Single Pass
Guiding Success in Cauterizing Deep Tissue Biopsy

Percutaneous biopsy plays a crucial role in providing efficient, minimally invasive, and cost-effective diagnoses of malignancy and parenchymal diseases, particularly in solid organs such as the liver and kidney. Coupled with advancements in image-guidance technologies, percutaneous biopsies can offer accurate clinical surveillance and diagnostic capabilities. However, this medical procedure is not devoid of its challenges.

Biopsies can lead to adverse events, such as uncontrolled bleeding and hemorrhage. While complications after biopsies are rare, the unpredictability of these events, where physicians can’t detect which patients may bleed or develop hematomas are higher.

The healthcare community lacks a standard procedure to identify and prevent bleeding post-biopsy. Clinicians rely on procedural techniques, like administering new medications, using hemostatic agents to plug the biopsy channel, and holding patients in the recovery area with pressure bandages for hours to minimize post-procedure complications.

Our Device Is The Only Patented, Innovative Electrocautery Device With A Probe That Can Fit Into Biopsy Channels. It Eliminates Procedural Anxiety And Gives Clinicians Total Control Of The Outcomes To Improve Patient Safety

Two interventional radiologists, Peter Sunenshine, MD and Kevin Hirsch, MD from Phoenix, Arizona, observed the inefficiencies of traditional biopsy techniques and how they can lead to hemorrhage and even death. These techniques also resulted in open surgical repair, blood transfusions, long patient recovery time, extended hospital stays, and high hospitalization costs.

To mitigate these issues, doctors Sunenshine and Hirsch designed a first-of-its-kind, disposable, bipolar electrocautery device. Together with Bill Colone and his partners, they established Single Pass, Inc. to usher in a new era of safe biopsy procedures. Its patented electrocautery device enhances patient experience and healthcare productivity by helping physicians prevent bleeding in patients after biopsy procedures.

A First-of-its-Kind Electrocautery Device

The revolutionary product from Single Pass provides clinical advantages and cost savings for millions of patients undergoing deep tissue biopsy procedures. It effectively seals biopsy channels by cauterizing tissue through a guide needle.

This simple and easy-to-use device uses battery current to heat the probe tip, which cauterizes the tissue damaged by biopsy tools at temperatures between 80 and 90 degrees Celsius. The electro-cauterization method is suitable for eliminating post-procedure bleeding after biopsies and other minor surgical procedures.

The Single Pass device is designed with a probe that fits through a biopsy guide needle, making it easy for professionals to perform biopsies without disrupting the procedure. After a normal sample collection, the clinician can simply insert the device through the guide needle and turn on the power switch to seal the biopsy channel. The device extends beyond the end of the guide needle, the same distance the tissue extractor extends, to effectively cauterize the entire channel. This improves the safety of biopsy procedures for at-risk patients while allowing clinicians to use larger guide needles to collect bigger tissue samples with fewer needle passes.

“Our device is the only patented, innovative electrocautery device with a probe that can fit into biopsy channels. It eliminates procedural anxiety and gives clinicians total control of the outcomes to improve patient safety,” says Bill Colone, CEO of Single Pass.

Validating the Excellence

Single Pass’s patented electrocautery device has undergone clinical evaluations, and the results were exceptional. The first study, conducted in Riga, Latvia, was supervised by Dainis Krievins, professor and director at the Institute of Research at Pauls Stradins Clinical University Hospital. It involved many successful liver and renal biopsy procedures, with CT imaging and duplex ultrasound confirming the cauterization of all tissues damaged by the guiding needle. There was no residual bleeding detected after any procedure.

Professor Krievins described the Single Pass device as intuitive and easy to use, with excellent clinical outcomes. The interventional radiologists at the Latvia facility were impressed because the biopsy channels were blood-free after cauterization, which helped increase their confidence in performing co-axial biopsy procedures without bleeding issues. Krievins also believes the device would be useful for other biopsies with potential bleeding.

In the U.S., the device underwent a clinical study where David Tahour, MD chief of vascular and interventional radiology at MemorialCare Miller Children’s & Women’s Hospital Long Beach, evaluated its performance. Dr. Tahour conducted several biopsies in the liver, kidney and other soft tissues using the Single Pass device to stop residual bleeding. The patients did not experience any device related adverse events despite kidney and liver biopsies being two of the highest-risk procedures. In addition, no patients required a second application, illustrating the device’s ability to stem bleeding the first time.

Dr. Tahour described the Single Pass device as an excellent innovation for patients undergoing percutaneous biopsy and at risk of bleeding complications. The device’s ability to stop bleeding in less than a second for 25 percent of patients and less than 10 seconds for 60 percent of patients is remarkable, as is zero device-related adverse events.

Bringing a Paradigm Shift

The results from its clinical evaluations illustrate that the Single Pass device fulfils its purpose of providing excellent clinical outcomes and patient experience. The device also has the potential to reduce procedure costs by eliminating the need for medications and hemostatic agents, as well as reducing post-procedure observation and recovery times. This is beneficial as it saves nursing time, allowing hospitals to allocate resources to timely care and attention to postprocedure observation.



Seed-funded by the NuFund Venture Group, Tech Coast Angels of Orange County (TCA), individual TCA members, physicians, and the co-founding management team, Single Pass is currently planning the global commercial launch. The team recently submitted the US 510(k) and the technical file has been accepted and approved by the company's Notified Body. Thus, the CE Mark will be issued soon.

The Single Pass device can bring standardization to biopsies and enhance the overall patient experience while optimizing healthcare productivity. All this is made possible with a team of medical device engineers that complements the management’s skills and experience in taking the product from ideation to regulatory clearance. The team has over 100 years of combined medical device development and commercial launch experience, from R&D, manufacturing, evaluation, and regulatory clearance to business management, and a track record of more than 150 patents. Single Pass has also established a strategic partnership with a highly regarded contract manufacturing organization to cost-efficiently design and develop the product.

The Single Pass team will soon be introducing the device to numerous interventional radiologists worldwide. It will use various distribution channels and partner firms to make significant outreach in Europe, Asia, Australia, and New Zealand. In the U.S., it plans to hire a direct sales team to reach radiologists. Single Pass’s membership in the U.S. Medicare database provides an advantage in that helps it adopt a targeted approach, where it can focus on high-value clinics and radiologists.

In parallel, Single Pass is collaborating with physicians to gather innovative ideas to improve the electrocautery device’s efficiency. The team is also exploring other avenues to apply its experience in the medical device industry to bridge gaps in medical procedures and operations.

“We are industry builders who are always open to innovative ideas from physicians and committed to making a difference in the global healthcare space,” says Colone.