ABOUT

We are a medical device company based in Santa Clara, CA, dedicated to helping people with heart failure feel better and live longer.

Ancora Heart is dedicated to providing new treatment options for patients suffering from heart failure. Our team has a deep appreciation for the challenges faced by the estimated 26 million patients across the globe who are living with this chronic, progressive disease. Despite advances in heart failure treatment, high rehospitalization and mortality rates persist. Patients suffer from debilitating symptoms, exercise intolerance, poor quality of life, frequent hospitalization, and reduced life expectancy. In fact, up to 50 percent of people who develop heart failure die within five years of diagnosis. It is clear that patients need new options to treat symptoms and improve their quality of life, and we are committed to developing new solutions that help change the course of this challenging condition.

To address this challenge, we developed the AccuCinch® Ventricular Restoration System, the only completely transcatheter device designed to treat the enlarged left ventricle, restore structure and function and bring relief to heart failure patients who remain symptomatic despite current guideline-directed medical care. The AccuCinch System procedure is minimally invasive and is designed to augment the existing care cardiologists provide their heart failure patients.

For patients who have heart failure with reduced ejection fraction (HFrEF, or pumping efficiency), in whom the disease has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide a new treatment option by filling the gap between medication or pacemaker therapy and more invasive treatments, including left ventricular assist devices (LVADs) or heart transplant.

The AccuCinch System has been studied in multiple clinical trials in the United States and the European Union, and is currently enrolling patients in the CORCINCH-HF Study, a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation, which is designed to enroll 400 patients at up to 80 centers worldwide.

The study has a unique design allowing initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up. (ClinicalTrials.gov Identifier: NCT04331769)

MEET OUR TEAM

PRESIDENT AND CEO

Jeffrey M. Closs

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Mr. Closs brings proven leadership in medical devices, health policy, and technology to the Ancora Heart team. He has dedicated his career to working at the intersections of change to promote innovative, life-changing solutions. He has extensive experience founding new ventures (Benu), driving a successful IPO (Perclose), and having leadership roles at Fortune 500 companies (Fox Hollow, Edwards, Guidant, Bentley). Formerly a director at Nellix Endovascular, which was acquired by Endologix, and BioIQ, a health tech company, he is also an adjunct professor at Stanford University Center for Health Policy and the former president of the St. Raymond School Board. Mr. Closs holds an MBA from Emory University and a BA from the University of California, Los Angeles.

CHIEF TECHNICAL OFFICER

Russel Sampson

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A champion for the development of minimally invasive surgical systems, Mr. Sampson brings a proven track record of invention (over 80 U.S. international patents) to his position at Ancora Heart. Leveraging his deep experience with CE and PMA approvals, commercialization, profitability and acquisition for companies such as Cytyc, Novacept, Abbott Laboratories, Space Systems/Loral and Ford Aerospace, he is responsible for our core technology, intellectual property and product development efforts. Mr. Sampson is the co-founder of Sierra Surgical Technologies (SST) and holds a BS in Mechanical Engineering (AMES) from the University of California, San Diego.

CHIEF COMMERCIAL OFFICER

Mark Miles

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Mr. Miles brings 25 years of experience scaling medical technology companies to his position as chief commercial officer (CCO) of Ancora Heart, including his most recent post as CCO of Terumo Aortic in Glasgow, Scotland. In that role, he was responsible for global sales and marketing, custom solutions, portfolio strategy and expansion into new markets, helping guide the company during a period of significant growth.
Prior to his time at Terumo Aortic, Mr. Miles served as senior director of commercial strategy at Invuity, where he played a key role in driving adoption of their core product lines across key surgical specialties throughout the United States. He was instrumental in facilitating significant growth through the company’s eventual IPO in 2015. Previously, Mr. Miles held positions of increasing responsibility at Medtronic, serving as director of global marketing of the Endovascular Business Unit. He began his career at Eli Lilly and Company, serving various commercial leadership roles during his eight-year tenure. Mr. Miles received an MBA from Pepperdine University and a BS in health sciences from James Madison University.

VICE PRESIDENT OF BIOSTATISTICS AND CLINICAL DATA MANAGEMENT

Christine Tjossem

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Ms. Tjossem brings a 35-year track record of successful growth and leadership in biostatistics and data management to her position at Ancora Heart. Her experience includes key roles establishing and managing biostatistical and data management efforts at some of the world’s leading clinical research and medical device organizations, including Medtronic, Boston Scientific, St. Jude and Berlin Heart. Ms. Tjossem began her career working in medical research for Mayo Clinic in Rochester, Minnesota. As Vice President of Biostatistics and Data Management, Ms. Tjossem is responsible for all facets of her team’s success in advising and implementing appropriate techniques and methods for statistical and data management areas. In addition to managing these line-of-business functions, Ms. Tjossem’s vast breadth and depth of experience allows her to make significant contributions to the company’s overall business, regulatory and clinical strategy. Christine received her Bachelor of Science degree in Statistics from Iowa State University.

VICE PRESIDENT OF CLINICAL AFFAIRS

Michael Zapien

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Drawing on his expertise in transitioning innovative medical devices from the developmental stage to commercial success at several emerging startups (Elixir, Nanostim), Mr. Zapien leads our clinical research. Previously the Director of Clinical and Medical Affairs at CardioDx, Inc., he also has clinical and commercial experience at Medi-Globe, Silk Road Medical, Abbott Vascular, and Guidant Corp. Mr. Zapien is a certified clinical researcher with a MS from the University of Maryland and a BS from San Francisco State University.

VICE PRESIDENT OF
STRATEGIC INITIATIVES

Bart Beasley

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A veteran of introducing early-stage and ground-breaking therapies to physicians, Mr. Beasley brings over 25 years of experience in healthcare marketing to Ancora Heart. By building partnerships with the clinical community, gathering first-hand insights towards procedure and product development, and enhancing clinical trial patient education and recruitment, he has helped drive the rapid growth of multiple revolutionary therapies and new therapeutic categories. Mr. Beasley served as Vice President of Marketing at Avinger, drove market development at Transcend Medical (acquired by Alcon), was Director of Marketing at Fox Hollow (acquired by ev3), and began his career at Perclose (acquired by Abbott). Mr. Beasley holds an MBA from IESE Business School in Barcelona, Spain and a BS in Economics from Santa Clara University.

VICE PRESIDENT OF REGULATORY AFFAIRS
AND QUALITY ASSURANCE

Michael Fritz

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Mr. Fritz comes to Ancora Heart with decades of medical device industry experience including strategic leadership, management, operational, and hands-on roles in regulatory affairs, clinical research, quality assurance, and engineering. His career includes roles with small start-ups (Synapse Biomedical and Cyberkinetics) and larger companies (Medtronic, Boston Scientific, and Guidant) developing class III implantable devices and class II minimally invasive devices in diverse fields including interventional cardiology, cardiac electrophysiology, neurology, pulmonary/respiratory, laparoscopic surgery, neurosurgery, rehabilitation medicine, and neuroprosthetics. Mr. Fritz holds an MS degree in software engineering from the University of St. Thomas and a bachelor of electrical engineering degree from the University of Minnesota.

Meet Our Board of Directors

CHAIRMAN

Bob Croce culminated 12 years as Company Group Chairman through a 36-year career at Johnson & Johnson. Beginning in 1968, Mr. Croce held a series of senior positions beginning as a Sales Representative for Ortho Pharmaceuticals where he was later named Vice President of Marketing. Prior to that, he served as Worldwide Franchise Chairman of Cordis and Ethicon Endo-Surgery. In 1985, Mr. Croce was named Vice President of Business Development at McNeil. He was later transferred to Ethicon, Inc., where he served as Group Vice President, and was later named President in 1990. In 1992, he was promoted to Worldwide President of Ethicon Endo-Surgery.

SAVITR CAPITAL

Savitr Capital was founded by Andrew Midler in 2008. Prior to Savitr Capital, Andrew founded Standard Pacific Capital in 1995. The investment management firm launched with $75 million of assets and grew to over $5 billion. Until 2005, Midler managed the firm’s Global Long/Short Equity Fund for Standard Pacific’s flagship product. He also supervised the firm’s credit opportunities, commodity, quantitative, and Japan long/short equity strategies. He served as the CIO and CEO of the firm from 1995 to 2007 before selling his majority ownership interest in the firm in December 2007. Prior to founding Standard Pacific, Midler was the Director of Equity Portfolio Management at CS First Boston, a global institutional money management firm. Previously, he managed a significant portion of the global hedge fund, Odyssey Partners. From 1986 through 1993, he worked at Fidelity Investments where he was Portfolio Manager of the Fidelity Convertible Securities Fund, Fidelity Equity Income II Fund and Fidelity Growth & Income Fund.

LCP VENTURES

Lew Pell is one of the most prolific and successful medical technology investors. Since 1975, Pell has been the lead investor and co-founder of 24 different medical device manufacturers, eight of which have been sold for a collective net gain of $1.6 billion. Pell’s founding of medical technology companies began in 1975, when he and Katsumi Oneda co-founded Machida America to sell flexible endoscopes. In 1979, he created Pentax Precision Instruments and sold it to Asahi Optical eleven years later. Over a span of 15 years, Pell co-founded various medical device companies including: American Endoscopy (acquired by Medtronic), Heart Technology (acquired by Boston Scientific), InStent (acquired by Medtronic), and Vision Sciences. He was also co-founder of Biosense (acquired by Johnson & Johnson), Influence, Inc. (acquired by American Medical Systems), and Disc-O-Tech (sold to Kyphon).

PAGONIA MEDICAL, INC.

Beverly Huss brings with her more than 20 years’ experience as a leader of both large corporations and start-up companies in the medical device space. Prior to founding Pagonia, Huss was president and CEO of Qool Therapeutics, Inc. a tissue preservation company. Previously she was co-founder and CEO of Vibrynt, Inc. a company that developed a novel minimally invasive therapeutic device for treatment of morbid obesity. Prior to this, Huss was with Santa Clara, California-based Guidant since 1986, fulfilling a variety of executive roles within the company’s various medical device divisions. She managed the worldwide Endovascular Solutions business as President and quadrupled worldwide revenues to $150 million for the carotid and peripheral vascular business in four years. In addition, she built Guidant’s coronary stent business to $1B with 90% gross margins.

PRESIDENT & CEO

Mr. Closs brings proven leadership in medical devices, health policy, and technology to the Ancora Heart team. He has dedicated his career to working at the intersections of change to promote innovative, life-changing solutions. He has extensive experience founding new ventures (Benu), driving a successful IPO (Perclose), and having leadership roles at Fortune 500 companies (Fox Hollow, Edwards, Guidant, Bentley). Formerly a director at Nellix Endovascular, which was acquired by Endologix, and BioIQ, a health tech company, he is also an adjunct professor at Stanford University Center for Health Policy and the former president of the St. Raymond School Board. Mr. Closs holds an MBA from Emory University and a BA from the University of California, Los Angeles.

WORK WITH US

Ancora Heart is looking for talented professionals to join our growing team. We value creativity, drive, accountability, and the ability to work collaboratively with one another. If you thrive in a fast-paced setting and are passionate about changing the way heart failure is treated, consider the following opportunities:

Chief Financial Officer

We are seeking a talented professional to represent the company on all financial matter in addition to interfacing with the financial community including potential investors, underwriters, and industry analysts.

Other duties include the following: 

  • Work with CEO and Board of Directors on all aspects of corporate financing.
  • Work with CEO and Board of Directors to develop strategy and manage all activities related to potential merger, acquisition, or IPO.
  • Assume responsibility for all corporate legal affairs including interfacing with outside legal counsel, managing internal legal staff members and overseeing contract negotiations and record keeping.
  • Act as the company representative in all matters related to shareholder/investor relations.
  • Select and implement an integrated comprehensive MRP system which includes a robust financial reporting module.
  • Manage the functional areas of general accounting, cost accounting, payroll, fixed assets, financial analysis, long-range financial planning, and accounts payable and receivable.
  • Coordinate various financial/administrative control and planning systems including operating plan, budgeting, reporting, long range financial planning and integrated manufacturing/accounting.

Qualified candidates must possess the following:

  • Bachelor’s Degree in business or life sciences or equivalent experience required.  MBA/CPA preferred.
  • Minimum fifteen years related experience in the medical equipment industry in addition to at least ten years management experience.
  • Prior experience in the management of an Initial Public Offering.
  • Expertise in the selection and use of MRP/Financial Reporting Systems.
  • Thorough working knowledge of the medical device industry is preferred.

Clinical Marketing Manager

The Clinical Marketing Manager is responsible for supporting the strategy and implementation of clinical marketing and educational initiatives that drive awareness and adoption of the AccuCinch® Ventricular Restoration System and successful enrollment of the CORCINCH-HF pivotal study.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Continually characterize the landscape of therapies (pharmacological and device-based) and guideline-based treatment recommendations for heart failure
  • Create and maintain positioning and messaging strategies to support communication of the differentiated benefits of the AccuCinch System to multiple stakeholders
  • Manage the creation of on-brand digital, video, audio and print collateral to support clinical marketing and educational objectives for internal and external stakeholders (structural heart interventionalists, heart failure specialists, referring cardiologists, research coordinators, APP’s, nurses, and patients).
  • Understand and clearly communicate the clinical and technical requirements (and benefits) of the AccuCinch System and serve as an expert in the field, training programs and clinical conferences
  • Contribute to the development, planning and implementation of awareness and educational programs (local, virtual) for clinical site stakeholders and referring physicians
  • Support planning and presence at industry events, tradeshows, and conference
  • Collaborate with cross-functional teams in Therapy Development, Site Management, Clinical Affairs, R&D, Regulatory and Data Management to identify needs, build and implement programs for programs
  • Support company goals and objectives, policies and procedures, and FDA regulations
  • Perform other duties as assigned

EDUCATION & EXPERIENCE REQUIREMENTS:

  • BA/BS with a minimum of 4 years experience in the medical device industry (minimum 2 years medical device marketing), or
  • MBA with a minimum of 2 years experience in medical device marketing

OTHER QUALIFICATIONS:

  • Strong clinical marketing skills – Effectively blend qualitative and quantitative insights/skills to create and deliver solutions to internal and external site stakeholders
  • Industry expertise – Comprehensive understanding of cardiovascular implantable medical devices, clinical evidence, healthcare systems and clinical/regulatory processes
  • Excellent communication skills – Effective and adaptable expertise in verbal, written and visual communication methods to support engagement with clinical opinion leaders, healthcare professionals and colleagues across functions within Ancora Heart
  • Strong team player—Ability to collaborate across functions to leverage organizational expertise, drive alignment and ensure delivery of projects to timelines
  • Must be willing to travel 25%

Clinical Research Associate (Field Operations)

We are looking for accomplished healthcare professionals to assist in the conduct of Ancora Heart’s clinical research trials.  Responsibilities include management of assigned clinical sites during study start up activities, study recruitment and treatment and follow-up study phases. Primary tasks include, but are not limited to, clinical education and implant case coverage, conducting site visits for study qualification, site initiation, site monitoring and site close out, and maintaining device accountability. Additional responsibilities include site collaboration with the study coordinator and investigator to ensure study compliance with study protocols, FDA,  IRB requirements and overall clinical objectives.  Other duties include the following:

  • Act as a company representative at clinical cases by traveling to  sites   ensuring protocol and regulatory compliance, proper collection of data and perform investigational device set-up at implant, as required.
  • Work with investigation team to ensure data is entered, imaging studies are submitted, and reports are complete and entered in database.
  • Monitor ongoing compliance to study protocols.  Ensure adherence to FDA and IRB requirements.   Work with investigators to quickly and effectively resolve discrepancies.  Review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation. Perform interim monitoring visits per SOP.
  • Work with Clinical Safety Manager to support S/AE reporting and assist in adverse event report preparation, as needed.

Qualified candidates must possess the following:

EDUCATION REQUIREMENTS:

  • BS preferred in Life Sciences, Nursing, Medicine, or other medical technical discipline.

EXPERIENCE REQUIREMENTS:

  • Minimum five years related experience in Life/Health Sciences, Nursing, Medicine, or medical technical discipline
  • Working knowledge of Good Clinical Practice, ISO and 21 CRF Regulation pertaining to clinical trial conduct and FDA regulatory requirements 
  • Experience in IDE clinical studies, preferably medical device
  • Clinical trial monitoring

OTHER QUALIFICATIONS

  • Must possess excellent written and verbal communication skills
  • Working with an early start-up company a plus
  • Medical device implant case support experience a plus
  • Experience with sterile technique and familiarity with operating room/cath lab sterile environments a plus
  • Ability to travel up to 75%

Director of Quality Assurance

We are seeking a talented professional to provide overall leadership and management of the Quality Assurance (QA) function and team at Ancora Heart.  This individual will be charged with providing mentorship to help each team member develop professionally and best contribute to the company’s goals; identify gaps in the quality system and opportunities for improvement in additional to defining and executing quality system improvement projects.  Other duties include the following:

  • Provide quality assurance leadership in the company’s transition from the R&D/clinical investigational phase to the post-market/commercialization phase
  • Act as primary liaison to external quality and regulatory compliance inspectors and auditors (e.g., FDA and Notified Body) as well as internal auditors
  • Provide quality assurance and regulatory compliance training and consulting to the company (including training on the external standards, regulations, and best practices that drive internal company SOPs)
  • Assist Regulatory Affairs in the preparation of quality, manufacturing, and engineering sections of submissions to FDA, Competent Authorities, Notified Bodies, and other regulatory bodies

Qualified candidates must possess the following:

  • Bachelor’s degree in engineering, scientific, or quantitative field
  • Proven track record of leadership and management of the quality assurance function
  • 10+ years experience in quality assurance including 5+ years in Class II or III medical device industry
  • Prior experience in the different phases of medical device development including engineering and product development, pre-clinical evaluation, clinical investigation, pre-market approval application, and post-market/commercialization
  • Demonstrated competence in technical and business writing as author and editor
  • Experience in the utilization of enterprise software to support QMS and documentation control, including experience in its selection, validation, and implementation

Ancora Heart offers a competitive compensation and benefits program as well as a progressive work environment. We are an equal opportunity employer. If you or someone you know might be interested in this position, please submit a resume and an introductory email to careers@ancoraheart.com

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