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Kelly Zitlow, 847-858-5230
kelly.zitlow@waterstreet.com

Viant Acquires Meraqi Medical

Viant, a leading global services provider to the medical device industry, announced today that it has acquired Meraqi Medical.  It is the fourth acquisition that Viant has completed in two years to expand its clinical market expertise, global footprint, and portfolio of solutions.

Headquartered in Silicon Valley, Meraqi extends Viant’s expertise in front-end design and development for interventional technologies and bioelectronics, and expands Viant’s platform within minimally invasive surgical devices. Meraqi also adds a West Coast design and development (D&D) hub to Viant’s East Coast D&D Center and global network of manufacturing sites. Viant will incorporate Meraqi’s engineering expertise and design capabilities into its suite of solutions that support customers with expanding their product offerings, optimizing their supply chains, and improving quality while managing costs.

“Meraqi stands out for its deep technical knowledge, passion for innovation and agility to help customers advance their technologies,” said Declan Smyth, president of Franchise, Viant. “Adding Meraqi’s expertise to Viant’s breadth of capabilities and global scale provides our customers with expanded access to end-to-end solutions for all their medtech needs.”

“Joining Viant will give our customers access to a world class, quality focused organization with global manufacturing facilities and scale,” said founder Al Hershey. “Additionally, this will enable Meraqi to accelerate the expansion of our capabilities and better serve our customers. Our shared passion for supporting innovative devices to address unmet patient needs and loving what we do makes this a very exciting time for our two companies and for our customers.”

Since partnering with Water Street Healthcare Partners and JLL Partners in 2016, Viant has grown to become one of the world’s premier outsourced manufacturers of medical devices.  The company has expanded its portfolio of design, development, and manufacturing capabilities to offer end-to-end solutions to medical device organizations.  Most recently, Viant announced the appointment of Alton E. Shader, a veteran medical device leader, to chief executive officer to accelerate the company’s strategic expansion.

About Meraqi Medical

Meraqi is a medical device design, development and manufacturing services firm that was established by industry veterans with an unyielding passion for innovation and for servicing customers. With many decades of combined experience, the Meraqi team provides expertise in bioelectronics and interventional and minimally invasive surgical devices. Meraqi provides everything from early brainstorming, concepting, and prototyping to clinical and commercial manufacturing. Meraqi has class 7 & 8 certified cleanrooms and is ISO13485:2016 certified. Learn more at www.meraqi.com.

About Viant

Viant is a global strategic manufacturing partner that helps medical device OEMs bring complex medical devices and components to market. Our deep materials expertise, combined with our experience in design, manufacturing, assembly, and packaging, allow us to bring our customers’ medical technology solutions to life. With nearly 6,000 associates across 24 locations worldwide, we are the perfect combination of big company scale and small company attention. For more information, visit www.viantmedical.com.

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Water Street Acquires THREAD

Water Street and JLL Partners announced today that they have acquired THREAD, an innovative provider of technology that enables virtual research approaches to modernize clinical studies and registries. Headquartered in Orange County, Calif., THREAD will leverage the investment to accelerate the expansion of its global offering.

THREAD’s platform and services are designed to make clinical trials and registries more accessible and less costly by replacing patient visits at investigator sites with technology-enabled interactions at more convenient locations, including patients’ homes. Growing numbers of biopharma, life science companies, contract research organizations (CROs), and non-profit researchers are engaging THREAD’s virtual research platform to capture clinical study data in between, as well as during or instead of clinic visits.  The company’s platform supports an integrated suite of user-friendly, highly configurable applications that support eConsent, ePRO/eCOA, patient engagement, telehealth virtual visits, site data capture, and medical device and consumer sensor connection.

“Water Street and JLL are the ideal partners for THREAD to accelerate our strategic expansion and solutions to our customers. Their life science expertise and resources will enable us to grow in a thoughtful way that will benefit all of our customers,” said Jeff Frazier, founder and chief executive officer, THREAD.

John Reites, partner and chief product officer, THREAD, added, “We’re excited to expand THREAD’s platform to modernize clinical research for our customers, participants, and sites.  This partnership will further our commitment to make virtual research approaches the standard in studies and registries.”

Water Street and JLL will invest their combined industry experience and network of resources to further develop and expand THREAD’s offering on a global scale. With this support, THREAD will extend its platform to offer customers a broader range of options that can be configured to address their individual needs by engaging components of its technology as standalone point solutions or activating its full suite of capabilities.

Mark A. Goldberg, M.D., a veteran life science leader who has been appointed executive chairman of THREAD, remarked, “THREAD’s platform is highly valued for its user-centric design, flexibility, ease of use, and broad functionality. Working together with our customers, we have the exciting opportunity to advance the next generation of clinical trials to accelerate product development and innovation.”

Last fall, Water Street and JLL invested in CATO Research, a company specializing in drug development support.  Dr. Goldberg, who also serves as executive chairman of CATO, said, “there are many opportunities for THREAD and CATO to collaborate in developing emerging approaches to clinical development.”

THREAD’s leadership team will continue to spearhead the company’s day-to-day operations, and report to Dr. Goldberg. Financial terms of Water Street and JLL’s investment are not being disclosed.

About THREAD

THREAD is a virtual research platform used by biopharma, CROs, non-profit researchers, and life science organizations to capture global clinical study data in between, as well as during and instead of clinic visits. Study sponsors and CROs work with THREAD to provide a more modern and technology-enabled experience for patients, sites, and their study teams. THREAD's platform and supporting services are designed to help customers reduce study launch timelines and budgets with Virtual Visits.  Visit www.THREADresearch.com for more information.

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Water Street Company Achieves Another FDA Approval

Water Street announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval of Insulin Human in 0.9% Sodium Chloride Injection (Insulin Human).  It is the first and only ready-to-use insulin for IV infusion.

The new presentation of Insulin Human features an extended shelf life of 30 days at room temperature (77 degrees Fahrenheit /25 degrees Celsius) or 24 months if refrigerated (36 – 46 degrees Fahrenheit/2-8 degrees Celsius) in the original carton to protect from light.  The product is provided in a standardized concentration of 100 units/100 mL in a flexible plastic container.

The approval of Insulin Human marks the eighth drug product successfully developed by Water Street’s company, Celerity Pharmaceuticals, LLC. Celerity funded, developed, and led the approval process of Insulin Human. After gaining FDA approval, Celerity transferred ownership of the product to its medical products company partner.

“We’re honored to be part of successfully developing this innovative presentation of insulin to advance our partner’s goal of introducing medicines in new presentations that help promote clinician efficiency and advance patient care,” said Dan Robins, Ph.D., president, Celerity.

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Pathnostics Announces CEO Appointment

Pathnostics, a diagnostic solutions company, announced today that its board of directors has appointed Samuel D. Riccitelli as chief executive officer, effective July 29, 2019.  With more than 30 years of experience in global laboratory services and specialty testing, Mr. Riccitelli will spearhead the fast-growing company’s continued expansion.  He will assume the CEO position from co-founder, David Pauluzzi, who will continue to serve on the board of directors as part of a planned leadership transition.

Mr. Riccitelli began his career as a biomedical engineer before joining Becton, Dickinson and Company,  where he led a patient safety start-up venture.  As executive vice president and chief operating officer at Genoptix, Inc., Mr. Riccitelli directed the company’s rapid growth and successful transformation into one of the world’s leading diagnostic reference laboratories. More recently, he served as president and CEO of Signal Genetics, Inc., a molecular diagnostic company acquired by Quest Diagnostics, Inc. and Miragen Therapeutics, Inc.

“Sam is an entrepreneurial executive who is passionate about building high-growth, high-service laboratory and specialty testing businesses.  His industry knowledge and operations experience will be key to advancing our goal of expanding Pathnostics’ innovative technology into new tests and therapies,” said Mr. Pauluzzi. “It’s been incredible to be part of building Pathnostics from the ground up and Sam is the ideal leader to take our company to the next level.”

Founded in 2014, Pathnostics specializes in diagnostic tests and services across a range of therapeutic areas, including urology, women’s health, and gastroenterology.  The company has grown rapidly in recent years as increasing numbers of specialists have adopted its Guidance test, which uses proprietary molecular technology to simultaneously diagnose and guide antibiotic treatment for complex, recurring urinary tract infections.  Earlier this year, Pathnostics chose to partner with Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, to extend its technology and product portfolio into new tests and therapeutic areas.

“It’s truly a privilege to join Pathnostics and be part of expanding its unique technology to benefit patients in new ways,” said Mr. Riccitelli.  “Dave and the team have established a robust platform that provides substantial opportunity to grow Pathnostics, and I’m eager to begin working with everyone to bring these opportunities to fruition.”

About Pathnostics

Pathnostics is a diagnostic solutions company that pioneers innovative approaches for improved patient care.  Leveraging its proprietary technology, the company develops solutions that address diagnostic and therapeutic issues for physicians and patients.  Headquartered in Irvine, Calif., Pathnostics is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.  For more information about the company and its portfolio of products, visit pathnostics.com.

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Key Surgical Signs Agreement to Acquire Insitumed

Key Surgical LLC, a leading global provider of sterile processing and operating theatre supplies, announced today that it has signed an agreement to acquire Hamburg, Germany-based Insitumed GmbH. The strategic acquisition will broaden Key Surgical’s portfolio of endoscopy products and further extend its global footprint.

The acquisition of Insitumed is Key Surgical’s most recent initiative to expand its suite of products and supplies focused on improving patient safety and surgical outcomes. Since merging in 2017 with Interlock Medizintechnik GmbH and Clinipak, Ltd., Key Surgical has grown to serve more than 10,000 hospitals and surgical centres across 70 countries.  The company will add Insitumed’s endoscopy offering to its portfolio of more than 5,000 products and supplies utilized for patient procedures, and cleaning and sterilizing surgical instrumentation.

JV Wulf, president, Key Surgical Europe, said, “Insitumed is highly regarded for its innovative customer-centric product development and its strong relationships with hospital-based endoscopy departments and office-based practices.  Bringing our companies together marks another exciting step forward for Key Surgical, as we continue to broaden and enhance our product offering to benefit our customers and their patients around the world.”

Wolfgang Drews, managing director, Insitumed, added, “We’re pleased to be joining with Key Surgical. Our product offerings are very complementary and together we have an important opportunity to significantly enhance our product offering to customers and extend our reach into new geographic markets.”

Financial terms of the acquisition are not being disclosed.

About Key Surgical

Key Surgical is a leading global provider of sterile processing and operating room supplies. The company offers a broad suite of thousands of products and supplies focused on instrument reprocessing, operating room, and patient procedures to nearly 10,000 facilities in 70 countries. Headquartered in Eden Prairie, Minnesota, Key Surgical is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. For more information, visit keysurgical.com.

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Viant Appoints Longtime Medical Device Leader to CEO

Viant, a leading global services provider to the medical device industry, announced today that its board of directors has appointed Alton E. Shader to chief executive officer, effective July 15, 2019.  Mr. Shader, who brings more than 20 years of medical device leadership experience to Viant, will spearhead the company’s continued expansion.  He assumes the CEO position from Brian King, who will continue to serve as a senior advisor to the company.

Mr. Shader is highly regarded for driving growth across a range of medical device companies.  As president of Front Line Care for Hill-Rom Holdings, Inc., he spearheaded two major acquisitions, including Welch Allyn, to establish the company’s fastest-growing and most profitable global business. Mr. Shader previously led North America for Hill-Rom, where he designed and implemented a customer-focused commercial organization, which achieved record levels of profitable growth.  Prior to Hill-Rom, Mr. Shader held senior positions in Europe for Baxter International before being promoted to general manager of its U.S. Renal business. He most recently served as president and CEO of Vein Clinics of America.

“Alton’s laser focus on serving the customer, combined with his operational discipline and extensive global experience make him the ideal leader to guide Viant through the company’s next stage of expansion,” said John Greisch, chairman, Viant.  “I want to take a moment to thank Brian for helping us to establish Viant’s strong foundation. We have a tremendous opportunity to build on Viant’s global network of solutions to address the full continuum of our customers’ manufacturing services needs.”

Viant has bolstered its portfolio of manufacturing solutions to the medical technology industry.  Over the past three years, the company has made significant organic investments and completed three strategic acquisitions to become one of the world’s leading outsourced contract manufacturers of medical devices.

“Viant’s commitment to becoming a long-term strategic partner to the world’s leading medical device companies is why I wanted to become part of this organization.  I’m excited to build on Viant’s end-to-end solutions to support our customers by expanding their product offerings, optimizing their supply chains, and improving quality while managing costs on a global scale,” said Mr. Shader.

About Viant

Viant is a global strategic manufacturing partner that helps medical device OEMs bring complex medical devices and components to market. Our deep materials expertise, combined with our experience in design, manufacturing, assembly, and packaging, allow us to bring our customers’ medical technology solutions to life. With nearly 6,000 associates across 24 locations worldwide, we are the perfect combination of big company scale and small company attention. For more information, visit www.viantmedical.com.

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Perrigo Announces Another FDA Approval in Partnership with Water Street Company

Perrigo Company plc (NYSE; TASE: PRGO) today announced its product development partner received final approval from the U.S. Food and Drug Administration for its AB-rated Abbreviated New Drug Application (“ANDA”) referencing Metrogel-Vaginal® (metronidazole vaginal gel 0.75%).  Perrigo will acquire full ownership of the ANDA under a pre-existing arrangement with its partner within 30 days and anticipates launching this product immediately thereafter.

Annual market sales for MetroGel-Vaginal® for the 12 months ending May 2019 were approximately $100 million as measured by IQVIA™.

The product is manufactured by Perrigo and was developed through its partnership with Capstone Development Solutions, a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.

Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan stated, “This launch exemplifies Perrigo's commitment to developing and launching products within the extended topicals category. Our robust R&D pipeline remains focused on introducing more products that will create savings for patients and the U.S. healthcare system.”

 About Perrigo

Perrigo Company plc (NYSE;TASE: PRGO) is dedicated to making lives better by bringing “Quality, Affordable Self-care Products™” that consumers trust everywhere they are sold. The Company is a leading provider of over-the-counter health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at http://www.perrigo.com.

 Forward-Looking Statements

Certain statements in this press release are “forward-looking statements.” These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “forecast,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, including: the timing, amount and cost of any share repurchases; future impairment charges; the success of management transition; customer acceptance of new products; competition from other industry participants, some of whom have greater marketing resources or larger market shares in certain product categories than the Company does; pricing pressures from customers and consumers; resolution of uncertain tax positions, including the Company’s appeal of the Notice of Assessment (the “NoA”) issued by the Irish tax authority and the Notice of Proposed Assessment (“NOPA”) issued by the U.S. Internal Revenue Service and the impact that an adverse result in such proceedings would have on operating results, cash flows, and liquidity; potential third-party claims and litigation, including litigation relating to the Company’s restatement of previously-filed financial information and litigation relating to uncertain tax positions, including the NoA and the NOPA; potential impacts of ongoing or future government investigations and regulatory initiatives; the impact of tax reform legislation and healthcare policy; general economic conditions; fluctuations in currency exchange rates and interest rates; the consummation of announced acquisitions or dispositions and the success of such transactions, and the Company’s ability to realize the desired benefits thereof; and the Company’s ability to execute and achieve the desired benefits of announced cost-reduction efforts and strategic and other initiatives.  Statements regarding the separation of the RX business, including the expected benefits, anticipated timing, form of any such separation and whether  the separation ultimately occurs, are all subject to various risks and uncertainties, including future financial and operating results, our ability to separate the business, the effect of existing interdependencies with our manufacturing and shared service operations, and the tax consequences of the planned separation to the Company or its shareholders. Furthermore, the Company may incur additional tax liabilities in respect of 2016 and prior years or be found to have breached certain provisions of Irish company law in connection with the Company’s restatement of previously-filed financial statements, which may result in additional expenses and penalties. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2018, as well as the Company’s subsequent filings with the United States Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

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Eversana Announces Acquisition

EVERSANA,™ the leading independent provider of commercial services to the life science industry, today announced the acquisition of Alamo Pharma Services®, Inc. and BexR Logistix®, LLC Telesales from Mission Pharmacal® Company.  Headquartered in Doylestown, Pa., Alamo is a leader in field sales, marketing and clinical solutions for pharmaceutical and biotech companies. BexR Telesales, operated from Broomfield, Colo. and previously a part of BexR Logistix, is also included in today’s acquisition.

EVERSANA offers a fully integrated and independent commercial services platform designed to solve pricing, access, reimbursement, adherence and product delivery challenges in the life science sector. With the acquisition of Alamo and BexR Telesales, EVERSANA adds comprehensive Field Solutions powered by digital and data capabilities, including sales representatives, telesales, reimbursement specialists, key/national account managers, clinical nurse educators, medical science liaisons, recruiting, training and complete back office operational support.

“Pharmaceutical companies face unprecedented challenges and need a fully resourced partner to drive commercial success from planning and operations to front-line brand representation,” said Jim Lang, CEO. “Field solutions are rapidly becoming more sophisticated, clinically oriented and data-driven. Adding Alamo’s leadership in this space to our full commercial platform creates a seamless experience where we can both describe value and capture the data to measure value for all patients, payers, and providers.”

Alamo and BexR Telesales operations will transition to the EVERSANA brand in the coming quarter and Alamo’s Chief Operating Officer Peter Marchesini will become president, Field Solutions and his team will transition immediately to EVERSANA.

“For our clients and employees, this is the perfect move during a pivotal time in the life science services industry,” shared Marchesini. “Being a part of EVERSANA’S emerging platform gives our current clients immediate access to expanded best-in-class services and solutions to address any commercial challenge. Additionally, our employees will grow with an organization that offers impressive benefits and opportunities for professional growth. We’re excited for the next chapter and adding value for all.”

Financial details of the acquisition are not being disclosed.

About EVERSANA™

EVERSANA™ is the leading independent provider of global services to the life science industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product lifecycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

About Mission Pharmacal

Mission Pharmacal Company is a privately held pharmaceutical company based in San Antonio, Texas. For more than seven decades, the company has been improving the lives of people through every stage of life by manufacturing and delivering innovative, high-quality prescription, over-the-counter, and dietary supplement products in the therapeutic areas of women’s health, urology, pediatrics, dermatology, and primary care. For additional information, please visit missionpharmacal.com.

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Perrigo Announces FDA Approval in Partnership with Water Street Company

Perrigo Company plc (NYSE; TASE: PRGO) today announced its partner received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) referencing Voltaren® Gel, 1% (diclofenac sodium topical gel, 1%). Perrigo will acquire full ownership of the ANDA under a pre-existing arrangement with its partner within 30 days. The Company anticipates launching this product within the next two months.

Annual market sales for Voltaren® Gel, 1% for the 12 months ending March 2019 were approximately $350 million as measured by IQVIA™.

Perrigo will manufacture diclofenac sodium topical gel 1% in its plant in Israel. The product was developed through its partnership with Capstone Development Solutions, a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.

Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan stated, “This is our fifth extended topical ANDA approval in 2019 which demonstrates our commitment to delivering high quality affordable extended topical products for patients in important categories.  Our strategic partnership with Water Street enables us to accelerate this commitment and lower the cost of healthcare for consumers.”

About Perrigo

Perrigo Company plc (NYSE;TASE: PRGO) is dedicated to making lives better by bringing “Quality, Affordable Self-care Products™” that consumers trust everywhere they are sold. The Company is a leading provider of over-the-counter health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at http://www.perrigo.com.

Forward-Looking Statements

Certain statements in this press release are “forward-looking statements.” These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “forecast,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, including: the timing, amount and cost of any share repurchases; future impairment charges; the success of management transition; customer acceptance of new products; competition from other industry participants, some of whom have greater marketing resources or larger market shares in certain product categories than the Company does; pricing pressures from customers and consumers; resolution of uncertain tax positions, including the Company’s appeal of the Notice of Assessment (the “NoA”) issued by the Irish tax authority and the Notice of Proposed Assessment (“NOPA”) issued by the U.S. Internal Revenue Service and the impact that an adverse result in such proceedings would have on operating results, cash flows, and liquidity; potential third-party claims and litigation, including litigation relating to the Company’s restatement of previously-filed financial information and litigation relating to uncertain tax positions, including the NoA and the NOPA; potential impacts of ongoing or future government investigations and regulatory initiatives; the impact of tax reform legislation and healthcare policy; general economic conditions; fluctuations in currency exchange rates and interest rates; the consummation of announced acquisitions or dispositions and the success of such transactions, and the Company’s ability to realize the desired benefits thereof; and the Company’s ability to execute and achieve the desired benefits of announced cost-reduction efforts and strategic and other initiatives.  Statements regarding the separation of the RX business, including the expected benefits, anticipated timing, form of any such separation and whether  the separation ultimately occurs, are all subject to various risks and uncertainties, including future financial and operating results, our ability to separate the business, the effect of existing interdependencies with our manufacturing and shared service operations, and the tax consequences of the planned separation to the Company or its shareholders. Furthermore, the Company may incur additional tax liabilities in respect of 2016 and prior years or be found to have breached certain provisions of Irish company law in connection with the Company’s restatement of previously-filed financial statements, which may result in additional expenses and penalties. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2018, as well as the Company’s subsequent filings with the United States Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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Orgentec Appoints Gary Winer to President & CEO

Orgentec Diagnostika, a leading specialty diagnostics company, announced today that its board of directors has appointed Gary Winer to president and chief executive officer, effective immediately.  Mr. Winer will leverage his global healthcare leadership experience to further Orgentec’s long-term growth and position as one of the world’s premier providers of diagnostic assays specializing in autoimmune and infectious diseases.

Over the course of his more than 20-year career, Mr. Winer has held senior leadership positions on an international scale with numerous diagnostic and pharmaceutical businesses, including AbbVie, Inc., Abbott Laboratories and Pfizer.  He has spearheaded successful launches and growth of blockbuster product lines, namely Celebrex and Humira, in the United States, Latin America, Asia and Japan.  During his nearly 10 years with Abbott, Mr. Winer managed the company’s diagnostic business in the U.S., Canada and Latin America before being promoted to lead Abbott Japan, the company’s largest affiliate outside the U.S.  In addition to driving strong growth, Mr. Winer was instrumental in helping the business to achieve “Best Places to Work” recognition three years in a row.  He continued in this leadership role after planning and completing the separation of Abbott’s pharmaceutical business in Japan to form AbbVie.

“The combination of Gary’s diagnostic and global experience is the ideal match for Orgentec. We’re thrilled to gain the benefit of his years of industry expertise and insight as we build and enhance Orgentec’s global reach, sizeable installed instrument base, and unique menu of diagnostic tests to support health care providers around the world with identifying rare conditions and diseases,” said Scott Garrett, chairman, Orgentec.

Founded in 1988, Orgentec is an established leader in the specialty diagnostics market, serving hospitals and reference laboratories throughout Europe and the U.S., as well as the emerging markets of Asia, Latin America and the Middle East.  Since partnering in 2014 with strategic healthcare investor Water Street Healthcare Partners, Orgentec has expanded its global footprint and menu of more than 300 tests through a combination of organic initiatives and acquisitions.  Water Street worked with Orgentec’s leadership team to recruit Mr. Winer to continue the company’s strategic expansion.

"I’m delighted to join Orgentec at this important point in the company’s evolution to becoming a world-class specialty diagnostics provider.  I’d like to thank Water Street and the board for their confidence in me to build upon the successful foundation established by my predecessor, Jim Widergren,” said Mr. Winer.  “I look forward to working with the outstanding team of professionals across the company to continue to expand our product offerings, particularly for our Alegria product line with its proprietary autoimmune and infectious disease testing menu."

In addition to his appointment as president and CEO, Mr. Winer will serve as a member of Orgentec’s board of directors.  Jim Widergren will continue to lead Corgenix, Orgentec’s U.S. business subsidiary, and also will continue to serve as a member of Orgentec’s board.

About Orgentec

Headquartered in Mainz, Germany, ORGENTEC Diagnostika offers one of the industry’s most comprehensive portfolios in autoimmune diagnostics and cardiovascular diagnostics with additional strengths in infectious disease and organ function testing. Alegria®, the automated instrument for autoimmune and infectious disease serology enables labs to complete multiple assays and deliver faster results at minimum cost. With subsidiaries in Austria, Hungary, France, U.S. and China, as well as an established global network of distribution partners, ORGENTEC’s products are benefitting patients in over 100 countries around the world.  Orgentec is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.  For more information, visit orgentec.com.

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