SynCardia and Hydrix Enter into Development Collaboration to Advance the Emperor, SynCardia’s Next Generation Total Artificial Heart

Rhea-AI Summary

Picard Medical announced that SynCardia entered a development collaboration with Hydrix on Jan 5, 2026 to advance the Emperor, SynCardia’s next‑generation fully implantable Total Artificial Heart (TAH).

Hydrix will perform an initial development phase through end of 2026 within a staged, multi‑year program that advances through defined engineering verification and regulatory milestones. The arrangement may allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review.

Positive

• Collaboration with Hydrix commenced on Jan 5, 2026
• Initial development phase scheduled through end of 2026
• Program structured as a multi‑stage, multi‑year engineering and regulatory pathway
• Potential Australian R&D tax incentive of ~43% of eligible expenditure

Negative

• Continuation between stages depends on demonstrated technical progress and regulatory alignment
• R&D tax incentive of ~43% is subject to qualification and review, not guaranteed

News Market Reaction

-1.19%

1 alert

-1.19% News Effect

On the day this news was published, PMI declined 1.19%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

R&D tax incentive rate: 43% of eligible expenditure Share price: $1.68 24h price change: -4.55% +5 more

8 metrics

R&D tax incentive rate 43% of eligible expenditure Potential Australian R&D tax incentives mentioned for Emperor program development

Share price $1.68 Pre-news current price from market context

24h price change -4.55% Pre-news 24h move ahead of collaboration announcement

52-week high $13.68 Medical devices 52-week range context for PMI

52-week low $0.15 Medical devices 52-week range context for PMI

Market cap $123,817,976 Equity value prior to development collaboration news

Today’s volume 192,468 shares Pre-news trading activity vs 20-day average 274,172

Development phase timing Through end of 2026 Initial Emperor collaboration phase duration under Hydrix agreement

Market Reality Check

Price: $1.74 Vol: Volume 192,468 vs 20-day ...

normal vol

$1.74 Last Close

Volume Volume 192,468 vs 20-day average 274,172 (relative volume 0.7x), showing no pre-news accumulation spike. normal

Technical Shares at $1.68 were trading below the 200-day MA of $2.71 and 87.72% below the 52-week high of $13.68, despite being 1020% above the 52-week low of $0.15.

Peers on Argus

PMI showed a -4.55% pre-news 24h move while peers were mixed: CTKB appeared in m...

1 Up

PMI showed a -4.55% pre-news 24h move while peers were mixed: CTKB appeared in momentum scanners up 6.09%, KIDS, LAB modestly down, and AVMR/ZIMV flat. Movements do not indicate a coordinated sector move.

Common Catalyst Same-day peer headlines for KIDS and CTKB focused on preliminary revenue results and guidance, pointing to an earnings-related theme in parts of the medical devices group rather than news tied to artificial heart technology development.

Historical Context

5 past events · Latest: Jan 07 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 07	Conference participation	Positive	+10.4%	Management attending high-profile JPM week investor and MedTech forums.
Jan 06	Product enhancement	Positive	+3.6%	Rollout of FDA-cleared connector accessory to improve comfort and safety.
Dec 30	Governance/leadership	Positive	-6.4%	CEO elected to AZBio Board, reinforcing ecosystem engagement.
Dec 24	Debt financing	Negative	-1.9%	Announcement of up to $50M senior secured notes with warrants.
Dec 18	Listing milestone	Positive	+10.3%	NYSE opening bell ceremony marking transition to public company.

Pattern Detected

Recent news has more often aligned with price direction, with positive operational and milestone updates tending to coincide with upward moves, while financing-related or neutral governance items have sometimes seen flat-to-negative reactions.

Recent Company History

Over the past month, Picard Medical has highlighted multiple milestones around SynCardia and the Emperor Total Artificial Heart. On Dec 18, 2025, ringing the NYSE opening bell as a new public company aligned with a strong positive move. Subsequent financing news for up to $50.0 million in senior secured notes due 2028 drew a modest negative reaction. Operational updates like rollout of an FDA-cleared accessory and conference participation during JPM week on Jan 12–14, 2026 were followed by positive price reactions. Today’s collaboration extends that Emperor-focused development narrative.

Market Pulse Summary

This announcement expands Picard Medical’s Emperor Total Artificial Heart program through a structur...

Analysis

This announcement expands Picard Medical’s Emperor Total Artificial Heart program through a structured, multi-year collaboration with Hydrix, adding external engineering depth to a fully implantable TAH platform. It follows recent clinical and corporate milestones, including first in vivo implantations and a transition to public markets, while the stock traded well below its $13.68 52-week high and under the $2.71 200-day MA. Investors may watch execution on defined engineering and regulatory milestones and future financing disclosures in SEC filings.

Key Terms

total artificial heart, fully implantable, mechanical circulatory support systems, r&d tax incentives, +1 more

5 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.

fully implantable medical

"next-generation, fully implantable Total Artificial Heart (TAH) technology, known as"

A fully implantable device is a medical or monitoring system placed entirely beneath the skin so there are no external pieces or wires visible or attached to the body. For investors, that matters because such designs tend to offer better patient comfort and lower infection risk but require more complex engineering, longer regulatory testing, and different service or replacement economics — all of which affect market potential, adoption speed, and long‑term revenue.

mechanical circulatory support systems medical

"track record developing regulated medical devices, including mechanical circulatory support systems."

Mechanical circulatory support systems are medical devices that help or temporarily replace the heart’s pumping action to keep blood flowing when the heart is too weak or needs support during procedures — think of them as external or implanted helpers that maintain circulation. Investors watch this area because device sales, recurring maintenance or replacements, clinical outcomes, regulatory approvals and insurance reimbursement all drive revenue potential and risk for companies in the heart‑care equipment market.

r&d tax incentives financial

"allow Picard to benefit from Australian R&D tax incentives of approximately 43%"

A government program that lets companies recover part of their spending on research and development through tax credits, deductions, or cash refunds. Like a discount or rebate on innovation costs, these incentives lower a company’s effective expenses and improve cash flow, which can boost short-term profits and support longer-term investment plans—factors investors watch when judging a firm’s growth potential and financial health.

regulatory milestones regulatory

"advancing through defined engineering verification and regulatory milestones with continuation"

Regulatory milestones are the key official steps a company must reach with government agencies—such as filings, approvals, clearances or formal reviews—before a product or business activity can move forward. For investors they matter because hitting or missing these milestones can change a company’s ability to sell products, unlock revenue, reduce legal and development risk, or trigger payments, much like a traffic light or checkpoint that determines whether a project can continue on schedule.

AI-generated analysis. Not financial advice.

01/12/2026 - 08:30 AM

TUCSON, Ariz., Jan. 12, 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. FDA and Health Canada, today announced that on January 5, 2026 SynCardia entered into a development collaboration agreement (the “Agreement”) with Hydrix Services Pty Ltd (“Hydrix”), a wholly owned subsidiary of Hydrix Limited (ASX: HYD), to commence an initial development phase for SynCardia’s next-generation, fully implantable Total Artificial Heart (TAH) technology, known as the Emperor. As a fully implantable TAH, Emperor would eliminate the use of an external driver and offer both greater convenience and increased freedom related to patient mobility.

SynCardia selected Hydrix as a development partner based on its proven expertise in complex critical engineering and its strong track record developing regulated medical devices, including mechanical circulatory support systems. The collaboration reflects Picard Medical’s focus on partnering with world-class engineering organizations capable of supporting long-term, high-value development programs for mission-critical, life-sustaining technologies.

Patrick N.J. Schnegelsberg, CEO of SynCardia Systems, commented, “Hydrix’s expertise and demonstrated track record in advancing complex cardiovascular technologies will support our shared objective of developing transformative solutions for patients with advanced heart failure. As we advance the Emperor program into its next phase of development, the structure may also allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review.”

“We are excited to commence this critical development with SynCardia, a highly regarded global leader in advanced heart replacement technology,” said Gavin Coote, Executive Chairman of Hydrix. “It endorses our capability to deliver complex, medical device development programs for leading international medical technology companies.”

Under the agreement, Hydrix will perform development work for Picard and SynCardia through the end of 2026 as a first phase within a broader staged development program for the Emperor. The program is structured as a multi-stage, multi-year effort advancing through defined engineering verification and regulatory milestones with continuation between stages dependent on demonstrated technical progress performance and safety validation regulatory alignment.

About Hydrix Limited and Hydrix Services

Hydrix Limited (ASX: HYD) is a powerful product innovation company. Hydrix's purpose is to enhance the health, safety, and well-being of a billion lives. The Company leverages its powerful product innovation capability across three business segments: Services: design, engineer and deliver world-first products and innovation; Ventures: invest in high potential MedTech clients; and Medical: distribute disruptive cardiovascular products.

About Picard Medical and SynCardia

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 additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov.

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. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov.

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

What did Picard Medical (PMI) announce on January 12, 2026 about the Emperor TAH?

Picard announced SynCardia entered a development collaboration with Hydrix on Jan 5, 2026 to advance the fully implantable Emperor TAH.

How long is the initial Emperor development phase with Hydrix under the PMI collaboration?

Hydrix will perform development work through the end of 2026 as the initial phase of a staged program.

What are the next steps and milestones for the Emperor program under PMI (PMI) collaboration?

The program will advance through defined engineering verification and regulatory milestones with continuation contingent on technical progress and safety validation.

Will Picard (PMI) receive Australian R&D tax incentives for the Emperor program?

The structure may allow Picard to benefit from approximately 43% of eligible Australian R&D expenditure, subject to qualification and review.

Why did SynCardia select Hydrix as a development partner for the Emperor TAH?

SynCardia selected Hydrix based on its experience in complex critical engineering and developing regulated medical devices, including circulatory support systems.