Our flagship products, Virtue SAB and BackBeat CNT, have the potential to improve clinical outcomes and provide distinct commercial advantages within two of the largest and most well-established global medical device markets.
Artery disease is caused by the buildup of fatty or calcified plaque in the arteries, also known as atherosclerosis, and is the leading cause of death in the United States and worldwide. According to the World Health Organization, coronary artery disease is the primary cause in over 9 million deaths annually worldwide.
The most common medical procedure used to treat artery disease is percutaneous (needle-access) catheter-based intervention using balloon angioplasty, stents and other technologies. There were over 6.3 million coronary and over 1.5 million peripheral catheter-based interventional procedures performed worldwide in 2019, according to LSI & HRI Research.
We believe significant unmet needs remain in certain artery disease indications where treatment options are limited or fail to adequately improve patient outcomes, including coronary in-stent restenosis, coronary small vessel disease, lesions in patients with high bleeding risk and below-the-knee peripheral vascular disease.
Our Virtue® Sirolimus AngioInfusion Balloon aims to be the first product to deliver extended focal release sirolimus during angioplasty for the treatment of atherosclerosis and the prevention of restenosis.
Hypertension is elevated blood pressure that increases risk of major cardiac events like heart attack and stroke and also can contribute to other significant conditions such as heart failure and kidney disease. Hypertension is the leading global risk factor for death and an estimated 1.13 billion adults worldwide are afflicted by hypertension, according to the World Health Organization. In the United States, 116 million adults, or approximately 46% of all adults, are estimated to have HTN according to the American Heart Association, or AHA. Cardiovascular risk doubles for every 10 mmHg increase in systolic blood pressure and the mortality rate doubles with an increase of 20 mmHg in systolic blood pressure, according to the National Center for Biotechnology Information or NCBI.
Based on the new ACC/AHA guidelines, we estimate that nearly 80% of U.S. patients that are indicated for the implant of a pacemaker have hypertension. Over 60% of the pacemaker-indicated patients are estimated to have uncontrolled hypertension and these patients are also at elevated risk of Isolated Systolic Hypertension, a more dangerous and difficult to treat form of hypertension. Further, pacemaker-indicated patients are elderly, 73 years old on average, and thus are more likely to suffer from other co-morbidities such as atherosclerosis, hyperlipidemia, diabetes mellitus and chronic kidney disease. We believe these patients could benefit substantially from a hypertension therapy like BackBeat CNT that can be administered via an already necessary pacemaker.
Virtue® SAB is not approved for commercial use in the US
BackBeat CNT™ is not approved for commercial use in the US
© 2022 Orchestra BioMed Inc. Virtue®, BackBeat CNT™ FreeHold Duo®, FreeHold Trio® and Orchestra BioMed™ are trademarks of Orchestra BioMed.
All other trademarks are trademarks of their respective owners.
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