NIA Small Business Showcase: Piccolo Medical, Inc.

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With more than 3 million peripherally inserted central catheters (PICCs) placed in the United States every year, the need for highly accurate bedside placement confirmation is paramount. Existing PICC tip confirmation systems are limited in patients with abnormal cardiac rhythm and have variable accuracy rates in all patients. Independent peer-reviewed literature indicates that as many as 56% of PICCs placed in intensive care units are misplaced when using the market leading BD Sherlock 3CG™ technology.

Piccolo Medical’s SmartPICC® System utilizes the intravascular electrocardiogram (ECG) technique for PICC tip confirmation. In addition, Piccolo’s novel ionic dilution technology characterizes the blood flow conditions at the tip of a catheter and provides visual feedback to the user to help determine anatomical location. With this dual-vector technology, the SmartPICC® System has the potential to become the most accurate, reliable, and easy-to-use PICC navigation system on the market. In addition, by not relying entirely on the patient’s ECG, the SmartPICC® System has the potential to provide tip confirmation in patients with abnormal rhythm, such as atrial fibrillation.

Globally, a total of 8.5 million PICCs are placed each year, driving approximately $1 billion in annual revenue. The U.S. PICC market alone drives approximately $550 million annually, with more than 3 million PICCs placed each year. Historically, PICC tip confirmation was achieved by X-ray or fluoroscopy, but a clear trend toward minimizing patient radiation, improving nurse efficiency, and reducing overall health care costs has led to a sharp increase in the use of bedside tip confirmation systems over the past decade.

The Piccolo SmartPICC® System has the potential to become the most accurate tip confirmation system on the market. By ensuring that all PICCs are placed accurately and eliminating the need for expensive and time consuming X-rays, the SmartPICC® System can improve patient outcomes and hospital profit margins.

Company Milestones

Scientific

  • 2017: NIH Small Business Innovation Research (SBIR) Phase I pediatric grant awarded: A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter Line Placement in Pediatric and Neonatal Patients
  • 2018: NIH SBIR NIA Phase I grant awarded: A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter Line Placement
  • 2018: NIH SBIR NIA Phase II grant awarded: A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter Line Placement
  • 2022: SmartPICC® Clinical Feasibility Study, a 42-patient safety and technical feasibility study

Business

  • 2018: Series A fundraising
  • 2021: Section 510(k) award for the SmartPICC® System

Financial Overview

Piccolo raised $6,401,500 from 2016 to 2022 from NIA for Phase I Small Business Technology Transfer (STTR). The company is currently seeking $3 million in Series A-1 equity funding and a $3 million NIH Commercial Readiness Pilot grant (application pending). Piccolo plans to raise $6 million to $10 million in Series B funding in 2023 and 2024.

Intellectual Property

Piccolo has three patent families with broad claims related to its core ionic dilution technology, including issued patents in the U.S., China, and Japan.

Product Development and Regulatory Strategy

Piccolo will launch the second-generation SmartPICC® System and SmartPICC® Stylet in the U.S. market in 2023. Future regulatory filings will target further device improvements, expansion of accessory offerings, and expansion of product labeling with respect to key patient populations, including patients with arrhythmia.

Commercialization Strategy

Piccolo will look to key strategic partners in the U.S. PICC market for commercial rollout of full maximum-barrier bedside PICC kits that are integrated with the SmartPICC® Stylet and compatible with the SmartPICC® System. Beyond the PICC market, future applications of the ionic dilution technology include central venous catheter (CVC) and acute dialysis catheter procedures.

Company Details

Piccolo Medical, Inc.
218 Mississippi Street
San Francisco, CA 94107

Industry: Devices

Management Team:

  • Chief Executive Officer: Augie Shanahan
  • Chief Operating Officer: John McKenzie
  • Chief Marketing Officer: Dan Burnett

Point of Contact:

Augie Shanahan
Email Augie Shanahan
617-842-4168