Your questions, answered.

A medical device company focused on the external part of PICC and central lines.

Clearport Medical Ltd (company no. 517402277) was incorporated on 3 September 2026. Its first product, the CP-100, is a securement and protection device for patients who live with a line at home for weeks or months.

The company designs the product and owns its intellectual property. Manufacturing will be carried out by an ISO 13485-certified contract manufacturer.

In October 2026 Clearport was accepted into a medtech commercialization accelerator program.

The first clinical study, CLEAR-1, has been proposed to a leading medical center. These discussions are ongoing.

Clinical validation first, then commercial launch in the United States.

The US is the main market because most long-term PICCs there are managed at home through home infusion. About 1.0 million US PICC courses a year continue at home, for an average of about six weeks each (Clearport estimate from published volumes and dwell times).

A thin, flexible tube placed in an upper-arm vein and threaded toward the heart.

A PICC (peripherally inserted central catheter, said "pick") stays in for weeks or months to deliver chemotherapy, IV antibiotics, parenteral nutrition and other infusions, often at home.

The part outside the body is what goes wrong in daily life: the juncture hub, the extension legs (one per lumen), the clamps and the end connectors. The CP-100 deals only with that external part.

Often enough to be a routine problem, even with today's securement in place.

These rates are measured with standard securement and a transparent dressing already in place.

A line that migrates or comes out usually means some combination of:

• an extra nurse visit, or a trip to a clinic or emergency department
• a replacement line, with another insertion procedure
• delayed or interrupted chemotherapy, antibiotics or nutrition
• in some cases, readmission to hospital

Lifted, soaked or snagged dressings cause a second, more frequent problem: unscheduled dressing changes between the routine weekly visits.

• INS 2024, Standard 39: use a securement method in addition to the primary dressing. Inadequate securement can cause dislodgement and premature removal (Level I evidence).
• INS 2024, Standard 53: use a securement product or a taped tension loop of tubing to reduce the risk of accidental dislodgement.
• CDC: replace transparent dressings on central lines at least every 7 days, or sooner if damp, loosened or soiled.

The CP-100 is designed with current INS and CDC guidance in mind.

Most securement devices focus on anchoring the catheter, not the rest of the external line.

Adhesive anchors hold the catheter near the insertion site. The extension legs, clamps and connectors are left loose. At home they catch on clothing, bedding and door handles, pull on the insertion site, and get wet in the shower. Patients often improvise with tape or buy separate sleeves and shower covers.

The CP-100 is designed for that gap: the whole external line, in the setting where most of the dwell time happens.

A single-use, non-sterile, skin-worn device that secures and shrouds the external part of an indwelling PICC or central line.

It holds the juncture hub, extension legs, clamps and end connectors in one low-profile housing on the upper arm (for a PICC) or the neck or chest (for a central line). The current design is the CP-100 V4.

Proposed indication: "The CP-100 is intended to secure and protect the external portion of an indwelling intravascular catheter (PICC or central venous catheter) to the patient's skin."

Each feature addresses a common problem with the external line.

• Anchors the hubHolds the catheter hub, designed to take tugs on the tubing away from the insertion site.
• Manages the tubingHolds excess tubing in a managed loop, designed to stop it catching or bending sharply.
• Shrouds the portsCovers the end connectors, which stay accessible for flushes and infusions.
• Keeps the site visibleA clear window over the insertion site and dressing allows visual checks without removing the device.

Designed for single-, dual- and triple-lumen PICCs sold in the US, and comparable central lines.

Fit is being validated on leading US PICCs.

No. It is an adjunct, worn on top of both.

The nurse places the line, the dressing and the securement device exactly as today, and applies the CP-100 over them. Facility line-care protocols stay the same. It can also be used alongside subcutaneous anchors.

No.

The CP-100 does not connect to the catheter, the connectors' fluid path or the insertion site. Because there is no fluid-path connection, small-bore connector standards (ISO 80369-7) do not apply. Flushes, infusions and blood draws go through the ports as usual, with the caps opened in place.

The CP-100 is non-sterile and worn over intact skin and over the existing dressing. Clearport makes no infection-prevention claim. Its function is mechanical: securement, tubing and port protection, site visibility and splash resistance.

Patent pending, owned by Clearport Medical Ltd.

Ambulatory adults with a PICC or central line managed at home or as outpatients.

• Oncology: lines for chemotherapy and frequent blood draws, often kept for 4–6 months. The longest-wearing group.
• OPAT: outpatient IV antibiotic courses through home infusion, typically a few weeks.
• Home parenteral nutrition, hydration, inotropes and other long-term home infusions.

It may be most relevant for patients at higher risk of line problems, such as very active or long-dwell patients.

• Hospital discharge: applied before the patient goes home, as part of a discharge kit, when risk is highest.
• Home infusion and home health: changed by the visiting nurse at the weekly dressing change.
• Infusion centers and oncology day care: supplied in bulk for patients between visits.
• Hospital-at-home programs that manage the line through the whole course.

By a nurse, at the routine dressing change, in a few simple steps.

Nothing is threaded over the line, and the existing dressing and securement stay in place. Full instructions for use will be published with the product.

• Routine: replaced with the dressing on its regular schedule, typically about once a week for transparent dressings.
• Sooner if it lifts at the edges, gets wet underneath, or is visibly soiled or damaged.
• Between changes it stays on through flushes, infusions, showering and sleep.
• Single-use: a new device at every change, never reapplied.

A typical home course uses about six devices. The first month after discharge is planned as a 4-device kit.

Proposed wear schedule. Final instructions for use will be confirmed in the patient and nurse validation study.

The line is held flat under one cover instead of hanging loose. It is designed to let patients dress, sleep and move without the tubing catching, and to resist splashes during showering. The site stays visible, so a caregiver can check it without lifting anything.

Comfort, showering, sleep and daily activities are all measured in the clinical study.

• Apply only to clean, dry, intact skin. Do not place over broken or irritated skin.
• Check the skin under the adhesive at each change for signs of adhesive-related irritation (MARSI).
• Non-sterile and single-use.
• Remove the device and assess the line if dislodgement is suspected.
• Always used with, never instead of, the primary dressing and facility line-care protocols.

Intended use and precautions are proposed and will be finalized with the instructions for use.

Expected Class I, 510(k)-exempt, as an intravascular catheter securement device.

The expected classification is 21 CFR 880.5210, product code KMK. If confirmed, the CP-100 would be registered and listed with the FDA rather than submitted for premarket clearance. Its quality file will include design controls, risk management (ISO 14971), biocompatibility testing for intact skin (ISO 10993), bench verification and UDI.

Bench testing will cover adhesion, wear over the dressing-change interval and fit on leading US PICCs.

Preliminary. To be confirmed by regulatory counsel. Not a regulatory determination.

A single-arm pilot study proposed at a leading medical center.

It is designed to evaluate how the device performs in everyday use: wear, application, comfort and line position. It will run under ethics committee approval and is led for Clearport by a key opinion leader. The proposal is under discussion and has not yet been approved.

• Safety: skin reactions and any device-related adverse events
• Wear: how well the device stays in place between dressing changes
• Application: how long it takes a nurse to apply
• Dressing changes: unplanned changes between routine visits
• Line position: any movement of the catheter
• Patient experience: comfort, site visibility and quality of life

Final endpoints will be set in the approved study protocol.

Only what the evidence supports.

Until clinical data is available, Clearport describes what the device is designed to do, not outcomes. No infection-prevention claim is made.

Clearport works with a specialist medical device design partner on design, prototyping and verification. Production will be with an ISO 13485-certified contract manufacturer.

The CP-100 is at the start of prototyping, and the first manufacturing batch is being contracted.

• Users: vascular-access, infusion, oncology and home-health nurses, and patients and caregivers at home.
• Buyers: home infusion providers, hospital oncology and OPAT programs (through value analysis committees), integrated delivery networks and payers.

Most of the cost of a failed line falls on the payer, not the provider who changes the dressing. Clearport's value case is therefore built around payers, Medicare Advantage plans and integrated systems, with home infusion providers as the channel to patients.

No billing code pays for the device itself.

Its cost falls within existing supply payments:

• Commercial home infusion: S5501, the per diem for complex catheter care (more than one lumen), which includes supplies. Not payable by Medicare.
• Medicare Part B (DME): A4221, weekly supplies for a non-insulin drug infusion catheter, only with a covered external infusion pump.
• Hospital: packaged into the inpatient DRG or outpatient APC payment.

Clearport is pursuing payer contracts and a billing route as a non-routine supply.

Preliminary coding analysis, pending review by a qualified reimbursement specialist. Not a coverage or payment determination.

Most securement products anchor the catheter itself, with an adhesive pad, a subcutaneous anchor or a securement dressing. Arm sleeves and covers protect the line for showering but do not secure it.

The CP-100 is designed to sit on top of these and cover the rest of the external line: the hub, extension legs, clamps and connectors. It does not replace primary securement or the dressing.

Not yet.

The CP-100 is in development and is not available for sale. Availability will be announced. Clinical teams and providers who would like to hear more can contact Clearport.