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News Article | April 26, 2017
Site: www.marketwired.com

CALGARY, ALBERTA--(Marketwired - April 26, 2017) - Loon Energy Corporation (NEX:LNE.H) ("Loon" or the "Company") announces its intention to issue 3,989,243 common shares at the deemed price of $0.05 per common share required by Exchange regulations to settle outstanding debt of CDN$199,477.15. No warrants or other convertible securities are to be issued in association with this settlement. The Company currently has 19,949,136 common shares issued and outstanding and will have 23,938,379 issued and outstanding after the issuance. All of the shares are being issued to insiders of the Company.


News Article | November 28, 2016
Site: www.businesswire.com

NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, today provides an update on the global development of its lead product, NBTXR3, across all indications. NBTXR3 is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. NBTXR3 has the potential to improve radiotherapy efficacy by destroying locally advanced tumors more efficiently. It has been engineered to increase the local absorption of the radiotherapy dose and thereby increasing the efficacy of radiotherapy with the benefit of not increasing toxicity or causing damage to surrounding healthy tissues. Elsa BORGHI, CMO of Nanobiotix said: “We made significant progress this year with the global clinical development of NBTXR3 across seven clinical trials and we are looking forward to potentially obtain a CE mark in 2017. Our filing was based on the scale and significance of the results already seen. The clinical and regulatory progress sets the stage for 2017, as we are getting closer to establishing NBTXR3 in combination with radiotherapy as a new treatment modality for patients suffering from solid cancers.” The Company currently has seven ongoing clinical trials across the world. Overall 15 countries with 54 clinical centers and more than 300 physicians are involved in Nanobiotix’s clinical trials. NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The company filed for certification of NBTXR3 in August 2016 based on the current level of clinical and scientific evidence. LNE/G-MED, the French notified body, has given guidance that the review of results for a potential CE mark is expected in 2017. In November, the Company presented preclinical data at the annual meeting of the Society for Immunotherapy of Cancer (SITC), demonstrating that NBTXR3 actively stimulates the host immune system to attack tumor cells. Study results suggested NBTXR3’s potential to transform the tumor into an in situ vaccine. On top of the Company’s core development activities, these findings could open new potential collaborations for NBTXR3 through combinations with other immuno-oncology drugs. Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company’s first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration. NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company has filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3. Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarter is based in Paris, France. Affiliate in Cambridge, United States. This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-0732 on July 22, 2016 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country.


News Article | February 15, 2017
Site: www.prweb.com

ZPower, the world’s only developer of rechargeable, silver-zinc microbatteries, and the manufacturer of the ZPower Rechargeable System for Hearing Aids, has met the Medical Device Quality System standard, which recognizes ZPower as a competent supplier of medical devices. Specifically, the notified body LNE GMED awarded ZPower the following new certifications: ISO 13485:2016, ISO 13485:2003 CMDCAS and the CE Mark for the ZPower Rechargeable System for Hearing Aids. These new certifications recognize ZPower as a medical device manufacturer and are a significant milestone in the global homologation of its Rechargeable System for Hearing Aids, which will enable distribution outside of the United States. “The level of quality in which we operate is in alignment with the expectations of the medical device industry,” said Damon Mikoy, VP of Quality and Regulatory Affairs, "and with LNE GMED’s certification as evidence of compliance to these standards, we look forward to supplying our innovative and safe silver-zinc battery technology to the medical device marketplace.” As medical device manufacturers strive to meet manufacturing, shipping and environmental regulations pertaining to the type of batteries utilized in tomorrow’s products, ZPower is uniquely positioned to offer an energy solution that meets all necessary requirements as well as design solutions. About ZPower, LLC: ZPower is a leader in the development of rechargeable, silver-zinc batteries for miniature battery applications whose headquarters and manufacturing facility is in Camarillo, Calif. The company provides a total solution for hearing instrument manufacturers which includes advanced silver-zinc battery technology and charger design support. The ZPower solution simplifies new product development and speeds time-to-market. For end users, ZPower batteries deliver unmatched performance, improved user experience and are better for the environment. ZPower is ISO13485:2016 and ISOISO 9001:2008 certified and its facility and devices registered with the FDA. For more information, visit http://www.zpowerbattery.com.


News Article | February 15, 2017
Site: www.marketwired.com

ATLANTA, GA--(Marketwired - Feb 15, 2017) - Medovex Corp. ( : MDVX), a developer of medical technology products, today announced that the Company successfully completed its final CE Mark audit meeting. The review of the Company's DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval. Patrick Kullmann, Medovex President and COO, stated, "We're very pleased to have completed our certification audit of the DenerveX System February 7-9, 2017 at the Company's Atlanta based offices. Our in-house development team, along with several representatives from our world-class suppliers and consultants, contributed extensively during this process due to their vast expertise in R&D, manufacturing, electro-surgery, regulatory, quality, and sterilization processes." Kullmann further stated, "Upon successfully completing this audit, the CE certificate would generally be expected to be issued paving the way to the future launch of the DenerveX System in the EU and other countries which accept the CE Mark." Previously on January 3, 2017, the Company announced it had successfully received certification of compliance for its DenerveX System from SGS S.A. a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union. Prior to that on November 3, 2016, the Company announced that it held a successful cadaver lab during NASS 2016. Medical advisory board members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD from Manchester, England, as well as Gabriel Davila, MD from Colombia, Latin America, highlighted the DenerveX System. Thirty spine surgeons from Europe and Latin America attended the lab, both experiencing and using the device. Jarrett Gorlin, Medovex CEO, commented, "I'm very proud of our team and how they prepared for and handled this important event. Together, we have spent countless hours in anticipation of meeting with representatives of LNE/GMED. Although a date has not been provided for the anticipated receipt of the CE certificate or the launch of the product, we believe we remain well on our way to completing the final regulatory step in the process of achieving CE Marking." The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options, and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available. About Medovex Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company's first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com Safe Harbor Statement Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the Securities and Exchange Commission (the "SEC"), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.


ATLANTA, GA--(Marketwired - Feb 27, 2017) -  Medovex Corp. ( : MDVX), a developer of medical technology products, today announced that on Friday, February 24, 2017, the Company filed a Form 8K with the Securities and Exchange Commission affirmatively stating its current compliance with NASDAQ's stockholder equity requirement. From the 8K, "The Company affirmatively states that as of the date of this Current Report on Form 8-K, that it has stockholders' equity in excess of $2,500,000 based on the culmination of the aforementioned transactions." On February 21, 2017, the Company provided the following corporate update. On February 15th, 2017, the Company announced that it had successfully completed its final CE Mark audit meeting. The review of the Company's DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval. On February 9, 2017, Medovex Corporation announced it had entered into a unit purchase agreement with selected accredited investors. Pursuant to the terms of the agreement, the Company sold an aggregate of 2,905,770 shares and 1,452,885 warrants for gross proceeds of $3,022,000. Each warrant has an initial exercise price of $1.50 per share, subject to adjustment, and is initially exercisable for a period of five years from the date of issuance. Certain officers and directors of Medovex participated in the financing. In conjunction with the closing of the transaction, the Company's previously issued $1,150,000 of senior secured promissory notes has been converted to 165,864 shares of Common Stock and 9399 shares of Series A Preferred Stock and warrants on the same terms as the other investors. Each share of Series A Preferred Stock is convertible into 100 shares of common stock and effectively has the same price of $1.04 per share of Common Stock. In addition to the recent financing transaction, in a transaction filed with the SEC on a Form 8k on December 6, 2016, insiders Jesse Crowne, Steve Gorlin and a third party, completed the purchase of 571,429 shares of the Company's common stock at above then market pricing of $1.75 per share, such that the Company received an aggregate of $1,000,000. On January 3, 2017, the Company announced it had successfully received certification of compliance for its DenerveX System from SGS S.A., a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union. Prior to that on November 3, 2016, the Company announced that it held a successful cadaver lab during NASS 2016. Medical advisory board members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD from Manchester, England, as well as Gabriel Davila, MD from Colombia, Latin America, highlighted the DenerveX System. Thirty spine surgeons from Europe and Latin America attended the lab, both experiencing and using the device. The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available. About Medovex Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company's first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com Safe Harbor Statement Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the Securities and Exchange Commission (the "SEC"), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.


News Article | February 21, 2017
Site: www.marketwired.com

Recent Completion of Final CE Mark Audit and Financing with Insider Participation Positions Company for 2017 ATLANTA, GA--(Marketwired - Feb 21, 2017) - Medovex Corp. ( : MDVX), a developer of medical technology products, today provided the following corporate update. On February 15th, 2017, the Company announced that it had successfully completed its final CE Mark audit meeting. The review of the Company's DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval. Patrick Kullmann, Medovex President and COO, stated, "Upon successfully completing this audit, the CE certificate would generally be expected to be issued paving the way to the future launch of the DenerveX System in the EU and other countries which accept the CE Mark." On February 9, 2017, Medovex Corporation announced it had entered into a unit purchase agreement with selected accredited investors. Pursuant to the terms of the agreement, the Company sold an aggregate of 2,905,770 shares and 1,452,885 warrants for gross proceeds of $3,022,000. Each warrant has an initial exercise price of $1.50 per share, subject to adjustment, and is initially exercisable for a period of five years from the date of issuance. Certain officers and directors of Medovex participated in the financing. In conjunction with the closing of the transaction, the Company's previously issued $1,150,000 of senior secured promissory notes has been converted to 165,864 shares of Common Stock and 9399 shares of Series A Preferred Stock and warrants on the same terms as the other investors. Each share of Series A Preferred Stock is convertible into 100 shares of common stock and effectively has the same price of $1.04 per share of Common Stock. In addition to the recent financing transaction, in a transaction filed with the SEC on a Form 8k on December 6, 2016, insiders Jesse Crowne, Steve Gorlin and a third party, completed the purchase of 571,429 shares of the Company's common stock at above then market pricing of $1.75 per share, such that the Company received an aggregate of $1,000,000. On January 3, 2017, the Company announced it had successfully received certification of compliance for its DenerveX System from SGS S.A. a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union. Prior to that on November 3, 2016, the Company announced that it held a successful cadaver lab during NASS 2016. Medical advisory board members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD from Manchester, England, as well as Gabriel Davila, MD from Colombia, Latin America, highlighted the DenerveX System. Thirty spine surgeons from Europe and Latin America attended the lab, both experiencing and using the device. Jarrett Gorlin, Medovex CEO, commented, "Design, development and commercialization of our flagship patented DenerveX System has been years in the making. It was designed by surgeons for surgeons to be less invasive with faster recovery time than current surgical treatment options, and is designed to provide for a longer lasting treatment solution while offering potential savings to the health care system. We are pleased with the recent completion of the final CE Mark audit meeting conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm." Gorlin concluded, "My personal commitment is no better evidenced than by my recent insider purchases as filed in recent Form 4 filings made with the SEC. In addition, both our Co-founder and VP of Business Development have too made recent insider purchases. I believe it important that we lead by example putting our own money where our mouth is. Recent filings memorializing our own actions affirm our collective commitment and belief in both our team and the opportunity." The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available. Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company's first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the Securities and Exchange Commission (the "SEC"), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.


News Article | November 29, 2016
Site: www.newsmaker.com.au

Paris, France and Cambridge, Massachusetts, USA, Nov 29, 2016 - (ACN Newswire) - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, today provides an update on the global development of its lead product, NBTXR3, across all indications. NBTXR3 is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. NBTXR3 has the potential to improve radiotherapy efficacy by destroying locally advanced tumors more efficiently. It has been engineered to increase the local absorption of the radiotherapy dose and thereby increasing the efficacy of radiotherapy with the benefit of not increasing toxicity or causing damage to surrounding healthy tissues. Elsa BORGHI, CMO of Nanobiotix said: "We made significant progress this year with the global clinical development of NBTXR3 across seven clinical trials and we are looking forward to potentially obtain a CE mark in 2017. Our filing was based on the scale and significance of the results already seen. The clinical and regulatory progress sets the stage for 2017, as we are getting closer to establishing NBTXR3 in combination with radiotherapy as a new treatment modality for patients suffering from solid cancers." Global development of NBTXR3 The Company currently has seven ongoing clinical trials across the world. Overall 15 countries with 54 clinical centers and more than 300 physicians are involved in Nanobiotix's clinical trials. Image 1: https://www.acnnewswire.com/topimg/Low_nanobiotix1611291.jpg Clinical development of NBTXR3 by indication NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix's Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region.  Highlights of clinical news: - 115 patients have been randomized and 153 have signed the informed consent in the STS pivotal clinical trial. The target of 104 patients needed for the interim readout has been reached. A total of 156 STS evaluable patients is expected in the "act.in.sarc" Phase II/III trial (www.actinsarc.com). - The Company expects to release the conclusion of the interim analysis conducted by an independent committee of experts in the coming months. This analysis will be performed four months after the 104th patient has been randomized (time to complete treatment plus readout). - PharmaEngine has started a new clinical trial in Asia in October 2016 for head and neck patient's population receiving chemotherapy in combination with radiotherapy. - A Phase I/II prostate cancer trial has been initiated in the US and now recruiting at Ronald Reagan UCLA Medical Center, Los Angeles and Thomas Jefferson University Hospital, Philadelphia. Dana Farber Cancer Institute, Boston should be joining the trial soon. Status of ongoing clinical trials Image 2: https://www.acnnewswire.com/topimg/Low_nanobiotix1611292.jpg NBTXR3 first market authorization filing The company filed for certification of NBTXR3 in August 2016 based on the current level of clinical and scientific evidence. LNE/G-MED, the French notified body, has given guidance that the review of results for a potential CE mark is expected in 2017. Expansion into immuno-oncology In November, the Company presented preclinical data at the annual meeting of the Society for Immunotherapy of Cancer (SITC), demonstrating that NBTXR3 actively stimulates the host immune system to attack tumor cells. Study results suggested NBTXR3's potential to transform the tumor into an in situ vaccine. On top of the Company's core development activities, these findings could open new potential collaborations for NBTXR3 through combinations with other immuno-oncology drugs. Latest publications - Clinical Cancer Research - on NBTXR3 in Soft Tissue Sarcoma Phase I/II Trial: "First human study testing a new concept of radio enhancement using nanoparticles (NBTXR3) activated by radiation therapy in patients with locally advanced soft tissue sarcomas (STS)", published 6 October 2016. Sylvie Bonvalot, Cecile Le Pechoux, Thierry Debaere, Guy Kantor, Xavier Buy, Eberhard Stoeckle, Paul Sargos, Philippe Terrier, Jean-michel Coindre, Nathalie Lassau, Rafik AIT SARKOUH, Mikaela Dimitriu, Elsa Borghi, Laurent Levy, Eric Deutsch and Jean Charles Soria. 10.1158/1078-0432.CCR-16-1297 - Poster presented at SITC conference "Hafnium oxide nanoparticles, a radiation enhancer for in situ cancer vaccine", authored by Paris S., Pottier A., Levy L., and Lu B. About NANOBIOTIX: www.nanobiotix.com Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company's first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration. NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix's Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company has filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3. Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarter is based in Paris, France. Affiliate in Cambridge, United States. Contact Nanobiotix Sarah Gaubert Head of Communication and Public Affairs +33 (0)1 40 26 07 55 [email protected] Media relations France - Springbok Consultants Marina Rosoff +33 (0)6 71 58 00 34 [email protected] EU Outside France - Instinctif Partners Melanie Toyne Sewell +44 (0) 207 457 2020 [email protected] United States - The Ruth Group Kirsten Thomas / Chris Hippolyte +1 508-280-6592 / +1 646-536-7023 [email protected] Disclaimer This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorite des Marches Financiers) under number D.16-0732 on July 22, 2016 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. ### This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: NANOBIOTIX via Globenewswire


News Article | November 28, 2016
Site: globenewswire.com

Seven clinical trials across the world More than 2/3 of STS patients recruited in the "act.in.sarc" Phase II/III trial Phase I/II prostate cancer trial now recruiting in the U.S. Paris, France and Cambridge, Massachusetts, USA, November 28, 2016 - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, today provides an update on the global development of its lead product, NBTXR3, across all indications. NBTXR3 is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. NBTXR3 has the potential to improve radiotherapy efficacy by destroying locally advanced tumors more efficiently. It has been engineered to increase the local absorption of the radiotherapy dose and thereby increasing the efficacy of radiotherapy with the benefit of not increasing toxicity or causing damage to surrounding healthy tissues. Elsa BORGHI, CMO of Nanobiotix said: "We made significant progress this year with the global clinical development of NBTXR3 across seven clinical trials and we are looking forward to potentially obtain a CE mark in 2017. Our filing was based on the scale and significance of the results already seen. The clinical and regulatory progress sets the stage for 2017, as we are getting closer to establishing NBTXR3 in combination with radiotherapy as a new treatment modality for patients suffering from solid cancers." Global development of NBTXR3 The Company currently has seven ongoing clinical trials across the world. Overall 15 countries with 54 clinical centers and more than 300 physicians are involved in Nanobiotix's clinical trials. Clinical development of NBTXR3 by indication NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix's Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region.   NBTXR3 first market authorization filing The company filed for certification of NBTXR3 in August 2016 based on the current level of clinical and scientific evidence. LNE/G-MED, the French notified body, has given guidance that the review of results for a potential CE mark is expected in 2017. Expansion into immuno-oncology In November, the Company presented preclinical data at the annual meeting of the Society for Immunotherapy of Cancer (SITC), demonstrating that NBTXR3 actively stimulates the host immune system to attack tumor cells. Study results suggested NBTXR3's potential to transform the tumor into an in situ vaccine. On top of the Company's core development activities, these findings could open new potential collaborations for NBTXR3 through combinations with other immuno-oncology drugs. Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company's first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration. NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix's Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company has filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3. Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarter is based in Paris, France. Affiliate in Cambridge, United States. Disclaimer This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-0732 on July 22, 2016 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country.


Home > Press > Nanobiotix Provides Update on Global Development of Lead Product NBTXR3: Seven clinical trials across the world: More than 2/3 of STS patients recruited in the “act.in.sarc” Phase II/III trial: Phase I/II prostate cancer trial now recruiting in the U.S. Abstract: NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, today provides an update on the global development of its lead product, NBTXR3, across all indications. NBTXR3 is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. NBTXR3 has the potential to improve radiotherapy efficacy by destroying locally advanced tumors more efficiently. It has been engineered to increase the local absorption of the radiotherapy dose and thereby increasing the efficacy of radiotherapy with the benefit of not increasing toxicity or causing damage to surrounding healthy tissues. Elsa BORGHI, CMO of Nanobiotix said: “We made significant progress this year with the global clinical development of NBTXR3 across seven clinical trials and we are looking forward to potentially obtain a CE mark in 2017. Our filing was based on the scale and significance of the results already seen. The clinical and regulatory progress sets the stage for 2017, as we are getting closer to establishing NBTXR3 in combination with radiotherapy as a new treatment modality for patients suffering from solid cancers.” Global development of NBTXR3 The Company currently has seven ongoing clinical trials across the world. Overall 15 countries with 54 clinical centers and more than 300 physicians are involved in Nanobiotix’s clinical trials. Clinical development of NBTXR3 by indication NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. Highlights of clinical news: 115 patients have been randomized and 153 have signed the informed consent in the STS pivotal clinical trial. The target of 104 patients needed for the interim readout has been reached. A total of 156 STS evaluable patients is expected in the “act.in.sarc” Phase II/III trial (www.actinsarc.com). The Company expects to release the conclusion of the interim analysis conducted by an independent committee of experts in the coming months. This analysis will be performed four months after the 104th patient has been randomized (time to complete treatment plus readout). PharmaEngine has started a new clinical trial in Asia in October 2016 for head and neck patient’s population receiving chemotherapy in combination with radiotherapy. A Phase I/II prostate cancer trial has been initiated in the US and now recruiting at Ronald Reagan UCLA Medical Center, Los Angeles and Thomas Jefferson University Hospital, Philadelphia. Dana Farber Cancer Institute, Boston should be joining the trial soon. Status of ongoing clinical trials NBTXR3 first market authorization filing The Company filed for certification of NBTXR3 in August 2016 based on the current level of clinical and scientific evidence. LNE/G-MED, the French notified body, has given guidance that the review of results for a potential CE mark is expected in 2017. Expansion into immuno-oncology In November, the Company presented preclinical data at the annual meeting of the Society for Immunotherapy of Cancer (SITC), demonstrating that NBTXR3 actively stimulates the host immune system to attack tumor cells. Study results suggested NBTXR3’s potential to transform the tumor into an in situ vaccine. On top of the Company’s core development activities, these findings could open new potential collaborations for NBTXR3 through combinations with other immuno-oncology drugs. Latest publications Clinical Cancer Research – on NBTXR3 in Soft Tissue Sarcoma Phase I/II Trial: “First human study testing a new concept of radio enhancement using nanoparticles (NBTXR3) activated by radiation therapy in patients with locally advanced soft tissue sarcomas (STS)”, published 6 October 2016. Sylvie Bonvalot, Cécile Le Pechoux, Thierry Debaere, Guy Kantor, Xavier Buy, Eberhard Stoeckle, Paul Sargos, Philippe Terrier, Jean-michel Coindre, Nathalie Lassau, Rafik AIT SARKOUH, Mikaela Dimitriu, Elsa Borghi, Laurent Levy, Eric Deutsch and Jean Charles Soria. 10.1158/1078-0432.CCR-16-1297 Poster presented at SITC conference “Hafnium oxide nanoparticles, a radiation enhancer for in situ cancer vaccine”, authored by Paris S., Pottier A., Levy L., and Lu B. About Nanobiotix Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company’s first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration. NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company has filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3. Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarter is based in Paris, France. Affiliate in Cambridge, United States. This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-0732 on July 22, 2016 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. For more information, please click Contacts: Nanobiotix Sarah Gaubert Head of Communication and Public Affairs +33 (0)1 40 26 07 55 Media Relations - France Springbok Consultants Marina Rosoff +33 (0)6 71 58 00 34 Media Relations - EU Outside France Instinctif Partners Melanie Toyne Sewell +44 (0) 207 457 2020 Media Relations - United States The Ruth Group Kirsten Thomas / Chris Hippolyte +1 508-280-6592 / +1 646-536-7023 If you have a comment, please us. Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.


News Article | December 13, 2016
Site: www.marketwired.com

The innovative ultrasound company demonstrates to customers and investors its commitment to responsible environmental management AIX-EN-PROVENCE, FRANCE--(Marketwired - Dec 13, 2016) - SuperSonic Imagine ( : SSI) (FR0010526814), a company specializing in innovative ultrasound medical imaging, today announced that it has been certified ISO 14001 compliant by LNE certification body. This accredited third-party certification confirms that SSI has voluntarily implemented an environmental management system that benefits its customers and investors. Demonstrating a strong commitment to minimize environmental impact, SuperSonic Imagine has established a mission to design and manage our products in an eco-friendly manner, and its employees are committed to achieving this goal. "This is an important step forward for SuperSonic Imagine, where we have worked diligently to develop an environmental management system that reflects and supports the quality of our products. Our processes are now compliant with the most recent environmental management standard and all its obligations for the design, development, production, distribution, installation and servicing of diagnostic ultrasound systems," explains Laurence Hermitte, Quality & Regulatory Director at SuperSonic Imagine. "As SuperSonic Imagine continues to develop innovative technologies and grows its market leadership in ultrasound technology, our customers can be confident that we do so while adhering to ISO 14001 and all industry standards to measure and manage our environmental impact." According to the International Organization for Standardization (ISO), based in Geneva, Switzerland, "ISO 14001 is an internationally agreed standard that sets out the requirements for an environmental management system. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders." Certified entities must demonstrate continuous improvement in their systems and their approach to environmental impacts, a commitment SSI is pleased to accept. About SuperSonic Imagine Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is a company specializing in medical imaging. The company designs, develops and markets a revolutionary ultrasound system, Aixplorer®, with an UltraFast™ platform that can acquire images 200 times faster than conventional ultrasound systems. In addition to providing exceptional image quality, this unique technology is the foundation of several innovations which have changed the paradigm of ultrasound imaging: ShearWave™ Elastography (SWE™), UltraFast™ Doppler and more recently Angio PL.U.S - Planewave UltraSensitive™ Imaging. ShearWave Elastography allows physicians to visualize and analyze the stiffness of tissue in a real-time, reliable, reproducible and non-invasive manner. This criteria has become an important parameter in diagnosing potentially malignant tissue or other diseased tissue. As of today, over 300 peer-reviewed publications have demonstrated the value of SWE for the clinical management of patients with a wide range of diseases. UltraFast Doppler combines Color Flow Imaging and Pulsed Wave Doppler into one simple exam, providing physicians with exam results simultaneously and helping to increase patient throughput. The latest innovation, Angio PL.U.S, provides a new level of microvascular imaging through significantly improved color sensitivity and spatial resolution while maintaining exceptional 2D imaging. SuperSonic Imagine has been granted regulatory clearances for the commercialization of Aixplorer in key global markets. SuperSonic Imagine is a listed company since April 2014 on the Euronext, symbol SSI. For more information about SuperSonic Imagine, please go to www.supersonicimagine.com.

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