Pipeline Biomedical Holdings and its subsidiaries are led by an experienced team of executives and professionals with proven strengths that cover all aspects of the medical device business. Our Management Team has a strong track record of developing and commercializing new products and creating shareholder value. This spirit of entrepreneurship lives on in Pipeline Biomedical Holdings.
The team's last venture was Implex Corp., where a novel biomaterial was developed, numerous patents issued, and over 30 unique spine, trauma, reconstructive orthopaedic and neuro products were commericialized, with the business being acquired for over $220 million. Pipeline Biomedical possesses the industry knowledge, scientific skills, financial know-how, sales and marketing experience, and operations efficiency to rapidly translate ideas into products and market success in a cost effective manner.
As a successful entrepreneur creating and selling several medical device companies,
Mr. Khowaylo provides broad experience in recognizing the value of technology and products. As senior executive, Mr. Khowaylo knows how to build effective organizations to maximize investor return while minimizing operating expenditures.
Previously, Mr. Khowaylo served as Chairman, CEO and President of Implex Corp, a company he founded. Implex brought a novel biomaterial into reality through coordinated testing, animal studies, human clinical studies, and the building of a unique manufacturing facility. The company focused on reconstructive, spinal, trauma and sports medicine device development. Implex entered into strategic partnerships with large market-leading companies such as Medtronic, Synthes-Stratec, and Zimmer Inc. Mr. Khowaylo executed an agreement with Zimmer to distribute the Implex orthopaedic products. After a period of high sales growth and new product development, Zimmer acquired Implex in an earn-out arrangement. The acquisition resulted in $100 million upon closing with a total return of over $220 million after three years.
Prior to that, Mr. Khowaylo served as President of Stryker Osteonics. Osteonics, which he co-founded, was acquired by Stryker. In addition to a portfolio of orthopaedic products, Stryker Osteonics brought new technologies successfully to market by establishing the patient need and obtaining clinical results at many prestigious medical institutions. As a result of Mr. Khowaylo’s leadership, at the time, Stryker Osteonics grew to globally the third largest hip and knee implant orthopedic company with end customer sales of over $120 million. With Stryker Osteonics having its own sales force, Mr. Khowaylo’s management responsibilities included product from the earliest research phases all the way through the end customer hospital sales. He is extremely knowledgeable of the relationship of cost to produce, hospital selling price and company profitability. As head of a separate Stryker operating division, Mr. Khowaylo interfaced with corporate Stryker senior executive management on a regular basis. Mr. Khowaylo was exposed to many corporate acquisitions and was directly involved in a number of them.
Prior to that, Mr. Khowaylo co-founded Meditec Inc., a medical device company. This company was eventually acquired by 3M. 3M retained Mr. Khowaylo to continue to build Meditec.
Mr. Khowaylo also had an operations management position at Howmedica, which at the time was the largest orthopaedic medical device company. In addition, Mr. Khowaylo has consulted to investment banking firms and other start-up companies.
Mr. Khowaylo received his BS in Mechanical Engineering from the New Jersey Institute of Technology.
Mr. Cohen provides extensive experience in the strategic positioning of medical products and technologies for investment return. In addition, his technical engineering background brings in-depth knowledge to all phases of the product development cycle including research, design, intellectual property, manufacturing, physician evaluations, clinical studies, and global regulatory.
Previously, Mr. Cohen served as President of Zimmer Spine, a division of Zimmer Inc. that develops spinal implants and surgical instrumentation and distributes globally. Zimmer Spine’s worldwide annual sales at the time were $150 million. In an effort to rapidly grow the division,
Mr. Cohen put the emphasis on product development, marketing and determining potential acquisition targets. Mr. Cohen participated in the valuation determination of start-up to mid-sized medical technology companies.
Prior to that, Mr. Cohen was the General Manager, Vice-President R&D, of Zimmer Trabecular Metal Technology Inc, a division of Zimmer Inc. that designs and manufactures various medical devices from a proprietary biomaterial. Mr. Cohen directed the dramatic growth of the New Jersey-based operations to over 200 employees, developed many new products, and increased production capabilities resulting in over $140 million of end customer sales. Mr. Cohen communicated the division’s strategic vision to Zimmer senior management, marketing personnel and sales distributors around the world to maximize the product portfolio’s potential.
Prior to the Zimmer positions, Mr. Cohen served as Vice-President of Research and Development at Implex Corp. Implex brought a novel biomaterial into reality through coordinated testing, animal studies, human clinical studies, and the building of a unique manufacturing facility. Under his leadership, the patented designs received favorable FDA and international regulatory acceptances that allowed the successful market release of numerous orthopaedic and neurological products. Through target marketing, interfacing with key medical institutions, and presentations on the clinical study results, Implex product sales increased exponentially. Zimmer acquired Implex Corp for $220 million in 2004. As a member of the acquisition and integration team, Mr. Cohen was heavily involved in all aspects of due diligence and the transition.
Prior to Implex, Mr. Cohen served as Director of Product Development at Stryker Osteonics, managing a large technical group focusing on all aspects of design for hip, knee, shoulder, elbow, and wrist reconstructive systems and specialty custom products.
In addition, Mr. Cohen has over 20 patents and numerous peer-review publications. He has presented globally at large medical conference meetings and hospital Grand Rounds on topics such as medical device design, clinical results, biomaterials and drug coatings. Mr. Cohen received his BS and Masters in Mechanical Engineering and his Masters in Management, all from the New Jersey Institute of Technology.
Mr. McCarthy brings extensive strategic sales and marketing experience gained from being a medical products distributor and serving in various executive corporate management capacities. He has brought numerous medical device technologies and novel products successfully into the healthcare marketplace. Mr. McCarthy has a thorough understanding of the necessary global selling efforts required to maximize a product’s potential. Through his direct interaction with sales representatives, physicians, and hospital purchasing administration, he has developed markets for new medical devices and generated sales revenues in relatively short timeframes. Many of these devices were acquired by industry leaders.
Most recently, Mr. McCarthy served as President and CEO of Endius Inc, a minimally invasive surgery spinal device company. Under his leadership, the company was restructured, refinanced, and saw an expansion of the company’s product portfolio. With new distributor agreements in place and the revitalized market positioning of the products complete, sales revenues increased substantially. Endius was sold for $80 million at a multiple of 6 times sales.
Previously, Mr. McCarthy served as Vice-President of Sales and Marketing for Implex Corp. Implex brought a novel biomaterial into reality through coordinated testing, animal studies, human clinical studies, and the building of a unique manufacturing facility. The company focused on reconstructive, spinal, trauma and sports medicine device development. For the United States market, Mr. McCarthy recruited clinical sites and surgeons for the device’s investigational regulatory study. Internationally, with many of the products obtaining regulatory clearance, he drove sales revenue by penetrating the market in certain countries. Implex was eventually sold to Zimmer for $220 million.
Prior to Implex, Mr. McCarthy was founder/principal of Oxford Medical Inc., an independent sales distribution organization for the Johnson & Johnson orthopaedic product portfolio. His distributorship covered seven states in the Northeast US where the business grew from $1.5M to over $40 million in end-customer sales over an eight year period. The Oxford organization was recognized as the most successful distribution model in J&J Orthopaedics and was awarded “Distributor of the Year” honors. Mr. McCarthy sold Oxford to J&J in 1998.
Prior to that, Mr. McCarthy served in various corporate Johnson and Johnson Orthopaedics sales and marketing positions, including Sales Training Manager, National Sales Manager and Director of Sales. As Director of Sales, he was responsible for restructuring the sales organization into two sectors; direct sales for fracture management products and an independent distribution network for joint reconstructive products. Under this new sales alignment, the company drove to record sales over $300M.
In addition, Mr. McCarthy received his BS Business Administration from Villanova University.
Mr. Washburn brings to Pipeline Biomedical strategic and tactical financial planning experience. In his leadership roles in both small and medium sized medical device companies. Mr. Washburn has had direct operational involvement in growing early stage businesses from their inception, to increasing sales and valuation, and to resulting acquisition. His knowledge of the medical device and technology market segments is extensive. As such, Mr. Washburn has established himself has a skilled presenter to Board and potential acquisition targets.
Previously, Mr. Washburn was a retained consultant for Endius, a spinal medical device company. He functioned in the capacity of Chief Operating Officer and participated in the development of a plan to build company value based on a modified product portfolio, redirected sales distribution efforts, and on their intellectual property portfolio. Mr. Washburn was responsible for communicating with the Board, overseeing equity financing and assisting the CEO with acquisition negotiations. Endius was sold for a six times multiple of sales in April 2006
Prior to that, Mr. Washburn served as a founder, COO, Vice-President of Finance & Operations and on the Board of Directors of Implex Corp. Implex brought a novel biomaterial into reality through coordinated testing, animal studies, human clinical studies, and the building of a unique manufacturing facility. The company focused on reconstructive, spinal, trauma and sports medicine device development. Mr. Washburn concentrated on the strategic business plan and implementation of the operating plan. He directly oversaw several rounds of financing involving corporate partners, venture capital, investment banking firms, private equity and shareholder debt. Mr. Washburn was involved in the negotiation and due diligence of potential Implex acquirers. Implex was eventually sold to Zimmer for $220 million in April 2004.
Prior to that, Mr. Washburn served as Vice-President of Operations of Stryker Osteonics. Osteonics, which was acquired by Stryker, developed and manufactured orthopaedic implant systems. He had responsibility over the finance, manufacturing operations, materials control, and human resources departments. Additionally, Mr. Washburn provided key support to the marketing/sales function that involved distribution agreements, compensation programs, product pricing and asset management programs. During his eight-year tenure, Osteonics saw a 43% annual compound sales growth resulting in an end-customer sales run rate of $150 million.
In addition, Mr. Washburn has consulted to start-up companies on financial and strategic business planning. Mr. Washburn received his Bachelor of Business Administration from the Western Michigan University and started his career as a staff and senior auditor at Price-Waterhouse.
Mr. Gabel brings expertise in operations, regulatory compliance and quality assurance with over 15 years of experience in the medical device industry. In key management positions in both large and start-up companies, his skills are well suited for a development company with a focus on streamlining a product to market.
Mr. Gabel served as Director of Quality Assurance at Implex Corp. Implex brought a novel biomaterial into reality through coordinated testing, animal studies, human clinical studies, and the building of a unique manufacturing facility. He was responsible for the Quality System and the related FDA and ISO Notified Body interactions including registrations and audits. He created and implemented product development, manufacturing and quality processes. Mr. Gabel had oversight of global project management; ensuring product development and production remained on schedule and within budget. In that role, he acquired a successful product release record which included the worldwide release of more than a dozen new product lines. His efforts contributed to numerous products receiving FDA 510(k) allowances and European market release CE Markings.
After the Zimmer acquisition of Implex, Mr. Gabel was a member of the integration team and also served as Director of Product Development. He was the technical liaison to the Zimmer corporate headquarters and was involved with the orthopedic product globalization efforts. He was a member of committees which dealt with medical device packaging, sterility, risk management, and design documentation.
Prior to Implex, Mr. Gabel served in quality assurance engineering positions at Stryker Osteonics. His product responsibilities included those in the heavy regulated hip, knee, and shoulder orthopedic reconstructive segments.
In addition, Mr. Gabel is proficient in the FDA Quality System Requirements (QSR), international standard ISO 13485:2003, Medical Device Directives (MDD), and Canadian Medical Device Requirements (CMDR). Mr. Gabel received his BS in Mechanical Engineering from the Rutgers University.
Dr. Poggie brings significant professional medical device experience with a focus on new products that are developed using novel technology. He has been involved in research, clinical study, regulatory approval, and market development activities in both large and start-up companies. In addition, he is a proficient author of journal publications and is a scientific presenter at medical society meetings.
Previously, Dr. Poggie served as the Director of Global Brand Management for Zimmer Trabecular Metal Technology, Inc. The spinal and joint replacement implant products he was responsible for saw rapid usage growth. He facilitated the products’ technical market positioning and served as the product management liaison to Zimmer corporate headquarters. Dr. Poggie directed the publication of several clinical studies of orthopedic implants, surgical protocols and product literature through the interfacing with prominent surgeon advisors. He wrote the FDA and international submissions that resulted in numerous regulatory clearances for spinal, hip, knee and shoulder products. He also created, or contributed to, the education and training materials for prospective surgeon users and the company’s sales associates.
Prior to his work for Zimmer, Dr. Poggie was Director of Applied Research for Implex Corp. Implex brought a novel biomaterial into reality through coordinated testing, animal studies, human clinical studies, and the building of a unique manufacturing facility. Dr. Poggie managed the research, the lab and university testing, and the worldwide regulatory clearances of all the orthopaedic products. Also, he initiated and managed several FDA regulated investigational studies, which included the recruitment of surgeon investigators, clinical data compilation, and publication of study results.
Prior to his tenure at Implex, Dr. Poggie was a senior research engineer for Smith & Nephew. He was responsible for metallurgical and tribological research. He contributed to the development and optimization of biomaterials to be used in medical devices.
In addition, Dr. Poggie has published over 35 peer reviewed papers and presented globally as invited faculty at over 100 medical conferences, Grand Rounds, and medical education courses. He is a member of several professional engineering and medical societies and has several patents. Dr. Poggie holds a BE in Mechanical Engineering and MS & PhD degrees in Materials Science & Engineering, all from Vanderbilt University.





