Biologics – Page 20 – Selby Spine

MARIETTA, Ga., Sept. 19, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 2 clinical trial for osteoarthritis of the knee.

The osteoarthritis clinical trial will study MiMedx’s AmnioFix® Injectable in a Phase 2, prospective, double-blinded, randomized controlled trial of the micronized dehydrated human amnion/chorion membrane (dHACM) injection as compared to saline placebo injection in the treatment of knee osteoarthritis. The Company expects patient enrollment to commence by the end of the year.

The trial will enroll approximately 318 study patients with a diagnosis of knee osteoarthritis defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. The IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of knee osteoarthritic pain.

The filed primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90, expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group. The Western Ontario and McMaster Universities (WOMAC) scores will be one of the study’s secondary endpoints measured at 30, 60, 90 and 180 days.

Osteoarthritis of the knee is an extremely common occurrence in older patients, where it represents the biggest cause of disability and reduction of activity in patients over the age of 50. There are 14 million individuals in the U.S. who have symptomatic knee osteoarthritis and there were 7.8 million knee joint pain injections in the U.S. in 2015. Common medical treatment options include injectable medications such as corticosteroid; other injections such as hyaluronic acid (HA) and platelet rich plasma (PRP); and surgery, such as knee arthroscopy and knee replacement. Randomized trials have shown that corticosteroid injections may present short-term relief to patients with the condition, but unfortunately, the condition tends to recur, and complications may occur, such as systemic hyperglycemia, septic arthritis, and joint degradation. Clinicians generally agree that a lifetime limit of 2-3 corticosteroid injections is appropriate in unresponsive patients.

HA injections may provide temporary symptomatic relief and are widely used. However, their use is not without controversy and is currently not recommended by the American Academy of Orthopedic Surgeons in their treatment guidelines. PRP preparations have been popularly deployed in the treatment of knee osteoarthritis. However, concerns exist regarding this modality, since various methods of producing the material have differing bioactivity, and there is some debate in the literature about whether or not PRP is universally effective.

Bill Taylor, President and COO, stated, “With the variability of efficacy, cost, and side effects of current treatments for osteoarthritis, other treatment options are needed. This is particularly true when chronicity begins to develop and surgery is becoming the only remaining option. We believe our PURION® Processed AmnioFix® Injectable would be an ideal treatment alternative for osteoarthritis of the knee. Studies have confirmed that the natural characteristics of amniotic membrane may provide clinical benefits in the areas of enhanced soft tissue healing and inflammation modulation.”

The osteoarthritis study will be the fourth IND trial for MiMedx AmnioFix Injectable. The other three IND trials include the Plantar Fasciitis Phase 2B, Plantar Fasciitis Phase 3, and Achilles Tendonitis Phase 3 trials. MiMedx also plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company’s Plantar Fasciitis Phase 3 trial completes.

Over 80 clinical studies documenting the efficacy and effectiveness of MiMedx allografts have been published to date. The Company’s robust compendium of current clinical activity includes 28 ongoing clinical studies in various stages of development and execution, 123 clinical sites under management, and 175 physicians currently contracted for research activities. This vigorous agenda of clinical activities encompasses over 450 legal agreements and contracts for study involvement.

Parker H. “Pete” Petit, CEO, said, “There should not be any further concerns about MiMedx becoming a biopharma focused organization in an expedited fashion. We have accomplished rapid asset development in these areas over the years, and in March we disclosed to shareholders that our new strategic focus would be new therapeutic areas as a biopharma company. At that point, I did not think our level of expertise and accomplishments to date were fully appreciated. However, having two ongoing phase 3 trials and one phase 2 trial at a large number of centers will be quite an accomplishment. We have been able to very efficiently and effectively conduct our trials to this point without the assistance of a Clinical Research Organization (CRO). We expect to continue to build our staff as our demands increase. Along those lines, we will shortly announce additional very experienced biopharma executives to our staff. They will help continue our rapid development of the opportunities we have with our placenta based technology.”

“We are anxious to commence the Phase 2 clinical trial and we expect the study results to be compelling. We look forward to reporting the results to the medical and investment communities,” added Taylor.

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

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s belief that AmnioFix Injectable is an ideal treatment alternative for osteoarthritis of the knee and expectations that study results will be compelling. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

September 18, 2017/Roxane Wergin, Director, Corporate Communications

ALACHUA, Fla. (September 18, 2017) – RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced today three new appointments to its senior leadership team to accelerate the Company’s strategic growth initiatives. They include Jonathon Singer, a member of RTI’s board of directors, as Chief Financial and Administrative Officer, effective October 2, 2017. Outgoing CFO Robert Jordheim will leave the company to pursue new endeavors following a successful transition. RTI also appointed Olivier Visa, formerly Vice President of Global Compounding for Baxter, and Julius Aviza, past Vice President of Global Quality at American Medical Systems, to lead its OEM, Donor Services, Sports business and quality assurance function, respectively.

The new management additions demonstrate another important step toward positioning RTI for continued progress in executing its strategic transformation plan. The augmented leadership team has decades of highly specialized functional and industry expertise, along with a diverse skill set that is aligned to build on RTI’s recent strong performance and to advance its progress toward returning RTI to long-term sustainable growth and profitability. Each leader will play a critical role in further developing their respective functional excellence, streamlining RTI’s businesses, upgrading its processes and reinforcing a culture that is laser focused on the customer.

New Chief Financial and Administrative Officer

Mr. Singer, an RTI board member since May 2016, will resign from the board to focus on his new role, which includes managing the company’s financial operations and overseeing RTI’s information technology, legal and business development functions. He will report to RTI Chief Executive Officer Camille Farhat.

“As we continue to implement our long-term growth strategy, we need the right team to accelerate and solidify our progress,” said Mr. Farhat. “I am particularly proud to welcome Jonathon who already has been a valuable contributor to RTI’s progress as one of our board members. His intricate knowledge of RTI combined with his broad business experience and deep background in strategic planning, finance, operations, IT, investor communications and business development will bring a new dimension to his role and help us accomplish the significant work ahead of us.”

Mr. Singer has more than 30 years of leadership experience at publicly-traded health care and pharmaceutical organizations. Previously, he was Executive Vice President and Chief Financial Officer at Sagent Pharmaceuticals, a producer of generic injectable products that won numerous awards for growth and innovation during his tenure. Mr. Singer also served as CFO of Landauer, a radiation safety products and services provider, and as Vice President for Global Finance and CFO of the Medical Segment at specialty medical device company, Teleflex. A certified public accountant, he has held finance, accounting and operations roles at Cardinal Health, R.R. Donnelley & Sons and KPMG.

“I would like to extend my appreciation and gratitude to Rob Jordheim for his service as CFO and interim CEO,” said Mr. Farhat. “His commitment to RTI’s mission has contributed to putting us back on the path toward growth. We all wish Rob the best in his future endeavors.”

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September 13, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced the first patients have been enrolled in its BONES (Bioventus Observational Non-interventional EXOGEN Studies) clinical development program. BONES includes three observational, non-interventional, direct-to-patient studies designed to collect real world data on the use of the EXOGEN Ultrasound Bone Healing System. EXOGEN uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural bone healing process.

The BONES studies will compare the incidence of fracture nonunions in patients utilizing EXOGEN with patients from a national health insurance claims database who received standard of care alone. The studies will include long and small bones of upper and lower extremities and the unique design of BONES was discussed with FDA during its development. Its primary endpoint is defined as the ability of EXOGEN to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors.

“We are excited to build on the vast clinical experience available on this established therapy and further develop our knowledge on the real world effectiveness of EXOGEN, by assessing its value in reducing nonunions, a highly disabling complication that also carries a significant societal burden,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “Accomplishing this ambitious goal requires an alternative methodology to randomized controlled trials and involves epidemiologically grounded research of large patient cohorts enrolled both prospectively, and within the big data available from US health insurance claims.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. 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, and EXOGEN are registered trademarks of Bioventus LLC.

EXOGEN – Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Contacts

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

MARIETTA, Ga., Sept. 12, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has been recognized by Fortune Magazine as the fifth ranked company in Fortune’s 2017 list of the top 100 fastest growing public companies.

The methodology utilized by Fortune Magazine for its ranking of the top 100 fastest growing public companies includes the company must be listed on a major U. S. stock exchange; have a minimum market capitalization of $250 million and a stock price of at least $5 on June 30, 2017; and have been trading continuously since June 30, 2014. These companies must have revenue and net income for the four quarters ended on or before April 30, 2017 of at least $50 million and $10 million, respectively; and have posted an annualized growth in revenue and earnings per share (EPS) of at least 15% annually over the three years ended on or before April 30, 2017.

Companies that meet these criteria are ranked by revenue growth rate, EPS growth rate, and three-year annualized total return for the period ended June 30, 2017. Fortune determines the overall rank based on the sum of the three ranks. Once the 100 companies are identified, they are then re-ranked within the 100, using these three equally weighted variables.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are pleased to be among the top 100 companies in this prestigious group, and we are extremely honored to be ranked number 5. This recognition is a tribute to the outstanding employees who comprise the MiMedx team and the remarkable healing capabilities of the regenerative medicine products we offer. We are pleased that our dehydrated human amnion chorion membrane (dHACM) allografts are playing an expanding role in helping the healthcare community to improve clinical outcomes and reduce costs.”

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

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the remarkable healing capabilities of the regenerative medicine products the Company offers and the expanding role played by the Company in helping the healthcare community improve clinical outcomes and reduce costs. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the healing capabilities of the Company’s products may not continue to have the same results and the Company may not continue to play an expanding role in helping the healthcare community improve clinical outcomes and reduce costs. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

WESTMINSTER, Colo., Sept. 12, 2017 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced the publication of two-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of i-FACTOR™ Peptide Enhanced Bone Graft. The results published in the peer reviewed journal Neurosurgery show i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft in anterior cervical discectomy and fusion (ACDF) procedures.

i‐FACTOR Bone Graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. In November 2015, Cerapedics received Premarket Approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in ACDF procedures.

“We are pleased that the statistical superiority in overall success for i-FACTOR Bone Graft versus autograft in ACDF procedures was maintained over two years in our IDE trial,” said Jeffrey Marx, Ph.D., president and COO of Cerapedics. “The Neurosurgery publication is a testament to the hard work and dedication of the clinical investigators who continue to pursue advanced treatment options for patients with degenerative cervical disc disease.”

In the IDE clinical trial, patients received either autograft or i-FACTOR Bone Graft in a cortical ring allograft. FDA-mandated success criteria included fusion, improvement in Neck Disability Index (NDI), neurological status, and safety. At two-year follow-up, a responder analysis of combined endpoints for overall success demonstrated 70 percent success for patients receiving i-FACTOR Bone Graft versus 56 percent for patients receiving autograft. This was statistically significant for superiority (p = 0.0302).

Fusion success was confirmed radiologically for 97 percent of i-FACTOR Bone Graft patients and 94 percent of autograft patients (p = 0.2195). A more than 15-point improvement from baseline NDI was reported for 77 percent of i-FACTOR Bone Graft patients and 69 percent of autograft patients (p = 0.1804). Improvement in neurological status was similar in both patient groups (95 percent of i-FACTOR Bone Graft patients and 94 percent of autograft patients, p = 0.6944). Safety success measured by the absence of re-operation, device explantation, and device-related serious adverse events was observed in 95 percent of i-FACTOR Bone Graft patients and 91 percent of autograft patients (p = 0.1379).

“The publication of the two-year results from this Level I clinical trial further validates previous findings that i-FACTOR™ Bone Graft, with P-15 technology, is statistically superior to autograft,” said Paul Arnold, M.D., neurosurgeon at the University of Kansas Hospital Marc A. Asher, M.D. Comprehensive Spine Center and lead author of the study. “we are pleased to be able to offer a new advanced biologic bone graft with outstanding safety and efficacy to our patients.”

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

Media contact:
Adam Daley
|Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

SOURCE Cerapedics

HAIFA, Israel, Sept. 05, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that its Phase III study of PLX-PAD cells to support recovery following surgery for femoral neck fracture has been awarded an $8.7 million (7.4 million Euro) non-dilutive grant from the Horizon 2020 program, the European Union’s largest research and innovation program. Final approval of the grant is subject to the finalization of the consortium and Horizon 2020 grant agreements. This marks the second grant awarded to a Pluristem Phase III trial by Horizon 2020, following an $8 million (7.6 million Euro) award for its ongoing Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI), which was awarded in August 2016.

The Phase III trial of PLX-PAD cells in the treatment of femoral neck fracture will be a collaborative effort between Pluristem and an international consortium led by the Charité – Universitätsmedizin Berlin, under the leadership of Dr. Tobias Winkler, Principal Investigator at the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. Dr. Winkler also served as Senior Scientist for Pluristem’s completed Phase I/II study of PLX-PAD for hip surgery. That trial demonstrated that patients treated with Pluristem’s PLX-PAD cells during total hip arthroplasty experienced significant muscle regeneration compared to the control group with an improvement in muscle force and in muscle volume six months after surgery.

Dr. Winkler commented, “Following the impressive results from the Phase I/II study of PLX-PAD cells in a similar orthopedic indication, we are excited to advance PLX-PAD cell therapy into a Phase III study to aid in muscle regeneration in patients recovering from femoral neck fracture. If similar results are achieved in this Phase III trial, it could show that PLX-PAD cells can improve outcomes in these procedures and change the way recovery is managed worldwide.”

Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone. The number of surgeries performed annually to treat femoral neck fractures is increasing as populations age. Following surgery, many patients do not regain their baseline capabilities due to poor muscle healing and regeneration, which leads to significantly increased morbidity and a lower quality of life.

“We are honored to receive this second grant from the Horizon 2020 program,” stated Pluristem Chairman and Co-CEO Zami Aberman. “We believe this grant reflects a vote of confidence by the European Union and signals the need for cell therapy solutions to enable patients to lead healthier lives and to relieve health systems’ financial burdens. We are confident that this grant will help us move towards rapid entry into the European and U.S. markets.”

Pluristem’s PLX-PAD program is one of only a handful to be accepted into Europe’s Adaptive Pathway program, the purpose of which is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. Pluristem plans to enroll patients at clinical sites throughout Europe and the U.S. The study is expected to serve as a pivotal trial for regulatory approval in both regions.

About the Berlin-Brandenburg Center for Regenerative Therapies

The Berlin-Brandenburg Center for Regenerative Therapies (BCRT) was founded as a cooperative research institution of the Charité University Hospital in Berlin, which is one of the largest university hospitals in Europe, and Germany’s largest research association, the Helmholtz Association. The goal of the BCRT is to enhance endogenous regeneration by cells, biomaterials, and factors which can be used to develop and implement innovative therapies and products. The primary focus of the BCRT is on diseases of the immune system, the musculoskeletal system and the cardiovascular system for which currently only unsatisfactory treatment options are available.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when its discusses the Phase III Studies of PLX-PAD cells and possible results, that the final approval of the Horizon 2020 grant is subject to finalizing the consortium and Horizon 2020 grant agreements, that Pluristem believes the grant is a vote of confidence by the European Union and signals the need for cell therapy solutions to enable patients to lead healthier lives and to relieve health systems’ financial burdens, when Pluristem states it is confident that the grant will help it move towards rapid entry into the European and U.S. markets and that the Phase III femoral neck fracture study is expected to serve as a pivotal trial for regulatory approval in the European Union and the U.S. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Karine Kleinhaus, MD, MPH 
Divisional VP, North America 
1-914-512-4109 
karinek@pluristem.com                                     

Efrat Kaduri 
Head of Investor and Public Relations 
972-74-7108600 
efratk@pluristem.com

Public Release: 5-Sep-2017

NYIT (New York Institute of Technology) has been awarded $442,000 to pursue research into a gene critical in the formation and healing of bones. The United States’ National Institutes of Health (NIH) has awarded Life Sciences professor Michael Hadjiargyrou, Ph.D., a multi-year grant to study a newly discovered musculoskeletal specific gene, Mustn1, and to determine its role in cartilage regeneration and skeletal repair. Hadjiargyrou’s research will also begin to elucidate a new and as yet uncharacterized protein family important for cartilage and bone biology.

The NIH funds will support generating genetically altered mice where Mustn1 is deleted at various stages of development. Experiments with these mice, known as knockout (KO) mice, constitute “the gold standard in gene/protein function analysis.” Using KO mice will allow Hadjiargyrou’s team, including NYIT students, to establish conclusively that Mustn1 is a key regulator in cartilage cells and is necessary for cartilage formation during embryonic development and also fracture repair.

Hadjiargyrou has spent much of his career working at the molecular and cellular level of skeletal repair, and Mustn1 was first discovered in his laboratory. It represents a newly discovered family of proteins, MUSTANG, which stands for Musculoskeletal Temporally Activated Novel Gene. While Hadjiargyrou’s prior research has demonstrated that Mustn1 is a factor in cartilage formation, he and his team are eager to take the next step: finding out its exact significance during bone development and regeneration by analyzing various conditions with and without the presence of the gene.

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September 05, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has received US FDA approval for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). Hyaluronic acid is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. Knee osteoarthritis involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues within the knee.

“More than 20 million Americans are afflicted with knee osteoarthritis and there is no cure, but the associated pain can be managed,” said Tony Bihl, CEO of Bioventus. “DUROLANE has been a proven knee OA pain reliever for more than 15 years, improving the lives of more than one million people worldwide. It will join our current offerings to provide even more efficacious treatment options for US patients, physicians and payers.”

DUROLANE will complement the company’s OA portfolio which includes three-injection HA GELSYN-3™ and the five-injection HA SUPARTZ FX™. Bioventus markets and sells DUROLANE in more than 25 countries including Canada, Mexico, Australia, and throughout much of Europe. It plans to launch DUROLANE the US market in early 2018.

About Bioventus

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 Corporation.

Contacts

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

MARIETTA, Ga., Aug. 31, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that their latest peer-reviewed clinical study of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts was accepted for publication in the International Wound Journal.

The paper entitled “A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers,” was authored by Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Doslouglu, MD, FACS; Gregory Tovmassian, DPM; and the EpiFix VLU Study Group of Delores Farrer, DPM, MBA, CWS; Elisa Taffe, MD; Lacey Loveland, DPM; David O’Connor, MD; Marc D. Baer, DPM, FACFAS; and Sara Dahle, DPM, MPH. The electronic publication of the article in the International Wound Journal is expected to be made in the next few weeks. At that time, MiMedx expects to issue a follow-up press release with the detailed study results and link to the article.

Parker H. Petit, Chairman and CEO, stated, “This is the first large scale successful Venous Leg Ulcer (VLU) study to be completed in nearly 20 years, and the first large randomized controlled trial (RCT) of this quality on a biological allograft. No other organization has completed such a VLU study and achieved such compelling results. Our EpiFix bilayer allograft is the first and only biologic with these confirmed clinical results. This study is evidence that MiMedx continues to distance itself from our competitors.”

Bill Taylor, President and COO, said, “The 16 week randomized, fifteen-center, clinical trial evaluated the efficacy of MiMedx EpiFix® as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. The 109 subjects were randomized to receive EpiFix in addition to moist dressings and compression or moist dressings and compression alone. The primary endpoint was time to complete healing. Secondary endpoints were the proportion of subjects with complete healing by 12 and 16 weeks.”

Taylor continued, “The study results for the patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing. These results are vastly superior to VLU healing rates reported in studies of other advanced wound care products. In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm²for Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm².”

“While we have achieved Medicare reimbursement coverage for both VLU’s and Diabetic Foot Ulcers (DFUs), our breadth of reimbursement coverage with commercial payers is primarily for DFUs. Commercial health insurance plans are heavily influenced by the results of published clinical studies, and numerous clinical studies have been conducted and published that confirm the healing effects of EpiFix on DFUs. With the publication of this study and its compelling results in VLU healing rates, we expect a significant revenue opportunity will develop for MiMedx as commercial payers see this body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of VLUs. We have used very conservative parameters to calculate the impact of gaining additional VLU coverage with payers. We estimate with the impact of this study, MiMedx can obtain VLU coverage for approximately 133 million additional commercial lives,” noted Petit.

Taylor added, “Published data indicates that the prevalence rate of VLUs in the commercial population is 0.183 percent. Assuming three to four EpiFix applications for a VLU, which is a very moderate assumption, and assuming an extremely conservative market penetration rate of 10 to 15 percent, we believe our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance will be between approximately $75 million and $150 million.”

Chris Cashman, EVP and Chief Commercialization Officer, commented, “We are extremely confident in our ability to achieve and exceed our VLU market penetration estimates if additional commercial insurance coverage is gained. Currently, only about 30% of the commercial plans that cover EpiFix for DFUs also cover EpiFix for VLUs as well. This study should dramatically increase that ratio. We now have approximately 350 sales professionals focused on the commercial wound care market, and we anticipate that number to grow to approximately 375 sales professionals by year-end. Given the VLU market opportunity, without even considering the approximate one million acute pressure ulcers that could also benefit from EpiFix applications, we are very excited about the revenue opportunities that this landmark clinical study can facilitate for MiMedx.”

“We are looking forward to soon reporting the full details of this study when the article is electronically published,” concluded Petit.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; the potential safety and efficacy, and additional approved uses and markets for our products; our expectations of how insurers will respond to this data and the size and timing of additional revenue opportunities; the estimated number of sales professionals by year-end; and the advantage over competitors that will be conferred by this result. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; insurance coverage decisions may not occur as anticipated or coverage requirements may change; that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be unable to hire sufficient qualified sales persons in a timely manner. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

13236-Bone_Therapeutics-Habillages_graphiques-Youtube-1.png

Gosselies, Belgium, 31 August 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris:BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedic and bone diseases, today announces the appointment of Jean-Luc Vandebroek as Chief Financial Officer, effective 1 September 2017. Jean-Luc will replace Wim Goemaere, who is leaving the Company to take up a senior position within a not-for-profit organisation. Wim will continue to support the Company as a Non-Executive Director, and will lead a managed succession during the transition period.

Jean-Luc Vandebroek is a seasoned finance executive with extensive international finance experience at major public and privately-owned companies. Jean-Luc has built a successful career spanning 15 years at the Belgian-US retailer, Delhaize Group (now Ahold Delhaize). During this period, he held various senior financial positions with increasing responsibility, including roles as Corporate Director Finance Europe and US and Vice President Finance BeLux. He later became Group Chief Financial Officer at Fluxys, a listed, pan-European gas infrastructure group, where he was responsible for the financing of large infrastructure investments using diverse forms of funding on capital markets. Prior to joining Bone Therapeutics, Jean-Luc served as Director and Chief Financial Officer of Moteo Two Wheels and Bihr Europe, the motorcycle division of Alcopa Group, a Belgian family holding with an annual revenue of around EUR 1.7 billion.

Steve Swinson, Chairman of Bone Therapeutics, commented: “We are pleased to welcome Jean-Luc Vandebroek to Bone Therapeutics. With his strong financial acumen, experience leading commercial-stage companies and understanding of corporate finance, Jean-Luc is well equipped to oversee Bone Therapeutics’ financial planning needs in its increasingly mature phase of development. The Board wishes to express its gratitude to Wim Goemaere for his significant contribution to the development of Bone Therapeutics, including stewarding the Company through a successful initial public offering in 2015 which raised EUR 37 million. We are glad that he will continue to support the Board of Bone Therapeutics as a Non-Executive Director and wish him well in his new role.”

Commenting on his appointment, Jean-Luc Vandebroek said: “I am delighted to be joining Bone Therapeutics at this exciting time in its development. I look forward to working with the Board and management team to help deliver value to shareholders and bring Bone Therapeutics’ innovative cell therapy products closer to the market and to patients.”

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB^®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB^®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA

Thomas Lienard, Chief Executive Officer

Wim Goemaere, Chief Financial Officer

Tel: +32 (0)2 529 59 90

investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:

Consilium Strategic Communications

Amber Fennell, Jessica Hodgson and Hendrik Thys

Tel: +44 (0) 20 3709 5701

bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:

NewCap Investor Relations & Financial Communications

Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau

Tel: + 33 (0)1 44 71 94 94

bone@newcap.eu

For US Media and Investor Enquiries

Westwicke Partners

John Woolford

Tel: + 1 443 213 0506

john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Bone Therapeutics SA via Globenewswire

This article appears in: News Headlines

Referenced Stocks: BOTHE

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