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Picard Medical, Inc.

$0.17

0 (-2.47%)

Market Cap
13.94 M
EPS
-0.45
P/E Ratio
-
Value Trade
80.25 M
SEC Financials
Q1 2026
  • Dilution Risk

    95%
  • Revenue

    1.15 M

  • R&D Expenses

    1.90 M

  • Operating CF

    -3.80 M


  • Total Assets

    11.22 M

  • Total Liabilities

    12.67 M

  • Equity

    -1.45 M

  • D/E Ratio

    12,345

-8.71 %
Week
-82.5 %
1 Month
-88.29 %
3 Month
-93.14 %
6 Month
-96.41 %
5 Year
-96.41 %
All Time
Cash Data
Critical
  • Cash Position

    121.00 K

  • Monthly Burn

    1.27 M

  • Runway

    0 mo

  • Burn Trend

    Stable
  • SEC Filing

    May 15, 2026
Overview
Volume
2.73 M
52 Week Range
0.13 - 13.68
% held by Insiders
79.48 %
% held by Institutions
0.43 %
Enterprise Value
17.10 M
Total Shares
75.16 M
Short %
5.13 %
Float Shares
26.23 M
Company Description
HQ: 1992 E. SILVERLAKE RD., TUCSON...
Employees:75

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%
Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%
Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%
Small Molecule
Oncology
Unlock Upcoming Catalyst data
Drug Pipeline Intelligence
Unlock Drug Pipeline Intelligence
Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
Example Drug
Example indication for clinical evaluation
Phase 3
2025-12-01
Example Drug
Example indication for clinical evaluation
Phase 3
2025-12-01
Example Drug
Example indication for clinical evaluation
Phase 3
2025-12-01
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
Biotech Analyst Ratings
Symbol
Firm
Rating
Action
Price Target
Upside
date
PMI
Example Securities
Buy
Initiated
$150.00
+25%
2026-01-15
PMI
Example Securities
Buy
Initiated
$150.00
+25%
2026-01-15
PMI
Example Securities
Buy
Initiated
$150.00
+25%
2026-01-15
Unlock Biotech Analyst Ratings data
PMI Stock Forecast & Analyst Consensus
BUY
Analyst Ratings
Buy65.0%
Hold25.0%
Sell10.0%
Price Target Trend
Average$24.00
Low$18.00
High$32.00
Unlock Price Target Trend
PMI Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
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Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
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Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
PMI
Jun 24, 2026
PMIGeneral

Picard Medical Announces Leadership Transition

Picard Medical, Inc. announced a leadership transition with Patrick NJ Schnegelsberg stepping down as CEO, effective June 18, 2026. Richard Fang, Ph.D., has been appointed as Interim CEO while the search for a permanent replacement begins. Fang, who is also the Executive Chairman, has a strong background in medical devices and aims to continue advancing the company's mission.

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PMI
Jun 16, 2026
PMIConferences/Events

Picard Medical and SynCardia to Present New In Vivo Emperor Total Artificial Heart Data and Patient Outcome Research at ASAIO 2026

Picard Medical and SynCardia will present new data on the Emperor Total Artificial Heart and patient outcomes at the ASAIO 2026 Annual Conference. The presentations will showcase advancements in artificial heart technology and real-world impacts on patients. This participation highlights their leadership in mechanical circulatory support and ongoing commitment to innovation.

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PMI
Jun 2, 2026
PMIPhases

Picard Medical / SynCardia Advances Emperor Total Artificial Heart Program with Successful Next-Generation Preclinical Implant Studies

Picard Medical has successfully completed preclinical studies for its next-generation Emperor Total Artificial Heart (TAH) at the University of Arizona. The studies demonstrated stable circulatory support and validated the independent dual motor design, which aims to enhance patient mobility. This progress marks a significant step towards developing a fully implantable artificial heart system.

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PMI
May 29, 2026
PMIGeneral

PICARD MEDICAL, INC. Issues Letter to Shareholders

Picard Medical, Inc. reported a strong start to 2026, with a significant revenue increase and positive gross profit margins. The company continues to focus on advancing its SynCardia Total Artificial Heart and developing the next-generation Emperor TAH. Despite challenges in profitability and regulatory uncertainties, the company is committed to improving its financial performance and expanding patient access to its life-saving technologies.

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PMI
May 21, 2026
PMIGeneral

Picard Medical / SynCardia Reports First Quarter 2026 Financial Results

Picard Medical, Inc. reported its first quarter 2026 financial results, showing an 85% revenue increase to $1.2 million and a return to positive gross profit. The company successfully reduced debt obligations and strengthened its capital structure. However, it also faced a net loss of $7.6 million and received notices of non-compliance from NYSE American regarding stockholders' equity. The company is preparing a compliance plan to address these issues.

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PMI
May 5, 2026
PMIGeneral

Picard Medical Announces Pricing of $5 Million Offering

Picard Medical, Inc. has announced the pricing of a $5 million offering, which includes shares of common stock and warrants. The offering is expected to close on May 6, 2026, and will provide funds for working capital and other corporate needs. The company is known for its SynCardia Total Artificial Heart, the only FDA-approved artificial heart in the U.S. and Canada.

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PMI
May 5, 2026
PMIGeneral

Medical Announces Pricing of $5 Million Offering

Picard Medical, Inc. has announced the pricing of a $5 million offering, which includes the sale of 16,666,667 shares of common stock and related warrants. The proceeds from the offering are intended for working capital and corporate purposes. This offering is set to close around May 6, 2026, pending customary conditions. The company, known for its SynCardia Total Artificial Heart, is using this opportunity to further bolster its financial position as it continues to lead in the artificial heart market.

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PMI
Apr 30, 2026
PMIGeneral

Picard Medical / SynCardia Recognizes Banner Health as Global Leader and Supporter in the Advancement of Total Artificial Heart Technology

Picard Medical has acknowledged Banner Health for its exceptional support in total artificial heart therapy, particularly in bridge-to-transplant cases. With over 50 successful implants of the SynCardia Total Artificial Heart, Banner Health demonstrates significant clinical expertise. The program is part of a broader initiative to enhance cardiac care for patients with advanced heart failure.

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PMI
Apr 22, 2026
PMIGeneral

Picard Medical / SynCardia Reports Revenue Growth Based on Top-line Results for the First Quarter 2026 - Growth driven by increased U.S. demand and pricing

Picard Medical, the parent company of SynCardia Systems, reported a significant revenue increase of 79.9% for Q1 2026, reaching $1.1 million, compared to $0.6 million in Q1 2025. This growth was primarily attributed to increased demand for their SynCardia Total Artificial Heart and adjustments in driver rental pricing. CEO Patrick NJ Schnegelsberg emphasized the company's focus on expanding patient access and advancing their next-generation artificial heart technology. The company plans to file comprehensive financial results by May 15, 2026.

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PMI
Apr 17, 2026
PMIConferences/Events

Picard Medical / SynCardia to Present Next Generation Total Artificial Heart Platform at ISHLT 2026 in Toronto

Picard Medical will present its next-generation total artificial heart platform at the ISHLT 2026 Annual Meeting in Toronto. The event serves as a key forum for advancements in heart and lung failure treatments. Vice President Andre R. Simon will present a poster on the Emperor Total Artificial Heart, emphasizing ongoing innovations in mechanical circulatory support.

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PMI
Mar 27, 2026
PMIConferences/Events

Opening and Strategic Overview Patrick NJ Schnegelsberg, CEO

The article presents insights from a strategic overview led by CEO Patrick NJ Schnegelsberg, focusing on the collaboration between SynCardia and UCSF on Total Artificial Heart (TAH) implementations. Key topics discussed include the operational strategies and financial overview of the program, as well as patient selection criteria and institutional outcomes. Notably, UCSF is enhancing its status as a major center for heart transplantation, despite challenges reflected in the outcomes of some TAH patients. Future plans include collaborative outreach to improve best practices and expand the program's impact.

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PMI
Mar 25, 2026
PMIGeneral

Picard Medical Reports Full Year 2025 Financial Results

Picard Medical reported a 12.5% revenue growth for the year ended December 31, 2025, totaling $4.9 million. The company highlighted its successful public listing and improved financial position despite an increased net loss of $(27.0) million. The SynCardia Total Artificial Heart continues to gain traction in the market, with over 2,100 implants performed globally.

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PMI
Mar 20, 2026
PMIConferences/Events

Picard Medical / SynCardia to Present its Next-Generation Emperor Total Artificial Heart Technology at the American College of Cardiology’s Annual Scientific Session

Picard Medical, Inc. will present new preclinical data on its next-generation Emperor Total Artificial Heart at the American College of Cardiology's Annual Scientific Session. The presentation aims to showcase the heart's design, which preserves physiological autoregulation while being fully implantable. The conference will also provide insights into SynCardia's current technologies and future developments.

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PMI
Mar 19, 2026
PMIGeneral

Picard Medical / SynCardia Highlight Second Successful Total Artificial Heart Bridge to Transplant at UCSF Health Case highlights young patient supported for 119 days with the SynCardia Total Artificial Heart before succ

Picard Medical has announced a successful case of heart transplantation after using the SynCardia Total Artificial Heart for a young patient with advanced heart failure. The patient was supported for 119 days with the device before receiving a successful transplant at UCSF Health. This case demonstrates the critical role of total artificial heart therapy in bridging patients to transplantation, with the product gaining traction amongst leading transplant centers. The ongoing relationship between SynCardia and medical institutions underscores the increasing need for advanced mechanical circulatory support.

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PMI
Mar 17, 2026
PMIGeneral

Picard Medical / SynCardia Announce Successful Four-Year Bridge to Transplant with SynCardia Total Artificial Heart Support -- 29-year-old patient supported for more than 1,600 days on the SynCardia Total Artificial Hear

Picard Medical announced a major milestone with the successful heart transplant of a 29-year-old patient who was supported for over four years by the SynCardia Total Artificial Heart. This device, designed for patients with severe biventricular heart failure, replaces the heart's pumping function, enabling patients to wait for donor organs at home. With a history of over 2,100 implants, the technology has shown to sustain patients for extended periods before transplantation. The successful outcome reinforces the role of the SynCardia Total Artificial Heart in treating advanced heart failure.

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PMI
Mar 13, 2026
PMIGeneral

Picard Medical / SynCardia Highlight Total Artificial Heart on BTV Program Airing on FOX Business News

Picard Medical, Inc. announced that its SynCardia Total Artificial Heart will be featured on BTV Business Television. The segment aims to highlight the technology's role in supporting patients awaiting heart transplants. With over 2,100 implants globally, the STAH is the most widely used artificial heart. The company is also developing a next-generation device to enhance patient mobility.

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PMI
Mar 13, 2026
PMIConferences/Events

Picard Medical / SynCardia to Host Annual Business Update Featuring Key Opinion Leaders and Patient Testimonial

Picard Medical, Inc. will host its Annual Business Update on March 25, 2026, featuring management discussions on fiscal results and the development of its next-generation artificial heart, Emperor. The webcast will include insights from leading cardiac surgeons and a patient testimonial on the SynCardia Total Artificial Heart. This event highlights the company's ongoing commitment to innovation in heart failure treatment.

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PMI
Mar 2, 2026
PMIConferences/Events

Picard Medical / SynCardia Showcases Leadership in Total Artificial Heart Therapy at Technology and Heart Failure Therapeutics Conference

Picard Medical, the parent company of SynCardia, announced that Dr. Andre Simon will present at the THT 2026 conference in Boston. His presentations will cover the SynCardia Total Artificial Heart and the next-generation Emperor system, focusing on advancements in mechanical circulatory support. The conference aims to foster collaboration and innovation in heart failure therapies.

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PMI
Feb 26, 2026
PMIConferences/Events

Picard Medical / SynCardia to Participate in Inaugural “Hands-On Training Day” at the Technology and Heart Failure Therapeutics Conference

Picard Medical, Inc. will participate in the inaugural Hands-On Training Day at the Technology and Heart Failure Therapeutics 2026 conference in Boston. This interactive program aims to enhance education on mechanical circulatory support and improve patient outcomes. Clinicians will engage in hands-on training with the SynCardia Total Artificial Heart, emphasizing the importance of collaboration in advanced heart failure management.

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PMI
Feb 23, 2026
PMIConferences/Events

Leading Heart Transplant Centers Convene in Houston for Picard Medical/ SynCardia’s Total Artificial Heart Surgical Training

Picard Medical is hosting a specialized training program for cardiac surgeons at Houston Methodist Hospital, focusing on the SynCardia Total Artificial Heart. The initiative aims to enhance surgical techniques and patient care for those with advanced heart failure. Led by Dr. Andre Simon, the program emphasizes collaboration and knowledge sharing among leading heart centers. This effort aligns with Picard's strategy to expand access to total artificial heart therapy across the U.S.

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PMI
Feb 12, 2026
PMIGeneral

Picard Medical/ SynCardia Highlights Successful Bridge-to-Transplant Case at UCSF Health Using the SynCardia Total Artificial Heart

Picard Medical announced a successful heart transplant at UCSF Health for a patient previously supported by the SynCardia Total Artificial Heart. This marks a significant milestone in treating advanced biventricular heart failure. The patient, who had been on the artificial heart for three months, is recovering well post-transplant. UCSF Health continues to lead in heart transplant procedures.

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PMI
Feb 11, 2026
PMIConferences/Events

Picard Medical/ SynCardia to Present at European Mechanical Circulatory Support Summit and International Course on Mechanical Circulatory Support and New Technologies in Heart Failure

Picard Medical, Inc. announced that Dr. Andre Simon will present data on the Emperor Total Artificial Heart at the upcoming European Mechanical Circulatory Support Summit in Barcelona. The presentation will focus on the first evaluations of SynCardia's electromechanical total artificial heart. This event aims to advance mechanical circulatory support and share best practices in heart failure treatment.

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PMI
Jan 13, 2026
PMIGeneral

Picard / SynCardia Featured on the Cruxx of MedTech Podcast

Picard Medical, Inc. has launched the Cruxx to MedTech Podcast, focusing on the SynCardia Total Artificial Heart (STAH) and the upcoming Emperor device. The podcast features patient stories and insights from CEO Patrick NJ Schnegelsberg, emphasizing the differentiation of STAH and the commercial potential due to the shortage of donor hearts. It aims to provide a platform for discussing advancements in heart failure treatment.

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PMI
Jan 13, 2026
PMIGeneral

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

SynCardia has partnered with Hydrix to develop the Emperor, a next-generation Total Artificial Heart. This collaboration aims to create a fully implantable heart device that enhances patient mobility by eliminating external drivers. The development phase is set to continue through 2026, with potential benefits from Australian R&D tax incentives. SynCardia is recognized for its pioneering work in artificial heart technology.

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PMI
Jan 13, 2026
PMIConferences/Events

/ SynCardia Featured on the Cruxx of MedTech Podcast

Picard Medical, Inc. (PMI) has launched the Cruxx to MedTech Podcast, focusing on its SynCardia Total Artificial Heart (STAH) and the upcoming Emperor device. The podcast highlights patient experiences and features insights from CEO Patrick NJ Schnegelsberg about the company's long-term vision and the significant opportunity in addressing the global shortage of donor hearts. The STAH is the only commercial artificial heart available in the U.S. and Canada, with extensive usage across various countries.

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PMI
Jan 13, 2026
PMIFDA Updates

Always seek the advice of your physician or a qualified health care provider with any questions you may have regarding a medical condition.

The article serves as a medical advisory statement from SynCardia Systems, LLC, emphasizing the importance of consulting healthcare professionals regarding medical conditions. It contains disclaimers about the information provided and reiterates that it should not substitute professional medical advice or delay seeking medical treatment. Furthermore, it highlights various company trademarks and mentions that SynCardia's products are approved for sale only in the U.S. and Canada. EU and international approvals for their products are currently pending.

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PMI
Dec 30, 2025
PMIGeneral

Picard Medical CEO Patrick NJ Schnegelsberg Elected to AZBio Board of Directors

Patrick NJ Schnegelsberg, CEO of Picard Medical, has been elected to the AZBio Board of Directors, a move that underscores his commitment to Arizona's bioscience community. His term will last until December 2028, during which he aims to enhance collaboration and innovation in the life sciences sector. This appointment reflects SynCardia's longstanding role in advancing medical technologies.

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PMI
Dec 30, 2025
PMIGeneral

Medical Announces Up to $50 Million Senior Secured Debt Financing

Picard Medical, Inc. has announced a definitive agreement for a private placement financing of up to $50 million in senior secured notes due in 2028. The company will start with an initial issuance of $15 million, with the possibility of raising an additional $35 million depending on certain conditions. These funds are intended for working capital and general corporate needs. Picard Medical is known for its SynCardia Total Artificial Heart, the only artificial heart approved by both the U.S. FDA and Health Canada.

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PMI
Dec 18, 2025
PMIGeneral

Picard Medical Marks Public Company Milestone by Ringing the NYSE Opening Bell - Picard Medical, Inc. / SynCardia Systems LLC commemorate the Company's transition to the public markets and continued advancement of their

Picard Medical, Inc., parent company of SynCardia Systems LLC, marked its transition to public markets by ringing the NYSE Opening Bell on December 18, 2025. This milestone emphasizes the company's ongoing dedication to advancing its Total Artificial Heart technology, which is the only one approved by both the U.S. FDA and Health Canada. The leadership expressed confidence in the company's ability to enhance its artificial heart platform and create long-term value for patients with end-stage heart failure.

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PMI
Dec 9, 2025
PMIGeneral

SECURITIES AND EXCHANGE COMMISSION

Picard Medical, Inc. has filed a report with the SEC, indicating an update regarding its SynCardia Total Artificial Heart. This filing falls under Section 13 or 15(d) of the Securities Exchange Act of 1934. The document includes details such as the company's registration and regulatory compliance status. No negative events or risks are mentioned in this filing.

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PMI
Dec 4, 2025
PMIPhases

Dcvicc csign Figure 1.

The article details the development and testing of the Emperor Total Artificial Heart (TAH), which utilizes electromechanical actuation while maintaining the successful design features of the SynCardia Total Artificial Heart (STAH). Initial evaluations show that the Emperor TAH exhibits comparable hemodynamic performance and autoregulation capabilities, suggesting its potential as an effective treatment for end-stage heart failure. The successful in vivo implantation in porcine models further underscores the device's viability for future clinical applications.

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PMI
Dec 3, 2025
PMIConferences/Events

Picard Medical, Inc.

Picard Medical, Inc. announced that CEO Patrick NJ Schnegelsberg will present at the CSI Focus D-HF 2025 conference in Frankfurt, Germany. The presentation will focus on the Emperor Total Artificial Heart, a fully implantable device for patients with severe heart failure. This event is significant as it gathers experts in the field of heart failure therapies. Picard Medical is noted for being the only provider of a commercially available total artificial heart approved by both U.S. and Canadian health authorities.

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PMI
Nov 26, 2025
PMIConferences/Events

Picard Medical to Present the Next Generation Fully Implantable SynCardia Total Artificial Heart at ISMCS 2025

Picard Medical, Inc. will present data on its Emperor Total Artificial Heart at ISMCS 2025. The presentation will showcase the device's performance and its innovative internal motor design, which enhances patient mobility. This event will gather experts in mechanical circulatory support to discuss advancements in the field.

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PMI
Nov 19, 2025
PMIPhases

SynCardia Completes First In Vivo Implantations of

Picard Medical, Inc., the parent company of SynCardia Systems, has successfully completed the first in vivo implantations of its next-generation Emperor Total Artificial Heart (TAH). The initial results indicate that the device performed well, providing stable blood circulation and functioning similarly to a natural heart. The company aims to refine the Emperor platform through further pre-clinical studies, which may enhance its potential as a fully implantable alternative to heart transplantation and broaden the market for total artificial hearts.

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PMI
Nov 14, 2025
PMIGeneral

Reports Third Quarter 2025 Financial Results

Picard Medical, Inc. (PMI) reported its third quarter 2025 financial results, highlighting a successful IPO that raised approximately $19.5 million. The company experienced a 35% increase in revenue compared to Q3 2024, attributed to higher U.S. product sales and driver rentals. Despite the financial growth, Picard Medical faced an operating loss of $3.36 million and a net loss of $22.7 million due to non-cash charges. The company has also focused on expanding its patent portfolio and has made strategic board appointments to guide its future growth as a public entity.

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PMI
Oct 27, 2025
PMIGeneral

Picard Issues Statement on Intraday Stock Price

Picard Medical, Inc. addressed recent stock price volatility, stating it is not aware of any undisclosed changes in its operations or financial condition. The company emphasized its commitment to its strategic goals while ensuring compliance with securities laws. Additionally, Picard's SynCardia Systems retains its position as the leader in total artificial heart technology.

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PMI
Sep 9, 2025
PMIGeneral

Picard Medical, Inc. Announces Exercise of Underwriters' Over-Allotment Option in Connection with its Initial Public Offering TUCSON, ARIZONA

Picard Medical, Inc. has announced the full exercise of the underwriters' over-allotment option in connection with its initial public offering of common stock. This resulted in the issuance of an additional 637,500 shares priced at $4.00, raising gross proceeds of $2,550,000. The shares have been trading on the NYSE American since August 29, 2025. The company, known for its SynCardia Total Artificial Heart, continues to expand its financial resources following the IPO.

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PMI
Aug 28, 2025
PMIGeneral

Picard Medical, Inc. Announces Pricing of $17 Million Initial Public Offering TUCSON, ARIZONA

Picard Medical, Inc. has announced the pricing of its initial public offering (IPO) at $4.00 per share, totaling $17 million in gross proceeds. The offering includes 4,250,000 shares and will begin trading on the NYSE American under the ticker symbol 'PMI'. Proceeds from the IPO will be directed towards market expansion, product research and development, inventory enhancement, debt repayment, and operational expenses. This IPO reinforces Picard's position as a leader in providing the only total artificial heart approved in the U.S. and Canada.

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