DSM Biomedical and Cerapedics partner for peptide enhanced bone graft

October 17, 2017 By 

DSM Biomedical has partnered with Cerapedics to create and manufacture the next generation of peptide-enhanced bone graft.

The partnerships allows for DSM’s regenerative materials capabilities to be used with Cerapedics’s proprietary synthetic small peptide (P-15) technology developed by Cerapedics.

Designed for fast and predictable remodeling in bone graft substitute applications, DSM’s newest bioceramic platform is make of a carbonated apatite matrix. The partnership states that DSM will provide collagen carrier, final packaging and full support throughout the product development process.

“The partnership combines the industry leading expertise and capabilities in bioceramic materials of DSM with Cerapedics’ innovative growth factor, delivering a new product solution to improve people’s lives,” David Yonce, VP and global head of innovation at DSM Biomedical, said. “Together, from concept to commercialization, we are at the leading edge of advanced healing solutions.”

 

READ THE REST HERE

 

 

MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee

MARIETTA, Ga.Oct. 17, 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 notified by the Food and Drug Administration (FDA) that its Investigational New Drug (IND) Phase 2B clinical study for osteoarthritis of the knee may proceed.

The clinical study consists of a Phase 2B, prospective, double-blinded, randomized controlled trial of MiMedx’s AmnioFix® Injectable (micronized dehydrated Human Amnion Chorion Membrane), compared to saline placebo in the treatment of knee osteoarthritis. The trial will enroll approximately 318 patients and the Company expects patient enrollment to commence in the next quarter.

In the Company’s press release of September 19, 2017, MiMedx announced that it had filed for this IND Phase 2 to be initiated. In that press release, the Company indicated 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 osteoarthritis of the knee. The primary efficacy endpoints of this study will be the change in Visual Analog Scale (VAS) score and the change in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index for patients between baseline and Day 90 between the AmnioFix Injectable group versus the placebo-control group. The primary safety endpoint will be the proportion of product-related Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during 12 months following injection in the AmnioFix Injectable group versus the placebo-control group.

Parker H. “Pete” Petit, CEO, said, “This knee osteoarthritis study is the fourth IND trial conducted by MiMedx for our AmnioFix Injectable. We are pleased to receive the FDA’s notification that we can proceed with another IND study in the Orthopedic/Sports Medicine area. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders apprised on our future study results. Later this year, we will hold a meeting in New York that will include presentations by MiMedx executives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities.”

Bill Taylor, President and COO, stated, “The first two ‘Biologics License Application (BLA) indications for use’ we are currently targeting for AmnioFix Injectable are General Tendonitis and Osteoarthritic Knee Pain, which represent approximately 80% of the more than 15 million injections done each year to treat musculoskeletal pain. We believe the results of our BLA clinical trials and safety profile will demand a price per dose of $1,000 or more. This expands the musculoskeletal degeneration market for our first two BLA products to more than a $12 billion U.S. market opportunity. We believe the non-degenerative aspect and potential reduction in opioid use due to our Amniotic Injectable product will drive significant adoption. We expect the study results to be compelling, and we look forward to the prospects of clinicians utilizing AmnioFix Injectable in the treatment of these debilitating conditions.”

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, expectations as to pricing and market opportunity, 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; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; reimbursement decisions by public and private payers may not occur as expected; and market opportunities may not materialize or may change in the future.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

MiMedx Warns Of Fake Emails

MARIETTA, Ga.Oct. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, warned today that certain individuals or entities not associated with the Company are establishing fake email accounts to impersonate executives at the Company.

The Company is aware of at least one instance in which emails were sent by someone using the CEO’s name and a Gmail account that had not, in fact, been set up by that Company executive.  The emails were sent to an analyst who reports on the Company.  The Company warns that any emails purporting to be from Company executives from non-MiMedx email accounts should be viewed skeptically.  The Company encourages anyone who has received a suspicious email to notify the Company.  This type of impersonation is quite unusual, and it is a crime.  The Company has turned the investigation over to the authorities.

Parker H. “Pete” Petit, Chairman and CEO, commented, “We believe this activity is related to the recent short seller attacks on the Company.  This particular group of short sellers continues to resort to ridiculous and unscrupulous means to attempt to do damage to MiMedx.  Of course, their ultimate goal is to depress the price of our stock.  However, by impersonating me in emails to our analysts, with comments that create insecurity relative to our Company’s performance or my ethics and integrity, is reprehensible and unlawful.  We have also seen other indications of unlawful activity.  The Company will continue to quietly go about its investigation of all these issues in a professional manner, and if and when we find violations of laws or regulations, they will be turned over to the proper authorities.”

Petit continued, “Within reason, we will continue to update our website with facts that refute some of the allegations.  However, as we stated, the allegations are becoming quite bizarre and are not relevant to any MiMedx related business processes or relationships.  Reasonable professionals trying to make points that regulators will review will present credible information from credible sources.  That has not happened in our case.”

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 there is a connection between the establishment of fake email accounts and short sell attacks.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Orthocell Appoints Surgical Specialties as Exclusive Distributor

October 10, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has appointed Surgical Specialties Pty Ltd (Surgical Specialties) as its exclusive distributor in Australia and New Zealand for its world leading cell therapies for tendon regeneration (Ortho-ATI®) and cartilage regeneration (Ortho-ACI®).

“Surgical Specialties is a leading distributor of innovative medical devices and one of the few local companies with its own national sales force and marketing teams,” said Managing Director of Orthocell, Paul Anderson. “Surgical Specialties is the ideal partner with established relationships with leading orthopaedic surgeons and sports physicians, a successful track record and a highly skilled and dedicated national sales force,” he added.

Surgical Specialties will take over distribution responsibilities for Orthocell’s cell therapies including targeted promotion activities and initiating sales, as well as assisting with expanding the network of referring doctors and physicians. The exclusive distribution agreement has a term of five years and the arrangement will allow Orthocell to maintain its focus on the development of its novel regenerative medicine products and driving national and international regulatory approvals for its technologies.

“We are very excited to be involved with Orthocell. Orthocell has the only cell therapy intervention listed on the Australian Register of Therapeutic Goods (ARTG) for the repair of damaged or degenerate cartilage in the knee or ankle joint, and an innovative market leading approach for the repair of degenerate tendons. Both products are based on ground-breaking technology and addresses a significant clinical need, particularly in the orthopaedic and sports physician market,” said CEO of Surgical Specialties, Phil Nicholl.

About Surgical Specialties Pty Ltd:

Established in 2006, Surgical Specialties now has a team of over 70 people, with sales offices throughout Australia and New Zealand. Surgical Specialties is an independent distributor of innovative medical devices to the Australian and New Zealand medical community. The business focuses on the following surgical areas: Arthroplasty, Extremities, Specialty Trauma, Orthobiologics, Critical Care and Operating Room Products.

Contacts

General enquiries
Orthocell
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor and Media enquiries
WE Buchan
Ben Walsh, + 61 411 520 012
bwalsh@buchanwe.com.au

AlloSource President and CEO Thomas Cycyota Receives American Association of Tissue Banks Award

CENTENNIAL, Colo.Oct. 10, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced that its President and Chief Executive Officer, Thomas Cycyota, received the Jeanne C. Mowe Distinguished Service Award from the American Association of Tissue Banks (AATB).

The annual Jeanne C. Mowe Distinguished Service Award recognizes an individual who has made a significant contribution in tissue banking or transplantation, whether in research, education, or laboratory improvement, or who has served the Association or the field of tissue banking.

“I am humbled and honored to receive this award from the AATB. AlloSource’s success is possible because of our strong relationships with our donor community, as well as our dedicated, passionate employees,” said Cycyota. “Being involved in the tissue donation and transplantation community has been a sacred part of my life for the last 17 years. I am continually in awe and inspired by the possibilities tissue donors create for patients in need.”

Cycyota has served as the President and Chief Executive Officer of AlloSource since 2000, leading the organization in its ongoing dedication to honoring the gift of tissue donation. Under his leadership, the organization has grown into a leading provider of allografts for use in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care applications. AlloSource continues to identify new opportunities to create innovative products that advance patient healing.

The award was presented on October 4 at the AATB Annual Meeting held in Orlando, Florida.

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact:
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org

Xtant Medical Announces Consolidation of Fixation Operations to Montana and Closure of Dayton Facility

BELGRADE, Mont., Oct. 06, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the closure of its Dayton, Ohio facility and the transitioning of its fixation operations to the Company’s headquarters in Belgrade, Montana. This decision will allow the Company to align operations with the current and future needs of its customers, and recognize cost-savings by consolidating facilities and reducing duplicative resources.

“In an effort to maximize the benefit of the 2015 merger with X-Spine, and optimize synergies including efficiencies and cost savings, we made the difficult decision of transitioning operations to Montana and closing the Dayton facility,” said Carl O’Connell, CEO of the Company. “Hardware will continue to be an important aspect of our business, and is an area we intend to build on in the future. We remain excited about the new technologies in development. With the continued efforts in 2017 towards restructuring and reducing costs, we are looking to strategically invest in both our existing business and new market opportunities, for hardware and biologics in 2018. We will be working to make this transition as smooth as possible for our employees and our customers.”

The Dayton, Ohio facility employs approximately 55 employees in various quality assurance, regulatory, inventory management, finance, engineering, and distribution positions. Many of these functions will ultimately transition to our Montana facility. Once the transition is completed, annualized cost savings are anticipated to be in excess of $2 million, resulting from right-sizing the organization and reduction in facilities. The one-time cost for executing this change is estimated to be $1.5 million.

The Company will file the Worker Adjustment and Retaining Notification with the State of Ohio and the Department of Job and Family Services.

About Xtant Medical
Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant 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 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: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the 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.” 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.

Investor Contact

CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com

Dr. Gloria Matthews Joins MiMedx As Its Senior Vice President Of Research And Development

MARIETTA, Ga.Oct. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that Dr. Gloria Matthews has joined the Company as its Senior Vice President, Research and Development.  Dr. Matthews will lead the Company’s overall research function as well as the development of new products.

Parker H. “Pete” Petit, Chairman and CEO, stated, “Dr. Matthews brings over 20 years of experience encompassing programs from discovery into Phase 3 clinical development for devices, orthobiologics, combination products, and new chemical entities for osteoarthritis, cartilage repair, and regenerative medicine.  She is an accomplished scientific leader with broad ranging expertise in orthopedic and rheumatologic diseases, among other therapeutic areas, and she has significant functional experience in cellular and gene therapy, biomaterials and growth factors.”

Bill Taylor, President and COO, commented, “The addition of Dr. Matthews to our staff is an important step in our continued expansion into biopharmaceuticals. We will continue to expand our clinical and scientific talent and resources to further drive our growth in this area. We are very excited to welcome Dr. Matthews to our organization.”

Immediately prior to joining MiMedx, Dr. Matthews served as Chief Medical Officer at Histogenics Corporation, where she oversaw all clinical and medical affairs activities with strategic oversight of various United States and global development programs across biologics, drugs and devices.

Prior to Histogenics, Dr. Matthews spent 12 years at Genzyme Corporation and Sanofi Genzyme.  During her tenure at Genzyme, Dr. Matthews held progressively more responsible leadership positions and was involved in clinical and preclinical development and/or post-market support of cell, gene, growth factor, small molecule and biomaterial based products in the orthopedic and rheumatologic space. Dr. Matthews last served with Sanofi Genzyme in the role of Senior Director and Global Head of Bone and Joint Disease Research and Development.

Dr. Matthews earned her DVM and Ph.D. from Cornell University.  Dr. Matthew’s Ph.D. concentration was in cell and molecular biology of osteoarthritis.

The Company also reaffirmed its previously communicated revenue expectations for the third quarter of 2017. “In our press releases of September 5 and September 13, 2017, we communicated that we expected to exceed the $80 millionupper end of our forecasted third quarter revenue range in spite of the disruption from Hurricane Harvey and Hurricane Irma. Our preliminary revenue estimates clearly show that our forecasting was correct. We are experiencing robust revenue growth, and we look forward to reporting our actual third quarter revenue on or about the 13th of October,” added Petit.

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 revenue expectations for the 2017 third quarter; and expectations for sales performance, despite the effects of Hurricane Harvey and Hurricane Irma.  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 Company’s revenue for the 2017 third quarter may not materialize as expected; and that the Company’s sales performance, may be more negatively impacted than anticipated due to  Hurricane Harvey and Hurricane Irma.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

MiMedx Completes Divestiture Of Its Stability Biologics Subsidiary

MARIETTA, Ga.Oct. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that it has completed the previously communicated divestiture of the Company’s subsidiary, Stability Biologics LLC (f/k/a Stability Inc.), back to the former stockholders of Stability Inc.

The transaction closed on September 30, 2017.  In the Company’s press release of August 18, 2017, MiMedx reported that the consideration included a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability Inc. of all claims and rights to any Earn-Out consideration. In that release, the Company also reported that it expects to book a one-time gain on this transaction. The amount of the gain will be disclosed in the Company’s third quarter of 2017 earnings release.

Parker H. “Pete” Petit, Chairman and CEO, said, “When we signed the definitive agreement for the divestiture, we communicated that if the transaction closed in the third quarter, we would maintain our full year revenue guidance, and even without the Stability Biologics revenue contribution in the fourth quarter, we were confident in our ability to meet our revenue guidance for the year. With the transaction’s closing completed within our projected timeline, we remain very confident in that guidance.”

Bill Taylor, President and COO, commented, “Our new ‘private label’ distribution agreement with Stability Biologics whereby we have retained the Stability Biologics key sales relationships for the spine and orthopedics areas of our surgical business, will also be an asset to the Company in our exclusive focus on our biopharma strategy. We are dedicating our efforts to continuing down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our human placental-based technology.”

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 expectations relative to its revenue guidance for the year and its belief that its distribution agreement with Stability Biologics will be an asset to the Company.  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 Company is not able to meet its revenue guidance without the revenue contribution of Stability Biologics or for some other reason, and that the distribution agreement with Stability Biologics does not produce the expected key sales relationships.  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.

Court Sets the Trial Date for MiMedx Patent Infringement Lawsuit Against MTF, Medline and Liventa

MARIETTA, Ga.Oct. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the United States District Court for the Northern District of Georgia has set a trial date of January 22, 2018 for the Company’s patent infringement lawsuit against Musculoskeletal Transplant Foundation, Inc. (“MTF”), Medline Industries, Inc. (“Medline”) and Liventa Bioscience, Inc. (“Liventa”).

In the Company’s press release of September 18, 2017, MiMedx communicated that the efforts of MTF, Liventa and Medline to avoid a trial through summary judgment and other legal maneuvers had failed, and that the matter was finally at a stage where the court could set a trial date. In that press release, the Company committed that once the Court advised MiMedx of the specific trial date, the Company would issue a subsequent press release announcing the trial date.

Parker H. “Pete” Petit, Chairman and CEO, said, “We filed this lawsuit in April 2014, and are very pleased to finally have a hard date set for this trial. We are anxiously awaiting January  22nd, and look forward to presenting our patent infringement allegations against these defendants during the five day period the court has allocated for this trial. The numerous legal maneuvers to avoid trial that were employed by MTF, Liventa and Medline have failed, and we are highly confident in our case against these defendants.”

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 confidence in its case and expectations for results of a trial.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions, and the risks of litigation.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Vivorté announces the commercial availability of FORTERA™ and REGENTO™ bone grafting solutions for orthopedic surgery

LOUISVILLE, KY — (October 3, 2017) — Vivorté, Inc., a vertically-integrated, specialty orthopedic biomaterials company, today announced the commercial availability of a complete line of bone grafting product solutions. Joining Trabexus EB, the company’s flagship bone grafting solution, Fortera is a completely synthetic calcium phosphate cement, capable of controlled delivery through a 16-gauge cannula.  REGENTO is a resorbable, particulate b-TCP bone void filler with engineered macroporosity to promote protein deposition and cell attachment.

These newly introduced products join Trabexus EB, which first received 510(k) clearance in 2015.  TRABEXUS EB is a self-setting, gradually resorbable, calcium phosphate matrix enhanced with partially demineralized allograft particles.  The engineered bone component is formed into “hourglass” shapes (TRABS®) using a proprietary manufacturing process.

This novel shape provides multiple benefits, including increased “interconnectivity” of adjacent particles, creation of channels for accelerated remodeling and greater overall surface area.  Further, the TRABS are partially demineralized, exposing key osteoinductive proteins, which are known to influence and direct the formation of new bone.  Trabexus EB is resorbed and remodeled by the body as new bone formation occurs during the healing process.

“With the introduction of Fortera and Regento to our product portfolio, Vivorté now offers a complete line of synthetic biomaterials possessing a wide range of clinical performance attributes” said Ruth Voor, CEO of Vivorté, Inc. “Vivorté is a unique, emerging company, with multiple 510(k) cleared technologies, vertically-integrated manufacturing capability and an R&D pipeline of orthopedic biomaterials and traditional metallic implants. To date, our products have been well-received in the marketplace by orthopedic surgeons and hospitals, and we continue to expand our distribution network to reach institutions across the United States.”

According to BioMedGPS, the current market for bone graft substitute products exceeds $1.7B annually in the United States alone.  Bone grafting procedures are necessary to fill defects or cavities in bone as the result of injury, reconstructive surgical procedures such as a joint replacement, or surgical excision following the removal of tumors or cysts.

Clinical considerations vary across these procedures, requiring biomaterials with differing handling characteristics, biological activity and mechanical performance.  Vivorté continually seeks to understand the surgical environment in order to design and develop products that best complement each surgeon’s unique operative technique.

The Fortera and REGENTO products will be made available concurrent with the Orthopaedic Trauma Association (OTA) Annual Meeting, being held October 11-14, 2017 in Vancouver, B.C., Canada.  Representatives from Vivorté will be attending the OTA meeting to further address product requests and inquiries.

 

About Vivorté, Inc.

Vivorté, Inc., headquartered in Louisville, Kentucky, is a privately-held, ISO-certified orthopedic biomaterials manufacturer, focused on developing innovative and cost-effective, surgical products for the benefit of surgeons, hospitals and patients.  The company’s products include TRABEXUS® EB Osteoinductive Bone Matrix, Fortera Injectable Bone Graft and Regento Bone Void Filler.  To learn more, please visit our website at www.vivorte.com.

Contact: Therese Montano / Vivorté, Inc. / 502-714-7234 / tmontano@vivorte.com