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Bioventus Enters Into Definitive Agreement to Divest BMP Development Program to Viscogliosi Brothers, LLC

Posted On July 23, 2018 By OrthoSpineNews In Financial, Top Stories /  

July 23, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into a definitive agreement to divest its next generation bone morphogenetic protein (BMP) development program to a new company formed by Viscogliosi Brothers, LLC (VB), a private equity investment firm focused on developing innovative neuromusculoskeletal technologies.

Bioventus acquired the exclusive, worldwide license to the BMP portfolio of development programs and associated intellectual property from Pfizer, Inc., in 2013. The portfolio, which will now be sold to VB, includes the next-generation BMP in development, as well as a BMP program for soft tissue indications.

The transaction is expected to close in late Q3 and is conditional on VB having raised the requisite funds to complete the sale. When completed, Bioventus will receive an equity stake in the new company formed by Viscogliosi Brothers that will work on the BMP program. In addition, Bioventus will have an observational board seat to follow the progress being made as the work continues. The parties have agreed not to disclose the sale price.

“Divesting the BMP program gives us the opportunity to increase the R&D investment in other areas of our portfolio to support additional short and mid-term programs, while maintaining a stake in its development,” said Tony Bihl, CEO of Bioventus. “We now expect to leverage resources to make additional investments that will expand and grow our portfolio in osteoarthritis, surgical and non-surgical bone healing.”

“Stimulating the body to heal itself is the future of healthcare.” said Anthony G. Viscogliosi, Principal of Viscogliosi Brothers, LLC. “Viscogliosi Brothers has formed a new company to actualize this future by acquiring the next generation BMP development program of Bioventus. Through this acquisition, we are fortunate for Bioventus’ effort to enable us to take the next steps of initiating a clinical program to further evaluate the BMP technology to do safer, faster, and better healing for spine fusion.”

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 orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. 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 and the Bioventus logo, are registered trademarks of Bioventus LLC

About Viscogliosi Brothers, LLC

Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony G. Viscogliosi in New York City, in 1999, Viscogliosi Brothers, LLC (VB), is a family office holding company specializing in venture capital, private equity and merchant banking in the neuro-musculoskeletal/orthopedic industry.

VB’s vision is dedicated to improving healthcare and the quality of life for humanity by finding innovative orthopedic concepts and supporting them to become sustainable technologies that can be commercialized globally to lead the evolution in orthopedic standards of care.

To accomplish this vision, VB discovers technologies, creates products and develops, builds, operates and finances companies founded on innovative and “life changing” technologies. VB principals have participated in more than 300 transactions, have invested in more than 20 companies and have formed more than ten funds.

Companies and funds that VB participated in have generated more than $1.5 billion in exit proceeds for investors through 14 exits in the last 18 years. Through its portfolio companies VB has defined 7 new orthopedic industry categories and its investments have helped commercialize more than 75 medtech devices, including eleven number one orthopedic technologies in seven market leading businesses.

VB orthopedic portfolio companies’ products have been implanted in nearly 300,000 people in more than 70 countries globally.

For additional information, please contact:

Anthony G. Viscogliosi, Principal
Email: aviscogliosi@vbllc.com
Website: www.vbllc.com

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities. The securities have not been registered under the Securities Act of 1933 (the “Act”) and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release is being issued pursuant to and in accordance with Rule 135c under the Act.

Contacts

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

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Using Patient-Specific 3D Printed Surgical Guides for Total Knee Replacement

Posted On July 23, 2018 By OrthoSpineNews In Recon /  

by  | Jul 13, 2018 | 3D Printing, Medical 3D Printing

While surgery has always, ultimately, been about the patient, it hasn’t always been patient-centered. Historically, patients have not had an easy time of understanding exactly what their surgery entails and have often been treated as if they were ancillary to the surgical problem presented. This can’t all be blamed on uncaring medical staff, as most people involved in medicine do care and care profoundly. Instead, it has largely been a result of resources and standing custom. Surgical procedures are complicated and difficult to understand, hence the reason why experts are the ones who address them, and the pressure and stress involved in going into a procedure largely blind has made it difficult for surgeons to relax and broaden their focus to include the patient beyond the problem.

3D technology is making great contributions to medicine, from aiding in research to assisting in the preparation of students to practice medicine to producing the tools necessary to perform better operations. It is being integrated into the surgical theater and changing the face of surgery as we know it. One of the ways it is doing this is through the provision of a greatly improved ability to plan for the procedure. 3D technology not only allows the medical team a sneak preview, 3D printing can create models of the particular areas to be addressed and allow surgeons to study them in advance. This helps minimize surprises and therefore reduces the stress on both the patient and the medical staff.

The staff at Orthoparc in the Netherlands has figured out another way to help create and deliver the best in patient centered care. Using 3D technology, they have developed a method of patient-centered total knee replacement that allows a patient to walk in, in the morning, and walk out that same day. Such a possibility requires a highly interconnected team of specialists working together to ensure that not only does the patient get the knee replacement they need, but their psychological, nutritional, and whole health needs are met as well.

One component of this is the integration of 3D printed, patient-specific surgical guides that take the uncertainty out of the procedure itself. These surgical guides are produced using data gathered about an individual patient’s knee and are fabricated in-house on a 3D printer. When placed upon the patient during surgery, they guide the surgeon to exactly where cuts need to be made in relationship to where the knee is resting. Dr. Saskia Boekhorst is an orthopedic surgeon at Orthoparc, and she described the impact these guides have had in her experience.

 

READ THE REST HERE

 

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OrthoSpin Ltd. Completes $3 Million Raise for Orthopedic Robotic External Fixation System

Posted On July 23, 2018 By OrthoSpineNews In Financial /  

MISGAV, Israel, July 23, 2018 /PRNewswire/ —

OrthoSpin Ltd. (“OrthoSpin”), a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T) (OTCQX: TRNLY), announced that it completed an investment round of $3 million for its smart, robotic external fixation system for orthopedic treatments. Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) led the investment round.

External fixation devices are a common treatment choice for bone lengthening, setting complex fractures, and correcting deformities. Patient compliance challenges and a lack of real-time feedback for physician follow-up present substantial challenges. Currently, effective treatment necessitates that patients manually adjust fixation devices on a daily basis, requiring complicated patient training. This often causes adjustment errors and non-compliance results in poor clinical outcomes.

The OrthoSpin system makes pre-programmed adjustments automatically and continuously – without the need for patient involvement. Integrated software enables physicians to chart patient progress, and, when required, immediately adjust treatment programs. The accurate OrthoSpin system eliminates the need for weekly follow-up and is generally expected to improve patient experience resulting from smaller incremental adjustments with reduced soft tissue damage.

“We are delighted to have this investment and support from JJDC, as we continue the development of OrthoSpin,” said Oren Cohen, CEO of OrthoSpin. “The funding will enable us to accelerate our development process and broaden our clinical trials. We are confident that this investment will be an important step in bringing OrthoSpin’s system to market.”

About OrthoSpin 

OrthoSpin was founded in December 2014, to offer a new robotic treatment system for use in orthopedics, specifically external fixation. OrthoSpin’s innovative system has the potential to change the outcomes of various orthopedic treatments, such as bone lengthening, setting complex fractures, and correcting deformities.

About Trendlines 

Trendlines is an innovation commercialization company that invents, discovers, invests in, and incubates innovation-based medical and agricultural technologies to fulfil its mission to improve the human condition. As intensely hands-on investors, Trendlines is involved in all aspects of its portfolio companies from technology development to business building. Trendlines’ shares are traded on the Singapore Stock Exchange (SGX: 42T) and in the United States as an American Depositary Receipt (ADR) on the OTCQX International (OTCQX: TRNLY).

For further information: 

Oren Cohen

CEO OrthoSpin

oren@orthospin.com 

Phone +972-54-334-2651

SOURCE OrthoSpin Ltd. and The Trendlines Group Ltd.

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Titan Spine Appoints Peter Wehrly to Board of Directors

Posted On July 23, 2018 By OrthoSpineNews In Spine /  

July 23, 2018

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, Inc., a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Peter Wehrly to its Board of Directors. Mr. Wehrly’s appointment, effective July 9, 2018, provides the Company with extensive medtech market knowledge and experience as it continues to drive improved patient outcomes1 through the deployment of its nanoLOCK® surface technology.

nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.2

Mr. Wehrly commented, “Titan Spine has done a remarkable job forging the surface technology category in spine over the past several years and has the opportunity to continue its leadership position with the company’s unique nanoLOCK® offering. I see a clear opportunity for the Company to further carve out a substantial share of the orthopedic market and look forward to contributing to Titan Spine’s growth and success.”

Mr. Wehrly is currently CEO of Synaptive Medical, a privately-held, Toronto-based company that combines proprietary surgical planning and robotic navigation platforms targeted initially for cranial and spinal applications. Prior to his appointment as CEO of Synaptive in October 2017, Mr. Wehrly was Chairman of the Board of Directors and an advisor to Synaptive from 2015 to 2017. From April 2016 to August 2017, Mr. Wehrly served as the CEO of PQ Bypass, a company based in Sunnyvale, California focused on breakthrough technology for the treatment of peripheral arterial disease. Previously, he was the Group President of Developed Markets at Covidien, a medical device manufacturer with annual sales of over $10.7 billion that was acquired by Medtronic, Inc. in 2015. In this position, Peter held profit and loss responsibility for the marketing and sale of products to all developed markets outside the U.S. between 2013 and 2015. Preceding this role, Peter was the Group President of Respiratory and Monitoring Solutions, Vascular Therapies, and for all of Covidien’s Japanese, Australian-New Zealand, and Canadian businesses. Prior to Covidien, Mr. Wehrly held the position of President and CEO at Medingo Youqneam, an Israel-based team that developed a novel insulin pump for diabetic patients. He also presided over Medtronic’s Spinal, Biologics, and Navigation businesses from 2004 to 2008. Peter started his career with DePuy, a Johnson & Johnson company.

Peter Ullrich, MD, Chief Executive Officer of Titan Spine, stated, “We recognize the importance of adding exceptional talent, guidance and expertise to our Board to help us continue driving Titan’s growth. Peter is a strategic leader who consistently delivers top-line growth and operational efficiencies across a wide range of global cultures. He has excelled in both public and private organizations, in both start-ups and multi-billion-dollar businesses, and in both developed and emerging markets. We are confident that Peter’s addition will advance our near and long-term goals for further building Titan Spine as the leader in surface technology medical devices.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, Inc. is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, headquartered in Mequon, Wisconsin, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S., Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

1 Data on file.

2 Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

3 Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

4 Matteson JL, Greenspan DC, Tighe TB, et al. Assessing the hierarchical structure of titanium implant surfaces. Journal of Biomedical Materials Research Part B Applied Biomaterials 104(6). May 2015. DOI:10.1002/jbm.b.33462.

Contacts

Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

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cultivate(MD) Funds Announce Investments Into Happe Spine

Posted On July 19, 2018 By OrthoSpineNews In Spine /  

HOLLAND, Mich., July 19, 2018 /PRNewswire/ — Genesis Innovation Group, LLC, announces the formation of HAPPE Spine LLC as well as investments by cultivate(MD) Capital Fund I, LLC and cultivate(MD) Capital Fund II, LP into HAPPE Spine.

Based on the work of Ryan K. Roeder, Ph.D. and researchers from the University of Notre Dame, HAPPE Spine has developed and will commercialize a material technology that allows for the construction of partial or fully porous hydroxyapatite reinforced polyetheretherketone (PEEK) implants.

Hydroxyapatite (HA) has been shown to encourage osteointegration of implants due to the unique nature of this material providing a very bone-friendly surface.  HA whisker reinforced PEEK with variable porosity allows HAPPE to create advanced spinal interbody implants.

Dr. Roeder explained, “More than a decade ago, we envisioned that modifying PEEK to be both porous and bioactive would provide an ideal implant material solution for interbody spinal fusion.  At that time, the market was not yet prepared for this innovation.  As surgeons are now recognizing the advantages of utilizing bioactive hydroxyapatite enhanced PEEK or surface-porous PEEK, we are excited to combine both innovations into the same device.”

Dave Blue, Managing Director of cultivate(MD) said, “We believe the technology has the potential to provide significant differentiation in the spinal interbody market.  But there are numerous other potential applications throughout the body and HAPPE will evaluate additional device applications as part of the product strategy.”

Rob Ball, Chairman and CEO, Genesis Innovation Group said, “Genesis is excited to have the opportunity to partner with Dr. Roeder and engage this exciting technology. The experienced talent at Genesis Innovation Group combined with financial capital at cultivate(MD) make for a powerful combination when envisioning the future of these types of innovations. Many orthopedic indications would benefit from a strong, bioactive, osteointegrative, and radiolucent material. We are making fast progress and continuing the development of this technology and products.”

Genesis Innovation Group and cultivate(MD) Capital Funds look forward to partnering with the developers of the material technology, all who will continue to be engaged with the Company as owners, investors, and advisors.

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies.  cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness.

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities.  There will not be any sale of any securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Contact:

Matt Ahearn

Vice President of Finance and Operations

https://genesisinnovationgroup.com/contact-us/

Forwarding-Looking Statements 

Certain Statements in this press release constitute forward-looking statements. When used in this press release, the words “will,” “anticipate,” and similar expressions or the negatives thereof are generally intended to identify forward-looking statements. Such forward-looking statements, including the intended actions and performance objectives of fund, its general partner, cultivate(MD) or any cultivate(MD) portfolio company referenced herein, involve known and unknown risks, uncertainties, and other important factors that could cause the actual results, performance, or achievements of the general partner, or any cultivate(MD) fund or portfolio company to differ materially from any future results, performance, or achievements expressed or implied by such forward-looking statements. No representation or warranty is made as to future performance or such forward-looking statements. All forward-looking statements in this press release speak only as of the date hereof.  The fund, its general partner and cultivate(MD) expressly disclaim any obligation or undertaking to disseminate any updates  or revisions to any forward-looking statement contained herein to reflect any change in its expectation with regard thereto or any change in events, conditions, or circumstances on which any such statement is based.

SOURCE cultivate(MD)

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MCRA Hires Bonnie Clothier, PhD, RN, Associate Director, Payor Relations, to Further Expand Reimbursement Payor Relations Service Division

Posted On July 19, 2018 By OrthoSpineNews In Regulatory /  

WASHINGTON, July 19, 2018 /PRNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce the recent hire of Bonnie Clothier, PhD, RN, as its Associate Director, Payor Relations, to further expand its medical technology reimbursement payor relations expertise and service offerings.

Ms. Clothier most recently worked for Independence Blue Cross where she was responsible for reviewing and updating medical policy coverage positions, providing clinical rationale for appropriateness of medical billing codes (ICD10, CPT and HCPCS),  and analyzing utilization patterns of claims data.

In her role at MCRA, Ms. Clothier will be responsible for providing internal and customer support to help identify specific payor issues and develop plans for gaining or improving U.S. coverage with health plans for new and innovative technologies.

Ms. Clothier said, “I am honored to join a talented, dynamic firm where I can leverage my private payor experience with my clinical and research background to assist MCRA’s clients with successfully obtaining covered access to evidenced-based care.”

Tim Hunter, MCRA’s Vice President of Health Economics, Reimbursement, and Public Policy said, “MCRA has a long history of working with payors to help them understand the important role and benefits of innovative medical devices and their associated procedures. We are excited that Bonnie has joined our Payor Relations team; with her combination of clinical and commercial insurance experience she will expand our ability to provide patient access to appropriate medical care.”

For more information on MCRA, please visit www.mcra.com

About MCRA 

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact 

David W. Lown 

General Manager, MCRA, LLC 

Phone: 212.583.0250 ext. 2111 

Email: dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

Related Links

http://www.mcra.com/

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Misonix Names Leading Medical Device Executive Gwen Watanabe to Board of Directors

Posted On July 19, 2018 By OrthoSpineNews In Financial /  

FARMINGDALE, N.Y., July 19, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (NASDAQ:MSON) (“Misonix” or the “Company”), a provider of minimally-invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced the appointment of Gwen Watanabe to its Board of Directors. Ms. Watanabe replaces John Gildea, the founding principal of Gildea Management Co., who has retired from his position on the Board of Directors.

“Gwen is a highly respected executive in the medical device sector who brings outstanding entrepreneurial skills to the Misonix Board as well as a proven, long-term track record of success in mergers and acquisitions at Teleflex,” stated Stavros Vizirgianakis, President and Chief Executive Officer of Misonix. “The ongoing execution of our cohesive strategy to grow Misonix’s leading ultrasonic surgical product platform is providing the Company with a solid foundation to continue expanding market share domestically as well as abroad. As we pursue the next phase of inorganic and organic growth for Misonix, we are confident Gwen’s presence on the Board of Directors will be tremendously valuable in helping the Company achieve our goals for sustainable revenue growth and profitability, as well as the enhancement of long-term shareholder value.”

Ms. Watanabe commented, “I am very excited at the opportunity to join the Misonix Board of Directors and be part of a fast-growing company that is leveraging its unique proprietary ultrasonic technology to bring to market medical devices that deliver demonstrated clinical benefits and improve patient outcomes. I look forward to sharing the experience and business relationships built over my career working with medical device start-ups and large public organizations to offer sound business counsel to Misonix as the Company continues to pursue its strategic growth initiatives and expand its leadership position in the ultrasound medical device industry.”

Stavros Vizirgianakis added, “I want to thank John Gildea for his many contributions and service to the Board and the Company over the last fourteen years. His leadership and financial expertise were instrumental in guiding Misonix through a period of significant change and positioning the Company for continued growth in the future.”

Gwen Watanabe has over 24 years of financial and executive management experience in the medical device industry. Ms. Watanabe presently serves as the vice president of global corporate development, strategy, and strategic partnerships for Teleflex Incorporated, a global provider of medical technology products, where she also serves as a member of the executive leadership team, reporting to Teleflex’s CEO. In her role at Teleflex, she is responsible for worldwide corporate strategy and mergers and acquisitions.

Prior to Teleflex, Ms. Watanabe served as president and chief executive officer of medical device start-up Hotspur Technology, Inc., where she led the company from initial idea and design concept in 2009 through commercial release before negotiating the successful sale of the business to Teleflex in 2012. From 2004 to 2009, Ms. Watanabe served as chief business officer and chief financial officer of Nellix Endovascular, Inc., a medical device start-up that she co-founded, where she successfully raised venture capital financing and led a broad range of strategic initiatives that resulted in the acquisition of the company by Endologix. Earlier in her career, she served as a business development manager at Bacchus Vascular, Inc. (acquired by Covidien) and a project engineer at Aneurx, Inc. (acquired by Medtronic). In addition, Ms. Watanabe was a general partner at Saratoga Ventures V, L.P. and Saratoga Ventures VI, L.P., which were all medical device venture funds.

Ms. Watanabe earned a Bachelor of Science degree in Mechanical Engineering from the Massachusetts Institute of Technology. She obtained her Master of Science in Mechanical Engineering, Design Division from Stanford University and a Master in Business Administration from Harvard University. She formerly served on the Board of Directors for Hotspur Technologies, Catharos Medical, NovaSom (formerly Sleep Solutions), Axis Surgical, Tibion, American Red Cross of Hawaii and the Gift Foundation of Hawaii.

About Misonix, Inc.

Misonix, Inc. (NASDAQ:MSON) designs, develops, manufactures and markets ultrasonic medical devices for the precise removal of hard and soft tissue, including bone removal, wound debridement and ultrasonic aspiration. Misonix is focused on leveraging its proprietary ultrasonic technology to become the standard of care in operating rooms and clinics around the world. Misonix’s proprietary ultrasonic medical devices are used in a growing number of medical procedures, including spine surgery, neurosurgery, orthopedic surgery, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. At Misonix, Better Matters to us. That is why throughout the Company’s history, Misonix has maintained its commitment to medical technology innovation and the development of ultrasonic surgical products that radically improve patient outcomes. Additional information is available on the Company’s web site at www.misonix.com.

Safe Harbor Statement

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Contact: 
Joe Dwyer
Chief Financial Officer
Misonix, Inc.
631-694-9555		 Joseph Jaffoni, Norberto Aja, Jennifer Neuman
JCIR
212-835-8500 or mson@jcir.com
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MiMedx Appoints Mark Graves Chief Compliance Officer To Strengthen Corporate Compliance Practices

Posted On July 19, 2018 By OrthoSpineNews In Regulatory /  

MARIETTA, Ga., July 18, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it has appointed Mark P. Graves to the position of Chief Compliance Officer.  Mr. Graves will be responsible for providing direction and oversight of MiMedx’s compliance program, including the Company’s regulatory and legal compliance matters related to the Company’s risk management, sales operations and financial reporting. Mr. Graves will report to Ed Borkowski, the Company’s Executive Vice President and Interim Chief Financial Officer on a day-to-day basis. He will also report directly to the newly formed Ethics and Compliance Committee of the Board of Directors.

“We are implementing plans to improve our corporate compliance practices in order to ensure our Company adheres to policies with the highest integrity, ethics and legal standards,” said David Coles, interim Chief Executive Officer, MiMedx. “Mark has a strong background in driving compliance strategy, risk awareness, training, and crafting effective policy. He will help MiMedx apply and execute on best-in-class compliance standards that reflect our commitment to enhancing value for all stakeholders. We are pleased to welcome him to our organization.”

Graves brings more than 20 years of pharmaceutical and biotech industry experience to MiMedx, ranging from compliance and sales management to government affairs. He most recently was the U.S. leader for the global Patient Experience & Value function in the neurology division of UCB, Inc., a biopharmaceutical company. From 2011 to 2015, he was UCB’s Deputy Compliance Officer involved in all aspects of compliance, including the implementation and management of the company’s corporate integrity agreement. Prior to that, Graves was Senior Director in the Office of Ethics and Compliance for the Pharmaceutical Products Division of Abbott Laboratories, as well as Deputy Ethics & Compliance Officer for Takeda Pharmaceuticals North America, Inc. and TAP Pharmaceutical Products, Inc. Prior to his pharmaceutical and biotech career, he practiced labor and employment law.

Graves holds a B.A. in Criminology and Law, and a J.D. from the University of Florida as well as an MBA from the University of Chicago Booth School of Business.

The Audit Committee and the Company are developing and implementing corrective measures to improve MiMedx’s accounting and internal control practices. As part of this initiative, and as noted in the Company’s June 7, 2018 press release, the MiMedx Board of Directors established an Ethics and Compliance Committee, which includes independent directors Luis A. Aguilar and Neil S. Yeston M.D. The Company also is conducting a formal search to fill the newly established positions of Chief Accounting Officer and Internal Auditor.

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself.  The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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Nuvasive Launches MAGEC X For Early Onset Scoliosis Treatment

Posted On July 19, 2018 By OrthoSpineNews In Spine, Top Stories /  

SAN DIEGO, July 19, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the U.S. launch of MAGEC X, a new procedural solution within the MAGEC product family that addresses Early Onset Scoliosis (EOS).

MAGEC X features updates across all rod diameters in the portfolio, including 5.0mm diameter rods for patients, delivering a 68 percent performance increase over the previous generation in titanium rod fatigue testing. When paired with the NuVasive Reline® Small Stature system, the first pediatric deformity fixation solution to integrate both 4.5mm and 5.0mm rods in a low-profile tulip, MAGEC X provides increased construct strength without sacrificing the optimal profile for EOS patients.

“NuVasive’s MAGEC X 5.0mm solution is unique because it allows you to upsize your rod with low-profile screws, giving you the flexibility at the time of surgery to use a larger rod without having to change your screws – that’s really key,” said Dr. Peter Sturm, Alvin H. Crawford Chair of Spine Surgery, Cincinnati Children’s Hospital Medical Center. “Further, the upgrade of the internal components in MAGEC X rods gives me even more confidence in the performance of a system that has radically changed how we treat this challenging patient population.”

The development of MAGEC X is also distinguished by a number of internal rod mechanism advancements, most notably a reinforced locking pin and a robust actuator seal designed to further contain and reduce the release of titanium wear debris. Additionally, it includes an anti-jam feature to simplify intraoperative and postoperative rod lengthening. Key aesthetic improvements, such as laser-marked sagittal bending lines, help to enhance surgeon workflow efficiency and ease of use.

“More than 100,000 children are diagnosed with scoliosis each year in the United States; the launch of MAGEC X exemplifies our continued dedication to the advancement of EOS treatment and support of the pediatric surgeon community,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “MAGEC X represents the culmination of over a decade of clinical experience and innovation, resulting in a stronger and smarter MAGEC implant design.”

This full commercial launch of MAGEC X follows the Company’s preview announcement, which occurred at the POSNA Annual Meeting in May in Austin, Texas.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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RTI Surgical® Schedules Second Quarter 2018 Earnings Call for August 2, 2018

Posted On July 19, 2018 By OrthoSpineNews In Financial /  

July 19, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results from the second quarter of 2018 on Thursday, August 2, 2018, prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss second quarter 2018 results at 9:00 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical, Inc.

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

Forward-Looking Statements

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

Contacts

RTI Surgical, Inc.
Media Contact:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
Investor Contact:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

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