To improve the lives of Heart Failure patients using Cardiac Contractility Modulation
Impulse Dynamics: A Medical Device Company Dedicated to Transforming the Treatment of Chronic Heart Failure
Impulse Dynamics is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe.
Impulse Dynamics’ mission is to develop and provide Cardiac Contractility Modulation by:
- Striving for excellence in our day-to-day work.
- Abiding by the requirements of the regulatory bodies.
- Facilitating global access to the benefits of our therapy.
- Exceeding the expectations of patients, clinicians, and caregivers.
- Fostering innovation, transparency, honesty, and accountability.
- Creating a work environment that attracts and retains outstanding talent.
- Building value for our shareholders.
COMPANY Q & A
Where Are Your Corporate Headquarters?
The headquarters office is located at 523 Fellowship Road, Mount Laurel, New Jersey.
Where and When Were You Incorporated?
Impulse Dynamics was incorporated in Curacao on December 15th, 1997.
Does Your Company Have a Direct Stock Purchase Plan?
Impulse Dynamics does not have a direct stock purchase plan.
Where Can I Find Your SEC Filings? Where Can I Download and View Quarterly and Annual Reports?
Impulse Dynamics does not have publicly-traded securities and therefore does not file reports with the U.S. Securities & Exchange Commission.
When Does Your Fiscal Year End?
Our fiscal year ends on December 31st each year.
Do You Pay Dividends?
Impulse Dynamics does not pay dividends.
What other countries have approved the company’s technology?
In addition to FDA approval, Optimizer® Smart obtained CE mark in October of 2016 and is available in the countries listed below among others covered by the CE mark. The CE mark is currently recognized in 33 countries including:
Click here For a full listing of CE Mark Countries
Optimizer® Smart also recently became available for patients with heart failure in China through a special NMPA (National Medical Products Administration) program, which allows implants in China’s Hainan province while the device application is under review by the NMPA.
What is a Transitional Pass-Through Payment, and how does it affect Impulse Dynamics?
Pass-through payments are additional reimbursements authorized by Medicare for devices or drugs that are new and that have met substantial clinical improvement criteria, and whose costs exceed currently established payment rates. These payments were designed by CMS to make new and potentially beneficial therapies more accessible to Medicare beneficiaries. CMS limits the eligibility for a pass-through payment to a period of at least 2 years, but not more than 3 years beginning on the date that CMS establishes a category of devices, therefore the pass-through status cannot be maintained for over 3-years.
Impulse Dynamics applied for Pass-through payments early in 2019 and was granted approval based on meeting all requirements on November 1, 2019. These payments will take effect for implants conducted in the outpatient hospital or ambulatory surgical center (ASC) setting effective January 1, 2019
How is a CCM therapy device implanted?
The Optimizer Smart System includes an implantable stimulation device (similar in size to a pacemaker) and an external charging station. The device is implanted in a small pocket under the skin of the upper chest, along with commercially available pacemaker leads that are placed in the heart’s right ventricular septum, while the patient is under light sedation. After implantation, the physician custom-programs and activates the device for the patient. The Optimizer Smart then begins sending electrical pulses to the heart muscle for a total of five hours a day, in one-hour treatments separated by regular intervals. The patient charges the device one hour per week using the external charger. Optimizer Smart systems are expected to last for at least 15 years before requiring replacement.
Who Should I Contact With Questions About Your Shares?
Impulse Dynamics is privately held.
Who Are the Members of Your Board of Directors?
To view a comprehensive listing, please visit our Board of Directors page.
Who Are the Members of Your Management Team?
You can learn more about our management team below.
When Is Your Next Earnings Release?
Impulse Dynamics is privately held and therefore does not issue public earnings releases.
How Do I Contact Investor Relations With a Question or Request?
You can reach Investor Relations by emailing email@example.com.
What is Optimizer® Smart & CCM therapy?
The Optimizer Smart is a minimally invasive, implantable device that delivers a proprietary therapy called CCM to patients with heart failure. CCM (cardiac contractility modulation) is a first-of-a-kind, life-changing treatment alternative for a vast population of heart failure patients who remain symptomatic despite guideline-directed medical therapy and are not yet sick enough for a heart pump.
Has the Optimizer been FDA approved?
The Optimizer® Smart device was approved on March 21st of 2019 for the delivery of CCMTM (Cardiac Contractility Modulation) therapy. This approval is unique since it represents the first device to attain the FDA’s Breakthrough Device status, and go on to the FDA’s Cardiovascular Devices review panel – where it received a unanimous recommendation for approval based on its benefit:risk ratio, and then to receive FDA PMA approval
Simos Kedikoglou, MD
Chief Executive Officer
Simos is our CEO since 2013 and working with the Board and the management team is responsible for defining and executing our corporate strategy. During his tenure, the company has obtained approvals and launched the Optimizer device globally with sales and/or clinical work in Europe, US, China, Japan, Australia, Brazil and India.
Simos was previously a Corporate Vice President of Business Development for Boston Scientific with responsibility for acquisitions, licensing and distribution deals in the US, Europe and Asia. Prior to Boston Scientific, Simos was an Associate Partner with McKinsey & Company in the US, advising clients in healthcare M&A.
Simos holds a Medical Degree from the University of Athens, Greece, an MBA with distinction from Harvard Business School, a Master’s in Public Health from Harvard University, and is a CFA Charterholder.
David Prutchi, Ph.D.
Executive VP of Product Development
Part of Impulse Dynamics since 1998, David brings over 20 years of experience in biomedical R&D and medical electronic instrumentation design and management to our team. This experience includes Bradycardia Advanced Technology for Sulzer-Intermedics Inc, where he led the design and development of next-generation implantable pacemakers.
Deborah L. Morley, Ph.D.
VP of Regulatory Affairs & Quality Assurance
Leading our Regulatory Affairs and Quality Assurance Department, Deborah has been a part of Impulse Dynamics since early 2014. Before being a part of our company, she was Vice President of Clinical Affairs at AtriCure, Inc. and Vice President of Clinical and Regulatory Affairs for CircuLite, Inc. Deborah was also an Assistant Professor of Medicine and Research Direction of Heart Failure and Transplant for the Hahnemann University of Philadelphia.
VP of Human Resources
Nitsan joined Impulse Dynamics in 2014, bringing over 15 years of experience in Global Human Resources and Corporate Management along with her. She has served in several HR executive roles, with responsibility for developing and implementing the strategies, infrastructure, and programs needed to build and optimize the human capital of the business. Nitsan holds a B.A. in Business Administration from Rupin Academic Center a M.A. in Management and Professional Communications from Clark University, a M.A in law from Bar Ilan University and an executive MBA from Bar Ilan University.
Mateusz Zelewski, MD, Ph.D.
VP of International Sales
Mateusz has been as part of Impulse Dynamics since 2016. He’s a senior manager with 22 years of experience in medical devices, pharma and diagnostics. Dr. Zelewski’s medical technology market expertise was gained from numerous managerial positions in sales, marketing, turnaround and training with Johnson & Johnson in Europe and US, with increasing responsibilities up to the Managing Director position. Dr. Zelewski is also experienced in business development, customer focused sales and marketing strategies, customer education programs, innovation, launching numerous medical technologies and employee leadership development.
Gerald M. Haines
Chief Financial Officer
Gerry joined Impulse Dynamics as Chief Financial Officer in July of 2019. With a proven track record in business, finance and strategy, he is responsible for the company’s overall financial strategy and execution as well as investor relations and strategic planning. His experience includes senior executive roles in multiple public companies where he has served as Chief Financial Officer in addition to leading the corporate development, legal and various other corporate functions. Most recently, he served as Chief Financial Officer at Mercury Systems, Inc. (NASDAQ: MRCY). Gerry holds a bachelor’s degree in Business Administration, magna cum laude, from Boston University and a law degree from Cornell University.
VP of US Commercial Operations
Chris joined the Impulse Dynamics team in May 2019, bringing with him two decades of experience in the cardiovascular arena. He has held leadership positions at Boston Scientific, Biotronik and Abbott. At Abbott, he held the position as Vice President of the Electrophysiology/CRM business unit.
General Counsel & Secretary
Since 2012, Marc has been the General Counsel and Secretary for our company, also serving as the VP Legal Counsel and Secretary of the Hobart Group. He offers vast experience in commercial transactions and corporate matters, holding an LLB and LLM from Brussels University and an LLM from University College London.
Jens Kalender, Dipl.-Ing.
VP of Commercial DACH
Jens Kalender joined Impulse Dynamics in 2016. Before joining our team, he was Sales Director for TriVascular Germany GmbH. His experience also includes work as a sales rep for Medtronic GmbH and was Regional Sales Manager for CRDM. His career began in 1990 and involves decades of experience in sales specific to cardiovascular therapies.