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Phase 1/2 Clinical Trial Results Positive for SpinalCyte’s CybroCell™ Dermal Fibroblasts

Posted On February 14, 2018 By OrthoSpineNews In Biologics /  

February 13, 2018

HOUSTON–(BUSINESS WIRE)–Degenerative disc disease has long been considered an inevitable part of aging, but new breakthrough research from SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs), suggests a new cell-based therapy could provide a cure for millions of sufferers. SpinalCyte has completed the first double blind, placebo-controlled human trial using HDF injections to treat sufferers of degenerative disc disease.

Almost 70 percent of patients who were treated with the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease, called CybroCell, reported significant therapeutic improvement. Prior research has shown that intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn generate the jelly-like material (disc nucleus) that provides cushioning for the spine1.

“CybroCell, in my opinion is the future of cell therapy,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “The current data suggests that CybroCell has the ability to significantly reduce pain, improve patient quality of life and be more effective than conventional stem cells. It has the added benefit of being more economical to produce and easier to acquire. Compared to all of the stem cells that I have worked with in my career, fibroblasts used in CybroCell are much superior.”

The landmark Phase 1/2 trial included 16 patients with chronic lower back pain caused by degenerative disc disease. The patients were randomly assigned to one of three groups. The first group received a placebo in the form of saline only; the second group received a single intradiscal injection of 10 million cells of CybroCell and the third group received a single intradiscal injection of 10 million cells of CybroCell in combination with platelet-rich plasma (PRP).

Using the Oswestry Disability Index (ODI), a widely used questionnaire measuring the intensity and disabling effect of lower back pain on daily activities, researchers determined that the ODI of four of the six patients (67 percent) treated with CybroCell decreased by more than 15 points, which is considered a significant therapeutic improvement. One of the four patients (25 percent) treated with CybroCell in combination with platelet-rich plasma (PRP) reported an ODI decrease of more than 15 points while one of six patients (17 percent) in the placebo group reported an ODI decrease of more than 15 points.

“The U.S. opioid crisis is a national emergency, so we consider the development of CybroCell, which may reduce or eliminate the need for opioids among patients suffering from chronic back pain as a result of degenerative disc disease, to be an urgent public health priority,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “Chronic lower back pain effects nearly 33 million Americans and over 7 million are related to degenerative disc disease 2. This creates a national crisis for their quality of life. Our human trials exceeded our most optimistic projections and we believe it will ultimately lead to a cure for degenerative disc disease. On behalf of everyone at SpinalCyte, I would like to thank the patients and physicians who participated in our Phase 1/Phase 2 trial and let them know we are committed to advancing this novel approach so all patients can benefit.”

SpinalCyte’s Phase 1/2 trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

Photo available for download: https://www.dpkpr.com/files/701/

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and international issued patents and has filed for an additional 48 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in biologics.

1Chee et al. Cell Therapy with Human Dermal Fibroblasts Enhances Intervertebral Disk Repair and Decreases Inflammation in the Rabbit Model. Global Spine J. 2016 Dec;6(8):771-779. https://0201.nccdn.net/1_2/000/000/18d/7d6/Global-Spine-Journal.pdf

2https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/pme.12809

 

(Photo: Dr. Torsten Wittmann/Science Photo Library/Getty Images)

 

Contacts

SpinalCyte, LLC
Investor Contact:
281.461.6211
info@spinalcyte.com
or
Media Contact:
Daniel Keeney, APR, 832.467.2904
dan@dpkpr.com

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SANUWAVE Signs $1 Million Equipment Financing Line With NFS Leasing

Posted On February 13, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, Feb. 12, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the Company has signed a one million dollar equipment financing lease agreement with NFS Leasing, Inc.  This agreement will enable SANUWAVE to begin placing the dermaPACE® System in the hands of clinicians and wound care centers in the United States to utilize in the treatment of diabetic foot ulcers, a billion dollar market.

NFS Leasing, Inc. has an extensive background in medical equipment financing and will be a valuable partner to SANUWAVE in our initial commercialization of dermaPACE in the United States after receiving FDA clearance in December 2017.  The line will be called as we order equipment, which will allow us to distribute the dermaPACE System domestically without dilution to the current shareholders.

“The agreement with NFS is a crucial announcement for the Company as we execute our plan for a successful rollout in the massive US diabetic foot ulcer (DFU) market.  This allows us to access capital to place devices which in turn will drive procedures and ultimately revenue,” stated Kevin A. Richardson II, Chief Executive Officer of SANUWAVE.  “We have a well developed plan in place to roll out dermaPACE methodically throughout 2018.  We are very excited to have this line in place which allows us to launch our rapid revenue growth,” concluded Mr. Richardson.

The Company has had overwhelming inbound information calls and support from the wound care community since the announcement of our FDA clearance.  We anticipate the first draw on this line later in February with our initial delivery shortly thereafter.

“We have been following SANUWAVE’s progress for a while and began discussions about doing business together prior to their good news from the FDA.  We are glad to be providing capital for a business model that will help heal a massive medical problem involving diabetic foot ulcers.  The Company has developed a great go to market strategy and we are looking forward to a successful strategic relationship,” stated David DePamphilis, Chief Operating Officer of NFS Leasing, Inc.

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.

About NFS Leasing, Inc.

NFS Leasing Inc. (www.nfsleasing.com) is an independent equipment leasing company, serving growth-oriented companies in a variety of fields.  NFS specializes in leasing technology equipment, scientific and medical equipment, as well as robotic, manufacturing and construction equipment.  Having helped a wide array of businesses grow for more than a decade, NFS is approaching a billion dollars in lease originations.  NFS’ management team averages over 25 years of technology and finance experience.  NFS has developed a broad base of extensive affiliations throughout the IT, medical, scientific, construction and manufacturing marketplace that can be leveraged to bring their customers unique incremental value.

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.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
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Bioventus to Continue Distributing SUPARTZ FX™ Through 2028

Posted On February 12, 2018 By OrthoSpineNews In Biologics /  

February 12, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into an extension of its agreement with Seikagaku Corporation to continue distributing SUPARTZ FX™, a five-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). Under terms of this new agreement, Bioventus will be the exclusive distributor of SUPARTZ FX in the US through May 2028.

“We are pleased SUPARTZ FX will remain in the Bioventus portfolio, along with three-injection HA GELSYN-3™ and DUROLANE®, our single-injection HA, for many years to come,” said Tony Bihl, CEO of Bioventus. “Joint fluid treatments safely manage knee osteoarthritis pain allowing people to resume active lives and we believe our complement of HA offerings is unmatched in meeting the varied needs of patients, physicians and payers in the US. This is consistent with our strategy to be a market leading biologics company in treatments for OA.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3 is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku.

SUPARTZ FX – Summary of Indications for Use:

SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.

Contacts

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

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SANUWAVE Announces Exhibition at Wounds Canada 2018 Spring Conference

Posted On February 7, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, Feb. 07, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company will exhibit at Wounds Canada 2018 Spring Conference in Winnipeg, Manitoba on 11 -12 May 2018. SANUWAVE cordially invites you to visit us in our booth.  Wounds Canada’s spring conference is a continuing education event designed to support healthcare professionals who work with patients with wounds or patients who are at risk for developing wounds. SANUWAVE is using this occasion to continue the education of Canadian customers on our lead wound care product, dermaPACE®.

“We are very excited about our US FDA approval received in December 2017 for our dermaPACE System to treat diabetic foot ulcers,” stated Kevin A. Richardson II, Chief Executive Officer of SANUWAVE.  “We have received great response to our FDA approval, including in Canada, and now we expect to become a material player in the wound care space in Canada as 2018 unfolds and develops.”

In Canada, 2.4 million people were living with diabetes in 2008-2009, a figure that is expected to rise to close to 4 million people by 2018-2019.  Ulceration of the foot is one of the major health problems for diabetics.  Also, in acute inpatient care the diabetic foot ulcers represent a serious chronic disease.  Wounds Canada, formerly Canadian Association of Wound Care, estimates that the average cost of treating a chronic wound in Canada is $10K and diabetes related ulcers cost the Canadian health care system $150M annually.  Early treatment intervention with dermaPACE System can prevent ulcers from developing complications such as infection that could lead to amputation.

Our Chief Financial Officer, Lisa Sundstrom, will be attending the conference on behalf of SANUWAVE.  Please feel free to contact Lisa directly at lisa.sundstrom@sanuwave.com to set up an appointment during the conference.

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.
Lisa Sundstrom
Chief Financial Officer
678-578-0117 (Office)
678-569-0881 (Fax)
Lisa.Sundstrom@sanuwave.com
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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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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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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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Anika Therapeutics Announces Strategic Collaboration with the Institute of Integrative Biology at the University of Liverpool to Develop an Innovative Therapy for Osteoarthritis

Posted On February 1, 2018 By OrthoSpineNews In Biologics /  

February 01, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced an agreement with the Institute of Integrative Biology at the University of Liverpool to collaborate on research to develop an injectable mesenchymal stem cell (MSC) therapy for the treatment of osteoarthritis (OA).

The purpose of this three-year research collaboration is to develop a novel MSC therapy for the treatment of OA, and if successful, is expected to yield a lead candidate that will move toward clinical development within a year of the collaboration’s completion.

Osteoarthritis is the most common chronic condition of the joints, affecting over 230 million people globally. OA can affect any joint, but it occurs most often in knees, hips, lower back, neck, small joints of the fingers, and the bases of the thumb and big toe. In normal joints, cartilage covers the end of each bone and acts as a cushion between the bones. However, osteoarthritis causes this cartilage to break down, causing pain, swelling and problems moving the joint.

“We are very excited to partner with the University of Liverpool and Professor Hollander to continue his research into an innovative treatment for osteoarthritis patients,” said Dr. Charles H. Sherwood, Chief Executive Officer, Anika Therapeutics. “This research will consist of a novel product design and pre-clinical testing, that has the potential to produce an advanced therapy to treat the joint damage and pain caused by this debilitating condition.”

Anthony Hollander, the Head of the Institute of Integrative Biology, said, “Cellular therapy is already being used in some countries for osteoarthritis with some evidence that it transiently reduces pain. Our new approach to cellular therapy may provide a durable treatment for osteoarthritis.” He added, “This collaboration with Anika will allow us to accelerate any discoveries through to clinical and commercial development.”

About the Institute for Integrative Biology at the University of Liverpool

The Institute of Integrative Biology (IIB; https://www.liverpool.ac.uk/integrative-biology/) provide one of the most vibrant and integrated biosciences environments in the UK. The Institute comprises 220 staff (including 75 Principal Investigators) and 150 postgraduate students. With a research income of ~£9.5m annually. Scientists deliver ground-breaking research within four key research themes, including the Centre for Genomic Research, the Centre for Proteome Research,, the Centre for Cell Imaging, and the NMR Centre for Structural Biology. The IIB has a large impact throughout the world, through major partnerships with large companies such as Unilever and AstraZeneca, and strong global links into major research enterprises in Japan, Brazil, USA and China.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the first, second, fourth, and fifth paragraphs of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the potential product that could be yielded by the Company’s collaboration with the University of Liverpool and the timeline for the delivery and clinical trial work associated with such product. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain pre-clinical or clinical data to support domestic and international pre-market approval applications or 510(k) applications, or timely file and receive FDA or other regulatory approvals or clearances of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (ii) the Company’s research and product development efforts, including those with the University of Liverpool, and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations and production planning; (iv) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (v) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (vi) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (vii) the Company’s ability to provide an adequate and timely supply of its products to its customers; (viii) the Company’s ability to continue to successfully manage Anika Therapeutics S.r.l.’s business; and (ix) the Company’s ability to achieve its growth targets.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, Chief Financial Officer
Tel: (781) 457-9000
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418, sonal@w2ogroup.com
or
University of Liverpool
Nicola Frost
Press Officer, External Relations, Marketing and Communications
University of Liverpool
nicola.frost@liverpool.ac.uk,
Tel: +44 (0)151 795 9620

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CollPlant Announces ADS Listing on NASDAQ

Posted On January 31, 2018 By OrthoSpineNews In Biologics /  

NESS ZIONA, Israel, January 31, 2018 /PRNewswire/ —

CollPlant (NASDAQ: CLGN) (TASE: CLGN), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), announced that its American Depository Shares (“ADSs”) have been approved for listing on The Nasdaq Capital Market. Trading commenced on Wednesday, January 31, 2018 under the ticker symbol “CLGN”. In addition, and simultaneously, Collplant’s ordinary shares will continue to trade on the Tel-Aviv Stock Exchange market (TASE: CLPT).

Yehiel Tal, CEO of CollPlant stated “We believe the Nasdaq listing gives us the opportunity to increase the trading liquidity of our securities, broaden our shareholder base and significantly raise our profile in the investment community. CollPlant’s proprietary product line addresses indications for a diverse fields of organ and tissue repair, and is making a real impact in the field of regenerative medicine. Our flagship rhCollagen BioInk product offering is being developed for 3D bioprinting of tissues and organs, and our Vergenix line of rhCollagen products includes a soft tissue repair matrix for the treatment of tendinopathy, as well as a wound repair matrix to promote rapid, optimal healing of acute and chronic wounds. Trading of CollPlant’s ADSs on Nasdaq is a natural extension of our growth goals.”

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Forward-Looking Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Collplant’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Collplant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Collplant’s actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which we operate; projected capital expenditures and liquidity; changes in our strategy; our ability to cooperate with third party collaborators; government regulations and approvals; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting Collplant is contained under the heading “Risk Factors” included in Collplant’s most recent registration statement on Form F-1 filed with the SEC on January 29, 2018, and in other filings that Collplant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Collplant’s current views with respect to future events, and Collplant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact at CollPlant:
Eran Rotem
Deputy CEO & Chief Financial Officer
Tel: +972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC:
Paula Schwartz (for US Investors)
Managing Director
Tel: 917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

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