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– Long history and significant US data package may enable full Marketing and Manufacturing Authorization of NeoCart subject to successful completion of small confirmatory clinical trial in Japan – – PMDA Consultations concluded in first quarter of 2017 encompass all parts of potential regulatory submission including:  Clinical Trial, Quality/Manufacturing and Non-Clinical Safety – – Japanese cartilage repair market estimated to be second largest in the world with established reimbursement, and physicians and patients seeking treatments for cartilage defects that may prevent osteoarthritis in the knee – WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has successfully completed all formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) regarding the Marketing and Manufacturing Authorization pathway for Histogenics’ NeoCart (autologous cell therapy designed to treat cartilage defects in the knee) in the Japanese market.  Histogenics is currently nearing the completion of enrollment in a 245 patient Phase 3 clinical trial of NeoCart that is being conducted under a Special Protocol Assessment (the SPA) with the U.S. Food and Drug Administration (the FDA). “We are very pleased with the formal feedback we received from the PMDA regarding the relatively expeditious approval pathway for NeoCart in Japan, and appreciate the thoughtful, rapid and collaborative approach provided by Japan regulators,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “These successful consultations and meetings are evidence of our execution of a broadening global regulatory strategy launched only seven months ago where we initiated efforts to leverage the robust U.S. clinical, preclinical and cGMP data for NeoCart into international markets.  We believe the clarity on this efficient regulatory pathway for full Marketing Authorization will be important to our efforts to seek a development and commercialization partner for NeoCart in Japan and other markets in Asia.” Various aspects of the Japanese regenerative medicine laws were updated in 2014 to potentially expedite the clinical development and commercialization pathways for innovative, qualified regenerative cell-based medicines that have demonstrated safety and probable efficacy.  Shortly after reacquiring Japanese rights for NeoCart from Purpose Co. in May 2016, Histogenics initiated preparatory pre-consultations (Jizen-Mendan) with the PMDA for the three discreet modules of the regulatory process: Clinical Trial, Non-clinical Safety and Quality/Manufacturing. During the first quarter of 2017, Histogenics held a series of consultations with the PMDA, including face-to-face (Taimen-Jogen) meetings.  In these consultations, the PMDA agreed that Histogenics’ ongoing Phase 3 clinical trial with its one-year primary endpoint could be appropriate and provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan. Furthermore, the PMDA agreed that 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.  This Japanese study will utilize the same protocol as the ongoing Phase 3 clinical trial of NeoCart.  Histogenics also confirmed that NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and that Histogenics’ current good manufacturing process (cGMP) in the U.S. could be utilized to manufacture and supply the confirmatory clinical study. These consultations with the PMDA were attended by representatives of Histogenics, including co-founder Dr. Shuichi Mizuno, regulatory and regenerative medicine experts, and two esteemed orthopedic surgeons from Japan, Dr. Akihiro Tsuchiya and Dr. Takumi Nakagawa, both of whom have trained on NeoCart procedures with U.S. surgeons. In addition to the confirmatory clinical trial, Histogenics agreed with the PMDA to conduct additional minor, non-clinical safety studies, including a short-term (three-month) general toxicity study and in vitro tumorigenicity studies to reflect current standards and to augment the significant amount of pre-clinical data previously generated by Histogenics.  These additional study protocols will be reviewed with the PMDA and will be conducted prior to the Marketing and Manufacturing Authorization.  With regards to Histogenics’ Quality/Manufacturing applications, the PMDA and Histogenics agreed to several updates for certain procedures and testing methodology, all of which are planned as part of Histogenics’ continuous improvement activities for the biologics license application (BLA) submission planned with the FDA. Histogenics believes that the PMDA’s conclusions are based on the strength of the NeoCart clinical and non-clinical data package and the long 15+ year cGMP manufacturing history of NeoCart. “We are thankful for the leadership and partnership with the PMDA,” commented Dr. Shuichi Mizuno, Ph.D., Co-founder of Histogenics, and Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School.  “We have been working collaboratively for nearly 20 years to provide substantial supportive basic science and non-clinical data as well as novel cell culture technology to guide the development of this important innovative therapy for cartilage defects.” In conjunction with the launch of its commercial partnering efforts, Histogenics commissioned through Locust Walk’s Japan team a quantitative market research study with approximately 80 orthopedic surgeons including a mix of hospital physicians and general practitioners in Japan regarding the market opportunity for NeoCart for knee cartilage defects in the Japanese market.  The findings paralleled what is observed from surgeons and patients in the United States – a market with a high unmet need characterized by long recoveries and variable clinical outcomes from current therapies, leaving many patients choosing to avoid having unsatisfactory treatments.  These data may reflect the opportunity for innovative regenerative medicine products such as NeoCart to grow the market substantially by providing satisfactory outcomes and better quality of life, while avoiding progression to osteoarthritis (OA) and unnecessary surgeries. The findings from the Japan survey include: “As is the case in the United States, we believe Japanese surgeons and patients are seeking new regenerative medicine options to repair cartilage defects that may offer both a more rapid recovery in terms of pain and function, as well as a more durable response over time with fewer repeat surgeries, which improves overall quality of life,” commented Dr. Tsuchiya, Vice President, Funabashi Orthopaedic Hospital, Chiba, Japan, and Chairman, Tokyo Women’s Medical College, Tokyo, Japan, and Dr. Nakagawa, Professor of Department of Orthopaedic Surgery, School of Medicine, Teikyo University, Tokyo, Japan.  “We have followed the development of NeoCart for many years and have trained with surgeons in the U.S., and along with our medical colleagues, look forward to potentially introducing this novel non-NSAID and non-opioid cell-based therapy product to our patients in Japan that currently do not have good options to treat the pain and loss of function due to knee cartilage defects.” Histogenics estimates the Japanese market represents a significant opportunity, with an estimated 200,000 procedures annually in Japan for patients suffering from pain associated with cartilage defects in the knee and limited options to treat the defect or related pain.  If left untreated, cartilage defects may result in OA and ultimately, total knee replacements as patients age, with a substantial economic impact on patients and insurance companies.  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 with the aging population. Once a development and commercial partner is identified, Histogenics intends to file with such partner the Clinical Trial Notification (CTN) to the PMDA to begin the proposed clinical trial. 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. 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; possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates in the U.S. and Japan, and the labeling for any approved products; Histogenics’ ability to find a development and commercialization partner for NeoCart 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; 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; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon is based; the additional expenses that Histogenics may 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, 2016, which is 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 ended March 31, 2017, to be filed with the SEC in the second quarter of 2017.  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.


– Long history and significant US data package may enable full Marketing and Manufacturing Authorization of NeoCart subject to successful completion of small confirmatory clinical trial in Japan – – PMDA Consultations concluded in first quarter of 2017 encompass all parts of potential regulatory submission including:  Clinical Trial, Quality/Manufacturing and Non-Clinical Safety – – Japanese cartilage repair market estimated to be second largest in the world with established reimbursement, and physicians and patients seeking treatments for cartilage defects that may prevent osteoarthritis in the knee – WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has successfully completed all formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) regarding the Marketing and Manufacturing Authorization pathway for Histogenics’ NeoCart (autologous cell therapy designed to treat cartilage defects in the knee) in the Japanese market.  Histogenics is currently nearing the completion of enrollment in a 245 patient Phase 3 clinical trial of NeoCart that is being conducted under a Special Protocol Assessment (the SPA) with the U.S. Food and Drug Administration (the FDA). “We are very pleased with the formal feedback we received from the PMDA regarding the relatively expeditious approval pathway for NeoCart in Japan, and appreciate the thoughtful, rapid and collaborative approach provided by Japan regulators,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “These successful consultations and meetings are evidence of our execution of a broadening global regulatory strategy launched only seven months ago where we initiated efforts to leverage the robust U.S. clinical, preclinical and cGMP data for NeoCart into international markets.  We believe the clarity on this efficient regulatory pathway for full Marketing Authorization will be important to our efforts to seek a development and commercialization partner for NeoCart in Japan and other markets in Asia.” Various aspects of the Japanese regenerative medicine laws were updated in 2014 to potentially expedite the clinical development and commercialization pathways for innovative, qualified regenerative cell-based medicines that have demonstrated safety and probable efficacy.  Shortly after reacquiring Japanese rights for NeoCart from Purpose Co. in May 2016, Histogenics initiated preparatory pre-consultations (Jizen-Mendan) with the PMDA for the three discreet modules of the regulatory process: Clinical Trial, Non-clinical Safety and Quality/Manufacturing. During the first quarter of 2017, Histogenics held a series of consultations with the PMDA, including face-to-face (Taimen-Jogen) meetings.  In these consultations, the PMDA agreed that Histogenics’ ongoing Phase 3 clinical trial with its one-year primary endpoint could be appropriate and provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan. Furthermore, the PMDA agreed that 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.  This Japanese study will utilize the same protocol as the ongoing Phase 3 clinical trial of NeoCart.  Histogenics also confirmed that NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and that Histogenics’ current good manufacturing process (cGMP) in the U.S. could be utilized to manufacture and supply the confirmatory clinical study. These consultations with the PMDA were attended by representatives of Histogenics, including co-founder Dr. Shuichi Mizuno, regulatory and regenerative medicine experts, and two esteemed orthopedic surgeons from Japan, Dr. Akihiro Tsuchiya and Dr. Takumi Nakagawa, both of whom have trained on NeoCart procedures with U.S. surgeons. In addition to the confirmatory clinical trial, Histogenics agreed with the PMDA to conduct additional minor, non-clinical safety studies, including a short-term (three-month) general toxicity study and in vitro tumorigenicity studies to reflect current standards and to augment the significant amount of pre-clinical data previously generated by Histogenics.  These additional study protocols will be reviewed with the PMDA and will be conducted prior to the Marketing and Manufacturing Authorization.  With regards to Histogenics’ Quality/Manufacturing applications, the PMDA and Histogenics agreed to several updates for certain procedures and testing methodology, all of which are planned as part of Histogenics’ continuous improvement activities for the biologics license application (BLA) submission planned with the FDA. Histogenics believes that the PMDA’s conclusions are based on the strength of the NeoCart clinical and non-clinical data package and the long 15+ year cGMP manufacturing history of NeoCart. “We are thankful for the leadership and partnership with the PMDA,” commented Dr. Shuichi Mizuno, Ph.D., Co-founder of Histogenics, and Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School.  “We have been working collaboratively for nearly 20 years to provide substantial supportive basic science and non-clinical data as well as novel cell culture technology to guide the development of this important innovative therapy for cartilage defects.” In conjunction with the launch of its commercial partnering efforts, Histogenics commissioned through Locust Walk’s Japan team a quantitative market research study with approximately 80 orthopedic surgeons including a mix of hospital physicians and general practitioners in Japan regarding the market opportunity for NeoCart for knee cartilage defects in the Japanese market.  The findings paralleled what is observed from surgeons and patients in the United States – a market with a high unmet need characterized by long recoveries and variable clinical outcomes from current therapies, leaving many patients choosing to avoid having unsatisfactory treatments.  These data may reflect the opportunity for innovative regenerative medicine products such as NeoCart to grow the market substantially by providing satisfactory outcomes and better quality of life, while avoiding progression to osteoarthritis (OA) and unnecessary surgeries. The findings from the Japan survey include: “As is the case in the United States, we believe Japanese surgeons and patients are seeking new regenerative medicine options to repair cartilage defects that may offer both a more rapid recovery in terms of pain and function, as well as a more durable response over time with fewer repeat surgeries, which improves overall quality of life,” commented Dr. Tsuchiya, Vice President, Funabashi Orthopaedic Hospital, Chiba, Japan, and Chairman, Tokyo Women’s Medical College, Tokyo, Japan, and Dr. Nakagawa, Professor of Department of Orthopaedic Surgery, School of Medicine, Teikyo University, Tokyo, Japan.  “We have followed the development of NeoCart for many years and have trained with surgeons in the U.S., and along with our medical colleagues, look forward to potentially introducing this novel non-NSAID and non-opioid cell-based therapy product to our patients in Japan that currently do not have good options to treat the pain and loss of function due to knee cartilage defects.” Histogenics estimates the Japanese market represents a significant opportunity, with an estimated 200,000 procedures annually in Japan for patients suffering from pain associated with cartilage defects in the knee and limited options to treat the defect or related pain.  If left untreated, cartilage defects may result in OA and ultimately, total knee replacements as patients age, with a substantial economic impact on patients and insurance companies.  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 with the aging population. Once a development and commercial partner is identified, Histogenics intends to file with such partner the Clinical Trial Notification (CTN) to the PMDA to begin the proposed clinical trial. 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. 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; possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates in the U.S. and Japan, and the labeling for any approved products; Histogenics’ ability to find a development and commercialization partner for NeoCart 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; 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; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon is based; the additional expenses that Histogenics may 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, 2016, which is 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 ended March 31, 2017, to be filed with the SEC in the second quarter of 2017.  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.


– Long history and significant US data package may enable full Marketing and Manufacturing Authorization of NeoCart subject to successful completion of small confirmatory clinical trial in Japan – – PMDA Consultations concluded in first quarter of 2017 encompass all parts of potential regulatory submission including:  Clinical Trial, Quality/Manufacturing and Non-Clinical Safety – – Japanese cartilage repair market estimated to be second largest in the world with established reimbursement, and physicians and patients seeking treatments for cartilage defects that may prevent osteoarthritis in the knee – WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has successfully completed all formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) regarding the Marketing and Manufacturing Authorization pathway for Histogenics’ NeoCart (autologous cell therapy designed to treat cartilage defects in the knee) in the Japanese market.  Histogenics is currently nearing the completion of enrollment in a 245 patient Phase 3 clinical trial of NeoCart that is being conducted under a Special Protocol Assessment (the SPA) with the U.S. Food and Drug Administration (the FDA). “We are very pleased with the formal feedback we received from the PMDA regarding the relatively expeditious approval pathway for NeoCart in Japan, and appreciate the thoughtful, rapid and collaborative approach provided by Japan regulators,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “These successful consultations and meetings are evidence of our execution of a broadening global regulatory strategy launched only seven months ago where we initiated efforts to leverage the robust U.S. clinical, preclinical and cGMP data for NeoCart into international markets.  We believe the clarity on this efficient regulatory pathway for full Marketing Authorization will be important to our efforts to seek a development and commercialization partner for NeoCart in Japan and other markets in Asia.” Various aspects of the Japanese regenerative medicine laws were updated in 2014 to potentially expedite the clinical development and commercialization pathways for innovative, qualified regenerative cell-based medicines that have demonstrated safety and probable efficacy.  Shortly after reacquiring Japanese rights for NeoCart from Purpose Co. in May 2016, Histogenics initiated preparatory pre-consultations (Jizen-Mendan) with the PMDA for the three discreet modules of the regulatory process: Clinical Trial, Non-clinical Safety and Quality/Manufacturing. During the first quarter of 2017, Histogenics held a series of consultations with the PMDA, including face-to-face (Taimen-Jogen) meetings.  In these consultations, the PMDA agreed that Histogenics’ ongoing Phase 3 clinical trial with its one-year primary endpoint could be appropriate and provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan. Furthermore, the PMDA agreed that 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.  This Japanese study will utilize the same protocol as the ongoing Phase 3 clinical trial of NeoCart.  Histogenics also confirmed that NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and that Histogenics’ current good manufacturing process (cGMP) in the U.S. could be utilized to manufacture and supply the confirmatory clinical study. These consultations with the PMDA were attended by representatives of Histogenics, including co-founder Dr. Shuichi Mizuno, regulatory and regenerative medicine experts, and two esteemed orthopedic surgeons from Japan, Dr. Akihiro Tsuchiya and Dr. Takumi Nakagawa, both of whom have trained on NeoCart procedures with U.S. surgeons. In addition to the confirmatory clinical trial, Histogenics agreed with the PMDA to conduct additional minor, non-clinical safety studies, including a short-term (three-month) general toxicity study and in vitro tumorigenicity studies to reflect current standards and to augment the significant amount of pre-clinical data previously generated by Histogenics.  These additional study protocols will be reviewed with the PMDA and will be conducted prior to the Marketing and Manufacturing Authorization.  With regards to Histogenics’ Quality/Manufacturing applications, the PMDA and Histogenics agreed to several updates for certain procedures and testing methodology, all of which are planned as part of Histogenics’ continuous improvement activities for the biologics license application (BLA) submission planned with the FDA. Histogenics believes that the PMDA’s conclusions are based on the strength of the NeoCart clinical and non-clinical data package and the long 15+ year cGMP manufacturing history of NeoCart. “We are thankful for the leadership and partnership with the PMDA,” commented Dr. Shuichi Mizuno, Ph.D., Co-founder of Histogenics, and Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School.  “We have been working collaboratively for nearly 20 years to provide substantial supportive basic science and non-clinical data as well as novel cell culture technology to guide the development of this important innovative therapy for cartilage defects.” In conjunction with the launch of its commercial partnering efforts, Histogenics commissioned through Locust Walk’s Japan team a quantitative market research study with approximately 80 orthopedic surgeons including a mix of hospital physicians and general practitioners in Japan regarding the market opportunity for NeoCart for knee cartilage defects in the Japanese market.  The findings paralleled what is observed from surgeons and patients in the United States – a market with a high unmet need characterized by long recoveries and variable clinical outcomes from current therapies, leaving many patients choosing to avoid having unsatisfactory treatments.  These data may reflect the opportunity for innovative regenerative medicine products such as NeoCart to grow the market substantially by providing satisfactory outcomes and better quality of life, while avoiding progression to osteoarthritis (OA) and unnecessary surgeries. The findings from the Japan survey include: “As is the case in the United States, we believe Japanese surgeons and patients are seeking new regenerative medicine options to repair cartilage defects that may offer both a more rapid recovery in terms of pain and function, as well as a more durable response over time with fewer repeat surgeries, which improves overall quality of life,” commented Dr. Tsuchiya, Vice President, Funabashi Orthopaedic Hospital, Chiba, Japan, and Chairman, Tokyo Women’s Medical College, Tokyo, Japan, and Dr. Nakagawa, Professor of Department of Orthopaedic Surgery, School of Medicine, Teikyo University, Tokyo, Japan.  “We have followed the development of NeoCart for many years and have trained with surgeons in the U.S., and along with our medical colleagues, look forward to potentially introducing this novel non-NSAID and non-opioid cell-based therapy product to our patients in Japan that currently do not have good options to treat the pain and loss of function due to knee cartilage defects.” Histogenics estimates the Japanese market represents a significant opportunity, with an estimated 200,000 procedures annually in Japan for patients suffering from pain associated with cartilage defects in the knee and limited options to treat the defect or related pain.  If left untreated, cartilage defects may result in OA and ultimately, total knee replacements as patients age, with a substantial economic impact on patients and insurance companies.  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 with the aging population. Once a development and commercial partner is identified, Histogenics intends to file with such partner the Clinical Trial Notification (CTN) to the PMDA to begin the proposed clinical trial. 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. 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; possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates in the U.S. and Japan, and the labeling for any approved products; Histogenics’ ability to find a development and commercialization partner for NeoCart 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; 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; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon is based; the additional expenses that Histogenics may 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, 2016, which is 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 ended March 31, 2017, to be filed with the SEC in the second quarter of 2017.  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.


– Long history and significant US data package may enable full Marketing and Manufacturing Authorization of NeoCart subject to successful completion of small confirmatory clinical trial in Japan – – PMDA Consultations concluded in first quarter of 2017 encompass all parts of potential regulatory submission including:  Clinical Trial, Quality/Manufacturing and Non-Clinical Safety – – Japanese cartilage repair market estimated to be second largest in the world with established reimbursement, and physicians and patients seeking treatments for cartilage defects that may prevent osteoarthritis in the knee – WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has successfully completed all formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) regarding the Marketing and Manufacturing Authorization pathway for Histogenics’ NeoCart (autologous cell therapy designed to treat cartilage defects in the knee) in the Japanese market.  Histogenics is currently nearing the completion of enrollment in a 245 patient Phase 3 clinical trial of NeoCart that is being conducted under a Special Protocol Assessment (the SPA) with the U.S. Food and Drug Administration (the FDA). “We are very pleased with the formal feedback we received from the PMDA regarding the relatively expeditious approval pathway for NeoCart in Japan, and appreciate the thoughtful, rapid and collaborative approach provided by Japan regulators,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “These successful consultations and meetings are evidence of our execution of a broadening global regulatory strategy launched only seven months ago where we initiated efforts to leverage the robust U.S. clinical, preclinical and cGMP data for NeoCart into international markets.  We believe the clarity on this efficient regulatory pathway for full Marketing Authorization will be important to our efforts to seek a development and commercialization partner for NeoCart in Japan and other markets in Asia.” Various aspects of the Japanese regenerative medicine laws were updated in 2014 to potentially expedite the clinical development and commercialization pathways for innovative, qualified regenerative cell-based medicines that have demonstrated safety and probable efficacy.  Shortly after reacquiring Japanese rights for NeoCart from Purpose Co. in May 2016, Histogenics initiated preparatory pre-consultations (Jizen-Mendan) with the PMDA for the three discreet modules of the regulatory process: Clinical Trial, Non-clinical Safety and Quality/Manufacturing. During the first quarter of 2017, Histogenics held a series of consultations with the PMDA, including face-to-face (Taimen-Jogen) meetings.  In these consultations, the PMDA agreed that Histogenics’ ongoing Phase 3 clinical trial with its one-year primary endpoint could be appropriate and provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan. Furthermore, the PMDA agreed that 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.  This Japanese study will utilize the same protocol as the ongoing Phase 3 clinical trial of NeoCart.  Histogenics also confirmed that NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and that Histogenics’ current good manufacturing process (cGMP) in the U.S. could be utilized to manufacture and supply the confirmatory clinical study. These consultations with the PMDA were attended by representatives of Histogenics, including co-founder Dr. Shuichi Mizuno, regulatory and regenerative medicine experts, and two esteemed orthopedic surgeons from Japan, Dr. Akihiro Tsuchiya and Dr. Takumi Nakagawa, both of whom have trained on NeoCart procedures with U.S. surgeons. In addition to the confirmatory clinical trial, Histogenics agreed with the PMDA to conduct additional minor, non-clinical safety studies, including a short-term (three-month) general toxicity study and in vitro tumorigenicity studies to reflect current standards and to augment the significant amount of pre-clinical data previously generated by Histogenics.  These additional study protocols will be reviewed with the PMDA and will be conducted prior to the Marketing and Manufacturing Authorization.  With regards to Histogenics’ Quality/Manufacturing applications, the PMDA and Histogenics agreed to several updates for certain procedures and testing methodology, all of which are planned as part of Histogenics’ continuous improvement activities for the biologics license application (BLA) submission planned with the FDA. Histogenics believes that the PMDA’s conclusions are based on the strength of the NeoCart clinical and non-clinical data package and the long 15+ year cGMP manufacturing history of NeoCart. “We are thankful for the leadership and partnership with the PMDA,” commented Dr. Shuichi Mizuno, Ph.D., Co-founder of Histogenics, and Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School.  “We have been working collaboratively for nearly 20 years to provide substantial supportive basic science and non-clinical data as well as novel cell culture technology to guide the development of this important innovative therapy for cartilage defects.” In conjunction with the launch of its commercial partnering efforts, Histogenics commissioned through Locust Walk’s Japan team a quantitative market research study with approximately 80 orthopedic surgeons including a mix of hospital physicians and general practitioners in Japan regarding the market opportunity for NeoCart for knee cartilage defects in the Japanese market.  The findings paralleled what is observed from surgeons and patients in the United States – a market with a high unmet need characterized by long recoveries and variable clinical outcomes from current therapies, leaving many patients choosing to avoid having unsatisfactory treatments.  These data may reflect the opportunity for innovative regenerative medicine products such as NeoCart to grow the market substantially by providing satisfactory outcomes and better quality of life, while avoiding progression to osteoarthritis (OA) and unnecessary surgeries. The findings from the Japan survey include: “As is the case in the United States, we believe Japanese surgeons and patients are seeking new regenerative medicine options to repair cartilage defects that may offer both a more rapid recovery in terms of pain and function, as well as a more durable response over time with fewer repeat surgeries, which improves overall quality of life,” commented Dr. Tsuchiya, Vice President, Funabashi Orthopaedic Hospital, Chiba, Japan, and Chairman, Tokyo Women’s Medical College, Tokyo, Japan, and Dr. Nakagawa, Professor of Department of Orthopaedic Surgery, School of Medicine, Teikyo University, Tokyo, Japan.  “We have followed the development of NeoCart for many years and have trained with surgeons in the U.S., and along with our medical colleagues, look forward to potentially introducing this novel non-NSAID and non-opioid cell-based therapy product to our patients in Japan that currently do not have good options to treat the pain and loss of function due to knee cartilage defects.” Histogenics estimates the Japanese market represents a significant opportunity, with an estimated 200,000 procedures annually in Japan for patients suffering from pain associated with cartilage defects in the knee and limited options to treat the defect or related pain.  If left untreated, cartilage defects may result in OA and ultimately, total knee replacements as patients age, with a substantial economic impact on patients and insurance companies.  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 with the aging population. Once a development and commercial partner is identified, Histogenics intends to file with such partner the Clinical Trial Notification (CTN) to the PMDA to begin the proposed clinical trial. 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. 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; possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates in the U.S. and Japan, and the labeling for any approved products; Histogenics’ ability to find a development and commercialization partner for NeoCart 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; 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; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon is based; the additional expenses that Histogenics may 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, 2016, which is 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 ended March 31, 2017, to be filed with the SEC in the second quarter of 2017.  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.


News Article | February 27, 2017
Site: www.marketwired.com

SALT LAKE CITY, UT--(Marketwired - Feb 27, 2017) - Amedica Corporation ( : AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that Researchers from the Department of Orthopaedic Surgery of Tokyo Medical University (Shinjuku-ku, Tokyo, Japan) led by Professor Kengo Yamamoto MD PhD recently completed a five million cycle (Mc) comparative hip simulator study examining the wear behavior of an advanced highly cross-linked and vitamin E stabilized polyethylene (E1® Zimmer-Biomet, Warsaw, IN, USA) against two different types of ceramic femoral heads -- MC2®silicon nitride (Amedica Corporation, Salt Lake City, UT, USA) and BIOLOX®delta (CeramTec, Plochingen, Germany). BIOLOX®delta is currently considered the "gold standard" for ceramic femoral head materials. While the polyethylene wear loss induced by both types of ceramic heads was extremely small (< 0.60 mg/Mc), mean wear associated with MC2®silicon nitride heads was approximately 15% lower than the BIOLOX®delta components. This independent wear study was conducted in accordance with international standards at the Medical Technology Laboratory of the Rizzoli Orthopaedic Institute (Bologna, Italy) by Professor Aldo Toni MD under the supervision of Dr. Saverio Affatato PhD (Rizzoli Institute) with consultation and support from Professor Giuseppe Pezzotti PhD (Ceramic Physics Laboratory, Kyoto Institute of Technology, Sakyo-ku, Kyoto Japan). Amedica and Zimmer-Biomet (Tokyo Office) provided the femoral heads and acetabular liners; however, neither company actively sponsored the research. The testing was independently conceived by Professors Yamamoto and Pezzotti, and funded by the Department of Orthopaedic Surgery of Tokyo Medical University. This is the first reported improvement in polyethylene wear performance by a ceramic other than BIOLOX®delta; and it is part of a series of planned comparative wear tests that will culminate at 12 Mc. Further details of this interim hip simulation test will be provided in a joint publication planned for release in a scientific journal. "We are thrilled, though not surprised, at the remarkable wear properties of silicon nitride femoral heads," said Dr. B. Sonny Bal, CEO and President of Amedica Corporation. "Our previous work, already published in peer-review forums, has shown superb phase stability of silicon nitride in vivo, plus oxygen-scavenging properties that may confer long-term protection to polyethylene acetabular liners, along with bacterial resistance inherent in silicon nitride, toughness that is superior to any other biomaterial, and resistance to corrosion. The present wear data reflect the considerable scientific work that went into a thorough understanding of the surface chemistry and composition of our femoral heads, with development of engineering processes and proprietary methods that lead to a consistent, ultra-smooth articulating surface. Taken together, this favorable combination of properties, supported by scientific data, reflect material science advancements that are necessary to differentiate total hip replacements in an otherwise commoditized market, and more importantly, toward extending the longevity of hip replacements beyond the second decade of life, post-implantation. These data will contribute to our continuing work and dialogue with the FDA to get the product approved for use clinically." About Amedica Corporation Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships. For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com. Forward-Looking Statements This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, there can be no assurance that we will be able to maintain our listing on any NASDAQ market. Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica's other filings with the SEC. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.


ARLINGTON, Tenn.--(BUSINESS WIRE)--MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting edge joint replacement implants designed to help patients achieve full function faster, announced that The Knee has published a study evaluating long-term clinical and radiographic outcomes of the Medial-Pivot Knee System. The results demonstrate excellent clinical outcomes for both satisfaction (95%) and survivorship (98.8%) at 17 years with patients noting a great sense of stability and comfort during regular activities.1 It has been reported that approximately 20% of patients are not satisfied with the outcome of their total knee replacement as a result of residual pain and functional issues often attributed to implant design.2 MicroPort’s Medial-Pivot Knee System is uniquely designed to restore stability and normal knee kinematics to deliver reproducible outcomes that can improve function and drive patient satisfaction. “I am in my third year of using the Evolution® Medial-Pivot Knee System and this publication validates the results that I have seen in my practice,” says David Backstein, MD, MEd, FRCSC, Head of Orthopaedic Surgery at Mount Sinai Hospital in Toronto, Ontario. “In my experience, the functional outcomes for patients treated with this system have certainly been superior than the systems I’ve used in the past and patients have fewer complaints. When I see them at six or eight weeks follow-up, they're at a different stage of recovery than I was seeing previously with traditional implant designs. I've been exceptionally happy with the results and feel comfortable knowing I am implanting a prosthesis with 98.8% survivorship at 17 years.” The paper, titled, A Long Term Clinical Outcome of the Medial Pivot Knee Arthroplasty System was authored by George A Macheras et al. from the “KAT” General Hospital, Athens, Greece. In the study, 325 patients with knee osteoarthritis underwent Total Knee Arthroplasty (TKA) using the Medial-Pivot prosthesis. All patients showed a statistically significant improvement in the Knee Society clinical rating system, Western Ontario and McMaster Universities Osteoarthritis Index, and Oxford knee score. The majority of patients (94%) were able to perform age-appropriate activities with average knee flexion of 120° and 98% of patients reported relief of pain to be excellent, very good or good. Additionally, survival analysis showed a cumulative success rate of 98.8% at 17 years. About MicroPort Orthopedics Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/. About MicroPort MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 20 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com. Forward-Looking Statements Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China. This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever. 1. George A. Macheras et al. “A long term clinical outcome of the Medial Pivot Knee Arthroplasty System.” The Knee Journal, Published: January 29, 2017. 2. Thambiah, Matthew Dhanaraj et al. “Patient Satisfaction after Total Knee Arthroplasty: An Asian Perspective.” Singapore Medical Journal 56.5 (2015): 259–263. PMC. Web. 22 Feb. 2017.


News Article | February 28, 2017
Site: www.cemag.us

A National Institute for Materials Science-Osaka University joint research team has developed a mesh which can be wrapped around injured peripheral nerves to facilitate their regeneration and restore their functions. The team — consisting of Mitsuhiro Ebara, MANA associate principal investigator, Mechanobiology Group, NIMS, and Hiroyuki Tanaka, assistant professor, Orthopaedic Surgery, Osaka University Graduate School of Medicine — created a mesh that incorporates vitamin B12, a substance vital to the normal functioning of nervous systems, which is very soft and degrades in the body. When the mesh was applied to injured sciatic nerves in rats, it promoted nerve regeneration and recovery of their motor and sensory functions. The team is currently considering clinical application of the mesh to treat peripheral nerve disorders such as carpal tunnel syndrome (CTS). Artificial nerve conduits have been developed in the past to treat peripheral nerve injuries, but they merely form a cross-link to the injury site and do not promote faster nerve regeneration. Moreover, their application is limited to relatively few patients suffering from a complete loss of nerve continuity. Vitamin B12 has been known to facilitate nerve regeneration, but oral administration of it has not proven to be very effective, and no devices capable of delivering vitamin B12 directly to affected sites had been available. Therefore, it had been hoped to develop such medical devices to actively promote nerve regeneration in the many patients who suffer from nerve injuries but have not lost nerve continuity. The NIMS-Osaka University joint research team recently developed a special mesh that can be wrapped around an injured nerve which releases vitamin B12 (methylcobalamin) until the injury heals. By developing very fine mesh fibers (several hundred nanometers in diameter) and reducing the crystallinity of the fibers, the team successfully created a very soft mesh that can be wrapped around a nerve. This mesh is made of a biodegradable plastic which, when implanted in animals, is eventually eliminated from the body. In fact, experiments demonstrated that application of the mesh directly to injured sciatic nerves in rats resulted in regeneration of axons and recovery of motor and sensory functions within six weeks. The team is currently negotiating with a pharmaceutical company and other organizations to jointly study clinical application of the mesh as a medical device to treat peripheral nerve disorders, such as CTS. This study was supported by the JSPS KAKENHI program (Grant Number JP15K10405) and AMED’s Project for Japan Translational and Clinical Research Core Centers (also known as Translational Research Network Program). This research was published online in the April 2017 issue of Acta Biomaterialia.

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