Sensydia Completes Fifth Study for Heart-Sound AI

Completion of this 50-subject study is a key milestone on the path to delivering the first device for non-invasive and accurate measurement of pulmonary pressure

Los Angeles, CA – January 16, 2024 – Non-invasive cardiac assessment company Sensydia announced that it has completed its 50-subject development study at the University of Minnesota (UMN). This study was conducted at UMN to collect data for its innovative AI-powered, non-invasive Cardiac Performance System (CPS) that uses heart sound analysis to enable earlier detection and more effective therapy guidance for patients suffering from heart failure and pulmonary hypertension.  

Sensydia is developing the CPS platform, which uses ultra-sensitive biosensors to provide clinicians with rapid, non-invasive measurement of ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure in a handheld device. Knowledge of these parameters is critical when caring for individuals with heart failure and pulmonary hypertension. To obtain these measurements today, patients must undergo echocardiography and invasive right heart catheterization, which are resource intensive, restricted to medical facilities, and only provide snapshot data. In contrast, CPS measurements are fast, safe, may be repeated as frequently as indicated, and can be performed essentially anywhere with minimal training. 

"This is Sensydia’s fifth successful study, and we will continue to collect data across leading cardiac care institutions to improve the performance and utility of the artificial intelligence algorithms that power our breakthrough CPS platform," said Anthony Arnold, President and CEO of Sensydia. “We’re working to overcome today’s barriers in acquiring vital hemodynamic measures for monitoring and managing cardiac patients, and we appreciate the participation of cardiologists and staff at University of Minnesota in working toward this goal.” 

“The CPS platform shows promise as a non-invasive alternative to routine echocardiography and right-heart catheterization. It has the potential to positively impact the way patients with heart failure are monitored, managed, and ultimately to improve clinical outcomes,” said Tamas Alexy, MD, Associate Professor of Medicine and Principal Investigator, UMN Medical School. “These measurements are essential in the diagnosis and ongoing management of patients with heart failure as well as pulmonary hypertension. We are pleased to help evaluate Sensydia’s platform utilizing acoustic sensing technology and advanced AI algorithms, reducing the need for repeat echocardiograms and invasive hemodynamic assessments.”... Sensydia’s Press Release -

Orchestra BioMed Announces Initiation of BACKBEAT Pivotal Study of AVIM Therapy in Hypertensive Pacemaker Patients

Orchestra BioMed and Medtronic, Inc., have an exclusive strategic collaboration for development and commercialization of AVIM therapy for hypertensive pacemaker population, which is estimated to be more than 750,000 patients annually worldwide

NEW HOPE, Pa., Jan. 08, 2024 -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the first patient was randomized in the BACKBEAT pivotal study in late December 2023. The BACKBEAT pivotal study will evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™), for the treatment of pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.

AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure. Orchestra BioMed and Medtronic, Inc. (NYSE: MDT) (“Medtronic”) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population, and Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.

“Our collaboration with Orchestra BioMed will explore how cardiac pacing can go beyond management of bradycardia and conduction disease to treat hypertension as well,” said Robert C. Kowal, M.D., Ph.D., vice president and general manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit. “Our goal is to deliver the best possible outcomes for patients; this study will help us understand the potential role of AVIM therapy in treating hypertension, a major source of cardiovascular illness and a comorbidity in more than 70% of patients receiving pacing therapy.”

Suman Pasupuleti, M.D., from Citrus Cardiology Consultants, the first site to randomize a patient in the BACKBEAT pivotal study, commented: “Blood pressure management with currently available treatments is especially challenging in many elderly patients who also are prone to side effects from medications. This leaves a gap in the care of these patients and increases their risk for heart attack, stroke and heart failure progression. We are excited to be among the first to enroll patients in the BACKBEAT study, which will evaluate the efficacy and safety of this therapy in patients with high blood pressure who also need pacemakers.”

“We are thrilled to announce the initiation of the BACKBEAT pivotal study. This is an essential milestone as we evaluate how this therapy may benefit pacemaker patients who confront the mortality and morbidity risks of elevated blood pressure,” commented David Hochman, chairman, chief executive officer and founder of Orchestra BioMed. “We have activated multiple clinical sites and are screening patients in the U.S. and Europe. We are grateful to the clinical sites, our team and Medtronic for their dedication to finalizing all the study initiation deliverables. Most importantly, we are thankful to the patients who will participate in this landmark study.”

The BACKBEAT pivotal study is a global, multi-center, prospective, randomized, double-blind study investigating the efficacy and safety of AVIM therapy in patients who have recently undergone implantation of a Medtronic dual-chamber cardiac pacemaker and have uncontrolled hypertension despite the use of antihypertensive medications. Orchestra BioMed is actively screening patients for enrollment in the BACKBEAT pivotal study. Site activations are expected to continue throughout 2024 with a target of activating approximately 80 centers in the U.S. and Europe. The study will randomize approximately 500 patients 1:1 to AVIM therapy combined with continued medical therapy (treatment) or continued medical therapy and standard pacing alone (control). The study’s primary efficacy endpoint will determine at three months post-randomization whether AVIM-treated patients experience a statistically significant reduction in daily average blood pressure (mean 24-hour ambulatory systolic blood pressure or “aSBP”) as compared to control patients. The primary safety endpoint will determine at three months post-randomization whether AVIM-treated patients experience serious adverse device effects that are not anticipated with cardiac pacing. Double-blind follow up will continue through 12 months to enable the collection of additional clinical endpoints. All patients will be eligible to cross over upon completion of the 12-month blinded follow-up phase.

The BACKBEAT pivotal study investigational device exemption (“IDE”) was supported by encouraging results from MODERATO II, a prospective, multi-center, randomized, double-blind, pilot study of pacemaker patients with persistent hypertension conducted in Europe. MODERATO II showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. There were no major adverse cardiac events in the treatment group, compared to three events in three patients in the control group (0.0% vs. 14.3%).1

More information on the BACKBEAT pivotal study can be found at: https://clinicaltrials.gov/study/NCT06059638 - Orchestra BioMed's Press Release -

Nanowear Announces FDA 510(k) Clearance for AI-enabled Continuous Blood Pressure Monitoring and Hypertension Diagnostic Management: SimpleSense-BP

 NEW YORK, NY, January 4, 2024 – Nanowear, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, SimpleSense™, has received FDA 510(k) clearance for a novel AI-enabled Software-as-a-Medical Device (SaMD). As the first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic, SimpleSense-BP provides a transformational tool in clinical diagnostic management of hypertension and is additive to the wearable platform’s previously cleared cardiopulmonary diagnostics.

“This FDA clearance represents an exciting and differentiating moment for Nanowear. Accelerated by the pandemic, the market has been eagerly searching for reliable, clinical-grade wearable, and data service solutions that find product market fit with the following three attributes: at-home, utilizing AI, and a proven team that executes,” says Venk Varadan, CEO and Co-founder of Nanowear, emphasizing the company’s distinction as the world’s only nanotechnology-based embedded sensor platform fueling irreproducible AI algorithms. “This SaMD is just the first example of what our nanotechnology and AI is capable of, in understanding the individualized risk signatures and cardiopulmonary care pathways of each patient, materially enabling precision medicine.”

With its fourth FDA 510(k) clearance, alongside 13 awarded and 12 pending patents covering its nanotechnology, scaled nanosensor manufacturing, multi-parametric wearable, software platform, ingestion pipeline, and AI algorithms in a closed-loop ecosystem, Nanowear’s SimpleSenseTM is uniquely positioned in the market: the platform is indicated for use at-home, in healthcare facilities, and clinical research. The novel 4-decision tree algorithmic model, SimpleSense-BP, was tested in three study arms with both training and validation performed in independent geographies and demographic populations mirroring the most recent US census and generalizability to the entire hypertensive population. SimpleSense-BP is validated to track changes of > +/- 15mmHg systolic and +/- 10mmHg diastolic blood pressures over a continuous recording period across all classes of hypertension, via its wearable undergarment and AI platform. 

NAMSA, the leading cardiovascular MedTech clinical research organization worldwide, sees Nanowear’s most recent clearance and indication for use as differentiating in customizing clinical research, a $50bn+ market with significant cost increases and requisite emphasis on real-world data reliability since the pandemic. “We often talk about whitecoat syndrome limiting our ability to understand the effect of therapeutics in blood pressure or other cardiopulmonary assessments. Whitecoat syndrome is just another word for ‘real-world’ living. Just as a patient’s blood pressure may be high in a 30 second reading due to whitecoat syndrome, the same patient may reduce their blood pressure by breathing calmly for five minutes before the 30 second reading. So, what are we actually learning about that individual patient or the therapeutic applied?” says NAMSA’s Chief Medical Officer, Ken Ouriel MD. “To date, existing healthcare wearables and software platforms are either restricted in scope and time; or are unreliable and unvalidated for what they can diagnose during ‘real-world’ conditions. Nanowear’s continuous device, software platform, and AI algorithms, can transform the way clinical research platforms operate. Efficiency, access, diversity, and standardization across geographies can be enhanced while significantly lowering trial costs. Importantly, sponsors would be able to receive clinically reliable and trended data driven insights; data from the real world; their patients’ homes, their workplace, and a myriad of other settings that comprise everyday life,” Dr. Ouriel concluded... Nanowear's Press Release -