Acrotec announces the entrance of AFT Micromechanics into their group.

Acrotec strengthens their diversification strategy with the addition to their group of a new company that specialise in the medical field. M Frésard, General Director of AFT Micromechanics who will remain at the head of his company, looks forward to this important move for his company. ” I am extremely happy to join the Acrotec group who will enable us to continue to advance the

Since its creation in 1997, AFT Micromechanics has specialised in the production of implants for orthopaedic and dental surgery as well as in the fields of urology, ENT and ophthalmology.

AFT benefits from extremely high-performance machining technology that guarantees impeccable quality and advantageous production costs. Since 2014, AFT has a 3D printing system for tool production and for the fast manufacturing of prototypes.

M François Billig, President of the Acrotec Group explains the logic behind this new development: “The acquisition of AFT Micromechanics is consistent with our industrial diversification plans by expanding our presence in the high precision medical field”.

– ENDS –

For further information please contact:

M.Michele Caracciolo – Tél. +41 77 410 35 60 – mcb@agencecrp.ch

About AFT Micromechanics :

Located in Fillinges, Haute Savoie (France), the company is situated along the Arve valley. Specialists for over 20 years in the machining of medical devices, they meet all the requirements of this market in order to guarantee an optimal level of quality and continual improvement, AFT Micromechnics are registered with FDA (Food and Drug Administration aux Etats-Unis). The company is certified ISO 13485/2016. www.aft-micromecanique.fr

About the Acrotec Group :

Acrotec is an independent group created by micromechanical professionals. Their main objective is to be the preferred subcontractor offering a wide range of precision component manufacturing processes. Their strategy is both to provide quality products « Swiss Made » to the entire watch-making industry as well as to the automotive, medical, jewellery and aeronautic industries. Acrotec distinguish themselves by their extent of know-how  provided under one roof, in their precision machining (CNC turning, multi-spindle CNC profile-turning, cam profile-turning, 3 & 5 axes milling, micro- profile-turning, transfer and machining of precious metals), by their support processes (surface treatment, gearing, assembling, heat treatment, laser decorating and engraving) and by their specific processes (UV-Liga component manufacturing, EDM, synthetic stone machining, laminating, spring shaping, design and manufacturing of machines and tooling, Silicon etching by DRIE process).  Today, the group has over 800 employees. www.acrotec.ch

Smile Invest announces today that it acquires a majority stake in Rovers Medical Devices (“Rovers”), global market leader in development and production of medical cell-sampling devices. The investment will facilitate the next phase of growth of the company with a focus on product development and leveraging the company’s global sales capabilities.

Rovers is a market leader in the development and production of medical devices used for cytological analysis, bacteriological-, HPV-, viral- and DNA testing. The devices are mainly used for screening of cervical cancer. From its headquarters and production facility in Oss, the Netherlands, Rovers supplies customers in over 50 countries worldwide. Its devices have been used to screen over half a billion women.

CEO and shareholder Meindert Zwart positioned the company as a key player in the market for medical cell-sampling devices. Rovers’ devices have consistently obtained excellent reviews in medical journals and are used together with testing kits from major medical technology companies. With its state-of-the-art production facilities Rovers is able to supply its customers globally while adhering to local regulatory requirements.

Meindert Zwart will stay on board and will reinvest alongside Smile Invest: “The arrival of Smile Invest as new investor offers us the possibility to strengthen our current market position and prepare the organization for further growth. Smile Invest’s expertise in the healthcare sector and access to successful medtech entrepreneurs is of huge value to Rovers.”

Ivo Vincente and Thomas Dewever, managing partners at Smile Invest add: “Rovers Medical Devices has positioned itself as a reference in its market. With the development of new self-sampling devices Rovers is able to tap into a promising market opportunity. Over 40% of women in developed countries are still not regularly being tested for cervical cancer. Rovers can play an important role in lowering the hurdle for screening in developed markets and could also provide medical professionals with tools to bring these tests to developing countries. We look forward to supporting Rovers in a new phase of growth.”

About Smile Invest:
Smile Invest is a European evergreen investment fund with €350 million of assets under management and a long term focus on innovative growth companies in the Benelux financed by around 40 entrepreneurial families. From its offices in Leuven and The Hague the team supports entrepreneurs and management to realise their growth plans based on many years of experience, expertise and an extended network.

Contact:

NL: Ivo Vincente, managing partner Smile Invest – ivo.vincente@smile-invest.com +31 70 76 30 151
Be: Thomas Dewever, managing partner Smile Invest – thomas.dewever@smile-invest.com +32 16 24 42 32

Maincare solutions announces the acquisition of Anticyclone, a leading French provider of speech recognition and document management software for hospitals.

Anticyclone was founded in 2004 and has experienced rapid growth on the back of i) its joint offer which combines best-of-breed speech recognition and document management and ii) strong demand for software optimising workflow management in public hospitals.  It now serves ~100 healthcare institutions and has a total user-base of 22,000 medical professionals.

Maincare and Anticyclone have been partners since 2009.  The acquisition will enable Maincare to embed a best-of-breed solution in its new software platform and drive commercial synergies across the business.  Anticyclone will become a new business unit within the Group.

Cambridge, UK and Indianapolis, US – Acacia Pharma (EURONEXT: ACPH) announces results from its latest study of BARHEMSYS™, its anti-emetic currently under FDA review for the management of post-operative nausea & vomiting (PONV).

The study did not find a significant risk for heart rhythm disturbances (arrhythmias) at the highest proposed dose of BARHEMSYS, given alone or in combination with intravenous ondansetron, a widely used PONV therapy with a known effect on the heart trace.

The data confirm that a single 10 mg dose of BARHEMSYS, which has previously been shown to reduce PONV in clinical trials, will not have a clinically significant effect on the QTc interval, part of the ECG trace which is an important indicator of cardiac risk, even when given with ondansetron. If approved, BARHEMSYS is likely to be given to many patients also receiving ondansetron.

In 30 healthy volunteers, the average maximum effect on the QTc interval of a single 10 mg dose of BARHEMSYS, infused over one minute, was 5.2 milliseconds (90% confidence interval 3.53-6.96 milliseconds). When a standard 4 mg dose of IV ondansetron was given at the same time, the average maximum effect was 7.3 milliseconds (90% confidence interval 5.48-9.16 milliseconds). The internationally agreed threshold level of regulatory concern for serious arrhythmias, such as torsade de pointes, is a mean effect on QTc of 10 milliseconds.

The randomised, double-blind, placebo-controlled, cross-over study, conducted in a specialist Phase 1 trials unit in London, UK, also demonstrated that a second 10 mg dose of BARHEMSYS, given two hours after the first, had a similar pharmacokinetic profile and did not significantly affect the QT or clinical safety profile of the drug. No serious adverse events were reported in the trial and there was no material difference in safety profile between BARHEMSYS (with or without concomitant ondansetron) and placebo.

The most common adverse events were infusion site pain/discomfort, which occurred in eight subjects (28%) with BARHEMSYS alone, nine subjects (30%) with BARHEMSYS plus ondansetron and 12 subjects (40%) with placebo; and headache, which occurred in four subjects (14%) with BARHEMSYS alone, three subjects (10%) with BARHEMSYS plus ondansetron and two subjects (7%) with placebo.

BARHEMSYS is currently under review by FDA for the proposed indications of the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics, with a target action date of May 5, 2019.

About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients. Acacia Pharma has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
Acacia Pharma’s lead project, BARHEMSYS™ for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma is based in Cambridge, UK and its US operations are centered in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
Website: www.acaciapharma.com

About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing €1 billion across two business lines: a venture & growth capital fund and a lower mid-market buy-out fund. Gilde Healthcare’s venture & growth capital fund invests in medtech, digital health and therapeutics. The portfolio companies are based in Europe and North America. Gilde Healthcare’s lower mid-market buy-out fund invests in profitable European healthcare services companies with a focus on the Benelux and DACH-region. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market.
Website: www.gildehealthcare.com

Gilde Healthcare II is supported by the European Communities Growth and Employment Initiative, MAP – ETF Start-up Facility.

3i Group plc (“3i”), and funds managed by 3i, have entered into a sale and purchase agreement to sell their investment in OneMed, the leading medical supplies distributor in Northern Europe, to Nalka Invest AB.

Proceeds to 3i will be c. £100m. The transaction is expected to complete in March 2019, subject to customary antitrust approvals.

3i invested in OneMed in 2011. During 3i’s ownership, the company successfully strengthened its market positions in Sweden, Denmark and Finland and built its international footprint through three strategic acquisitions in the Netherlands and a major expansion in Norway.

For further information, contact:
3i Group plc
Silvia Santoro
Investor enquiries
Kathryn van der Kroft
Media enquiries
Tel: +44 20 7975 3258
Email: silvia.santoro@3i.com
Tel: +44 20 7975 3021
Email: kathryn.vanderkroft@3i.com

Irvine, CA – January 7, 2019 —

Smile Brands Inc. announced today it has made a strategic investment in support of DecisionOne Dental Partners based in Schaumburg, Illinois. The investment will help fund DecisionOne’s continued growth and acquisitions throughout Chicagoland and neighboring states. DecisionOne Dental Partners management will continue to lead and operate the business.

Smile Brands Inc. is a leading dental support organization (DSO) that provides business support services to over 400 locations across 17 states. Smile Brands is able to provide DecisionOne significant expansion capital as well as access to additional business support services. CEO Dr. AJ Acierno of DecisionOne and CEO Steve Bilt of Smile Brands realize the future of mid-market DSOs is to have an investment and business support partner like Smile Brands who has services that can help accelerate growth while continuing to meet the needs of providers and patients.

DecisionOne was founded in 2011 by two brothers, Dr. AJ Acierno and Dr. Mike Acierno. It is one of the most respected and fastest growing dental support organizations in the U.S. with approximately 30 affiliated practices in the Chicago area. By blending the values of a solo practitioner dental office with the business efficiencies of larger group practices, DecisionOne has created a proven partnership model that puts patients first while helping providers navigate the increasing complexity of the dental landscape.

“Many DSOs help remove day to day management headaches allowing providers to focus on clinical excellence. At DecisonOne, we go beyond standard DSO administrative support by building offices around our doctors instead of simply inserting providers into cookie cutter offices,” explains Dr. AJ Acierno. “This approach allows us to create individual office cultures that result in lasting patient relationships. We believe strongly that building patient relationships based on trust is the key to guaranteeing access to care and making patients better.”

The world of dentistry has changed dramatically over the past several decades. Dental students are graduating with high amounts of debt, technologic advancements require higher overhead and payment administration is increasingly complex. More and more providers are looking to affiliate with a dental support organization, but finding the right fit is imperative. Smile Brands CEO, Steve Bilt understands the importance of there being a strong cultural connection in any partnership.

“Today there are hundreds of DSOs and thousands of group practices in the U.S.,” says Bilt, “Each group has its unique affiliation model in terms of financial compensation, business support and management processes, but the success of a partnership comes down to whether the groups share a common set of values. Our investment behind DecisionOne is as much about shared values as it is about business expansion. I am confident that Drs. AJ, Mike and the rest of the DecisionOne team will further our mission of delivering Smiles for Everyone®.”

Dr. Mike Acierno, Chief Dental Officer, insists that clinical autonomy is key in a patient-first delivery model. “After dental school, I went into private practice and AJ took the DSO path,” explains Mike. “That gives us a unique perspective on the industry and how to improve the lives of our patients, team members and providers. When it came time to find a partner, we needed to find someone as committed to our patient care model as we are.”

About Smile Brands 
Based in Irvine California, Smile Brands Inc. is one of the largest providers of support services to dental groups in the United States. Smile Brands provides expansion capital and access to support services to independent dental groups and DSOs. The organization delivers comprehensive business support services through exclusive long term agreements with affiliate dental groups, so dentists can spend more time caring for their patients and less time on the administrative, marketing, and financial aspects of operating a dental practice. Smile Brands supports over 400 Bright Now!® Dental, Monarch Dental®, Castle Dental®, A+ Dental Care, OneSmile Dental, Johnson Family Dental, P3 Dental Group, and DecisionOne Dental offices in 17 states, including Arizona, Arkansas, California, Colorado, Florida, Illinois, Indiana, Maryland, Nevada, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Washington. Smile Brands is a portfolio company of Gryphon Investors, a leading middle-market private equity firm based in San Francisco, CA. For more information, visit www.smilebrands.com.

About DecisionOne Dental Partners 
DecisionOne Dental is a network of carefully curated dental professionals who value personal doctor-patient relationships and high quality of patient care. Over the last decade, the growing complexity of the dental sector has diluted doctors’ focus and led to a reduction in the perception of patient care and trust. DecisionOne Dental Partners was founded by brothers Dr. AJ and Dr. Mike Acierno, both practicing family dentists, who believe dentistry can thrive locally while adhering to the core values that support patients above all else. With approximately 30 current locations, DecisionOne is the fastest growing dental group in Illinois. The Chicago Tribune named them one of the top midsized workplaces in the Chicago area for 2018, plus Acierno Dental in Schaumburg was recently featured in Chicago magazine’s “2018 Top Doctors” issue named as a top Chicagoland dental practice. For more information about DecisionOne Dental or to find a dentist, visit www.decisiononedental.com.

BRISBANE, Calif.–(BUSINESS WIRE)–Jan. 4, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that it has entered into a $170 million loan agreement with an affiliate of KKR, a leading global investment firm.

“The addition of the KKR loan financing to Aimmune’s capital resources is expected to fully fund the commercialization of AR101, an investigational biologic oral immunotherapy for the treatment of peanut allergy,” said Eric Bjerkholt, Chief Financial Officer of Aimmune Therapeutics. “In addition, this financing secures resources to support the continued advancement of our pipeline of additional food allergy treatments, including the Phase 2 trial of AR201 for egg allergy, which is anticipated to commence this year.”

In December 2018, Aimmune submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration(FDA) for AR101 for the treatment of peanut allergy in children and adolescents ages 4–17 years based on data from the landmark Phase 3 PALISADE trial, which met its primary and key secondary endpoints, and from additional ongoing and completed AR101 clinical trials. The FDA has granted Breakthrough Therapy Designation to AR101 for the desensitization of peanut-allergic patients 4–17 years of age.

The loan agreement provides Aimmune with an up to $170 million term loan in three tranches. Forty million dollars was funded at close, with $85 million to follow upon FDA approval of AR101 and satisfaction of other customary borrowing conditions, and $45 million at the company’s option in 2020 upon the satisfaction of certain borrowing conditions. The loan can be prepaid at Aimmune’s discretion, at any time, subject to prepayment fees. Further information with respect to the term loan is set forth in a Form 8-K filed by Aimmune with the Securities and Exchange Commission on January 4, 2019.

Aimmune reported September 30, 2018, cash, cash equivalents and short-term investments of $255 million. With the $98 million equity investment from Nestlé Health Science announced in November 2018 and the $170 million KKR loan, assuming full borrowings under all tranches, Aimmune’s capital resources as of September 30, 2018, would have exceeded $500 million.

For KKR, the investment is part of the firm’s Health Care Royalty and Income strategy, which is focused on providing non-dilutive capital to companies for which KKR can help reach scale and achieve strategic objectives.

“Aimmune is leading the way in meeting the critical, growing need to offer treatment to the millions of people affected by food allergies,” said Emily Janvey, M.D., Head of Health Care Royalty and Income strategy at KKR. “We’re proud to help support Aimmune’s important work, especially as the company prepares to launch what could be the world’s first approved medical treatment for peanut allergy.”

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™ is AR101. Aimmune intends to submit a regulatory filing for marketing approval of AR101 in Europe during the first half of 2019 based on data from Aimmune’s pivotal Phase 3 PALISADE clinical trial of AR101, which in 4–17-year-old subjects met its primary and key secondary endpoints, and additional ongoing and completed AR101 clinical trials. Aimmune has filed an IND application for its second product, AR201, for the treatment of egg allergy and intends to start a randomized Phase 2 clinical trial in the first half of 2019. For more information, please see www.aimmune.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_Co.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the timing and availability of the full amount of proceeds under the loan agreement; Aimmune’s expectations regarding the sufficiency of its cash resources; Aimmune’s expectations regarding the potential benefits of AR101; Aimmune’s expectations regarding the potential commercialization of AR101, including the timing of a potential approval of AR101; Aimmune’s expectations on the timing of initiating a Phase 2 clinical trial for AR201; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 for peanut allergy in Europe; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the satisfaction of closing conditions for each subsequent tranche of the loan agreement; the expectation that Aimmune will need additional funds to finance its operations; Aimmune’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune’s most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This press release concerns AR101, a product that is under clinical investigation, and AR201, a product that Aimmune expects will be under clinical investigation in 2019. Neither AR101 nor AR201 has been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). AR101 and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190104005280/en/

Source: Aimmune Therapeutics, Inc.

Aimmune
Investors
Laura Hansen, Ph.D.
(650) 396-3814
lhansen@aimmune.com

Media
Alison Marquiss
(650) 376-5583
amarquiss@aimmune.com

KKR
Kristi Huller or Samantha Norquist
(212) 750-8300
media@KKR.com