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Osiris Appoints Willi Miesch to its Board of Directors, Change in CEO

Posted On February 6, 2018 By OrthoSpineNews In Biologics /  

COLUMBIA, Md., Feb. 06, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (Pink Sheets:OSIR) is pleased to announce that its Board of Directors, at a Board Meeting on February 6th, 2018, appointed Mr. Willi Miesch as a Director, upon recommendation of the Nominating Committee.  Mr. Miesch joins Osiris (the Company) as an independent Board Member and will stand for election at the Company’s 2018 Stockholders Meeting.

“We are pleased to have Mr. Miesch join Osiris at this important time,” said Peter Friedli, Chairman of the Board. “Willi is an expert in the development and marketing of medical devices, and has extensive entrepreneurial experience in building and developing successful healthcare companies.”

Mr. Miesch has more than 20 years of Chief Executive Officer experience with a track record of achievement in operations, manufacturing and marketing medical technology.  Mr. Miesch serves as Chief Executive Officer of Medartis, a Swiss medical technology company. Prior to joining Medartis in 1998, Mr. Miesch held positions with the Institut Straumann AG Switzerland & USA, and Stratec Medical.

Linda Palczuk, President and Chief Executive Officer has announced her decision to resign her position effective on February 9, 2018 to accept the position of Chief Operating Officer at Verrica Pharmaceuticals located in West Chester, Pennsylvania.  Ms. Palczuk advised the Company that her decision is due to the new position being a unique opportunity and one that is closer to her home residence.

Jason Keefer, the VP of Marketing for the Company, has been appointed as the Interim President & CEO.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the Company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine — including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in wound care, orthopedics, and sports medicine, including Grafix®, Stravix®, BIO4® (available exclusively through Stryker), and Cartiform® (available exclusively through Arthrex). Osiris, Grafix, Stravix and Cartiform are registered trademarks of Osiris Therapeutics, Inc., and BIO4 is a registered trademark of Howmedica Osteonics Corp. Osiris makes no claims concerning functional activities of Grafix or Stravix. Although well characterized in scientific literature and studies, preservation of tissue integrity including cells may not be indicative of clinical outcome. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

 For additional information, please contact:

Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1839
OsirisPR@Osiris.com

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Misonix Reports Record Second Quarter Revenue

Posted On February 6, 2018 By OrthoSpineNews In Financial /  

FARMINGDALE, N.Y., Feb. 06, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today reported financial results for the second quarter of fiscal year 2018 ended December 31, 2017 as summarized below:

($ in millions) Three Months Ended Six Months Ended
December 31, December 31,
2017 2016 2017 2016
Revenue $   8.3 $   6.0 $   15.6 $   12.2
Gross Profit $   5.9 $   4.2 $   11.0 $   8.5
Gross Profit Percentage 70.4 % 69.8 % 70.2 % 69.4 %
Operating loss $   (1.4 ) $   (1.6 ) $   (3.3 ) $   (3.1 )
Net loss $   (6.9 ) $   (0.6 ) $   (8.1 ) $   (1.1 )
EBITDA (1) $   (1.0 ) $   (0.4 ) $   (2.1 ) $   (0.7 )
Adjusted EBITDA (1) $   0.4 $   (0.1 ) $   0.5 $   (0.6 )
December 31, June 30,
2017 2017
Long Term Debt $ – $ –
Cash $   12.1 $   11.6

(1) Definitions and disclosures regarding non-GAAP financial information including reconciliations are included at the end of this press release.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix stated, “Misonix’s record fiscal second quarter revenue results again highlight the value of our leading ultrasonic medical device platform and continued execution against our strategy to transform our operating model into a rapidly growing business with high-margin recurring revenue streams.  Our domestic and international sales growth reflects rising market demand for our products, which led to our highest ever quarterly revenue, including 26% growth in our consumables business and a near doubling of our equipment sales.  We are particularly encouraged by our ability to grow total revenue by 38% while also maintaining our gross margin above 70%, further highlighting the leverage we are achieving from the planned shift in our sales mix toward higher margin products and the positive impact the transition to a consignment model is having across our domestic sales.

“Our initiatives to position Misonix for near and long term growth and profitability are yielding positive results across many areas of our business.  Our consumable products are driving growth in our recurring revenue base both domestically and internationally with 22% growth in consumable products in fiscal 2018 to date.  In addition, we are pleased with the strong performance our core products, including the 36% rise in BoneScalpel sales and the robust sales growth in SonaStar both in the US and abroad during the quarter.

“Our strategic investments in various areas of the business also contributed to the quarterly revenue growth and we expect growing returns from these investments in the second half of this fiscal year.  During the second quarter, we increased our R&D spend to accelerate our comprehensive product development roadmap and now expect to bring our next generation of therapeutic ultrasonic medical device platform to market by the end of 2018.  In addition, we expanded our commercialization team to over 43 sales personnel, which will allow us to better penetrate both existing and new markets.  These results provide us with added confidence in our ability to reach our goal of having Misonix consumable products utilized in 100,000 surgical procedures per year across the world within the next three years.

“Looking forward, Misonix has several significant opportunities to create substantial shareholder value and we remain confident that we will end fiscal 2018 with double-digit top-line growth with revenues exceeding $31 million as we capitalize on the recently implemented sales and marketing initiatives and further benefit from our ongoing efforts to transform Misonix into a customer centric and R&D-driven business.”

READ THE REST HERE

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7D Surgical Completes Significant Round of Financing

Posted On February 6, 2018 By OrthoSpineNews In Spine /  

TORONTO, Feb. 6, 2018 /PRNewswire/ — 7D Surgical is pleased to announce the completion of the largest round of financing secured by the company to date, providing the funding necessary to support the commercial launch of its FDA 510(k) approved Machine-vision Image Guided Surgery (MvIGS) system along with the development of an exciting pipeline of innovative and groundbreaking features for both spine and cranial surgical navigation.

“The latest investment into 7D Surgical will allow our team to aggressively scale our commercial footprint to meet the demand for our MvIGS technologies,” said Beau Standish, Chief Executive Officer at 7D Surgical. “We believe the hospital market will continue to adopt innovations that will lower costs while improving efficiency and safety.  The 7D Surgical system is perfectly positioned to fulfill each of these objectives.”

7D Surgical has integrated principles common in self-driving vehicles and facial recognition to create the first and only MvIGS platform.  7D Surgical’s Flash™ Registration and Flash™ Fix technology allows spine surgeons to perform spinal registration in just seconds, saving valuable operative time.  Clinicians can also update the patient registration with a simple foot pedal click at any time.  The system uses only visible light, eliminating the patient and staff exposure to intraoperative radiation which is common with older technologies.

“We have been thrilled by the response from clinicians who have implemented the MvIGS technology,” said Brian Stuart, Vice-President of Sales and Marketing at 7D Surgical. “The immediate and positive impact on surgical workflows, radiation reduction and sterile control of the technology has strongly resonated with surgeons and operating room staff.  These advantages, along with the significant cost savings over current options, makes MvIGS a win for everyone, including hospital administration.”

Demonstrations of the 7D Surgical System are available through a state-of-the-art audio-visual experience. Schedule a time to see our Flash™ Registration and Flash™ Fix technologies at contact@7Dsurgical.com. The company will also be presenting live demonstrations at the upcoming Texas Association of Neurological Surgeons Meeting in Houston from Feb 9-10, 2018 and at the Spine Summit Meeting in Orlando from March 15-16, 2018.

About 7D Surgical

7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada-approved MvIGS system delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties.  www.7Dsurgical.com

Flash™ Registration: https://7dsurgical.com/7d-surgical-system/spine-navigation/

Flash™ Fix: http://7dsurgical.com/7d-surgical-system/flash-technology/

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
189947@email4pr.com

SOURCE 7D Surgical

Related Links

http://www.7Dsurgical.com

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EOS imaging Announces New Installation in a Top-Ranking Specialty Orthopedic Hospital in China

Posted On February 6, 2018 By OrthoSpineNews In Extremities /  

February 06, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the installation of an EOS® system at the Beijing Jishuitan Hospital in Beijing Shi, China.

Beijing Jishuitan Hospital is a large-scale, first-level hospital that focuses on orthopedics through its Beijing Bone and Arthropathy Researching Center, Post-Operative Total Joint Arthroplasty Evaluation Center, and Orthopaedics Training Center. The hospital has approximately 1,000 beds, 200 doctors, and 2,200 full-time staff members. In 2016, Beijing Jishuitan Hospital performed more than 40,000 orthopedic surgeries, making it the first specialty orthopedic institution worldwide in terms of surgical volumes.

“As the head of the Radiology Department at Beijing Jishuitan Hospital, patient safety and diagnostic quality are very important to me, which is why I’m looking forward to providing the lowest dose imaging system to our patients and the valuable 2D/3D images and data to our surgeons. EOS is the optimal choice to satisfy our demands for safe imaging and sustainable long term positive outcomes, and I am sure our patients will now have a better experience here,” commented Professor Xiaoguang Cheng, Head of the Radiology Department at Beijing Jishuitan Hospital and Committee and Vice Chief Secretary of the Chinese Association of Radiologists.

“Following the first Chinese installations in Shanghai and the Jiangsu Province in 2017, we are pleased with the continued growth in the country, championed by leading physicians and prestigious institutions such as Jishuitan,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “The Chinese market includes more than 1,200 top grade hospitals, and we look forward to providing our technology to the patients they treat.”

About EOS imaging

EOS imaging designs, develops and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2017 sales of €37.1 million and employs 152 people at December 2017. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

EOS imaging has been selected to integrate the EnterNext © PEA – SME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Next press release: 2017 Results and Q1 Sales, April 11, 2018 (after market close)

Contacts

EOS imaging
Pierre Schwich, +33 (0)1 55 25 61 24
CFO
investors@eos-imaging.com
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

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Orthofix Announces 510(k) Clearance and US Limited Market Launch of FORZA XP Expandable Spacer System

Posted On February 6, 2018 By OrthoSpineNews In Regulatory, Top Stories /  

February 06, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ: OFIX), a global medical device company focused on musculoskeletal healing products, today announced the 510(k) clearance and U.S. limited market launch of the FORZA® XP Expandable Spacer System.

Designed to restore normal disc height in patients suffering from degenerative disc disease, the FORZA XP Expandable Spacer System can be expanded after insertion into the disc space in order to fit the patient’s anatomy. Made primarily of titanium alloy, these expandable interbodies are used for PLIF (Posterior Lumbar Interbody Fusion) and TLIF (Transforaminal Lumbar Interbody Fusion) procedures. Unlike the incremental expansion offered by some expandable interbody devices, the Orthofix System allows for a continuous controlled expansion and a custom fit to the disc space. Once the desired expansion is achieved the device features automatic locking which further adds to its ease of use.

“The FORZA XP Expandable Spacer System is a strong addition to our robust portfolio and makes Orthofix competitive in one of the fastest growing segments in spine,” said Ray Fujikawa, President of Orthofix Spine Fixation. “This new system offers an industry-leading 6.5mm starting height and also enables surgeons to place bone graft material inside the device after implantation. The ability to pack our new expandable device with bone graft post expansion is extremely important to ensure proper contact of the material with the vertebral endplates.”

The FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine. The FORZA XP Expandable Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation such as the Orthofix Trinity ELITE® allograft tissue and the Firebird® Spinal Fixation System.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix, International N.V.
Investor Relations:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

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Positive Pre-Clinical Results Using CelGro® in Anterior Cruciate Ligament (ACL) Reconstruction

Posted On February 5, 2018 By OrthoSpineNews In Biologics, Top Stories /  

February 04, 2018

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC) (“Orthocell” or the “Company”) is pleased to announce positive pre-clinical results using CelGro® collagen rope for Anterior Cruciate Ligament (ACL) reconstruction.

Orthocell Managing Director Paul Anderson said:“We are extremely excited by the potential of this technology.An off the shelf biological device that augments ACL reconstruction is highly desired by the orthopaedic industry and Orthocell is ideally placed to deliver a superior product in this rapidly growing and lucrative market.Not only does this data support the potential for an off the shelf augment to ACL reconstruction, but it also acts to validate CelGro® as a collagen medical device platform technology, for use across multiple indications including bone, tendons and peripheral nerves.”

The pre-clinical study was led by Chief Scientific Officer, Professor Ming-Hao Zheng, in conjunction with the University of Western Australia. The study was designed to show CelGro® collagen rope was equal to, or better than the use of an autologous tendon graft (such as hamstring) for ACL reconstruction, which can result in donor site discomfort and other associated complications.

The top line data indicated CelGro® rope, made from braided collagen fibers has superior biomechanical properties and is capable of replacing autologous grafts for ACL reconstruction. Further, the host ligament stem cells from the ACL stump are capable of ingrowth into the collagen rope for tissue regeneration and integrating with native bone with a tensile strength similar to that of the natural ligament. Professor Zheng presented the positive results at the Raine Medical Research Foundation ACL symposium (“ACL Symposium”), highlighting that collagen rope may eliminate the need for autograft harvest, thus circumventing the donor site morbidity.

Professor Freddie Fu, keynote speaker at the ACL Symposium, Chairman of the Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, specialist in ACL reconstruction, commented: “The use of this new collagen rope for ACL reconstruction is very promising. It could reduce the donor site morbidity and shorten surgical timeframes.” Professor Freddie Fu is a world-renowned orthopaedic surgeon and has treated high profile athletes, including Zlatan Ibrahimovic, striker for Manchester United.

72 cases were involved in the study with 36 cases receiving an autograft and the other 36 cases receiving CelGro® collagen rope for ACL reconstruction. Cases were evaluated at multiple time points undergoing either a regeneration assessment or mechanical test to assess the performance of the CelGro® collagen rope when compared to autologous tendon graft for ACL reconstruction. More pre-clinical studies will be required before human trials can begin.

Treatment of ruptured anterior cruciate ligaments

The ACL is one of the major stabilising ligaments of the knee. It connects the thigh bone (femur) to the shin bone (tibia), and once it ruptures, it is incapable of healing. The ACL can be injured in several ways including changing direction rapidly, landing from a jump or direct contact or impact. A ruptured ACL is a common injury suffered by active patients, usually requiring surgical intervention, with a long period for rehabilitation before returning to preinjury activities. There are between 100,000 and 200,000 ACL ruptures per year in the United States alone.

Successful ACL reconstruction surgery tightens your knee and restores its stability. It also helps patients avoid further injury and a return to work and playing sports. Surgical repair mostly involves reconstructing the ACL using grafts from the patient’s hamstring tendon, a procedure that removes part of the patients own tendon to take the place of the ruptured ACL. However, harvesting the patient’s tendon to replace the ruptured ACL is time consuming and can be problematic with ongoing donor site discomfort and in some cases subsequent rupturing of the harvested tendon.

To address the ACL reconstruction issues, Orthocell is developing a biological augment for ACL reconstruction, which could make treatment much more efficient and effective by simplifying techniques, reducing surgery time and mitigating the risks associated with harvesting the patient’s own tendon.

Contacts

General enquiries:

Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor enquiries:
Vesparum Capital
Joel Seah, +61 3 8582 4800
orthocell@vesparum.com
or
Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012
bwalsh@buchanwe.com.au

 

Photo of ACL reconstruction using CelGro(R) collagen rope (Graphic: Business Wire)

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New Data and Surgical Experiences with OMNIBotics® Active Spacer™ Ligament Balancing System Presented at Prestigious Orthopaedics Conference

Posted On February 5, 2018 By OrthoSpineNews In Recon /  

RAYNHAM, Mass., Feb. 5, 2018 /PRNewswire/ — OMNIlife science™, Inc. (“OMNI™”), an established medical technology company targeting the $15 billion global hip and knee replacement device market, announced that several presentations about their breakthrough OMNIBotics Active Spacer technology were featured at the International Congress for Joint Reconstruction (ICJR) 10th Annual Hip & Knee Conference held in Vail, CO from January 18-21.

The ICJR focuses on providing a comprehensive orthopaedic learning experience for their members, delivering timely and relevant education. The more than 150 attendees learned about OMNIBotics Active Spacer technology in both a pre-recorded surgery presentation and a podium presentation. The surgery, “TKA Utilizing OMNIBotics Active Spacer Robotically Assisted Ligament Balancing System” was performed and narrated by Jeffrey H. DeClaire, MD, DeClaire LaMacchia Orthopaedic Institute, Rochester Hills, MI. The podium presentation “Ligament Balancing Technology in TKA” was given by John Keggi, M.D., Connecticut Joint Replacement Institute, Hartford, CT.

Dr. DeClaire commented, “With this new technology and the ability to capture accurate data, the Active Spacer can help to more accurately and consistently restore the normal soft tissue balance of the knee with the potential to improve patient outcomes and patient satisfaction.”

The OMNIBotics Active Spacer, with more than 150 procedures performed to date, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. Since sub-optimal soft tissue balancing is a potential contributing factor to patient dissatisfaction with their knee replacement, OMNI developed this device to address that need. When the OMNIBotics Active Spacer is combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal and a soft tissue perspective.

“The Active Spacer provides the most accurate and useful information to date for achieving good balance in knee replacement patients,” stated Dr. Keggi. “Surgeons can now see the full motion and precise balance of the knee in real time, which provides important feedback to optimize the function of the knee.”

The OMNIBotics Active Spacer received FDA clearance in early September, 2017 and is currently in clinical evaluation at six sites in the United States and one in Australia.

About OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

Forward-Looking Statements

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward‐looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward‐looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

Contact

Cindy Holloway, Director of Marketing Communications
Phone: (508) 824‐2444
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com

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InVivo Therapeutics Announces Appointment of Richard Toselli, M.D., as President and Chief Executive Officer

Posted On February 5, 2018 By OrthoSpineNews In Biologics /  

February 05, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Richard Toselli, M.D., has been appointed President and Chief Executive Officer of InVivo, having been appointed the company’s Acting CEO in December 2017. Dr. Toselli also has been appointed to the company’s Board of Directors and will continue to serve in his capacity as InVivo’s Chief Medical Officer, which role he assumed upon joining the company in July 2017. Dr. Toselli, a Board-certified neurosurgeon, has led an accomplished career in surgical medical affairs, with senior leadership experience at Sanofi, DePuy, and Johnson & Johnson.

“I am delighted to announce Rich’s full-time role as CEO,” stated Ann Merrifield, InVivo’s Chair of the Board of Directors. “Rich has demonstrated clear vision, a strategic mind, and committed leadership in his time at InVivo. His background in surgical device innovation and neurological surgery is uniquely suited to the company’s focus in development.”

Dr. Toselli said, “I am excited about the opportunity to work closely with our seasoned leadership team and accomplished Board members and advisors as we chart the company’s path forward. Our priority is to focus on our core competencies, advance our breakthrough Neuro-Spinal Scaffold™ clinical program, and achieve this progress in an expedited, cost-efficient manner. We continue to evaluate our strategic and financing options, regarding which we believe we have gained additional flexibility by entering into the recently announced stock purchase agreement with Lincoln Park.”

Dr. Toselli continued, “As we have previously announced, we are in ongoing discussions with the FDA, including the potential of a proposed randomized controlled clinical trial to supplement the existing clinical evidence we have attained in our INSPIRE study for our Neuro-Spinal Scaffold™ investigational device. We expect to provide additional clarity on this clinical path in the second quarter of this year.”

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.

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 initiate, conduct and complete clinical trials; the expected benefits and potential 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 trials and future product commercialization; and other risks associated with the company’s business, research, product development, attainment of 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 most recent Form 10-K, its Form 10-Qs and its 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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SANUWAVE Announces First Time Exhibition at EWMA in Poland in May 2018

Posted On February 2, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, Feb. 02, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company will exhibit at EWMA (European Wound Management Association) in Krakow, Poland on May 9 – 11, 2018. This will be a great opportunity to re-invigorate our flagship wound care device, the dermaPACE® System, after receiving US FDA clearance for the treatment of Diabetic Foot Ulcers (DFUs) in December 2017.  The dermaPACE system is currently CE Marked within Europe for the treatment of various acute and chronic conditions of the skin.

“We are excited to be presenting at EWMA in Krakow, Poland, our first time as an exhibitor.  Since FDA clearance, the support coming from the wound care community has been overwhelmingly positive, both domestically and internationally,” stated Kevin A. Richardson, CEO and Chairman of the Board.  Mr. Richardson continued, “This will be the start of our reemergence in the wound care space.”  The Company is using this occasion to showcase their lead wound care product, the dermaPACE System.  This Extracorporeal Shockwave Technology (ESWT) device based upon electrohydraulic principles has been proven, in two US-based randomized-controlled clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers.  Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects.  The dermaPACE System exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment.  The use of the dermaPACE System allows the clinician to more easily, and more cost-effectively, manage wounds.   More importantly, the patient’s quality of life improves significantly.  While new to the U.S. market, the dermaPACE System already enjoys a strong support base in Italy, Spain, and the BeNeLex countries.  Additional distribution bases include: Germany, Austria, Switzerland, Romania and Great Britain.

If you are interested in scheduling a meeting with the team, please contact Peter Stegagno via e-mail at peter.stegagno@sanuwave.com; otherwise, please stop by our booth at the conference in May.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers.  The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

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

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

Contact:

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

SANUWAVE Health, Inc.
Peter Stegagno

Vice President Operation, Regulatory, and Clinical

678-578-0111 (Office)

678-670-9478 (Mobile)

peter.stegagno@sanuwave.com
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Hard-to-Heal Bones Could Use a Protein Boost

Posted On February 2, 2018 By OrthoSpineNews In Extremities /  
February 1, 2018/GEN

The occasional bone fracture from a sports injury, motor vehicle accident, or just plain bad luck may seem commonplace in today’s world of advanced medical treatments. Yet, there is always the possibility that the break won’t heal properly or quickly—even with the aid of pins, plates, or a cast. Scientists and physicians have unsuccessfully tried to overcome this potential problem through the administration of bone morphogenetic proteins (BMPs). These regenerative factors were initially designed to promote spinal fusion and bone repair, but studies found that the molecules can over perform, causing excessive or misdirected bone growth.

Now a collaborative team of investigators, led by scientists at the University of Michigan Medical School, have discovered a new molecule they believe will provide the assisted growth to bones that was originally intended using BMPs. Findings from the new study were published today in npj Regenerative Medicine, in an article entitled “Intraoperative Delivery of the Notch Ligand Jagged-1 Regenerates Appendicular and Craniofacial Bone Defects.”

“Each year, 33% of US citizens suffer from a musculoskeletal condition that requires medical intervention, with direct medical costs approaching $1 trillion USD per year,” the researchers write. “Despite the ubiquity of skeletal dysfunction, there are currently limited safe and efficacious bone growth factors in clinical use.”

“Novel therapies have gone underdeveloped because of this assumption that bones heal without problem,” added senior study investigator Kurt Hankenson, D.V.M., Ph.D., a professor of orthopedic surgery at Michigan Medicine. “The reality is there’s a huge number of fractures that occur each year that don’t heal very well.”

Due to the limited number of options for aiding patients with bone healing, the research team began to look for novel approaches. What they attempted was the delivery of additional Jagged-1—a potent osteoinductive protein known to activate the Notch signaling pathway that regulates bone healing—at the spot of a bone injury.

 

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