Products: The OsciPulse System
OsciFlex has developed a new lead product, the OsciPulse system. The OsciPulse system is designed to create very rapid but shallow bursts of compression to enhance venous blood flow. OsciFlex recently completed initial testing of the device on healthy subjects with promising results. The new product design and functionality was described in a new provisional patent filing made this year by OsciFlex LLC.
The first clinical trial evaluating the tolerability and hemodynamic efficacy of the OsciPulse system is set to begin at Presbyterian Hospital at the University of Pennsylvania in early 2021, pending IRB approval. The study is sponsored by the University of Pennsylvania and funded by the 2019 Cardiovascular Research Institute Dream Team award to the Kahn Lab. The protocol was finalized and submitted to the Penn IRB in November, 2020 and patient enrollment is expected to being in January, 2021. The Company has manufactured all the necessary units to conduct the study using an ISO certified medical device development and manufacturing company, IDE Group. The trial will seek to enroll ICU patients to investigate the tolerability and function of the OsciPulse system, while also assessingthe design for optimal patient comfort and staff usability.
The OsciFlex System
The Company recently completed human studies at the University of Pennsylvania to assess the physiological impact of the device on muscle stimulation. The development of the OsciFlex system is the focus of a pending Phase 2 SBIR grant submission to the National Science Foundation, following up on our successful Phase 1 award.
OsciFlex LLC was awarded a Phase 2 SBIR award titled “Mechanical device for the prevention of VTE in high-risk patient populations” by the National Heart, Lung, and Blood Institute. The award is for $1.7M over two years and will support large scale clinical efficacy testing, as well as the Company’s preparation and submission for US FDA 501(k) approval of the OsciPulse system. The award will also provide funds to recruit additional staff to support the Company’s engineering and regulatory activities.
OsciFlex was happy to have Ken Piña join our team as an advisor during 2020. Ken is providing strategic business and regulatory support. He is presently the Managing Partner of Vassar Life Sciences, LLC and was formerly the Executive Vice President of Nalpropion Pharmaceuticals and the Senior Vice President, Chief Legal and Compliance Officer & Corporate Secretary of Pernix Therapeutics, a Nasdaq-traded public company. He previously was a co-founder and the Managing Principal of Core Risks Ltd., an international life sciences consulting firm that was acquired by Jardine Lloyd Thompson, which is now part of Marsh, a global risk management firm.