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Bob White Named Executive V.P. and Pres. of Medtronic’s MITG; Chris Lee to Assume Leadership of Asia Pacific Region

Posted On December 19, 2017 By OrthoSpineNews In Financial /  

DUBLIN – December 19, 2017 – Medtronic plc (NYSE: MDT) announced today that Bob White, previously Senior Vice President and President of Medtronic’s Asia Pacific (APAC) Region, has been named Executive Vice President and President of Medtronic’s Minimally Invasive Therapies Group (MITG). In addition, the company announced that Chris Lee, Senior Vice President and President of Medtronic’s Greater China Region, will assume the position of APAC Region President. Lee will remain the Interim President of the Greater China Region until a permanent successor is named in the coming weeks. These leadership changes are effective immediately.

The leadership changes are a result of Bryan Hanson’s departure to become President and CEO of another public, medical technology company, effective today. Hanson was the former Executive Vice President of MITG.

“We are pleased to name Bob White and Chris Lee to these new leadership assignments. Their extensive knowledge and expertise of the Medtronic businesses and regions involved – as well as their demonstrated track records of success – will ensure continuity to our overall business strategies and objectives,” said Omar Ishrak, Chairman and CEO of Medtronic. “Bob is uniquely qualified to take on the MITG role given his prior leadership experience in the former Covidien company and his most recent role as President of our APAC region, where he was responsible for advancing MITG and our three other groups in the region. Chris has strong experience across Asia Pacific, having previously led the operations of several leading pharmaceutical companies in the region. Both Bob and Chris have strong records of delivering results, and I look forward to working with them in their new roles.”

“We thank Bryan for his contributions to Medtronic through the Covidien acquisition, its integration into Medtronic and to its current, solid performance as the Minimally Invasive Therapies Group,” added Ishrak. “We wish him and his family well with his new endeavor.”

Bob White joined Medtronic upon the close of the Covidien acquisition by Medtronic in 2015 as President for the APAC Region, based in Singapore. In this role, White was responsible for the commercial growth of Medtronic’s business in the region, including leadership for Medtronic’s four main product and therapy groups, regional business development efforts, government and partner development strategies, talent development and retention, and the operations of the company’s enabling functions. Under White’s leadership, the region has grown its revenue from $2.1 billion in fiscal year 2015 to $3.4 billion in fiscal year 2017.

White’s previous leadership positions with Covidien included serving as President of the Respiratory and Monitoring business and President of Emerging Markets. Prior to his time at Covidien, White held various leadership positions with General Electric and IBM.

Chris Lee joined Medtronic from Bayer HealthCare in 2012 and has served as the President of the Greater China Region, based in Shanghai, since that time. Medtronic’s Greater China Region includes China, Hong Kong, and Taiwan. Lee is responsible for all Medtronic commercial operations in the region, talent development and retention, and has served as the principal liaison with the Chinese government. Under Lee’s leadership, the region has maintained double digit revenue growth, having grown its revenue from $0.6 billion in fiscal year 2012 to $1.6 billion in fiscal year 2017.

Prior to joining Medtronic, Lee worked for Bayer HealthCare, where he led their Asia Pacific region, based in Singapore, and their Greater China Region, based in Beijing. In previous assignments, Lee led operations for Korea, Vietnam, Japan, Australia and New Zealand and other sub-regions in Asia Pacific for both Bayer and Bristol Meyers Squibb.

About the Medtronic Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group is organized into the Surgical Innovations and the Respiratory, Gastrointestinal & Renal divisions. The Group had revenues of $9.9 billion in fiscal year 2017.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

 

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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MiMedx Agrees To Lawsuit Settlement With Former Employee

Posted On December 19, 2017 By OrthoSpineNews In Regulatory /  

MARIETTA, Ga., Dec. 19, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Company has agreed to a confidential lawsuit settlement from one former employee.

MiMedx has reached a mutually agreeable settlement in its lawsuit with former employee, William T. Mills, who voluntarily resigned from MiMedx in January 2017.  In its suit, MiMedx alleged that Mills breached his restrictive covenants and his duty of loyalty to MiMedx by selling another company’s medical products while employed by MiMedx, and continued to breach his restrictive covenants after he voluntarily left MiMedx’s employ.  This lawsuit was a dispute solely over Mr. Mills’ MiMedx employment agreement, and no other allegations have been made by either party.

In addition to an undisclosed monetary settlement, other settlement terms were reached.  In this regard, Mills has agreed not to sell any products of his current employer to any MiMedx customer serviced by Mills for nine months.

Mills also acknowledges and confirms that he made no allegations of “channel stuffing” by MiMedx in this lawsuit.  Mills stated, “I have no knowledge of the agreements or payment terms between MiMedx and its customers.  I also do not know or have any way of knowing of how sales of products were accounted for by the Company in its financial statements.  To my knowledge, the vast majority of the MiMedx products which were sold into my accounts were used and were not returned.  MiMedx makes an excellent product.  I look forward to continuing my employment with my current employer.”

Parker H. “Pete” Petit, CEO, said, “We are pleased to have settled this lawsuit with Mr. Mills.  The prosecution of our other lawsuits is critical to ensuring the appropriate legal remedies and to rectify the misconduct committed by those individuals.  Mr. Mills did not bring any claims alleging channel stuffing, as other employees have, and he does not have enough knowledge of accounting matters to make such an allegation.  We are glad we were able to resolve this matter amicably with Mr. Mills.  We look forward to achieving appropriate outcomes from our legal actions against those other individuals.”

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding potential outcomes of legal actions.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions, and the risks of litigation.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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Zimmer Biomet Announces Appointment of Bryan C. Hanson as President and Chief Executive Officer

Posted On December 19, 2017 By OrthoSpineNews In Recon, Top Stories /  

WARSAW, Ind., Dec. 19, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that Bryan C. Hanson has been appointed President and Chief Executive Officer and a member of the Board of Directors, effective today.  Daniel P. Florin, who has served as Interim CEO since July 11, 2017, will continue in his role as Senior Vice President and Chief Financial Officer.

Larry C. Glasscock, Chairman of the Zimmer Biomet Board of Directors, stated, “On behalf of the Board, I am thrilled to welcome Bryan to the Zimmer Biomet team.  The Board of Directors, with the assistance of a leading executive search firm, carefully identified, evaluated and interviewed a number of highly-qualified candidates and concluded that Bryan is the best fit to lead the Company.  Bryan is a proven executive with a track record of successfully leading, growing and transforming global medical device businesses to achieve higher levels of innovation, commercial success and profitability.  This leadership announcement comes at an important time in Zimmer Biomet’s history, and we look forward to working closely with Bryan to further leverage our leading portfolio of technologies, solutions and personalized services to enhance stockholder value.”

Mr. Hanson joins Zimmer Biomet with more than 20 years of experience in the medical device industry.  Most recently, he served as a member of Medtronic’s Executive Committee and as the Executive Vice President and President of Medtronic’s Minimally Invasive Therapies Group, where he oversaw and provided strategic direction to this approximately $9 billion business.  Prior to Medtronic, Mr. Hanson served in a number of executive roles of increasing responsibility.  In 2013, he was named Group President of Covidien’s Medical Devices business.  In 2011, as Surgical Solutions Group President, Mr. Hanson transformed two of Covidien’s largest divisions—Energy-based Devices and Surgical Devices—into one global business unit.  Mr. Hanson also serves on the board of AmeriCares, an emergency response and global health organization committed to saving lives and building healthier futures for people in crisis.

Mr. Hanson stated, “I am honored and excited to join the talented team at Zimmer Biomet.  I have long admired Zimmer Biomet, including its strong brand, commercial excellence and market-leading salesforce, healthy portfolio of marquee products and strong innovation pipeline.  I share the Company’s purpose of improving the quality of life for patients and I look forward to deeply familiarizing myself with Zimmer Biomet’s global operations to ensure we have the right foundation in place to support our customers and the patients they serve around the world, while driving sustained shareholder value.”

Mr. Florin commented, “It has been a privilege to lead the Zimmer Biomet organization as Interim CEO.  I join the rest of the management team in welcoming Bryan, and I am confident the Company will thrive under his leadership.”

Mr. Glasscock added, “On behalf of everyone at Zimmer Biomet, I want to thank Dan for serving as the Company’s Interim CEO for the past five months.  We are grateful that Dan assumed this role at such an important time, and we look forward to continuing to benefit from his expertise through his ongoing service as CFO.”

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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Spineology Announces Appointment of Mr. Richard Nigon as New Board of Directors Member

Posted On December 19, 2017 By OrthoSpineNews In Spine /  

December 19, 2017

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today the appointment of Mr. Richard J. Nigon to its board of directors effective immediately. This appointment expands Spineology’s board to five directors.

“We are extremely pleased to have Dick join our board,” said John Booth, CEO of Spineology. “With more than 20 years of leadership experience as a board member in the life science industry and over 45 years of experience in the financial sector, I am confident Dick will provide significant and valuable experience to our board as we continue to grow our market presence and execute our corporate objectives.”

Mr. Nigon currently serves on the board of directors of Celcuity Inc., Northern Technologies International, Incisive Surgical and Tactile Systems Technology. He also served on the boards of Vascular Solutions, Inc., Virtual Radiologic Corporation, Restore Medical and Endocardial Solutions until they were acquired. Mr. Nigon is currently Senior Vice President of Cedar Point Capital, LLC, a private company that raises capital for early stage companies. Previously he was a Director of Equity Corporate Finance for Miller Johnson Steichen Kinnard, a privately held investment firm, until its acquisition in December 2006 by Stifel Nicolaus, where he stayed on as the Managing Director of Private Placements. Mr. Nigon was employed by Ernst & Young for 30 years, with 19 as a partner and Director of Ernst & Young’s Twin Cities Entrepreneurial Group, and was the coordinating partner on numerous publicly traded companies. Mr. Nigon received a B.A. degree in Economics and Accounting from Saint John’s University.

“I’m thrilled to join the Spineology team at such an exciting time,” said Nigon. “The company has very unique product portfolio, a strong culture, and is experiencing growth in all of their product lines. I look forward to contributing to Spineology’s continued growth and success.”

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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HSS Researchers Receive Grant for Clinical Trial to Improve Outcomes for Rotator Cuff Tears

Posted On December 18, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /  

NEW YORK, Dec. 18, 2017 /PRNewswire-USNewswire/ — A multidisciplinary team led by Scott Rodeo, MD, and Christopher Mendias, PhD, at Hospital for Special Surgery (HSS) has been awarded the Orthopaedic Research and Education Foundation (OREF) Clinical Research Grant in Cellular Therapy in honor of James Urbaniak, MD in Collaboration with National Stem Cell Foundation (NSCF). The $800,000 grant will fund a clinical trial to determine if the use of stem cell therapy can improve outcomes for patients who suffer rotator cuff tears. To date, this is the largest grant given in OREF history.

Rotator cuff tears are one of the most prevalent musculoskeletal conditions yet surgical repair does not reverse muscle atrophy so patients may continue to feel weakness and pain even after surgery.

While surgical techniques have evolved over the years, there is still a high re-tear rate, which warrants more research to identify a better solution.

“The results of rotator cuff repair surgery are adversely affected by muscle atrophy and weakness, making it difficult for many patients to return to full function,” said Dr. Rodeo, co-principal investigator and sports medicine surgeon at HSS.

Previous studies have shown that stem cells that are harvested from body fat in the abdominal and thigh area can improve the regeneration of musculoskeletal tissues.  These cells, known as stromal vascular fraction cells (SVFCs), contain a population of pluripotent stem cells that can differentiate into skeletal muscle and tendon tissue. These cells also secrete anti-inflammatory and tissue regeneration molecules.

The grant will move research ahead to a phase II clinical trial to evaluate the safety and efficacy of SVFCs in improving outcomes for patients who undergo arthroscopic surgical repair for rotator cuff tears.

“This study may be the first to determine if stem cells from a patient’s own adipose tissue can improve outcomes after rotator cuff repair,” said Dr. Mendias, co-principal investigator and associate scientist at HSS. “We believe that the patients who receive SVFCs may see improved function and demonstrate improved tissue healing on both clinical imaging and tissue histological studies.”

Over 50 patients will be enrolled in the study, with HSS following patients for two years to track strength and range of motion measurements, imaging assessments of muscle and tendon regeneration, and patient-reported outcome scores.  In order to evaluate return to normal function, the primary outcome measure will be shoulder strength.

“If we demonstrate that this cell therapy is successful, then there is a clear justification for a pivotal phase III clinical trial in patients with rotator cuff tears,” added Dr. Rodeo. “We are very excited about the journey ahead.”

The other HSS investigators are Russell F. Warren, MD; Frank A. Cordasco, MD; Hollis G. Potter, MD; Matthew F. Koff, PhD; and Ogonna Kenechi Nwawka, MD.

About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2017-2018), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. HSS has locations in New York, New Jersey and Connecticut.
www.hss.edu

 

SOURCE Hospital for Special Surgery

Related Links

http://www.hss.edu

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TransEnterix Announces Global SurgiBot System Agreement

Posted On December 18, 2017 By OrthoSpineNews In Robotics /  

December 18, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that the Company has entered into an agreement with Great Belief International Limited (GBIL), to advance the SurgiBot System towards global commercialization. The SurgiBot System is the single-port, robotically enhanced laparoscopic surgical platform developed by TransEnterix.

This agreement transfers ownership of the SurgiBot System assets, while the Company retains the option to distribute or co-distribute the SurgiBot System outside of China. Upon completion of the transfer of all SurgiBot System assets, GBIL will have the System manufactured in China and obtain Chinese regulatory clearance from the China Food and Drug Administration (“CFDA”), while entering into a nationwide distribution agreement with China National Scientific and Instruments and Materials Company (CSIMC) for the Chinese market. Being the largest medical device distribution company in China, CSIMC will help GBIL maximize the commercial potential of the SurgiBot System in the Chinese market, and optimize post-sale services to Chinese hospitals. The Company retains the right to commercialize the SurgiBot System outside of China after manufacturing has been established and the necessary regulatory approvals have been obtained.

The agreement provides the Company with proceeds of at least $29 million, of which $7.5 million is expected to be received by the end of December 2017 and $7.5 million is expected to be received by March 31, 2018, which includes a $3.0 million equity investment in TransEnterix common stock at $2.33 per share, a 10% premium to the closing price on the date which the agreement was executed. The remaining $14 million, representing minimum royalties, will be paid beginning on the earlier of receipt of Chinese regulatory approval or five years.

“The relationship announced today with GBIL will allow us to advance the SurgiBot System toward global commercialization while significantly reducing our required investment and simultaneously leveraging ‘in-country’ manufacturing in the world’s most populous country,” said Todd M. Pope, President and CEO at TransEnterix. “This is a strong validation of the value of the SurgiBot platform, the world’s only abdominal surgical robot that allows surgeons to remain in the sterile field. We believe this relationship provides us with a significant opportunity to expand our product offerings of robotic solutions for hospitals and patients around the world.”

“We see a tremendous commercial opportunity for the SurgiBot System in China and are extremely enthusiastic to work with TransEnterix to bring this product to China along with the rest of the world,” said Gary Wang, President of GBIL. “The SurgiBot is unique in so many ways; we believe it can be transformational for our healthcare system.”

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. The company has also developed the SurgiBot System, a single-port, robotically enhanced laparoscopic surgical platform that is the subject of this press release. For more information, visit the TransEnterix website at www.transenterix.com.

About China National Scientific and Instruments and Materials Company (CSIMC)

CSIMC (China National Scientific Instruments and Materials Co., Ltd.) is the core enterprise of China National Pharmaceutical Group Corporation (SINOPHARM), specializing in scientific instruments and medical equipment. Being the largest medical equipment and device distribution enterprise, CSIMC has an operational network of 95 subsidiaries and branches across China, covering 26 provinces (more than 90% of regions of the whole country), and having business relationships with hundreds of global medical companies. From 2010 to 2016, CSIMC achieved CAGR of company revenue of more than 50%, leading to a total revenue of more than 3.4 billion USD in 2016. For more information, visit the CSIMC website at http://www.csimc.com.cn.

About Great Belief International Limited (GBIL):

GBIL is a BVI based company dedicated in investment and asset management in the healthcare industry. Their main business revenues are from investment in the Chinese medical sector.

Forward Looking Statements

This press release includes statements relating to the SurgiBot System and our agreement with GBIL for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the parties to the agreements successfully complete all of the anticipated activities and milestones, whether TransEnterix will receive at least $29 million (including minimum royalties) from GBIL, whether GBIL will be able to obtain the necessary clearances to sell the SurgiBot System in China, whether the agreement with GBIL will provide TransEnterix a significant opportunity to expand its product offerings, whether TransEnterix will be able to successfully distribute or co-distribute the SurgiBot System in other jurisdictions, and realize revenues beyond the initial consideration and minimum royalties and whether the SurgiBot System can become a transformational device in the healthcare system. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investors:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, + 1 951-751-1858
joanna@greymattermarketing.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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Wright Medical Group N.V. Announces Acquisition of IMASCAP SAS

Posted On December 18, 2017 By OrthoSpineNews In Extremities, Financial, Top Stories /  

AMSTERDAM, The Netherlands, Dec. 14, 2017 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced the acquisition of IMASCAP SAS, a leader in the development of software-based solutions for preoperative planning of shoulder replacement surgery.  The transaction ensures exclusive access to breakthrough software enabling technology and patents to further differentiate Wright’s product portfolio and to further accelerate growth opportunities in Wright’s global Extremities business.

Under the terms of the agreement with IMASCAP, Wright acquired 100% of IMASCAP’s outstanding equity on a fully diluted basis for total consideration, net of acquired cash, of €75.1 million or approximately $88.8 million, consisting of approximately €39.7 million, or approximately $46.9 million, in cash and approximately €13.2 million, or approximately $15.6 million, of Wright ordinary shares, payable at closing, and approximately €22.2 million, or approximately $26.3 million, in potential earnouts and milestone payments for new software modules and a potential future implant system.

IMASCAP’s Glenosys technology is the preoperative planning software behind Wright’s BLUEPRINT™ 3D planning software, which allows the surgeon to simulate the position of a shoulder prosthesis using CT image data.  The surgeon is able to visualize the shoulder in 3D and rotate through the complete range of motion in any direction.  Before the surgery, the surgeon can optimize the surgical plan adapted to the patient to choose the best implant from a range of possibilities.  With its simple and intuitive interface, this virtual surgical plan is seamlessly translated into the operating room on the day of surgery offering the potential for reduced surgical time, better outcomes and less inventory.

Robert Palmisano, president and chief executive officer, commented, “Wright, and previously Tornier, has been involved with IMASCAP for many years with our BLUEPRINT case planning software, and we have seen first-hand the innovation, creativity and differentiated solutions that the IMASCAP team has developed.  Software-enhanced solutions are the future, and with the acquisition of IMASCAP, we have the opportunity to take a significant lead in this area.  We are thrilled that we had an opportunity to acquire IMASCAP, which is the company that has developed the technology behind our BLUEPRINT case planning software for our shoulder portfolio.  This is a highly differentiated, enabling technology for the shoulder and has a number of potential applications to enhance our PROPHECY planning for ankles as well.”

Palmisano continued, “While our BLUEPRINT planning software is a significant differentiator today, IMASCAP has a rich pipeline of potential breakthrough technologies under development and patent-pending.  We believe the future of orthopaedic implant surgery will include advanced elements of artificial intelligence and augmented reality.  When fully developed, we believe such software enabled surgery will leapfrog the current mechanical approaches some orthopaedic companies have developed primarily for hip and knee replacement surgery.”

Palmisano further commented, “IMASCAP is led by its founder and CEO, Jean Chaoui.  Jean has an impressive background, with degrees in Biomedical Engineering from Damascus University and Telecom Brittany (Masters & PhD) with a focus in Biomedical Imaging.  Jean has received 11 patents and has written more than 30 scientific publications in the field of computer assisted surgery, and he has completed multiple projects in the areas of image and bio-signal processing, artificial intelligence and brain/computer interface.  He is a recent recipient of the MIT Technology Review – Top 10 French Innovators under 35 and a Fellow in the Young Transatlantic Innovative Leaders Initiative, representing France.  We are delighted that Jean and the entire IMASCAP team are joining Wright.”

Jean Chaoui, president and chief executive officer of IMASCAP, added, “We are delighted to have found an excellent strategic buyer in Wright, a company that shares IMASCAP’s commitment to technological leadership and who is deeply committed to the success of our technology.  We believe that Wright, with its global leadership position in the extremities market and expertise in medical education and product development, is the ideal partner to realize the full potential of IMASCAP’s technology and product pipeline and will continue to provide the focus and investment to enable it to reach its full potential.  Also, very importantly, this will provide our employees with enhanced opportunities for career growth and development.  We look forward to an exciting future as part of Wright Medical.”

IMASCAP has no revenues; therefore, there is no impact to Wright’s previously provided full-year 2017 annual net sales guidance of $740 million to $745 million.  Due to the timing of the closing, the company anticipates incurring minimal incremental expenses in 2017, and therefore is maintaining its current full-year 2017 non-GAAP adjusted EBITDA from continuing operations guidance range of $84 million to $88 million.  The company currently plans to offer this important enabling technology at no cost to physicians who are implanting Wright’s shoulder products.  Wright will provide additional information on the financial impact of this transaction and 2018 guidance on its fourth quarter 2017 earnings call, which is currently scheduled for February 27, 2018.

For more information on this transaction, please refer to the investor presentation that is available in the Investor Relations section of Wright’s website at www.wright.com.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates,  registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

About IMASCAP SAS

IMASCAP SAS develops software for preoperative planning of shoulder replacement surgery.  IMASCAP software system is the only system in the world allowing orthopaedic surgeons complete independence for planning, with nothing more than image data provided by CT scan of the patient. The software allows the surgeon to automatically conceive a surgical guide adapted particularly to the patient anatomy, which permits the surgeon to implant the prosthesis in a position that closely matched the software plan. The system has been developed in close collaboration with internationally recognized experts in the shoulder field, providing an innovative and practical solution to the operating room.  IMASCAP is focused on applying its technical expertise to serve orthopaedic surgery by furnishing patient specific solutions and participating in the development of new generations of prostheses adapting this new and innovative technology.  For more information please visit www.imascap.com.

Non-GAAP Financial Measures

To supplement the company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles, the company uses certain non-GAAP financial measures in this release, including . EBITDA, as adjusted, from continuing operations. The company’s non-GAAP adjusted EBITDA from continuing operations target is measured by adding back to net loss from continuing operations charges for interest, income taxes, depreciation and amortization expenses, non-cash share-based compensation expense and non-operating income and expense. Additionally, the company’s adjusted EBITDA from continuing operations target excludes possible future acquisitions; other material future business developments; and due diligence, transaction and transition costs associated with acquisitions and divestitures. Further, this adjusted EBITDA from continuing operations target excludes any expenses, earnings or losses related to the divested large joints business, legacy Wright’s divested OrthoRecon business and legacy Tornier’s divested ankle replacement and silastic toe products. The company’s management believes that the presentation of non-GAAP financial measures provides useful information to investors. These measures may assist investors in evaluating the company’s operations, period over period. Wright’s non-GAAP financial measures exclude such items as non-cash interest expense related to the company’s 2017 convertible notes, 2020 convertible notes and 2021 convertible notes, net gains and losses on mark-to-market adjustments on and settlements of derivative assets and liabilities, write-off of unamortized debt discount and deferred financing charges following the partial settlement of 2017 convertible notes and 2020 convertible notes, mark-to-market adjustments on CVRs, transaction and transition costs and tax impacts from changes in the realizability of net operating losses, all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the company’s reported results of operations for a period. It is for this reason that the company cannot provide without unreasonable effort a quantitative reconciliation to the most directly comparable GAAP measures for its 2017 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations. Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “look forward,” “continue,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the future anticipated success and benefits of the company’s software-based solutions for preoperative planning of shoulder replacement surgery and the company’s anticipated financial results for 2017, including net sales from continuing operations and adjusted EBITDA from continuing operations. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the failure to realize the full anticipated benefits of the company’s software-based solutions for preoperative planning of shoulder replacement surgery; risks involved in the acquisition of IMASCAP and the anticipated registration of the resale of the Wright ordinary shares issued in connection therewith; failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; failure of the company’s recent U.S. sales force additions, focus on core product portfolio and incentives to drive U.S. lower extremities and biologics sales or delay in realization thereof; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated benefits from approval of AUGMENT® Bone Graft; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 25, 2016 filed by Wright with the SEC on February 23, 2017 and in other subsequent SEC filings by Wright, including Wright’s Quarterly Report on Form 10-Q for the quarterly period ended September 24, 2017 filed by Wright with the SEC on November 2, 2017. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Tracy
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.tracy@wright.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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Orthocell Granted European Tendon Regeneration Patent

Posted On December 15, 2017 By OrthoSpineNews In Regulatory, Sports Medicine /  

December 14, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has been granted a key European Patent. The patent is entitled ‘Culture medium, culturing method and use of tenocytes’ protecting the method of manufacturing tendon regeneration cells (Tenocytes) to form the Autologous Tenocyte Implantation (Ortho-ATI®) product. The patent expires in 2027 and provides additional important intellectual property (IP) to protect Orthocell’s tendon repair applications, now granted in EU, USA, China, Australia, Singapore, Hong Kong and New Zealand.

“Securing this patent for tendon repair in Europe is another milestone in strengthening our IP position as we drive our novel world leading tendon repair product into the global market. Orthocell is focused on building and maintaining patent protection for our regenerative medicine technologies and treatment processes,” Orthocell Managing Director Paul Anderson said.

Global IP protection for Ortho-ATI® further underpins the international rollout of Orthocell’s world leading tendon repair technology. Orthocell is well positioned to commercialise Ortho-ATI® with mature manufacturing facilities in place, proven safety and efficacy, published clinical data and a clear pathway to market.

Orthocell maintains an active program of patenting, with ownership of 29 granted patents across the Ortho-ATI®, Ortho-ACI® and CelGro® technologies, and related methods of treatment and manufacturing.

About Ortho-ATI®:

Ortho-ATI® is a world leading breakthrough in regenerative medicine – a novel, cell therapy developed to treat chronic degenerative tendon injuries (tendinopathy / tendonitis), it can be utilised in both surgical and non-surgical applications.

  • Tendon injury and its end point, tendinopathy, are a common cause of occupational and sporting disability reported to affect 1% to 3% of the general population every year
  • Significant financial burden to the public health care system expected to increase as the population ages, as a result, new treatments are required that are safe, effective and cost efficient
  • Ortho-ATI® meets the market need by enabling the accelerated regeneration of injured tendons, directly addressing the underlying cause of injury, replenishing degenerative tissue with healthy mature tendon cells (known as tenocytes)
  • Extensive clinical validation with published clinical data up to 4.5 years post treatment in leading peer reviewed journals, (e.g. American Journal Sports Medicine) clearly demonstrating durability and efficacy as the leading tendon regeneration treatment

Contacts

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

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