December, 2020 Progress Update

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.

Grants

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.

Team

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. 

July 1, 2020 Progress Update

Although 2020 has been a challenging time, we have been highly active and productive, and we appreciate the continued support of our investors and the medical community.

OsciFlex LLC, a developer of medical devices based on a novel scientific discovery of the mechanism underlying VTE, aims to protect immobile patients from deadly blood clots.  The OsciFlex system provides the benefits of ambulation (including both natural anti-thrombotic effects and muscle stimulation) using passive stimulation. Often patients recovering from major surgery, a stroke, a difficult pregnancy or trauma are unable to walk, putting them at increased risk for blood clots that form in the deep venous system and may result in lethal pulmonary embolism (collectively referred to as VTE).  VTE is a leading cause of death in the US and prevention of hospital-acquired VTE is a priority for US healthcare providers and payers.

Funding

John Martinson (Newtown PA) has made an investment into OsciFlex and will actively support the development and growth of the firm.  John was a founder and managing partner of Edison Ventures for 29 years and has been Chairman of Martinson ventures since its founding in 2015.

Ben Franklin Technology Partners of Southeastern Pennsylvania invested $75,000 in OsciFlex in the spring of 2020. OsciFlex is grateful for this investment, as well as for the support, access to talent, introductions to prospective clients and ongoing mentorship that they provide.

The University of Pennsylvania Cardiovascular Institute (CVI) has awarded Osciflex a Translational Dream Team grant of $ 200,000 grant for a second year, bringing total funding from the CVI to OsciFlex to $ 400,000. The Penn CVI seeks to promote focused companies with well-defined areas of opportunity of significant potential for translational breakthroughs and unmet clinical needs. OsciFlex was the first such company in which the CVI invested and it remains a strong partner.

In April 2020 OsciFlex submitted an NIH SBIR Phase 2 grant for “Mechanical device for the prevention of VTE in high risk patient populations”. The feedback we have received has been positive and we anticipate funding of $ 1.75M late fall of 2020.  This proposal is predicted to support the continued development of the OsciFlex system to optimize final product design in preparation for rigorous clinical efficacy testing and commercial sale.

In May 2020 OsciFlex submitted its application for an NSF SBIR  Phase 1 grant in response to a call for COVID-related technologies.  VTE have been identified as a common and deadly complication of COVID-19 infection despite standard of care prophylaxis. This grant will support development of an OsciFlex device designed to provide a mechanical therapy to modify venous blood flow in low mobility persons in the home setting.  This second generation device will benefit a large population of individuals who are at risk for VTE outside the hospital that is expanding rapidly during the COVID-19 pandemic.

Product Development

During 2020 the OsciFlex system has been technically refined and its performance improved significantly.  Testing on human subjects confirms that the device works as intended and generates robust peri-valvular blood flow at levels similar to that associated with natural ambulation.  The most critical refinements are patient-focused, e.g. the creation of newly designed patient boots that are both cool and comfortable.

OsciFlex has enlisted GreenLight Guru, a medical device-specific Quality Management Software service, to assist in the build and maintenance of its Quality System. OsciFlex is presently preparing for an FDA 510K application in the near future.

Marketing

The newly-launced OsciFlex website will be used to educate clinical staff and non-clinical medical decision makers on the current status of DVT prevention efforts.  Included in the site is a news section, containing pictures of the device, as well as links to publications such as that in the Journal of Clinical Investigation in which the founders of OsciFlex published their groundbreaking findings (see link https://www.jci.org/articles/view/124791).

OsciFlex has also set up a company page on Linkedin.  Please check it out and follow our progress at:  www.linkedin.com/company/osciflex-llc/

Team Development

Dr. Mark Kahn, Co-Founder of Osciflex, has assumed the role of Chief Medical Officer.

Robert Edelstein, who has advised Osciflex since 2017, has assumed the role of Chief Business Development Officer.