Management Team
John Zehren
CEO & Board Member
John Zehren, as the CEO of Single Pass brings over 30 years of commercial and leadership experience in medical devices. He specializes in commercialization having launched numerous medical devices. With FDA approval of the first electrocautery device for biopsy closure, John is essential in the company’s commercialization success. He also served as CEO of the Green OR, Chief Commercial Officer of Endologix and Cagent Vascular, VP at Medtronic, Covidien, and Edwards Life Sciences. John’s extensive experience and significant level of success at all revenue stages is critical in scaling high-potential ventures like Single Pass.
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Dan Hughes
Head of Sales Operations
Dan comes to us with over 30 years of Medical Device Sales Experience in recent leadership roles at Medtronic Neurovascular, RapidAI and Mivi Neurosciences. He is leading the U.S. Commercial launch with our distribution partners and developing commercial strategy for the only FDA approved Biopsy Closure device. Dan has a reputation as a builder of successful teams and structures within the neurovascular space. His strengths in this environment include developing compensation programs heavily weighted towards overachievers, streamlining communication, and attracting the highest level of professional. ​
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Steve Fried
Head of Commercial Excellence
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Steve Fried is a seasoned healthcare marketing and sales leader with over 25 years of experience driving growth for medtech and AI health startups. He has led commercial teams at Viz.ai, RhythmX AI, Regard, and Medtronic, scaling revenue and securing major IDN partnerships. A former cardiovascular perfusionist, Steve combines clinical insight with proven go-to-market execution. At SinglePass, he guides the Western U.S. sales strategy and health system engagement.​
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Randall Takahashi
Chief Engineer
Randall Takahashi is a seasoned medical device engineer with over 21 years of experience across the Neurovascular, Cardiovascular, Ophthalmology, and Dental sectors. As Chief Engineer, he leads the development of Class I–III devices, including catheters, guidewires, drug-delivery systems, and implantables. Randall has deep expertise in the full product development cycle, advanced manufacturing, and materials selection. He holds 19 issued and pending patents and has held senior leadership roles at Medtronic, Abbott, and Balt, as well as co-founding multiple ventures. Known for his collaborative style and commitment to innovation, Randall values engineering integrity, design excellence, and transparency. He earned a B.S. in Biomedical Engineering from UC San Diego.
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Meera Shier
SVP Marketing
Meera Shier joins the Single Pass team after 16 years of experience in the Neurovascular space. Most recently, she led Global Marketing at Terumo Neuro (MicroVention) and consistently drove growth and revenue achievement. Prior to Terumo, Meera was a senior marketer and product launch leader at ev3/Covidien. Meera brings extensive experience launching innovative medical devices globally, building impactful brands, establishing deep customer relationships, and creating promotional programs to drive adoption and awareness. She will leverage her experience and skills to further expand and develop Single Pass's presence in the market.
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Ryan Ippolito, CPA, MBA
CFO
​Ryan Ippolito is a finance executive with more than 25 years of experience supporting high-growth companies across the life sciences, medical device, pharmaceutical, SaaS, and consumer sectors. He has held senior leadership roles in both public and private organizations, helping raise over $250 million in capital and leading M&A transactions exceeding $300 million. Ryan currently serves as CFO for multiple medical device startups, where he has supported initial commercialization and driven meaningful revenue growth. Previously, he served as CFO of Terumo Neuro (formerly MicroVention), a nearly $1 billion global leader in interventional neurology, where he led revenue expansion, EBITDA growth, global operational scaling, and strategic acquisitions.
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Board of Directors
Dave Ferrera
Board Member
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David Ferrera is an entrepreneur, engineer and inventor with nearly 30 years of experience in the medical device industry. He is CEO of RC Medical, an Orange County venture studio advancing interventional neurology and radiology innovations in collaboration with physician-entrepreneurs. Dave is CEO of Sonorous Neurovascular, a spinout of RC Medical. He previously served as CTO of Balt Global and co-founded Blockade Medical, acquired by Balt in 2016. His earlier roles include successful leadership positions at MindFrame (acquired by Covidien), Microvention (acquired by Terumo), and Micrus Endovascular (acquired by Johnson & Johnson). Mr. Ferrera holds over 80 patents and authored Innovation in Translation (Advantage-Forbes, 2021). He sits on multiple medical device boards and holds a B.S. in Plastics Engineering from UMass Lowell.​
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Sam Milstein
Board Member
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Sam Milstein is a seasoned biotechnology entrepreneur and investor with over four decades of experience founding, leading, and advising life science companies. He is CEO of Mortar & Pestle Consulting, offering strategic and technical expertise to biotech firms and investors. He co-founded or held executive roles at pioneering companies including Emisphere Technologies, Ception Therapeutics (acquired by Cephalon), and Athena Neurosciences (acquired by Elan). He currently serves as Board Chair of Cerus Endovascular, and is a Board Member of the Regenerative Medicine Foundation. He also advises early-stage ventures through the Mid-Atlantic Bio Angels. His career spans drug discovery, stem cell therapeutics, medical devices, and venture development.​
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Peter Sunenshine, MD
Board Member & Co-Founder
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Dr. Peter Sunenshine, MD, serves as the Chief of Neurointerventional Radiology at Banner University Medical Center in Phoenix, AZ, and holds a clinical assistant professorship at the University of Arizona College of Medicine - Phoenix. He completed a comprehensive 7-year residency program in radiology, neurology, and neuroradiology at New York University Medical Center/Bellevue Medical Center, followed by a fellowship in Neurointerventional Radiology at NYU. With over 15 years of experience, Dr. Sunenshine is a seasoned Neuroradiologist/Neurointerventional Radiologist, actively involved in various research projects and clinical trials.
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Paul Brooke
Board Member
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Paul Brooke is a seasoned healthcare executive and investor with decades of leadership across biotech, medical devices, and finance. He served as Chairman of Caelum Biosciences until its acquisition by AstraZeneca in 2021, and was a board member at Cerus Endovascular until its sale to Stryker in 2023. He currently chairs Browne Trading and serves on the board of Sonorous. Mr. Brooke is Managing Member of PMSV Holdings, a private investment firm, and was a founder and managing partner of venBio. He previously held senior roles at Morgan Stanley and Tiger Management, and has served as a director of several public and private companies. He brings deep expertise in healthcare strategy, investment, and board governance, with decades of experience guiding innovative companies to successful outcomes.
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Stephen Griffin
Board Member
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​Stephen Griffin brings almost 30 years experience in the medical device industry, working in the peripheral vascular, neurovascular and cardiovascular disease states. With a PhD in Biomedical Engineering from the University of Limerick, he started his career in R&D and held various technical and leadership positions. Most recently, Stephen, as CEO at Cerus Endovascular, was at the forefront of design and development of a platform of neurovascular Class III devices, and led the company through a successful transaction with Stryker Corp. in 2023. He brings a unique combination of technical expertise, clinical understanding, and commercial strategy to the medical device space.
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Shahin Enayati
Board Member
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Shahin Enayati is a purpose-driven entrepreneur and operator with over 25 years of experience building and scaling companies at the intersection of health, safety, and technology. He is the Founder and Managing Partner of Response Ready, a diversified emergency preparedness platform with B2B and B2C brands including CPR1.com, AEDLeader.com, and MDSIMedical.com. His work spans acquisitions, digital innovation, and vertical integration—empowering businesses and communities to better prepare for medical emergencies. Through his investment firm, Sustain Equity, and venture studio, Made Noble Companies, Shahin backs and accelerates impact-focused ventures. He brings a strategic, investor-minded approach to leadership and is committed to leveraging technology, education, and proactive planning to build safer, more resilient futures for individuals and organizations alike.
Kevin Hirsch, MD
Board Member & Co-Founder
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​Dr. Kevin Hirsch, a highly respected interventional radiologist, graduated from the University of Southern California School of Medicine in 1998. He joined Banner University Medical Center-Phoenix, elevating its interventional radiology program to a top referral center and later becoming Chair of the Department of Radiology in 2006. With extensive leadership experience and committee involvement, he played a key role in establishing programs like interventional oncology and the Interventional Stroke Program, making Banner University Phoenix the first certified Comprehensive Stroke Center in Arizona. Dr. Hirsch, a lifelong educator, was appointed Interim Chair of Radiology at University of Arizona College of Medicine, Phoenix in 2015 and has been promoted to full Clinical Professor. A consultant to the medical industry and co-founder of a medical device company, he continues to lead in research and clinical trials. Voted as one of Phoenix Magazine's Top Docs, Dr. Hirsch enjoys family time outside of his medical endeavors.
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Single Pass is headquartered in Lake Forest, California, and has pioneered a patented battery-powered electrocautery device for cauterizing deep tissue biopsy channels post solid organ procedures. Developed by Dr. Peter Sunenshine, a renowned Interventional Radiologist and Chairman at Banner University Medical Center in Phoenix, Arizona, this innovative technology revolutionizes biopsy procedures. With a management team boasting over 100 years of collective experience in successful medical device development and commercialization, Single Pass operates from its ISO certified facility in California, ensuring excellence in product quality and performance.
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Click Here to Hear Dr. Sunenshine Discuss The Origins and Benefits of Single Pass.
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Our Features
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The Single Pass Kronos Electrocautery Device is a patented, disposable tool designed to reduce post-biopsy bleeding and minimize hemorrhage risk. It cauterizes tissue through a guide needle, enabling larger needle use for substantial samples with fewer passes. The heated probe seals biopsy channels efficiently, enhancing safety for high-risk patients and ensuring precise, seamless procedures.
The Single Pass Kronos Electrocautery Device is a patented, disposable tool designed to reduce post-biopsy bleeding and minimize hemorrhage risk. It cauterizes tissue through a guide needle, enabling larger needle use for substantial samples with fewer passes. The heated probe seals biopsy channels efficiently, enhancing safety for high-risk patients and ensuring precise, seamless procedures.
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ROME, Feb. 19, 2024 /PRNewswire/ -- Single Pass, with the first and only biopsy closure cauterization device, is delighted to announce the successful completion of the first real- life cases utilizing the groundbreaking device. These cutting-edge procedures, conducted at the Universitario Campus Bio Medico, Fondazione Policlinico in Rome, Italy, demonstrate the device's exceptional capabilities and potential to revolutionize the field of biopsy closure.
In a remarkable stride towards improving healthcare, SinglePass, Inc. led by CEO Bill Colone, is redefining the way biopsy procedures are performed, enhancing the safety of these critical processes. Their core offering is a single-use disposable device designed to significantly improve the safety of biopsy procedures. This device stands out in terms of speed and ease of use and currently has no direct competitors. The technology has garnered significant interest in the medical community with two issued patents to date and two more patents pending.
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SinglePass Inc. addresses patient concerns about biopsy risks by focusing on reducing internal bleeding. Their flagship single-use disposable device streamlines biopsy procedures, enhancing patient safety and comfort. With a user-friendly design, it benefits both patients and medical staff. This innovation has already secured two patents, with two more pending, showcasing the company's commitment to excellence and ongoing innovation in healthcare.
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Millions undergo organ biopsies annually, yet post-biopsy bleeding poses risks, necessitating additional procedures, surgery, and prolonged recovery, even fatalities in severe cases. Single Pass Inc. offers a groundbreaking solution: the first disposable electrocautery device. It prevents bleeding by safely cauterizing deep tissue through a guide needle, promising swift, easy, and safe biopsy procedures.
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The Single Pass device will reduce the normal patient and physician anxiety as there currently does not exist a method or device that can stop or prevent bleeding. Thus, patients and physicians simply “hope” there are no complications. Our device can provide assurance before they leave the procedure room that there will be no complications. In turn, procedure and hospitalization costs will be significantly reduced.
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Single Pass, a leading provider of innovative medical devices, is pleased to announce an exclusive distribution agreement with Mermaid Medical Group, a renowned global medical technology company. This partnership will bring Single Pass's cutting-edge biopsy closure device to the US market, providing healthcare professionals with a groundbreaking solution for biopsy closure procedures.
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Single Pass is a local OC company solving the unique problem physicians face when conducting biopsies. David Friedman was the Deal Lead for Single Pass. In today’s “Angel’s Angle”, David will be sharing the 5 reasons TCA Invested in Single Pass. Single Pass is the only electrical cauterization device that can fit inside a guidewire. Product patents are heavily reliant on the wording used within the patent. Based upon the team, it seemed like they had that patent locked up.
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Nov. 20, 2023 CEO, Bill Colone, announced today receipt of the CE Mark under EU MDR for their Kronos Biopsy Closure device. The cautery device prevents or stops bleeding caused by biopsy tools during co-axial biopsy procedures and is most useful in liver, kidney, lung, and breast biopsy procedures.