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

December 20, 2017

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

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

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

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

About Bone Biologics

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

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

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

Contacts

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

SpineGuard: 60,000 Spine Surgeries Performed with PediGuard® and DSG™ Devices

December 19, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer, announced today that 60,000 spine procedures have been performed using its family of PediGuard and Dynamic Surgical Guidance (DSG™) equipped devices for accurate pedicle screw placement.

The PediGuard product line includes the PediGuard Straight, PediGuard Curved, PediGuard Cannulated and PediGuard Threaded each of them matching specific clinical needs and adapted to surgeons preferences in the OR. DSG is also integrated into the Z-Direct screw system (partnership with Zavation) and G2S screw system (partnership with Neuro France Implants), which enables single-step insertion of pedicle screws.

This significant milestone is the clear demonstration of the robustness and clinical value of our DSG™ technology that helps to make spine surgeries safer. It also reinforces our confidence in reaching our announced goal of operational breakeven by the end of 2018. Beyond our existing products, we also have exciting DSG applications in our R&D pipeline for surgical robots in spine and visual feedback, as an enhancement to audio feedback, that will come into fruition in 2018” concludes Stéphane Bette, CEO and co-founder of SpineGuard.”

Next financial press release: 2017 full year revenue, January 4, 2018

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette, Tel. : +33 (0) 1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi, Tel: +33 (0)1 45 18 45 19
Chief Financial Officer
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr

IMPLANET fully paid off the Kreos bond loan

December 19, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces that it has paid off the bond loan taken out with Kreos Capital IV (UK) Ltd. in 2013.

On July 19, 2013, IMPLANET had signed a venture loan agreement with Kreos Capital IV (UK) Ltd. for the underwriting of a €5 million bond loan. As well as the loan itself, the contract foresaw the pledging of the Company’s business and intellectual property (IP).

David Dieumegard, CFO of IMPLANET says: “We are satisfied that this loan has now been entirely repaid, allowing IMPLANET to obtain the lifting of the pledges, including on its IP. Therefore, the reimbursement (principal and interest) of this loan in 2017 representing €1.1 million, IMPLANET should reduce its cash burn by the same amount.”

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1-917-385-2160
implanet@alphabronze.net

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

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

MiMedx Agrees To Lawsuit Settlement With Former Employee

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

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

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

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

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

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

NEW YORKDec. 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 YorkNew Jersey and Connecticut.
www.hss.edu

 

SOURCE Hospital for Special Surgery

Related Links

http://www.hss.edu

TransEnterix Announces Global SurgiBot System Agreement

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

InVivo Therapeutics Announces Executive Management and Board Changes

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