Bluebee receives Health Data Hosting (HDS) accreditation

Rijswijk, The Netherlands: 6 March 2019 – Bluebee, a global bioinformatics solutions provider, has been awarded the HDS:2018 certification for its Information Security Management System (ISMS). The Hébergeurs de Données de Santé or Health Data Hosting (HDS) accreditation is required for entities hosting personal health data governed by French laws. The British Standards Institution (BSI) conducted the audit and confirmed Bluebee’s compliance with all requirements and controls defined by the French Agency, Agence des Systèmes d’Information Partagés de Santé (ASIP).

Bluebee’s ISMS governs HDS outsourcer host activities, including development, management, support and maintenance of cloud infrastructure and cloud-based information systems that process large volumes of omics and health data. The achievement of this accreditation reaffirms Bluebee’s continued commitment to providing the most secure and reliable data management solutions to clinical laboratories, diagnostic assay manufacturers and population genomics initiatives.

Axonics® Announces Fourth Quarter and Full Year 2018 Financial Results and Operational Update

GIlde Healthcare

IRVINE, CA – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, reported today financial results for the fourth quarter and year ended December 31, 2018, and provided an update on operational initiatives.

Recent Business Highlights

  • In Q4, commercial sales of the miniaturized rechargeable Axonics r-SNM® System totaled $0.5 million.
  • On February 11, filed full-body magnetic resonance imaging (“MRI”) data with the U.S. Food and Drug Administration (“FDA”) seeking conditional labeling for the miniaturized rechargeable Axonics r-SNM System.
  • On February 19, disclosed top-line six-month clinical results on the full cohort of patients for the ARTISAN-SNM pivotal clinical study of the Axonics r-SNM System which indicated 90% of all implanted subjects met the efficacy endpoint and that the study met all primary and secondary endpoints.
  • On February 21, filed a detailed six-month clinical study report with the FDA on the results of the ARTISAN-SNM pivotal clinical study.
  • On February 22, announced CE Mark approval for full-body MRI conditional labeling in Europe for the Axonics r-SNM System, making the Axonics system the first SNM device that allows a safe full-body MRI scan while implanted.
  • On March 4, appointed Michael H. Carrel to the Board of Directors.

Raymond W. Cohen, CEO of Axonics, commented, “We view the generation of $0.5 million of revenue in the fourth quarter, serving a handful of customers with a small team of sales professionals, to be a harbinger of things to come. We are seeking measurable market share gains in 2019 from our two primary markets in Europe, the United Kingdom and the Netherlands. The accounts we have secured in these markets are exceeding our expectations in terms of the percentage of SNM implants using the Axonics system. Moreover, we now have the only SNM device with full-body MRI labeling, an advantage that should aid us in gaining further traction.”

Cohen continued, “Our primary focus continues to be gaining FDA approval in the shortest possible timeframe. To that end, and based on interaction with the FDA, we determined our best course of action was to further enrich our current literature-based PMA with the full cohort of ARTISAN-SNM study data as well as the full-body MRI data. As we advance our regulatory strategy, we continue to press forward on our initiative to be fully prepared to execute a broad, fully staffed U.S. launch upon FDA approval. We are building a world-class team and have been pleased that many experienced neuromodulation and urology professionals view Axonics as an attractive place to work that represents an exciting career opportunity. Overall, we are making excellent progress on our key operational objectives.”

Fourth Quarter 2018 Financial Results

Net revenue was $0.5 million in the fourth quarter ended December 31, 2018, derived from the sale of the Company’s r-SNM Systems to customers in Europe and Canada, as compared to no net revenue for the same period of last year.

Gross margin was 50.4% in the fourth quarter of 2018.

Operating expense was $9.7 million for the fourth quarter of 2018, as compared to $4.9 million in the prior-year quarter. This increase was primarily due to higher personnel costs across the organization as well as the costs of operating as a public company.

Net loss for the fourth quarter of 2018 was $9.7 million as compared to $4.9 million in the prior-year quarter. Net loss per share for the fourth quarter of 2018 was $0.50 per share.

As of December 31, 2018, cash, cash equivalents and short-term investments were $157.5 million.

Dan L. Dearen, Axonics President and CFO, said, “We have been actively hiring commercial, operations, regulatory, and quality personnel to ensure we execute on our strategy of fielding a full complement of sales and marketing professionals with sufficient inventory on hand to support a U.S. launch upon FDA approval. To date, we have hired 60 well-qualified sales professionals, 11 regional sales directors and 12 clinical specialists, putting us ahead of schedule and in a good position with the build out of our team and its ability to execute if the approval were to come before our initial projection. The accelerated costs associated with that shift puts us in the best position to achieve our commercial goals when approved.”

Full Year 2018 Financial Results

Net revenue was $0.7 million in fiscal year 2018, derived from the sale of the Company’s r-SNM Systems to customers in Europe and Canada, as compared to $0.1 million in fiscal year 2017.

Gross margin was 49.7% in fiscal year 2018, compared to 7.9% gross margin in fiscal year 2017. The increase in gross margin is primarily due to country and product mix.

Operating expense was $32.5 million in fiscal year 2018, as compared to $18.2 million in fiscal year 2017. This increase was primarily due to increases in personnel, regulatory submissions and clinical development, contract fabrication and manufacturing, and legal costs.

Net loss for the year was $32.5 million as compared to $18.1 million in the prior year. Net loss per share for fiscal year 2018 was $4.64 per share.

Webcast and Conference Call

Today, on Tuesday, March 5, 2019, at 4:30 p.m. Eastern Time, the Company will host a conference call with the investment community to discuss the financial results and recent business developments.
Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using conference ID 3386378.

A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 90 days.
About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is focused on the development and commercialization of novel implantable Sacral Neuromodulation devices for patients with urinary and bowel dysfunction. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence. SNM therapy is a well-established treatment that has been widely used and reimbursed in Europe and the U.S. for the past two decades. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia, and the first SNM system to gain CE mark for full-body MRI conditional labeling. Premarket Approval (PMA) for the r-SNM System is currently pending with the U.S. FDA. For more information, visit the Company’s website at www.axonicsmodulation.com.

Forward Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

 

Contacts:

Axonics’ Contact

Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact

W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

 

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KKR Completes Acquisition of BrightSpring Health Services

KKR

BrightSpring merges with PharMerica to form leading provider of health and pharmacy services

 

LOUISVILLE, Ky.–(BUSINESS WIRE)–Global investment firm KKR and BrightSpring Health Services (“BrightSpring”), one of the largest home and community-based health services providers, announced today that KKR has closed on its acquisition of BrightSpring. As part of this transaction, BrightSpring has merged with PharMerica Corporation (“PharMerica”) to now become a leading provider of both home and community-based health and pharmacy services for high-need and medically complex populations.

The strategic combination of BrightSpring and PharMerica creates a uniquely positioned, diversified health care platform with comprehensive care capabilities across clinical, pharmacy, and non-clinical support services in multiple care settings. Upon close, the combined company will serve over 300,000 clients daily in 47 states, Puerto Rico and Canada with combined revenue of approximately $4.5 billion.

“Today marks the start of a new and exciting chapter for BrightSpring and PharMerica. We look forward to working with the team on the combined company’s next phase of growth and development,” said KKR member Max Lin.

“Combining BrightSpring and PharMerica brings together two well-respected, high quality and innovative leaders within their markets. Together, we will have unmatched capabilities to drive improved outcomes and reduced costs through integrated service and care models for all of the people and stakeholders we serve. Through the combination of our community-based health services and pharmacy capabilities, our complementary offerings will have valuable benefits to our clients, patients and customers and provide new opportunities together,” said Jon Rousseau, President and Chief Executive Officer of BrightSpring and Chief Executive Officer of PharMerica.

With the combined enterprise led by Rousseau as CEO, Bob Dries has been named the President of PharMerica as part of the combination. “Greater independence, improved health outcomes and reduced hospitalizations all depend on three things to be present – non-clinical support services, daily medication optimization and clinical monitoring and interventions when required, which is what we are focused on providing to deliver value as a combined company,” said Dries. “With PharMerica, we provide industry leading medication availability, cost containment results, and clinical, regulatory and education support for our customers and their residents and patients – through our proprietary programs and systems,” he added.

BrightSpring and PharMerica will continue to support all operations from Louisville, Kentucky, where both businesses are headquartered, and anticipate many benefits to its customers and people served from its scale and scope of integrated services. The combined organization will continue to take a local and customized approach when serving its behavioral, senior and specialty populations in the community, as well as offering differentiated capabilities and a unique set of comprehensive offerings to the skilled nursing, senior living, hospital, behavioral provider, and home infusion and specialty clinic customers that it serves. The increased breadth of the company’s services and its proximity in serving complex populations, which are most often significant polypharmacy populations, will provide added solutions and opportunities for working with Medicare, states and other payers to improve outcomes and lower costs.

Under the terms of the deal originally announced on Dec. 10, 2018, KKR has purchased BrightSpring for approximately $1.32 billion with an affiliate of Walgreens Boots Alliance, Inc. as a minority investor. KKR is making the investment from KKR’s Americas XII Fund.

About BrightSpring

BrightSpring Health Services is the parent company of a family of brands and services that provides clinical, nonclinical and pharmacy and other ancillary care services for people of all ages, health and skill levels across home and community settings. BrightSpring is one of the largest providers of diversified home and community-based health services to complex, high-cost populations. Its primary businesses include: behavioral health (including autism services), home health care (including personal care, home health, and hospice), neuro therapy, and job placement and vocational training, supported by pharmacy and telecare ancillary technologies and services. These businesses employ over 45,000 dedicated team members in more than 40 states and provide services to over 2 million people annually.

BrightSpring Health Services is focused on providing quality and lower-cost outcomes to challenging and high-cost populations, through best-in-class services and technology innovation. Its Connected Home care model is becoming an industry-leading approach to the future of health care services to achieve strong quality and compliance while also driving efficiency and cutting waste. The company’s care professionals work in thousands of communities across the United States providing critically needed daily support services, as well as clinical and pharmacy health services, in community settings. Founded and headquartered in Louisville, Kentucky, BrightSpring has been making a difference in people’s lives and communities since 1974 – helping people live their best life. For more information, visit www.BrightSpringHealth.com.

About PharMerica

PharMerica Corporation is a leading provider of institutional and community-based pharmacy services. The company serves the long-term care, senior living, hospital, home infusion, behavioral, specialty and oncology pharmacy markets. Today, PharMerica operates 96 institutional pharmacies, 20 specialty home infusion pharmacies and five specialty oncology pharmacies in 45 states. PharMerica is a customer service and patient-focused organization serving institutional healthcare providers, such as skilled nursing facilities, senior living communities, hospitals, behavioral and seniors individuals receiving in-home care, and patients with cancer. The company provides highly reliable and accurate medication delivery and support services to approximately 250,000 individuals a day with unmatched service reliability, cost containment, and clinical, regulatory and educational support for its clients and their residents and patients. For more information visit www.PharMerica.com.

About KKR

KKR is a leading global investment firm that manages multiple alternative asset classes, including private equity, energy, infrastructure, real estate and credit, with strategic partners that manage hedge funds. KKR aims to generate attractive investment returns for its fund investors by following a patient and disciplined investment approach, employing world-class people, and driving growth and value creation with KKR portfolio companies. KKR invests its own capital alongside the capital it manages for fund investors and provides financing solutions and investment opportunities through its capital markets business. References to KKR’s investments may include the activities of its sponsored funds. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR’s website at www.kkr.com and on Twitter @KKR_C.

Contacts
KKR Americas
Kristi Huller
+1 212-750-8300
Media@KKR.com

BrightSpring / PharMerica
Barnard Baker
+1 502-630-7254
Barnard.Baker@BrightSpringHealth.com

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Sivantos and Widex successfully complete merger: new company to operate as WS Audiology

eqt

  • Global top three contender with revenues of EUR 1.7 billion and a comprehensive sales and distribution platform in more than 125 markets
  • Jørgen Jensen, until now CEO of Widex, appointed CEO; Wolfgang Ollig, Sivantos’ current CFO, appointed CFO of WS Audiology
  • Thomas Ebeling, Chairman of the Board of Directors of Sivantos, appointed Chairman of the Board of Directors of WS Audiology; Jan Tøpholm, Chairman of Widex A/S, appointed Deputy Chairman
  • Ignacio Martinez, to date CEO of Sivantos, will join the Board of Directors

Lynge/Denmark and Singapore – March 1, 2019: EQT funds, owners of Sivantos Pte. Ltd. (“Sivantos”), and the Tøpholm and Westermann families, owners of Widex A/S (“Widex”), today announced the successful completion of the business combination between Sivantos and Widex. The newly created company will operate under the name WS Audiology and be headquartered in Lynge, Denmark and Singapore.

The successful merger between two leading hearing aid companies has created a strong player with combined revenues of more than EUR 1.7 billion, over 10,000 employees and one of the strongest R&D teams in the industry. WS Audiology is driven by a passion to improve the quality of life for more than 700 million people with hearing needs. Together, the two pioneers have a combined experience of more than 170 years and will redefine the competitive landscape in the more than 125 countries they are present in.

WS Audiology will be led by a highly experienced management team with a balanced representation from both Sivantos and Widex. Jørgen Jensen, until now CEO of Widex, will head the new company as Chief Executive Officer. Before joining Widex in 2013, he spent 15 years at Nilfisk-Advance, the last eight of which as President and CEO. He previously worked for McKinsey.

Wolfgang Ollig, Sivantos’ current CFO, will continue in the same position at the new company. Prior to joining Sivantos in 2016, he held the role of CFO at Hella, one of the world’s leading automotive suppliers, for 10 years. Like Jørgen Jensen, he started his career at McKinsey.

Thomas Ebeling, Chairman of the Board of Directors of Sivantos, has been appointed Chairman of the Board of Directors of WS Audiology. Jan Tøpholm, up to now Chairman of Widex, will take on the role as Deputy Chairman. Ignacio Martinez, to date CEO of Sivantos, will join the Board of Directors, and Henrik Bender, until now CFO of Widex, will lead the integration process.

“Today marks the beginning of a great new journey. Two pioneers joining forces with one clear ambition: to expand access to hearing aids and care to serve the millions of people with hearing needs across the world. This merger gives WS Audiology the scale and innovation capabilities to deliver on this goal. We are setting out to excel with best-in-class products and accelerate our shared growth across all our brands. The future holds great opportunities and together, as one team, we will be able to seize the momentum we have gained,” said Jørgen Jensen, CEO of WS Audiology.

“Both Widex and Sivantos have been at the forefront of innovation in the industry. Together, WS Audiology has abundant resources to create excellent products and further accelerate innovation with creative, high-tech and easy-to-use products and services, broadening the choice for hearing aid users,” said Thomas Ebeling, Chairman of the Board of Directors of WS Audiology.

“As WS Audiology takes shape today, we are one big step closer to becoming the clear innovation leader, developing the best possible hearing aids to improve the life of those with hearing needs. We are united by our proud heritage, our long history as ‘first movers’, and our insatiable curiosity that drives our innovation and technology,” said Jan Tøpholm, Deputy Chairman of the Board of Directors of WS Audiology.

WS Audiology will offer a diverse portfolio of technologically advanced hearing aid products and services. With its brands Signia, Widex, Rexton, Audio Service and others, WS Audiology addresses the needs of the millions of people with hearing requirements.

Going forward, WS Audiology will accelerate its growth, strengthen its market penetration and enhance efficiencies to enable additional investments in R&D and the supply chain. This will allow the company to expand access to hearing healthcare via its dedicated salesforce, increasing the quality of life for millions of people and allowing them to experience the world of sound to the fullest.

This press release is translated into multiple languages for information purposes. In case of a discrepancy, the English version shall prevail.

Contacts

  • Andrew Arnold (Corporate Communications): + 45 25 65 75 47
  • Gert van Santen (Corporate Communications): +49 152 028 743 20
  • EQT (Press office): press@eqtpartners.com | +46 8 506 55 334

About WS Audiology
WS Audiology was formed in 2019 through the combination of Singapore-headquartered Sivantos with Lynge/Denmark-based Widex. Today, the business employs more than 10,000 people worldwide, is active in more than 125 markets and has revenues of more than EUR 1.7 billion annually. WS Audiology offers a diverse portfolio of technologically advanced hearing aid products and services across its brands Signia, Widex, Rexton, Audio Service and others. WS Audiology is owned by the Tøpholm and Westermann families and funds under the management of global investment firm EQT as well as the Strüngmann family.

More info: www.wsaudiology.com

About EQT
EQT is a leading investment firm with more than EUR 50 billion in raised capital across 28 funds. EQT funds have portfolio companies in Europe, Asia and the US with total sales of more than EUR 19 billion and approximately 110,000 employees. EQT works with portfolio companies to

achieve sustainable growth, operational excellence and market leadership.

More info: www.eqtpartners.com

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Segulah IV L.P. divests CCS Healthcare

Segula

On March 1, 2019, Segulah IV L.P. and minority shareholders signed an agreement to divest 100% of CCS Healthcare Holding AB to KiiltoClean Group. KiiltoClean Group is a part of Kiilto, a family-owned Finnish company that develops, manufactures and markets chemical industry solutions and operates in four business areas: construction, industrial bonding and hygiene solutions, professional cleanliness and hygiene and consumer products. The transaction was simultaneously carried through.

CCS Healthcare provides hygiene and safety products to the professional business-to-business markets and holds the leading position within hand hygiene and surface disinfection products in the Nordic region. Additionally, the Company holds a strong position within portable eyewash products in Denmark and Germany.

CCS Healthcare was acquired by Segulah IV in May 2011. During Segulah IV’s ownership, CCS Healthcare has completed four add-on acquisitions, mainly within the hygiene product segment. In March 2016, CCS Healthcare divested its pharma portfolio and Clinomyn brand to Trimb Healthcare. The Consumer Skincare business unit was divested through two separate transactions in January 2019. The skincare brand portfolio was acquired by Trimb Healthcare and the factory and contract manufacturing activities in Sweden were acquired by Svenska Krämfabriken. Pro forma for the Consumer Skincare divestment, CCS Healthcare generated revenues of ca. MSEK 440 in 2018.

“CCS Healthcare has in recent years significantly transformed its operations and showed good profitable growth. Following the successful divestment of the Consumer Skincare business unit, the industrial merit of combining CCS Healthcare with Kiilto is evident, creating a Nordic powerhouse positioned for future growth”, says Dario Aganovic, CEO of CCS Healthcare.

”We are very pleased with how CCS Healthcare has performed over the past years under the leadership of the current management team. We are convinced that Kiilto as a new owner will be able to further develop CCS Healthcare’s strong position across key Nordic and European markets”, says Sebastian Ehrnrooth, Chairman of Segulah Advisor AB.

 

 

For further information please contact:

Dario Aganovic, CEO, CCS Healthcare, +46 72 555 11 01

Sebastian Ehrnrooth, Chairman, Segulah Advisor AB, +46 73 360 42 05

Johan Möllerström, Director, Segulah Advisor AB, +46 72 543 79 11

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Blackstone Life Sciences and Novartis Launch Anthos Therapeutics to Develop Innovative Medicines for Cardiovascular Disease

Blackstone

Blackstone Life Sciences provides $250M Financing

Cambridge, Massachusetts, February 27, 2019 – Blackstone Life Sciences today announced the launch of Anthos Therapeutics Inc. (“Anthos”), a new biopharmaceutical company focused on advancing next-generation targeted therapies for high-risk cardiovascular patients.

As part of this launch, Novartis has licensed to Anthos MAA868, an antibody directed at Factor XI and XIa, key components of the intrinsic coagulation pathway. A large unmet medical need exists for next-generation anti-thrombotic therapies in patients currently underserved by conventional anti-coagulant therapies. As a promising anti-thrombotic modulating genetically and pharmacologically validated components of the intrinsic pathway, MAA868 has the potential to prevent a variety of cardiovascular disorders with minimal or no bleeding risk within a new long-acting treatment paradigm, which would provide major advantages over the conventional standards of care.

Funds managed by Blackstone Life Sciences, a private investment platform with capabilities to invest across the lifecycle of companies and products within the key life sciences sectors, provided $250M for Anthos and will control the development of the products.  Novartis will retain a minority equity interest in Anthos.

According to the American Heart Association, thrombotic disorders cause nearly 500,000 deaths each year. Thrombotic disorders can affect arteries or veins, manifesting as ischemic heart disease, ischemic stroke, peripheral artery disease, venous thromboembolism, and many debilitating orphan diseases. Atrial fibrillation, the most common type of heart arrhythmia, is a major risk factor for ischemic stroke and systemic arterial thromboembolism.

“The need for new medicines to treat cardiovascular diseases is clear, and this agreement is part of our strategy to work with innovators outside our walls to advance medicines that have the potential to have a positive impact for patients,” said Jay Bradner, MD, President of the Novartis Institutes for BioMedical Research. “Blackstone Life Sciences has the necessary experience and has assembled a first-class team at Anthos to drive the further development of MAA868.”

“Blackstone Life Sciences is focused on bringing important medicines and healthcare technologies to market, often working in partnership with major biopharmaceutical companies to provide them with access to capital, scientific expertise and hands-on operational leadership,” said Nick Galakatos, Ph.D., Head of Blackstone Life Sciences and Chairman of Anthos.  “We are excited to collaborate with Novartis to create Anthos, with the goal of delivering important therapies for the high-risk cardiovascular patients who need them.”

Founding members of Anthos’ Board of Directors include Blackstone Managing Director Paris Panayiotopoulos, former CEO of Ariad Pharmaceuticals, and Blackstone Principal Ari Brettman, MD. Jonathan Freeman, MBA, Ph.D., Blackstone Senior Advisor and Anthos co-founder, joins as Chief Operating Officer.

Shaun Coughlin, MD, Ph.D., Novartis’ Global Head of Cardiovascular and Metabolism joins as an Observer to Anthos’ Board. Craig Basson, MD, Ph.D., Novartis’ Head of Cardiovascular and Metabolism Translational Medicine joins Anthos’ Scientific Advisory Board.

John Glasspool, a former leader of Novartis’ cardiovascular franchise with 30 years of experience in the biopharmaceutical industry, joins Anthos as CEO. Mr. Glasspool served as Global Head of Novartis’ Cardiovascular and Metabolic Diseases franchise from 2004-2008 and more recently served as Head of Corporate Strategy and a member of the Executive Team at Baxalta that led its acquisition by Shire.

“I am excited to be leading Anthos upon its formation by Blackstone Life Sciences and Novartis. Anthos is well-positioned to leverage contributions from Blackstone and Novartis to deliver life-saving therapies to patients with cardiovascular disease. We are building a leading cardiovascular company, laser focused on genetically and pharmacologically validated targets.” said Mr. Glasspool.

Anthos Therapeutics is based in Cambridge, Massachusetts.

About Anthos Therapeutics
Anthos Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated therapies for high-risk cardiovascular patient populations. Anthos’ most advanced program is MAA868, an anti- Factor XI / XIa monoclonal antibody, which represents a promising next generation anti-thrombotic investigational therapy with the potential to prevent multiple thrombotic diseases with minimal or no bleeding risk. Anthos is located in Cambridge, Massachusetts.

About Blackstone Life Sciences
Blackstone Life Sciences is a private investment platform with capabilities to invest across the life-cycle of companies and products within the key life science sectors.  By combining scale investments and hands-on operational leadership, Blackstone Life Sciences helps bring to market promising new medicines that improve patients’ lives. In launching this new platform, Blackstone acquired Clarus, a leading global life-sciences firm.

Contacts
Blackstone
Jennifer Friedman
+1 (212) 583-5122
Jennifer.Friedman@blackstone.com

Novartis
Eric Althoff
+1 (646) 438-4335
Eric.Althoff@novartis.com

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Calypso Biotech BV secures 20 Million EUR in Series A Financing and Strengthens Team to Develop Anti-IL-15 Therapeutic Antibody for Autoimmune Diseases.

Inkef Capital

Calypso Biotech, an emerging leader in the development of therapeutic antibodies for autoimmune diseases, announces today the closing of a €20M Series A financing co-led by Gilde Healthcare and Inkef Capital. They are joined by Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and the company’s founding investor M Ventures. Further, Calypso Biotech has become Resident Company at Johnson & Johnson Innovation JLABS at Beerse in Belgium (JLABS@BE). Arthur Franken from Gilde Healthcare will join Fiona MacLaughlin (Inkef Capital), Jeanne Bolger (JJDC) and Jasper Bos (M Ventures) on the Board of Directors.

 

The proceeds from this financing round will support the development of Calypso Biotech’s best-in class anti-Interleukin-15 (IL-15) antibody CALY-002 up to First-in-Patient studies in several autoimmune indications. IL-15 is an immune checkpoint cytokine that controls inflammation as well as multiple tissue-resident immune cells and recently attracted much attention in the immune-oncology space. Especially, IL-15 is being recognized as a key factor in the survival of tissue resident memory T cells, a population of immune cells involved in disease maintenance and recurrence.  Calypso Biotech scientists believe that targeting tissue resident memory T cells offers significant advantages over traditional cytokine interventional approaches and could provide for unprecedented disease-modifying effects.

 

Calypso Biotech has chosen to develop CALY-002 in Eosinophilic Esophagitis (EoE) as well as in other undisclosed auto-immune indications. EoE is a severe and debilitating immune-related chronic disease of the esophagus that is the second leading cause of dysphagia (difficulty in swallowing) in adults. EoE has emerged as a frequent and significant cause of upper gastrointestinal morbidity particularly associated with important quality of life impairment and significant financial healthcare burden. CALY-002 has secured Orphan Drug Designation status from the European Medicines and Food & Drug Administration agencies for EoE.

 

“We believe the unique immunological insight and understanding  for the role of IL15 in disease brought by founders Alain Vicari and Yolande Chvatchko is now ready for translation into a therapy for patients with EoE, for whom limited therapies are available today, as well as in several large auto-immune indications” said Fiona MacLaughlin, Inkef Capital.

 

Calypso Biotech is also announcing major strengthening of its team. Bernard Coulie, current president and CEO of Pliant Therapeutics, will be appointed as independent Chairman of the Board. Together with Alexandre LeBeaut, Executive Vice-President and CSO of Ipsen and current independent Director of Calypso Biotech, they will contribute to develop its strategic vision and corporate success. Prof. Bart Lambrecht, from the VIB-UGent Center for Inflammation Research (Belgium), a leading translational immunology expert, will join Calypso Biotech Scientific Advisory Board. Dr. Josephin-Beate Holz (ex Ablynx NV), Dr Greg Elson (ex Glenmark, Novimmune), Dr Susana Salgado (ex Novimmune), and Duc Tran (ex Prexton Therepeutics, Preglem, Pfizer) will join as medical, manufacturing, non-clinical development and strategic planning advisors, respectively.

 

“We appreciate the confidence placed in our team by a strong and well-balanced investor syndicate” said Alain Vicari, CEO and co-Founder of Calypso Biotech. “With the proceeds of the Series A and our newly recruited team of seasoned experts, we are now well positioned to advance CALY-002 towards value-creating near-term milestones”.

 

 

 About Calypso Biotech BV

Calypso Biotech BV is a private biotechnology company focused on the research and development of novel biologics to address unmet medical need in immunological diseases, especially gastrointestinal indications. Calypso Biotech was established in 2013 as a spin-off by the healthcare business of Merck founded by Alain Vicari, Yolande Chvatchko and M Ventures, and is headquartered in Amsterdam, The Netherlands. Calypso is led by a team with strong experience and track record in translational immunology and the development of biologics, supported by an advisory board of clinical experts. For more information www.calypsobiotech.com

 

About INKEF Capital

INKEF Capital is an Amsterdam-based venture capital firm that focuses on long-term collaboration and active support of innovative technology companies. INKEF Capital was founded in 2010 by Dutch pension fund ABP and with €500 million under management is one of the largest venture capital funds in the Netherlands. INKEF focuses on investment opportunities in Healthcare, Technology, IT/New Media & FinTech. For more information www.inkefcapital.com

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Colisée partners with Armonea Group NV to create the fourth largest elderly care group in Europe

ik-investment-partners

Colisée, a leading player in the elderly care segment in France, Italy and Spain, has signed an agreement to acquire Armonea Group NV, a leading independent senior care organisation in Belgium also active in Spain and Germany. Colisée is supported by the IK VIII Fund and its advisor IK Investment Partners. Financial terms of the transaction are not disclosed and completion of the transaction is subject to regulatory approvals.

Founded in 2008 from the merger of Restel Residences and Group Van den Brande, Armonea is the leading senior care organisation in Belgium, Spain and Germany with more than 17,000 beds under management. The Company manages nursing homes, service flats & residencies. Owned by Verlinvest and Group Van den Brande, Armonea is headquartered in Belgium and employs c. 6,500 FTEs.

The acquisition of Armonea is at the core of Colisée’s strategy to build a European leader in the elderly care segment.

The combination of Armonea and Colisée is based on a complementary geographic profile as well as shared values and vision that will enable synergies at a group level. The combined Group will become the fourth largest European player in the elderly care segment with c. €1bn of revenues.

”This is the combination of two recognised players in their core geographies, with a clear alignment in terms of culture and shared values. Both strive to offer the highest quality of care to their residents. We are very pleased to welcome Armonea’s management team and employees in a combined group totalling c.270 facilities and more than 26,800 residents in five major European countries,” said Christine Jeandel, CEO of Colisée.

”We are delighted and very proud to support Colisée in building the fourth largest European player, thus actively participating in the reshaping of a consolidating industry. We look forward to partnering with an enlarged, experienced and talented management team led by Christine Jeandel,” added Dan Soudry, Managing Partner at IK.

The Group will refinance its existing debt with the support of Barclays, Natixis, SG and CIC. The transaction is subject to regulatory approvals.

Parties involved 
Colisée: Christine Jeandel, Damien Delacourt, Alexis Jungels, Brigitte Siad
IK Investment Partners: Dan Soudry, Rémi Buttiaux, Diki Korniloff, Guillaume Veber, Vincent Valkiers
Buy-side M&A advisors: Lazard (Francois Guichot-Perere, Emmanuel Plantin), Natixis Partners (Ludovic Tron), Case (Damien Segond, William Gobbi)
Buy-side Strategic DD: LEK (Serge Hovsepian, Arnaud Sergent)
Buy-side Financial DD: 8A (Pascal Raidron, Katia Wagner)
Buy-side Legal advisor: White & Case (Thierry Bosly, Muriel Alhadeff, Raphael Richard)
Financing banks: Natixis (Arnaud Brogi), Barclays (Thibery Gleizes), CIC (Brice Bourrely), SG (Patrick Sandray)
Legal advisors financing banks: Latham & Watkins (Xavier Farde)
Sell-side M&A advisors: Rothschild (Franck Demeoen, Jean-Francois Limpens), PJT (Alberto Fernandez, Kiara Mitchinson)

For further questions, please contact: 

Colisée
Marie-Gabrielle de Marchis
Phone: +33 6 69 40 32 17
mg.demarchis@nouvellesaison.com

Armonea
Koen Peeters
Phone: +33 1 70 38 25 54
koen.peeters@armonea.be

IK Investment Partners
Dan Soudry, Partner
Phone: +33 1 44 43 06 60

Mikaela Murekian
Director Communications & ESG
Phone: +44 77 87 573 566
mikaela.murekian@ikinvest.com

About Colisée
Colisée is a key player in the global health care and old-age dependency sector, and has developed a real expertise in elderly people care and well-being. Its network includes 119 facilities in France, Italy and Spain and home-based services agencies in France. In those two business segments, Colisée employs more than 8,000 people. For more information, please visit www.groupecolisee.com

About Armonea
Armonea is the largest independent senior care organisation in Belgium. Every day our 6,500 employees help more than 9,000 seniors enjoy their age in the way that suits them best. In its (almost) 40 years of existence Armonea gained a great deal of expertise in dementia, including with a specialised residential care center in Uccle. Through our dementia knowledge center Anahata, we share this knowledge and experience with our 74 residential care centers in Flanders, Brussels and Wallonia. Armonea also provides stays in residences or assistance homes. Armonea is also active in Spain and Germany. More information about Armonea and our residential care centers on www.armonea.be

About IK Investment Partners
IK Investment Partners (“IK”) is a Pan-European private equity firm focused on investments in the Nordics, DACH region, France, and Benelux. Since 1989, IK has raised more than €9.5 billion of capital and invested in over 125 European companies. IK funds support companies with strong underlying potential, partnering with management teams and investors to create robust, well-positioned businesses with excellent long-term prospects. For more information, visit www.ikinvest.com

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Proposed merger between Widex and Sivantos receives final clearance from European Commission

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eqt

  • Merger creates company with combined revenues of more than EUR 1.7bn
  • Transaction expected to close in early March 2019
  • Truly global footprint through comprehensive sales and distribution platform

Singapore and Lynge, Denmark – February 14, 2019: The European Commission has approved, under the EU Merger Regulation, the merger between Sivantos Pte. Ltd. (“Sivantos”), owned by EQT funds, and Widex A/S (“Widex”), owned by T&W Medical A/S. Sivantos offers a diverse portfolio of technologically advanced hearing aid products across brands like Signia, Audio Service, Rexton and others. Widex’ portfolio of products includes a range of sophisticated hearing aid technology with a focus on the high-end segment.

The Commission concluded the merger would raise no competition concerns. The merger has already been approved in all other relevant jurisdictions.

“Our goal at Widex has always been to develop the best possible hearing aids to improve the life of those with hearing needs. The merger with Sivantos brings us one step closer to that goal by building a company with one of the strongest research and development resources in the business and the sales channels to ensure our innovative products reach as many people as possible,” said Jan Tøpholm, Chairman of Widex A/S.

“The merger between Widex and Sivantos is a transformative combination and unique opportunity to drive innovation through one of the most dynamic R&D teams in the industry to benefit the more than 700 million people with hearing needs,” said Marcus Brennecke, Global Co-Head of EQT Private Equity.

The newly created company will be a global leader with a presence in more than 125 markets, combined revenues of more than EUR 1.7 billion and more than 10,000 employees worldwide. All Widex and Sivantos brands will continue to operate with separate sales forces and organizations following the combination.

The transaction remains subject to final and customary closing conditions. The parties expect the transaction to close in early March 2019.

This press release is translated into multiple languages for information purposes. In case of a discrepancy, the English version shall prevail. To read this press release in Danish, follow this link.

Contacts
Widex | Andrew Arnold (Corporate Communications): +45 25 65 75 47
Sivantos | Gert van Santen (Corporate Communications): +49 152 028 743 20
EQT | Press office: press@eqtpartners.com, +46 8 506 55 334

About Sivantos Group
The business operations of the former Siemens AG hearing aid division have been combined into the Sivantos Group since early 2015. Sivantos can look back on 140 years of German engineering and countless global innovations. Today Sivantos is one of the leading hearing aid manufacturers worldwide, with brands like Signia, Audio Service, Rexton and others. With its around 6,000 employees, the group recorded revenues of 1100 million euros in the fiscal year 2017/2018 and an adj. EBITDA of 262 million euros. Sivantos’ international sales organization supplies hearing care specialists and sales partners in more than 120 countries. Particularly high value is placed on product development. The owners of Sivantos are the anchor investors EQT along with the Strüngmann family as a co-investor. Sivantos GmbH is a brand license holder of Siemens AG.

More info: www.sivantos.com

About Widex
With more than 60 years’ experience developing state-of-the-art hearing technology, Widex (headquartered in Lynge, Denmark) provides hearing solutions that are easy to use, seamlessly integrated in daily life and enable people to hear naturally. One of the world’s leading hearing aid producers, Widex employs around 4,250 people across sales, manufacturing, operations, distribution and R&D in 38 countries, and its products are sold in 105 countries. The current strategy, introduced in 2018, aims at doubling the business in five years. Widex is owned by the Tøpholm and Westermann families, descendants of the founders.

More info: www.widex.com

About EQT
EQT is a leading investment firm with approximately EUR 50 billion in raised capital across 28 funds. EQT funds have portfolio companies in Europe, Asia and the US with total sales of more than EUR 19 billion and approximately 110,000 employees. EQT works with portfolio companies to achieve sustainable growth, operational excellence and market leadership.

More info: www.eqtpartners.com

 

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Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System

GIlde Healthcare

Irvine, CA – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of complete test data to the U.S. Food & Drug Administration (“FDA”) for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging (“MRI”) labeling approval for the Axonics r-SNM® System  for urinary and bowel dysfunction. This data was submitted as an amendment to the Company’s previously filed premarket approval application (“PMA”).

Raymond W. Cohen, CEO of Axonics, commented, “Without this Full Body labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator and lead surgically explanted prior to the MRI scan, resulting in loss of an effective treatment, another surgery for the patient and additional cost to the patient and healthcare system. Our robust testing and analyses conclude that Full Body MRI scans can be safely performed on patients with an implanted Axonics r-SNM system.”

The Axonics r-SNM System is already approved for head and neck MR scans in Europe, Canada and Australia. CE Mark approval of Full Body MRI conditional labeling for the Axonics r-SNM System is currently pending.
Cohen continued, “We met with the FDA in January 2019 and determined it was advantageous to file an amendment to the current literature-based PMA. The FDA now has all of our MRI test data for both head and full body and we believe that, once PMA approved, our r-SNM System will include conditional labeling for 1.5T MRI scans.”

Axonics has performed all the required tests to support Full Body conditional labeling on 1.5T MR scanners for the implantable components of its r-SNM System.
What is MRI Conditional Labeling

MRI is short for Magnetic Resonance Imaging. MR scanners come in different magnet field strengths measured in Tesla or “T”, usually between 0.5T and 3.0T. They also come in varying sizes including open and wide-bore. Simplistically, an MR scanner is a very large, strong magnet into which a patient lies. A radio wave is used to send signals to the body of the patient. The returning signals are received and converted into images by a computer attached to the MR scanner.  The image quality of an MRI depends on signal and field strength.  MRI Conditional Labeling means a product has been tested and demonstrated to pose no known hazards to the patient in a specified MRI environment with specified conditions of use and the results of testing are sufficient to characterize the behavior of the product in the MRI environment. Testing for devices that may be placed in the MRI environment should address magnetically induced displacement force and torque, unintended stimulation, and thermal injury. Other possible safety issues include but are not limited to, image artifact, device vibration, interaction among devices, the safe functioning of the device and the safe operation of the MRI system. Any parameter that affects the safety of the device should be listed and any condition that is known to produce an unsafe consequence must be described.

 

About Overactive Bladder and Sacral Neuromodulation

Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the U.S. and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also a proven therapy to treat urinary retention and fecal incontinence.   Reimbursement for SNM is well established and available in the United States, Europe, Canada and Australia.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is focused on development and commercialization of a novel implantable SNM system for patients with urinary and bowel dysfunction. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia. The r-SNM System offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived stimulator that is qualified to function for at least 15 years. Also included is a tined lead, as well as patient-friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming. For more information, visit the Company’s website at www.axonicsmodulation.com

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

 

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