ROSEMONT, Ill. (Sept. 21, 2016)—Karen L. Hackett, FACHE, CAE, announced that she will retire from her position as chief executive officer of the American Academy of Orthopaedic Surgeons (AAOS), after 14 years at the organization’s helm, effective April 14, 2017.
Throughout her tenure, Ms. Hackett has overseen a number of major developments at the Academy, including the opening of the Orthopaedic Headquarters in Rosemont, Ill. in 2015. She has worked directly with the AAOS Board of Directors and executive management team to oversee a staff of 250 employees and manage an annual budget of $60 million.
“Karen’s leadership has been instrumental to the Academy’s success and growth,” said AAOS President Gerald R. Williams, Jr., MD. “Thanks to her bold vision, valuable insight and exceptional dedication, the Academy has created educational programming and new initiatives that continue to support and champion our members, all while navigating unprecedented change in the health care arena.”
“I have been so proud to be the CEO of an organization representing such a devoted, dedicated and driven group of physicians,” said Hackett. “I thank the AAOS Board of Directors, volunteers, members and staff for the opportunity to serve this dynamic organization.”
Under Hackett’s leadership, the Academy created new quality and performance standards, including guidelines and appropriate use criteria for 18 orthopaedic conditions; hosted an inaugural National Surgical Patient Safety Summit (NSPSS), bringing together 150 representatives from medical professional associations, insurers, health care systems, payers and government agencies to develop surgical care, research and education standards; oversaw numerous legislative and national policy advancements on behalf of orthopaedic surgeons and patients; and fostered ongoing unity among the various orthopaedic specialties and industry stakeholders. In addition, the organization produced yearly, award-winning public service campaigns on injury prevention and safety topics, including distracted driving and walking; a traveling “Wounded in Action” art exhibit; and a website and activities related to the organization’s 75th anniversary.
Prior to joining the Academy as CEO in 2003, Hackett was the executive vice president and chief operating officer of the American College of Healthcare Executives (ACHE). Previously, she served as vice president for the Metropolitan Chicago Healthcare Council, senior manager for Ernst and Young and director of technical services for the Healthcare Financial Management Association. Hackett is a Certified Association Executive (CAE) of the American Society of Association Executives (ASAE), and a past chairman of the organization’s Board of Directors (2010-2011). She also is board certified in health care management and an ACHE fellow. Hackett earned a master’s degree in business administration from Lewis University in Romeoville, Ill., and a bachelor’s degree from the University of Central Florida.
Hackett has been honored for her tremendous career accomplishments. In 2009, she received the Samuel B. Shapiro Award, presented by the Association Forum of Chicagoland to a chief executive officer for outstanding service and accomplishment in association management. In 2011, she was selected for induction into the University of Central Florida’s College of Business Hall of Fame; that same year, Lewis University honored Hackett with the Alumni Achievement Award in the field of Business.
The AAOS Board of Directors has retained executive search firm Korn Ferry to lead the search for a new CEO.
About the AAOS
With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.
Visit AAOS at: Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests. ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery. Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
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
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SMA occurs when people lack a gene called survival motor neuron 1 (SMN1). It can affect children in the womb or adults. This makes them unable to produce enough SMN protein, resulting is motor neuron degeneration and increasing muscle weakness. However, people have an almost identical gene called SMN2.
Existing proposed treatments are based on altering SMN2 to include a crucial part that is found in SMN1, enabling the production of SMN protein. This uses a splice-switching oligonucleotide or SSO. However, the difficulties of getting SSOs across the blood-brain barrier and into the central nervous system mean that they have to be injected into the spine with a lumbar puncture.
Researcher Dr Suzan Hammond explained: ‘Intrathecal delivery — injection around the spinal cord — makes a treatment less straightforward. Around a third of patients experience side effects. An additional complication is that SMA frequently leads to scoliosis — twisting of the spine — which can restrict such injections.’
The team at Oxford’s Department of Physiology, Anatomy and Genetics developed a treatment called Pip6a-PMO, in which the SSO was delivered using a peptide called Pip6a.
Dr Hammond explained: ‘Pip6a is highly effective at delivering SSOs to a wide variety of tissue in the body. We have confirmed that it can also get them into the brain and spinal cords in young and adult mice.’
When young mice — known as pups — with genetically engineered SMA were injected with the Pip6a-PMO, the results were rapidly clear: At just seven days old they were noticeably heavier and faster growing than untreated pups; at 12 days, tests found the treated pups much stronger than untreated counterparts. They also lived much longer, a median 167 days for mice treated with one dose of 10 microgrammes per gram of weight of Pip6a-PMO, compared to untreated pups’ 12 days.
Tests also found that two such doses of Pip6a-PMO markedly improved survival — with all mice treated in this way surviving at least 200 days and median survival of 457 days, 38 times longer than untreated mice and nearly three times longer than those who received a single dose.
Study of neuromuscular junctions, where motor neurons connect to muscles, showed that the effect of SMA, which destroys nerves at the junctions, was reversed by a single dose of the treatment, returning the connections to normal levels.
Professor Matthew Wood said: ‘While Pip6a was initially designed for Duchenne muscular dystrophy, we have shown that it can also be highly effective in SMA treatment. The survival of mice in this trial was far longer than any other treatment. The advantage is that it is both a central nervous system treatment and a systemic treatment for the wider body. Such an approach could also work for diseases like Parkinson’s, Huntingdon’s and ALS, and our focus will be extending the clinical applications of Pip-PMOs.’
The team are currently planning a 2-year study that would start next year, to evaluate this treatment in patients.
Story Source:
The above post is reprinted from materials provided byUniversity of Oxford. Note: Content may be edited for style and length.
Journal Reference:
Suzan M. Hammond, Gareth Hazell, Fazel Shabanpoor, Amer F. Saleh, Melissa Bowerman, James N. Sleigh, Katharina E. Meijboom, Haiyan Zhou, Francesco Muntoni, Kevin Talbot, Michael J. Gait, Matthew J. A. Wood. Systemic peptide-mediated oligonucleotide therapy improves long-term survival in spinal muscular atrophy.Proceedings of the National Academy of Sciences, 2016; 201605731 DOI: 10.1073/pnas.1605731113
University of Oxford. “Trial offers hope of a treatment for spinal muscular atrophy.” ScienceDaily. ScienceDaily, 20 September 2016. <www.sciencedaily.com/releases/2016/09/160920154551.htm>.
Spring Loaded Technology today reports the findings of a recent third-party study which links its LevitationTM, the world’s first compact bionic knee brace, to a significant reduction in factors that can lead to muscle fatigue. Research scientists observed the oxygen intake, carbon dioxide production and muscle activity of three healthy individuals as they repeated a squat to stand task with and without the assistance of the knee brace.
The study found that the LevitationTM Knee Brace, which uses a liquid spring technology to store energy as the leg is bent and return it as the leg is straightened, requires significantly less exertion from the user during energy expensive movements like rising to a stand from a full squat or crouched position. Data from the study revealed that participants used 25 percent less oxygen during the task cycle when compared to their consumption without the brace’s assistance. The researchers also found a drastic 40 percent reduction in carbon dioxide production.
The study was performed through the NSERC Engage Program at the University of New Brunswick by research scientists, Dr. Chris McGibbon in the Faculty of Kinesiology and Abeer Mohamed Abdelhady, PhD Candidate in the Dept. Mechanical Engineering.
“With the knee brace’s assistance, participants consumed less energy and were able to do more physical activity as measured with our squat test,” said Dr. Chris McGibbon. “The participants in this study also demonstrated a reduced respiratory exchange ratio (RER) while wearing the LevitationTM, meaning that they were burning more fat stores than carbohydrates. These findings are consistent with Spring Loaded Technology’s claim that LevitationTM reduces factors known to be associated with muscle fatigue—an exciting and unique accomplishment for knee braces and the field of bionics.”
The findings also support the brace’s ability to reduce demand on the muscles in order to improve performance, with participants showing an 85 percent reduction of activity in the quadriceps muscles and a 50 percent reduction of activity in the hamstring muscles during the squat task. Study participants were also able to perform up to 20 percent more squats when wearing the brace compared to the number of squats achieved when their knees were unassisted.
This data was drawn at the Levitation™ Knee Brace’s maximum assistance level. The level of assistance is adjustable and can be tailored to the user’s needs. This allows the user to specify different settings for different activities, or if the individual is recovering from an injury, to gradually reduce the level of assistance provided to zero as they recover their full strength.
“LevitationTM was designed to go above and beyond joint stabilization to assist strength and reduce fatigue. The result is a product intended to enhance mobility and expedite rehabilitation,” said Chris Cowper-Smith, CEO at Spring Loaded Technology. “It was important to us to have a study that shows our customers what sets us apart in the marketplace as they make an informed decision about which brace is best for them.”
LevitationTM Knee Braces ($1,750 USD) are currently available for pre-order.
MINNETONKA, Minn., Sept. 20, 2016 /PRNewswire/ — Medical Device Testing (MDT) Services has added spine and knee wear testing to its extensive orthopaedic device testing portfolio. For the past 26 years, MDT has served the medical device industry as a contract test laboratory focused on mechanical testing and materials characterization.
MDT was founded in 1990 as a division of EnduraTEC Systems Corporation, which specialized in the development of novel material test instruments for the medical device community. In 2000, MDT was spun off as a separate company to provide greater focus on testing services. MDT is an ISO 17025 certified laboratory that provides test design, execution, and documentation using a rigorous quality program that helps customers fast-track their submissions to the FDA and other regulatory agencies.
MDT recently added an MTS Bionix Spine Wear Tester and multiple Knee Motion Wear Simulators to expand capabilities in orthopaedic medical device testing. While MDT has a strong brand recognition in the medical device market for cardiovascular device testing, a significant part of its business has always been in orthopaedics. “In fact, the very first applications we worked on when we launched the company in 1990 were spinal fixation device fatigue testing and knee motion simulation. Over the last 26 years, we have been fortunate to work with the most original device designs targeting applications from head to toe,” saidKent Vilendrer, President and CEO of MDT.
About Medical Device Testing Services
Medical Device Testing Services is one of the largest A2LA accredited medical device testing companies in the world with over$6 million in commercial fatigue and durability test systems, inspection instruments, and test fixturing inventory. Find out more about the medical device mechanical testing and materials characterization specialists at www.devicetesting.com.
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
(NASDAQ:IART), a leading global medical technology company, today announced that the first three procedures using the Integra® Cadence™ Total Ankle System in Europe were successfully completed since July 13, 2016 by Dr. Thibaut Leemrijse, of the Foot and Ankle Institute, Parc Léopold Clinic, Brussels, Belgium. Internationally renowned for his expertise in foot surgery, Dr. Leemrijse and his team are considered leaders in the field of ankle arthroplasty.
“Integra’s new Cadence system offers a two-component implant, designed to adapt to a patient’s anatomy by providing improved range of motion, intraoperatively,” said Dr. Leemrijse. “The instrumentation allows ideal positioning of the implant, and the learning curve for this new device seems short, based on our first cases.”
The European introduction of the Cadence system supports Integra’s role as a leader in this rapidly expanding market. New and improved designs and advanced surgical education programs, such as the ones developed by Integra, are fueling the growth of the ankle prosthesis segment.
“Our innovative arthroplasty device is an example of the close cooperation between our company and expert surgeons, which seeks to develop devices that can be efficiently implanted in various anatomies,” said Stéphane Corp, Integra’s Vice President, Orthopedics & Tissue Technologies, for Europe, Middle East and Africa.
The Cadence system’s differentiated anatomic design and streamlined surgical technique allow Integra to continue offering a complete set of options to treat the continuum of care in total ankle prosthesis, one of the fastest growing extremities segments.
About Integra
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies. For more information, please visit www.integralife.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Integra LifeSciences Holdings Company
Investors
Angela Steinway
609-936-2268
angela.steinway@integralife.com
Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com
Media Europe
Marie-Anne Girel
marie-anne.girel@integralife.com
Media U.S.
Gianna Sabella
609-775-8553
gianna.sabella@integralife.com
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.
