JUPITER, Fla., May 28, 2026 (GLOBE NEWSWIRE) — Dyadic International, Inc. (“Dyadic,” “we,” “us,” “our,” or the “Company”) (NASDAQ: DYAI), d/b/a Dyadic Applied BioSolutions, a biotechnology company focused on the development and commercialization of scalable microbial protein production platforms for use across life sciences, food, nutrition, industrial, and biopharmaceutical applications, today announced that Dyadic Applied BioSolutions and researchers at Scripps Research are collaborating to evaluate monoclonal antibody and vaccine candidates targeting hantaviruses, including Andes virus, a hantavirus strain associated with Hantavirus Pulmonary Syndrome (HPS), a severe and potentially fatal respiratory disease in humans.

A series of recently reported hantavirus and Ebola cases worldwide have underscored the importance of pandemic preparedness and highlighted the need to improve the speed, scalability, flexibility, and cost-effectiveness of biologic manufacturing during rapidly evolving public health events. The collaboration builds upon Dyadic’s prior Andes virus monoclonal antibody work and combines the complementary expertise of Dyadic and Scripps Research to further assess the potential of Dyadic’s proprietary C1 platform for rapid development timelines, high-productivity microbial fermentation, large-scale manufacturing, and biologic production intended to support future infectious disease preparedness.

Dyadic’s microbial fungal-based C1 platform has been applied to multiple biologic modalities, including recombinant vaccine antigens and monoclonal antibodies targeting RSV, malaria, the Andes virus, Ebola, and Marburg, which is similar to Ebola and comes from the same family of viruses-the Filovirus family, and has demonstrated in preclinical studies the ability to produce monoclonal antibodies with binding, neutralization, and efficacy characteristics comparable to those generated by traditional mammalian expression systems.

In prior Andes virus-related work, Dyadic developed a C1 strain expressing the recombinant anti-Andes virus monoclonal antibody rANDV-44, where, Dyadic believes, the data generated demonstrated virus neutralization activity comparable to ExpiCHO-produced material in a pseudovirus neutralization assay.

Dyadic has also previously demonstrated GMP-compliant manufacturing and Phase 1 clinical evaluation of biologics produced using its C1 platform as part of earlier infectious disease initiatives. The Company is currently involved in multiple funded biopharmaceutical collaborations, including programs supported by the Gates Foundation and the Coalition for Epidemic Preparedness Innovations (“CEPI”) in collaboration with Fondazione Biotecnopolo di Siena (“FBS”), aimed at accelerating recombinant protein vaccines and monoclonal antibody development workflows using the C1 platform.

Dyadic’s C1 platform was previously included in the European Union-supported Zoonosis Anticipation and Preparedness Initiative (“ZAPI”), a five-year pandemic preparedness program involving leading global human and animal health organizations focused on accelerating biologic manufacturing technologies for emerging infectious diseases. Building upon the progress achieved from ZAPI, Dyadic’s more recent and ongoing funded collaborations supported by the Gates Foundation, CEPI, FBS, and activities associated with the EU Vaccine Hub continue to advance rapid, scalable biologic manufacturing approaches using the C1 platform to help address many of the manufacturing bottlenecks revealed during COVID-19 and other emerging infectious disease outbreaks.

Together, these programs continue to generate data that support the potential advantages of the C1 platform, including compressed development timelines, scalable microbial fermentation, and streamlined manufacturing processes. Additional studies have shown that C1-produced monoclonal antibodies can achieve binding and neutralization properties comparable to antibodies produced in traditional mammalian systems.

“One of the key lessons from recent global outbreaks is that scientific innovation alone is not sufficient – manufacturing flexibility, scale and speed are also critical,” said Jiang Zhu, Professor at Scripps Research. “Collaborations that bring together advanced antibody and antigen research with rapid biologic production technologies may help strengthen preparedness for future infectious disease threats.”

Dr. Zhu continued, “My laboratory at Scripps Research has developed proprietary structure-based protein designs optimized for conformational integrity, trimer closure, and antigen quality. In parallel, innovative expression technologies such as Dyadic’s C1 platform may offer opportunities to further evaluate faster, more scalable and potentially lower-cost approaches for the development and manufacture of complex biologics targeting emerging infectious diseases.”

“COVID-19 demonstrated that manufacturing scalability and deployment speed remain critical challenges during global outbreaks,” said Mark Emalfarb, Dyadic’s Chief Executive Officer. “Our collaboration with Scripps builds upon prior hantavirus-related work and reflects our broader strategy of partnering with leading research institutions and global health organizations to evaluate how we anticipate the C1 platform will contribute to future pandemic preparedness initiatives.”

Mr. Emalfarb continued, “Importantly, these activities continue to be pursued through grants, sponsored research, and strategic collaborations, allowing Dyadic to further validate the C1 platform in a capital-efficient manner while maintaining our primary commercial focus on non-pharmaceutical protein products and industrial-scale biomanufacturing opportunities.”

Dyadic and Scripps plan to jointly explore external partnership and non-dilutive funding opportunities to support additional development activities related to monoclonal antibodies, and vaccine candidates, and broader infectious disease preparedness applications.

Dyadic recently highlighted growing commercial activity with recombinant proteins and enzymes in non-pharmaceutical applications, including animal-free proteins for life sciences, cell culture media, nutrition, wellness, and industrial markets.

About Dyadic Applied BioSolutions

Dyadic Applied BioSolutions is a global biotechnology company that aims to develop and commercialize scalable, non-animal protein production platforms to meet growing global demand across the life sciences, food and nutrition, and bio-industrial markets. These high-value proteins are designed to enable customers to develop more efficient, scalable, and sustainable products. Dyadic’s proprietary Dapibus™ and C1 expression systems support rapid, cost-effective, and flexible manufacturing.

For more information, please visit http://www.dyadic.com.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including those regarding Dyadic International’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of our clinical trial and interest in our protein production platforms, our research projects and third-party collaborations, as well as the availability of necessary funding. Forward-looking statements generally can be identified by use of the words “expect,” “should,” “intend,” “anticipate,” “will,” “project,” “may,” “might,” “potential,” or “continue” and other similar terms or variations of them or similar terminology. Dyadic International, Inc., and its subsidiaries caution readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information. Such statements reflect the current views of our management with respect to our operations, results of operations and future financial performance. Forward-looking statements involve many risks, uncertainties, or other factors beyond Dyadic’s control. These factors include, but are not limited to (i) our history of net losses; (ii) market and regulatory acceptance of our microbial protein production platforms and other technologies; (iii) failure to commercialize our microbial protein production platforms or our other technologies; (iv) competition, including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) our capital needs; (vii) changes in global economic and financial conditions; (viii) our reliance on information technology; (ix) our dependence on third parties; (x) government regulations and environmental, social and governance issues; (xi) intellectual property risks; (xii) our ability to comply with the listing standards of the Nasdaq Stock Market LLC; and (xii) other factors discussed in Dyadic’s publicly available filings, including information set forth under the caption “Risk Factors” in Dyadic’s annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 25, 2026, as amended on April 30, 2026, and quarterly report on Form 10-Q filed with the SEC on May 13, 2026, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. The forward-looking statements contained in this press release are made only as of the date hereof, and except as required by law, we undertake no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in our expectations.

Media contacts:
Dyadic Applied BioSolutions:
Ping Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: ir@dyadic.com

Mar 4, 2026 | Press Releases

JUPITER, Fla. and BENGALURU, India, March 04, 2026 (GLOBE NEWSWIRE) — Dyadic Applied BioSolutions (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company producing precision-engineered, animal-free proteins and enzymes for life science, food and nutrition, and bio-industrial uses, and Fermbox Bio (“Fermbox”), a biotech research and manufacturing company developing sustainable bio-based products through precision fermentation and advanced biotechnology tools, today announced the commercial launch of animal-origin-free Recombinant DNase I (RNase-free). This represents the first commercialized product under the companies expanded collaboration announced in 2025 and marks another step in Dyadic’s accelerating transition from platform development to commercial product expansion and recurring revenue growth.

Produced using Dyadic’s proprietary high-yield fungal microbial expression platforms and Fermbox Bio’s scale-up and biomanufacturing capabilities, Recombinant DNase I (RNase-free) is currently available in research grade with a cGMP-grade version in development to support biopharmaceutical manufacturing and cell and gene therapy applications.

“Launching animal-origin-free Recombinant DNase I marks an important first step in translating our expanded collaboration with Fermbox Bio into commercial products,” said Joe Hazelton, President & COO of Dyadic Applied BioSolutions. “This milestone demonstrates the strength of our microbial expression platforms and our shared ability to bring high-quality, scalable recombinant enzymes and proteins to research and biomanufacturing customers worldwide.”

Recombinant DNase I (RNase-free) is an endonuclease enzyme used for nucleic-acid clean-up and sample preparation workflows where residual DNA can interfere with analytical results. Its RNase-free specification supports RNA integrity in sensitive RNA workflows across biological research, biotechnology, and molecular diagnostics.

DNase I (RNase-free) is a strategically important enzyme and the first in a planned series of recombinant enzymes and proteins expected to be commercially introduced throughout 2026.

Planned pipeline products under the collaboration include recombinant α-lactalbumin, recombinant transferrin, recombinant human FGF-2, recombinant human lactoferrin, and additional recombinant proteins expressed using Dyadic’s fungal microbial platforms. The initial portfolio targets high-demand segments in cell culture media, media supplementation, and molecular biology reagents, supporting applications such as cell and gene therapy (CGT), vaccine and monoclonal antibody manufacturing, regenerative medicine, and advanced biologics development.

Under the collaboration framework, Dyadic provides its fungal microbial expression platforms, production strains, and development support, while Fermbox Bio leads downstream process development, scale-up, and manufacturing. The companies are aligned on global commercialization to serve research and biomanufacturing customers worldwide.

About Dyadic Applied BioSolutions

Dyadic Applied BioSolutions is a global biotechnology company that uses its proprietary microbial platforms to produce recombinant proteins that are sold or licensed to partners across the life sciences, food and nutrition, and bio-industrial markets. These high-quality proteins are designed to enable customers to develop more efficient, scalable, and sustainable products. Dyadic’s C1 and Dapibus™ expression systems support flexible, cost-effective manufacturing, and are the foundation of a growing portfolio of commercial and partnered programs. For more information about Dyadic, please visit www.dyadic.com

About Fermbox Bio

Fermbox Bio is a biotechnology research and manufacturing company based in India with a subsidiary in the USA. The company develops sustainable bio-based products using precision fermentation and advanced biotechnology. For more information about Fermbox Bio, please visit www.fermbox.bio

Safe Harbor Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including those regarding Dyadic’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of Dyadic’s clinical trial and interest in its protein production platforms, Dyadic’s research projects and third-party collaborations, as well as the availability of necessary funding. Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (i) Dyadic’s history of net losses; (ii) market and regulatory acceptance of Dyadic’s microbial protein production platforms and other technologies; (iii) failure to commercialize Dyadic’s microbial protein production platforms or its other technologies; (iv) competition, including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) Dyadic’s capital needs; (vii) changes in global economic and financial conditions; (viii) Dyadic’s reliance on information technology; (ix) Dyadic’s dependence on third parties; (x) government regulations and environmental, social and governance issues; (xi) intellectual property risks; and (xii) Dyadic’s ability to comply with the listing standards of the Nasdaq Stock Market LLC. For a more complete description of the risks that could cause Dyadic’s actual results to differ from its current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. All forward-looking statements speak only as of the date made, and except as required by applicable law, Dyadic assumes no obligation to publicly update any such forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in Dyadic’s expectations.

Company contacts:

Dyadic Applied BioSolutions:
Joe Hazelton
President & COO
Email: info@dyadic.com

Fermbox Bio:
Mr. Binod Daga
President Business development & Strategic Partnerships
Email: Info@fermbox.bio

JUPITER, Fla. and COPENHAGEN, Denmark, March 02, 2026 (GLOBE NEWSWIRE) — Dyadic Applied BioSolutions (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company producing precision-engineered, animal-free proteins and enzymes for life science, food and nutrition, and bio-industrial uses, and Inzymes ApS (“Inzymes”), a Denmark-based enzyme company specializing in the development, scale-up, and commercialization of enzymes for sustainable food and beverage applications, today announced the planned 2026 commercialization of recombinant non-animal bovine chymosin, a key enzyme used in cheese production and dairy processing, following the successful completion of final development activities under the companies’ collaboration agreement.

Completion of these development activities represents a contractual milestone under the parties’ 2023 development and commercialization agreement focused on non-animal dairy enzymes produced using Dyadic’s proprietary microbial expression platforms. With achievement of this milestone, Dyadic has earned and received a $200,000 milestone payment and remains eligible to receive royalties on future commercial sales.

Chymosin is the primary milk-clotting enzyme used in cheese manufacturing. The global market for dairy processing enzymes is estimated to be approximately $1.5-$2.0 billion annually, driven by increasing global cheese consumption and rising demand for sustainable, fermentation-derived alternatives to traditional animal-sourced enzymes.

“This milestone reflects the strength of our partnership with Dyadic and our shared commitment to delivering innovative, sustainable enzyme solutions to the dairy industry,” said Michael Fooken Jensen, CEO of Inzymes ApS. “With final development activities successfully completed, we are advancing with preparations for commercialization in 2026. By combining Dyadic’s high-productivity microbial platforms with our scale-up and commercialization expertise, we are positioning this non-animal chymosin to meet evolving customer requirements for performance, consistency, and supply reliability.”

Joe Hazelton, President and COO of Dyadic Applied BioSolutions, stated: “The achievement of this development milestone marks important progress under our agreement with Inzymes and demonstrates our ability to advance programs from development through commercialization. We believe our microbial expression platforms support efficient development and scalable manufacturing, and we look forward to expanding into additional enzyme and protein opportunities across our business segments.”

Additional non-animal dairy enzyme candidates continue to progress under the collaboration, supporting expansion of the companies’ portfolio within the growing market for fermentation-derived food enzymes. The successful completion of final development steps toward commercialization further reinforces the versatility of Dyadic’s platforms across food and nutrition, life sciences, and industrial biotechnology applications.

About Dyadic Applied BioSolutions

Dyadic Applied BioSolutions is a global biotechnology company that uses its proprietary microbial platforms to produce recombinant proteins that are sold or licensed to partners across the life sciences, food and nutrition, and bio-industrial markets. These high-quality proteins are designed to enable customers to develop more efficient, scalable, and sustainable products. Dyadic’s C1 and Dapibus™ expression systems support flexible, cost-effective manufacturing, and are the foundation of a growing portfolio of commercial and partnered programs. For more information about Dyadic, please visit www.dyadic.com.

About Inzymes ApS

Inzymes ApS is a Denmark-based enzyme innovation company focused on the development, scale-up, and commercialization of high-performance enzymes for food and beverage applications. Leveraging expertise in fermentation, formulation, and industrial enzyme deployment, Inzymes partners across the value chain to deliver sustainable, food-grade enzyme solutions that improve functionality, efficiency, and product quality. The company is committed to advancing next-generation bioprocessing technologies that support a more sustainable global food system. For more information please visit www.inzymes.com.

Safe Harbor Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including those regarding Dyadic’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of Dyadic’s clinical trial and interest in its protein production platforms, Dyadic’s research projects and third-party collaborations, as well as the availability of necessary funding. Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (i) Dyadic’s history of net losses; (ii) market and regulatory acceptance of Dyadic’s microbial protein production platforms and other technologies; (iii) failure to commercialize Dyadic’s microbial protein production platforms or its other technologies; (iv) competition, including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) Dyadic’s capital needs; (vii) changes in global economic and financial conditions; (viii) Dyadic’s reliance on information technology; (ix) Dyadic’s dependence on third parties; (x) government regulations and environmental, social and governance issues; (xi) intellectual property risks; and (xii) Dyadic’s ability to comply with the listing standards of the Nasdaq Stock Market LLC. For a more complete description of the risks that could cause Dyadic’s actual results to differ from its current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. All forward-looking statements speak only as of the date made, and except as required by applicable law, Dyadic assumes no obligation to publicly update any such forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in Dyadic’s expectations.

Media contacts:

Dyadic Applied BioSolutions:
Ping Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email:ir@dyadic.com

Inzymes ApS:
Michael Fooken Jensen
Email: michael@inzymes.com

WEST PALM BEACH, Fla—Contemporary Health Systems, LLC, a life sciences developer of
predictive, early biomarker assessments of cognitive and sensory functioning, announced that it
has received a U. S. Patent for its non-invasive assessment of olfactory and gustatory functioning,
which has valid proof of concept multiple uses as a diagnostic screener, longitudinal assessment
tool and treatment outcomes indicator.

NEURO-Scan™ features a proprietary 5-minute assessment of the four sensory components
identified physiologically as the ‘four corners’ of taste and smell. Loss or diminished taste and
smell was identified early by the Centers of Disease Control(CDC) as a recognized early
symptom of Sars-Cov2(corona virus), which extends the importance of the assessment of these
sensory deficits beyond the multiple other medical and neurological conditions already known to
be marked by these sensory deficits. It is easy to administer in the office or at home, validly
detects impairments and improvements in function, and normative standards for performance
are available.

The NEURO-Scan assessment is indicated for the detection and assessment of sensory
changes in multiple cognitive and neurological conditions including ordnance- atmospheric- and
kinetic-induced concussion, Long COVID, Alzheimer’s Disease, Parkinson’s Disease, dementia,
ALS, Repetitive Head Injury(RHI), chronic traumatic encephalopathy(CTE), post-traumatic
stress disorder(PTSD) and traumatic brain injury(TBI). Extensive proof of concept peer-reviewed research data validation supports the assessment of olfactory and gustatory functioning as an early indicator and improvement tracker of these conditions. This test-of-function biomarker assessment is recommended to all healthcare providers for their patients for early/periodic evaluations and screenings.

Dr. Philip Harvey, Leonard M. Miller Professor of Psychiatry at the University of Miami Miller
School of Medicine said that “The importance of assessing these sensory deficits for the
identification and management of multiple medical and neurological conditions is clear. In contrast to other assessment strategies, which examine diagnostic biomarkers that do not change with improvement, olfactory and gustatory functions can change with improvements in clinical condition and have wide-ranging promise as an early diagnostic biomarker as well as an indicator of clinical improvement.”

An easily administered test of function assessment of olfactory and gustatory biomarkers has the potential for very broad use in medical and neurological assessments, including repeated
assessments without the practice or exposure effects associated with performance-based cognitive assessments or biases associated self-reports of functioning.

About Contemporary Health Systems
Contemporary Health System, LLC is a predictive Life Sciences company engaged in the research of test-of-function, first in-class assessments to address unmet clinical needs. NEURO- Scan™ is
new, novel, unrivaled and is destined to become an integral part of “The Acceptable Standard of Care” for all HealthCare Providers.

"NEURO-Scan" and "CovaKit" are registered trademarks of Contemporary Health Systems, LLC and are FDA Registered Class 2 Medical Devices with 510K exemptions.

Contact:
Dr. Robert Fish
Chief Science Officer, Director
dr.robertfish@contemporaryhs.com

The company claims that by making a small structural change during the upstream biologics process for
existing antibody therapeutics, the cancer cell killing mechanism of that specific therapeutic is greatly
improved. Through library screening, Score has identified tens of thousands of potential modulators for
its patented (Japan) and patent-pending (US, EU) process technology that will act as the duplicatable
platform for improvement of commercially available therapies.

Score is now preparing to conduct scientific confirmation studies at Southern Research, targeting its first
clinical application in HER2-positive breast cancer.

“We couldn’t be happier with the results we’re seeing in our early studies,” said Jennifer Riggs-Sauthier,
Ph.D., Chief Development Officer & Vice President of Chemistry at Score Pharma. “Cancer takes the lives
of about 27,000 people every day. That’s one cancer death every three seconds. This advancement
brings us one step closer to the clinic – and ultimately, to helping patients benefit from stronger, more
effective antibody therapies.”

About Score Pharma Inc.
Score Pharma Inc. is dedicated to developing new, more potent antibody therapeutics by transforming
existing clinically proven antibody therapeutics for an improved patient response. Through a science-driven
strategy and disciplined execution, the company aims to deliver transformative outcomes for
patients and sustainable returns for shareholders.

Media Contact
Kip Wolf, Chief Operating Officer & Vice President, Business Development
kwolf@scorepharma.com or +1 717-376-6672

Strategic agreement underscores Psilera's commitment to advancing PSIL-006 with precision neurology approach

Results are expected in Q3 2025

ORLANDO, Fla. and TAMPA, Fla., June 9, 2025 /PRNewswire/ -- Psilera, Inc. ("Psilera"), a biotechnology company developing groundbreaking therapies for hard-to-treat neurological disorders and Hesperos Inc., a leader in organ-on-a-chip technology, today announced a strategic agreement to accelerate the preclinical development of Psilera's lead compound, PSIL-006, targeting frontotemporal dementia (FTD).

The partnership leverages Hesperos' proprietary Human-on-a-Chip® platform, which integrates patient-derived induced pluripotent stem cells (iPSCs) into interconnected, multi-organ systems. This advanced modeling approach enables precise evaluation of drug efficacy and safety, recently touted by the FDA to reduce reliance on animal testing and expedite clinic-ready datasets.

"Our collaboration with Hesperos represents a significant step forward in our mission to develop new treatments for neurodegenerative diseases," said Dr. Jackie von Salm, Co-Founder and Chief Scientific Officer of Psilera. "Utilizing their cutting-edge platform allows us to gain deeper insights into PSIL-006's mechanism of action as we design our upcoming first-in-human trials."

Hesperos' platform has been recognized for its ability to replicate human physiological responses, providing valuable data on drug interactions across multiple organ systems. The platform has successfully supported multiple Investigational New Drug (IND) and Orphan Drug Designation (ODD) applications, demonstrating its utility in advancing drug candidates toward clinical evaluation.

"We are excited to partner with Psilera as they advance next-generation neuroplastogens to potentially treat a range of hard-to-treat diseases," said Dr. James Hickman, Co-Founder and Chief Scientist at Hesperos. "Our platform offers a unique opportunity to assess the compound's effects on neural tissues derived from patients with neurodegeneration, potentially accelerating the development of a much-needed therapy utilizing clinically relevant functional readouts."

FTD is a progressive neurodegenerative disorder with limited treatment options. The integration of next-generation neuroplastogen, PSIL-006, with Hesperos' advanced biological platform aims to develop targeted treatments to address this unmet medical need. Results from Psilera's preclinical modeling are expected in Q3 2025.

About Psilera
Psilera is a biopharmaceutical company developing groundbreaking therapeutics for hard-to-treat neurodegenerative diseases. By utilizing their proprietary neuroplastogen drug design platform, Psilera has amassed a leading pipeline of next-generation assets including PSIL-006, a first-in-class therapeutic for the treatment of frontotemporal dementia (FTD). With a deep commitment to scientific excellence and patient centricity, Psilera is transforming the lives of individuals affected by devastating neurodegenerative diseases. Welcome to the new era of mindful medicine. For more information visit www.psilera.com.

About Hesperos Inc.
Hesperos is a global contract research organization (CRO) specializing in preclinical drug development services utilizing its Human-on-a-Chip® platform. By replicating key aspects of human biology (and thus avoiding expensive, time-consuming, and often less informative animal testing), Human-on-a-Chip® organ-system models provide product development teams with more meaningful insights that can accurately predict an agent's therapeutic profile while lowering costs and accelerating development timelines. For more information, visit www.hesperosinc.com.

Media Contacts:

Psilera Inc.
Michael Lauer
MDL Strategic Communications
michael@mdlcomms.com

Hesperos Inc.
Nathan Post
npost@hesperosinc.com

Cloud 9 Care™ Awarded U.S. Patent for Groundbreaking Pressure Injury Prevention System

Hillsboro, OR

— May 6, 2025 —

Cloud 9 Care, a nurse-led healthcare innovation company, today announced that its flagship mattress overlay system designed to prevent and heal pressure injuries has been awarded a U.S. patent (Patent No. 12, 290, 483).
Developed by Suzanne Mayer, BSN, RN, the Cloud 9 Care system offers a new approach to tackling the longstanding issue of pressure injuries, which affect 2.5 million patients annually in the U.S. and cost the healthcare system more than $26 billion each year.
Born out of personal experience during home hospice care, Cloud 9 Care’s patented design uses a low-friction, moisture-wicking double-layered fabric with uniquely stitched pockets to securely hold repositioning wedges. This system targets four key causes of pressure injuries — friction, shear, moisture, and prolonged pressure — while dramatically easing caregiver workload.
“This patent validates years of innovation driven by a single goal: to ease suffering for patients and reduce the burden on caregivers,” said Mayer, founder and CEO of Cloud 9 Care. “We envision a future closer to zero harm — and today, we are one step closer.”
Pressure injuries are not only the only hospital-acquired injury increasing in prevalence but also contribute to 60,000 deaths each year. Trials with Cloud 9 Care show prevention and healing of these wounds, helping patients avoid hospital readmissions.
Cloud 9 Care is seeking partners, healthcare providers, and investors to expand its impact across home care, hospice, and hospital markets.
For media inquiries, partnership opportunities, or trial information, visit cloud9caresystem.com or contact Suzanne Mayer at smayer@cloud9caresystem.com.
About Cloud 9 Care Cloud 9 Care was founded by a critical care nurse who believed patients and caregivers deserve better. Built from real-world experience and compassion, the patented Cloud 9 Care system makes it easier to prevent pressure injuries, ease suffering, and support those who deliver care every day.

December 12, 2024 By Sean Whooley

Medtronic(NYSE: MDT)+ today announced the first-ever patient procedure ingestion using its next-generation PillCam Genius SB capsule endoscopy kit.

The University of Miami Health System (UHealth)HeH successfully performed the first ingestion of the newest PillCam offering. Medtronic won FDA clearance for this enhanced offering in May.

PillCam capsule endoscopy has been in use for more than 20 years. Medtronic won FDA clearance for the PillCam Small Bowel (SB) 3 system for remote endoscopy procedures in late 2021. The technology is delivered straight to a patient, and via a telehealth appointment, a provider guides the patient through the remote procedure.

The PillCam Genius SB kit offers flexibility through simplified equipment management. It enables the procedure to take place at a hospital, clinic or the home. Medtronic designed it specifically to visualize the small bowel mucosa in adult patients. It aids in the detection and monitoring of conditions like Crohn’s disease, obscure gastrointestinal bleeding and iron deficiency anemia. It’s especially useful when these abnormalities are not identified through traditional upper or lower endoscopy.

Medtronic said its offering features a link device that replaces traditional data recorders as well. The wearable, single-use device efficiently stores images transmitted by the capsule. It also alerts patients via haptic vibrations, audible signals, and LED lights when they complete the procedure. The company says its system minimizes discomfort with a patient-friendly adhesive, too.

“Advancing diagnostic precision while prioritizing patient convenience is at the core of what we do,” said Raj Thomas, president of the Endoscopy business at Medtronic. “This first ingestion highlights the potential of the PillCam Genius SB kit to transform small bowel diagnostics, providing greater accessibility and ease for both patients and clinicians alike.”

News provided by

MeCo Diagnostics 

Oct 17, 2024, 12:43 ET

Positive study enables valuable repositioning of new antifibrotic drug candidates by a growing number of pharma companies

SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- MeCo Diagnostics, a venture-backed startup dedicated to unlocking a new therapeutic modality for cancer, has announced a publication in Clinical Cancer Research, the leading clinical journal of the American Association for Cancer Research (AACR). The article details a successful Phase 2 study of 130 patients with breast cancer, conducted in collaboration with the Spanish National Cancer Research Centre (CNIO), following a pre-specified analysis plan to evaluate long-term survival after antifibrotic therapy. This study establishes the MeCo Score as the first clinically validated predictive biomarker for antifibrotic therapy—a fundamentally new way to fight breast cancer.

Patients with early-stage, HER2-negative breast tumors with High MeCo Scores who received nintedanib (antifibrotic therapy) plus chemotherapy experienced a 62% reduction in risk of recurrence compared to chemotherapy alone, with a median follow-up time of 9.7 years (P<0.05). This combined magnitude and duration of benefit appears unprecedented among targeted therapies which are currently FDA-approved for these patients, representing a large majority of breast cancers. Crucially, Low MeCo Scores were not associated with benefit from antifibrotic therapy, suggesting the MeCo Score is essential to leverage this promising modality.

"Our enabling research began over 10 years ago, coinciding with the start of this trial. That serendipity has now culminated in a stunning outcome: High MeCo Score patients who received a short course of antifibrotic therapy experienced a remarkable improvement in their long-term survival rate," said Dr. Adam Watson, CEO of MeCo Diagnostics.

Nintedanib will soon become a generic medicine, which could provide substantial financial relief to patients/payers if incorporated into clinical practice guidelines. A larger, pivotal trial to confirm this study has been planned, setting up the MeCo Score to potentially unlock the first low-cost, low-toxicity, targeted therapy approved for breast cancer. Moreover, the MeCo Score was designed to be drug-agnostic to facilitate repositioning of any antifibrotic drug for breast cancer—including new drug candidates that may be superior to nintedanib.

Overall, this study serves as a valuable proof of concept for this entire class of drugs under development by numerous pharma companies.

About MeCo Diagnostics Holdings, Inc.

MeCo Diagnostics™ is a seed-stage startup based in San Diego, CA, developing first-in-class predictive biomarkers to leverage antifibrotic therapy for cancer treatment. https://mecodiagnostics.com/

SOURCE MeCo Diagnostics

MIPLYFFA is the first FDA-approved treatment for Niemann-Pick disease type C (NPC), an ultra-rare and progressive neurodegenerative disease

MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adults and pediatric patients 2 years of age and older

Zevra receives rare pediatric disease priority review voucher in conjunction with approval

Company launches AmplifyAssist™ patient support program

Conference call and webcast set for 8:00 a.m. EDT on Monday, Sept. 23, 2024

CELEBRATION, Fla., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage rare disease therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has approved MIPLYFFA™ (MY-PLY-FAH) (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC). The first NPC drug approved by the FDA, MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older. In addition, the Company announced that it has received a rare pediatric disease priority review voucher (PRV) in conjunction with the approval.

“NPC is an ultra-rare, relentlessly progressive, degenerative, and fatal disease for which there were no FDA-approved treatment options until today,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra Therapeutics, Inc. “The approval of MIPLYFFA is a monumental milestone for NPC patients and their family members in the U.S. We are immensely grateful for the unwavering support we have received over the years from the families and individuals impacted by NPC as well as the collaborative efforts of advocacy groups, researchers, and clinicians.”

In the U.S., it is estimated that 900 people are living with NPC, of which approximately one-third have been diagnosed with this ultra-rare, relentlessly progressive, and fatal neurodegenerative disease.ⁱ Both children and adults can be affected by NPC with varying clinical presentations. Characteristically, those living with NPC experience progressive physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills.

“Until now, those living with NPC have had no FDA-approved treatment to combat this devastating disease,” said Laurie Turner, Family Services Manager, National Niemann-Pick Disease Foundation (NNPDF). “For more than 30 years, NNPDF and the community have been working to find treatments for NPC, and we are grateful for the diligence and commitment of the researchers, clinicians, families and Zevra for making this approval possible.”

“The FDA approval of MIPLYFFA marks a significant moment for those living with NPC and the global NPC community,” stated Dr. Elizabeth Berry-Kravis, Professor, Departments of Pediatrics, Neurological Sciences, Anatomy and Cell Biology, Director, RUSH Pediatric Neurosciences F.A.S.T. Center for Translational Research at Rush University Medical Center, “Effective management of NPC requires multiple treatment options due to the complexity of the disease. Until today, there were no approved therapies in the U.S. for NPC. With this labeled indication, patients will now have more access to treatments to tackle this devastating disease.”

The approval of MIPLYFFA for the treatment of NPC is based on the totality of the data in the New Drug Application (NDA), which included additional evidence supporting trial endpoints, FDA-preferred analyses, and additional confirmatory evidence, both clinical and nonclinical. The safety and effectiveness of MIPLYFFA were studied in a 12-month multicenter, randomized, double-blind, placebo-controlled trial in patients with NPC between two and 19 years of age. In this trial, 76% of patients in the MIPLYFFA group and 81% of those in the placebo group received miglustat as part of their routine care. The effectiveness of MIPLYFFA was evaluated using the rescored 4-domain NPC Clinical Severity Scale (R4DNPCCSS). Results from this trial demonstrated:

• MIPLYFFA, in combination with miglustat, halted disease progression through 12 months of treatment, as demonstrated by a decrease of 0.2 points from baseline on the R4DNPCCSS compared to 1.9 points of progression for patients treated with miglustat alone.

Additional confirmatory evidence included data from a 48-month open-label extension study which suggested improved outcomes when compared to a matched National Institutes of Health NPC natural history cohort.

MIPLYFFA is administered orally, three times a day with or without food, with the exact dosage ranging from 47 mg to 124 mg dependent on body weight, by appropriate patients or caregivers with follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Full and Instructions for Use for information on the proper administration of MIPLYFFA.

Zevra will immediately initiate its launch activities for MIPLYFFA, which is expected to be commercially available in the U.S. in eight to 12 weeks.

Launch of AmplifyAssist™ — Comprehensive Support for Patients

Zevra is committed to assisting those whose lives are affected by NPC to overcome the barriers and challenges that may impact their treatment journey. The Company today launched AmplifyAssist, Zevra’s comprehensive patient support program. The mission of the program is to support the individual needs of eligible patients and those who care for them. Available resources include personalized insurance coverage education and support, copay and alternate funding identification assistance for eligible patients^, product needs, disease state information and therapy management counseling, and ongoing interactions to address barriers while facilitating timely prescription refills. Information about the program is available at MIPLYFFA.com or via telephone. The AmplifyAssist team can be reached toll-free at (888) 668-4198 from 8 a.m. CT to 6 p.m. CT Monday through Friday. Healthcare providers who want to submit prescriptions can visit MIPLYFFA.com to complete the prescription enrollment form that initiates the process for accessing the treatment.

Conference Call and Webcast Information

Zevra Therapeutics, Inc. will host a conference call and audio webcast at 8 a.m. ET on Monday, September 23, 2024, to discuss FDA approval of MIPLYFFA. A link to the audio webcast will be accessible via the Investor Relations section of the Company’s website, https://investors.zevra.com/. To join the meeting by conference call, use the dial-in information below:

(800) 267-6316 (U.S.)
+1 (203) 518- 9783 (International)
Conference ID: ZVRA0923

An archive of the webcast will be available for ninety (90) days beginning at approximately 9 a.m. ET, on September 23, 2024, at https://investors.zevra.com/.

About MIPLYFFA™ (arimoclomol)

MIPLYFFA (arimoclomol) increases the activation of the transcription factors EB (TFEB) and E3 (TFE3) resulting in the upregulation of coordinated lysosomal expression and regulation (CLEAR) genes. MIPLYFFA has also been shown to reduce unesterified cholesterol in the lysosomes of human NPC fibroblasts. The clinical significance of these findings is not fully understood. MIPLYFFA was granted Breakthrough Therapy designation, Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation by the FDA for the treatment of NPC. MIPLYFFA was further granted Orphan Medicinal Product designation by the European Medicines Agency (EMA) for the treatment of NPC.

INDICATIONS AND USAGE

MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions:

Hypersensitivity reactions such as urticaria and angioedema have been reported in patients treated with MIPLYFFA during Trial 1: two patients reported both urticaria and angioedema (6%) and one patient (3%) experienced urticaria alone within the first two months of treatment. Discontinue MIPLYFFA in patients who develop severe hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, stop MIPLYFFA and treat promptly. Monitor the patient until signs and symptoms resolve.

Embryofetal Toxicity:

MIPLYFFA may cause embryofetal harm when administered during pregnancy based on findings from animal reproduction studies. Advise pregnant females of the potential risk to the fetus and consider pregnancy planning and prevention for females of reproductive potential.

Increased Creatinine without Affecting Glomerular Function:
Across clinical trials of MIPLYFFA, mean increases in serum creatinine of 10% to 20% compared to baseline were reported. These increases occurred mostly in the first month of MIPLYFFA treatment and were not associated with changes in glomerular function.

During MIPLYFFA treatment, use alternative measures that are not based on creatinine to assess renal function. Increases in creatinine reversed upon MIPLYFFA discontinuation.

The most common adverse reactions in Trial 1 (≥15%) in MIPLYFFA-treated patients who also received miglustat were upper respiratory tract infection, diarrhea, and decreased weight.

Three (6%) of the MIPLYFFA-treated patients had the following adverse reactions that led to withdrawal from Trial 1: increased serum creatinine (one patient), and progressive urticaria and angioedema (two patients). Serious adverse reactions reported in MIPLYFFA-treated patients were hypersensitivity reactions including urticaria and angioedema.

To report SUSPECTED ADVERSE REACTIONS, contact Zevra Therapeutics, Inc. at toll-free phone 1-844-600-2237 or FDA at 1‑800-FDA-1088 or www.fda.gov/medwatch.

Drug Interaction(s):
Arimoclomol is an inhibitor of the organic cationic transporter 2 (OCT2) transporter and may increase the exposure of drugs that are OCT2 substrates. When MIPLYFFA is used concomitantly with OCT2 substrates, monitor for adverse reactions and reduce the dosage of the OCT2 substrate.

Use in Females and Males of Reproductive Potential:
Based on animal findings, MIPLYFFA may impair fertility and may increase post-implantation loss and reduce maternal, placental, and fetal weights.

Renal Impairment:
The recommended dosage of MIPLYFFA, in combination with miglustat, in patients with an eGFR ≥15 mL/minute to <50 mL/minute is lower than the recommended dosage (less frequent dosing) in patients with normal renal function.

MIPLYFFA capsules for oral use are available in the following strengths: 47 mg, 62 mg, 93 mg, and 124 mg.

About Niemann-Pick Disease Type C (NPC)

Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder characterized by an inability of the body to transport cholesterol and other lipids within the cell, leading to an accumulation of these substances in various cell types, including neurons. The disease is caused by mutations in the NPC1 or NPC2 genes, which are responsible for making the NPC1 and NPC2 lysosomal proteins. Both children and adults can be affected by NPC with varying clinical presentations. Those living with NPC can lose independence due to physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills. Disease diagnosis can often take years, with disease progression being irreversible and often leading to early mortality.

About Zevra Therapeutics, Inc.

Zevra Therapeutics, Inc. is a commercial-stage rare disease company combining science, data, and patient needs to create transformational therapies for diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community.

Expanded access programs are made available by Zevra Therapeutics, Inc. and its affiliates and are subject to the Company's Expanded Access Program (EAP) policy, as published on its website. Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician's discretion.

For more information, please visit www.zevra.com or follow us on X (formerly Twitter) and LinkedIn.

Cautionary Note Concerning Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding upcoming events or Zevra’s participation at such events. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2023, Zevra’s quarterly report for the three months ended June 30, 2024, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.
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1. Burton et.al., Molecular Genetics and Metabolism Volume 134, Issues 1–2, September–October 2021, Pages 182-187

Zevra Contact

Nichol Ochsner
+1 (732) 754-2545
nochsner@zevra.com

Russo Partners Contacts

David Schull
+1 (858) 717-2310
david.schull@russopartnersllc.com

Ignacio Guerrero-Ros, Ph.D.
+1 (646) 942-5604
ignacio.guerrero-ros@russopartnersllc.com 

The potential addressable market opportunity for ONP-002 includes an estimated 69 million concussions globally

August 08, 2024 08:45 ET| Source: Oragenics

SARASOTA, Fla., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion successfully completed a study that indicates ONP-002 does not cause cardiotoxicity. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial, the U.S. Food and Drug Administration (FDA) requires pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations.

Oragenics conducted hERG (human Ether-à-go-go-Related Gene) ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories. Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar. Based on Phase I ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia.

“We are pleased that ONP-002 has demonstrated a strong safety margin for the heart, enabling us to continue planning the Phase II trials. Safety remains our top priority, and we will continuously monitor all safety parameters throughout the trials,” stated Michael Redmond, President of Oragenics. “Furthermore, a Phase II study is being planned to further evaluate the drug in concussed patients.”

Concussion is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. Common causes of concussions include falls, motor vehicle accidents, and contact sports. According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds $40.6 billion. This includes $10.1 billion covered by private insurance, $22.5 billion by Medicare, and $8 billion by Medicaid. Concussions have been associated with other neurological disorders, such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Additionally, post-concussion symptoms, which can occur in up to 20% of affected individuals, are linked to long-term disability.

About Oragenics
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.

Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug-device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com

Investor Relations:
Rich Cockrell
CG Capital
404-736-3838
ogen@cg.capital

July 18, 2024—Ichor Vascular Inc. announced it has received FDA 510(k) clearance for the company’s 7-F peripheral reperfusion system, which is indicated for the nonsurgical removal of emboli and thrombi from venous blood vessels.

According to Ichor Vascular, its percutaneous arterial and venous peripheral solutions are designed to replicate simple, proven mechanisms of action (compliant balloon sweeping, aspiration, and snaring) without the need for surgery, lytics, or capital equipment.

Additionally, it noted that the Ichor Vascular reperfusion system provides interventional versatility and simplicity that fit into current workflows and treatment algorithms for peripheral thrombectomy.

Postmarket data will be focused on improving time to reperfusion; reductions in blood loss compared to vacuum pump-based systems; reductions in distal embolization; eliminating vessel and valve damage; and reducing or eliminating surgical and drug complications by embracing a straightforward endovascular approach, advised the company.

“We essentially replicated the parameters of a successful surgical thrombectomy; we simply made it an endovascular procedure,” commented Tim Blair, CEO of Ichor Vascular, in the company’s press release. “Physicians will be able to treat 3- to 10-mm arterial anatomy across a wide range of morphology—from acute clot, acute-on-chronic clot, and embolic material to lengthy organized thrombus—with a single packaged device. Open the kit and go.”