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.
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.
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.
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/
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.