed to the expansion.

“Fidia is building upon its structure and experience to expand its business and strengthen its presence in the U.S. and globally,” said Aldo Donati, president, FIDIA PHARMA USA. “Fidia Farmaceutici has invested in research and development of hyaluronic acid-based products for more than 70 years. Today, Fidia is growing its product portfolio with new, innovative solutions to meet challenges in the field of osteoarthritis using science, our legacy and our drive.”

In the United States, FIDIA PHARMA USA Inc. offers HYMOVIS® and HYALGAN®, which are viscoelastic hyaluronan injection treatments for osteoarthritis (OA) knee pain that may help to delay total knee replacements2.

More than 20 million Americans suffer from knee OA. By 2030, 20 percent of Americans over the age of 65 will be at risk for developing OA, according to the U.S. National Library of Medicine. The rise in OA of the knee diagnoses is reported to be attributed to an increase in life expectancy, obesity and sedentary behavior3.

The United States continues to hold the largest market share in the global viscosupplementation market. Growth is anticipated to be based off of the latest health care infrastructure, well-established reimbursement, aggressive marketing efforts on supply, and trends toward early intervention and demand for nonsurgical OA treatment.

HYMOVIS® is a breakthrough in HA-based intra-articular (IA) therapy for the treatment of OA knee pain. Specifically engineered to fulfill a need of having a true viscoelastic hydrogel that is non-crosslinked and naturally derived from non-avian sources, HYMOVIS®maintains enhanced properties of improved lubrication to decrease friction, exhibits greater elasticity in recovering its original structure even after repeated mechanical stresses, and demonstrates increased residence time in the knee joint*. HYMOVIS® is delivered as an IA injection in a convenient two-dose regimen, with each injection given one week apart.

HYALGAN® is a solution that contains a natural substance called hyaluronate, which is normally found in the fluid that lubricates and cushions the knee joint. HYALGAN® is injected into the knee to relieve pain due to osteoarthritis. It is a five-injection regimen given at weekly intervals that provides long-lasting pain relief for up to six months. Some patients get benefits with three injections given at weekly intervals as reported in the published literature in which patients were followed for 60 days.

About FIDIA PHARMA USA Inc.

FIDIA PHARMA USA Inc. is a wholly owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid market segment. FIDIA PHARMA USA Inc. is focused on expanding Fidia’s position in the U.S. and Canadian market, while upholding the company’s mission to provide consumers with innovative products that offer quality, safety and performance. FIDIA PHARMA USA Inc. is headquartered in Parsippany, N.J. For more information, please visit www.fidiapharma.us.

About Fidia Farmaceutici S.p.A.

Fidia Farmaceutici Fidia Farmaceutici is an Italian company founded in 1946 with proven expertise in Neuroscience, acquired over the years thanks to an activity of Research and Development unique in the Italian pharmaceutical scenario. It is also a top leading company in marketing products based on hyaluronic acid, which have many applications in the biomedical field, in areas such as rheumatology, orthopaedics, wound care, tissue repair and dermo-aesthetics, with worldwide leadership in viscosupplementation. Fidia Farmaceutici is part of the Milanese P&R Holding group. The company is well established in Italy, with R&D activities carried out both in Abano (where the company’s headquarter is located) and at the Research Unit in Noto (Sicily, Italy). The turnover will amount over 300 million Euros in 2017, of which 70% generated in international markets. Fidia Farmaceutici’s products are marketed in over 100 countries, through wholly-owned subsidiaries – in USA, Kazakhstan, Germany, Spain, Russia and the Middle East – and a comprehensive network of international partners and distributors. Thanks to its investment in R&D, it has managed to create a time-honored legacy of products, with over 900 patents to its name.

Indications: HYALGAN® and HYMOVIS® are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).

Important Safety Information: HYALGAN® and HYMOVIS® are contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram positive bacterial proteins (HYMOVIS® only) or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.Hyalgan.comand www.Hymovis.com. Rx Only

HYMOVIS® and HYALGAN® are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2017 FIDIA PHARMA USA Inc., Parsippany, NJ, a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID523-06.2017

*Data on file – Preclinical studies may not be indicative of human clinical outcomes.

Rx Only

1 http://www.rnrmarketresearch.com/medipoint-viscosupplementation-global-analysis-and-market-forecasts-market-report.html

2 Turajane T, Tanavaree A, Labpiboonpong V, Maungsiri, S. Outcomes of intra-articular injection of sodium hyaluronate for the treatment of osteoarthritis of the knee. J Med Assoc Thai. 2007;90(9):1845-1852.

3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612336/

Contacts

FIDIA PHARMA USA Inc.
Carolyn Kong, 1-973-507-5120
ckong@fidiapharma.us

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BiologicsTop Stories

Regenexx Announces Successful Merger with Harbor View Medical

July 12, 2017 OrthoSpineNews

July 11, 2017

BROOMFIELD, Colo.–(BUSINESS WIRE)–Regenexx, a Colorado-based stem-cell-treatment network and pioneer in the invention of interventional orthopedics, today announced that it successfully merged with Harbor View Medical, a leader in orthopedic stem cell therapy and part of the Regenexx network, which became effective in May 2017. As part of the transition, Jason Hellickson has assumed the CEO role. This merger positions Regenexx to further expand its National Network to better serve patients and our corporate partners.

Regenexx Corporate will be headquartered in Des Moines, IA, while Regenexx’s Affiliate Program and Research and Development will be lead out of the company’s Broomfield, CO location. Dr. Christopher Centeno, founder of orthopedic stem cell treatments and leader of interventional orthopedics in the United States and pioneer of the Regenexx patented procedures, will continue his role as Chief Medical Officer and remain in clinic operations in Broomfield, and continues the advancements of regenerative medicine through the largest research and data collection effort in orthopedic regenerative medicine.

“As the most advanced non-surgical orthopedic care available in the United States, I’m excited to continue our mission to producing the best possible patient outcomes through interventional orthopedics,” said Jason Hellickson, CEO, Regenexx. “In addition to individual personalized care, we will continue to provide both employers and their employees with cost savings results and successful interventions to orthopedic surgery.”

Since joining the Regenexx Network in late 2014, Hellickson has reengineered clinic operations which increased capacity by more than 300 percent while offering a streamlined approach beneficial to both patients and clinic staff. He is the innovator and leader of the Regenexx Corporate Program that enables large employers access to the Regenexx procedures. Since adding Regenexx procedures to their self-funded health and workers’ compensation plans, corporate partners have saved as much as 83 percent in their orthopedic surgical expenses, totaling in the many millions of dollars. In his new role, Hellickson will continue to architect the Regenexx national clinical operations to create more streamlined approaches to patient care and expand Regenexx clinics nationwide.

“We look forward to continuing the build-out of Regenexx clinics, streamlining affiliate networks of more than 50 clinics nationwide, and adding additional clinics in major metropolitan areas including Chicago, Atlanta, Dallas, Philadelphia, and Charlotte under Jason’s helm,” said Christopher Centeno, MD. “We’re excited about the experience and enthusiasm that Jason brings to Regenexx.”

Regenexx is the world leader in interventional orthopedics using orthobiologics and has been issued many patents for it’s evidence-based stem cell and blood platelet treatments used for back pain, joint pain, arthritis and acute orthopedic injuries. The benefits of interventional orthopedics are so revolutionary that seventy percent of orthopedic issues currently treated with surgery could instead be handled using regenerative methods. Mesenchymal stem cells are multipotent, adult stem cells that are therapeutic agents in the repair and regeneration of muscle, tissue, cartilage and bone. Regenexx procedures use a patient’s own bone marrow-derived stem cells, or blood platelets, through a blood draw, to customize needle-based, precisely-guided procedures to treat common orthopedic conditions. Its procedures have been proven to have the same or better outcomes compared to their surgical alternative.

For more information on the Regenexx Corporate Program call: 888-547-6667. For general information on Regenexx, please visit www.Regenexxcorporate.com. For a map of current Regenexx clinics and providers click here.

About Regenexx and the Regenexx Physician Network
The Regenexx® Procedures are the nation’s most advanced non-surgical stem cell and blood platelet treatments for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone.

For more information on Regenexx, please visit: http://www.regenexx.com

Contacts

For Regenexx
Kaitlyn Ethier
kethier@matternow.com

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BiologicsNeuroTop Stories

InVivo Therapeutics Appoints Richard Toselli, M.D. as Chief Medical Officer

July 10, 2017 OrthoSpineNews

July 10, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the appointment of Richard Toselli, M.D., as Chief Medical Officer, effective July 5, 2017. Dr. Toselli, a fellowship-trained spinal neurosurgeon, will assume all responsibilities related to the company’s clinical and regulatory strategy.

Prior to joining InVivo, Dr. Toselli served as Chief Medical Officer for Cochlear Limited. In that role, he was responsible for global clinical, regulatory, and medical affairs teams reporting to the CEO. Prior to that, Dr. Toselli served five years at Sanofi in various levels of increasing responsibility, including Vice President of Global Medical Affairs – Immunology and Inflammation, Biologics Division; Vice President of Global Medical Affairs and Head of the Biosurgery Discovery Performance Unit; and Vice President of Global Medical Affairs, Biosurgery. Before his time at Sanofi, he served as Chief Medical/Technology Officer for Covidien Surgical, and earlier held various roles at DePuy Spine including Director of Medical Affairs, Worldwide Vice President of Research and Development, and Worldwide Vice President of Clinical Evidence and External Relations. He subsequently held the position of Vice President of Evidence-Based Medicine at Johnson & Johnson for the device sector.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We are pleased to welcome Rich to the InVivo team during this pivotal moment in the company’s history. His deep industry experience paired with his medical training as a spine trauma neurosurgeon make him an invaluable asset as we look to finish enrollment of our pivotal probable benefit study and file for marketing approval.”

Dr. Toselli’s previous academic positions include Assistant Professor at Brown University, Associate Professor, Director of Spine Center, and Associate Chief of Staff at the University of North Carolina (UNC), and Associate Professor at the University of Vermont. He holds a bachelor of arts from Providence College, his medical degree from Brown University, and a masters of business administration from the UNC’s Kenan-Flagler Business School. Dr. Toselli is a board-certified neurological surgeon.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the progress of the clinical program and the timing of the completion of enrollment in the INSPIRE Study and of the filing of an application for marketing approval. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

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BiologicsTop Stories

Bone Therapeutics Strengthens Board of Directors

July 5, 2017 OrthoSpineNews

Gosselies, Belgium, 3 July 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 that Steve Swinson has been elected as Chairman of the Board of Directors. He will replace Michel Helbig, who has stood down as Chairman but will continue as a Non-Executive Director.

Bone Therapeutics has also continued to strengthen its Board with the appointment of Dirk Dembski as a Non-Executive Director. The appointment of Dirk, a seasoned executive with expertise in orthopaedics and biotechnology and experience in sales, marketing, business development and medical education for global life sciences companies, complements the recent appointments of Steve Swinson and Damian Marron, who both joined the Bone Therapeutics Board in May. These appointments significantly increase the breadth of specialist orthopaedic and regenerative therapy expertise at the Company and will help support the new management team, led by Chief Executive Thomas Lienard.

Steve Swinson has served in a number of senior roles in orthopaedic medical technology and electronics, including general management, senior strategy, sales, marketing and commercial operation positions at Medtronic. 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 division. with substantial revenue responsibility. In a 30-year international business career covering Asia, US, Europe and Africa, he has also held senior positions in the diagnostic and medical divisions of 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. Steve Swinson is currently chairman of the board of Vexim, a medical device company specializing in minimally invasive treatment of vertebral fractures and is also on the board of directors of Acteon Group, a leader in dental equipment and imaging products.

Dirk Dembski has held a variety of roles in biotechnology, orthopaedics and medical companies and has built and driven global sales and marketing operations and served in business development positions. He is currently serving as Managing Director of bricon Group, the German business unit of Naton Medical Group, one of China’s largest Medtech companies, where he completed several acquisitions and drives the international business. He also worked as Vice President of Sales, Marketing and Business Development at Olympus Biotech for EMEA, Asia Pacific and Latin America, where he successfully marketed a portfolio of bone growth factors, cell technologies and innovative biomaterials. Dirk has also worked as director of sales and marketing for Small Bone Innovations, a bone medical technology company which was acquired by Stryker.

Marc Nolet de Brauwere van Steeland, stepped down as a Non-Executive Director on 30 June having served on the Bone Therapeutics Board since 2015.

Thomas Lienard, Chief Executive of Bone Therapeutics, said: “With the election of Steve Swinson as Chairman, and the appointments of Dirk Dembski and Damian Marron, we have a world-leading Board to support Bone Therapeutics as we approach critical inflection points for our allogeneic cell therapy platform. Our new Board members bring a unique and highly complementary set of skills and expertise in the development and commercialisation of orthopaedic and cell therapy products. I would like to welcome Steve and our other new Board members and also to thank Michel Helbig for his four years of service to Bone Therapeutics. Michel has provided calm and judicious guidance to the company through key strategic developments, including helping to steer the Company through its 2015 Initial Public Offering. Michel was instrumental in building the strong management team that will prove critical as the Company advances its allogeneic cell therapy platform towards commercialization, as well as in the development of the board since IPO. He has also played a key role more recently in recruiting top-level board members with strong international experience in the field in which Bone Therapeutics operates. We are delighted that he will remain on the Board to provide continued support.“

Steve Swinson, Chairman of Bone Therapeutics, commented: “I feel excited and privileged to be taking the role of Chairman at Bone Therapeutics. This is the most advanced Company in regenerative therapies for bone diseases which I believe has the potential to transform medical practice in this field. I hope to be able to apply my deep experience in medical technology to support Thomas Lienard and his team, alongside my colleagues on the Board, as we move this key product platform towards commercialization.“

Dirk Dembski added: “I feel my previous experience and expertise wil be invaluable to Bone Therapeutics as it develops into a commercially ready company. I look forward to working with Steve and the rest of the Board to help steer the company as it brings its exciting technologies to market.“

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.

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

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.

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