Core Insights - Orchestra BioMed is expanding its intellectual property portfolio, securing 10 new patents related to hypertension treatment, bringing the total to 120 patents in this area [2][6] - The company has also increased its patent estate for heart failure treatment to 17 issued patents, enhancing its overall IP platform [2][6] - AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study for treating uncontrolled hypertension in patients indicated for pacemakers, highlighting its potential impact on broader cardiovascular health [2][8] Intellectual Property Expansion - The global intellectual property portfolio for AVIM therapy includes patent protection in key markets such as the United States, Europe, Japan, and China [3] - The hypertension-specific patent estate now consists of 46 issued U.S. patents and 91 patents outside the U.S., collectively comprising over 2100 claims related to hypertension and heart failure [6] Strategic Collaborations - Orchestra BioMed has a strategic collaboration with Medtronic for the development and commercialization of AVIM therapy, focusing on hypertension treatment in pacemaker-indicated patients [4] - The company is also partnered with Terumo for the development of the Virtue Sirolimus AngioInfusion™ Balloon for treating atherosclerotic artery disease [4] Regulatory Designations - AVIM therapy has received Breakthrough Device Designation from the U.S. FDA for treating uncontrolled hypertension with increased cardiovascular risk, which may expedite its development and market access [2][6][9]

Core Insights - The U.S. FDA has granted Breakthrough Device Designation for Orchestra BioMed's AVIM therapy, which aims to manage hypertension in patients at high cardiovascular risk [1][3][6] Regulatory and Clinical Development - The Breakthrough Device Designation is specifically for an implantable system (pacemaker) that delivers AVIM therapy to reduce blood pressure in patients with increased ten-year ASCVD risk and uncontrolled hypertension [2][6] - There are over 7.7 million patients in the U.S. who meet the criteria for this therapy [2][6] - AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, which is a collaboration between Orchestra BioMed and Medtronic [2][3][7] Market Potential and Collaboration - The collaboration with Medtronic allows for the development and commercialization of AVIM therapy, particularly for patients indicated for pacemakers [7][8] - The Breakthrough Device Designation may facilitate favorable reimbursement pathways, including eligibility for NTAP and TPT under CMS programs [4][11] Clinical Efficacy - Pilot studies have shown that AVIM therapy can lead to significant reductions in blood pressure, with net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months [10]