MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., a medical device company pioneering innovative advancements in the treatment of complex Peripheral Artery Disease (PAD), names Heather Simonsen as its President. With this appointment, PQ Bypass now outperforms 90% of Health Technology companies with regards to women representation at the executive level.1
“With almost 30 years of healthcare experience and a proven track record of success leading organizations in both early- and late-stage ventures, Heather is uniquely qualified to guide the future strategic direction of PQ Bypass,” says Rich Ferrari, PQ Bypass Chairman of the Board and CEO. “The Board and I are confident that the leadership she has demonstrated at PQ Bypass over the past four years, combined with her extensive knowledge of the peripheral intervention space, will be invaluable as we move into our pre-market stage for not one, but two PMA submissions.”
Simonsen has held senior leadership roles for both venture-funded medical technology startups and Fortune 500 companies such as Abbott and Johnson & Johnson. She spent the early part of her career in hospital administration and management consulting with a specialty focus on risk management for healthcare organizations. Her record in effectively and efficiently bringing multiple companies from start-up to liquidity was a key factor in the Board of Directors’ decision.
“I am proud and honored to be appointed to the role of President of PQ Bypass, and look forward to further advancing our mission to develop new options for patients with complex PAD,” says Simonsen. “I thank Rich and the Board for the opportunity to lead our incredibly driven and talented team.”
In addition to her operating roles, Simonsen was one of the founding board members for the Healthcare Businesswomen’s Association (HBA) in San Francisco and also served on the HBA national Board of Directors, as well as the board of the Medical Marketing Association. Currently, she serves on the Founders Board of Advisors for Stanford’s StartX incubation program for entrepreneurial companies focused on changing the future of healthcare. She has an MBA from Chicago’s DePaul Kellstadt School of Business and completed the Executive Program at the Tuck School of Business at Dartmouth.
The company also announces the promotion of two industry veterans into key leadership roles to support Simonsen and the company during the next phase of company growth. Marion Larrea has been appointed Vice President of Operations, and Colleen Holthe has been appointed Vice President of Clinical Affairs. “Colleen and Marion have been integral to the success of the company and the significant milestones we achieved this year,” says Simonsen, of the Detour System’s admittance into the prestigious FDA Breakthrough Device Program, and the company’s nearing enrollment completion for both of its IDE studies. “Their leadership and expertise will be vital to the future of PQ Bypass.”
About the Company:
PQ Bypass, Inc. is a rapidly advancing medical technology company pioneering a first-of-its-kind technology to address the complexity of treatment for severe peripheral arterial disease. Its proprietary Detour platform for percutaneous femoral-popliteal bypass–designated by the FDA as a Breakthrough Device–is designed to be a significant technological advancement enabling novel, transformational interventions in outpatient settings. PQ Bypass is a former Company-In-Residence at the renowned Fogarty Institute for Innovation and is operated by recognized leaders in the medical device industry, including veterans from Boston Scientific, Phillips, Medtronic, Abbott and Johnson & Johnson.
PQ Bypass is currently sponsoring two multicenter IDE trials, DETOUR2 and TORUS2, focused on complex SFA disease.
For more information on Detour2, please visit https://clinicaltrials.gov/ct2/show/NCT03119233
For more information on Torus2, please visit https://clinicaltrials.gov/ct2/show/NCT04130737
PQ Bypass is recognized by MedTech Outlook magazine as one of the Top 10 Cardiovascular Companies of 2019 and earned Frost and Sullivan’s European Technology Innovation award in 2017. The Detour System and the TORUS Stent Graft are limited by federal law to investigational use only and are not available for sale. For more information, please visit www.pqbypass.com
1 Technology: A Call to Action. Ann Biomed Eng 48, 1573–1586 (2020). https://doi.org/10.1007/s10439-020-02478-0