Picard Medical to Begin Rollout of FDA-Cleared Accessory for its SynCardia Total Artificial Heart

Picard Medical (NYSE American: PMI) will begin incorporating an FDA-cleared accessory, CPC1 “Connector Covers”, into the SynCardia Total Artificial Heart (STAH) design to enhance patient comfort and reinforce device safety and reliability.

Rhea-AI Summary

Picard Medical (NYSE American: PMI) will begin incorporating an FDA-cleared accessory, CPC1 “Connector Covers”, into the SynCardia Total Artificial Heart (STAH) design to enhance patient comfort and reinforce device safety and reliability.

The CPC Connector Covers add a protective layer over the metal release buttons on STAH CPC connectors that link SynCardia Drivers to the two pneumatic drive cannulas. The company expects rollout into U.S. clinical practice beginning January 15, 2026. All SynCardia sales and clinical staff have completed required training; SynCardia will provide hospitals with training materials, implementation guidance, and support for existing patients.

Positive

• FDA-cleared accessory rollout starting January 15, 2026
• All SynCardia sales and clinical staff completed required training
• Connector covers add extra protection over metal release buttons

Negative

• None.

Argus Jan 6 session

+3.59% close to close Open Argus

Details

News Market Reaction – PMI

On Jan 6, the day this news came out, PMI closed 3.59% above the previous close.

Data tracked by StockTitan Argus for the Jan 6 session.

Key Figures

STAH support duration: 2,900 days Senior secured notes capacity: $50.0 million Initial notes issued: $15.0 million +5 more

STAH support duration

2,900 days

Longest recorded time on an artificial heart, prior SynCardia update

Senior secured notes capacity

$50.0 million

Private placement notes due 2028, announced Dec 24, 2025

Initial notes issued

$15.0 million

First tranche of senior secured notes at closing

Bridge note principal

$1,000,000

Unsecured promissory note dated Nov 26, 2025

Bridge note interest

6% annually

Interest rate on $1,000,000 bridge financing

Q3 2025 revenue

$1.187 million

Quarter ended Sep 30, 2025

Q3 2025 net loss

$10.426 million

Quarter ended Sep 30, 2025

Shares outstanding

73,701,176 shares

As of Nov 10, 2025 per 10-Q

Historical Context

5 past events · Latest: Dec 30

5 events

1. Dec 30

   Management/board update

   24h Move

   -6.4%

   CEO elected to AZBio Board, reinforcing industry engagement and visibility.

2. Dec 24

   Debt financing

   24h Move

   -1.9%

   Up to $50M senior secured notes and warrants for working capital needs.

3. Dec 18

   Listing milestone

   24h Move

   +10.3%

   NYSE Opening Bell event marking transition to public-company status.

4. Dec 09

   Clinical durability

   24h Move

   -8.7%

   Patient reached 2,900 days on SynCardia Total Artificial Heart support.

5. Dec 03

   Conference presentation

   24h Move

   +2.0%

   CEO presenting Emperor Total Artificial Heart data at CSI Focus D-HF.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

total artificial heart, u.s. food and drug administration (fda), pneumatic drive cannulas

3 terms

total artificial heart medical

"maker of the world’s first total artificial heart approved by both the U.S."

A total artificial heart is a surgically implanted mechanical device that replaces the heart’s two main pumping chambers and takes over circulation, acting like a continuous pump that keeps blood moving through the body. Investors care because it is a high-cost, high-stakes medical product whose commercial success depends on clinical trial results, regulatory approvals, hospital adoption, reimbursement rules and long-term patient outcomes — factors that drive revenue potential and risk.

u.s. food and drug administration (fda) regulatory

"only total artificial heart approved by both the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

pneumatic drive cannulas medical

"connect SynCardia Drivers to the two pneumatic drive cannulas of the STAH ventricles"

Pneumatic drive cannulas are hollow medical tubes that connect to a compressed‑air powered handpiece to deliver or remove fluids, gases, or to drive cutting or aspiration tips during minimally invasive procedures. Think of them like a powered attachment on a drill that lets a surgeon precisely move fluids or tissue; their reliability, precision and regulatory clearance directly affect clinical outcomes, device adoption and therefore sales and liability risk for investors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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The new component is designed to enhance comfort for patients as well as further reinforce the safety and reliability of the device

TUCSON, Ariz., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems, LLC, maker of the world’s first total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada today announced that it would begin to incorporate an additional design component of an FDA-cleared accessory, CPC¹ “Connector Covers”, into its SynCardia Total Artificial Heart (STAH) design that is intended to provide comfort during daily activities while reinforcing system safety and reliability.

Specifically, the CPC Connector Covers will offer an extra layer of protection over the metal release buttons that are found on the STAH CPC connectors which externally connect SynCardia Drivers to the two pneumatic drive cannulas of the STAH ventricles. The rollout is expected to be incorporated into standard clinical practice for patients in the U.S. beginning January 15, 2026.

“Patient safety and quality of life are central to everything we do,” said Steve Langford, Senior Clinical Specialist at SynCardia Systems. “This enhancement reflects our ongoing commitment to practical improvements that support confidence and ease of use for both patients and clinicians.”

All SynCardia sales and clinical staff have completed the required training in advance of the rollout. SynCardia will work directly with hospital and clinical teams to provide training materials, implementation guidance, and support for existing patients as appropriate.

About Picard Medical, Inc.
Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world. For more information, please visit https://www.syncardia.com.

References

¹Cold Products Company, a part of Dover (NYSE: DOV) and a leading manufacturer of connection technologies used in liquid cooling of electronics.

Forward-Looking Statements
This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Contact:

Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
eric@lifesciadvisors.com

Picard Medical, Inc./SynCardia Systems, LLC
IR@picardmedical.com

General/Media
Brittany Lanza
blanza@syncardia.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Picard Medical (PMI) announcing for the SynCardia Total Artificial Heart on January 15, 2026?

Picard will begin incorporating the FDA-cleared CPC1 Connector Covers into STAH as standard clinical practice on January 15, 2026.

How do the CPC1 Connector Covers change SynCardia Total Artificial Heart device connections?

They provide an extra protective layer over the metal release buttons on CPC connectors that link Drivers to the two pneumatic drive cannulas.

Will hospitals receive training for the CPC1 Connector Covers rollout for PMI devices?

Yes; all SynCardia sales and clinical staff completed required training and SynCardia will provide training materials and implementation guidance to hospitals.

Does the January 2026 rollout of the CPC1 Connector Covers have FDA clearance for PMI devices?

Yes; the CPC1 Connector Covers are described as an FDA-cleared accessory incorporated into the STAH design.

What patient benefits does Picard expect from adding CPC1 Connector Covers to the STAH?

The company says the covers are intended to enhance patient comfort during daily activities and reinforce system safety and reliability.

Will existing SynCardia patients be supported during the PMI Connector Covers implementation?

SynCardia will work directly with hospital and clinical teams to provide support for existing patients as appropriate.