Bone Solutions Inc. Reaches 50 Implants Of Its Proprietary Magnesium-Based Bone Void Filler

Posted On January 29, 2018 By OrthoSpineNews In Biologics /

DALLAS (PRWEB)-Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, TX, is proud to announce it has reached 50 successful implants of OsteoCrete®, its magnesium-based orthopedic medical device. OsteoCrete®, which was launched in September 2017, is a bone void filler designed to assist with bone repair and generation. It’s the first in the U.S. to incorporate magnesium, a critical property for bone health and development.

“This milestone is a huge accomplishment for our company, and we’re excited to continue to introduce our product to surgeons around the country,” says BSI president and CEO Drew Diaz.

The OsteoCrete® implants were performed by various surgeons in the U.S. during BSI’s 90-day launch period, which ran from October 1 to December 31, 2017. The company worked with a network of distributors to deliver and implement the product. BSI will now shift its focus to attaining approvals at various hospital systems in the U.S.

OsteoCrete® is the only bone-repair product in the market made with magnesium. This gives surgeons an advantage as compared to using calcium-based devices, which do not have the unique combination of compressive strength and expandability necessary for optimal binding quality. OsteoCrete® is resorbable, or capable of being assimilated back into the body, as it is replaced with bone as the patient heals. It’s also injectable, moldable, and biocompatible.

“I am confident 2018 will be a banner year for the company, and we look forward to the continued growth of both the market and the use of OsteoCrete® in future surgical applications,” says Diaz.

About Bone Solutions Inc.
Bone Solutions Inc. (‘BSI’) (http://www.bonesolutionsinc.com) is an orthobiologics company with a vision to provide orthopedic surgeons a means to improve clinical outcomes in a number of complex procedures while lowering costs. The company is revolutionizing a new solution for orthopedic surgeons for human uses with their FDA-cleared magnesium-based platform bone void filler.

Media Contact:

Bone Solutions Inc.:
Drew Diaz
President/CEO
817-809-8850
diaz(at)bonesolutions(dot)net

Implantable medical devices bolstered by next-gen surface modification

Posted On January 26, 2018 By OrthoSpineNews In Biologics /

January 24, 2018-Credit: University of Sydney

A discovery by University of Sydney researchers could underpin a new class of implantable devices that provide biological signals to surrounding tissue for better integration with the body and reduced risk of infection.

Modern medicine increasingly relies on implantable biomedical devices but their effectiveness is often limited because of unsuccessful integration with host tissue or the development of untreatable infections, necessitating replacement of the device through revision surgery.

The team at the Applied Plasma Physics and Surface Engineering Laboratory has developed practical techniques to guide and attach peptides to surfaces; computer simulations and experiments demonstrated control of both peptide orientation and surface concentration, which can be achieved by applying an electric field like that delivered by a small household-sized battery.

The findings are published today in Nature Communications.

Corresponding author Professor of Applied Physics and Surface Engineering Marcela Bilek said biomaterial coatings can mask the implanted devices and mimic surrounding tissue.

“The holy grail is a surface that interacts seamlessly and naturally with host tissue through biomolecular signalling,” said Professor Bilek, who is a member of the University of Sydney Nano Institute and the Charles Perkins Centre.

Robust attachment of biological molecules to the bio-device surface is required to achieve this, as enabled by unique surface modification processes developed by Professor Bilek.

“Although proteins have successfully been used in a number of applications, they don’t always survive harsh sterilisation treatments — and introduce the risk of pathogen transfer due to their production in micro-organisms,” Professor Bilek said.

Professor Bilek — together with Dr Behnam Akhavan from the School of Aerospace, Mechanical and Mechatronic Engineering and the School of Physics and lead author PhD candidate, Lewis Martin from the School of Physics — are exploring the use of short protein segments called peptides that, when strategically designed, can recapitulate the function of the protein.

Mr Martin said the team was able to tune the orientation of extremely small biomolecules (less than 10 nanometres in size) on the surface. “We used specialised equipment to perform the experiments, but the electric fields could be applied by anyone using a home electronics kit,” he said.

Dr Akhavan said that assuming industry support and funding for clinical trials, improved implants could be available to patients within five years.

“The application of our approach ranges from bone-implants to cardiovascular stents and artificial blood vessels,” Dr Akhavan said.

“For the bone implantable devices, for example, such modern bio-compatible surfaces will directly benefit patients suffering from bone fracture, osteoporosis, and bone cancer.”

Because of their small size, the peptides can be produced synthetically and they are resilient during sterilisation. The main difficulty in using peptides is ensuring they are attached at appropriate densities and in orientations that effectively expose their active sites.

Using applied electric fields and buffer chemistry, the researchers discovered several new levers that control peptide attachment. Charge separation on peptides creates permanent dipole moments that can be aligned with an electric field to provide optimal orientation of the molecules and the amount of peptide immobilised can also be tuned by the electrostatic interactions when the peptides have an overall charge.

The paper said this knowledge is being used to design strategies to create a new generation of synthetic biomolecules.

“Our findings shed light on mechanisms of biomolecule immobilisation that are extremely important for the design of synthetic peptides and biofunctionalisation of advanced implantable materials,” the paper states.

Story Source:

Materials provided by University of Sydney

Journal Reference:

Lewis J. Martin, Behnam Akhavan, Marcela M. M. Bilek. Electric fields control the orientation of peptides irreversibly immobilized on radical-functionalized surfaces. Nature Communications, 2018; 9 (1) DOI: 10.1038/s41467-017-02545-6

University of Sydney. “Implantable medical devices bolstered by next-gen surface modification: Synthetic peptides could integrate seamlessly with host tissue.” ScienceDaily. ScienceDaily, 24 January 2018. <www.sciencedaily.com/releases/2018/01/180124111239.htm>.

BioRestorative Therapies Announces the Appointment of Adam D. Bergstein as Sr. VP, Planning and Business Development

Posted On January 23, 2018 By OrthoSpineNews In Biologics /

MELVILLE, N.Y., Jan. 22, 2018 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (OTC:BRTX), a life sciences company focused on stem cell-based therapies, today announced the appointment of Adam Bergstein as Senior Vice President, Planning and Business Development. In this capacity, Mr. Bergstein will be responsible for strategic planning, business development, capital market activities and related endeavors.

From 2008 until 2017, Mr. Bergstein founded and operated PharmaShield, an analytics company that created the first known data model that accurately predicts litigation loss and the timing of outcomes in branded pharmaceutical patent cases. From 2006 through 2008, Mr. Bergstein worked as a consultant to a health economics group inside RAND Corporation, during which time he created derivatives to help mitigate risk within the broader healthcare markets. From 1998 through 2006, Mr. Bergstein was a private equity investor in the healthcare and technology sectors.

Mr. Bergstein has an MBA from the J.L. Kellogg Graduate School of Management with concentrations in finance and organizational behavior, as well as a Bachelor of Arts degree in Economics with distinction from the University of Pennsylvania.

“Based on the 33 human patients that received the precursor to BRTX-100, I believe that BioRestorative’s disc therapy stands an excellent chance of receiving regulatory clearance from the FDA within a relatively short time frame. I believe the therapy will significantly improve the lives of so many with chronic lumbar disc disease,” Mr. Bergstein commented.

Mark Weinreb, CEO of BioRestorative, further commented, “We are extremely excited to have Adam join BioRestorative at this important time of our development. With his industry expertise, capital markets experience and impressive track record, Adam will be a strong addition to our senior management team as we accelerate our clinical, regulatory and business development activities.”

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The BRTX-100 production process involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received clearance from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs.

• Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company’s Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Email: ir@biorestorative.com

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Biogennix Reports Record Growth for 2017; Expands Executive Management Team

Posted On January 18, 2018 By OrthoSpineNews In Biologics /

January 17, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Irvine-based Biogennix, an osteobiologics company that develops, manufactures, and distributes proprietary bone graft substitutes used for bone fusion procedures, revealed today that it achieved record growth in 2017. The company closed the year with 47% growth, the broadest increase the company has experienced in its history.

The majority of Biogennix’s growth is attributed to increases in sales of the company’s novel bone graft substitutes, Morpheus™ and osteoSPAN™, both of which are resorbable, osteoconductive scaffolds ideally suited for bone regeneration. The Morpheus product is a moldable version of osteoSPAN which combines the granules with an organic binder, providing optimal handling characteristics for surgeons.

The company also kicked off 2018 with the announcement of two key new hires: Rob Cripe, who will assume the role of Chief Marketing Officer; and Peter Gordon, who has been named Eastern Area Sales Director.

Cripe brings over 25 years of medical device industry experience, specializing in worldwide commercial execution. Having held executive responsibilities for sales, marketing, clinical and product development teams with companies such as Zimmer/Biomet, Smith and Nephew and DJO Global, Cripe has a deep understanding of successful execution strategies in multi-billion dollar, public organizations. He has also held executive roles for smaller, privately held companies in biologics, stroke therapy and orthotics and prosthetics, giving him a well-rounded perspective of the start-up environment.

Gordon comes to Biogennix after five years with LDR Spine where he was responsible for sales growth in the New England region. Working through a distributor sales force he consistently grew sales each year and was one of the top ten Regional Managers in sales growth 4 out of 5 years during his tenure. Prior to LDR Spine Peter was Director of Field Marketing for Archus Orthopedics. He also has served as Director of Spinal Arthroplasty Education and as Regional Sales Manager with DePuy Spine while based in Seattle. He also gained experience with bone graft materials and biologics with GenSci Orthobiologics where he was Eastern Regional Sales Director, growing sales from 0 to over 5 million dollars in less than three years.

“We’re pleased to report that 2017 was a benchmark year for us,” said Scott Bauccio, Biogennix’s Vice President of Sales and Business Development. “Our Morpheus and osteoSPAN bone graft products continued to exceed expectations on a national level and we believe that the products will fast become the standard of effectiveness and ease of use when it comes to bone graft substitutes in 2018. By further strengthening our executive team with top-caliber industry talent and expertise offered by Rob Cripe and Peter Gordon, we expect to continue to grow exponentially and expand upon last year’s success.”

Biogennix is a leading developer of osteobiologic products specifically designed for spine fusion and bone trauma. The company is led by a team of scientists and industry veterans committed to delivering unique products for bone regeneration. Biogennix designs, manufactures and distributes all of its products from its Irvine facilities.

Biogennix™ is a fully-integrated osteobiologic company headquartered in Irvine which develops, manufactures, and distributes proprietary bone graft substitutes used in bone fusion procedures. Learn more at biogennix.com.

Contacts

Biogennix
Paul Williams, 310-569-0023
paul@medialinecommunications.com

Regenexx Publishes New Research Findings That May Help Alleviate the Opioid Crisis

Posted On January 16, 2018 By OrthoSpineNews In Biologics /

January 16, 2018

BROOMFIELD, Colo.–(BUSINESS WIRE)–A significant number of opioid deaths worldwide involve patients who become addicted to prescription narcotics due to severe low back pain. Regenexx, a physician-run medical network and pioneer in the invention of orthopedic stem cell injections, has today released new research that examines a more effective alternative for treating lower back pain to bypass the harmful effects of opioids and high dose steroids. The study, led by Regenexx founder and world-renowned leader for interventional orthopedics, Christopher J. Centeno, MD, was recently published in the 2017 Journal of Experimental Orthopedics, titled, “The Use of Lumbar Epidural Injection of Platelet Lysate for Treatment of Radicular Pain.”

Epidural steroid injections have been a mainstay of lower back treatment for decades, but the fact that they often fail to manage pain long-term has led many patients to seek relief through high dose and addictive narcotics. “Despite being the most common non-surgical procedure for sciatica and lower back pain performed in the U.S., there is limited evidence of the efficacy of epidural steroid injections (ESI),” said Christopher J. Centeno, MD, CMO of Regenexx. “Additionally, some evidence suggests that high dose use of corticosteroids may have significant side effects.”

The research’s methodology included a registry-based, case series evaluating the use of platelet lysate epidural injections for the treatment of lumbar radicular pain as an alternative to corticosteroids. Backed by MRI findings that were consistent with symptoms, 470 participants were treated with epidural injections presenting with symptoms of lumbar radicular pain (also known as sciatica). Collected outcomes included numeric pain score, functional rating index, and a modified single assessment numeric evaluation rating.

“The main advantage of platelet lysate is that it’s anabolic rather than catabolic,” said Dr. Centeno. “This means that it has growth factors that can help things heal rather than high-dose steroids that can destroy tissue by killing cells. Platelet lysate also has anti-inflammatory cytokines, like A2M, IRAP, and TIMPs.”

Following treatment with platelet lysate, patients reported significant improvements in pain and subjective improvement through their 2-year follow-up. Notably, the regenerative platelet lysate injections produced relief for longer periods than usually seen with epidural steroid injections. These findings are very encouraging to physicians who treat lower back pain, as they are now actively seeking ways to help patients without turning to narcotics.

The research team consisted of Christopher Centeno, Jason Markle, Ehren Dodson, Ian Stemper, Matter Hyzy, Christopher Williams and Michael Freeman. The full study can be found online at the Journal of Orthopedics.

About Regenexx and the Regenexx Physician Network
The Regenexx® Procedures are the nation’s most advanced non-surgical stem cell and blood platelet treatments for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone.

For more information on Regenexx, please visit: http://www.regenexx.com

Contacts

Regenexx
Susannah Spruill, 720-577-5409
regenexx@matternow.com

MiMedx Announces First Patients Have Enrolled In The Phase 3 Clinical Trial Of AmnioFix® Injectable In Patients With Recalcitrant Plantar Fasciitis Pain

Posted On January 16, 2018 By OrthoSpineNews In Biologics /

MARIETTA, Ga., Jan. 16, 2018 /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, today announced the first patients have been randomized and enrolled in the pivotal Phase 3 Investigational New Drug (IND) clinical trial to assess the safety and efficacy of AmnioFix® Injectable in patients with recalcitrant plantar fasciitis pain.

Top-line results from this study are expected in the second half of 2019. Following the conclusion of this trial, MiMedx intends to file a Biologic License Application (BLA) with the U.S. Food and Drug Administration for AmnioFix® Injectable to treat moderate to severe plantar fasciitis pain that has failed conservative treatment for at least 30 days. The Company projects the filing of the BLA related to plantar fasciitis will be in 2020.

Plantar fasciitis is the most common cause of chronic heel pain in adults, making up 11–15% of the foot symptoms requiring professional care among adults, according to studies published in the Journal of Research in Medical Sciences. It is estimated that 1 in 10 people will develop PF during their lifetime. Plantar Fasciitis is one of the most common orthopedic complaints relating to the foot, affecting approximately 9% of the U.S. population with approximately one million people per year seeking medical treatment. The Company believes 60% of these patients could be potential candidates to receive an AmnioFix injection, which MiMedx estimates represents approximately a $450 million annual market opportunity for the Company.

This Phase 3, prospective, double blinded, randomized controlled trial will enroll approximately 164 patients at 15 centers. Patients will be randomized 1:1 into two treatment groups; a single injection of saline (placebo control) or a single injection of 40mg of AmnioFix Injectable. The primary efficacy endpoint is the change in Visual Analog Scale (VAS) score between baseline and day 90, expressed as the difference in means between the two groups. The primary safety endpoint is 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-controlled group.

Parker H. “Pete” Petit, Chairman and CEO, said, “I am pleased to announce that we have commenced enrolling the first Phase 3 patients in this significant study. For a long time, physicians treating musculoskeletal degeneration pain have highlighted the need for a new safe and durable first-line therapy, especially an injectable product. We believe AmnioFix Injectable meets this need and will quickly become the physician’s product of choice for the vast majority of their patients.”

Bill Taylor, President and COO, added, “We expect this Phase 3 study will confirm the results seen in our Phase 2B study that showed AmnioFix Injectable has the potential to provide an effective, safe and durable relief from pain associated with chronic plantar fasciitis.”

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 million 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.

Safe Harbor Statement
This press release includes forward-looking statements, including statements regarding the Company’s intention and timing of the filing of its Biologic License Application with the FDA, the belief that AmnioFix Injectable meets a market need and will quickly become the product of choice for physicians, and that the Phase 3 study results will confirm the results seen in the Phase 2B study.. 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 additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; 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 the market may not adopt the utilization of AmnioFix Injectable as anticipated and it may not become the product of choice for physicians. 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.

FDA Clears Bone Scaffold ReBOSSIS® for New Indication

Posted On January 12, 2018 By OrthoSpineNews In Biologics, Regulatory /

GEORGETOWN, TEXAS (PRWEB) JANUARY 11, 2018

Last month, the Food and Drug Administration cleared ReBOSSIS®, the only biosynthetic bone scaffold with electrospun microfiber construction, for use in posterolateral spine procedures.

“Having ReBOSSIS® used in these types of procedures reaffirms its place in today’s biologic market,” says Doris Blake, president and COO of ORTHOReBIRTH USA, a wholly owned subsidiary of ORTHOReBIRTH Co. Ltd., which produces ReBOSSIS®. “Surgeons have been impressed with the superior handling characteristics and the clinical results produced utilizing ReBOSSIS® as one of a number of treatment modalities that support successful outcomes for their patients.”

In addition, tests performed at the Cleveland Clinic Lerner Research Institute and at the Orthopaedic Stem Cell Research Laboratory at Cedars-Sinai further validated the fact that ReBOSSIS® supports cell activation, retention, and proliferation. ReBOSSIS® also stands out from the competition with its demonstrated 54 percent compression recovery rate and optimal fit and fill—qualities that have led ReBOSSIS® to recently surpassing the 1,500-procedure milestone.

“We have been pleased with the outcomes seen with ReBOSSIS®,” says Blake, “and we are excited to witness its continued success in this new application.”

About ORTHOReBIRTH USA

We recognize the challenges associated with orthopedic surgery—for patients, surgeons and hospitals alike. We are committed to bringing to market cutting-edge orthopedic biologics that improve patients’ quality of life and offer superior outcomes. We have carried out extensive studies on what makes biologic materials successful and have used that knowledge to engineer world-class products for use in a host of orthopedic surgical procedures. ORTHOReBIRTH USA is proud to bring premium orthopedic biologics, such as ReBOSSIS®, to surgeons practicing around the world.

FzioMed Announces 500,000 Units of Oxiplex® Shipped Worldwide

Posted On January 11, 2018 By OrthoSpineNews In Biologics /

January 10, 2018

SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc. a leading biomaterials company, is pleased to announce that Oxiplex sales have now passed the 500,000 unit mark.

Oxiplex is approved outside the United States in more than 70 countries and distributed under various brand names; including, Oxiplex, Oxiplex/SP, MediShield, and Interpose.

Oxiplex is an absorbable gel applied to neural tissues following spine surgery. Oxiplex creates a temporary physical barrier between adjacent tissues and has been shown in multiple peer reviewed studies to reduce leg pain, back pain, and neurologic symptoms.

“This milestone provides further evidence of the safety and effectiveness of Oxiplex in an ever increasing number of patients around the world,” said John Krelle, FzioMed’s President and Chief Executive Officer. “The fact that sales have continued to grow over many years in a real-world setting is a remarkable achievement and provides the impetus for our supportive FDA approved US IDE study. A large number of clinical sites around the country have expressed interest in the study, which will commence enrollment early this year.”

About FzioMed, Inc.

FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable surgical biomaterials based on its patented scientific technology. For more information, please contact John Krelle at jkrelle@fziomed.com. You can also visit www.fziomed.com or contact investorrelations@fziomed.com.

FzioMed®, Oxiplex®, Oxiplex/SP® and Interpose® are registered trademarks of FzioMed, Inc.

Contacts

FzioMed, Inc.
John Krelle
jkrelle@fziomed.com

Histogenics Corporation Announces Receipt of $10 Million Up-front Payment for Japanese NeoCart Agreement

Posted On January 10, 2018 By OrthoSpineNews In Biologics, Top Stories /

WALTHAM, Mass., Jan. 09, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that it has received the $10 million up-front payment from MEDINET Co., Ltd. (MEDINET), under the previously announced agreement for the development and commercialization of NeoCart® for the Japanese market. Per the terms of the agreement, the up-front payment was due within ten days of entering into the agreement. Histogenics and MEDINET announced entering into the agreement in December 2017, which included up to $87 million in total milestones and tiered royalties on sales, and a goal of commercializing NeoCart in Japan in 2021, if approved.

“Our partnership with MEDINET for NeoCart is off to a strong start, and we’re pleased to receive the initial $10 million payment. The clinical and operations teams at both companies have initiated work to prepare for the upcoming confirmatory Phase 3 clinical trial in Japan,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “Histogenics is also rapidly evaluating partnerships in other potential regions for NeoCart as part of our strategy to leverage our robust restorative cell therapy platform globally.”

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

About MEDINET Co., Ltd.

MEDINET is a pioneering leader in the development and commercialization of cancer immuno-cell therapies. MEDINET is also rigorously preparing to enter into the regenerative medical product market to leverage its long clinical and translational medicine history responding to the expected aging of the population. MEDINET went public in October, 2003 on the MOTHERS, Tokyo Stock Exchange. For more information, visit http://www.medinet-inc.co.jp/english/.

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 generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; 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; 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017, to be filed with the SEC in the first quarter of 2018. 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.

Histogenics Corporation and MEDINET Co., Ltd Enter Into Licensing Agreement for Development and Commercialization of NeoCart for the Japanese Market

Posted On December 22, 2017 By OrthoSpineNews In Biologics, Top Stories /

WALTHAM, Mass., Dec. 21, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that it has entered into an agreement with MEDINET Co., Ltd. (MEDINET), a pioneering leader in the development and commercialization of cancer immuno-cell therapy technologies, for the development and commercialization of NeoCart^® for the Japanese market.

“This transformative collaboration for Histogenics is a clear validation of the value NeoCart potentially provides to the physicians and patients who suffer from painful cartilage defects and related loss of function. MEDINET is one of the leaders of the burgeoning regenerative medicine sector in Japan, with strong capabilities in development and manufacturing of cell therapy products. We believe their recent initiatives to further develop their therapeutic capabilities with the addition of innovative products such as NeoCart will provide a rapid entry into the Japanese market,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “Our ability to leverage our long clinical and translational medicine history in the U.S. in markets such as Japan was a first step in bringing NeoCart to other regions, and we look forward to expanding our global presence more broadly in 2018 into other potential territories in Asia and Europe.”

Histogenics’ formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) concluded in the second quarter of 2017 and the positive conclusion of those consultations played an integral role in enabling this collaboration. Formal feedback from the PMDA regarding the development and approval pathway for NeoCart in Japan included:

A 30-patient, one-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan in conjunction with data from Histogenics’ fully enrolled U.S. Phase 3 clinical trial.
NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and Histogenics can supply the confirmatory clinical trial from the U.S. using the current good manufacturing process (cGMP) for NeoCart.

“I am excited about the potential to bring this exciting therapy to Japanese patients and physicians through this new partnership,” stated Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School, in whose laboratory the underlying technology for NeoCart was discovered.

Japanese Cartilage Repair Market

The Japanese cartilage repair market is estimated to be the second largest market in the world after the U.S. and it is estimated that there may be at least 10,000 NeoCart treatments per year. If left untreated, cartilage defects may result in Osteoarthritis (OA) and ultimately, total knee replacements. Market forecasts predict that the number of OA patients in Japan aged 40 and older amounts to more than 25 million and is expected to accelerate as the population ages.

In the first half of 2017, Histogenics conducted market research in Japan with approximately 80 leading surgeons with the findings summarized below:

Approximately 60% of patients with knee cartilage defects are either not treated, or treated solely for temporary pain relief.
Approximately 60-70% of patients with knee cartilage defects that are left untreated will likely progress to OA in the knee.
Cartilage defects are believed to have caused OA in 15-20% of patients suffering from knee OA.
More than 85% of orthopedic surgeons are not satisfied with the current options to treat knee cartilage defects.
Approximately 80% of orthopedic surgeons consider early improvement in pain and function to be important and more than half of the surgeons feel they would prescribe NeoCart based on published data.

“This licensing deal has been realized based on our longtime close relationship with Histogenics. I am excited about and proud of, the big challenge to enter into the regenerative medical product market with NeoCart in collaboration with the excellent team of Histogenics,” stated Yoshiji Kimura, Chief Executive Officer of MEDINET. “We believe this restorative cell therapy will contribute to better treatment by the physicians and quality life, of the patients with knee cartilage defects in Japan.”

Locust Walk served as transaction advisor to Histogenics.

Conference Call and Webcast Information

Histogenics’ management will host a conference call on Thursday, December 21, 2017 at 9:00 a.m. ET. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial 877-930-8064 (domestic) or 253-336-8040 (international) and provide the conference ID: 5982636 five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the “Investor Relations” page of the Histogenics website, www.histogenics.com, or by clicking here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

About MEDINET Co., Ltd.

Forward-Looking Statements

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 generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; 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; 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. 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.

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