PLAINSBORO, N.J., Oct. 17, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART) recently organized a hands-on regenerative wound management workshop at the Symposium on Advanced Wound Care (SAWC) Fall meeting in Las Vegas, Nevada. The workshop, led by renowned wound care experts John Lantis, MD, and Paul Kim, DPM, focused on best practices for outpatient chronic wound management, including the use of Integra® dermal regenerative technologies in the chronic wound environment. A unique combination of a hands-on skills lab and lecture attracted surgeons, physicians, and mid-level healthcare providers.

“Many chronic wounds need more than just re-epithelialization strategies,” said Dr. Kim, a leading foot and ankle surgeon at Georgetown University Hospital. “This workshop highlighted the importance of good wound care practices, such as good wound bed preparation, to maximize the benefits of dermal regeneration technologies.”

Additionally, nine posters were presented by surgeons and wound care specialists on their latest clinical experiences, using Integra products for wound management. These posters featured the use of PriMatrix for the management of full-thickness chronic wounds and complex pressure ulcer reconstructions as well as a sub-analysis of the Omnigraft® FOot Ulcer New DErmal Replacement (FOUNDER) study.

John Lantis, MD, a leading vascular surgeon at Mount Sinai St Luke’s and Mount Sinai West Hospitals, independently presented his work on using PriMatrix for the management of complex wounds with exposed subcutaneous structures.

“Providing optimal wound care is essential in helping our patients enhance their quality of life,” said Dr. Lantis. “PriMatrix has become an important part of my limb preservation practice and helps me treat patients with very challenging wounds.”

The SAWC serves as a forum to connect physicians, nurses, clinical researchers and scientists with leading experts in wound care, improving patient outcomes through collaboration and education. More than 1,300 healthcare professionals attended the Fall meeting.

About the FOUNDER Study
The FOot Ulcer New DErmal Replacement (FOUNDER) study was a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). The pivotal clinical trial enrolled 307 patients at 32 sites, and patients were followed for up to 29 weeks. The primary endpoint of the study was the incidence of complete wound closure at 16 weeks. The secondary outcome measures included time to complete wound closure, incidence of recurrence, and quality of life. The median number of applications per patient, including the initial application, for the IDRT group was one. The results from the FOUNDER study were printed in the November/December issue of Wound Repair and Regeneration in the publication, “A Clinical Trial of Integra® Template for Diabetic Foot Ulcer Treatment.”

About Omnigraft® Dermal Regeneration Matrix
Omnigraft® Dermal Regeneration Matrix is the only FDA approved product that regenerates dermal tissue. It is an advanced bi-layer dermal regeneration matrix indicated for use in the treatment of partial and full-thickness neuropathic diabetic foot ulcers (DFUs) that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care. Based on the FOUNDER study, Omnigraft increases the incidence of wound closure by 59%, increases the average rate of wound size closure by 50%, and reduces the median time to wound closure by five weeks, compared to conventional therapy. Additionally, Omnigraft healed patients with fewer applications, with 92% of those who healed requiring two applications or fewer.

About PriMatrix® Dermal Repair Scaffold
PriMatrix® Dermal Repair Scaffold is a unique dermal repair scaffold made with proprietary processing technology that purifies fetal bovine dermis and preserves the beneficial properties of the natural fetal dermal collagen fibers. PriMatrix is indicated for the management of wounds that include: partial and full thickness wounds; pressure, diabetic, and venous ulcers; second-degree burns; surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations and skin tears); tunneled/undermined wounds; and draining wounds.

About Integra
Integra LifeSciences Holdings Corporation, a world leader in medical technology, is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies. For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Angela Steinway
609-936-2268
angela.steinway@integralife.com  
 
Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com  
 
Media 
Laurene Isip
609-750-7984
laurene.isip@integralife.com

SINGAPORE, Oct. 14, 2016 /PRNewswire/ — Osteopore International is honoured with the 2016 Frost & Sullivan Singapore 3D Scaffolds Entrepreneurial Company of the Year Award in the Transformational Healthcare category.

This award is presented to Osteopore at the 2016 Frost & Sullivan Singapore Excellence Awards luncheon at the Conrad Centennial Singapore.

Ms. Vandana Iyer, Research Analyst at Frost & Sullivan said that Osteopore’s 3-D scaffold tissue engineering technology platform is uniquely poised above its competitors as it facilitates natural tissue healing and regenerative functions. “The technology comprises novel biomimetic and bioresorbable 3-D printed microstructure implants that can be efficiently used across neurological, craniofacial, maxillofacial, orthopaedic, spinal and dental applications. The company’s innovative 3D scaffold technology also has the potential to address the rising incidence of bone-related injuries and may transform the global bone graft market that is currently valued at around USD5 billion,” she added.

“Osteopore is proud to receive the 2016 Singapore 3D Scaffolds Entrepreneurial Company of the Year Award from Frost & Sullivan. The award is a testament to our vision and ability to transform healthcare with Singapore’s developed medical device technology,” said Mr. Goh Khoon Seng, Chief Executive Officer, Osteopore International.

“Our company has been harnessing 3D printing technology to design, develop and manufacture implantable devices that facilitate natural tissue regeneration, and has delivered successful clinical outcome over the past 10 years.  This technology has the potential to minimise or eliminate late morbidity and re-surgery thus reducing cost for healthcare payers and patients,” he added.

The Frost & Sullivan Excellence Awards have identified and honoured best-in class companies that have demonstrated excellence in their respective industries. Award recipients were identified based on in-depth interviews, analysis, and extensive secondary research conducted by Frost & Sullivan’s analysts. Companies are typically studied on their revenues, market share, capabilities, and overall contribution to the industry in order to identify best practices.

For the Entrepreneurial Company of the Year Award, Frost & Sullivan analysts independently evaluated two key factors, Entrepreneurial Innovation and Customer Impact.

The Entrepreneurial Innovation criteria that were assessed include market disruption, competitive differentiation, market gaps, Blue Ocean Strategy and passionate persistence.

Customer Impact criteria include price/performance value, customer purchase experience, customer ownership experience, customer service experience and brand equity.

About Osteopore International

Osteopore International, based in Singapore, is the world leader in 3D printed biomimetic and bioresorbable implant devices that empowers the body to regenerate tissue.  We collaborate with clinicians and researchers internationally to develop products that address unmet healthcare needs, reduce healthcare cost, improve patient outcomes and enhance lives.  For more information, visit us at www.osteopore.com.

Contact : Goh Khoon Seng, (65) 9670-0812, goh_khoon_seng@osteopore.com

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.  For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. For more information, please visit www.frost.com

This content was issued through the press release distribution service at Newswire.com. For more info visit: http://www.newswire.com.

SOURCE Osteopore International Pte Ltd

Related Links

http://www.osteopore.com

COLUMBIA, Md., Oct. 06, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) today announced that it has appointed R. Alberto Avendano, M.D., as the Company’s Chief Medical Officer.

Dr. Avendano brings to Osiris his expertise in medical education and communication, academic and industry clinical research, pharmacovigilance and regulatory affairs.  In his role as Chief Medical Officer, Dr. Avendano will manage and oversee the continued growth of the Company’s Medical Affairs and Clinical Operations, act as the Company’s medical spokesperson, and participate in development of clinical programs for the Company’s products and technologies.

“Alberto brings a wealth of managerial and life sciences expertise to Osiris during an important time in our company’s growth,” said David A. Dresner, Interim CEO of Osiris.  “Alberto will bridge our research and development team to our marketing team, furthering our commitment to help patients both today and into the future, as we continue to launch innovative therapies into the regenerative medicine space.”

Dr. Avendano received his license to practice medicine almost 30 years ago.  From June 2013 until joining Osiris, Dr. Avendano served as the Medical Director for Indivior Inc. (previously Reckitt Benckisser Pharmaceuticals).  Prior to joining Indivior, Dr. Avendano served in a variety of medical director and research positions, most recently as Associate Medical Director at EMD Serono, Inc.

Osiris welcomes Dr. Avendano as the newest member of the team.

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 orthopaedics, sports medicine and wound care, including BIO⁴®, Cartiform®, Grafix® , TruSkin^TM and Stravix^TM. Osiris, Grafix, and Cartiform are registered trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc. BIO⁴® is a trademark of Howmedica Osteonics Corp. More information can be found on the company’s website, www.Osiris.com. (OSIR-G).

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: the outcome of the NASDAQ listing qualification deficiency process, including the ability of the Company to successfully maintain its NASDAQ listing; the outcome of the restatements, including the materiality, significance, nature, subject matter, timing or quantitative effects of the Company’s restated financial statements; the timing of the transition to a new independent registered public accounting firm; the completion of the audit of the Company’s 2015 financial statements; and the timing of the filing of the Company’s 2015 Form 10-K, Q1 2016 Form 10-Q and Q2 2016 Form 10-Q. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with?the SEC. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

For additional information, please contact:

Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

WALTHAM, Mass., Oct. 06, 2016 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced today the addition of Professor Lawrence Bonassar to its Scientific Advisory Board (SAB).  The SAB’s mission is to provide strategic scientific and technical oversight as Histogenics brings NeoCart through its ongoing Phase 3 clinical trial, and seeks to expand its pipeline with additional indications and next generation cartilage therapies by leveraging its biomaterials manufacturing experience and cell therapy technology platform.

Dr. Bonassar is a Professor at Cornell University in the Meinig School of Biomedical Engineering and the Sibley School of Mechanical and Aerospace Engineering.  His research focuses on cartilage biomechanics and tissue engineering, with a goal of understanding structure-property relationships in cartilage to elucidate mechanisms of disease and inform design of tissue replacements. He has authored more than 160 peer reviewed manuscripts, is an inventor on 11 patents and won several national and international awards including the Hansjorg Wyss ResearchAward at the World Forum for Spine Research. Prior to joining the faculty at Cornell, Dr. Bonassar was an Assistant Professor in the Center for Tissue Engineering at the University of Massachusetts Medical School. He received his bachelor’s degree from the Departments of Biomedical Engineering and Materials Science and Engineering from the Johns Hopkins University and received both his masters and doctoral degrees from the Department of Materials Science and Engineering at MIT. Dr. Bonassar also completed postdoctoral training in the Department of Orthopaedic Surgery at Massachusetts General Hospital.

“We are pleased to have Dr. Bonassar join our distinguished team of scientific advisors. Our Sponsored Research Agreement with his lab at Cornell has been highly successful in demonstrating the biomechanical competence of cartilage tissue engineered using our NeoCart manufacturing technology.  The work we have done together has resulted in two presentations to date, the first at the Orthopedic Research Society annual meeting in March 2016 and a more recent presentation at the Biomedical Engineering Society Annual Meeting in October 2016,” stated Stephen Kennedy, Chief Technology Officer of Histogenics.  “Dr. Bonassar’s expertise in biomechanics and tissue engineering will be invaluable to Histogenics as we advance NeoCart through our ongoing Phase 3 clinical trial and prepare to file a biologics license application with the FDA,” continued Mr. Kennedy.

Dr. Bonassar joins current SAB members Dr. Kyriacos A. Athanasiou, PhD, Professor of Biomedical Engineering and Orthopaedic Surgery, University of California Davis; Dr. Charles Cooney, PhD, Professor Emeritus, Massachusetts Institute of Technology; Dr. Jennifer Elisseeff, PhD, Professor Biomedical Engineering, Johns Hopkins University; Dr. Shuichi Mizuno, PhD, Assistant Professor, Orthopedic Surgery, Harvard Medical School and co-founder of Histogenics; Dr. Lonnie Shea, PhD, Professor Biomedical Engineering, University of Michigan; and Dr. R. Lane Smith, PhD, Professor of Orthopedic Surgery, Stanford University School of Medicine.

About NeoCart

NeoCart is a cartilage-like, tissue-engineered implant created from a patient’s own cartilage cells that is currently in Phase 3 clinical development.  The ongoing 245 patient clinical trial is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture.  Histogenics is conducting the trial under a Special Protocol Assessment with the U.S. Food and Drug Administration and expects enrollment to be between 190 and 200 patients at the end of 2016 and to be complete by the end of the second quarter of 2017.  Histogenics designed and manufactures NeoCart using a proprietary, ex vivo bioengineering process so that each NeoCart implant is primed to begin functioning like healthy cartilage upon implantation in the knee.  Histogenics believes that these attributes may offer patients a more rapid recovery and a more durable treatment option, if approved, than other products and procedures, either on the market or in development.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions.  Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase 3 clinical development.  NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells.  Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year.  NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options.  For more information, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and the availability of additional financing on commercially reasonable terms; Histogenics’ ability to attract or retain key personnel; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon is based; the additional expenses that Histogenics will incur in connection with its exclusive channel collaboration agreement with Intrexon Corporation and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016 and June 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ending September 30, 2016, to be filed with the SEC in the fourth quarter of 2016.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Investor Relations

Tel: +1 (781) 547-7909

InvestorRelations@histogenics.com

BELGRADE, Mont., Oct. 06, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the appointment of Carl O’Connell as President, reporting to the CEO effective October 6, 2016.

Mr. O’Connell will lead all commercial efforts by providing the vision, leadership, strategy and management skills necessary to continue and further develop Xtant Medical’s successful commercial business. He has worked to transform and grow companies into market leaders in Orthopedics, Neurosurgery, Ophthalmology, ENT and Dentistry. His extensive leadership experience in both U.S. and global medical device markets will be an asset to Xtant Medical.

“We are pleased to have an executive of Carl’s stature and experience as a leader for Xtant Medical,” said Dan Goldberger, Chief Executive Officer of Xtant Medical. “He brings a wealth of knowledge and a vast network of strong relationships within the medical device market, and has been directly responsible for creating growth strategies, opportunities and leadership platforms in his prior positions. I share the excitement of the Company in welcoming Carl to the team.”

“I am honored and excited for the opportunity to be a part of this Company,” states Carl O’Connell, President of Xtant Medical. “Xtant Medical is an organization that has been focused on delivering quality products to its customers, and has taken great pride and responsibility as stewards of the gift of donation. My goal is to continue and build upon the positive momentum that Xtant Medical has achieved, and to work closely with the talented team to drive value for our customers, employees, and stakeholders.”

Carl O’Connell has over 30 years of experience in the healthcare and medical device arena. He most recently worked as Global Vice President of Marketing for Wright Medical as the leader for the Foot and Ankle division, the fastest growing segment in Orthopedics. He has also served as President for the U.S. healthcare division of the Japanese conglomerate, ITOCHU Corporation, and previously as Global Vice President for Stryker Spine, and President for Carl Zeiss Surgical, Inc. Mr. O’Connell’s responsibilities have spanned from global marketing, sales, manufacturing, leadership development, regulatory affairs, corporate quality systems, research, product and business development functions. Carl received a bachelor’s degree in Psychology and an M.B.A. from Mount St. Mary’s College, Maryland.

About Xtant Medical Holdings

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

PITTSBURGH, Oct. 5, 2016 /PRNewswire/ — Carmell Therapeutics, a biosurgical technology company focused on the development and commercialization of innovative plasma-based bioactive materials, continues to grow and add the necessary management capabilities to advance its products towards US FDA regulatory approval. Carmell’s first product, REPAIR™ Putty, is designed to accelerate bone healing with the first application in long bone fractures.  Future clinical studies are planned to expand the label to include other orthopedic bone applications. The Carmell near-term pipeline also includes REPAIR™ Paste for accelerated soft tissue healing, such as surgical site and chronic wound management.

To successfully advance these programs through the development and commercialization process, Carmell is significantly expanding their senior management capabilities. Joining Randy Hubbell, CEO, and Dr. James Hart, Chief Medical Officer, are:

• Donna Godward, Chief Quality Officer – Ms. Godward spent most of her career at J&J before retiring as a Chief Quality Officer for J&J’s Medical Device and Diagnostic Business.
• Stephanie Kladakis, PhD, VP of R&D – Dr. Kladakis brings with her over 14 years of experience in product development, from concept through CE Mark and PMA approvals, and was most recently the VP of R&D for Cohera Medical.
• Janet Vargo, PhD, VP of Clinical Sciences – Dr. Vargo has extensive experience in designing and executing clinical trials and most recently worked at Mentor, LLC (J&J) as Head of Clinical Development and Regulatory Affairs.
• Carmell is also expanding the expertise and capabilities of their Board of Directors with the addition of:
• David Anderson, President and CEO, Orteq Sports Medicine as an independent board member. Mr. Anderson has over 20 years experience as a senior executive in the orthobiologics space. His insights and knowledge will be extremely useful to the Carmell management team as they expand their development pipeline and prepare for commercialization.

“I am very excited to be able to assemble an extremely experienced team of experts that will ensure success for Carmell,” commented Randy Hubbell.

About Carmell Therapeutics

Founded in 2007 as a spin out from Carnegie Mellon University in Pittsburgh, PA, Carmell Therapeutics Corporation is a privately-owned biosurgical technology company focused on the development and commercialization of innovative plasma-based bioactive materials (PBMs). These PBMs contain a concentration of natural regenerative factors that promote healing, reduce complications, and lead to healthcare savings. Utilizing its proprietary cross-linking process, the company has successfully developed multiple PBM formulations such as pastes, putties, scaffolds, plugs and screws, using pooled plasma from healthy donors.  Unlike previous approaches to delivering growth factors to injuries/surgeries, Carmell’s plasma-based devices can be designed to vary the release time of active biologics to accommodate the needs of the body. Carmell’s first product, REPAIR™ Putty, has been designed to treat bone fractures through accelerated bone healing of the fracture and surrounding soft tissues while reducing complications, infections and duration of care. Early human clinical evidence suggests that REPAIR™ Putty is efficacious, safe, consistent and affordable.  Carmell’s proprietary blood plasma-based technology will serve as the foundation for groundbreaking products designed to improve the lives of patients and to reduce the costs of healthcare across variety of surgical procedures.

For more information on Carmell Therapeutics, please visit the Company’s website at http://www.carmellrx.com/

CERTAIN STATEMENTS IN THIS RELEASE ARE FORWARD LOOKING STATEMENTS ABOUT CARMELL’S FUTURE PLANS, OBJECTIVES AND PROJECTED PERFORMANCE.  THESE FORWARD-LOOKING STATEMENTS ARE BASED ON CERTAIN ASSUMPTIONS THAT THE COMPANY BELIEVES ARE REASONABLE, BUT ARE SUBJECT TO KNOWN AND UNKNOWN RISKS AND UNCERTAINTIES. CARMELL MAKES NO REPRESENTATION, WARRANTY OR CLAIM REGARDING THE INFORMATION IN THIS RELEASE OR ANY OF ITS PRODUCTS. ACTUAL RESULTS MAY VARY SIGNIFICANTLY FROM OUR PREDICTIONS AND DEPEND ON KNOWN AND UNKNOWN RISKS.  CARMELL’S PRODUCTS ARE NOT CURRENTLY AVAILABLE FOR SALE OR USE AND HAVE NOT BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION OR ANY COUNTRY’S REGULATORY AUTHORITY.

Logo – http://photos.prnewswire.com/prnh/20161004/415072LOGO

Contact:
Randy Hubbell
rhubbell@carmellrx.com
(215) 688-6196

SOURCE Carmell Therapeutics Corporation

Related Links

http://www.carmellrx.com