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Fuse Medical, Inc. Signs Definitive Purchase Agreement to Acquire CPM Medical Consultants, LLC

Posted On December 21, 2017 By OrthoSpineNews In Biologics, Extremities, Recon, Spine /  

December 19, 2017

RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc., (OTC: FZMD), (“Fuse” or the “Company”), announced today that it signed a definitive purchase agreement to acquire CPM Medical Consultants, LLC (“CPM”), a privately-owned nationwide distributor of medical device implants and biologics.

CPM is a stocking distributor with an extensive portfolio of orthopedic implants for total joint reconstruction, sports medicine, internal and external fixation products for extremities, and full spinal implants and instrumentation. CPM also offers an extensive assortment of biologics, which include human allograft with cell based products, regenerative tissue, and amniotic fluids to augment all types of surgical procedures.

Fuse expects the transaction to be accretive to 2018, and it anticipates the 2018 consolidated company revenues generated from its product sales and distribution to be at approximately $35 million. The transaction is subject to customary conditions of closing, which is expected to occur by December 31, 2017. Following the transaction, CPM will be a wholly-owned subsidiary of Fuse.

Management Commentary on Acquisition

Christopher C. Reeg, Chief Executive Officer of Fuse, said, “We are thrilled to have the CPM family join the Fuse team, and look forward to welcoming new business associates to Fuse. We are confident that the consolidated Fuse and CPM organizations will provide the necessary platform to achieve our numerous growth and expansion goals.”

“The acquisition of CPM is an ideal complement to our strategic objectives as it brings an experienced and proven distribution organization consisting of direct sales employees, independent sales agents, and sub-distributors who are focused in specific surgical areas. In developing our strategies in this market sector, we believe this new sales channel will provide us with an opportune pipeline for the expansion of national distribution and the launch of new product offerings, both internally developed and acquired,” added Mr. Reeg.

Mark W. Brooks, CPM Founder and Owner, stated, “We are excited with the expected benefits both organizations will gain from this transaction. CPM brings the ideal combination of broad product assortment, sales and distribution, and employee talents in a strategic market sector with outstanding growth potential. We expect our extensive product portfolio to strengthen and complement Fuse.”

“The prospect of combining the collective Fuse and CPM product portfolios is synergistic to both organizations,” commented Mr. Brooks.

About Fuse Medical, Inc.

Fuse provides a broad portfolio of orthopedic implants including internal and external fixation products; upper and lower extremity plating; total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; full spinal implants for trauma, degenerative disc disease, and deformity indications; human allografts, substitute bone materials, and tendons; and regenerative tissues and fluids to augment orthopedic surgeries and wound care. For more information about Fuse, please visit: www.fusemedical.com.

Forward-Looking Statements

Certain statements in this press release, including those related to an anticipated purchase of all of the outstanding membership units and plans for the consolidated company, constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based only on information available to the Company as of the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the Securities and Exchange Commission; the failure of the Company to close the transaction; and integration issues with the consolidated company. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events, or otherwise, except as required by law.

Contacts

Fuse Medical, Inc.
Devon Peddie, 469-862-3030
Investor Relations Analyst
Facsimile 469-862-3035
info@Fusemedical.com

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Physicians, patients should be aware of benefits, risks associated with biologic treatments for osteoarthritis according to new AAOS position statement

Posted On December 20, 2017 By OrthoSpineNews In Biologics /  

ROSEMONT, Ill., Dec. 20, 2017 /PRNewswire-USNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved a new “Use of Emerging Biologic Therapies” position statement urging orthopaedic surgeons and patients to be fully aware of the risks and benefits of stem cell and other biologic treatments for musculoskeletal joint conditions.

The development and use of biologics has expanded within orthopaedics over the past decade with some products reaching the market without extensive research or data. Biologics are treatments isolated or derived from natural sources—human or animal stem cells or tissues, or other microorganisms—through innovative technologies. Common biologic treatments include the injection of platelet rich plasma, a patient’s or donor’s blood heavily concentrated with platelets, into an osteoarthritis infected joint. Biologics also are used to repair damaged cartilage. Through a process called autologous chondrocyte implantation, healthy cartilage cells are removed from a patient, altered in a lab, and then implanted into a patient’s damaged cartilage to help spur regrowth.

“While gaining in popularity, and providing relief for some patients, biologic treatments may lack the demonstrated safety and efficacy of many traditional orthopaedic therapeutics,” said J. Tracy Watson, MD, chair of the AAOS Biologics Committee. “The Academy wants to make sure that doctors and patients are making informed treatment decisions, based on the most current research and product indications.”

The AAOS “believes that surgeons should be cognizant of the risks, benefits, regulatory status and labeled indications of the products they use,” according to the new statement. Two additional Academy guidelines are reference in the new statement: Orthopaedic Surgical Consent and Standards of Professionalism (LINK), which reinforces the role of the orthopaedic surgeons in fully informing patients of the risks and benefits of various treatments, including biologics, and securing patient consent before moving forward with a particular modality.

Finally, the new statement recommends that orthopaedic surgeons and their affiliated hospitals and clinics/organizations participate in orthopaedic registries and other data collection systems to provide much-needed data on the efficacy of biologic treatments.

More Information about the AAOS
With more than 38,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS, at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Facebook.org/AAOS1
Twitter.com/AAOS1
Instagram.com/AAOS_1

 

SOURCE American Academy of Orthopaedic Surgeons

Related Links

http://www.aaos.org

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Bone Biologics Release: New Preclinical Data For Spine Fusion Demonstrates Osteopromotive Properties

Posted On December 20, 2017 By OrthoSpineNews In Biologics, Spine /  

December 20, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp. (OTC QB: BBLG), a developer of orthobiologic products for the spinal fusion, trauma and osteoporosis markets, today has announced that it has completed a preclinical study, which shows its rhNELL-1 growth factor effectively promotes bone formation in a phylogenetically advanced spine model. In addition, rhNELL-1 was shown to be well tolerated and there were no findings of inflammation.

“We are very encouraged by the results of our Pilot animal study and look forward to commencing our Pivotal animal study by mid-2018 and presenting results at future scientific conferences,” said Steve La Neve, chief executive officer of Bone Biologics.

“In its first clinically relevant sheep study, rhNELL-1 demonstrated increases in fusion and quantity of bone compared to the control,” said Dr. Bill Walsh, professor and director, Surgical and Orthopedic Research Laboratories (SORL).

“We look forward to completing ongoing activities to advance into clinical trials in 2019,” stated La Neve.

About Bone Biologics

Bone Biologics (OTC QB: BBLG) is pursuing regenerative medicine for bone including undertaking groundbreaking work and building on unprecedented research on the NELL-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. NELL-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Compass Investor Relations
Mark Collinson, 714-222-5161
mcollinson@compass-ir.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com

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InVivo Therapeutics Announces Executive Management and Board Changes

Posted On December 18, 2017 By OrthoSpineNews In Biologics /  

December 18, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Richard Toselli, M.D., has been appointed Acting Chief Executive Officer of InVivo, replacing Mark D. Perrin, who has resigned as Chief Executive Officer and Chairman of InVivo’s Board of Directors. Dr. Toselli, a Board-certified neurosurgeon possessing senior leadership experience in surgical medical affairs at firms including Sanofi, DePuy, and Johnson & Johnson, will continue to serve in his capacity as InVivo’s Chief Medical Officer, which role he assumed upon joining the Company in July 2017. Mr. Perrin has agreed to serve as a consultant to the company for a period of six months.

The Company also announced that Ann Merrifield was appointed as Chair of the Board of Directors. Ms. Merrifield previously served as the Company’s Lead Director.

“We are pleased to have Dr. Toselli accept the role as Acting Chief Executive Officer. He brings a successful track record in clinical and regulatory affairs advancing transformational technologies, and following our recent discussions with the FDA, we believe Dr. Toselli’s experience and capabilities are well-suited to the important work ahead,” stated Ms. Merrifield.

Dr. Toselli said, “As announced earlier this quarter, the Company continues to engage with the FDA to understand how we can reset the Neuro-Spinal Scaffold™ clinical program, which is currently on hold. We look forward to continued discussions with the FDA with the goal of providing additional clarity on the Neuro-Spinal Scaffold™ program in the near term.”

Robert S. Langer, Ph.D., InVivo Co-Founder and Scientific Advisory Board member, and David H. Koch Institute Professor at MIT, stated, “I am confident in Dr. Toselli’s ability to lead InVivo forward. His background in surgical device innovation and neurological surgery will be critical as the company progresses its promising technology addressing the substantial needs in treating patients with spinal cord injury.”

Dr. Langer and Ms. Merrifield added jointly, “We are thankful for Mark Perrin’s formative contributions to the Company. Over the past four years, InVivo has been established as a Nasdaq-traded, clinical-stage company advancing the Neuro-Spinal Scaffold™.”

“It was extremely rewarding to initiate the first-in-man clinical trial of the Neuro-Spinal Scaffold™ and to learn from the results thus far from the INSPIRE trial. I wish the InVivo Board and management team the best in their pursuit of the company’s mission to redefine the lives of spinal cord-injured patients,” said Mr. Perrin.

Biographical Background

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 Chief Executive Officer. Previously, 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. Prior to this, 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 held the position of Vice President of Evidence-Based Medicine at Johnson & Johnson for the device sector. Dr. Toselli holds a bachelor of arts from Providence College, his medical degree from Brown University, and a master of business administration from the UNC’s Kenan-Flagler Business School. Dr. Toselli is a board-certified neurological surgeon.

Ms. Merrifield serves as a Director on a number of boards, including Flexion Therapeutics, Juniper Pharmaceuticals and Veritas Genetics. She recently served as President and Chief Executive Officer at PathoGenetix, a genomics company developing an automated system for rapid bacterial identification. Prior to this, Ms. Merrifield spent 18 years at Genzyme in a number of leadership roles, including as President of Genzyme Biosurgery and as President of Genzyme Genetics. Previously, she was a Partner at Bain and Company. Ms. Merrifield received a bachelor of arts in zoology and a master of education from the University of Maine, as well as a master of business administration from the Amos Tuck School of Business at Dartmouth College.

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 status of the company’s clinical program. 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 discussions and engagement with the FDA; the company’s ability to successfully re-open clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; 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 September 30, 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 Holdings Corp
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

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PolarityTE™ Announces Application of SkinTE™ on First Patients

Posted On December 15, 2017 By OrthoSpineNews In Biologics, Top Stories /  

SALT LAKE CITY, Dec. 15, 2017 (GLOBE NEWSWIRE) — PolarityTE, Inc. (NASDAQ:COOL) announced that human use of SkinTE™ is underway, and the product is now on patients, at multiple centers, within a variety of wound types and indications including acute and chronic wounds, burn wounds, surgical reconstructions and scar revisions. In addition, several patients with healed skin grafts, the gold standard treatment, have undergone removal of those grafts and replacement with SkinTE. Multiple medical centers have scheduled additional procedures through the end of 2017, and the Company expects an increasing number of applications during the first half of 2018 to meet market demand for the product. As clinical application grows, results and outcomes from the first group of treated patients are expected to be published throughout the first half 2018, addressing the many different patient populations treated.

“Application of SkinTE across this wide spectrum of cutaneous defects demonstrates the broad utility of this novel product beyond burn care, and we look forward to the results for all of the amazing patients being treated with SkinTE,” said Dr. Denver Lough, Chief Executive Officer of PolarityTE. “We are confident and believe that SkinTE will replicate its preclinical success and help patients regenerate their own full-thickness, hair-bearing skin. We did not set out to bring another iteration to the field of regenerative medicine—we set out to change it entirely. Welcome to the Shift™.”

About SkinTE™ and FDA Tissue Establishment Registration
SkinTE™ is regulated by the FDA as an HCT/P solely under Section 361 of the Public Health Service Act and 21 CFR 1271. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.

SkinTE is processed and marketed in accordance with the FDA’s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured by American Association of Tissue Banks (AATB)- and Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facilities.

Important Safety Information
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for SkinTE, as such conditions may compromise successful outcomes or lead to sub-optimal results.
Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. Unused or expired tissue product should be discarded according to local, state, federal and institutional requirements. Utilization of the SkinTE construct, process and/or technology is limited to healthcare professionals and facilities that are capable of handling such tissue products.

Proper aseptic procedural and/or surgical handling is mandatory when using SkinTE. Failure to ensure proper aseptic technique may result in contamination of the tissue product and wound bed. Contamination of the tissue product and/or wound bed due to failure to ensure aseptic technique could result in local, regional, or systemic infection, partial or complete failure of graft take, healing, and/or regeneration, serious injury, and/or death. Failure to follow instructions may lead to sub-optimal outcomes and/or product failure.

Potential adverse effects may include but are not limited to the following: local tissue, wound bed, regional tissue,  or systemic infection, hypersensitive, allergic, or other  immune response to the product or trace amounts of antibiotic retained from primary harvest, deleterious effects on potential surrounding or adjacent autologous, allogeneic, or xenogenic grafts, skin substitutes, or other reconstructions including infection and/or failure of adjacent grafted material to take and heal, requirement for further surgical operation(s) and/or debridement, or death.

About PolarityTE™
PolarityTE™, Inc. is a regenerative medicine company, and the first to successfully regenerate full-thickness tissue. The Company’s novel regenerative medicine platform and proprietary technology employs a patient’s own cells for the healing of full-thickness, functionally-polarized tissues. If clinically successful, the PolarityTE™ platform will provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient’s own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. The PolarityTE™ platform leverages natural and biologically-sound principles which are readily adaptable to a wide spectrum of organ and tissue systems. This revolutionary technology, paired with the Company’s world-renowned clinical advisory board, position PolarityTE™ to drastically change the field and future of translational regenerative medicine. More information can be found online at www.PolarityTE.com.

Forward Looking Statements
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company’s ongoing compliance with the requirements of The NASDAQ Stock Market and the Company’s ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should'” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Investor Contact
John Stetson
InvestorRelations@PolarityTE.com
(385) 237-2365

Media Contacts
Scott Santiamo
Russo Partners LLC
Scott.Santiamo@RussoPartnersLLC.com
(718) 344-5843
David Schull
Russo Partners LLC
David.Schull@RussoPartnersLLC.com
(858) 717-2310

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Source: PolarityTE, Inc.

Released December 15, 2017

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AlloSource Announces Raime Leeby Muhle As Chief Financial Officer

Posted On December 14, 2017 By OrthoSpineNews In Biologics, Top Stories /  

CENTENNIAL, Colo., Dec. 14, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced the appointment of Raime Leeby Muhle as Chief Financial Officer.

With over 18 years of experience, her background spans from emerging high growth businesses to large and mature organizations. She has worked in a variety of industries including technology, distribution, manufacturing, and telecommunications. Leeby Muhle’s expertise in complex environments, as well as working cross-functionally, will help her lead the accounting, financial, and information technology teams at AlloSource. Leeby Muhle is taking over for current Chief Financial Officer, Olivia Thompson, who is transitioning into retirement to focus on project-based work.

“We are thrilled to welcome Raime to our executive team,” said Thomas Cycyota, AlloSource President and Chief Executive Officer. “Her financial expertise and leadership, as well as her passion for our mission, will help drive AlloSource’s growth as we continue to evolve the advanced allograft therapies we provide for surgeons.”

Leeby Muhle has held various senior-level roles with finance and operational responsibilities. Prior to AlloSource, she served in key leadership positions at Arrow Electronics and Level 3 Communications.

“AlloSource has such a unique impact on our communities, and I am committed to helping the company continue to grow and innovate,” said Leeby Muhle. “I look forward to putting my background and skills towards our goal of achieving greater results in advancing biological healing.”

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

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

SOURCE AlloSource

Related Links

http://www.allosource.org

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Kuros Biosciences Announces Management Succession

Posted On December 14, 2017 By OrthoSpineNews In Biologics /  1

Schlieren (Zurich), Switzerland, December 14, 2017

Kuros announced today the appointment of Michael Grau as Chief Financial Officer (CFO) effective February 1, 2018. Michael Grau succeeds Harry Welten, who will step down as CFO on February 1, 2018 to focus on his board roles and part-time CFO functions in privately held companies. Harry Welten will remain on the Board of Directors of Kuros.

Kuros’ Chief Executive Officer Dr. Joost de Bruijn commented: “I am delighted to welcome Michael Grau to the executive team. Michael has extensive experience in corporate finance and auditing in private and public companies. With his strong operational background, we believe Michael brings highly relevant experience and financial leadership to the Company that will help us as we capitalize on new opportunities to becoming a leading commercial-stage orthobiologics company.”

Joost de Bruijn continued: “I am sincerely grateful to Harry for leading the company through capital raises, restructurings, mergers and acquisitions in the past seven years. Harry’s continued involvement will ensure a smooth transition to Michael.”

Kuros’ Chairman Christian Itin said: “We are grateful for Harry’s valuable contributions and services to the Company. As CFO, Harry restructured CHF 70 million in private and public debt and raised more than CHF 80 million in equity, ensuring that the company has a solid capital base and structure for its next steps of growth and start of commercialization. We wish Harry all the best for his future endeavors.”

Christian Itin continued: “With Michael’s extensive experience as CFO of several small- and medium-sized companies, accounting and fundraising background, we have found a highly capable successor to Harry to help lead the company during its next growth stage. Michael has more than 15 years of experience in the medtech and pharma field and is therefore extremely well suited to take up this position.”

Biographical background on Michael Grau

Michael Grau has an impressive track record of 25 years` experience in corporate finance, controlling, accounting and general management in diverse industries and, since 2001, with a focus on medtech, biotech and pharma. He was responsible for multiple capital market transactions, financing rounds and several merger and acquisition agreements for public and private companies. Most recently, Mr. Grau served as CFO of Proteros Biostructures, a biotech company focusing on enabling lead discovery, Correvio, a Geneva-based hospital specialty pharma company, and Endosense, another Geneva-based private medtech company. He started his career working for KPMG Pat Marwick. Mr. Grau holds a BA in European Finance and Accounting from Bremen University, Germany, and Leeds University, U.K., and an executive MBA from Henley Business School at the University of Reading, U.K. Mr. Grau is citizen of Germany.

For further information, please contact:

Harry Welten, MBA

Chief Financial Officer

Phone +41 79 750 15 64

harry.welten@kurosbio.com

 

Joost de Bruijn

Chief Executive Officer

Phone +31 621 21 7603

joost.de.bruijn@kurosbio.com

About Kuros Biosciences AG

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

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.
News release (pdf)
Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren
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Antibacterial Benefits of PEKK for Orthopedic Applications Detailed in Study of 3D-Printed OsteoFab® Structures

Posted On December 6, 2017 By OrthoSpineNews In Biologics /  

SOUTH WINDSOR, Conn., Dec. 05, 2017 (GLOBE NEWSWIRE) — Oxford Performance Materials, Inc. (OPM), a leader in advanced materials science and high performance additive manufacturing (HPAM™), today announced the results of an independent scientific study that reveals superior antibacterial properties of 3D printed PEKK (poly-ether-ketone-ketone) structures vs. conventional PEEK (poly-ether-ether-ketone) surfaces for orthopedic applications. The September 2017 study1 examined 3D printed PEKK samples produced by OPM’s proprietary OsteoFab® process and “demonstrated for the first time the promise that nanostructured2 PEKK has for numerous anti-infection orthopedic implant applications.”

OPM’s OsteoFab® technology was first commercialized in 2013 and utilizes the Company’s exclusive OXPEKK® material, a high performance PEKK polymer formulation that meets FDA and EU requirements for long-term implantable medical device applications. The properties of OPM’s OXPEKK polymer and OsteoFab 3D printing technology combine to form an inherently rough, nanostructured surface that has been demonstrated to enhance bone attachment.3

The antibacterial attributes of 3D printed PEKK are significant, since they address two areas of growing concern in medicine. “Orthopedic implant infections have been steadily increasing while, at the same time, antibiotics developed to kill such bacteria have proven less and less effective with every passing day,” according to the researchers. “It is clear that new approaches that do not rely on the use of antibiotics are needed to decrease medical device infections.”  As a result, the antibacterial properties detailed in this new study that apply to OsteoFab devices will provide another important layer of differentiation for the performance of OPM medical devices in the marketplace.

Dr. Gregory Chotkowski, Board Certified Oral and Maxillofacial surgeon, commented on the comparative benefits of OsteoFab devices: “I am excited that there is another option available for custom facial bony augmentation. The products currently available are porous and have a high incidence of infection when placed through a transoral surgical approach,” Dr. Chotkowski stated, “I had the opportunity to use OPM’s 3D printed PEKK mandibular angle implants on several occasions and feel that this material is far superior.  The bacteriostatic properties – combined with custom fabrication – makes this an ideal material for facial augmentation through a transoral approach.”

Five FDA 510(k) clearances have been obtained for OsteoFab devices.  OPM is the only company with FDA clearances for 3D printed polymeric implants, and the Company was granted a patent from the European Patent Office for its “Customized Implant for Bone Replacement” manufacturing process. In addition to obtaining its own clearances, OPM has customers that have obtained regulatory approvals for devices made from OXPEKK polymer in Asia, Europe, and South America. The Company is an OEM of its craniomaxillofacial (CMF) OsteoFab implant line, which is exclusively distributed worldwide by Zimmer Biomet. Over 1,700 patient specific cranial and facial devices have been shipped to date, and the OsteoFab facial line was officially launched earlier this year.

OPM recently introduced its OsteoFab technology to the spinal device market through its partnership with U.S.-based RTI Surgical.  RTI announced last month the commercial launch of Fortilink-C IBF System with TETRAfuse® 3D Technology. The Fortilink-C IBF System is the first 3D printed polymer-based, cervical interbody device to incorporate macro, micro and nano-rough features beyond the endplate surfaces to the entire implant surface. Today, OPM is well positioned to produce a full range of standard sizes in spine, providing OPM with the first high volume, mass application for its OsteoFab 3D printing technology using its proprietary OXPEKK polymer.

About Oxford Performance Materials, Inc.

A recognized leader in advanced materials science, Oxford Performance Materials Inc. (OPM) was founded in 2000 to exploit and commercialize the world’s highest performing thermoplastics, with a focus on poly-ether-ketone-ketone (PEKK).  OPM develops proprietary material, process, and application technologies and applies high performance additive manufacturing (HPAM™) to produce fully functional, end-use structural parts. The Company has three strategic business units: OPM Materials develops proprietary OXPEKK® thermoplastic products and other materials for biomedical, aerospace, and industrial applications. OPM Biomedical is a pioneer in personalized medicine, 3D printing OsteoFab® cranial and facial implants as an OEM, and additional products on a contract manufacturing basis. OPM Biomedical is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants, and has a total of four 510(k) clearances in its portfolio. OPM Aerospace & Industrial produces 3D printed OXFAB® production parts for highly demanding aerospace, satellite, and defense applications. OXFAB® structures offer significant weight, cost, and time-to-market reductions that are defined in a set of specified performance attributes in the exhaustive OPM B-Basis database, developed in conjunction with NASA. For more information, please visit: www.oxfordpm.com

Company Contact:
Bernie Plishtin
Oxford Performance Materials
860-656-9446
bplishtin@oxfordpm.com

1 “Antibacterial Properties of PEKK for Orthopedic Applications,” International Journal of Nanomedicine, Dovepress 15-Sep-2017, Mian Wang, Garima Bhardwaj (Department of Chemical Engineering, Northeastern University, Boston MA) and Thomas J. Webster (Department of Chemical Engineering, Northeastern University, Boston MA and Wenzhou Institute of Biomaterials and Engineering, Wenzhou Medical University, Wenzhou, China). The full study by Mian Wang, et al. may be viewed at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5592909/
2 Nanostructured materials are those having properties defined by features smaller than 100 nanometers.
3 Hacking, Adam, “The Tissue Response to PEKK Femoral Rods Implanted in the Medullary Canal of the Rabbit Femur”. OPM Internal Report, January 23, 2013.

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SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh

Posted On December 1, 2017 By OrthoSpineNews In Biologics, Regulatory, Spine, Top Stories /  

CARLSBAD, Calif., Nov. 30, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its OsteoBallast™ Demineralized Bone Matrix (DBM) in Resorbable Mesh.

The OsteoBallast product is the latest innovation in SeaSpine’s orthobiologics portfolio that is designed to facilitate fusion.  OsteoBallast, which consists of a resorbable mesh containing 100% DBM without a carrier, simplifies graft placement and helps prevent graft migration while maximizing DBM content. OsteoBallast is designed to provide surgeons with a simple means for delivering bone graft in posterior spine surgery that contours to the local anatomy while maintaining shape and volume under compression. The simplified technique is particularly valuable in MIS procedures, where placing the graft accurately through tubes and small incisions can be challenging.

“This product demonstrates SeaSpine’s continued commitment to innovation and our focus on delivering improved procedural spine solutions and clinical value through cost-effective orthobiologics,” commented Tyler Lipschultz, SeaSpine’s Vice President of Orthobiologics and Business Development. “Coupled with the recent launch of our OsteoStrand™ Demineralized Bone Fibers product and our established Accell Bone Matrix (ABM) technology, SeaSpine now can offer surgeons additional options to address the varied needs of their patients.”

SeaSpine plans to launch the OsteoBallast product with a limited release by year-end and full commercial launch by mid-2018.

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

Forward-Looking Statements

SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the features and potential benefits of OsteoBallast DBM in Resorbable Mesh, including its ability to provide surgeons a simple means for delivering bone graft in posterior spine surgeries and help prevent graft migration during posterolateral fusion, as well as contour to local anatomy and maintain shape and volume under compression; and the timing of limited and full commercial launches of OsteoBallast DBM in Resorbable Mesh.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that OsteoBallast DBM in Resorbable Mesh has not been validated clinically, may not address adequately surgeon requirements, and may require substantial additional development activities, which could introduce unexpected expense and delay, including potentially requiring resubmission of one or more products to FDA for clearance, which clearance cannot be certain, whether on a timely basis or at all; surgeons’ willingness to use OsteoBallast DBM in Resorbable Mesh; the risk that OsteoBallast DBM in Resorbable Mesh may not demonstrate adequate safety or efficacy, including improved fusion, independently or relative to competitive products, to support a full commercial launch; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

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

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

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Rotation Medical Bioinductive Implant Promotes Consistent Rotator Cuff Healing, Mitigates Tear Progression

Posted On November 30, 2017 By OrthoSpineNews In Biologics, Sports Medicine, Top Stories /  

November 30, 2017

PLYMOUTH, Minn.–(BUSINESS WIRE)–Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced results of a study published online in the Journal of Shoulder and Elbow Surgery that shows the company’s Bioinductive Implant consistently heals rotator cuff tears and mitigates tear progression. The Rotation Medical Bioinductive Implant is part of the company’s novel rotator cuff system for rotator cuff repair and a new alternative to traditional surgical repair.

“Partial thickness rotator cuff tears do not heal spontaneously and have a high propensity to increase in size and/or develop into full-thickness lesions,” said Theodore F. Schlegel, MD, lead investigator of the study and orthopedic surgeon at Steadman Hawkins Clinic Denver. “This study shows that the Bioinductive Implant not only repairs the tear and increases tendon thickness, but it also prevents tear progression. In addition, because the native tendon footprint remains intact around the location of the defect, the Bioinductive Implant may accelerate rehabilitation and recovery as compared with more conservative postoperative management when partial thickness lesions are taken down and repaired as full thickness tears.”

The study enrolled 33 patients with chronic, degenerative, intermediate- (n=12) to high-grade (n=21) partial-thickness tears (11 articular, 10 bursal, four intra-substance, eight hybrid) of the supraspinatus tendon. Clinical outcomes were assessed using American Shoulder and Elbow Surgeons (ASES) and Constant-Murley scores preoperatively and at three and 12 months postoperatively. Magnetic resonance imaging (MRI) was performed to assess postoperative tendon healing and thickness at the original tear site. One-year results of the multi-center study include:

  • Clinical scores improved significantly (p<0.0001), and mean tendon thickness increased by 2.0 mm (p<0.0001); new tissue was indistinguishable from the underlying tendon.
  • 94 percent of patients experienced complete healing or considerable reduction in defect size; consistent partial to complete fill-in of the original bursal, intrasubstance and articular partial-thickness tear defects were observed as early as three months postoperatively, with sustained efficacy through 12 months.
  • 94 percent of patients either agreed or strongly agreed that they were satisfied with the results of their surgery.
  • No tears progressed to full-thickness in patients who followed the postoperative rehabilitation protocol.
  • No serious adverse events related to the implant were reported.

“In addition to further demonstrating that our Bioinductive Implant increases tendon thickness and prevents re-tears, we are pleased that the majority of patients in this study said they were satisfied with the results of their rotator cuff surgeries,” said Martha Shadan, president and CEO of Rotation Medical. “As health systems transition to value-based care, data like these are becoming increasingly necessary to demonstrate the effectiveness of medical devices on indicators such as patient satisfaction, in addition to key health economic drivers that we are measuring in our REBUILD Registry Study.”

The study, “Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multi-center study,” adds to the growing body of literature supporting the use of the Rotation Medical Bioinductive Implant as a novel treatment for rotator cuff injury. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website.

About Rotator Cuff Tears
Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.

About the Rotation Medical Bioinductive Implant
Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical Bioinductive Implant is designed to address both the biomechanics and biology required to heal a rotator cuff tendon tear by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly. For important safety information, visit http://rotationmedical.com/our-solution/risks/.

About Rotation Medical
Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit http://www.rotationmedical.com/.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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