COLUMBIA, Md., Sept. 16, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) (the “Company”) provided today an update concerning the status of its compliance with the Listing Rules of the NASDAQ Stock Market (“NASDAQ”).
As previously disclosed, the Company is working diligently to complete its previously announced restatements of prior period financial statements and transition to a new independent registered public accounting firm for the 2015 audit so that it is in a position to bring its SEC filings up to date.
The Audit Committee of the Board of Directors has completed an independent review of the accounting matters with the assistance of outside professionals. The Company, under the direction of the Audit Committee, is working diligently with its former independent registered accounting firm to complete the restatement of its 2014 audited and interim financial statements as soon as possible. Once that process is complete, the Company expects to transition to a new independent registered accounting firm and begin work on the 2015 financial statements.
As a result of these matters, the Company has delayed the filing of its Annual Report on Form 10-K for the year ended December 31, 2015 (“2015 Form 10-K”), its Quarterly Report on Form 10-Q for the quarter endedMarch 31, 2016 (“Q1 2016 Form 10-Q”), and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (“Q2 2016 Form 10-Q”). As a result, the Company is currently out of compliance with NASDAQ Stock Market Listing Rule 5250(c)(1).
As previously disclosed, the Company submitted to the NASDAQ listing qualifications staff (the “Staff”) a plan to regain compliance with NASDAQ’s continued listing requirements. On May 24, 2016, NASDAQ granted an exemption to the NASDAQ Listing Rule, extending the deadline until September 12, 2016 for the Company to file all delinquent reports with the SEC, including the 2015 Form 10-K, Q1 2016 Form 10-Q, and Q2 2016 Form 10-Q. Although the Company is working diligently to finalize these reports, the Company was unable to bring its SEC filings up to date by the September 12, 2016 deadline.
Consequently, on September 14, 2016, the Company received an anticipated letter from NASDAQ, stating that unless the Company requests a hearing before a NASDAQ Listing Qualifications Panel (a “Hearings Panel”) bySeptember 21, 2016, the Company’s common stock will be delisted. Under NASDAQ’s rules and procedures, in general, a company’s request for such a hearing automatically stays any delisting for 15 calendar days from the deadline to request a hearing. The Company will file a hearing request on or prior to September 21, 2016 and request a further stay. The letter states that the hearing would be expected to occur 30-45 days from the date of the hearing request.
If the Hearings Panel grants the Company’s request for a further stay (which is discretionary on the part of the Hearings Panel and therefore not assured), any final delisting will be stayed until further Hearings Panelproceedings. The NASDAQ Rules also permit the Company to appeal decisions from the Hearings Department to the NASDAQ Listing Council.
While the Company is continuing to work diligently to complete its previously announced restatements of prior period financial statements and bring its SEC filings up to date, there can be no assurance regarding the timing or ultimate outcome of this process or the ability of the Company to successfully maintain its NASDAQ listing.
The Company is making this announcement in compliance with NASDAQ Listing Rule 5810(b), which requires prompt disclosure of receipt of a noncompliance letter.
About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO4®, Cartiform®, Grafix®, TruSkin ™ and Stravix™.
Osiris, Grafix, and Cartiform are registered trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc. BIO4® is a trademark of Howmedica Osteonics Corp. More information can be found on the company’s website, www.Osiris.com. (OSIR-G).
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: the outcome of the NASDAQ listing qualification deficiency process, including the ability of the Company to successfully maintain its NASDAQ listing; the outcome of the restatements, including the materiality, significance, nature, subject matter, timing or quantitative effects of the Company’s restated financial statements; the timing of the transition to a new independent registered public accounting firm; the completion of the audit of the Company’s 2015 financial statements; and the timing of the filing of the Company’s 2015 Form 10-K, Q1 2016 Form 10-Q and Q2 2016 Form 10-Q. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the SEC. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.
SAN ANTONIO–(BUSINESS WIRE)–Acelity L.P. Inc. (“Acelity”), a global advanced wound care and regenerative medicine company, today announced the results, as of 5:00 p.m., New York City time, on September 19, 2016 (the “Early Tender and Consent Date”), of (A) the private offer to Eligible Holders (as defined below) (the “Exchange Offer”) by its wholly-owned subsidiaries, Kinetic Concepts, Inc. (“KCI”) and KCI USA, Inc. (together with KCI, the “Issuers”), to exchange a portion of their 12.5% Senior Notes due 2019 (the “Existing Unsecured Notes”) for up to $450.0 million aggregate principal amount of their new 12.5% Limited Third Lien Senior Secured Notes due 2021 (the “New Notes”) and (B) the solicitation (the “Consent Solicitation”) of consents (the “Consents”), for no consideration, from holders of Existing Unsecured Notes to certain proposed amendments (the “Proposed Amendments”) to the indenture governing the Existing Unsecured Notes (the “Existing Unsecured Notes Indenture”).
The Issuers were advised by the exchange agent for the Exchange Offer that, as of the Early Tender and Consent Date, a total of $445,061,000 aggregate principal amount of outstanding Existing Unsecured Notes, representing approximately 72.72% of the outstanding Existing Unsecured Notes, were validly tendered (and not validly withdrawn) in the Exchange Offer. These holders also delivered their Consents to the Proposed Amendments with respect to the Existing Unsecured Notes tendered.
The Issuers will accept for exchange such amount of Existing Unsecured Notes properly tendered and not validly withdrawn in the Exchange Offer, such that the aggregate principal amount of New Notes issued in the Exchange Offer does not exceed $450.0 million. If the Exchange Offer is oversubscribed as of the Expiration Date, upon the terms and subject to the conditions of the Exchange Offer, the Existing Unsecured Notes will be accepted for exchange on a pro rata basis. As of June 30, 2016, there was $612.0 million aggregate principal amount of the Existing Unsecured Notes outstanding.
In addition, as of the Early Tender and Consent Date, the Issuers have received Consents from holders of at least a majority of the outstanding principal amount of Existing Unsecured Notes required to adopt the Proposed Amendments. Therefore, the Issuers, the guarantors party thereto and the trustee for the Existing Unsecured Notes will enter into a supplemental indenture (the “Supplemental Indenture”) to the Existing Unsecured Notes Indenture giving effect to the Proposed Amendments on the date hereof or as soon as possible thereafter. The Supplemental Indenture will be effective and binding upon its execution. The Consent Solicitation and the effectiveness of the Supplemental Indenture are not conditioned on the consummation of the Exchange Offer, and the Proposed Amendments will become operative upon the execution and delivery of the Supplemental Indenture.
The Exchange Offer will expire at midnight, New York City time, on October 3, 2016 unless extended by the Issuers (such time and date as may be later extended, the “Expiration Date”).
Holders of Existing Unsecured Notes whose Existing Unsecured Notes were properly tendered (and not validly withdrawn) at or prior to the Early Tender and Consent Date will receive, in respect of each $1,000 principal amount of Existing Unsecured Notes accepted for exchange, the “Total Exchange Consideration” of $1,000 principal amount of New Notes, which includes the “Early Participation Premium” of $50 principal amount of New Notes. Holders of Existing Unsecured Notes whose Existing Unsecured Notes are properly tendered (and not validly withdrawn) after the Early Tender and Consent Date but at or prior to the Expiration Date will receive, in respect of each $1,000 principal amount of Existing Unsecured Notes accepted for exchange, the “Exchange Consideration” of $950 principal amount of New Notes, which does not include the Early Participation Premium. In addition, holders whose Existing Unsecured Notes are exchanged in the Exchange Offer will receive accrued and unpaid interest in cash in respect of their exchanged Existing Unsecured Notes from the last applicable interest payment date to, but not including, the settlement date for the Exchange Offer.
The Exchange Offer is subject to certain conditions set forth in the Confidential Offering Memorandum and Consent Solicitation Statement (the “Offering Memorandum”) and the related letter of transmittal and consent (the “Letter of Transmittal”), including a $100.0 million equity contribution by Acelity’s sponsors and the consummation of a proposed offering by the Issuers of new second lien senior secured notes. The Issuers reserve the right, subject to applicable law, to terminate, withdraw or amend the Exchange Offer at any time and from time to time as described in the Offering Memorandum.
The Exchange Offer is being made, and the New Notes are being offered and issued, in a private transaction in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), only to (i) “qualified institutional buyers” in accordance with Rule 144A under the Securities Act and to (ii) non-U.S. persons outside the United States in accordance with Regulation S under the Securities Act (collectively, the “Eligible Holders”).
The complete terms and conditions of the Exchange Offer and the Consent Solicitation, as well as the terms of the New Notes, are set forth in the Offering Memorandum and the Letter of Transmittal. The Offering Memorandum and the Letter of Transmittal will only be made available to holders who confirm their status as Eligible Holders. Eligible Holders may obtain copies by contacting D.F. King & Co., Inc., the information and exchange agent in connection with the Exchange Offer and Consent Solicitation, at 800.207.3159 (toll-free) or 212.269.5550 (banks and brokers) or by visiting www.dfking.com/kinetic to complete the eligibility process.
This press release is for informational purposes only. This press release is neither an offer to sell nor a solicitation of an offer to buy any New Notes and is neither an offer to purchase nor a solicitation of an offer to sell any Existing Unsecured Notes. This press release is neither an offer to sell nor a solicitation of an offer to buy any second lien senior secured notes or other securities that may be offered in the other transactions. The Exchange Offer and the Consent Solicitation are made only by, and pursuant to, the terms set forth in the Offering Memorandum and the Letter of Transmittal. The Exchange Offer and the Consent Solicitation are not being made to persons in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction.
Forward-Looking Statements
Certain statements included in this press release may be considered “forward-looking statements”, which are based on information available to Acelity on the date of this release. Words such as “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek,” “foreseeable,” the negative versions of these words and/or similar terms and phrases are used to identify these forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties. Acelity cannot assure you that future developments affecting Acelity will be those that have been anticipated. Actual results may differ materially from these expectations due to changes in global, regional or local economic, business, competitive, market regulatory and other factors, many of which are beyond Acelity’s control, as well as other risks described from time to time under “Risk Factors” in Acelity’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q (available at www.sec.gov). Any forward-looking statement speaks only as of the date of this press release. Factors or events that could cause Acelity’s actual results to differ may emerge from time to time, and it is not possible to predict all of them. Acelity may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the forward-looking statements. Acelity’s forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions Acelity may make. Acelity undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
The world advanced wound care market was valued at $7,117 million in 2015 and is expected to reach $12,454 million, growing at a CAGR of 8.3% during 2016-2022.
KEY BENEFITS FOR STAKEHOLDERS:
The report provides an in-depth analysis of the advanced wound care market across major geographies and total revenue generated during the forecast period.
Quantitative analysis of the current trends and future estimations from 2015 to 2022 is presented, which assists the manufacturers to analyze the market.
The projections in the report are made by analyzing the current market trends and highlighting the market potential, in terms of value.
Extensive analysis is conducted by closely following key product positioning and monitoring the top contenders within the market framework.
The report also provides quantitative as well as qualitative market trends to facilitate the stakeholders in understanding the situations prevailing in the market.
SWOT analysis studies the internal environment of the leading companies for strategy formulation.
Companies Mentioned:
3M Company
Smith & Nephew plc
Coloplast A/S
Medtronic plc
Acelity L.P. Inc.
ConvaTec Healthcare B S.à.r.l.
Mölnlycke Health Care AB (a subsidiary of INVESTOR AB)
BSN Medical GmbH
Alliqua BioMedical, Inc.
Integra LifeSciences Holdings Corporation
Report Structure:
CHAPTER 1 INTRODUCTION
CHAPTER 2 EXECUTIVE SUMMARY
CHAPTER 3 MARKET OVERVIEW
CHAPTER 4 ADVANCED WOUND CARE (AWC) MARKET, BY PRODUCT, 2014-2022
CHAPTER 5 ADVANCED WOUND CARE (AWC) MARKET, BY APPLICATION, 2014-2022
CHAPTER 6 ADVANCED WOUND CARE (AWC) MARKET, BY END USER, 2014-2022
CHAPTER 7 ADVANCED WOUND CARE MARKET, BY GEOGRAPHY, 2014-2022
Research and Markets
Laura Wood, Senior Manager press@researchandmarkets.com
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LEUVEN, Belgium, Sept. 20, 2016 (GLOBE NEWSWIRE) — TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today reported its business and financial highlights for the first half of 2016.
Below are the key business and financial highlights for the first half of 2016, ending June 30, 2016, as well as other post period events:
Cx601 continued to reach significant major value inflection points
Cx601 delivered positive follow-up results at 52 weeks, confirming its sustained efficacy and safety profile. Cx601’s positive Phase III 24-week results were presented at the European Crohn’s and Colitis Organization (ECCO), at the Digestive Disease Week (DDW) in the US and published in The Lancet
Significant progress was also made on the regulatory front. Based on the data from the pivotal Phase III trial in Europe, TiGenix submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA). Cx601’s marketing authorization is expected to be granted in the second half of 2017
Licensing agreement for the ex-US rights of Cx601 signed in July with Takeda for up to EUR 380 million in regulatory and sales milestones, of which EUR 25 million at signing, and double digit royalties on net sales. Takeda committed to a EUR 10 million equity investment within the 12 months following the signing
TiGenix retains 100% of the US rights, estimated to be 50% of the global market as well as the right to further develop Cx601 in new indications
Significant progress with the pipeline and strategic focus reconfirmed
Broadening of the shareholder base with European and US marquee investors
Cash position at June 30, 2016 of EUR 24.1 million, further strengthened in July by the upfront cash payment of EUR 25 million received from Takeda
“It has been an extremely positive first half of the year for us. We have made solid progress both on the operations and in the financial front,” said Eduardo Bravo, CEO of TiGenix. “With our recent licensing agreement with Takeda, with their solid track record and strong leadership position in gastroenterology, we have the best partner with the needed capabilities and resources to secure the commercial success of Cx601. We have also gained the financial strength to move forward with the clinical development of Cx601 in the US and continue to make progress with the rest of the assets in development such as AlloCSC-01 in Acute Myocardial Infarction and Cx611 for Severe Sepsis. TiGenix is in an excellent position with clear value-creation catalysts in the medium-to-short term.”
Business Highlights for the first half 2016 and post June 30, 2016
Cx601 continued to reach significant major value inflection points
In February TiGenix secured the license for the commercial production of cell therapy products, a relevant achievement to secure the needed commercial manufacturing capacity for the forthcoming launch of Cx601 as well as for the fulfillment of the final requirements to file a Marketing Authorization Application (MAA) for Cx601 with the European Medicines Agency (EMA).
In March TiGenix announced positive follow-up results at 52 weeks for Cx601, reporting sustained efficacy and safety profile. Top line follow-up data showed that in the ITT[1] population (n=212), Cx601 achieved statistical superiority (p=0.012) with 54% combined remission at week 52 compared to 37% in the placebo arm. The 52-week data also showed a higher rate of sustained closure in those patients treated with Cx601 and in combined remission at week 24 (75.0%) compared to patients in the placebo group (55.9%). In terms of safety, treatment-emergent adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and placebo groups.
In March TiGenix submitted a centralized European MAA for Cx601.The centralized procedure offers a substantial benefit for the marketing authorization holder as it allows to market the medicine and make it available to patients and healthcare professionals throughout the European Union on the basis of a single marketing authorization. Once granted, the centralized marketing authorization is valid in all European Union member states as well as in the European Economic Area (EEA) countries, as well as Iceland, Liechtenstein and Norway. TiGenix is currently preparing the responses to the Day 120 List of Questions received from the Committee of Human Medicinal Products (CHMP within EMA). We expect a marketing authorization by the European Commission could be forthcoming by the second half 2017.
The relevance of the 24-week results of Cx601 and its potential as a truly innovative treatment for complex perianal fistulas in Crohn’s disease patients was further confirmed by their selection for oral presentation at the two most important medical congresses in this field: in March in Europe at the ECCO, the main European congress for Crohn’s and Colitis specialists, with more than 6,000 delegates registered this year; in May in the US at the Digestive Disease Week, the largest congress with international attendees and organized in the US for the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Furthermore, in July, the 24-week results were published by The Lancet[2], one of the most highly regarded and well-known medical journals in the world. This publication will increase awareness of Cx601 results ahead of the initiation of the pivotal Phase III trial for registration of Cx601 in the US.
In July TiGenix entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the US. Under the terms of the licensing agreement, TiGenix received a cash payment of EUR 25 million after signing. In addition TiGenix is eligible to receive additional regulatory and sales milestone payments for up to a potential total of EUR 355 million plus double-digit royalties on net sales. The first anticipated milestone payment will be EUR 15 million upon obtaining the marketing authorization of Cx601 in Europe. Takeda has also committed to an equity investment of EUR 10 million within 12 months from signing the agreement. This agreement increases the probability of commercial success of Cx601 by drawing on the reimbursement and commercial expertise of one of the leaders in the field. Finally, this agreement provides TiGenix with the financial strength necessary to move forward with the development of Cx601 for registration in the US and advance with the other assets in its allogeneic stem cell platforms.
TiGenix retains 100% of the US rights, estimated to be 50% of Cx601 global market, as well as the right to further develop Cx601 in new indications. The US Food and Drug Administration, or FDA, agreed through a special protocol assessment procedure (SPA) in 2015 that the pivotal Phase III trial, if successful, could, together with the European Phase III data, serve as supportive evidence for filing a biologics license application, or BLA, for regulatory approval of Cx601 with the FDA. TiGenix expects to initiate such trial in the first half of 2017. TiGenix is currently exploring different expedited pathways, which could facilitate and accelerate Cx601 development and the review of its future BLA.
Progress with Pipeline and strategic focus reconfirmed
In June, TiGenix announced the preliminary interim six-month Phase I/II results of AlloCSC-01 in Acute Myocardial Infarction. As per the protocol design, the primary objective of this study is to provide evidence of the acute and long-term safety profile of AlloCSC-01. On the primary acute safety endpoint, no mortality from any cause within one month was recorded for both placebo and AlloCSC-01 groups, as was reported at six months. Similarly, no major adverse cardiac event (MACE) was recorded within one month in either group. Importantly for the long-term safety evaluation, no MACE was recorded in either of the two groups at six months. The safety results confirm that the intracoronary delivery of AlloCSC-01 is well tolerated during the acute and sub-acute phases of the infarct, fulfilling the principal goal of the study at six months. Preliminary secondary efficacy data at six months was limited to infarct size evolution, defined as a percent of the left ventricular mass measured by magnetic resonance imaging. The mean absolute change in infarct size from baseline to six months was similar in both groups. The final full set of safety and efficacy study results at twelve months will be reported in the first half of 2017.
With respect to Cx611, our second allogeneic expanded adipose-derived stem cell based (eASCs)-product candidate intravenously-administered, TiGenix has made solid progress in the preparation activities for the Phase Ib/IIa clinical trial in severe sepsis secondary to severe community-acquired pneumonia (sCAP). The study is a randomized, double blind, placebo controlled multicenter trial expecting to enroll 180 patients across Europe (the SEPCELL study). TiGenix expects to enroll the first patient of this study in the second half of 2016. SEPCELL has been awarded a EUR 5.4 million grant by the European Union under the Horizon 2020 Research and Innovation Programme.
In July TiGenix announced the initiation of the withdrawal of the marketing authorization for ChondroCelect for commercial reasons. This decision is in line with TiGenix’s strategy to concentrate its resources and capabilities on its allogeneic stem cell platforms.
Financial Highlights for the first half 2016
During the first half 2016, total revenues remained stable at EUR 0.9 million when compared to the same period of 2015. Revenues mainly represented royalties and other operating income received from Sobi.
Research and development expenses for the first half 2016 amounted to EUR 9.7 million, compared to EUR 7.7 million for the same period in 2015, a 26% increase which is mainly attributable to clinical activities in connection with the ongoing Phase I/II clinical trial for AlloCSC-01 in acute myocardial infarction, the preparation activities for the launching of the pivotal Phase III trial for the registration of Cx601 in the US and the Phase Ib/IIa clinical trial for Cx611 in severe sepsis as well as other key activities related to the filing of Cx601 MAA in Europe.
General and administrative expenses in the first half of 2016 increased by 54% and amounted to EUR 4.3 million. This increase was mainly attributable to non-recurrent expenses related to advisory fees for the preparation of the US IPO and the Takeda licensing agreement.
As a result of the above, the operating loss amounted to EUR 13.1 million compared to EUR 9.6 million during the same period of 2015.
The net financial income of the first six months of 2016 amounted to EUR 3.8 million compared to the net financial loss of EUR 1.0 million during the same period of 2015. Net financial income/(loss) comprised of financial income, interest on borrowings and other financial costs, fair value gains/(losses) and foreign exchange differences. The main driver that explains the evolution during the first half of 2016 is the change in the fair value (mainly non-cash) of the embedded derivative on the convertible bonds issued in March 2015.
As a result, the loss for the first half 2016 amounted to EUR 9.4 million, compared to EUR 10.6 million for the same period in 2015, which represents a decrease of 11%.
At the end of June 2016, the Company had cash and cash equivalents of EUR 24.1 million, compared to EUR 18.0 million at the beginning of the year. This increase is mainly due to gross proceeds of EUR 23.8 million raised through the March private placement via an accelerated book-building procedure with specialist investors in Europe and in the US. Net cash used in operating activities in the first half of 2016 amounted to EUR 12.6 million. Additionally in July TiGenix obtained a cash payment of EUR 25.0 million after the signing of the licensing agreement with Takeda.
Outlook
TiGenix anticipates announcing the following key milestones over the next 18 months:
2H 2016: initiate enrolment of Cx611 Phase Ib/IIa trial in severe sepsis
1H 2017: announce final results of the Phase II trial of AlloSCS-01 (CAREMI) in acute myocardial infarction
1H 2017: start of Cx601 pivotal Phase III trial for registration in the US
2H 2017: grant of Market Authorisation in the European Economic Area (EEA) to Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients. If granted, Takeda will become the marketing authorization holder and will be responsible for all commercialization and regulatory activities of Cx601 in the EEA
Auditor’s limited review
The review of the statutory auditor of the Company, BDO Bedrijfsrevisoren Burg. Ven. CBVA, can be found in the Condensed Consolidated Interim Financial Information for the first half of 2016 in the investor section of the TiGenix website at http://www.tigenix.com.
Interim financial statements
The interim financial information for the first half of 2016 can be found in the investor section of the TiGenix website at http://www.tigenix.com
Webcast
On Tuesday, September 20, 2016 at 10:00 am CET, TiGenix will conduct a conference call and webcast. The following speakers will present the first half 2016 business and financial update, and take questions afterwards:
The press release and the webcast slide presentation will be made available in the Newsroom section of the TiGenix website. A replay of the webcast will be available on the website shortly after the live webcast has finished.
TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development: Cx601 in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients; Cx611 which has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in Acute Myocardial Infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally injected. Cx601 is an investigational agent being developed for the treatment of complex perianal fistulas in Crohn’s disease patients that failed conventional therapy including antibiotics, immunosuppressant, or anti-TNF therapy. Crohn’s disease is a chronic inflammatory disease of the intestine and patients can suffer from complex perianal fistulas for which there is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognizing the debilitating nature of the disease and the lack of treatment options. Cx601 has met the primary end-point in the Phase III ADMIRE-CD study in Crohn’s disease patients with complex perianal fistula, a randomized, double-blind, placebo-controlled trial run in Europe and Israel and designed to comply with the requirements laid down by the EMA. ‘Madrid Network’ issued a soft loan to help finance this Phase III study, which was funded by the Secretary of State for Research, Development and Innovation (Ministry of Economy and Competitiveness) within the framework of the INNTEGRA plan. The study’s primary endpoint was combined remission, defined as clinical assessment at week 24 of closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI. In the ITT population (n=212), Cx601 achieved statistically significant superiority (p=0.024) on the primary endpoint with 50% combined remission at week 24 compared to 34% in the placebo arm. Efficacy results were robust and consistent across all statistical populations. Treatment emergent adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and placebo arms. The 24-weeks results have been published by The Lancet, one of the most highly regarded and well-known medical journals in the world. The Phase III study has completed a follow-up analysis at 52 weeks confirming its sustained efficacy and safety profile. Top line follow-up data showed that in the ITT population Cx601 achieved statistical superiority (p=0.012) with 54% combined remission at week 52 compared to 37% in the placebo arm. The 52-week data also showed a higher rate of sustained closure in those patients treated with Cx601 and in combined remission at week 24 (75.0%) compared to patients in the placebo group (55.9%). Based on the positive 24-weeks Phase III study results, TiGenix has submitted a Marketing Authorization Application to the EMA in early 2016. TiGenix is preparing to develop Cx601 in the U.S. after having reached an agreement with the FDA through a special protocol assessment procedure (SPA) in 2015. On July 4, 2016 TiGenix entered into a licensing agreement with Takeda, a pharmaceutical company leader in gastroenterology, whereby Takeda acquired an exclusive right to commercialize Cx601 for complex perianal fistulas in Crohn’s patients outside of the U.S.
About AlloCSC-01
AlloCSC-01 is a cellular product consisting of adult allogeneic cardiac stem cells isolated from the right atrial appendages of donors, and expanded in vitro. Pre-clinical data has shown evidence of the strong cardio-protective and immune-regulatory activity of AlloCSC-01. In vivo studies suggest that AlloCSC-01 has cardio-reparative potential by activating endogenous regenerative pathways and by promoting the formation of new cardiac tissue. In addition, AlloCSC-01 has displayed a strong tropism for the heart enabling a high retention of cells in the myocardium after intracoronary administration. AlloCSC-01 is currently in clinical development in a Phase I/II clinical trial (CAREMI). The CAREMI trial comprises two consecutive phases: an open-label dose-escalation phase (n=6) and a 2:1 randomized, double-blind, placebo-controlled phase (n=49). The objective of this clinical trial is to evaluate the safety and the efficacy of the cardiac stem cells product AlloCSC-01 in the acute phase of ischemic heart disease. The primary endpoint of the CAREMI Phase I study is all-cause mortality within 30 days and all adverse events of any cause from the patient’s inclusion until 7 days after treatment administration. Secondary endpoints for the randomization phase include efficacy MRI parameters (evolution of infarct size and evolution of biomechanical parameters), clinical parameters (including the 6 minute walking test and the New York Heart Association scale) and safety (all AEs within 30 days, then monthly up to 6 months, then quarterly post-AlloCSC-01, all-cause mortality and death from cardiovascular cause at 12 months, and MACE measured at 6 and 12 months). MACE is a broader safety endpoint that covers all-cause mortality as well as new AMI, hospitalization due to heart failure, sustained ventricular tachycardia, ventricular fibrillation and stroke. Eight centers are participating in Spain and Belgium and patient recruitment is now finished.The eight participating centers are Hospital General Universitario Gregorio Marañón – Madrid, Hospital de Navarra, Hospital Clínico Universitario de Valladolid, Hospital Universitario de Donostia, Hospital Universitario de Salamanca, Hospital Clínico Universitario de Valencia, and Hospital Virgen de la Victoria de Málaga all in Spain and UZ Leuven in Belgium. The CAREMI trial has benefitted from the support of the CARE-MI consortium (Grant Number 242038, http://www.caremiproject.eu/) funded by the Seventh Framework Programme of the European Commission under the coordination of the Centro Nacional the Investigaciones Cardiovasculares (CNIC) and the participation of research institutions and companies from nine EU countries. The six-month interim analysis of blinded and exploratory efficacy data has been reported in June 2016. Final results will be released in the first half of 2017.
About Cx611 in Severe Sepsis
Cx611 is an intravenously-administered product of allogeneic expanded adipose-derived stem cells (eASCs). In May 2015, TiGenix completed a Phase I sepsis challenge trial demonstrating the favorablesafety and tolerability profile of Cx611. Based on the results of this study, TiGenix has designed a Phase Ib/IIa trial in severe sepsis secondary to severe community-acquired pneumonia (sCAP) which is expected to enrol 180 patients across Europe (the SEPCELL project). The SEPCELL Phase Ib/IIa study in severe sepsis is expected to start in the second half of 2016. SEPCELL has been awarded a EUR 5.4M grant by the European Union under the Horizon 2020 Research and Innovation Programme under Grant Agreement 681031.
Forward-looking information
This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can berecognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company’s control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.
[1]ITT: Intention to treat i.e. all patients randomized in the trial.
[2]Panés P, et al. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomized, double-blind controlled trial. The Lancet [online]. Published online July 28, 2016, available at http://dx.doi.org/10.1016/S0140-6736(16)31203-X.
Spineart today announces that it secured a EUR 30 million investment from Gimv[1], which thus becomes an important shareholder in the company. These proceeds will be used to reinforce the company’s sales organization and processes, for further geographical expansion in selective markets such as the US, as well as for continued development of innovative and disruptive products.
Spineart (www.spineart.com) is a fast-growing Swiss medical device company focused on simplifying spinal surgery by designing, developing and promoting safe and efficient solutions to surgeons, operating room teams and patients. Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of motion preservation, fusion, biologics, minimally invasive surgery and fractures treatment. Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus promoting greater safety, cost-efficiency, and compliance at the hospital. On top it offers strong customer service as well as high-quality training to physicians.
The company was co-founded in 2005 by Jérome Levieux and Stéphane Mugnier-Jacob, who both have over 20 years’ experience in the spine industry and co-lead Spineart. Over the past five years, Spineart grew by 16% on a yearly basis to reach a worldwide turnover of EUR 34 million in 2015. The goal for the coming years is to continue and further accelerate its expansion, by growing its market share in Europe and the US as well as by entering new markets. The company currently employs about 100 FTEs.
“Gimv is the partner we need to reach the next level. Its Health & Care team’s experience in accompanying fast growing companies will help to reach Spineart’s ambitious goals. Therefore, we are very pleased to have them on board and are excited to write together the next chapter in Spineart’s history,” said Jérôme Levieux and Stéphane Mugnier-Jabob, co-founders and co-CEOs of Spineart.
Peter Byloos, Partner in Gimv’s Health & Care team, comments: “Spine surgery is an attractive global market offering plenty of room for challengers such as Spineart. Next to its broad product portfolio and recognized European brand, the company differentiates itself by a strong focus on product innovation and full R&D pipeline. We look forward to share our expertise in the field of Building Companies and International Operations with Spineart’s experienced and committed leadership team. After EndoStim (US-NL), G-Therapeutics (CH) and Topas Therapeutics (GE) this is the fourth new investment of our Health & Care platform since the beginning of the year.”
[1] Joint-investment by Gimv and the Gimv Health & Care Fund
Alphatec Holdings (NASDAQ: WATT) shares reached a new 52-week high of $7.44 yesterday, before closing at $6.27. A number of other analysts have commented on the stock recently, and the company has earned a consensus one-year price target of $38.40, $6.54.
Shares of Alphatec Holdings (NASDAQ: WATT) opened at $6.54 and traded in a range between, $6.10 and $7.44 yesterday, and last traded at $6.27, which represents a change of $ -0.05 over the previous closing price. Most stocks that hit a new 52-week high go higher. The easiest, and best way to assemble a list of potential high performers is to refer to the new 52-week highs list.
Look for heavy-volume accumulation by institutional investors, particularly at buy points.
Alphatec Holdings (NASDAQ: WATT) now has a market cap of $N/A
The average daily volume for Alphatec Holdings (NASDAQ: WATT) is 72,553 shares out of a total float N/A and some 620,304 shares traded hands on yesterday, 28 percent higher than normal. Significant increases in trading volume and price appreciation together could signal heavy volume accumulation by institutional investors.
As with all breakouts, investors look for volume to be at least 40%-50% higher than normal on the breakout to show that fund managers and other professional investors are jumping in. If the share price rises sharply and the trading volume spikes well above average, that indicates demand.
A moving average can also act as support or resistance. In an uptrend a 50-day, 100-day or 200-day moving average may act as a support level, as shown in the figure below. This is because the average acts like a floor (support), so the price bounces up off of it. In a downtrend a moving average may act as resistance; like a ceiling, the price hits it and then starts to drop again.
September 20, 2016 – TOULOUSE, France–(BUSINESS WIRE)
VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, announces its consolidated results for the first half of 20161 in line with guidance.
“Sales increased sharply throughout the first half of 2016, a continued trend that should be reinforced in the second half of 2016. Therefore, we are confident we should reach our profitability target in 2016. In addition, the clinical study we launched in June 2015, with the aim of receiving the 510(k) clearance required to market the SpineJack® in the United States, continues on plan. These various accomplishments indicate that our company is well positioned to become a global leader in the spine-trauma market”, comments Vincent Gardès, VEXIM’s CEO.
+40% increase in sales, gross margin up 45% and significant loss reduction
VEXIM’s sales reached €8.6 million in the first half of 2016, up 40% compared to the same period in 2015. This significant revenue growth shows the effectiveness of the direct sales strategy implemented for the SpineJack® in Europe, combined with a network of specialized distributors at the international level (see press release on VEXIM’s sales in the first half of 20162).
The gross margin on sales increased by 45% compared to the first half of 2015, up to €6.4 million, representing 74.2% of sales vs. 71.9%. This resulted from rising sales in Europe in a context of stable prices as well as from the direct sales strategy implemented.
Compared to the 40% increase in revenue, operating expenses only increased by 12%, up to €8.7 million, compared with the first half of 2015. Such effective control over operating expenses resulted in a saving of €1 million in the net operating loss, down to €2.4 million. Net loss for the period was €2.5 million.
Consolidated statement as of June 30, 2016:
in € millions
First Half 2016
First Half 2015
YoY (%)
Sales
8.565
6.111
+40%
Gross margin (% of sales)
6.359 (74.2%)
4.392 (71.9%)
+45%
Operating expenses
8.722
7.802
+12%
Net operating income (loss)
-2.363
-3.410
+30%
Net income (loss)
-2.529
-3.647
+30%
Solid cash position at €9.4 million
In January 2016, VEXIM reinforced its cash position thanks to a successful €10.4 million private placement. As of June 30, 2016,VEXIM had €9.4 million in cash, allowing the company to secure its future development. The company’s current cash position and future cash flows should allow VEXIM to continue to grow in line with its ambitions.
Other business achievements over the first half of 2016
Launch of a medico-economic study comparing the SpineJack® to a conventional treatment (bracing) with a 1- and 2-year follow-up.
Strengthening of the executive team, with the addition of Francois Cathelineau as VP Operations and of Sebastien Lemoine as VP International & Marketing.
Full-year 2016 guidance confirmed
Thanks to its solid results in the first half of 2016, VEXIM is in running order to reach its full-year 2016 objectives:
Maintain strong revenue growth between 30% to 40% over the full year 2016;
Achieve profitability for the full second half of 2016 and generate operational positive cash-flows;
Further expand internationally through upcoming distribution agreements in South Africa and Australia in 2016, and in Brazil and South Korea in 2017;
Continue the enrollment of patients for the FDA clinical study of the SpineJack® and continue looking for the adequate distribution model for the SpineJack® in the U.S.
Keep innovating in the treatment of high energy vertebral fractures through product development projects, leveraging the SpineJack® platform.
Conference call – 2016 first-half results presentation (in English) Tuesday 20 September 2016, at 6:30 PM (Paris time)
To join the call please contact ALIZE RP
By telephone at: +33 (0)1 44 54 36 62 – By email at:
A replay of the conference call will be available on VEXIM’s website within 48 hours at: http://www.vexim.com/us/ (US section of the website) > Shareholder area
***
Financial reporting schedule:
3rd quarter sales results: Thursday, October 13, 2016* (after market close)
*indicative date, subject to change
About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital3 and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 62 employees, including its own sales teams in Europe and a network of international distributors.
VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com
SpineJack® 4, a revolutionary implant for treating Vertebral Fractures
The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.
MasterflowTM2, a high-performance orthopedic cement delivery system
The MasterflowTM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the MasterflowTM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The MasterflowTM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.
Name : VEXIM ISIN code : FR0011072602 Ticker : ALVXM
1 The results, which were subject to a limited review, have been approved by the Board of Directors of Vexim at its meeting held on 14 September 2016. 2 Press release published on July 12, 2016: http://www.vexim.com/us/vexim-40-revenue-growth-in-the-1st-half-2016-upper-range-of-goals/ 3 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr. 4 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.
Contacts
VEXIM Vincent Gardès CEO
or José Da Gloria Chief Financial Officer
Tél. : +33 5 61 48 48 38 investisseur@vexim.com
or PRESS ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94 vexim@alizerp.com
Posted in Health Reform Watch | Sept., 2016 – Carolyn LaWell is ORTHOWORLD’s Chief Content Officer
To thrive in the healthcare environment of tomorrow, orthopaedic device companies will need to operate within a greater portion of the supply chain, assisting upstream and downstream customers in finding operational value. This will require companies to forge stronger relationships, focus on internal efficiencies and launch services, not just devices. Ultimately, the business models of orthopaedic device companies must radically change if they want to maintain profitability, margins and independence in coming years. This was the message from OMTEC® 2016 keynote speaker Bill Tribe, Ph.D., Partner at A.T. Kearney’s Health Practice.
The message is bold, yet not surprising. One needs to look no further than the product—not device, but product—launches of the largest industry players in recent years. Observe a number of examples: DePuy Synthes’ focus on bundled payment services,Stryker’s purchase and subsequent launch of the Mako robot, Smith & Nephew’s development of Syncera. Additional players and offerings, like Cardinal Health’s expansion into the commercialization of orthopaedic implants and Millstone Medical Outsourcing’s direct-to-patient and hospital distribution model, are reaching new portions of the supply chain.
Tribe referred to these as pilot programs. While it can be assumed that a large amount of research and resources, both personnel and capital, went into the creation of these technologies and services to gain meaningful return on their investments, most on this list are too early in their lifecycles to deem successful long-term.
What these companies attempt to do with these models, though, is to solve a different problem for their customers while generating a new revenue stream for themselves. They move beyond legacy devices and distribution to target new price points and customers, and even create new audiences. Tribe argued that all orthopaedic companies, regardless of size or position in the supply chain, should introduce alternative business models that match the shifts in healthcare and their own company needs.
Here is why.
The Economic Case
Margins across the medical device sector have been falling for more than a decade, and will continue to erode by about 5% if unaddressed, according to Tribe’s research. Compounding that is the continued negative impact of price pressure, at nearly 3% per year. An average orthopaedic company would need to reduce its cost of goods by 12% or its Selling, General and Administrative expenses by 8%, or some combination of the two, to offset that 3% in price pressure, he says. That pressure is consistent; therefore, companies must get leaner each year.
On a positive note, orthopaedics is a $46 billion industry growing in the low-single-digits year over year, according to ORTHOWORLD’s THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. Healthy procedural volumes due to a growing and aging population, and untapped and underserved markets, mean that the industry remains attractive.
Troubled Community Health Systems is considering selling its entire business, according to various reports Friday.
Quoting anonymous sources “with knowledge of the matter,” Bloomberg said hospital giant CHS had enlisted advisers to consider options. Deliberations are in the early stages and there is no certainty of a deal, according to reports.
CHS’s battered stock price surged on the rumors, closing up 16% Friday to $12.27 per share.
CHS spokeswoman Tomi Galen said CHS does not comment on rumors.
Earlier this month, Modern Healthcare reported that CHS plans to sell more than the 12 hospitals it has for sale, quoting CFO Larry Cash speaking at the Wells Fargo Securities Healthcare Conference in Boston.
Cash said they are getting interest in additional hospitals. And after examining its portfolio of 159 hospitals, it likely will see “other transactions” before the end of the year, he said.
Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, announces the acquisition of the remaining minority interests (40%) in its Brazilian subsidiary.
Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “On such a major and high-potential market as Brazil, we now totally control our distribution subsidiary. In Brazil, where Amplitude Surgical has been established since 2014 (and present – via a distributor – since 2006), this transaction should enable us to continue the particularly buoyant growth we have been recording in that country, over 30% in local currency in FY 2015-16, and thus to carry on benefiting from the considerable potential of this market, which already accounts for almost 10% of the Group’s sales.”
After acquiring a 50% stake in Unimplant, its historic distributor in Brazil, in February 2014 and an additional 10% stake in April 2015, Amplitude Surgical recently increased its stake in its subsidiary to 100% by exercising its call option on the remaining (40%) minority interests.
This latter operation, for approximately €4.1 million, significantly benefited from the Brazilian real’s weakness compared with the euro, as the stake’s value was booked as €4.4 million at the end of December 2015 and €6.6 million at June 30, 2015.
Next financial press release: 2015-16 annual results, on Thursday October 6, 2016, after market.
About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. As of June 30, 2016, Amplitude Surgical had a workforce of almost 290 staff and recorded sales of over 80 million euros.
