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 ®, which is delivered by the company’s Optimizer® Smart Mini System. CCM is first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe.
To improve the lives of Heart Failure patients using Cardiac Contractility Modulation.
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?
50 Lake Center Executive Park
401 Route 73 N, Building 50, Suite 100
Marlton, NJ 08053-3449.
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 Mini 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 Mini 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 Mini systems are expected to last for at least 20 years before requiring replacement.
Who Should I Contact With Questions About Your Shares?
Impulse Dynamics is privately held.
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 CCM® therapy?
The Optimizer® Smart and its successor, the Optimizer® Smart Mini are 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